HELENA, Montana — States frustrated by private laboratories' increasingly long turnarounds for COVID-19 test results are scrambling to find ways to salvage their testing programs.
Montana said Wednesday that it is dropping Quest Diagnostics, one of the nation's largest diagnostic testing companies. The Secaucus, New Jersey-based company had done all the state's surveillance COVID-19 testing — drive-thru testing that moves from community to community to help track COVID's spread. But it told state officials last week that it was at capacity and would be unable to accommodate more tests for two or three weeks.
"We don't want to be left high and dry again in the event that the national demand for testing puts a state like ours onto the back burner," Democratic Gov. Steve Bullock said.
Instead, he said, the state is enlisting Montana State University's lab to process up to 500 tests a day and has finalized a contract with a new private lab, North Carolina-based Mako Medical, for an additional 1,000 tests a day.
California, Florida and other states that work with Quest have started experimenting with separate, expedited lines for people who have symptoms of the disease. Some states are contracting with other private labs. And CVS, which uses Quest for COVID tests at many of its sites nationwide, said it is looking for more lab partners to reduce wait times for results.
Quest, LabCorp and other private labs have struggled to expand quickly enough to meet demand as states expand their testing and cases soar across the nation. Officials for Quest, which handles about 130,000 tests daily in 20 laboratories, said its ability to expand has been limited by a global shortage of the machines and chemical reagents needed to perform COVID-19 testing.
On Monday, Quest announced that turnaround times had slowed to a week or more, up from three or four days in June. It also said some patients may face wait times of up to two weeks. Quest officials warned this week that could get worse as flu season starts this fall.
A wait of a week or more for results can make the tests moot, since few people, especially those without symptoms, are likely to remain quarantined that long — and if the test comes back positive, they may already be over the disease.
"We are working with a number of different organizations to provide as much testing as possible, but some of these constraints are out of our control," Quest spokesperson Wendy Bost said. "We've taken the step of asking our clients to modulate the testing demand by focusing on patients who are most in need at this time."
The Trump administration is also trying to speed up turnaround times by allowing some labs to use an approach known as pooled testing, which combines samples from multiple people and then screens the individual samples only if the batch comes back positive for the virus. But public health experts worry it may be too late to try pool testing, as the percentage of positive results has doubled or tripled in many parts of the country.
States grappling with rising caseloads amid the testing slowdown have grown exasperated. Colorado Gov. Jared Polis, a Democrat, told NBC's "Meet the Press" on Sunday that it can take up to nine days to get test results from Quest and LabCorp.
"Almost useless from an epidemiological or even diagnostic perspective," Polis said.
LabCorp officials say turnaround times are improving.
Those who worry they have COVID-19 are also frustrated. In San Francisco, Mark Mackler, a 71-year-old retired law librarian, went with his husband to get a free test at the Bernal Heights Recreation Center on June 28 for peace of mind. He expected results after five days, but the test, processed by Quest, took 16 days — it came back negative for COVID-19.
"I was just annoyed and concerned the taxpayers were getting taken for a ride on something expensive and useless to a lot of people," Mackler said.
In California, Democratic Gov. Gavin Newsom acknowledged Quest's slow turnaround times at a press conference Wednesday.
"It's rather preposterous that you get a test and 13, 14 days later you get the results," Newsom said, adding that the results in those cases are "utterly meaningless."
But, he added, "We're not going to abandon Quest. We need them as one of our partners."
California is partnering with other private and university labs to expedite test results, ramping up from 2,000 tests a day early in the pandemic to an average of more than 125,000 a day, Newsom said. Test results now average between five and seven days, and state health officials said they have told all labs to first process from high-risk groups, such as people with COVID symptoms, those in hospitals and those in long-term care facilities.
In Florida, Quest has performed more than 600,000 COVID tests, the most of any lab. After reports of labs taking seven to 10 days to turn around test results, health officials created special lanes at four testing sites for symptomatic people that will allow them to receive their results faster. If that program goes well, Florida officials said, it will be expanded to all 50 state-run sites.
Pennsylvania health officials plan to cut the number of drive-thru testing sites it runs with Quest and Walmart from 19 to 13. They also are relocating some site locations that have seen low testing numbers to more populated areas with higher positivity rates.
Weeklong waits for COVID tests are not the norm everywhere. In Texas, state-run mobile test sites are providing results within two to three days because the state has "spread the load" of testing among many lab companies, said Seth Christensen, spokesperson for the Texas Division of Emergency Management. The state does not use Quest but instead uses more than 10 other lab companies, including LabCorp, another of the nation's largest lab chains.
Return times vary widely by company. LabCorp said turnaround time for outpatient test results improved to three to five days this week from four to six last week. BioReference Laboratories, another big lab chain, said it has improved turnaround time from about six days in June to three or fewer this month. Walmart, which has used Quest and eTrueNorth for more than 150,000 COVID tests, said on its website that Quest results take a week, compared with three to five days with eTrueNorth.
In Montana, the Quest delays forced the state to pause its community testing program, which aims to serve as an alert system for how the virus is spreading. Officials plan to resume next week once it has Montana State and the North Carolina lab in place, Bullock said.
Montana, with 2,813 confirmed cases as of Tuesday, has one of the lowest per-capita rates in the nation. But the average daily caseload in the state has risen 112% in the past two weeks — the country's third-highest rate increase, according to an analysis by NPR.
Quest started running the state's mass-testing events in the spring, with promised turnaround times of two or three days. But that started to stretch into a week or longer, Bullock said.
Bost, the Quest spokesperson, described the delay in community testing as a temporary agreement with state officials.
"We mutually agreed to postpone some community events for the general population in order to ensure testing is available for the patients who are most in need, such as those who are symptomatic and ill in the hospital," she said.
Montana hasn't canceled its contract with Quest, but state officials said they are unsure whether the state will resume using the company.
"We can meet the need that we have in Montana with these two solutions," Bullock said, referring to the Montana State University and North Carolina laboratories. "But that doesn't mean that we won't be returning to Quest at some point."
KHN correspondent Rachel Bluth contributed to this report.
Research already shows that germicidal UV can effectively inactivate airborne microbes that transmit measles, tuberculosis and SARS-CoV-1, a close relative of the novel coronavirus.
This article was first published on Wednesday, July 22, 2020 in Kaiser Health News.
High up near the ceiling, in the dining room of his Seattle-area restaurant, Musa Firat recently installed a "killing zone" — a place where swaths of invisible electromagnetic energy penetrate the air, ready to disarm the coronavirus and other dangerous pathogens that drift upward in tiny, airborne particles.
Firat's new system draws on a century-old technology forfending off infectious diseases: Energetic waves of ultraviolet light — known as germicidal UV, or GUV — are delivered in the right dose to wipe out viruses, bacteria and other microorganisms.
Research already shows that germicidal UV can effectively inactivate airborne microbes that transmit measles, tuberculosis and SARS-CoV-1, a close relative of the novel coronavirus. Now, with concern mounting that the coronavirus that causes COVID-19 may be easily transmittedthrough microscopic floating particles known as aerosols, some researchers and physicians hope the technology can be recruited yet again to help disinfect high-risk indoor settings.
"I thought it was a great idea, and I want my customers to be safe," said Firat whose casual eatery, Marlaina's Mediterranean Kitchen, is 20 minutes south of downtown Seattle.
As the U.S. grapples with how to interrupt the spread of the highly infectious virus, UV is being used to decontaminate surfaces on public transit and in hospitals where infectious droplets may have landed, as well as to disinfectN95 masks for reuse. But so far using this technology to provide continuous air disinfection has remained outside of most mainstream, policy-setting conversations about the coronavirus.
Experts attribute this to a combination of factors: misconceptions about UV's safety, a lack of public awareness and technical know-how, concerns about the costs of installing the technology, and a general reluctance to consider the role of aerosols in the spread of the coronavirus.
