Wear a Mask. If Only It Were That Simple.

KFF Health News, October 3, 2020

Scientists are warning of a larger wave of infection this winter. They agree the simplest, easiest way to fight that surge is to get most people to wear masks most of the time.

This article was published on Friday, October 2, 2020 in Kaiser Health News.

By Michael McAuliff and Julio Ochoa, WUSF and Jackie Fortiér, KPCC and Blake Farmer, Nashville Public Radio

Nils Hase, a retiree who lives in Tarpon Springs, Florida, is wearing a mask and loading his Home Depot haul into his car on a recent weekday afternoon. In the store, because Home Depot insists customers and staff across the country wear masks, most faces were covered.

But out here in the parking lot, in a state with a serious infection rate but no mask mandate, plenty of those masks hang down around people’s chins.

“It bothers me. They are being defiant,” Hase said. “And most of the people I see that walk in without a mask are just looking for a fight. They are asking you to ‘Just ask me. Just give me a reason to yell at you.’ I just stay away from them and keep on with my own life.”

Six and a half months after President Donald Trump declared the coronavirus emergency, COVID-19 has killed more than 207,000 Americans and infected 7.3 million, now including Trump himself and the first lady.

Scientists are warning of a larger wave of infection this winter. They agree the simplest, easiest way to fight that surge is to get most people to wear masks most of the time.

Yet the political fight over face coverings rages. It plays out on city streets, in suburban grocery stores, in rural sheriff’s offices and at the highest echelons of government — all the way to the presidential debate stage this week in Cleveland. There, most of Trump’s contingent refused to wear required masks, and one of them tested positive soon afterward. Only time will tell if they spread the infection, but their behavior is mirrored across the nation.

Hefty Price in Iowa

In April, Iowa health officials cut an agreement with Iowa University to do modeling on the impact of coronavirus. Among the data are estimates of future death rates and the projection that more than a thousand Iowans could be saved by adopting a universal mask policy.

Later that month, the researchers warned Republican Gov. Kim Reynolds not to ease restrictions aimed at curtailing the virus, saying a spike would result later in the year. They also recommended a strong policy on facial coverings, producing a report that said face shields would dramatically lower the virus’s toll.

Reynolds took none of that advice. She started easing restrictions in late April. She argued it was more important to reopen the state’s economy while encouraging people to be responsible and wear masks than to throw down a mandate she called unenforceable.

“I think the goal is to strongly encourage and recommend that people wear them,” she said in late August. “I believe that people are.”

Yet at that moment, Iowa was proving the university’s predictions true, suffering the highest infection rate in the nation. In late September, the state was one of only seven that remained in the “red zone,” averaging more than 890 new infections a day.

The governor’s intransigence on masks highlights a troubling problem. At a time when experts believe the nation needs to unite around a strategy to curb a potentially catastrophic winter, the cheapest, best option — masks — have become increasingly politicized. Even Republicans like Reynolds, who agree masks work, refuse to take the advice of their experts. They oppose mandates and favor an educational approach that many people actively resist.

Dissent Within the Trump Administration

The trouble starts at the top. The Trump administration’s leading medical advisers have testified repeatedly that masks were the country’s best tool to blunt a second wave that could be significantly deadlier than the initial spike.

Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, went as far to say face coverings were a more certain bet than a vaccine if everyone would wear them.

“If we did it for six, eight, 10, 12 weeks, we’d bring this pandemic under control,” Redfield said during a Sept. 16 hearing. “They are our best defense.”

Trump contradicted him before the day was done, and just a few days earlier, as the president and his coterie did in Cleveland, Trump modeled exactly the opposite behavior. At a campaign rally of thousands in Nevada, he cheered on the mostly maskless crowd. The next day, he held a massive mask-optional indoor rally at a warehouse in Henderson, Nevada, defying state restrictions. He advised the owner (who was later fined $3,000) that he’d protect the man if the state went after him.

“I’ll be with you all the way. Don’t worry about a thing,” Trump said.

But Trump’s actions and statements are worrisome for scientists and public health experts. They have watched in horror and frustration as the president’s dismissive attitude toward masks and COVID-19 itself has gone hand in hand with growing politicization of the public health response.

Meanwhile, the White House Coronavirus Task Force, led by Vice President Mike Pence, issued a “state report” on Montana on Sept. 20 that included the suggestion that the state “consider fines for violations of face mask mandates in high transmission areas.” At a press conference, Gov. Steve Bullock, a Democrat, said fining people would not be “the Montana way.” The state is, however, one of 34 with a mask mandate in place.

Indeed, the single-strongest predictor of whether or not a state will mandate strong mask policies bears little relationship to a state’s disease problem, according to a recent study by a team at the University of Washington.

After analyzing comprehensive data on mask policies, researchers led by Chris Adolph, a professor of political science and statistics, found that having a Republican governor would predict a 30-day delay in recommending mask policies. In a state that is also ideologically conservative, the delay would be closer to 40 days. A state’s death rate or infection rate had a much weaker influence.

“Because mask mandates are far less costly than business closures or stay-at-home orders, when we started to monitor these policies in April, we hoped their adoption would be universal,” Adolph said. “Instead, we found the same pattern: Republican governors resisted mandating masks even when public health conditions called for them.”

Adolph’s research suggests Trump is at least amplifying disdain for masks and, in fact, the phenomenon has been playing out across the country, most strikingly among some of Trump’s most ardent supporters — law enforcement and extremely conservative politicians.

Anti-Mask Sheriffs

In Washington state, Florida and even Democratic California, sheriffs made headlines by taking actions in opposition to local masking guidelines.

In Washington’s Snohomish County, where the first case of COVID-19 was discovered in the United States, Sheriff Adam Fortney declared in an April Facebook post: “The impacts of COVID 19 no longer warrant the suspension of our constitutional rights.”

Democratic Gov. Jay Inslee ordered people to wear masks in public in late June, just as a summer-long rise of infections began. Lewis County Sheriff Rob Snaza responded by telling a cheering crowd outside a church, “Don’t be a sheep.” Klickitat County Sheriff Bob Songer on the radio called Inslee “an idiot” over the order.

In Florida, anti-mask resistance has been especially fierce. Again, sheriffs offered the most startling opposition. One, Marion County Sheriff Billy Woods, banned masks for his deputies and visitors to the sheriff’s department offices, though he later relented on visitors.

Even in solid-blue Los Angeles County, the sheriff’s office was reprimanded by the county inspector general because deputies refused to wear masks, in violation of public health orders.

Surprisingly, officials there who support masks were disinclined to push tough enforcement.

“One of the things in all of this is we’re not going to enforce or fine our way out of this,” L.A.’s top public health official, Dr. Muntu Davis, told reporters recently.

Researchers disagree with Davis and Reynolds, not because education doesn’t work, but because it takes a long, sustained effort.

“Developing and deploying health education programs takes time, so in emergencies where rapid compliance is essential for reducing the spread of a novel pathogen, mandates are a critical element,” said Adolph.

Tickets in Tennessee

That’s the path officials took in Nashville, Tennessee, though initially officers opted for a more lenient approach than the mayor wanted. They had to be forced to write tickets with a potential fine of $50. The police still mostly have been giving warnings — thousands on any given weekend — but they’ve also written dozens of tickets and made some arrests.

City officials credit the crackdown with curbing COVID-19, even as it ran rampant in rural Tennessee counties where there are no mask mandates. In late September, Nashville’s Davidson County had 13.5 cases per 100,000 people, while more than three dozen less populous counties had “red zone” infection rates, with more than 25 cases per 100,000 people.

Amid the conflicting messages, including where enforcement has worked, not everyone is convinced that covering your nose and mouth is something that should rise to the level of police.

“I think they have better things to do than force anybody to wear a mask,” said Jennifer Johnson, an X-ray tech in downtown Nashville. “I think it should be at your own risk, but that’s just my opinion.”

Lawsuits Plus Weekly Protests in Florida

Plenty of conservative-leaning citizens and lawmakers agree with her, to the point of suing to block mandates.

In Hillsborough County, Florida, home to Tampa, county commissioners must vote each week to renew a state of emergency that requires masks to be worn in indoor public places.

Jason Kimball, a regular speaker at those meetings opposing the order, grew so angry he started a GoFundMe campaign for a lawsuit. He hit his $5,000 goal in 24 hours.

