KFF Health News

KFF Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

When the Eye on Older Patients Is a Camera

KFF Health News, November 23, 2021

New monitoring technology is helping family caregivers manage the relentless task of looking out for older adults with cognitive decline.

This article was published on Tuesday, November 23, 2021 in Kaiser Health News.

By Sofie Kodner

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lifting DC's Strict Indoor Mask Mandate Triggers Mix of Confusion, Anxiety and Relief

KFF Health News, November 22, 2021

On the whole, Washington has been especially cautious when it comes to covid, which has helped the city avoid the worst of the pandemic.

This article was published on Monday, November 22, 2021 in Kaiser Health News.

By Amanda Michelle Gomez

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

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

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

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

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

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

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

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

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

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

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

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

“Being the mask police sucks,” she added.

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

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

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

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

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

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

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

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

Success of Covid Antiviral Pills Hinges on Access to Speedy and Accurate Tests

KFF Health News, November 22, 2021

Experts say the success of the treatments would hinge on one uncertain factor: whether high-risk patients infected with covid will be able to get tested — and then treated — fast enough to make a difference.

This article was published on Monday, November 22, 2021 in Kaiser Health News.

By JoNel Aleccia

Within a few weeks, perhaps before many Americans finish decorating for the holidays, the U.S. could have access to a new antiviral pill from Merck expected to alter the deadly trajectory of the covid-19 pandemic — with a second option from Pfizer to follow shortly after.

Now under federal review, both pills are being hailed by infectious-disease doctors not prone to superlatives.

“This is truly a game changer,” said Dr. Daniel Griffin, an expert on infectious diseases and immunology at Columbia University. “This is up there with vaccines. It’s not a substitute for vaccines; we still want to get people vaccinated. But, boy, this is just another great tool to have.”

The new regimens, which require 30 or 40 pills to be taken over five days, have been shown to dramatically reduce hospitalizations and prevent deaths in adults with mild to moderate covid who are at risk for severe disease because of age or underlying conditions. But experts say the success of the treatments would hinge on one uncertain factor: whether high-risk patients infected with covid will be able to get tested — and then treated — fast enough to make a difference.

“Early, accessible testing and access to the results in a time frame that allows us to make a decision is really going to be key to these medications,” said Dr. Erica Johnson, who chairs the Infectious Disease Board of the American Board of Internal Medicine. “It puts the onus on our public health strategy to make these available.”

In clinical trials, molnupiravir, the antiviral drug developed by Merck & Co. and Ridgeback Biotherapeutics, was given to non-hospitalized, unvaccinated, high-risk adult patients within five days of their first covid symptoms. Pfizer’s product, Paxlovid, was tested in similar patients as early as three days — just 72 hours — after symptoms emerged.

Results from the Merck trial, released last month, showed the drug reduced the risk of hospitalizations by about 50% and prevented deaths entirely. It will be considered by an advisory panel to the federal Food and Drug Administration on Nov. 30. Pfizer officials, who requested FDA emergency authorization for their drug on Nov. 16, said Paxlovid cut the risk of hospitalizations and deaths by 89%. Both drugs work by hampering the way the covid virus reproduces, though they do so at different points in the process.

But those promising results assume the drugs can be administered in the narrow window of time used in the trials, a proven challenge when getting antiviral treatments to actual patients. Similar drugs can prevent dire outcomes from influenza if given early, but research shows that only about 40% of high-risk patients during five recent flu seasons sought medical care within three days of falling ill.

“That’s just not human nature,” said Kelly Wroblewski, director of infectious disease programs for the Association of Public Health Laboratories. “If you have a sniffle, you wait to see if it gets worse.”

Even when patients do seek early care, access to covid testing has been wildly variable since the start of the pandemic. U.S. testing capacity continues to be plagued by a host of problems, including supply-chain bottlenecks, staffing shortages, intermittent spikes in demand and results that can take hours — or far longer.

PCR, or polymerase chain reaction tests, the gold standard to detect SARS-CoV-2, can require scheduled appointments at medical offices or urgent care centers, and patients often wait days to learn the results. Rapid antigen tests are faster but less accurate, and some medical providers are hesitant to rely on them. Over-the-counter tests that can be used at home provide results quickly but are hard to find in stores and remain expensive. And it’s not yet clear how those results would be confirmed and whether they would be accepted as a reason for treatment.

“Get ready,” Griffin said. “You don’t want to call someone four days later to say, ‘Ooh, you’re now outside the window,’ and the efficacy of this oral medication has been lost because of problems on our end with getting those results.”

The situation is expected to improve after a Biden administration push to invest $3 billion in rapid testing, including $650 million to ramp up manufacturing capacity for rapid tests. But it could be months before the change is apparent.

“Supplies will be getting better, but it’s going to be slow,” said Mara Aspinall, co-founder of Arizona State University’s biomedical diagnostics program, who writes a weekly newsletter monitoring national testing capacity.

If getting tests will be tough, acquiring doses of the antiviral drugs is expected to be tougher, at least at first. The federal government has agreed to purchase about 3.1 million courses of molnupiravir for $2.2 billion, which works out to about $700 per course of treatment. The Biden administration is planning to announce a deal to pay $5 billion for 10 million courses of the Pfizer drug, paying about $500 per treatment course, according to The Washington Post.

Doses of the drugs distributed by the federal government would go to states and patients at no cost. But only a fraction of the planned inventory will be available to start, said Dr. Lisa Piercey, Tennessee’s health commissioner, who has been part of a small group of state health officials working on the distribution plans.

Under one scenario, in which 100,000 courses of the Merck drug are available as early as Dec. 6, Piercey said Tennessee would receive just 2,000 patient courses even as the state is reporting more than 1,200 new cases a week on average. Deciding which sick patients receive those scarce supplies will be “an educated stab in the dark,” Piercey said.