Aerosols are microdroplets expelled when someone exhales, speaks or coughs. Unlike the larger and heavier respiratory droplets that fall quickly to the ground, aerosols can linger in the air a long time and travel through indoor spaces. When someone catches a virus this way, the process is called "airborne transmission."
It's already recognized that the coronavirus can spread by means of aerosols during medical procedures, which is why healthcare workers are advised to wear respirators, such as N95 masks, that filter out these tiny particles. Yet there is still considerable debate over how likely the virus is to spread in other settings via aerosols.
Recently, the question of airborne transmission gained new urgency when a group of 239 scientistscalled on the World Health Organization to take the threat of infectious aerosols more seriously, arguing that the "lack of clear recommendations on the control measures against the airborne virus will have significant consequences."
WHO officials conceded that more research is needed but maintained that most infections do not happen this way.
As the science continues to evolve, UV could emerge as an attractive safeguard against airborne transmission — one with a track record against pathogens — that can be deployed to reduce the risk of infectious aerosols accumulating in indoor settings such as schools and businesses.
Welcome to the 'Killing Zone'
At Marlaina's restaurant, there are just two visible clues of the new UV disinfection system — a subtle glow of blue light above the black grates of the drop ceiling, and a hand-chalked sign at the door, proudly announcing to diners: "Coronavirus Disinfected Here!"
The system was installed while the restaurant was closed during Washington state's lockdown. The setup is known as "upper-room germicidal UV" because the UV fixtures are mounted high and angled away from humans below.
Ceiling fans circulate the air, eventually pushing any suspended viral particles that have accumulated in the dining space through the grated drop ceiling, to the area where UV lights, positioned horizontally, blast them with radiant energy.
The inspiration and technical assistance for Marlaina's owner came from customer Bruce Davidson, a pulmonary physician who was Philadelphia's "tuberculosis czar" in the mid-'90s. Back then, the U.S. was grappling with a new outbreak of TB that included strains resistant to existing drugs.
"Preventing transmission was the most important part, because we had no drugs, no vaccine," recalled Davidson, who now lives outside Seattle. UV light proved to be a key strategy back then, and Davidson thinks it can help again: "It really ought to be in most indoor public spaces now."
To demonstrate the concept, Davidson lit a cigar inside Marlaina's and showed how the smoke danced upward, collecting in the ceiling space with the UV fixtures.
"If somebody has undetected coronavirus and doesn't eat with a mask and is talking and so on, the vast majority of their particles are going to get pulled up there into the killing zone and circulate and bounce around," Davidson said. "Statistically, the risk to other people is going to be very low."
Research shows close to 90% of airborne particles from a previous coronavirus (SARS-CoV-1) can be inactivated in about 16 seconds when exposed to the same strength of UV as in the restaurant's ceiling. Other viruses, such as the adenovirus, are more resistant and require a higher dose of UV.
"Although it's not perfect, it probably offers the best solution for direct air disinfection" in the current pandemic, said David Sliney, a faculty member at Johns Hopkins University and longtime researcher on germicidal UV.
When used with proper ventilation, upper-room GUV is about 80% effective against the spread of airborne tuberculosis,according to several studies. This is equivalent to replacing the air in a room up to 24 times an hour.
But widespread adoption of UV systems could be an uphill battle, Sliney said, because in the U.S., interest in using UV for air disinfection has waned in recent decades as scientists focused their attention on powerful vaccines and drugs to deal with infectious diseases.
Understanding Aerosols and Airborne Transmission
UV can be a powerful weapon against an airborne virus, but it can go only so far toward preventing infection. People can still get sick from the larger, heavier droplets ejected via coughs and sneezes. They can directly inhale those droplets or touch a surface contaminated with them, and then touch their eyes, nose or mouth.
UV also does not prevent someone from being exposed to infectious aerosols that have just emerged from an infected person — and are lingering quite near his or her body — what researcher Richard Corsi called the "near field."
"In that scenario, you're inhaling a very concentrated cloud of these tiny particles that you can't see," said Corsi, dean of the Maseeh College of Engineering & Computer Science at Portland State University. "You're getting a pretty significant dose in your respiratory system."
So, even if there is upper-room UV in a building, Corsi said, face masks and social distancing are still necessary to block larger respiratory droplets and remove some of the aerosols in the near field. But Corsi said there's now enough evidenceto show that coronavirus aerosols can hang in the air and spread throughout a room ("the far field"), and it's time to take that airborne spread seriously.
One example of far-field transmission is documented in a study of a restaurant in China at which some diners seated at neighboring tables contracted the COVID-19 virus despite never coming into close contact with the "index case-patient." Another piece of evidencecame from a March 10 choir practice in Mount Vernon, Washington, after which the majority of singers contracted the coronavirus, even though members of the group took precautions to use hand sanitizer and avoid hugs and handshakes.
In their letter to WHO, scientists note that the coronavirus that causes MERS can spread through aerosols, and "there is every reason to expect that [the COVID virus] behaves similarly."
Understanding the Technology and Safety
Germicidal UV harnesses a portion of the electromagnetic spectrum that contains short waves of radiant energy, called UV-C. This wavelength is further away from the visible spectrum than other forms of UV light.
Think of it as giving the virus a lethal sunburn.
"We have very little practical experience to show how effective it can be [in a pandemic] since it's been out of use in this country and in Western Europe," said Sliney of Johns Hopkins, who chairs a committee with the Illuminating Engineering Society, which recently released new guidance on GUV.
Sliney recommends installing UV in big-box stores, restaurants and grocery stores, which typically have high ceilings. "There needs to be vertical air exchange," he said, as with ceiling fans, so "it's not just sterilizing the air in the upper space of the room."
"No one doubts the efficacy of germicidal UV in killing small microorganisms and pathogens. I think the bigger controversy, if there is any, is misperceptions around safety," said Dr. Edward Nardell, a professor at Harvard Medical School who researches GUV.
Low-dose germicidal UV can damage the eyes and skin, but Nardell said those risks can be avoided by following the appropriate guidelines. While international guidelines warn against directly exposing humans to UV-C, the risks of skin cancer are considered negligible, especially compared with longer wavelengths of UV that can penetrate more deeply.
Could UV Make a Comeback?
With interest in UV climbing, there is concern about shoddy products on the market and exaggerated claims about their effectiveness against the virus, said Jim Malley, a professor at the University of New Hampshire who studies public health and disinfection.
Consumers should be wary of marketing claims about "UV wands" that can be waved quickly over surfaces or special "portals" that people walk through, he said, because those are probably not correctly calibrated to inactivate the virus and could be dangerous.
Malley said he does not think there's much of a viable market for upper-room GUV outside healthcare settings, but he supports installing the technology in the most high-risk settings, such as meatpacking plants and nursing facilities.
"My gut feeling is we should do anything we can in those places, because we have a horrendous fatality record" with the coronavirus, he said.
At Marlaina's restaurant, the installation was relatively straightforward.
The owner, Firat, purchased four UV fixtures (at $165 each), hired an electrician to install the fans and bought black gridded plastic panels to enclose the ceiling space where the UV is mounted.
Firat still encourages his customers to wear masks and maintain social distance. But he said the UV has become part of the ambiance.
"It's more modern and clean, and the response is great, absolutely great," he said.
This story is part of a partnership that includes NPR and Kaiser Health News.
NIH researchers are trying to get a better sense of how socioeconomic factors like income, family structure, diet and access to health care affect COVID infections and outcomes.
This article was first published on Tuesday, July 21, 2020 in Kaiser Health News.
While the disproportionate impact of COVID-19 on Black and Hispanic Americans is no secret, federal officials have launched studies of the disparity that they hope will better prepare the country for the next great epidemic.
The National Institutes of Health began the ambitious “All of Us” research project in 2018 with the goal of enrolling at least a million people in the world’s most diverse health database. Officials saw it as an antidote to medical research that traditionally has skewed heavily white, well-off and male.