“You can only do so much as a commission legally, without violating the state constitution and the United States Constitution,” Kimball said at a recent meeting.

Rep. Anthony Sabatini, a state lawmaker who has filed 15 similar lawsuits on behalf of others all over the state, took the case. He claims mask ordinances are an overreach by government and a violation of Florida’s privacy clause.

“The government has never done this before,” Sabatini said. “It’s never told people that they have to wear masks everywhere they go all day long, and that’s basically what it’s come to.”

A judge dismissed Sabatini’s case in Hillsborough County and several of his other lawsuits have been denied.

Like Kimball and many other mask opponents, Sabatini insists masks don’t work, saying anyone can Google it to find out.

Scientists beg to differ, and are distressed political ideology has trumped real data and made it impossible for science to dictate the best responses.

“That’s certainly been a source of frustration for those of us who work in public health,” said Joe Cavanaugh, who runs the Department of Biostatistics at the University of Iowa’s College of Public Health and helped build the modeling distributed to Gov. Reynolds.

Watching Other Countries Succeed

Dr. Ali Mokdad, a former outbreak scientist at the CDC who works for the Institute for Health Metrics and Evaluation at the University of Washington’s School of Medicine, finds it especially painful to watch other countries deal with the pandemic better than the United States.

He traveled the globe to stop outbreaks, and now other countries are using the methods he and his former colleagues at the CDC taught them.

“Why aren’t people wearing a mask? For the first time in our history, of humankind, we have a measure that is really very cheap,” he said. “You can make it at home yourself from something old you have. It saves lives. It saves the economy.”

It is doubly frustrating — and alarming — because while mask adoption had been rising over the summer, it’s recently begun to slip. The shift caused IHME to adjust upward its model of how many people would get infected and die by Jan. 1 in the United States.

“This change in the last week is due mainly to the decline in masks and the increase in mobility,” Mokdad said.

The death rate estimate has since moderated — projected this week at 372,000.

One place where mask use has declined is Iowa, where Mokdad said only 28% of people say in surveys they are always likely to wear a mask when they go out.

Scientists at the University of Iowa had been using data similar to what IHME uses for its coronavirus models. The state won’t let the university make its modeling public, but when some of its data was online, the projection was that Iowa would see more than 1,000 deaths by the end of August if no additional safety steps were taken. As of Tuesday, the state’s official toll was 1,328.

By IHME’s most recent similar estimates, more than 3,400 Iowans will die by Jan. 1. With a universal mask requirement, some 1,600 could be saved. Nationally, nearly 115,000 lives could be spared.

Winter Is Coming

Cavanaugh would welcome even a toothless mandate to spare some of those lives. “Just sending that message at the state level is, I think, an important step in emphasizing the importance of it,” said the University of Iowa researcher.

Sixteen states still do not have a mandate, all of them led by Republicans.

The especially frightening element to the anti-mask movement is that it can only worsen what scientists already warn is going to be a bad winter.

When it’s cold, the virus can survive longer on surfaces, and people are stuck indoors where it can become more concentrated in the aerosolized droplets people exhale.

“We’ve seen it in our data. We’ve seen it in other countries,” Mokdad said. “It’s very strong, and it’s going to happen in the U.S., unfortunately.”

Back in Florida, Nils Hase will keep wearing his mask.

“I’ve always believed in the science behind it,” Hase said. “It’s a virus and we need to be aware of what’s going on. People who don’t, they’re just idiots.”

This story is from a reporting partnership that includes Health News Florida, KPCC, Nashville Public Radio, KHN and NPR. 

Trump's COVID Program for Uninsured People: It Exists, but Falls Short

KFF Health News, October 2, 2020

The administration's program appears to provide narrow financial assistance for COVID-related health care costs. But patients who fall through the cracks may find themselves facing substantial bills.

This article was published on Friday, October 2, 2020 in Kaiser Health News.

By Julie Appleby 

"For example, when the COVID-19 pandemic hit, my Administration implemented a program to provide any individual without health-insurance coverage access to necessary COVID‑19‑related testing and treatment."

President Donald Trump, in an executive order, Sept. 24, 2020

In a wide-ranging executive order, President Donald Trump this month outlined some of the efforts he has made to affect health care since taking office.

This story was produced in partnership with PolitiFact.

This story can be republished for free (details).

One involved uninsured people and the current pandemic. The administration, Trump said, set up a program to provide them "access to necessary COVID-19-related testing and treatment."

Did it?

We asked the White House for more specifics about the program Trump mentioned but did not get a reply.

Nonetheless, experts said he is likely referring to reimbursement assistance to help pay the COVID testing and treatment costs of uninsured patients, which is available through the Provider Relief Fund.

This fund was established by Congress in the Coronavirus Aid, Relief and Economic Security Act to bolster eligible health care providers for lost revenue or expenses related to the pandemic.

The Trump administration said this spring it would tap into the fund to reimburse providers who test and treat uninsured COVID patients; hence, the executive order's reference to "coverage access." Here's how it works: The assistance doesn't go directly to patients. Instead, health care providers can apply for reimbursement of costs associated with testing or treating uninsured people for COVID-19. Patients must be uninsured and their primary diagnosis must be COVID-19. The program does not check immigration status in determining eligibility.

Our experts acknowledged that the fund overall has helped providers by making money available, especially important since many physicians, hospitals and other health care facilities are struggling with reduced income as elective surgeries and visits have nose-dived during the pandemic. The relief fund pays providers at standard Medicare rates for testing or treating uninsured COVID patients.

Still, many patients, and some providers, don't know about the funding to reimburse for uninsured costs. And even providers who are aware of it don't necessarily know how to use it. Hospitals and other providers are not required to publicize it. Additionally, eligibility restrictions can make it hard for some patients to qualify to have their bills paid.

"It's absolutely not broad protection or a guarantee of coverage," said Karen Pollitz, a senior fellow with KFF. "People are uninsured. They remain uninsured. If they don't know how to ask for this or the provider can't figure out how to use it, [their bills] are uncollectable." (KHN is an editorially independent program of KFF.)

What Exactly Is 'Coverage Access'?

Even before the pandemic, uninsured patients had a hard time finding medical care, often delaying needed medical services until a crisis sent them to the hospital. Federal law ensures that no one needing emergency care is turned away and must be treated until stabilized.

The relief fund program came amid calls from health insurers, Democrats and others for the Trump administration to reopen enrollment in the Affordable Care Act through the federal marketplace, which operates in 38 states.

Usually, the insurance sign-up period occurs each November. When the virus began causing concern in the U.S. in the spring, some of the 12 states (and the District of Columbia) that run their own marketplaces moved to reopen because of the pandemic, so uninsured residents could sign up.

But the Trump administration decided not to reopen the federal marketplace. Uninsured people who want to enroll either have to wait to sign up starting in November for coverage next year or see if they qualify for special enrollment because they have experienced one of several "qualifying life events." One such event is job loss that ends health coverage.

That potentially left hospitals and other medical providers holding the bag for the uninsured who fall sick with COVID.

Enter the relief fund.

The Health Resources and Services Administration said the fund so far has handed out a little more than $1 billion for uninsured patient reimbursement, a substantial amount but well short of publicized estimates of what it will ultimately cost hospitals and medical providers to test and treat uninsured COVID patients.

"We are appreciative" that Congress and the administration "did provide some coverage for the uninsured," said Molly Smith, vice president for coverage and state issues at the American Hospital Association. "But we don't think it's the best approach for covering the uninsured." Hospitals would have preferred something that "would have expanded comprehensive coverage."

Parts of the program work well, she said, but "there are some pretty substantial flaws."

Why 'Access' Becomes a Slippery Term

When it comes to program eligibility, two main criteria present hurdles for patients: fitting the definition of "uninsured" and receiving a primary diagnosis of COVID-19.

Failing either test could make a patient ineligible. In that case, the hospital or medical provider can either seek payment from the patient — or eat the cost.

To qualify for coverage, the patient cannot have any kind of health insurance coverage, according to guidelines published online by HRSA.