U.S. Department of Health and Human Services officials have said the antiviral treatments will be distributed through the same state-based system adopted for monoclonal antibody treatments. The lab-made molecules, delivered via IV infusion or injection, mimic human antibodies that fight the covid virus and reduce the risk of severe disease and death. Federal officials took over distribution in September, after a covid surge in Southern states with low vaccination rates led to a run on national supplies. They’re now allotted to states based on the number of recent covid cases and hospitalizations and past use.

The antivirals will be cheaper than the monoclonal antibody treatments, which cost the government about $1,250 per dose and can carry infusion fees that leave patients with hundreds of dollars in copays. The pills are much easier to use, and pharmacies likely will be allowed to order and dispense them for home use.

Still, the antiviral pills won’t replace the antibody treatments, said Dr. Brandon Webb, an infectious-disease specialist at Intermountain Healthcare in Salt Lake City.

Questions remain about the long-term safety of the drugs in some populations. Merck’s molnupiravir works by causing mutations that prevent the virus from reproducing. The Pfizer treatment, which includes Paxlovid and a low dose of ritonavir, an HIV antiretroviral, may cause interactions with other drugs or even over-the-counter supplements, Webb said.

Consequently, the antivirals likely won’t be used in children, people with kidney or liver disease, or pregnant people. They’ll need to be administered to patients capable of taking multiple pills at once, a couple of times a day, and those patients should be monitored to make sure they complete the therapy.

“We’ll be on an interesting tightrope in which we’ll be trying to identify eligible patients early on to treat them with antivirals,” Webb said. “We’re just going to need to be nimble and ready to pivot.”

Why You Can’t Find Cheap At-Home Covid Tests

KFF Health News, November 22, 2021

The U.S. produced covid-19 vaccines in record time, but, nearly two years into the pandemic, consumers have few options for cheap tests that quickly screen for infection.

This article was published on Monday, November 22, 2021 in Kaiser Health News.

By Rachana Pradhan and Hannah Norman

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Companies’ View

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

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

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

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

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

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

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

The View From the FDA

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

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

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

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

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

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

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

Vaccine-or-Test Requirements Increase Work and Costs for Governments

KFF Health News, November 19, 2021

Mandates have been costly, often requiring governments to use federal covid relief dollars they would rather have spent elsewhere.

By Amanda Michelle Gomez and Phil Galewitz

Amanda Kostroski, a 911 dispatcher in Madison, Wisconsin, leaves her busy job once a week to go to a county health clinic to be tested for covid-19.

She’s been making the 15-minute drive from work since late September, when Dane County mandated all employees get vaccinated or tested weekly. The testing is free, and she is typically back to work within an hour.

Kostroski is among 10% of county employees who are unvaccinated and get weekly tests. She chose not to get immunized because she thinks the vaccines are too new and she fears side effects.

Kostroski said she doesn’t understand the need for the shots or why vaccinated people are not tested, since they can sometimes also transmit the virus. “I think it’s pointless,” said Kostroski, 34, who has always tested negative. She’s been told by vaccinated colleagues that they feel burdened filling in for people getting tested.

Dane is one of several dozen counties, cities and states that require workers to get a covid vaccine or get tested regularly. While some employees complained about the policy, county officials say, it helps keep the workplace safe with modest interruptions. They also say vaccinated workers don’t need testing because they are less likely to get infected and, if they do, are less likely to contract a severe case of covid. But it has been costly, often requiring governments to use federal covid relief dollars they would rather have spent elsewhere.

Some private employers have adopted similar policies. And starting Jan. 4, the Biden administration will require private employers with 100 or more workers to insist on shots or weekly testing.

But opposition to those mandates runs deep among some workers, unions and conservative leaders. More than two dozen Republican state attorneys general sued the administration, arguing the federal government lacks the authority. A federal appeals court agreed with them and temporarily blocked the order, and the case might end up before the Supreme Court.

Still, these early efforts by state and local governments offer insights into what Biden’s rule might mean for the wider private sector as companies deal with setting up and paying for testing and then monitoring the results. The regimen adds more work for government managers even in localities like Dane County, where nearly 90% of adults are at least partly vaccinated.

Nationally, about 81% of adults are at least partly vaccinated against covid, although rates vary widely among states, according to the Centers for Disease Control and Prevention.

Jurisdictions run by conservative officials tend to have lower vaccination rates and are unlikely to require vaccinations or testing for workers — meaning experiences to date don’t reflect areas that have had strong opposition to vaccines and other covid requirements.

Local and state governments that have embraced the testing option have done so because it straddles the line between creating a safe work environment and giving reluctant employees a way to opt out of the vaccine without losing their job.

Blaire Bryant, associate legislative director for health at the National Association of Counties, said, “It’s too early to give a definitive answer on how well it’s going, but so far [we have] not heard any major issues.”

Counties are relying on free covid testing in their communities, paying for it through federal covid relief dollars, or having their health insurance companies foot the bill.

Local governments have a smorgasbord of policies on who is subject to the vaccine-or-test requirement and how it’s enforced. For example, all unvaccinated employees of San Diego County, California, who do not work in a health care setting need to provide proof of weekly testing to their supervisor, said spokesperson Michael Workman.

Miami-Dade County’s policy applies only to nonunion workers, or about 9% of its 29,000 employees. About 380 undergo weekly testing. The Florida county is still negotiating with unions about adding the requirement.

Virginia’s Department of Corrections requires unvaccinated employees who work in crowded settings to get tested every three days, and the rest, every seven days. And the expense? It cost the department nearly $7,000 to test 442 staff members over two days in October. The state is tapping federal covid relief funds to pay for the testing.

Securing scarce testing supplies can be difficult. The Virginia State Police had to wait more than a month to start a testing program in part because of delays in delivery.

While the Biden administration hoped its rule would motivate more people to get vaccinated, counties have had mixed results.