Amid a wavering federal response that has allowed staggering levels of disease to sweep the country, the NIH program is a potential bright spot. About 350,000 people have consented to be part of the project, and more than 270,000 of them have shared their electronic health records and submitted blood or DNA samples. Of the latter, more than half are members of minority groups, and 81% are from traditionally underrepresented groups in terms of socioeconomic background, sexual identity or other categories, according to NIH.
NIH researchers are trying to get a better sense of how socioeconomic factors like income, family structure, diet and access to health care affect COVID infections and outcomes. The hope is to come up with insights that will better prepare the country, especially its Black and Hispanic communities, for the next pandemic.
The participants’ blood and DNA samples, and access to their electronic health records, offer researchers a trove of data about the pandemic’s effect on minorities. As part of the program, NIH has promised to return research results to all participants in plain language.
In a sense, “All of Us was designed for COVID-19,” said Hugo Campos, a program participant and ambassador who lives in Oakland, California. “If we can’t deliver value to participants now, we might as well just forget it.”
The NIH constructed All of Us with the expectation “that something like COVID-19 could come,” said Josh Denny, the project’s chief executive officer.
All of Us, started by NIH Director Francis Collins under President Barack Obama, aims to answer questions that will allow health care to be tailored to individuals based on their unique genetics, environmental exposures, socioeconomics and other determinants of health. Now, scientists are tapping into its database to ask how factors like isolation, mental health, insurance coverage and work status affect COVID-19 infections and outcomes.
The first NIH study employing the database, already underway, will conduct antibody testing on the blood of at least 10,000 program volunteers, starting with those who joined most recently and going back in time to determine when COVID-19 entered the U.S.
Beginning in early May, All of Us has distributed monthly surveys to participants, via email or text, inquiring about stress levels associated with social distancing, work habits and environments, mask-wearing and hand-washing. It’s also asking whether participants have had COVID-19 symptoms or have been tested, and includes queries about insurance coverage, drug use and mental health status.
Another study will provide researchers with de-identified data, including antibody test results and digital health information, to study whether symptoms vary among people who have tested positive for COVID-19 depending on their ethnicity, socioeconomic status and other categories.
Federal data shows that Black seniors have been four times as likely, and Latino seniors twice as likely, to be hospitalized with COVID-19 as white seniors. It’s understood that structural racism and socioeconomic differences contribute to this gap, but All of Us hopes to help pinpoint reasons and potential solutions.
The minorities who’ve experienced the poorest COVID-19 outcomes are well represented in the All of Us research cohort, said Denny. “We will really be able to layer a number of kinds of information on what’s happening to different populations and try to drive at some of that ‘Why?’ Are there genetic differences, differences in prior medical history, timing of testing?”
One of the precepts of All of Us is to share the results of its studies with participants as well as involve them in study designs. NIH hired leaders of churches, community organizations and other grassroots groups to spread the word on the program.
The largely Spanish-speaking clientele at San Ysidro Health, a federally qualified health center based in San Diego, has been eager to participate in the COVID-19 research, said Fatima Muñoz, the health system’s director of research and health promotion. Most of the All of Us participants she helped recruit prefer in-person interactions, but they are adapting to the pandemic’s online requirements, she said.
“There is historically a well-founded mistrust amongst some diverse populations and communities of color in biomedical research,” said Denny. “We can’t control history but can try to engage authentically going forward.”
The Black Lives Matter protest movement has pushed the program’s leaders to do more for its diverse participants, Denny said.
“It’s caused us to think more of how we can promote diversity in researchers, which had not been as much of a focus,” he said. “It has heightened some of the urgency and importance of what we’re doing. It’s a great call to action.”
The All of Us program is funded with $1.5 billion over 10 years through the 21st Century Cures Act of 2016. Denny said he expects results from the antibody testing, an $850,000 project that was contracted out to Quest Diagnostics, to be published this year, with insights from the surveys published after that.
The All of Us database provides unparalleled access to information on research groups whose level of harm by the virus would have been hard to predict, said Dr. Elizabeth Cohn, a professor of nursing at Hunter College in New York. Cohn is a community engagement lead for All of Us and chairs its publications committee.
“This is the demonstration of why we built this platform,” said Cohn. “This is a big moment for All of Us because this is what it was built to do.”
The pandemic has made it even clearer why it’s necessary to have a multicultural base for health research, said Dr. Randall Morgan, executive director of the W. Montague Cobb/National Medical Association Health Institute, an All of Us partner.
“When we get to 1 million, we hope to still have that level of representation,” he said.
DENVER — Dr. Michelle Barron, medical director of infection prevention and control at UCHealth University of Colorado Hospital, received an unusual call last month from the microbiology lab: confirmation of the third case this year of trench fever, a rare condition transmitted by body lice that plagued soldiers during World War I.
Barron's epidemiological training kicked in.
"Two is always an outbreak, and then when we found a third — OK, we clearly have something going on," Barron recalled thinking.
Barron, who said she'd never before seen a case in her 20 years here, contacted state public health officials, who issued an advisory Thursday and said a fourth person with a suspected case had been identified. They asked physicians to be on the lookout for additional cases.
Trench fever is characterized by relapsing fever, bone pain (particularly in the shins), headache, nausea, vomiting and malaise. Some of those infected can develop skin lesions or a life-threatening infection of their heart valves.
The condition is caused by the bacterium Bartonella quintana, a close relative of the bug that causes cat scratch fever. Colonies of it live in the digestive systems of body lice and are excreted in their feces. The bugs can enter the body through a scratch in the skin or through the eyes or nose. Dried lice feces can be infectious for up to 12 months.
Trench fever is most commonly diagnosed among people experiencing homelessness or living in conditions where good hygiene is difficult. Those with compromised immune systems are particularly at risk.
Public health officials are trying to find a common thread among the four cases identified so far in Colorado. They occurred months apart, and the patients appear to have no connection other than having been homeless in the Denver area.
Other cases of the disease may have been overlooked. This outbreak comes, after all, at a time when much attention is being diverted to the coronavirus pandemic. But the economic fallout of that crisis could be fueling the outbreak of an illness that thrives on hardship.
Trench fever can be an easy diagnosis to miss, Barron said. Patients often have other health problems that could explain their symptoms, and doctors will try to rule out the more common causes before considering a rare one.
Moreover, the bacteria grow very slowly in lab cultures — it can take up to 21 days, and labs usually discard cultures after seven days. Barron said the bacteria in two of the confirmed cases grew just before the cell cultures were due to be thrown out.
Doctors will often treat the symptoms of a disease like trench fever with antibiotics. If the patient heals, it's possible no tests will be pursued to determine the organism causing the illness, said Dr.Kristy Murray, an infectious disease specialist with Baylor College of Medicine and Texas Children's Hospital in Houston.
"With this particular disease, unless you work in a setting where you're with the homeless all the time, you're not thinking about it or looking for it," she said. "It is very rare."
Nonetheless, in recent years, outbreaks have occurred in San Francisco and Seattlehomeless camps.
Barry Pittendrigh, a Michigan State University entomologist who was part of an international collaborative studying the lice that cause trench fever, said head lice can also carry the bacteria, but their immune systems are strong enough to keep it in check. Body lice live in clothing, coming on and off to feed on the body. Their immune systems aren't as strong, he said, so the bacteria can flourish.
"We see scenarios when social crises are occurring — wars, economic downturn, displacement of people — when there is this chance that we'll have problems around hygiene that, in turn, these louse populations take off and you get these diseases," Pittendrigh said.
A spike in body lice occurred during the 2008 recession, he said, and before that, during the Great Depression and the two world wars. The current economic and health disruption caused by the COVID-19 pandemic could lead to another increase.
As public health agencies struggle with the coronavirus, fewer resources are left to track down outbreaks of other infectious diseases.