Sources:

Telephone interview with Karen Pollitz, senior fellow at KFF, Sept. 25, 2020

Telephone interview with Jack Hoadley, research professor emeritus at Georgetown University, Sept. 25, 2020

Telephone interview with Molly Smith, vice president for coverage and state issues at the American Hospital Association, Sept. 27, 2020

U.S. Department of Health and Human Services, CARES Act Provider Relief Fund, accessed Sept. 25, 2020

Politico, "Trump Rejects Obamacare Special Enrollment Period Amid Pandemic," March 31, 2020

The New York Times, "Eleven States Now Letting Uninsured Sign Up for Obamacare," March 23, 2020

Healthcare.gov, "Special Enrollment Period," accessed Sept. 25, 2020

KFF, "Limitations of the Program for Uninsured COVID-19 Patients Raise Concerns," Aug. 24, 2020

Health Resources and Services Administration, "COVID-19 Claims Reimbursement," accessed Sept. 25, 2020

Health Resources and Services Administration, "FAQS for Covid-19 Claims Reimbursement to Health Care Providers for Testing and Treatment of Uninsured," accessed Sept. 25, 2020

The New York Times, "Trump Program to Cover Uninsured Covid-19 Patients Falls Short of Promise," Aug 29, 2020, updated Sept. 17, 2020

Even having very limited coverage — such as a program in Medicaid that covers only family planning services such as birth control — would disqualify a patient, said Smith. Another disqualification would be the purchase of one of the limited coverage plans touted by the administration that don't cover all the same services an ACA plan would include.

The second hurdle: COVID-19 must be the primary diagnosis.

"If someone with a heart attack comes in and it turns out COVID is also involved — or could have even been the trigger," the provider might not be eligible for reimbursement, said Jack Hoadley, a research professor emeritus at Georgetown University.

Another common example, Smith said, is a patient with COVID-19 who develops sepsis, a life-threatening blood infection. Under long-standing coding and billing rules, sepsis would be the primary diagnosis, making any coronavirus-related patient care ineligible under the provider relief program.

Our Ruling

The Trump administration did implement a program to reimburse medical providers for testing and treatment of some uninsured patients, tapping into funding allocated by Congress.

Whether — and to what extent — the measure improved "coverage access" to care is hard to determine. The fund has paid out more than $1 billion so far.

The administration chose this route, which experts said was an incomplete fix, over following some states' lead in allowing a special enrollment period on the federal marketplace, which would have enabled people without health insurance to buy more comprehensive coverage. Meanwhile, the program has not been publicized and has confusing eligibility rules — both of which have led to speculation that it is not being used as widely as possible.

The administration's program appears to provide narrow financial assistance for COVID-related health care costs. But patients who fall through the cracks may find themselves facing substantial bills.

We rate this statement as Mostly True.

Julie Appleby: jappleby@kff.org, @Julie_Appleby

Old Drug Turned 'Cash Cow' as Company Pumped Price to $40K a Vial, Emails Show

KFF Health News, October 2, 2020

The premium price when Mallinckrodt acquired H.P. Acthar gel was $31,626 for a single vial, after Questcor had hiked it from around $100 in 2000. Mallinckrodt hiked the price five times to ultimately reach $39,864.

This article was published on Friday, October 2, 2020 in Kaiser Health News.

By Michael McAuliff

For a dad whose infant son was afflicted with a rare seizure disorder, a drug invented in 1952 was indispensable for his boy. It was also indispensable to executives at the pharmaceutical firm that acquired the drug in 2014 — not because it was a cure, but because it was a "cash cow," according to documents released at a House hearing Thursday.

The firm, Mallinckrodt Pharmaceuticals, got ahold of the venerable drug called H.P. Acthar gel by buying the company that owned it before, Questcor, for $5.8 billion in 2014.

According to the documents obtained and released by the House Oversight Committee in a broad probe of drug pricing practices, Mallinckrodt targeted Questcor primarily because of Acthar, a so-called orphan drug that helps 2,500 kids a year in the U.S. afflicted by infantile spasms.

Acthar was a "premium-priced product" with a "robust cash flow profile" that would help the company "achieve aspirational goals with a single transaction," according to the company's internal discussions.

The premium price when Mallinckrodt acquired the drug was $31,626 for a single vial, after Questcor had hiked it from around $100 in 2000, according to the committee investigation. Mallinckrodt continued the trend, hiking the price five times to ultimately reach $39,864.

That's what it cost when the father had a doctor prescribe six vials for a six-week course for his son. The premium price was a shock, and his insurance company would cover only four doses.

He appealed to Mallinckrodt.

"We are in a serious bind here," he said in a message that was among 140,000 documents obtained from the company by House investigators. "Your medication is extremely expensive and we are unable to afford the 80,000 dollars needed for the remaining 2 vials."

The father is not identified in the committee documents.

A spokesperson for the company said it helped patients who reached out "get access to Acthar," but did not specify what that entailed.

Mallinckrodt CEO Mark Trudeau told the Oversight Committee on Thursday that his firm "is steadfastly committed to knocking down barriers to patient access — that's particularly true with Acthar gel."

"We've also improved the ability of patients with a prescription to obtain Acthar through our robust free drug and commercial copay assistance programs, which lead to many patients paying nothing out-of-pocket," he said, later testifying that the company is committed to lowering the "net price" of the drug to 2015 levels.

Yet, according to the documents, knocking down barriers or lowering prices has had little to do with the interest in owning Acthar. It was more about expanding the market for the drug, and profits for the company, as was the case with five other companies hauled before the committee over two days.

Indeed, Acthar was so important to the goal that executives preparing a presentation on the company's 2018 prospects bluntly wrote: "Acthar Modernization Strategy defines the Future of the Brand as either a Growth Asset or Cash Cow."

Trudeau told the committee that presentation was never made. According to the documents, even executives preparing the material seemed aware the words were too bald — but just barely. One junior executive asked in an email, "Do we really want to say 'cash cow' to the board?" The company's chief commercial officer, Hugh O'Neill, responded, "Instead of 'cash cow,' I will replace it with profit maximizer."

Committee Chairwoman Rep. Carolyn Maloney (D-N.Y.) quizzed Trudeau on the description, asking if it's true "this is how you really see this drug, not as an innovative therapy?"

"That's in fact not true," Trudeau said. "That term is typically applied to products for which no investment is likely to be going forward, and, in fact, that's exactly the opposite."

He argued that Mallinckrodt had invested $660 million in improving manufacturing of the drug and in seeking evidence that Acthar works for many other uses that the FDA permits.

Rep. Jimmy Gomez (D-Calif.) said Trudeau's answer misled the committee and he owed Maloney an apology.

"Replacing one term with another term, 'cash cow' with 'profit maximizer,' doesn't change the intent of your company, which is to make as much money as possible," Gomez said.

The "cash cow" document was about getting more patients, saying the strategy was to convince skeptics of Acthar's other uses that it was not an "overpriced steroid," and to overcome "lack of acceptance of academic opinion leaders" whose criticism "limits product penetration."

Democrats on the committee argued that not only was Mallinckrodt's intent to squeeze as much out of Acthar as it could, but also to get it from taxpayers through Medicare, where prices cannot be negotiated by law.

Rep. Harley Rouda (D-Calif.) pointed out that about 25% of Acthar sales went through Medicare when Mallinckrodt bought Questcor, and that share is over 60% now. Revenue from Medicare rose from under $50 million in 2011 to $725 million in 2018. Overall, the drug accounted for about a third of all the company's net sales in recent years, Trudeau said.

The hearing was the second this week stemming from an investigation into sky-rocketing drug prices that the committee launched in 2019. Besides Mallinckrodt, the committee hauled in executives at Amgen, Novartis, Celgene, Bristol Myers Squibb and Teva.

"What we learned was shocking. Drug companies are hiking their prices higher and higher — and placing an ever-greater burden on the very patients who rely on these drugs to survive," Maloney said.

"We also learned that claims by drug companies that their price increases are necessary for research and development are completely bogus," she added. "The internal company documents we obtained show that drug companies hike prices almost entirely for selfish reasons — they do it to meet internal revenue targets, or to increase their own bonuses in some cases."

Republicans on the committee were far less critical of the pharmaceutical companies, though many of them also complained that drug prices are too high and that Americans should be able to pay the lower prices available to people in other nations. Some argued that clamping down on pricing in the United States might inhibit new medicines from coming to market.

Michael McAuliff: @mmcauliff ‏

 

Opinion: We Follow Laws on Seat Belts and Smoking. Why Not on Masks?