Officials in Fairfax County, Virginia, outside Washington, D.C., said they have not seen a significant increase in employees submitting vaccination verification since its mandatory shot policy took effect in October. More than 80% of county employees are vaccinated.

The county distributes and pays for self-administered tests for its 2,300 employees who need them, said spokesperson Dawn Nieters. The cost ranges from $35 for a rapid test to $53 for a PCR test, considered the gold standard for detecting covid.

Mecklenburg County, North Carolina, which includes Charlotte, did see the needle move. Employees there are responsible for getting their own tests. The vaccination rate jumped from 62% to 85% one month after the requirement was implemented in early September.

George Dunlap, chairman of Mecklenburg’s Board of County Commissioners, said he prefers the vaccine-or-test requirement to a vaccine-only mandate because “you have to allow for human behavior that might be different than yours.” But he isn’t sure the policy will encourage any more workers to get vaccinated.

“The people that I know personally who decided to do the testing are still getting testing. They didn’t change their mind about the vaccination,” he said.

Some health experts question the value of testing as a backup and instead favor mandating the shots.

“A vaccine-and/or-testing policy is second best,” said Jeffrey Levi, a professor of health management and policy at George Washington University. “A testing policy catches a problem early. It doesn’t prevent a problem, whereas the vaccination requirement helps to prevent it.”

Marc Elrich, the executive in Montgomery County, Maryland, in suburban Washington, supports a vaccine-only mandate in theory but worries imposing it would result in workers leaving for jobs in neighboring jurisdictions without similar requirements.

“I wish the federal government would impose a [vaccine-only] mandate, because if the feds were to do it, there wouldn’t be any job portability,” said Elrich. “I wouldn’t have to deal with an employee’s ability to go from, particularly in this region, Montgomery County Police Department to pretty much every other police department around here.”

Robb Pitts, who chairs the Fulton County Board of Commissioners in Atlanta, would also like to do away with the testing option. “But I don’t think my colleagues would necessarily go along with that,” he said. About a third of county employees have opted for testing instead of vaccination.

“Why did I compromise? Because I felt, well, we had to do something,” Pitts said. “A lot of times, politics is the art of compromise.”

According to Pitts’ office, Fulton County saw its largest increase in vaccinations since May in September, when the vaccine-or-test policy was implemented. The vaccination rate now hovers around 72%.

The ER Charged Him $6,500 for Six Stitches. No Wonder His Critically Ill Wife Avoided the ER.

KFF Health News, November 19, 2021

Couple snagged by major problems in American health care: very high billing, obscure pricing, high-deductible insurance plans, and few care options in rural areas.

By Blake Farmer, Nashville Public Radio

Jason and DeeAnn Dean recently relocated to her hometown of Dellrose, Tennessee, where she grew up on a farm. Both in their late 40s, they’re trying to start a green dream business that combines organic farming with a health and wellness consulting company. They want to inspire people to grow their own food in this fertile rolling farmland, just north of the border with Alabama.

Until the business fully launches, Jason is working construction. In May, he was injured on the job site when a piece of sheet metal slipped and caught him on the kneecap. He bled quite a bit. After closing the wound with a butterfly bandage, he thought that might be enough. But on his drive home, he figured it’d be best to have a professional stitch it up.

It was late in the day, and the emergency room seemed the best option since his doctor’s office was closed. He and DeeAnn had opted for a health plan with lower monthly payments and a high deductible. So, he knew the cost of care wouldn’t be cheap — and he was right. When the bills for thousands of dollars came, they were shocked. They were in the midst of fighting them in August when DeeAnn started feeling as bad as she’s ever felt.

“I haven’t eaten. I’m not drinking. I have a horrible fever. I can’t get out of bed. I’m shaking,” she said.

She was pretty sure she had contracted covid-19 — the delta variant was surging across the South. The natural-health fanatic was kicking herself for putting off vaccination. She got tested and the result was negative. She visited a doctor the next day, who said her condition was bad enough to go to the ER — but she regarded that option as financially unacceptable.

“That is fear,” said DeeAnn. “If they charged Jason this much, what would they charge me?”

She was terrified of a potential bill from the same ER in Pulaski, Tennessee, that had treated her husband. So even though she was deliriously ill, she hit the road in search of cheaper treatment, asking her parents to drive her. They headed south first to an ER in Huntsville, Alabama, but it was so full of covid patients, she would have had to wait all day. Then, they drove north nearly an hour to Maury Regional Medical Center, a public hospital in Columbia, Tennessee, where she was diagnosed with Rocky Mountain spotted fever, a potentially deadly tick-borne infection. She got treatment with appropriate antibiotics and IV fluids.

“I would have had organ damage or possibly death in a few days,” she said.

And then the bills came.

The Patients: Jason and DeeAnn Dean, entrepreneurs and aspiring organic farmers who bought a BlueCross BlueShield of Tennessee insurance plan with a deductible of $8,000.

Medical Services: Jason received six sutures for a laceration on his knee and a tetanus shot. DeeAnn received diagnosis and treatment for Rocky Mountain spotted fever.

Total Bills: Jason was charged $4,582.77 by the hospital for a Level 4 emergency visit, including $497.40 for a tetanus shot. The ER physicians who treated him sent a separate bill of $2,007, for a total of $6,589.77. The Deans’ share of these bills came to $4,278.05. At a different ER, DeeAnn was charged for a Level 4 emergency and lab tests. BCBST paid a negotiated rate of $1,990.63 and the Deans owed $566.33.

Service Providers: Jason received care at Southern Tennessee Regional Health System-Pulaski, part of the LifePoint Health hospital chain. DeeAnn received care at Maury Regional Medical Center, a county-owned hospital in Columbia, Tennessee, about twice as far from her home as the Pulaski hospital.