Colorado is committed to battling both issues, said state health department spokesperson Deanna Herbert. "We are continuing to grow the COVID-19 response staff, which allows us to balance other outbreaks and needs with responding to the global pandemic," she wrote in an email. "Scaling to the size we have is a tremendous undertaking, but we have a staff that is absolutely committed to being as responsive as possible to the needs of all Coloradans."
Murray said an outbreak often can be interrupted with outreach to homeless shelters and other groups that provide services to those living on the street. Mobile showers or offering to launder or replace their clothes can help. Body lice can be killed by washing and drying clothes at high temperatures — at least 130 degrees Fahrenheit.
The pesticide permethrin can also be used to treat clothing, bedding and backpacks to prevent lice infestation. Most people don't need to worry, though: According to the federal Centers for Disease Control and Prevention, infestation is unlikely to persist on anyone who bathes regularly and switches to clean clothes and bedding every week.
Still, trench fever has been considered a reemerging disease since the 1990s.
"Old infectious diseases always still have the potential to come back," Barron said. "Even though we live in a society that we consider very modern and very safe on so many levels, these organisms, at the end of the day, have been here longer than us and plan to survive."
By extending the time frame to sign up for COBRA coverage, people have at least 120 days to decide whether they want to elect COBRA, and possibly longer depending on when they lost their jobs.
This article was first published on Monday, July 20, 2020 in Kaiser Health News.
People who've been laid off or furloughed from their jobs now have significantly more time to decide whether to hang on to their employer-sponsored health insurance, according to a recent federal rule.
Under the federal law known as COBRA, people who lose their job-based coverage because of a layoff or a reduction in their hours generally have 60 days to decide whether to continue their health insurance. But under the new rule, that clock doesn't start ticking until the end of the COVID-19 "outbreak period," which started March 1 and continues for 60 days after the COVID-19 national emergency ends. That end date hasn't been determined yet.
By extending the time frame to sign up for COBRA coverage, people have at least 120 days to decide whether they want to elect COBRA, and possibly longer depending on when they lost their jobs.
Take the example of someone who was laid off in April, and imagine that the national emergency ends Aug. 31. Sixty days after that date takes the person to the end of October. Then the regular 60-day COBRA election period would start after that. So, under this example, someone whose employer coverage ended at the beginning of May could have until the end of December to make a decision about whether to sign up for COBRA, with coverage retroactive to the beginning of May.
Some health policy experts question the usefulness of the change, given how expensive COBRA coverage can be for consumers, and how limited its reach: It isn't an option for people who are uninsured or self-employed or who work for small companies.
"For ideological reasons, this administration can't do anything to expand on the Affordable Care Act's safety net," said Sabrina Corlette, a research professor at Georgetown University's Center on Health Insurance Reforms. "So they're using these other vehicles. But it's really a fig leaf. It doesn't do much to actually help people."
What does this rule change mean for workers? If you have lost your job, here are some things to consider.
Playing a Waiting Game
Under the new rule, workers can keep their COBRA options open far longer than before. It's always been the case that people could take a wait-and-see approach to signing up for COBRA during the first 60 days after losing their coverage. If they needed care during that time, they could elect COBRA, pay the back premiums and continue their coverage. But if they didn't need care during that time, they could save a chunk of money on premiums before opting for other coverage to kick in after the 60-day period.
Now, people have even more time to wait and see. Under the rule, once the administration declares the national emergency over, laid-off workers would get 120 days to decide whether to purchase their job-based insurance — 60 days under the new rule and the regular 60 days allowed as part of the COBRA law.
"It becomes a long-term unpaid insurance policy," said Jason Levitis, a nonresident fellow at the Center for Health Policy at the Brookings Institution. "There's no reason to enroll until something bad happens."
This is not without risk, consumer advocates point out. Someone who has a serious medical emergency — a car accident or a stroke — might not be able to process their COBRA paperwork before they need medical care.
Waiting too long could also affect people's ability to sign up for other coverage. When people lose job-based coverage, it triggers a special enrollment period that allows them to sign up for new coverage on their state health insurance marketplace for up to 60 days afterward.
"You could miss your opportunity to enroll in the [insurance] exchange" created under the Affordable Care Act, said Katy Johnson, senior counsel for health policy at the American Benefits Council, an employer advocacy group.
Don't Count on the Boss to Clue You In
Employers are not mandated to tell people promptly about their eligibility for COBRA. The same federal rule that gives workers more time to sign up for COBRA also pushes back the notification requirements for employers.
"Once an employer lays you off, they don't have to notify you that you're eligible for COBRA until after the emergency period," said Karen Pollitz, a senior fellow at KFF, the Kaiser Family Foundation. (KHN is an editorially independent program of the foundation.)
For many employers, especially large ones that outsource their benefits administration, notifications are routine and are continuing despite the federal change, said Alan Silver, a senior director at benefits consultant Willis Towers Watson. However, for smaller companies with fewer than 200 workers, getting the information out might be an issue, Silver said.
Costs Can Be Jaw-Dropping
Opting for COBRA is expensive because workers have to pay both their portion of the premium and their employer's share, plus a 2% administrative fee. A 48-year-old paid $599 a month on average for individual COBRA coverage last year, according to a KFF analysis.
In addition, if people elect COBRA several months after losing their coverage, they could be on the hook for thousands of dollars in back premiums.
The upside for former employees is that sticking with their previous employer's plan means they don't have to start from scratch paying down a new deductible on a new plan. Nor do they have to find new doctors, as often happens when people switch health plans and provider networks change.
Ten percent of workers laid off or furloughed because of the coronavirus pandemic reported they had COBRA coverage, according to a survey conducted last spring by the Commonwealth Fund.
The COBRA extension is available only to people who worked at firms with 20 or more employees and had job-sponsored coverage before being laid off or furloughed. If the company goes out of business, there's no health insurance to continue to buy.
Might Hospitals Step In to Pay Premiums?
Employers are typically not big fans of the program. Workers who elect COBRA are typically older and sicker than others with employer coverage, the KFF analysis found. They may have serious medical conditions that make them expensive to cover and raise employer costs.
Some policy experts are concerned that giving people more time to sign up for COBRA leaves the door open for hospitals or other providers to offer to pay sick patients' back premiums in order to increase their own payment above what they'd receive if someone were on Medicaid or uninsured. Doing so could be a boon for some patients but raise healthcare costs for employers, said Christopher Condeluci, a healthcare lawyer who does legal and policy work around the Affordable Care Act and ERISA issues.
"Employers are worried," said Pollitz. After getting laid off, "what if you're uninsured and you wind up in the hospital six months in, and then the hospital social worker learns you're eligible for COBRA and offers to pay your premium?"
Correction: This story was updated on July 20 at 9:40 a.m. ET to correct Jason Levitis' title. He is a nonresident fellow at the Center for Health Policy at the Brookings Institution.
In advance of an upcoming road trip with her elderly parents, Wendy Epstein's physician agreed it would be "prudent" for her and her kids to get tested for COVID-19.
Seeing the tests as a "medical need," the doctor said insurance would likely pay for them, with no out-of-pocket cost to Epstein. But her children's pediatrician said the test would count as a screening test — since the children were not showing symptoms — and she would probably have to foot the bill herself.
It made no sense. "That's two different responses for the exact same scenario," said Epstein, a health law professor at DePaul University in Chicago, who deferred the tests as she clarified the options.
Early on in the coronavirus pandemic — when scarce COVID testing was limited to those with serious symptoms or serious exposure — the government and insurers vowed that tests would be dispensed for free (with no copays, deductibles or other out-of-pocket expense) to ensure that those in need had ready access.
Now, those promises are being rolled back in ways that are creating turmoil for consumers, even as testing has become more plentiful and more people — like Epstein — are being advised to get them.
Late last month, the Trump administration issued guidance saying insurers had to waive patient costs only for "medically appropriate" tests "primarily intended for individualized diagnosis or treatment of COVID-19." It made clear that insurers do not have to fully waive cost sharing for screening tests, even when required for employees returning to work or for assisting in public health surveillance efforts.