KFF Health News, October 1, 2020

Thirty-four states and Washington, D.C., have some sort of mask mandate, but many citizens and law enforcement agencies are blatantly ignoring them.

This article was published on Thursday, October 1, 2020 in Kaiser Health News.

By Elisabeth Rosenthal

I was a reporter in Rome in 2005 when Italy banned smoking in restaurants. I was skeptical. For many Italians, having a cigarette with after-dinner coffee was simply part of the meal, like dessert. Also, Italians are famously lax about following rules: They dodge their taxes and park on sidewalks. As I wrote back then: "Smokers declared — basta! — they would never comply."

But to my shock (and ease of breathing, since I have asthma), very quickly everyone did.

If the Italians could do it with cigarettes, how come so many people in the United States aren't following relatively simple mandates to prevent the spread of COVID-19, which has killed more than 200,000 Americans?

Thirty-four states and Washington, D.C., have some sort of mask mandate, but many citizens and law enforcement agencies are blatantly ignoring them.

On Sept. 13, President Donald Trump held an indoor rally with thousands of mostly unmasked supporters in Henderson, Nevada, in violation of a state mandate that prohibits gatherings of more than 50 people. Last week, Trump held a rally in an airport hangar outside Pittsburgh, where thousands of mostly maskless people were crammed, cheering, cheek-to-jowl — even though the governor had asked the campaign to follow the state's COVID-19 rules on mask use and social distancing.

An infectious disease doctor in Florida told me she felt safest when she was in the hospital because, she estimated, fewer than a fifth of the people in her community were masking or social distancing in stores, despite a mask mandate.

Some conservative groups have challenged governors' broad authority to order COVID-19 prevention measures. Last week, a judge appointed by Trump overturned Pennsylvania's limits on gatherings. But the legal standing is relatively clear. "Governors absolutely have the authority during a public health emergency to make laws — to force people to wear masks, to limit gatherings," said Jaime King, an expert on health law at the University of California Hastings College of the Law. "So I'm perplexed at why people say, 'You can't force me.'"

People who act as if these rules are optional might point to a double standard, asking why they should have to obey when others — such as protesters against racial injustice this summer — didn't. But at the protests I observed in Washington and New York City, everyone was wearing masks and mostly kept at least 3 feet apart, outdoors and moving. Yes, some people broke curfews, but there were very visible attempts at enforcement.

Mark Hall, a professor of healthcare law and public health at Wake Forest University, noted that there are what he calls "hortatory laws" — laws that are more about encouraging social norms rather than mandating behavior. But, he said, those involve "trivial" trespasses. "This does seem like a law that has much more serious consequences," he said about the masking measures. "It's not jaywalking or loitering or pooper scooping."

Maybe people just don't like masks. But we routinely obey — and police officers routinely enforce — laws with which we don't entirely agree.

You might think you can drive safely much faster than the speed limit. So maybe you push the boundary a bit, driving 65 in a 55-mph zone. But those who drive 70, 80 or more know they could well get a big ticket and so they (mostly) curb the impulse.

Many people originally objected to seat belt laws as an infringement on personal freedoms, but who doesn't buckle up these days? Not smoking in restaurants and stores is now inviolable. My family had a dog in New York City when the Canine Waste Law took effect in 1978, and it was gratifying to watch women in minks suddenly start doing their pooper-scooping duty.

A big part of the reason adherence has been so variable is that governors generally declare the mandates, and local and city officials are left to decide how to enforce them. And these simple, sensible laws to protect public health have been politicized and wrapped up in controversy as no such laws before.

So now we have some law enforcement officials announcing that they won't enforce masking laws or limits on gatherings imposed by their own governors in states like Ohio and Wisconsin.

"A sheriff or police chief giving advance notice that it's OK to break the law?" said Hall. "There's a new level of lawlessness to that." Imagine the authorities announcing it was fine to ignore stop signs.

The Italians' miraculous turnaround on restaurant smoking offers lessons. There was consistent messaging: The law was there to protect nonsmokers' health. And there were fines: 275 euros, around $320 today, for people smoking, and 220 euros for the restaurant managers or owners. The Italian police, who themselves could frequently be seen smoking while walking their beats, enforced the rule.

Gov. Andrew Cuomo was one of the few American governors who approached the coronavirus edicts almost militaristically (so un-New York) and got a tragic outbreak under control. In Maryland, a state with a Republican governor, a man who had two parties of 50 people at his home was sentenced to a year in jail.

But more governors have enforced these mandates timidly, almost apologetically. In many states, the message was muddled. In Pennsylvania, where disobedience could, on paper, lead to a $300 fine or up to 30 days in prison, state officials announced it wouldn't be enforced against individuals. Officials announced businesses could face citations if they didn't enforce the law, but the state was otherwise relying on citizens' "good sense and cooperative spirit."

The repercussions from the Trump rally that defiantly ignored Nevada's mandate? An angry tweet from the state's Democratic governor criticizing "reckless and selfish actions." Donald Ahern, the businessman who allowed the event to take place in his company's warehouse, was fined $3,000.

Enforcement is difficult when "permission comes from the top," said King. How can we expect Americans to mask up when they're watching a Trump rally and "even he is breaking the law"?

Elisabeth Rosenthal: erosenthal@kff.org, @rosenthalhealth

New Laws Keep Pandemic-Weary California at Forefront of Health Policy Innovation

KFF Health News, October 1, 2020

This year's legislative season took place against the backdrop of an unprecedented pandemic.

This article was published on Thursday, October 1, 2020 in Kaiser Health News.

By Samantha Young and Angela  

SACRAMENTO, Calif. — Though COVID-19 forced California leaders to scale back their ambitious healthcare agenda, they still managed to enact significant new laws intended to lower consumer healthcare spending and expand access to health coverage.

When Democratic Gov. Gavin Newsom concluded the chaotic legislative year Wednesday what emerged wasn't the sweeping platform he and state lawmakers had outlined at the beginning of the year. But the dozens of healthcare measures they approved included first-in-the-nation policies to require more comprehensive coverage of mental health and addiction, and thrusting the state into the generic drug-making business.

"We had less time, less money and less focus, but COVID makes the causes of expanding coverage and trying to control healthcare costs that much more important," said Anthony Wright, executive director of Health Access California, a Sacramento-based consumer advocacy group.

The governor also signed into law a raft of COVID-related bills intended to address the biggest public health emergency in a century, such as measures to stockpile protective gear for healthcare workers.

This year's legislative season took place against the backdrop of an unprecedented pandemic that sparked a statewide stay-at-home order, back-to-back emergency legislative recesses, the Capitol's first foray into remote voting and a projected $54 billion budget deficit.

Among the most controversial changes Newsom signed into law was the largest expansion of the state's family leave program since it was enacted in 2014, an upgrade opposed by the state's business interests. The tobacco industry also took a hit when Newsom approved a measure banning retail sale of flavored tobacco products, including menthol, with exceptions made for flavored hookah products. And Newsom bucked the powerful doctors' lobby by granting nurse practitioners the ability to practice without physician supervision.

But several contentious health bills stalled in the legislature and never made it to Newsom's desk, including measures that would have given the state attorney general more authority to reject hospital consolidations, expanded the state's Medicaid program, called Medi-Cal, to unauthorized immigrants ages 65 and up, and capped consumers' out-of-pocket costs for insulin.

Among Newsom's vetoes were a pair of bills that sought to expand telemedicine, as well as legislation to adopt patient privacy protections for COVID-19 genetic testing.

"I think we all wish we'd had more opportunities to move more things forward," said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee. "Under the circumstances, I think we did a good job."

Here's a look at some of the major health measures Newsom signed into law this year. Most will take effect on Jan. 1.

Behavioral Health

Lawmakers made significant changes to mental health coverage, and perhaps the most consequential is a mental health parity bill. SB-855 requires state-regulated health insurers in California to cover all treatment deemed medically necessary for mental health and substance abuse disorders, from depression to opioid addiction. Health insurers opposed the bill, arguing it would drive up healthcare spending.

Mental health parity is already enshrined in state and federal law, but advocates say insurers regularly don't cover the critical care that patients need.

Julie Snyder, a lobbyist for the Sacramento-based Steinberg Institute, which advocates for mental healthcare policy changes, called the new law a model for the rest of the country.

