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

KFF Health News, June 2, 2020

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

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

By Nina Feldman, WHYY

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

He’s still living on the streets.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Police resumed arrests at the beginning of May.

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

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

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

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

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

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

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

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

KFF Health News, June 2, 2020

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

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

By Rachel Bluth

California’s health care industry has a consolidation problem.

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

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

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

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

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

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

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

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

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

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

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

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

Yet Becerra isn’t convinced passage will be smooth.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A Senator From Arizona Emerges As A Pharma Favorite

KFF Health News, May 30, 2020

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

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

By Jay Hancock and Elizabeth Lucas

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

KFF Health News, May 28, 2020

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

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

By Christie Aschwanden

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

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

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

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

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

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

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

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

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

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

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

Accuracy Questions Raised

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

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

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

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

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

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

Officials Back Off, Community Members Step In

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

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

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

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

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

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

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

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

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

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

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

Nearly Half of Americans Delayed Medical Care Due to Pandemic

KFF Health News, May 27, 2020

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

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

By Elizabeth Lawrence

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

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

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

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

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

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

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

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

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

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

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

Elizabeth Lawrence: elizabethla@kff.org

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

KFF Health News, May 26, 2020

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

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

By Phil Galewitz

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

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

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

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

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

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

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

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

Then the bill came.

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

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

Service Provider: Denver Health, a large public health system

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Coronavirus Tests The Value Of Artificial Intelligence In Medicine

KFF Health News, May 23, 2020

Overall, AI's implementation in everyday clinical care is less common than hype over the technology would suggest. Yet the coronavirus crisis has inspired some hospital systems to accelerate promising applications.

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

By Ashley Gold

Dr. Albert Hsiao and his colleagues at the University of California-San Diego health system had been working for 18 months on an artificial intelligence program designed to help doctors identify pneumonia on a chest X-ray. When the coronavirus hit the United States, they decided to see what it could do.

The researchers quickly deployed the application, which dots X-ray images with spots of color where there may be lung damage or other signs of pneumonia. It has now been applied to more than 6,000 chest X-rays, and it’s providing some value in diagnosis, said Hsiao, the director of UCSD’s augmented imaging and artificial intelligence data analytics laboratory.

His team is one of several around the country that has pushed AI programs developed in a calmer time into the COVID-19 crisis to perform tasks like deciding which patients face the greatest risk of complications and which can be safely channeled into lower-intensity care.

The machine-learning programs scroll through millions of pieces of data to detect patterns that may be hard for clinicians to discern. Yet few of the algorithms have been rigorously tested against standard procedures. So while they often appear helpful, rolling out the programs in the midst of a pandemic could be confusing to doctors or even dangerous for patients, some AI experts warn.

“AI is being used for things that are questionable right now,” said Dr. Eric Topol, director of the Scripps Research Translational Institute and author of several books on health IT.

Topol singled out a system created by Epic, a major vendor of electronic health records software, that predicts which coronavirus patients may become critically ill. Using the tool before it has been validated is “pandemic exceptionalism,” he said.

Epic said the company’s model had been validated with data from more 16,000 hospitalized COVID-19 patients in 21 health care organizations. No research on the tool has been published, but, in any case, it was “developed to help clinicians make treatment decisions and is not a substitute for their judgment,” said James Hickman, a software developer on Epic’s cognitive computing team.

Others see the COVID-19 crisis as an opportunity to learn about the value of AI tools.

“My intuition is it’s a little bit of the good, bad and ugly,” said Eric Perakslis, a data science fellow at Duke University and former chief information officer at the Food and Drug Administration. “Research in this setting is important.”

Nearly $2 billion poured into companies touting advancements in health care AI in 2019. Investments in the first quarter of 2020 totaled $635 million, up from $155 million in the first quarter of 2019, according to digital health technology funder Rock Health.

At least three health care AI technology companies have made funding deals specific to the COVID-19 crisis, including Vida Diagnostics, an AI-powered lung-imaging analysis company, according to Rock Health.

Overall, AI’s implementation in everyday clinical care is less common than hype over the technology would suggest. Yet the coronavirus crisis has inspired some hospital systems to accelerate promising applications.

UCSD sped up its AI imaging project, rolling it out in only two weeks.

Hsiao’s project, with research funding from Amazon Web Services, the University of California and the National Science Foundation, runs every chest X-ray taken at its hospital through an AI algorithm. While no data on the implementation has been published yet, doctors report that the tool influences their clinical decision-making about a third of the time, said Dr. Christopher Longhurst, UC San Diego Health’s chief information officer.