Left unclear are situations like that faced by Epstein — and others who seek a test to clear a child for summer camp or day care. Public health officials have been unanimous in the opinion that widespread, readily available testing is crucial for getting businesses and schools open again, and society back on its feet.
But who should bear the costs of that testing — or a share of them — is an unresolved question.
Who pays when all employees are required to have a negative COVID test in order to return to work? Or if a factory tests workers every two weeks? Or just because someone wants to know for their own peace of mind?
The questions may be compounded in some cities and states where tests are widely available at clinics or drive-thru centers. In New York, CityMD clinics bill insurers $300 for the service, according to an explanation-of-benefits document given to KHN by a patient. The related charge from the lab that processed the test, according to the same patient's insurance statement, was $55. Most patients don't have to pay a share of those amounts.
The clinic has a partnership with the city allowing anyone who wants a test for the virus to get one. Still, no test is truly free, as labs bill insurers or submit for reimbursement from government programs.
Until a recent spike in virus cases created long delays in many areas, some other regions also took a test-everyone-who-wants-a-test approach. While that is one way to get a picture of where the virus is spreading, it can also become a cash cow providing income to clinics and labs, as residents seek multiple "free" tests after each potential exposure.
In an email, a spokesperson for CityMD would not say how much the clinic is reimbursed for testing. The clinics do not bill for lab testing, she wrote, referring questions about those costs to the laboratories that process them.
Insurers will be making judgment calls — likely on a case-by-case basis — about how they will handle cost sharing for screening tests under the new Trump administration guidance.
What is clear: Insurers have argued against requirements that they waive all cost sharing for workplace COVID testing, noting they don't do that for other screening efforts, such as drug-testing programs. For now, insurers will "continue to pay for tests recommended by a doctor," Kristine Grow, spokesperson for AHIP, an industry group, wrote in an email to KHN.
But AHIP also sent a clear signal that it would not embrace cost sharing waivers for workplace or public health screening efforts. Earlier this month, the organization lobbied federal lawmakers to include funding in the next stimulus package for public health surveillance and workplace testing programs — a cost estimated between $6 billion and $25 billion annually in an earlier study commissioned by the group.
The Evolving Rules for Free Testing
The coronavirus relief legislation passed by Congress in March, and April guidance from the Trump administration implementing it, agreed that patients should not be burdened with payments for COVID testing and treatment that is "medically appropriate."
But as the pandemic has evolved and grown, the definition of that term has both broadened and become fuzzier.
The Centers for Disease Control and Prevention says testing is appropriate for people who fall into five broad categories, including those with suspected exposure and those required to be tested for "purposes of public health surveillance," which it defines as checking for disease hot spots or trends.
"There's definitely a disconnect between what public health experts are recommending for testing and how it's going to be paid for," said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University.
And tension is mounting among insurers, employers and consumers over who should pay. While insurers say employers should cover the cost for back-to-work testing, many employers are struggling financially and may not be able to do so. At the same time, workers, especially those in lower-wage jobs, also cannot afford out-of-pocket costs for testing, particularly if it is required regularly.
Among those waiting to hear if their insurance will cover the test is Enna Allen of Glencoe, Illinois, who urged her au pair to get a test after the young woman traveled to New Orleans. She had been on a plane, after all, and New Orleans has its share of COVID cases.
"I wanted her to have a test before she returned to work with my kids," said Allen.
As Allen called around to find a testing site, she explained the test was needed for employment — for someone with no symptoms. After some effort, she found a clinic that, for $275, offered a 15-minute rapid test and said it would accept her au pair's insurance.
"I'm assuming they [the insurer] will cover it unless I get a bill weeks from now," said Allen, who said she would pay the bill for her employee if that happens.
There is also a great gray area in deciding who should qualify for free testing after "suspected" exposure. What is suspected exposure? Sharing a small office with an infected co-worker? Participating in a protest? Or simply living in or visiting the Sun Belt, where community spread is accelerating?
"If the au pair went to a clinic and said she was just in New Orleans, and the doctor said that's enough of a risk to order a test, even though she doesn't have symptoms, my read of the guidance is the health plan has to cover it 100%," said Corlette.
Yet a child who's mainly been sheltering at home who needs a test before being admitted to summer camp probably would not meet the definition.
"That's a different story because it's harder to argue there's been exposure or potential exposure," said Corlette. "At the end of the day, there's many ways to interpret the guidance."
Congressional Democrats have accused the Trump administration in its new guidance of "giving insurance companies loopholes instead of getting people the free testing they need."
Insurers, patients and politicians have locked horns before when screening tests were billed differently than those same tests for diagnostic purposes, since the boundary is often unclear. Under the Affordable Care Act, for example, colonoscopy screening for cancer is "free," meaning no patient copayment. But if a polyp is found, doctors sometimes code the procedure as a diagnostic test, which can lead to hundreds or even thousands of dollars in copayments.
While vital, testing is costly — or can be. Medicare reimburses up to $100 for the COVID test. On top of that, there may also be costs associated with the office or clinic visit. And the price is widely variable in the private market, according to a reportout last week by KFF, the Kaiser Family Foundation. Prices ranged from $20 to $850 for a single test. (KHN is an editorially independent program of the foundation.)
Media reports have shown tests average $100, but some labs bill insurers for thousands of dollars for each one.
Without a copay, many patients never learn how much their tests actually cost their insurers, which could lead to overuse.
Also, when patients are entirely shielded from the cost, test makers, labs and medical providers are more likely to seek price increases, said Heather Meade, a principal at Washington Council Ernst & Young.
In the end, consumers may still feel a resulting pinch in the form of higher premiums.
Wondering about the sharply different views of her doctors on whether her insurance would fully cover the cost, law professor Epstein called her insurer, which assured her the tests would be covered 100% at in-network providers with no copay or deductible, as long as they were coded correctly. The family will be tested soon, and it appears she's dodged a financial bullet. But Epstein cautioned in an email: "It's unclear to me how many insurers will maintain this policy."
In an email, Missouri Hospital Association spokesperson Dave Dillon called the move "a major disruption."
This article was first published on Friday, July 17, 2020 in Kaiser Health News.
Just as the number of people hospitalized for COVID-19 approaches new highs in some parts of the country, hospital data in Kansas and Missouri is suddenly incomplete or missing.
The Missouri Hospital Association reports that it no longer has access to the data it uses to guide state coronavirus mitigation efforts, and Kansas officials say their hospital data may be delayed.
The Trump administration this week directed hospitals to change how they report data to the federal government and how that data will be made available.
In an email, Missouri Hospital Association spokesperson Dave Dillon called the move “a major disruption.”
“All evidence suggests that Missouri’s numbers are headed in the wrong direction,” Dillon said. “And, for now, we will have very limited situational awareness. That’s all very bad news.”
The absence of the data will make it harder for health and public officials, as well as the general public, to understand how the virus is spreading.
“It’s hugely problematic,” said Dr. Karen Maddox, a public health researcher at Washington University in St. Louis. “The only way that we know where things are going up and where things are going down and where we need to be putting resources and where we need to be planning is because of those data.”
The White House instructed hospitals to report data to the Department of Health and Human Services through a new system created by a Pennsylvania-based company, TeleTracking, instead of to the Centers for Disease Control and Prevention.
The directive came as a surprise to hospitals, according to Kansas Hospital Association spokesperson Cindy Samuelson.
“From our perspective, these changes are big,” Samuelson said. “We only found out Tuesday, and we had to update the data by Wednesday night — so, less than 48 hours.”
The Missouri Hospital Association currently does not have access to the new HHS system, according to Dillon. He said the new system is also significantly different from the CDC system.
“The new datasets for reporting are not identical and in several cases are ill-defined,” Dillon said. “That has complicated hospitals’ efforts.”