"There's no other state that has anything this comprehensive," Snyder said.

Another bill, SB-803, will allow peer providers — people with their own histories of mental illness or substance abuse who help other Californians navigate behavioral health issues — to be certified by the state. Once certified, they can bill Medi-Cal for their services.

Scope of Practice

Newsom gave nurse practitioners, who are nurses with advanced training and degrees, the power to practice independently, after years of failed attempts and despite major opposition from the California Medical Association, which represents doctors. Supporters say AB-890 will help address healthcare provider shortages, especially in rural and underserved communities.

Certified nurse-midwives will also be allowed to attend low-risk pregnancies in both hospital and home settings without a physician's supervision under SB-1237.

Cutting Healthcare Costs

California will enter the highly competitive generic drug market as a result of SB-852, a first-in-the-nation law that will put the state government in direct competition with private drug manufacturers.

"The cost of healthcare is way too high," Newsom said in a statement upon signing the bill.

By January, California must forge partnerships with one or more drug companies to make or distribute a broad range of generic and biosimilar drugs that are cheaper than brand-name products. The bill specifically calls for the production of the diabetes medicine insulin, because makers have hiked prices sharply in recent years.

Newsom also approved an under-the-radar healthcare transparency measure requiring the state to collect data on the amount state-regulated health insurers pay for specific medical services, from knee replacements to asthma treatments. The data could help policymakers identify excessive spending on certain treatments and provide fodder for proposals to control healthcare costs.

"While the examination of cost has slowed down, it hasn't ended," said state Sen. Richard Pan (D-Sacramento), who chairs the Senate Health Committee.

Newsom also signed legislation cementing into state law key provisions in the Affordable Care Act, a move guaranteeing Californians will not lose coverage protections should the U.S. Supreme Court strike down the law.

SB-406 will ban health insurers in California from imposing annual or lifetime limits on coverage, and also requires health insurers to cover a range of preventive care services, from cholesterol and blood pressure screenings to immunizations, without charging patients copays or deductibles.

COVID-19

As California continues to grapple with the highest COVID-19 case counts in the country, lawmakers approved a suite of bills in response to the pandemic, largely intended to protect essential workers.

Employers will have to provide written notice within one business day to employees who may have been exposed to the COVID-19 virus at their worksite. They must also report the details of workplace outbreaks to local public health authorities within 48 hours. AB-685 was prompted by major outbreaks this year at food-processing plants.

Newsom also signed legislation making it easier for firefighters, healthcare workers and other front-line workers infected with the coronavirus to get workers' compensation. SB-1159 took effect Sept. 17, the day the governor signed it.

State law now presumes these front-line workers were infected with the virus on the job unless their employers prove otherwise.

Certain employees who have been exposed to the virus will also have more paid sick leave time. Under AB-1867, food-processing companies with at least 500 workers must provide two weeks of paid sick leave to workers who have been exposed to COVID-19 or have been advised to quarantine.

The law also grants healthcare workers and emergency responders two weeks of paid sick leave, closing a loophole in a COVID-relief bill Congress approved this spring.

Two new laws will address another major challenge exposed by the coronavirus pandemic: the lack of adequate personal protective gear for healthcare workers. AB-2537 will require hospitals to stockpile a three-month supply of protective gear by April, while SB-275 mandates that the California Department of Public Health establish an additional stockpile for health and other essential workers to last 90 days during a pandemic.

Nursing homes, which have been at the epicenter of COVID-19 deaths, will be required to have a full-time "infection preventionist" on staff to help stem the spread of disease. The bill, AB-2644, also will require nursing homes to report deaths from a communicable disease to the state within 24 hours during an emergency related to that disease.

And California's roughly 40,000 licensed pharmacists will be allowed to administer COVID-19 vaccines that have been approved by the Food and Drug Administration under AB-1710.

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

Samantha Young: syoung@kff.org, @youngsamantha

Angela Hart: ahart@kff.org, @ahartreports

The Mask Hypocrisy: How COVID Memos Contradict the White House's Public Face

KFF Health News, October 1, 2020

The mixed messages from President Trump and ensuing confusion leave governors, and often state and local health officials, holding the bag of political consequences.

This article was published on Thursday, October 1, 2020 in Kaiser Health News.

By Lauren Weber and Katheryn Houghton

While the president and vice president forgo masks at rallies, the White House is quietly encouraging governors to implement mask mandates and, for some, enforce them with fines.

In reports issued to governors on Sept. 20, the White House Coronavirus Task Force recommended statewide mask mandates in Iowa, Missouri and Oklahoma. The weekly memos, some of which have been made public by the Center for Public Integrity, advocate mask usage for other states and have even encouraged doling out fines in Alaska, Idaho and, recently, Montana.

Masks, a political flashpoint since the beginning of the coronavirus pandemic, are considered by public health officials to be a top safeguard against spreading the COVID-19 virus as the country awaits a vaccine. But the president's own actions on masks have wavered: He has called them "patriotic" but often doesn't wear one himself and has contradicted the advice of the Centers for Disease Control and Prevention director. During the presidential debate Tuesday, the president said masks were "OK" and then mocked Democratic presidential candidate Joe Biden's mask-wearing habits. In the audience, some Trump family members and staffers were not wearing masks, despite the rules set by the Cleveland Clinic, which hosted the debate.

The mixed messages and ensuing confusion leave governors, and often state and local health officials, holding the bag of political consequences.

"At some point, we have to turn the corner on this ridiculous separation of what we're being told is best practice and being guided by science and data, and what the actual practices are by the people who issue them," said Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials.

So far, 16 states have yet to enact mask mandates for the general public — all of them are run by Republican governors. Three out of 4 Americans support enacting state laws to require mask-wearing in public at all times, according to an August NPR/Ipsos poll.

To be sure, messaging and the science on masks have evolved: U.S. public health officials did not recommend mask-wearing until April. And the White House argues the president has been clear.

"He recommends wearing a mask when you cannot socially distance," White House spokesperson Brian Morgenstern told KHN. "He has worn masks on numerous occasions himself when appropriate and regularly encourages others to do so, as well, when social distancing is not possible."

The pandemic task force sends weekly memos to states to share data and recommendations with leaders to help them make decisions, Morgenstern added. "They're free to share that information as they see fit."

Courtney Parella, a spokesperson for the Trump campaign, said that the staffers check the temperature of every attendee before admission to rallies, provide masks and encourage attendees to wear them, and offer hand sanitizer.

However, campaign events that President Donald Trump and Vice President Mike Pence attend often feature crowds of maskless attendees.

On Sept. 14, Pence stood before a crowd of hundreds in Belgrade, Montana, to stump for the state's Republicans, including Sen. Steve Daines, gubernatorial candidate U.S. Rep. Greg Gianforte and congressional candidate Matt Rosendale. Photos show that most who attended went without masks, including the vice president, despite a mask order in effect for the surrounding county.

Montana calls on everyone to wear masks at outdoor gatherings of 50 or more people in counties with at least four active cases when attendees don't stay 6 feet apart.

Photos show people sitting and standing close together at the event in southwestern Montana. Pence signed hats as people gathered shoulder to shoulder by the rails of a crowd divider.

Six days later, the White House coronavirus reports recommended Montana officials issue fines for those who ignore mask mandates in places the disease is spreading fast.

"What would be helpful from the White House is consistency in their recommendations and their actions," said Matt Kelley, health officer for the Gallatin City-County Health Department. "It's one thing to make a recommendation to state and local health officials to fine people. It's made more difficult to do that when we have the vice president coming here to a rally where no one, very few people, were wearing masks."

During a press call last week, Montana Gov. Steve Bullock said he didn't plan to follow the White House advice to punish those without masks. The Democrat, who is running for Senate, said it's better to encourage people to use masks than rely on fines.

But Bullock said the point of the White House's request was clear. "Even the federal government says we need to be taking wearing masks seriously," he said. "It's not just governors saying that we should do this and it's not just health experts saying we should be wearing masks."

Missouri Gov. Mike Parson is among the Republican governors who have resisted a statewide masking order, despite the White House's recommendation.

"You don't need government to tell you to wear a dang mask," Parson said in July at a Missouri Cattlemen's Association steak fry, according to the Springfield News-Leader. "If you want to wear a dang mask, wear a mask."