What Gives: The Deans were snagged by a host of major problems in American health care: very high billing, obscure pricing, high-deductible insurance plans and few options for care in rural areas. The net result could have cost DeeAnn her life.

When Jason went to the only local ER for stitches, the staff assured him his insurance would cover the treatment. “I’m not versed in medical billing or medical law,” he said. “So I said, ‘Let’s go ahead and stitch it up.’”

It took 30 minutes. Despite his questions about coverage, no one ever told him what he would be charged. He guessed no more than $1,000 for the 30-minute visit.

Then, a few weeks later, he began receiving bills. The hospital charged a total of $4,582.77, asking him to pay $3,391.25 for his six stitches.

LifePoint Health, the hospital’s owner, is a large hospital chain headquartered in Nashville that specializes in rural hospital operations. The ER physicians, who sent a separate bill for $2,007 (discounted to $886.80), are part of TeamHealth, based in Knoxville. His ER visit was coded as Level 4 on the five-level scale. A Level 4 is supposed to require a detailed examination and medical history, along with decision-making of moderate complexity.

Both the physicians and the hospital are part of companies recently taken over by private-equity investors. TeamHealth has been sued by the nation’s largest health insurer, UnitedHealthcare, for overusing Level 4 and Level 5 charges on bills. It’s a practice insurance companies refer to as “upcoding.” TeamHealth calls the accusation an attempt at “downcoding” a physician’s expertise.

Both companies, through spokespeople, essentially said Jason’s charges are what they are. LifePoint wouldn’t discuss specifics.

DeeAnn was still worried about her Maury Regional bill, especially after a battery of tests and being hooked to IV fluids. But, despite the high level of care she received and having the same high-deductible plan as her husband, she’s out only $600 — an amount she said she will gladly pay.

As is so often the case with Bill of the Month sagas, the question of responsibility has all sides blaming the others. TeamHealth, the ER staffing firm, which controls billing in an estimated 17% of all emergency rooms, blames insurers for selling high-deductible plans. And patients.

“Unfortunately, it is all too common that patients are not knowledgeable about their financial responsibilities under high-deductible plans,” TeamHealth spokesperson Greg Blair said in a written statement.

And the high prices do come at a cost for people’s health. For 1 in 10 Americans, according to the Peterson-KFF Health System Tracker, costs cause patients to put off necessary care.

Resolution: The Deans spent hours on the phone, asking the hospital and the physicians’ group to review the charges for Jason’s $1,000-per-stitch care. Both companies are sticking by the original bills. But the Deans are still fighting.

DeeAnn said they regret gambling on a high-deductible plan. But the difference in monthly premiums was substantial compared with low-deductible plans, especially when they’re launching a business, and the risk seemed minimal given their lack of chronic conditions and focus on healthy living.

Pulaski is lucky to still have a hospital, though. Southern states — and Tennessee especially — have seen rural hospitals close faster than anywhere else in the country. It’s a phenomenon routinely blamed on the lack of Medicaid expansion, which leaves many people uninsured.

“I get it,” DeeAnn said. “But that doesn’t mean they get to take advantage of the people going through there.”

The Takeaway: It is a national tragedy that many Americans avoid or defer needed medical care because of fear of costs. Still, there are steps you can take to protect yourself.

Emergency rooms are expensive places, so think twice before using them — although, in many circumstances, they are the only option on nights and weekends, particularly in rural areas.

Don’t be reassured by a provider’s insistence that your insurance should cover treatment. If you have a high-deductible plan, “you’re covered” doesn’t mean much because you’re responsible for — in Jason’s case — the first $8,000 in charges. Also, even if your insurer, in theory, covers your medical encounter, you may receive big bills from doctors outside your network or be required to contribute a hefty coinsurance share under the terms of your plan.

You can ask whether the self-pay cash price is an option — thereby waiving your insurance. But many facilities will require those who have insurance to use it — knowing they can bill higher prices that way.

If a physician gives you the option of having a lab test, MRI or X-ray on the spot in the ER versus doing it once you’re discharged, choose the latter. Tests run while in the ER are often many times more expensive than elsewhere. After your visit, check how it was coded. If the bill says Level 4 or 5 and the visit was fairly simple, ask more questions. Here’s a handy chart with descriptions of the five CPT (current procedural terminology) codes for the levels of ER service.

Finally, it’s worth knowing in advance who staffs the emergency departments of hospitals in your area, especially if you have a high-deductible plan. Are the doctors employed by the hospital or are they employed by a private-equity-owned staffing firm? The latter type of arrangement, research shows, often means high prices and more aggressive billing. Driving a few extra miles could save thousands of dollars.

Public Opinion Is Unified on Lowering Prescription Drug Prices. Why Are Leaders Settling for Less?

KFF Health News, November 18, 2021

With public opinion so unified in our politically divided society, why are congressional Democrats settling on a menu of weaker, halfway measures to address the problem of sky-high drug prices?

This article was published on Thursday, November 18, 2021 in Kaiser Health News.

By Elisabeth Rosenthal

Democrats and Republicans are crystal clear in polls that they want government to be allowed to negotiate down high drug prices. Americans pay nearly three times as much for drugs as patients in dozens of other countries. In the past two years, numerous Democratic candidates — including President Joe Biden — have campaigned on enacting such legislation.

This year, the polling group at KFF asked respondents about support for drug price negotiations after giving them the commonly offered arguments, pro and con: On the pro side, lower prices mean people can better afford their medicines; on the con side, lower profits mean the possibility of less innovation and fewer new drugs. Large majorities supported the idea of Medicare negotiating with pharmaceutical firms to get lower prices for both its beneficiaries and people with private insurance: 83% overall, including 95% of Democrats, 82% of independents and 71% of Republicans.