In the wake of the announcement, the Missouri Department of Health and Senior Services posted a notice on its website this week that the daily and weekly updates on hospitals, including the numbers of people hospitalized and the availability of standard hospital beds, ICU beds and ventilators, would be temporarily halted.
“Missouri Hospital Association (MHA) and the State of Missouri will be unable to access critical hospitalization data during the transition. While we are working to collect interim data, situational awareness will be limited,” the notice on the department’s website says.
Dillon said the hospital association hopes to have “within a few days or weeks” hospital and coronavirus data that had been available through the CDC.
“However, in the short term, we’ll be very much in the dark,” Dillon said.
The hospital association will create an alternative reporting system for hospitals, according to Dillon, and plans to continue producing weekly reports, despite the uncertainty about data.
The Missouri Department of Health and Senior Services did not respond to inquiries regarding the data.
Kansas health officials are still able to access hospital and coronavirus data through the CDC and TeleTracking, according to Kansas Department of Health and Environment spokesperson Kristi Zears.
However, Kansas Hospital Association spokesperson Samuelson said the Kansas hospital data may be delayed if it is incomplete.
“If we’re not able to get a bulk of our members converted and uploading, I’m not sure we want to show it because then it will look like things have gotten a lot better,” Samuelson said.
The most recent data shows that as of July 12, 875 Missourians were hospitalized with COVID-19, among the highest reported numbers since an early May peak of 984. Kansas’ most recent data shows 1,393 people have been hospitalized with the disease.
The Trump administration said the reporting change was needed due to reporting delays and other problems with the CDC.
But the move has been widely criticized for being disruptive, especially as COVID-19 infection numbers reach new highs and hospitals in some areas of the country are reaching capacity.
“By now, we should have a foolproof, streamlined reporting system for COVID,” Maddox said. “And this change — midstream — is not going to do anything to help our ability to fight the disease.”
This story is part of a reporting partnership that includes KCUR, NPR and Kaiser Health News.
As public health workers scramble to summon enough of a workforce to address a once-in-a-generation pandemic, they're being pulled from normal mosquito-related tasks.
This article was first published on Thursday, July 16, 2020 in Kaiser Health News.
The U.S. public health system has been starved for decades and lacks the resources necessary to confront the worst health crisis in a century. Read the investigation from KHN and The Associated Press.
And in a normal year, the health department serving Ohio's Delaware County would be setting out more than 90 mosquito traps a week — black tubs of stagnant water with nets designed to ensnare the little buggers.
But this year, because of COVID-19, the mosquitoes will fly free.
The coronavirus has pulled the staffers away, so they haven't set a single trap yet this year, according to Dustin Kent, the program manager of the residential services unit. Even if workers had the time, the state lab that typically tests the insects for viruses that infect humans isn't able to take the samples because it also is too busy with COVID-19.
That means the surrounding community, just north of Columbus, Ohio, has to wait until potentially deadly mosquito-borne illnesses such as that caused by the West Nile virus sicken humans to find out if the insects are carrying disease.
"It's frustrating knowing that we can do a more preventative approach," Kent said. "But we're stuck reacting."
In Washtenaw County, Michigan, mosquito samples aren't being collected because the health department didn't have the staff or ability to hire and train summer interns who would typically perform the work. In Houston, a COVID-19 hot spot, a third of mosquito control staffers are working the COVID call center, stocking warehouses and preparing coronavirus testing materials. And across Florida, public health officials couldn't test chicken blood for exposure to mosquito-borne viruses — chickens get bitten by the insects, too, so that can serve as a warning — at the overwhelmed state lab until mid-June, a task that normally begins in the spring.
Monitoring and killing mosquitoes is a key public health task used to curb the spread of deadly disease. In recent years, top mosquito-borne illnesses have killed some 200 people annually in the U.S. But that relatively low toll is due in part to the efforts of public health departments to keep the spread at bay, unlike in other countries where hundreds of thousands are sickened and die each year.
"Mosquitoes are the biggest nuisance and pest on this planet. Hands down," said Ary Faraji, president of the American Mosquito Control Association, a nonprofit that supports public agencies dedicated to mosquito control. "They are responsible for more deaths than any other organism on this planet, including humans."
This is a physical job that can't be done by telecommuting from home. Keeping track of mosquitoes and the diseases they carry requires setting up traps, and searching backyards and commercial lots. Public health workers patrol irrigation ditches and overturn the backyard tires, plastic bins and garbage that can hold standing water where mosquitoes breed.
Around the U.S., more than half of public health departments combat mosquitoes. In some states, including Florida and California, specific departments are dedicated to tracking and preventing their spread. The goal is to find infected mosquito populations and kill them before they get to humans, or at least warn the community about their presence as mosquito-borne epidemics are happening more frequently nationally as temperatures rise.
But a joint investigationpublished this month by KHN and The Associated Press detailed how state and local public health departments across the U.S. have been starved for decades, leaving them underfunded and without adequate resources to confront the coronavirus pandemic, let alone perform the other work like mosquito control they are tasked to handle at the same time. Over 38,000 public health worker jobs have been lost since 2008. Per capita spending on local health departments has been cut by 18% since 2010.
So as public health workers scramble to summon enough of a workforce to address a once-in-a-generation pandemic, they're being pulled from normal mosquito-related tasks. The short staffing is leaving many localities — especially those without separate, dedicated control districts — flying blind on potential mosquito threats.
The Centers for Disease Control and Prevention has stepped in to help and is now running mosquito testing for at least nine states, including Florida, Arizona and the Carolinas, said Roxanne Connelly, entomology and ecology team lead for the CDC's National Center for Emerging and Zoonotic Infectious Diseases, as well as evaluating human blood samples for mosquito-borne disease for 40 states. Concerned about the disruptions, the CDC issued a policy brief with the Environmental Protection Agency on Thursday, stressing that mosquito prevention and spraying of insecticides was an essential service that needs to continue even in a national health emergency.
"Mosquitoes are still going to be around, and still causing diseases, no matter what sort of pandemic is going on," Connelly said.
Even with relatively low rates of disease, in part because of limited testing to measure the problem so far this year, there are worrying signs. Fourteen people in the Florida Keys have come down with locally acquired dengue, which can cause fever, severe body aches and vomiting. Massachusetts has found its first mosquito carrying Eastern equine encephalitis, which kills approximately a third of people infected, according to the CDC. West Nile virus has been found in mosquitoes, birds or other species in at least 18 states and has infected people in nine.
"This year it's more of a wild card; we're not getting the surveillance we'd normally get," said David Brown, the technical adviser for the American Mosquito Control Association.
The flu-like symptoms of diseases like West Nile — fever, body aches — especially worry Nina Dacko, who supervises the mosquito control program for Tarrant County Public Health in Fort Worth, Texas.
"I wonder which cases are going to be missed as everyone is going to expect COVID and then move on when they test negative," she said.
Budget cuts are coming in waves as tax shortfalls rock local health departments. Three municipalities in Texas, including Watauga, Saginaw and Lake Worth, haven't sent any mosquitoes in for testing this year — they don't have the time, or have lost staffing and money due to revenue shortfalls from COVID-19, Dacko said.
Smaller health departments appear to be bearing the brunt of the problems, North Carolina state public health entomologist Michael Doyle said in an email, as they have fewer staffers to fight the coronavirus. Some larger departments and programs — like those covering Houston, California's Central Valley or Maricopa County, Arizona — say they've been able to operate close to normal.
And while public health officials say small outdoor gatherings are safest when it comes to avoiding exposure to the coronavirus, some worry that the risk of acquiring mosquito-borne diseases could rise.
Labs swamped by COVID tests may be increasing that risk. Local governments often rely on the same public health labs to test whether mosquitoes are carrying diseases like West Nile, dengue or Eastern equine encephalitis that they do to test humans for infectious diseases, like COVID-19. As a result, much of the country is weeks behind where they would typically be in testing mosquitoes for the presence of dangerous diseases, Brown said.