Parson and his wife, Teresa, tested positive for COVID-19 last Wednesday.

Spokesperson Kelli Jones said last Thursday that the governor does not plan to enact a mask order, based on an assessment of current COVID data. She added state officials consider the White House reports "really more of an FYI" than a mandate.

"It's kind of a bizarre document, truthfully," she said. "We read them and look at them — and make our own policy."

The reports, which are sent to the governors, also leave local and state public health officials in the dark, said Freeman, of NACCHO.

"If the White House were truly serious about making these — what sounds like solid, scientific-backed, data-backed recommendations — if they were truly serious about it, tell the world, share them, be transparent," she said.

Instead, former CDC director Dr. Tom Frieden said, the White House has fueled the partisan breakdown on masks.

"One of the many failures of this administration is the politicization of masks, and that has really cost lives," Frieden said. "There is no reason masks should be partisan."

Meanwhile back in Montana, Gallatin County appears to be heading toward its third surge in cases since the pandemic began.

"I don't really have a lot of time to worry about inconsistency of messaging from the White House," health officer Kelley said.

The county now has outbreaks in nursing homes and several confirmed cases in schools, he said, and the county's positivity rate is heading toward 10%.

Lauren Weber: LaurenW@kff.org, @LaurenWeberHP

Katheryn Houghton: khoughton@kff.org, @K_Hought

To Free Doctors from Computers, Far-Flung Scribes Are Now Taking Notes for Them

KFF Health News, October 1, 2020

Remote scribes are patched into the exam room's sound via a tablet or speaker, or through a video connection.

This article was published on Thursday, October 1, 2020 in Kaiser Health News.

By Sarah Kwon

Podiatrist Dr. Mark Lewis greets his first patient of the morning in his suburban Seattle exam room and points to a tiny video camera mounted on the right rim of his glasses. "This is my scribe, Jacqueline," he says. "She can see us and hear us."

Jacqueline is watching the appointment on her computer screen after the sun has set, 8,000 miles away in Mysore, a southern Indian city known for its palaces and jasmine flowers. She copiously documents the details of each visit and enters them into the patient's electronic health record, or EHR.

Jacqueline (her real first name, according to her employer), works for San Francisco-based Augmedix, a startup with 1,000 medical scribes in South Asia and the U.S. The company is part of a growing industry that profits from a confluence of healthcare trends — including, now, the pandemic — that are dispersing patient care around the globe.

Medical scribes first appeared in the 1970s as note takers for emergency room physicians. But the practice took off after 2009, when the federal HITECH Act incentivized healthcare providers to adopt EHRs. These were supposed to simplify patient record-keeping, but instead they generated a need for scribes. Doctors find entering notes and data into poorly designed EHR software cumbersome and time-consuming. So scribing is a fast-growing field in the U.S., with the workforce expanding from 15,000 in 2015 to an estimated 100,000 this year.

A 2016 study found that doctors spent 37% of a patient visit on a computer and an average of two extra hours after work on EHR tasks. EHR use contributes to physician burnout, increasingly considered a public health crisis in itself.

Before COVID-19, most scribes — typically young, aspiring health professionals — worked in the exam room a few paces away from the doctor and patient. This year, as the pandemic led patients to shun clinics and hospitals, many scribes were laid off or furloughed. Many have returned, but scribes are increasingly working online — even from the other side of the world.

Remote scribes are patched into the exam room's sound via a tablet or speaker, or through a video connection. Some create doctors' notes in real time; others annotate after visits. And some have help from speech-recognition software programs that grow more accurate with use.

While many remote scribes are based in the United States, others are abroad, primarily in India. Chanchal Toor was a dental school graduate facing limited job opportunities in India when a subcontractor to Augmedix hired her in 2015. Some of her scribe colleagues also trained or aspired to become dentists or other health professionals, she said. Now a manager for Augmedix in San Francisco, Toor said scribing, even remotely, made her feel like part of a healthcare team.

Augmedix recruits people who have a bachelor's degree or the equivalent, and screens for proficiency in English reading, listening comprehension and writing, the company said. Once on board, scribes undergo about three months of training. The curriculum includes medical terminology, anatomy, physiology and mock visits.

Revenue has grown this year, and his sales team has grown from four to 14 members, Augmedix CEO Manny Krakaris said. Sachin Gupta, CEO of IKS Health, which employs Indian doctors as remote scribes for their U.S. counterparts, projects 50% revenue growth this year for its scribing business. He said the company employs 4,000 people but declined to share how many are scribes.

Remote scribe "Edwin" gives internist Dr. Susan Fesmire more time, freeing her from having to finish 20 charts at the end of every day. "It was like constantly having homework that you don't finish," she said. With the help of "Edwin" — Fesmire said he declines to use his real name — she had the time and energy to become chief operating officer of her small Dallas practice. Edwin works for Physicians Angels, which employs 500 remote scribes in India. Fesmire pays $14 an hour for his services.

Doctors with foreign scribes say notes may need minor editing for dialectal differences and scribes may be unfamiliar with local vocabulary. "I had a patient from Louisiana," said Fesmire, "and Edwin said afterward, 'What is chicory, doctor?'" But she also praised his notes as more accurate and complete than her own.

Kevin Brady, president of Physicians Angels, said their scribes start at $500 to $600 per month, plus healthcare and retirement benefits, while senior scribes make $1,000 to $1,500 — middle-class family incomes in India. Employers are required to provide employees with health insurance, although many scribes are contractors, and the job site Indeed.com says the average salary for a scribe in India is $500 a month. Scribes in the U.S. get about $2,500.

Remote scribing is still a small part of the market. Craig Newman, chief strategy officer of HealthChannels, parent to ScribeAmerica, the largest scribing company in the U.S., said that the firm's remote scribing business has increased threefold since the pandemic's outset but that "a large majority" of the company's 26,000 U.S. scribes still work in person.

It's a highly unregulated industry for which training and certification aren't required. The service typically costs physicians $12 to $25 an hour, and studies show scribe use is linked to less time on patient documentation, higher job satisfaction and seeing more patients — which can mean more revenue.

For patients, studies suggest scribes have a positive or neutral effect on satisfaction. Some have privacy concerns, though, and state laws vary on whether a patient must be notified that someone is watching and listening many miles away.

Only 1% of patients refuse a remote scribe when asked by physicians at Massachusetts General Physicians Organization, said Dr. David Ting, the practice's chief medical information officer. His group, an IKS Health client, always seeks patient consent, Ting said.

Scribes aren't for everyone, though. Janis Ulevich, a retiree in Palo Alto, California, declines her primary care doctor's remote scribe. "Conversations with your doctor can be intimate," said Ulevich. "I don't like other people listening in."

Some patients may not have the opportunity to decline. With limited exceptions, federal laws like HIPAA, the Health Insurance Portability and Accountability Act of 1996, don't require doctors to seek a patient's consent before sharing their health information with a company that supports the practice's work (like a scribe firm), as long as that company signed a contract agreeing to protect the patient's data, said Chris Apgar, a former HIPAA compliance officer.

About one-quarter of U.S. states require all parties in a conversation to agree to be recorded, meaning they require a patient's permission. Some states also have special privacy protections for certain groups, like people with HIV/AIDS, or very strict informed-consent or privacy laws, said Matt Fisher, a partner at Massachusetts law firm Mirick O'Connell.

Remote scribing also raises cybersecurity concerns. Reported data breaches are rare, but some scribe companies have lax security, said Cliff Baker, CEO of the healthcare cybersecurity firm Corl Technologies.

The next step in the trend could be no human scribes at all. Tech giants like Google, EHR companies and venture-backed startups are developing or already marketing artificial intelligence tools aimed at reducing or eliminating the need for humans to document visits.

AI and scribes won't eliminate physician burnout that stems from the nature of the healthcare system, said Dr. Rebekah Gardner, an associate professor of medicine at Brown University who researches the issue. Neither can take on burnout-driving EHR tasks like submitting requests for insurance company approval of procedures, drugs and tests, she said.

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

Sarah Kwon: @skwonjournalist

 

Post-COVID Clinics Get Jump-Start From Patients With Lingering Illness

KFF Health News, September 30, 2020

A small but growing number of clinics are focusing on the long-term treatment and study patients who have had the unpredictable coronavirus.