“The results to date are very encouraging, and we’re not seeing any unintended consequences,” he said. “Anecdotally, we’re feeling like it’s helpful, not hurtful.”

AI has advanced further in imaging than other areas of clinical medicine because radiological images have tons of data for algorithms to process, and more data makes the programs more effective, said Longhurst.

But while AI specialists have tried to get AI to do things like predict sepsis and acute respiratory distress — researchers at Johns Hopkins University recently won a National Science Foundation grant to use it to predict heart damage in COVID-19 patients — it has been easier to plug it into less risky areas such as hospital logistics.

In New York City, two major hospital systems are using AI-enabled algorithms to help them decide when and how patients should move into another phase of care or be sent home.

At Mount Sinai Health System, an artificial intelligence algorithm pinpoints which patients might be ready to be discharged from the hospital within 72 hours, said Robbie Freeman, vice president of clinical innovation at Mount Sinai.

Freeman described the AI’s suggestion as a “conversation starter,” meant to help assist clinicians working on patient cases decide what to do. AI isn’t making the decisions.

NYU Langone Health has developed a similar AI model. It predicts whether a COVID-19 patient entering the hospital will suffer adverse events within the next four days, said Dr. Yindalon Aphinyanaphongs, who leads NYU Langone’s predictive analytics team.

The model will be run in a four- to six-week trial with patients randomized into two groups: one whose doctors will receive the alerts, and another whose doctors will not. The algorithm should help doctors generate a list of things that may predict whether patients are at risk for complications after they’re admitted to the hospital, Aphinyanaphongs said.

Some health systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn’t need AI to deal with the coronavirus.

Stanford Health Care is not using AI to manage hospitalized patients with COVID-19, said Ron Li, the center’s medical informatics director for AI clinical integration. The San Francisco Bay Area hasn’t seen the expected surge of patients who would have provided the mass of data needed to make sure AI works on a population, he said.

Outside the hospital, AI-enabled risk factor modeling is being used to help health systems track patients who aren’t infected with the coronavirus but might be susceptible to complications if they contract COVID-19.

At Scripps Health in San Diego, clinicians are stratifying patients to assess their risk of getting COVID-19 and experiencing severe symptoms using a risk-scoring model that considers factors like age, chronic conditions and recent hospital visits. When a patient scores 7 or higher, a triage nurse reaches out with information about the coronavirus and may schedule an appointment.

Though emergencies provide unique opportunities to try out advanced tools, it’s essential for health systems to ensure doctors are comfortable with them, and to use the tools cautiously, with extensive testing and validation, Topol said.

“When people are in the heat of battle and overstretched, it would be great to have an algorithm to support them,” he said. “We just have to make sure the algorithm and the AI tool isn’t misleading, because lives are at stake here.”

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

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

Congress Said COVID-19 Tests Should Be Free — But Who's Paying?

KFF Health News, May 22, 2020

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

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

By Blake Farmer, Nashville Public Radio

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Coronavirus Tests the Value of Artificial Intelligence in Medicine

KFF Health News, May 22, 2020

Many see the COVID-19 crisis as an opportunity to learn about the value of AI tools.

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

By Ashley Gold

Dr. Albert Hsiao and his colleagues at the University of California-San Diego health system had been working for 18 months on an artificial intelligence program designed to help doctors identify pneumonia on a chest X-ray. When the coronavirus hit the United States, they decided to see what it could do.

The researchers quickly deployed the application, which dots X-ray images with spots of color where there may be lung damage or other signs of pneumonia. It has now been applied to more than 6,000 chest X-rays, and it's providing some value in diagnosis, said Hsiao, the director of UCSD's augmented imaging and artificial intelligence data analytics laboratory.

His team is one of several around the country that has pushed AI programs developed in a calmer time into the COVID-19 crisis to perform tasks like deciding which patients face the greatest risk of complications and which can be safely channeled into lower-intensity care.

The machine-learning programs scroll through millions of pieces of data to detect patterns that may be hard for clinicians to discern. Yet few of the algorithms have been rigorously tested against standard procedures. So while they often appear helpful, rolling out the programs in the midst of a pandemic could be confusing to doctors or even dangerous for patients, some AI experts warn.

"AI is being used for things that are questionable right now," said Dr. Eric Topol, director of the Scripps Research Translational Institute and author of several books on health IT.

Topol singled out a system created by Epic, a major vendor of electronic health records software, that predicts which coronavirus patients may become critically ill. Using the tool before it has been validated is "pandemic exceptionalism," he said.