Stopping mosquitoes requires getting information in real time. If a mosquito is carrying West Nile virus, "you want to know that today, not two weeks from now," Brown said.
When the COVID pandemic hit Salt Lake City, which has its own labs to test mosquitoes, the mosquito department shared its materials with the labs testing for COVID-19 and donated N95 masks that its staff uses when spraying mosquito-killing chemicals, according to Faraji, who is also the executive director of the Salt Lake City Mosquito Abatement District. Utah has done about 5% of the mosquito testing it would usually do by this point, he said.
"Our underlying concern is that one public health emergency doesn't lead into another," Faraji said.
Any grand fix to the hole in the nation's current mosquito netting is going to require some serious cash, Gridley-Smith said, to allow for dedicated staffing, instead of expecting public health workers to juggle it alongside multiple other programs.
The Southern Nevada Health District — which includes Las Vegas — doesn't have a dedicated mosquito department. From April to October, workers there trap, collect and test mosquitoes for viruses, said Vivek Raman, who oversees the efforts. The rest of the year, the same team is in charge of sanitation for all the area hotels and mobile home parks, including those on the casino strip. But restaurant inspections, permitting and sanitation help pay their way.
"One of the challenges with mosquitoes is they don't pay permit fees," he said.
For the CDC's Connelly, the lack of dollars is just another part of the boom-bust nature of funding for health departments and mosquito control programs nationally. Infusions of cash after bouts with mosquito-borne Zika or hurricanes aren't enough to fully maintain robust programs, she said, and they often have to start over when the next crisis hits.
Raman and his colleagues did have plans this year to work with the CDC on a project to reduce the population of Aedes aegypti, an invasive mosquito species that can carry a range of deadly viruses, including Zika, and which first showed up in southern Nevada around 2017. That project is on hold until next year.
AP journalists Mike Householder in Canton Township, Michigan, Juan A. Lozano in Houston and Jeannie Ohm in Arlington, Virginia, contributed to this report.
This story is a collaboration between The Associated Press and KHN. To reach the AP's investigative team, email investigative@ap.org.
Israel Shippy doesn't remember much about having COVID-19 — or the unusual auto-immune disease it triggered — other than being groggy and uncomfortable for a bunch of days. He's a 5-year-old, and would much rather talk about cartoons, or the ideas for inventions that constantly pop into his head.
"Hold your horses, I think I know what I'm gonna make," he said, holding up a finger in the middle of a conversation. "I'm gonna make something that lights up and attaches to things with glue, so if you don't have a flashlight, you can just use it!"
In New York, at least 237 kids, including Israel, appear to have Multisystem Inflammatory Syndrome in Children, or MIS-C. And state officials continue to track the syndrome, but the Centers for Disease Control and Prevention did not respond to repeated requests for information on how many children nationwide have been diagnosed so far with MIS-C.
A study published June 29 in the New England Journal of Medicine reported on 186 patients in 26 states who had been diagnosed with MIS-C. A researcher writing in the same issue added reports from other countries, findingthat about 1,000 children worldwide have been diagnosed with MIS-C.
Tracking the Long-Term Health Effects of MIS-C
Israel is friendly and energetic, but he's also really good at sitting still. During a recent checkup at Children's Hospital at Montefiore, in the Bronx, he had no complaints about all the stickers and wires a health aide attached to him for an EKG. And when Dr. Marc Foca, an infectious disease specialist, came by to listen to his heart and lungs, and prod his abdomen, Israel barely seemed to notice.
There were still some tests pending, but overall, Foca said, "Israel looks like a totally healthy 5-year-old."
"Stay safe!" Israel called out, as Foca left. It's his new signoff, instead of goodbye. His mother, Janelle Moholland, explained Israel came up with it himself.
And she's also hoping that after a harrowing couple of weeks in early May, Israel himself will "stay safe."
That's why they've been returning to Montefiore for the periodic checkups, even though Israel seems to have recovered fully from both COVID-19 and MIS-C.
MIS-C is relatively rare, and it apparently responds well to treatment, but it is new enough — and mysterious enough — that doctors here want to make sure the children who recover don't experience any related health complications in the future.
"We've seen these kids get really sick, and get better and recover and go home, yet we don't know what the long-term outcomes are," said Dr. Nadine Choueiter, a pediatric cardiologist at Montefiore. "So that's why we will be seeing them."
When Israel first got sick at the end of April, his illness didn't exactly look like COVID-19. He had persistent high fevers, with his temperature reaching 104 degrees — but no problems breathing. He wasn't eating. He was barely drinking. He wasn't using the bathroom. He had abdominal pains. His eyes were red.
They went to the emergency room a couple of times and visited an urgent care center, but the doctors sent them home without testing him for the coronavirus. Moholland, 29, said she felt powerless.
"There was nothing I could do but make him comfortable," she said. "I literally had to just trust in a higher power and just hope that He would come through for us. It taught me a lot about patience and faith."
As Israel grew sicker, and they still had no answers, Moholland grew frustrated. "I wish his pediatrician and [the emergency room and urgent care staff] had done what they were supposed to do and given him a test" when Israel first got sick, Moholland said. "What harm would it have done? He suffered for about 10 or 11 days that could have been avoided."
In a later interview, she talked with NPR about how COVID-19 has disproportionately affected the African American community, due to a combination of underlying health conditions and lack of access to good healthcare. She said she felt she, too, had fallen victim to those disparities.
"It affects me, personally, because I am African American, but you just never know," she said. "It's hard. We're living in uncertain times — very uncertain times."
Finally, Children's Hospital at Montefiore admitted Israel — and the test she'd been trying to get for days confirmed he had the virus.
"I was literally in tears, like begging them not to discharge me because I knew he was not fine," she recalled.
Israel was in shock, and by the time he got to the hospital, doctors were on the lookout for MIS-C, so they recognized his symptoms — which were distinct from most people with COVID-19.
Doctors gave Israel fluids and intravenous immune globulin, a substance obtained from donated human plasma, which is used to treat deficiencies in the immune system.
Immune globulin has been effective in children like Israel because MIS-C appears to be caused by an immune overreaction to the initial coronavirus infection, according to Choueiter, the Montefiore pediatric cardiologist.
"The immune system starts attacking the body itself, including the arteries of the heart," she said.
In some MIS-C cases — though not Israel's — the attack occurs in the coronary arteries, inflaming and dilating them. That also happens in a different syndrome affecting children, Kawasaki disease. About 5% of Kawasaki patients experience aneurysms — which can fatally rupture blood vessels — after the initial condition subsides.
Choueiter and her colleagues want to make sure MIS-C patients don't face similar risks. So far, they're cautiously optimistic.
"We have not seen any new decrease in heart function or any new coronary artery dilations," she said. "When we check their blood, their inflammatory markers are back to normal. For the parents, the child is back to baseline, and it's as if this illness is a nightmare that's long gone."
For a Pennsylvania Teen, the MIS-C Diagnosis Came Much Later
Not every child who develops MIS-C tests positive for the coronavirus, though many will test positive for antibodies to the coronavirus, indicating they had been infected previously. That was the case with Andrew Lis, a boy from Pennsylvania who was the first MIS-C patient seen at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Delaware.
Andrew had been a healthy 14-year-old before he got sick. He and his twin brother love sports and video games. He said the first symptom was a bad headache. He developed a fever the next day, then constipation and intense stomach pain.
"It was terrible," Andrew said. "It was unbearable. I couldn't really move a lot."
His mother, Ingrid Lis, said they were thinking appendicitis, not coronavirus, at first. In fact, she hesitated to take Andrew to the hospital, for fear of exposing him to the virus. But after Andrew stopped eating because of his headache and stomach discomfort, "I knew I couldn't keep him home anymore," Lis said.
Andrew was admitted to the hospital April 12, but that was before reports of the mysterious syndrome had started trickling out of Europe.