This article was published on Wednesday, September 30, 2020 in Kaiser Health News.

By Julie Appleby   

Clarence Troutman survived a two-month hospital stay with COVID-19, then went home in early June. But he's far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

"Before COVID, I was a 59-year-old, relatively healthy man," said the broadband technician from Denver. "If I had to say where I'm at now, I'd say about 50% of where I was, but when I first went home, I was at 20%."

He credits much of his progress to the "motivation and education" gleaned from a new program for post-COVID patients at the University of Colorado, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurological concerns, anxiety and depression.

"We need to think about how we're going to provide care for patients who may be recovering for years after the virus," said Dr. Sarah Jolley, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth's Post-Covid Clinic, where Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California-San Francisco, Stanford University Medical Center and the University of Pennsylvania. The Cleveland Clinic plans to open one early next year. And it's not just academic medical centers: St. John's Well Child and Family Center, part of a network of community clinics in South Central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

"Some of our patients, even those on a ventilator on death's door, will come out remarkably unscathed," said Dr. Lekshmi Santhosh, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UC-San Francisco, called the OPTIMAL clinic. "Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain and shortness of breath, and there's a whole spectrum in between."

'Staggering' Medical Need

It's too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage six weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Dr. Zijian Chen, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct — and Chen emphasized that more research is needed to make sure — it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% — say 500,000 — already have long-lasting symptoms, "that number is staggering," Chen said. "How much medical care will be needed for that?"

Though startup costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Chen at Mount Sinai said the specialized centers can help lower health spending by providing more cost-effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

"We've seen patients that when they come in, they've already had four MRI or CT scans and a stack of bloodwork," he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what's causing patients' long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

"I believe in the patients," said Chen.

About half the clinic's patients have received test results showing damage, said Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

"That makes it more difficult to treat," said Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he's heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

"In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab," he said. "Even if the primary thing these clinics did was to say to patients, 'This is real, it is not all in your head,'" he added, "that impact would be important."

A Question of Feasibility

Financing is the largest obstacle, program proponents say. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

"So, it's not a great time to be pitching a new activity that requires a startup subsidy," said Glenn Melnick, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Santhosh. Mount Sinai's Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Jackson, at Vanderbilt, said unfortunately there's not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

"In the early days, there may have been questions about how much value does this add," he noted. "Now, the question is not so much is it a good idea, but is it feasible?"

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute.

"If these guys get good at treating long-term symptoms, that's good for all of us," said Nichols. "There's not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions."

Julie Appleby: jappleby@kff.org, @Julie_Appleby

What We Know About the Airborne Spread of the Coronavirus

KFF Health News, September 30, 2020

The emerging picture is a work-in-progress, but many of the pieces do point toward the potential for airborne transmission.

This story was published on Wednesday, September 30, 2020 in Kaiser Health News.

By Jon Greenberg, PolitiFact

The federal government did a quick pivot on the threat of the coronavirus spreading through the air, changing a key piece of guidance over the weekend.

On Sept. 18, the Centers for Disease Control and Prevention warned that tiny airborne particles, not just the bigger water droplets from a sneeze or cough, could infect others. It cited growing "evidence."

By Sept. 21, that warning was gone from its website, with a note saying it had been posted in error and the CDC was in the process of updating its recommendations.

The move put the CDC in the middle of a debate over how the coronavirus infects people. Its guidelines could make the difference between restaurants, bars and other places where people gather fully reopening sooner or much later.

And it raised more questions about politics at the public health agency and whether White House officials are dictating policy to health authorities.

So what does the science on airborne transmission actually say?

The emerging picture is a work-in-progress, but many of the pieces do point toward the potential for airborne transmission.

The Challenge of Proving Airborne Transmission

The CDC's retracted language said, "There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes)."

Why is this a big deal? It means the guidelines for proper physical distancing might need to be increased.

Six feet is the benchmark for safety that has helped shape the reopening of schools and businesses nationwide. The number is based on the long-held finding that larger water drops from a cough are so heavy that most of them fall to the ground before the 6-foot mark.

But much smaller droplets can hang in the air longer. The debate is whether they carry enough of the virus to infect another person. If the answer is yes, the implications for everyday life could be substantial.

University of Maryland Medical School professor Donald Milton sees plenty of evidence that airborne transmission is a major factor, but he emphasized that a definitive answer is hard to come by.

No one disagrees that being near someone with the disease is the main threat. But Milton said what happens during that time is tough to untangle.

"It could be they cough and you get infected by getting a direct hit on your eye or mouth," Milton said. "Or could it be through an airborne particle that you inhale. Or you might have touched something and then touched your nose or your mouth. It's fiendishly difficult to sort that out."

That said, many incidents and studies point toward the idea that airborne particles play a bigger role than has been thought.

The Research

An international group of researchers from China, Australia and the United States recently reviewed the evidence for airborne transmission. They concluded it was highly plausible.

A study published in the Proceedings of the National Academy of Sciences reported that one minute of loud talking could produce "1,000 virus-containing droplet nuclei that could remain airborne for more than eight minutes."

The authors' conclusion? "These are likely to be inhaled by others and hence trigger new infections."

Public transit is a key testing ground.

In China, scientists looked at 126 passengers on two buses making a trip that lasted about an hour and a half. One bus was virus-free, the other had one infected rider. The people on the bus with the virus were 41.5 times more likely to be infected.

Many other researchers have noted the super-spreading event at the 2½-hour-long choir practice of the Skagit Valley Chorale in Mount Vernon, Washington. Of the 61 people who attended, there were 53 confirmed and potential cases and two deaths.

A University of Florida study sampled the air in the hospital rooms of two COVID patients. They found aerosol particles carrying enough viral load to infect someone more than 15 feet away from the patients.

In July, 239 researchers co-signed an open letter that called on national and international health agencies to "recognize the potential for airborne spread" of COVID-19.

Credible studies, they wrote, "have demonstrated beyond any reasonable doubt that viruses are released during exhalation, talking, and coughing in microdroplets small enough to remain aloft in air and pose a risk of exposure."

Still, a July World Health Organization report found while airborne transmission was possible, more robust research was needed to confirm that it presents an appreciable risk.

If public health leaders take airborne transmission more seriously, Milton said, there are a few implications. Most business activity could continue, but restaurants and bars — because masks don't fit with eating and drinking — would face a higher hurdle.

Beyond that, more attention to ventilation in more closed spaces becomes important, as does the supply of N95 masks. Those masks continue to be in short supply.

'You're Going to Release Him When He Was Hurting Himself?'

KFF Health News, September 29, 2020

Daniel Prude's family knew he needed psychiatric care and tried to get it for him. Instead, his encounter with police hours after he was released from Strong Memorial Hospital in Rochester, New York, proved fatal.

This article was published on Tuesday, September 29, 2020 in Kaiser Health News.

By Brett Dahlberg, WXXI September 29, 2020

When Joe Prude called Rochester, New York, police to report his brother missing, he was struggling to understand why Daniel Prude had been released from the hospital hours earlier. Joe Prude described his brother's suicidal behavior.

"He jumped 21 stairs down to my basement, headfirst," Joe said in a video recorded by the responding officer's body camera in the early hours of March 23. Joe's wife, Valerie, described Daniel nearly jumping in front of a train on the tracks that run behind their house the previous day.

"The train missed him by this much," Joe said, holding his thumb and pointer finger a few inches apart.

"When the doctor called me and told me that they released him, I'm saying, 'How you going to sit here and tell me you're going to release him when he was hurting himself? Come on. You weren't sworn to do that,'" he said on the body camera footage.

At the point of this recorded conversation just after 3 a.m., Joe and Valerie Prude knew only that Daniel was missing, delusional and vulnerable. They didn't know his next encounter with the police would be fatal.

Police would find Daniel minutes later ― naked, acting irrationally. Because he spat in the direction of officers and allegedly said he had the novel coronavirus, officers placed a white hood, called a "spit hood," over his head. When he started trying to stand up, despite being restrained by handcuffs, an officer placed much of his body weight over Daniel's head and pushed it into the pavement.

Daniel died a week later when his family took him off life support. The county medical examiner's autopsy described his death as a homicide and listed the immediate cause of death as "complications of asphyxia in the setting of physical restraint." The incident garnered widespread attention as another example of a Black man killed after an encounter with police.