Similarly, in recent polling funded by the Robert Wood Johnson Foundation, 84% of respondents said the government should be allowed to put limits on prices for drugs that save lives and for common chronic illnesses, like diabetes. (Funding from the foundation supports KHN’s journalism.)

No wonder groups linked to PhRMA, the pharmaceutical industry’s trade association, are blanketing the airwaves with ads featuring patients with serious illnesses who say that price negotiation would mean people would not get vital medicines and could die. Voters aren’t buying it: 93% of Americans and 90% of Republicans said they believe that drugmakers would still make enough money to develop drugs if prices were lowered, the KFF poll found. (KHN is an editorially independent program of the Kaiser Family Foundation.)

With public opinion so unified in our politically divided society, why are congressional Democrats settling on a menu of weaker, halfway measures to address the problem of sky-high drug prices?

The current proposal on drug prices in Biden’s Build Back Better spending package with support from Congress (so far) contains strong consumer protections — such as limiting out-of-pocket prescription drug payments for Medicare beneficiaries to $2,000 annually and limiting yearly price increases, which have long outpaced inflation.

But when it comes to allowing the government to negotiate better prices, the provisions are narrow, byzantine and distant. The government would identify 100 high-cost medicines and choose 10 for price negotiation annually, with those prices first taking effect in 2025. It could negotiate only on medicines that had been on the market for at least nine to 13 years, depending on the drug type.

There are many reasons the public’s strong view on this issue hasn’t translated to more forceful law.

While the idea of drug price negotiations is extremely popular, the benefits of such a program are diffuse — affecting patient pocketbooks here and there. And politicians generally don’t expect to be punished by voters for failing to deliver on this single issue.

On the other side, PhRMA regards drug price negotiation for Medicare as an existential threat to its business — potentially costing billions. It spent $23 million on lobbying in the first nine months of the year, on pace to surpass the previous record.

As public support for price negotiations has gained momentum in recent years, PhRMA’s campaign donations have been directed with surgical precision to the few sympathetic or moderate Democrats it needed on its side to prevent drug price negotiation being written into law.

Though Democratic Sen. Kyrsten Sinema of Arizona had made bringing down the cost of prescription drugs a central campaign issue in 2018, she helped block a more ambitious House proposal from moving forward that would have allowed Medicare to negotiate prices of 250 drugs and extend those prices to those with other types of insurance. She did so even though polling in her state showed 94% of Arizonans support Medicare negotiating cheaper prices. She received about $100,000 in campaign contributions from the industry in 2019-20, one of the leading congressional recipients.

Another hurdle is that Democrats have a thin majority in both houses of Congress and some key Democrats, such as New Jersey’s Sen. Bob Menendez and Rep. Scott Peters of San Diego, represent states or districts with many drug manufacturers. Thirteen of the world’s 20 largest manufacturers are located in New Jersey.

Menendez had long declined to say whether he supports Medicare drug price negotiation. He announced earlier this month that he would support the current limited Democratic proposal in a carefully worded statement that avoided endorsing the practice.

Finally, the image of the pharmaceutical industry has been at least somewhat burnished by its role in developing covid-19 vaccines and drugs, an accomplishment it has deployed this fall as an argument to head off price limitations. “The White House is trying to make it more difficult for our industry to continue the fight against this pandemic and plan for future health crises,” Stephen Ubl, president of PhRMA, said in a September statement.

Politicians and many health experts did their best to see the glass half-full in the plan put forward by the Democrats and the president. “It’s a far cry from what they do in other industrialized countries, but it’s a pretty good first step that would have been unimaginable five years ago,” said Dr. Aaron Kesselheim, a professor at Harvard Medical School, who studies drug costs. Senate Majority Leader Chuck Schumer called it “a massive step forward,” though he noted in the same breath that “many of us would have wanted to go much further.”

So would most voters, public surveys show.

Instead, the plan allows the Democrats to say they kept a promise, passing drug price negotiation, however meager. And the drugmakers get a distant, narrow program that is unlikely — at least for now — to drastically affect their nice profits.

Stranded by the Pandemic, He Had Only Travel Insurance. It Left Him With a $38,000 Bill.

KFF Health News, November 18, 2021

Travel insurance generally covers only emergency or urgent medical expenses, according to the California state insurance commission, which regulates policies in the state.

This article was published on Thursday, November 18, 2021 in Kaiser Health News.

By Arthur Allen

Duy Hoa Tran, a retired Vietnamese schoolteacher, arrived in Los Angeles in February 2020 to visit his daughter and 2-month-old grandson. Two weeks later, the door closed behind him. To prevent the spread of covid-19, Vietnam shut its borders. No commercial flights would be allowed into the country for the next 18 months.

Tran’s daughter, An Tran, who has a doctorate in business administration and teaches marketing at the University of La Verne in California, did what she thought was necessary to ensure medical coverage for her then-65-year-old father during the pandemic. But the only option for a visitor on a tourist visa was travel insurance. In early March 2020, An Tran found and purchased a policy, for about $350 a month, from a company called Seven Corners.

She might as well not have bothered.

The elder Tran had been staying at An’s home in Diamond Bar, California, about a year when he told his daughter he was having trouble seeing out of his right eye. A visit to an ophthalmologist produced a solemn verdict: Tran had severe glaucoma and would quickly go blind unless he got surgery.

Seven Corners gave written preapproval for the procedures recommended by Dr. Brian Chen. To be safe, An Tran called the insurer “many times” to confirm it would cover the expense, but no one she spoke with would give her a definitive answer, she said. Chen, however, assured An that insurance companies typically covered the treatment, which was pretty routine.

On April 19, Tran underwent the first of three eye surgeries to resolve the glaucoma. The surgeries — the last was on July 19 — were successful. And then on Aug. 5, Seven Corners sent An Tran a denial of service letter.

The company’s policy excluded coverage for any “preexisting condition,” by which it meant any condition “whether or not previously manifested, symptomatic, known, diagnosed, treated or disclosed,” the letter said.