Over about five days in the pediatric intensive care unit, Andrew's condition deteriorated rapidly, as doctors struggled to figure out what was wrong. Puzzled, they tried treatments for scarlet fever, strep throat and toxic shock syndrome. Andrew's body broke out in rashes, then his heart began failing and he was put on a ventilator. Andrew's father, Ed Lis, said doctors told the family to brace for the worst: "We've got a healthy kid who a few days ago was just having these sort of strange symptoms. And now they're telling us that we could lose him."
Though Andrew's symptoms were atypical for Kawasaki disease, doctors decided to give him the standard treatment for that condition — administering intravenous immune globulin, the same treatment Israel Shippy received.
"Within the 24 hours of the infusion, he was a different person," Ingrid Lis said. Andrew was removed from the ventilator, and his appetite eventually returned. "That's when we knew that we had turned that corner."
It wasn't until after Andrew's discharge that his doctors learned about MIS-C from colleagues in Europe. They recommended the whole family be tested for antibodies to the coronavirus. Although Andrew tested positive, the rest of the family — both parents, Andrew's twin brother and two older siblings — all tested negative. Andrew's mother is still not sure how he was exposed since the family had been observing a strict lockdown since mid-March. Both she and her husband were working remotely from home, and she says they all wore masks and were conscientious about hand-washing when they ventured out for groceries. She thinks Andrew must have been exposed at least a month before his illness began.
And she's puzzled why the rest of her close-knit family wasn't infected as well. "We are a Latino family," Ingrid Lis said. "We are very used to being together, clustering in the same room." Even when Andrew was sick, she says, all six of them huddled in his bedroom to comfort him.
Meanwhile, Andrew has made a quick recovery. Not long after his discharge in April, he turned 15 and resumed an exercise routine involving running, pushups and situps. A few weeks later, an echocardiogram showed Andrew's heart was "perfect," Ed Lis said. Still, doctors have asked Andrew to follow up with a cardiologist every three months.
An Eye on the Long-Term Effects
The medical team at Montefiore is tracking the 40 children they have already treated and discharged. With kids showing few symptoms in the immediate aftermath, Chouetier hopes the long-term trajectory after MIS-C will be similar to what happens after Kawasaki disease.
"Usually children who have had coronary artery dilations [from Kawasaki disease] that have resolved within the first six weeks of the illness do well long-term," said Choueiter, who runs the Kawasaki disease program at Montefiore.
The Montefiore team is asking patients affected by MIS-C to return for a checkup one week after discharge, then after one month, three months, six months and a year. They will be evaluated by pediatric cardiologists, hematologists, rheumatologists and infectious disease specialists.
Montefiore and other children's hospitals around the country are sharing information. Choueiter wants to establish an even longer-term monitoring program for MIS-C, comparable to registries that exist for other diseases.
Moholland is glad the hospital is being vigilant.
"The uncertainty of not knowing whether it could come back in his future is a little unsettling," she said. "But I am hopeful."
This story is part of a partnership that includes WNYC, NPR and Kaiser Health News.
More than four months into the coronavirus pandemic, how close are the U.S. and the world to a safe and effective vaccine? Scientists say they see steady progress and are expressing cautious optimism that a vaccine could be ready by spring.
As of early July, roughly 160 vaccine projects were underway worldwide, according to the World Health Organization.
Generally, a vaccine trial has several phases. In an initial phase, the vaccine is given to 20 to 100 healthy volunteers. The focus in this phase is to make sure the vaccine is safe, and to note any side effects.
In the second phase, there are hundreds of volunteers. In addition to monitoring safety, researchers try to determine whether shots produce an immune-system response.
The third phase involves thousands of patients. This phase continues the goals of the first two, but adds a focus on how effective the vaccine is in protecting people exposed to the pathogen, in this case the coronavirus. This phase also collects data on more unusual negative side effects.
In ordinary circumstances, these phases take years to complete. But for the coronavirus, the timeline is being shortened. This has spurred more public-private partnerships and significantly increased funding.
Here's a rundown of the vaccine candidates that are furthest along in the clinical phases:
The three vaccine candidates that are furthest along are in phase 3.
One is being developed by researchers at Oxford University in the U.K. It uses a weakened version of a virus that causes common colds in chimpanzees. Researchers then added proteins, known as antigens, from the novel coronavirus, in the hope that these could prime the human immune system to fight the virus once it encounters it.
Another candidate in a phase 3 trial is being developed in China. It uses a killed, and thus safe, version of the novel coronavirus to spur an immune reaction.
And on July 15, the biotech company Moderna, which is partnering with the National Institutes of Health, announced that it would be moving to phase 3 within two weeks.
Two others have made it as far as phase 2, while eight others are finishing their phase 1 trials while also beginning phase 2 trials.
These candidates are being developed by a mix of corporations and institutions in several countries. These efforts seek to leverage a range of technologies.
One uses RNA material that provides the instructions for a body to produce the needed antigens itself. This is a relatively untested approach to vaccination, but if it works, it has aspects that could make it easier to manufacture. Another approach is similar, but uses DNA instead of RNA.
One U.S. biotech firm, Novavax, is receiving federal funding to produce a vaccine that uses a lab-made protein to inspire an immune response.
Beyond these, another 10 vaccine candidates are in phase 1 clinical trials, while 140 haven't reached the clinical phase yet.
Having so many potential vaccines this far along is impressive, experts say, given the short time scientists have known about the novel coronavirus.
"Overall, the pace of development and advancement to phase 3 trials is impressive," said Matthew B. Laurens, associate professor at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health. "The public-private partnerships have been highly successful and are achieving goals for rapid vaccine development."
In addition, the fact that several types of vaccine approaches are being tested means we aren't putting all of our eggs in one basket.
"We will need several candidates should any one of these experience difficulties in manufacturing or show a safety signal when implemented in larger numbers of people," Laurens said.
Meanwhile, at a time of rising public skepticism of government and vaccines, the Food and Drug Administration recently released additional guidelines on vaccine effectiveness. The new guidance requires vaccines to prevent or decrease the severity of the disease at least 50% of the time if they are to win the agency's approval.
The FDA guidelines "reaffirmed the very rigorous FDA process for approving any vaccine. That gives a great deal of reassurance that this was going to be handled by the book," said William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center. "The more we talk about doing things fast, the more the public thinks, 'They're probably cutting corners.'"
How fast will we have access to a workable vaccine?
In early April, Kathleen M. Neuzil, director of the University of Maryland's vaccine center, toldPolitiFactthat if all went well, there might be five or six vaccines in trials within six months. Now, 3 1/2 months later, there are two to three times that number.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and other officials have remained consistent in their estimation of the timeline: 12 to 18 months from the start of the pandemic, or roughly the late spring of 2021.
Schaffner told PolitiFact that he continues to see the first quarter of 2021 as a reasonable target. "I think that's where the needle is pointing," he said.
It remains to be seen how fast vaccines can be manufactured and distributed once approved for general use. Officials are also grappling with which Americans will get access first. So it's unclear how long a person would have to wait to get vaccinated.
Laurens said he is not overly concerned about the distribution, because that is something that officials have long experience with. "Well-established programs exist for vaccine distribution, including for seasonal vaccination of large numbers of individuals," he said.
Another hopeful sign, Schaffner said, is that the coronavirus itself seems to be relatively stable. There had been concern that the novel coronavirus, like many other viruses, is mutating over time. If the virus changes enough, that could become a problem that bedevils vaccine researchers.
But so far, that hasn't happened. Even if evidence emerges that mutations are making the virus more transmissible, or that a new variant is making people sicker, that shouldn't affect the vaccine process. "The central core of the virus would remain the same," Schaffner said.
During the past month, there has been relatively little news about how much progress is being made on particular vaccines. Schaffner is not worried by the relative quiet.
"In a vaccine trial, if there's an adverse safety finding, the guillotine comes down and that trial is stopped," he said. "So quiet is good, because we'd know if something bad happens."