Less attention has been paid to what happened to Daniel Prude in the preceding hours, when he was treated and released after a psychiatric assessment at Strong Memorial Hospital, run by the University of Rochester Medical Center.

Joe Prude called police at about 7 p.m. on March 22 because he needed help getting Daniel to the hospital. Daniel had been having problems with a PCP addiction, Joe told officers. Now he had begun telling Joe and Valerie that people were out to get him, and he wanted to die.

By about 11 p.m., Daniel was released from the hospital, according to Joe and police records. "He was calm as hell when he got back here," Joe told police.

That didn't last.

"He was fine for a little bit, then all of a sudden started acting crazy," Joe said. He told police that Daniel asked him for a cigarette, and when he went to get one, Daniel took off running. He was barefoot, wearing only a tank top and long johns in 30-degree weather.

"He was gone. Track star status. Hauled ass like Carl Lewis," Joe told the officer.

Around 3 a.m. the next day, four hours after his release from the hospital, emergency dispatchers started fielding calls about Daniel Prude. His brother reported him missing, and a tow truck driver spotted him, naked and bloodied, on West Main Street, police records show.

Police body camera footage shows that by 3:20 a.m., officer Mark Vaughn was pressing Daniel Prude's head into the pavement.

While restrained, Prude stopped breathing. An ambulance crew resuscitated him, but he was in critical condition. His brain was damaged after being deprived of oxygen. He died a week later at Strong Memorial after being taken off life support.

The University of Rochester Medical Center said patient privacy laws bar it from discussing the specifics of Prude's treatment and release, but, in general terms, spokesperson Chip Partner said, the hospital is bound by a New York state law that requires patients to be released within 24 hours unless they have a mental illness that is likely to result in serious harm to themselves or others and that requires immediate observation, care and hospital treatment.

The details of Prude's encounters with law enforcement and the healthcare system offer a look into the practice of emergency psychiatry, and how, as in many branches of medicine in the U.S., mistakes in that field are disproportionately borne by Black people.

Medical decisions in a case like Daniel Prude's are high-stakes, with little margin for error, said Dr. Ken Duckworth, chief medical officer of the National Alliance on Mental Illness.

"Emergency psychiatric assessment is very challenging, and the potential for catastrophic outcomes following your decision is very real," he said.

The hospital where Prude died has faced scrutiny over its treatment of psychiatric patients and discharge procedures before.

In April 2018, federal inspectors found security officers at the hospital had used law enforcement restraint techniques against a pediatric psychiatry patient, breaking her arm and sending her to the emergency room.

Months later, inspectors found the hospital discharged a patient who was in the emergency room with a history of dementia and multiple medical problems despite a discrepancy in her address between her medical record and the information she gave hospital staff.

Two years earlier, inspectors found that hospital staff had placed patients in ankle and wrist restraints without an order to do so, and placed another patient in restraints without documenting when the restraints were released. Restraints are meant to be used only with a physician's order, and federal rules require precise documentation of their use.

None of these incidents at Strong Memorial Hospital garnered media attention at the time they happened or at the time the reports were made public.

Strong spokesperson Partner said that immediately after the April 2018 inspection the hospital changed its public safety protocol to eliminate the use of law enforcement techniques to manage a violent patient unless that patient is being arrested.

He said updated staff training and discharge protocol after these incidents now mitigates the risk of discharging someone who was not ready to be released. "These protocols were well established in 2020 and had absolutely no bearing on the evaluation or treatment of Daniel Prude on March 22," Partner said.

Prude's case is unusual because the consequences of the decision by doctors to release him have played out so publicly, said Duckworth. Usually, emergency room psychiatrists never find out what happened to their patients.

"You make a very big decision, which usually has no known outcome. You put this person in the hospital, you go on to the next patient. You send this person home, you go on to the next patient," he said.

Duckworth said he would not second-guess the actions of Prude's hospital team in the moment, but with the benefit of hindsight, "there's overwhelming evidence that he had a psychotic illness and was quite vulnerable," he said. "He didn't need to die."

In a statement, URMC said its treatment of Prude was "medically appropriate and compassionate."

Several oversight organizations are investigating.

The Joint Commission, which certifies hospitals to receive federal funding, said it's reviewing Prude's treatment at Strong. New York state's Justice Center is investigating on behalf of the state Office of Mental Health.

The university medical center itself is still conducting an internal clinical review.

In response to questions from NPR and KHN about whether the hospital's treatment of Prude could have been affected by his race, Partner said the medical center asked Dr. Altha Stewart, past president of the American Psychiatric Association, "to conduct a third-party independent review through her lens as a national expert on racism and bias in psychiatric care."

In a separate interview before the request from URMC, she described how unconscious bias can cloud clinicians' judgment and make it difficult for them to make the best possible decisions for their patients.

"It is very clear that in today's healthcare system, bias is built in structurally," Stewart said. "Seeing a tall, imposing Black man who is behaving aggressively puts in place a series of ideas and thoughts and assumptions that direct decision-making."

Psychiatric disorders in Black patients are less likely to be taken seriously than in white patients, Stewart said. Unequal treatment starts early.

Black boys are viewed as adults more often than white boys of the same age, said Stewart, who is also the director of the Center for Health in Justice Involved Youth.

"So a Black child with a meltdown is described as aggressive, obstinate, oppositional," she said, "as opposed to traumatized, depressed, anxious."

Those expectations follow Black boys through adulthood and in the healthcare system, increasing the odds that doctors will view Black men as a lost cause and provide subpar care, Stewart said.

She stressed that she does not have any direct knowledge of deficiencies in the care of Daniel Prude, but she said that Black men, like Prude, are disproportionately likely to be misdiagnosed, mistreated and written off as a result of structural bias and unconscious racism.

A group of medical students at the University of Rochester wrote in an open letter that Daniel Prude was "sentenced to death by our failed healthcare system."

"Not only do our current models of healthcare leave gaping holes for individuals such as Daniel to fall through, but they do so in manners which are fraught with racism," the students wrote.

Partner, the medical center spokesperson, said the psychiatry department's Office of Diversity, Inclusion, Culture and Equity will evaluate Daniel's treatment for potential bias. He said the medical center "recognizes that we have a long way to go before we can confidently say that our policies and practices are universally culturally appropriate to the populations we serve."

Both Stewart and Duckworth said reducing the role that police play in addressing mental health crises would increase the odds of survival for a person released too early from psychiatric care.

Federal inspection reports show that hospitals across the country have released patients who, like Prude, ended up in grave danger only shortly thereafter.

In March 2018, a patient with a history of schizophrenia, post-traumatic stress disorder and suicide attempts arrived at Russell County Hospital in Kentucky complaining of alcohol withdrawal, depression, anxiety and pain. An hour and a half later, the patient was discharged with instructions to "follow up with his/her primary care provider and take medications as prescribed." Two hours later, the patient was back in the same hospital. A physician's notes said the patient had drunk a bottle of Benadryl "in effort to kill self."

In August 2018, federal inspectors found that UT Health East Texas Pittsburg Hospital discharged a patient who had verbalized a plan for suicide. The patient got a ride to his truck from the county sheriff. Later that day, the patient was found dead in the truck from a self-inflicted gunshot wound.

Last summer at Stafford County Hospital in Kansas, a patient arrived in the emergency room saying she had drunk half a liter of vodka because she was upset and wanted to die. She told hospital staff that she started drinking that day after two years of sobriety and that she "did not feel safe to go home due to the presence of alcohol." The hospital discharged her 11 minutes later.

Earlier this year, inspectors found that a patient with a history of psychosis went to the emergency room at Mercy Hospital in St. Louis and told staff she needed to get back on her medication. She was delusional, disoriented, homeless and unable to give her name. She was discharged with a voucher for cab fare but no follow-up appointments or services and no plan to ensure she got her medication.

A spokesperson for UT Health East Texas said the health system has since implemented a process for staff to more thoroughly document mental health concerns in patient records. Mercy Hospital in St. Louis said it takes the health and safety of each patient very seriously "regardless of race, ethnicity or ability to pay."

Neither of the other hospitals responded to emails or calls seeking comment.

This story is part of a partnership that includes Side Effects Public Media, NPR and KHN.

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