An Tran and her father were on the hook for nearly $38,000 in medical bills, although Seven Corners had preauthorized the surgery and she had paid around $6,000 for the insurance over the previous year and a half.

As for the bill, “my dad obviously can’t pay it,” Tran said. His $260 monthly pension from the Vietnamese government isn’t enough even for him to live on in Vietnam, she said.

The surgical procedures Duy Hoa Tran received are quite routine in the United States, said Dr. Davinder Grover, an ophthalmologist in the Dallas area and clinical spokesperson for the American Academy of Ophthalmology.

Medicare would generally pay about a quarter of the $37,896.83 Tran was billed for the surgeries, Grover said. If Tran’s daughter had known beforehand that insurance wouldn’t cover the procedures, the physician’s practice might have been willing to charge something like $12,000, he said.

The policy An Tran purchased had no deductible and offered coverage of up to $100,000 in medical bills, including covid care. But travel insurance generally covers only emergency or urgent medical expenses, according to the California state insurance commission, which regulates policies in the state.

Megan Moncrief, chief marketing officer for Squaremouth, which aggregates various companies’ travel insurance plans — including some from Seven Corners — and offers them through its website, said the policy language was not unusual for travel insurance. She noted the policy’s stipulation that it covered some acute conditions only if the patient sought treatment within 24 hours of the initial symptoms.

Moncrief said the fact that Tran did not seek treatment immediately may be the reason his surgeries weren’t covered. (Seven Corners refused all comment on the case.) She acknowledged it was hardly surprising he hadn’t dashed to the doctor at the first sign of discomfort: “I don’t know that I would have done that either, if I just had blurry vision.”

As for Seven Corners’ refusal to pay despite precertification, this is not uncommon, she said. By precertifying, the insurer verifies that a procedure is a covered benefit but doesn’t guarantee the insurer will cover it for that particular patient.

Travel insurance typically offers little protection for any health problem linked to a preexisting condition, regardless of whether that condition has ever been diagnosed, says Susan Yates, general manager in the U.S. for Falck Global Assistance, an international insurer.

“For visitors to the U.S., especially those who are not permanent residents or citizens, it can be difficult to obtain health insurance,” she said. The Affordable Care Act doesn’t cover tourists, though some resident noncitizens can buy coverage.

“It’s usually better for a visitor to buy travel insurance from their country of origin, but in some countries (Vietnam being one), the insurance market is not developed,” Yates wrote in an email.

Tran had tried unsuccessfully for months to fly home to his town near Ho Chi Minh City, where his wife lives with another grandchild. On 14 occasions, An bought him tickets on regular commercial flights that were subsequently canceled. He was also unable to get a seat on charter flights arranged by the Vietnamese government; those tickets generally were available only through third parties charging up to $10,000.

The eye surgeon, Chen, offered to discuss the case with KHN, but his medical group’s counsel said it had a policy against discussing insurance issues with reporters, even with the patient’s consent.

After KHN approached him to discuss the issue, Chen told An Tran that he was waiving his $8,144 fee for the surgeries. The Acuity Eye Group, where he practices, would not immediately confirm Chen’s offer, but told An Tran they were seeking approvals to waive his fee and all other charges as well.

On Sept. 15, Duy Hoa Tran finally managed to get on a charter flight back to Vietnam. He’s happy to be home, An Tran said.

Under California’s filial responsibility laws, she could be liable for his remaining bills.

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

Schools, Pediatricians Look to Make Up Lost Ground on Non-Covid Vaccinations

KFF Health News, November 18, 2021

Routine immunizations protect children against 16 infectious diseases, including measles, diphtheria, and chickenpox, and inhibit transmission to the community; the rollout of covid shots for younger kids is an opportunity to catch up on routine vaccinations.

This article was published on Thursday, November 18, 2021 in Kaiser Health News.

By Kate Ruder

WESTMINSTER, Colo. — Melissa Blatzer was determined to get her three children caught up on their routine immunizations on a recent Saturday morning at a walk-in clinic in this Denver suburb. It had been about a year since the kids’ last shots, a delay Blatzer chalked up to the pandemic.

Two-year-old Lincoln Blatzer, in his fleece dinosaur pajamas, waited anxiously in line for his hepatitis A vaccine. His siblings, 14-year-old Nyla Kusumah and 11-year-old Nevan Kusumah, were there for their TDAP, HPV and meningococcal vaccines, plus a covid-19 shot for Nyla.

“You don’t have to make an appointment and you can take all three at once,” said Blatzer, who lives several miles away in Commerce City. That convenience outweighed the difficulty of getting everyone up early on a weekend.

Child health experts hope community clinics like this, along with the return to in-person classes, more well-child visits and the rollout of covid shots for younger children, can help boost routine childhood immunizations, which dropped during the pandemic. Despite a rebound, immunization rates are still lower than in 2019, and disparities in rates between racial and economic groups, particularly for Black children, have been exacerbated.

“We’re still not back to where we need to be,” said Dr. Sean O’Leary, a pediatric infectious-disease doctor at Children’s Hospital Colorado and a professor of pediatrics at the University of Colorado School of Medicine.

Routine immunizations protect children against 16 infectious diseases, including measles, diphtheria and chickenpox, and inhibit transmission to the community.

The rollout of covid shots for younger kids is an opportunity to catch up on routine vaccinations, said O’Leary, adding that children can receive these vaccines together. Primary care practices, where many children are likely to receive the covid shots, usually have other childhood vaccines on hand.

“It’s really important that parents and health care providers work together so that all children are up to date on these recommended vaccines,” said Dr. Malini DeSilva, an internist and pediatrician at HealthPartners in the Minneapolis-St. Paul area. “Not only for the child’s health but for our community’s health.”