Epic said the company's model had been validated with data from more 16,000 hospitalized COVID-19 patients in 21 health care organizations. No research on the tool has been published, but, in any case, it was "developed to help clinicians make treatment decisions and is not a substitute for their judgment," said James Hickman, a software developer on Epic's cognitive computing team.

Others see the COVID-19 crisis as an opportunity to learn about the value of AI tools.

"My intuition is it's a little bit of the good, bad and ugly," said Eric Perakslis, a data science fellow at Duke University and former chief information officer at the Food and Drug Administration. "Research in this setting is important."

Nearly $2 billion poured into companies touting advancements in health care AI in 2019. Investments in the first quarter of 2020 totaled $635 million, up from $155 million in the first quarter of 2019, according to digital health technology funder Rock Health.

At least three health care AI technology companies have made funding deals specific to the COVID-19 crisis, including Vida Diagnostics, an AI-powered lung-imaging analysis company, according to Rock Health.

Overall, AI's implementation in everyday clinical care is less common than hype over the technology would suggest. Yet the coronavirus crisis has inspired some hospital systems to accelerate promising applications.

UCSD sped up its AI imaging project, rolling it out in only two weeks.

Hsiao's project, with research funding from Amazon Web Services, the University of California and the National Science Foundation, runs every chest X-ray taken at its hospital through an AI algorithm. While no data on the implementation has been published yet, doctors report that the tool influences their clinical decision-making about a third of the time, said Dr. Christopher Longhurst, UC San Diego Health's chief information officer.

"The results to date are very encouraging, and we're not seeing any unintended consequences," he said. "Anecdotally, we're feeling like it's helpful, not hurtful."

AI has advanced further in imaging than other areas of clinical medicine because radiological images have tons of data for algorithms to process, and more data makes the programs more effective, said Longhurst.

But while AI specialists have tried to get AI to do things like predict sepsis and acute respiratory distress — researchers at Johns Hopkins University recently won a National Science Foundation grant to use it to predict heart damage in COVID-19 patients — it has been easier to plug it into less risky areas such as hospital logistics.

In New York City, two major hospital systems are using AI-enabled algorithms to help them decide when and how patients should move into another phase of care or be sent home.

At Mount Sinai Health System, an artificial intelligence algorithm pinpoints which patients might be ready to be discharged from the hospital within 72 hours, said Robbie Freeman, vice president of clinical innovation at Mount Sinai.

Freeman described the AI's suggestion as a "conversation starter," meant to help assist clinicians working on patient cases decide what to do. AI isn't making the decisions.

NYU Langone Health has developed a similar AI model. It predicts whether a COVID-19 patient entering the hospital will suffer adverse events within the next four days, said Dr. Yindalon Aphinyanaphongs, who leads NYU Langone's predictive analytics team.

The model will be run in a four- to six-week trial with patients randomized into two groups: one whose doctors will receive the alerts, and another whose doctors will not. The algorithm should help doctors generate a list of things that may predict whether patients are at risk for complications after they're admitted to the hospital, Aphinyanaphongs said.

Some health systems are leery of rolling out a technology that requires clinical validation in the middle of a pandemic. Others say they didn't need AI to deal with the coronavirus.

Stanford Health Care is not using AI to manage hospitalized patients with COVID-19, said Ron Li, the center's medical informatics director for AI clinical integration. The San Francisco Bay Area hasn't seen the expected surge of patients who would have provided the mass of data needed to make sure AI works on a population, he said.

Outside the hospital, AI-enabled risk factor modeling is being used to help health systems track patients who aren't infected with the coronavirus but might be susceptible to complications if they contract COVID-19.

At Scripps Health in San Diego, clinicians are stratifying patients to assess their risk of getting COVID-19 and experiencing severe symptoms using a risk-scoring model that considers factors like age, chronic conditions and recent hospital visits. When a patient scores 7 or higher, a triage nurse reaches out with information about the coronavirus and may schedule an appointment.

Though emergencies provide unique opportunities to try out advanced tools, it's essential for health systems to ensure doctors are comfortable with them, and to use the tools cautiously, with extensive testing and validation, Topol said.

"When people are in the heat of battle and overstretched, it would be great to have an algorithm to support them," he said. "We just have to make sure the algorithm and the AI tool isn't misleading, because lives are at stake here."

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

Analysis: Get Ready for the Vaccine — They're Never Simple

KFF Health News, May 21, 2020

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

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

By Arthur Allen

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Arthur Allen: ArthurA@kff.org

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