People were reluctant to come out for routine immunizations at the height of the pandemic, said Karen Miller, an immunization nurse manager for the Denver area’s Tri-County Health Department, which ran the Westminster clinic. National and global data confirm what Miller saw on the ground.

Global vaccine coverage in children fell from 2019 to 2020, according to a recent study by scientists at the Centers for Disease Control and Prevention, the World Health Organization and UNICEF. Reasons included reduced access, lack of transportation, worries about covid exposure and supply chain interruptions, the study said.

Third doses of the diphtheria, tetanus and whooping cough (DTP) vaccine and of the polio vaccine decreased from 86% of all eligible children in 2019 to 83% in 2020, according to the study. Worldwide, 22.7 million children had not had their third dose of DTP in 2020, compared with 19 million in 2019. Three doses are far more effective than one or two at protecting children and communities.

In the United States, researchers who studied 2019 and 2020 data on routine vaccinations in California, Colorado, Minnesota, Oregon, Washington and Wisconsin found substantial disruptions in vaccination rates during the pandemic that continued into September 2020. For example, the percentage of 7-month-old babies who were up to date on vaccinations decreased from 81% in September 2019 to 74% a year later.

The proportion of Black children up to date on immunizations in almost all age groups was lower than that of children in other racial and ethnic groups. This was most pronounced in those turning 18 months old: Only 41% of Black children that age were caught up on vaccinations in September 2020, compared with 57% of all children at 18 months, said DeSilva, who led that study.

A CDC study of data from the National Immunization Surveys found that race and ethnicity, poverty and lack of insurance created the greatest disparities in vaccination rates, and the authors noted that extra efforts are needed to counter the pandemic’s disruptions.

In addition to the problems caused by covid, Miller said, competing life priorities like work and school impede families from keeping up with shots. Weekend vaccination clinics can help working parents get their children caught up on routine immunizations while they get a flu or covid shot. Miller and O’Leary also said reminders via phone, text or email can boost immunizations.

“Vaccines are so effective that I think it’s easy for families to put immunizations on the back burner because we don’t often hear about these diseases,” she said.

It’s a long and nasty list that includes hepatitis A and B, measles, mumps, whooping cough, polio, rubella, rotavirus, pneumococcus, tetanus, diphtheria, human papillomavirus and meningococcal disease, among others. Even small drops in vaccination coverage can lead to outbreaks. And measles is the perfect example that worries experts, particularly as international travel opens up.

“Measles is among the most contagious diseases known to humankind, meaning that we have to keep very high vaccination coverage to keep it from spreading,” said O’Leary.

In 2019, 22 measles outbreaks occurred in 17 states in mostly unvaccinated children and adults. O’Leary said outbreaks in New York City were contained because surrounding areas had high vaccination coverage. But an outbreak in an undervaccinated community still could spread beyond its borders, he said.

In some states a significant number of parents were opposed to routine childhood vaccines even before the pandemic for religious or personal reasons, posing another challenge for health professionals. For example, 87% of Colorado kindergartners were vaccinated against measles, mumps and rubella during the 2018-19 school year, one of the nation’s lowest rates.

Those rates bumped up to 91% in 2019-20 but are still below the CDC’s target of 95%.

O’Leary said he does not see the same level of hesitancy for routine immunizations as for covid. “There has always been vaccine hesitancy and vaccine refusers. But we’ve maintained vaccination rates north of 90% for all routine childhood vaccines for a long time now,” he said.

Malini said the “ripple effects” of missed vaccinations earlier in the pandemic continued into 2021. As children returned to in-person learning this fall, schools may have been the first place families heard about missed vaccinations. Individual states set vaccination requirements, and allowable exemptions, for entry at schools and child care facilities. Last year, Colorado passed a school entry immunization law that tightened allowable exemptions.

“Schools, where vaccination requirements are generally enforced, are stretched thin for a variety of reasons, including covid,” said O’Leary, adding that managing vaccine requirements may be more difficult for some, but not all, schools.

Anayeli Dominguez, 13, was at the Westminster clinic for a TDAP vaccine because her middle school had noticed she was not up to date.

“School nurses play an important role in helping identify students in need of immunizations, and also by connecting families to resources both within the district and in the larger community,” said Denver Public Schools spokesperson Will Jones.

Patients Get Stranded Out of Network as Insurer-Hospital Contract Talks Fall Apart

KFF Health News, November 17, 2021

In the past, even when contract negotiations became publicly antagonistic, they typically would be resolved before the deadline for termination.

This article was published on Wednesday, November 17, 2021 in Kaiser Health News.

By Andy Miller

In September, when Shelly Azzopardi went to Wellstar Kennestone Hospital with abdominal pain, she didn’t worry about her insurance.

Doctors said she had a case of appendicitis. But she also tested positive at the hospital in Marietta, Georgia, for covid-19. Physicians decided not to do surgery and treated her with antibiotics and painkillers. Azzopardi, 47, went home after a couple of days in the hospital, feeling better.

But in October, the appendix pain again flared. Her husband took her to the same hospital, where surgery was performed successfully. This time, though, she ran into a snag with her insurance.

Azzopardi has UnitedHealthcare coverage, and as of Oct. 3, Wellstar Health System was no longer in the giant insurer’s network, after the two sides did not agree on a new contract.

Wellstar dominates the Cobb County area where Azzopardi and her husband live. She has applied to UnitedHealthcare for a “continuity of care” waiver, which would extend her previous in-network coverage for the treatment of an ongoing condition for the October hospital visit and surgery. If it doesn’t work out, she could owe thousands of dollars. “I don’t know where it stands,” Azzopardi said.

On a larger level, the severed contract between a hospital system and health insurer reflects tensions that have been growing nationally this year. In the past, even when contract negotiations became publicly antagonistic, they typically would be resolved before the deadline for termination.

Now health care consultants and industry officials say an increasing number of contracts end without a deal. Even if they are eventually resolved, those terminations throw tens of thousands of patients into the difficult position of choosing between much higher out-of-pocket costs or leaving a trusted physician and hospital.

The Wellstar vs. UnitedHealthcare situation — and an even bigger dispute looming in metro Atlanta involving Anthem Blue Cross and Blue Shield — come at a tricky time, during open enrollment season when many employers have already picked their insurance offerings and many consumers must choose their health plan.

“We are seeing more insurers terminate contracts without a deal, and this is both a national and local trend,” said Beth Spoto, a Georgia-based health care consultant with Spoto & Associates. From the insurers’ point of view, she said, it’s a hardball tactic to lower payment rates to medical providers for services.

“Health systems are getting quite large, so you are dealing with hundreds of millions of dollars,” she said. “The fighting is getting pretty tough.”

Recent contract terminations involving big insurers include UnitedHealthcare vs. Montefiore Health System in New York, and Anthem vs. Dignity Health in California. Each conflict was eventually resolved, though Montefiore took several months to settle.

Hospitals are reporting higher tensions in negotiations with health insurers, said Molly Smith, an American Hospital Association vice president. She said contract talks often are not conducted by local executives of the insurer, which might allow for more collaboration, but are directed instead by company headquarters.

Just in the Atlanta area, other out-of-network situations involving insurance heavyweights UnitedHealthcare and Anthem have occurred in the past couple of years. Northside Hospital’s Gwinnett County facilities were out of network for UnitedHealthcare members for five months, while Northeast Georgia Health System in Gainesville left Anthem’s lineup for three months.

In the most recent dispute, Wellstar said it wants UHC to pay reimbursements similar to those it gets from other insurers. UnitedHealthcare, based in Minnesota, counters that Wellstar wants “egregious” rate hikes that the insurer said would amount to 37% over three years.

“Both sides said the other is just out for money,” Azzopardi said. The impasse, she said, “is cruel to the patients who have done nothing wrong.”

The open enrollment quandary has Emilie Cousineau of Smyrna, Georgia, wondering whether to stay with UnitedHealthcare or switch to Anthem, which she said would cost her more for the upcoming benefits year in her employer plan.

Cousineau canceled a Wellstar well-check appointment recently because suddenly it was out of network. “Right now, it’s an inconvenience.” But her doctor as well as her kids’ pediatrician are Wellstar physicians. “I’m picky about my health care,” she said.

Uncertainty over covid and rising hospital labor costs are fueling the disruptions, consultants said.

Health insurers recorded sky-high profits last year as people avoided medical care because of fears about covid. This year, profits have been lower but still healthy. For hospitals, the pandemic brought mixed results. Some richer, bigger health systems racked up huge surpluses, helped by covid relief funds, while many safety-net and rural hospitals fought hard to break even.

Cole Manbeck, a spokesperson for UnitedHealthcare, said affordability of health care is of prime importance to consumers and employers. They expect the insurer to help contain costs, which requires maintaining fair and competitive agreements with hospitals and doctors in its network, he said.

Insurers also point out that health care systems have enhanced their bargaining clout by acquiring additional hospitals and doctor practices. The tough negotiations extend to physician group contracts, said Dave Smith with the health care consulting firm Kearny Street Management. Insurers, he said, “are trying to drive health care costs down, and are doing it on the backs of physicians and hospitals.”

Factoring into the fray are payment delays involving insurers Anthem and UnitedHealthcare. Hospitals are dealing with a spike in retroactive claim denials by UnitedHealthcare for emergency department care, the AHA’s Smith said.

KHN also recently reported that Anthem Blue Cross is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, according to hospital officials in multiple states.

Tom Mee, CEO of North Country Healthcare in New Hampshire, said the outstanding claims owed to his system by Anthem rose $250,000 in one quarter to reach $1 million.

Indianapolis-based Anthem said the contract rifts and the claims issue are not related. Both it and UnitedHealthcare noted that the large majority of contracts are renewed without public attention.

Employers, meanwhile, don’t like these network disruptions, said Ash Shehata, a health care consultant with KPMG. But, he added, employers also don’t want to subsidize the rate increases.

“When times are good, and everybody is doing well, generally you don’t see these negotiation issues,” he said. “As long as the environment remains unpredictable, we’ll see some unpredictable negotiations.”

Contract terminations harm hospitals more than insurers, said Nathan Kaufman of Kaufman Strategic Advisors. For example, UnitedHealthcare and Anthem, which operate in several states, “can take a hit in one state,” he said, because they’re diversified and insurers still receive premium payments for members after a contract with a hospital lapses.

“On day one, the hospitals start feeling increased financial stress,” Kaufman said. “They experience this financial jolt.”

The Atlanta market is facing another such contract disruption. Anthem has alerted consumers that Northside Hospital and its facilities may not be part of its network come Jan. 1. While the Wellstar vs. UnitedHealthcare tug-of-war involves an estimated 80,000 consumers, the Northside contract could affect four or five times that many, according to Northside officials.

“Anthem’s timing is very unfavorable to our patients,” said Lee Echols, a Northside spokesperson. “It’s hard to understand. We’re still in a pandemic, and this is the open enrollment period for health care policyholders. Many people are returning to their physicians and hospitals for deferred care, and Anthem’s threats make that process really challenging.”

But Anthem spokesperson Christina Gaines said that the company is fighting to curb health care costs, and that Northside is one of the most expensive systems in Georgia.

The showdown has consumers such as Carol Lander of Sandy Springs, Georgia, concerned and confused.

She has been an Anthem member for years and has used nearby Northside facilities and doctors. She’s now shopping for other plans to see if they include Northside in their networks. One insurance plan has her doctor but not her sons’ physician.

“It’s so frustrating,” said Lander. “This is a huge deal in this area.”

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