Category: From California Healthline.org

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.

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 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.

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.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family 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.

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In August, Robert Pettigrew was working a series of odd jobs. While washing the windows of a cellphone store he saw a sign, one that he believes the “good Lord” placed there for him.

“Facing eviction?” the sign read. “You could be eligible for up to $3,000 in rent assistance. Apply today.”

It seemed a hopeful omen after a series of financial and health blows. In March, Pettigrew, 52, learned he has an invasive mass on his lung that restricts his breathing. His doctor told him his condition puts him at high risk of developing deadly complications from COVID-19 and advised him to stop working as a night auditor at a Motel 6, where he manned the front desk. Reluctantly, he had to leave that job and start piecing together other work.

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With pay coming in less steadily, Pettigrew and his wife, Stephanie, fell behind on the rent. Eventually, they were many months late, and the couple’s landlord filed to evict them.

Then Pettigrew saw the rental assistance sign.

“There were nights I would lay in bed and my wife would be asleep, and all I could do was say, ‘God, you need to help me. We need you,’” Pettigrew said. “And here he came. He showed himself to us.”

As many as 40 million Americans faced a looming eviction risk in August, according to a report authored by 10 national housing and eviction experts. The Centers for Disease Control and Prevention cited that estimate in early September when it ordered an unprecedented, nationwide eviction moratorium through the end of 2020.

That move — a moratorium from the country’s top public health agency — spotlights a message experts have preached for years without prompting much policy action: Housing stability and health are intertwined.

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The CDC is now citing stable housing as a vital tool to control the coronavirus, which has killed more than 200,000 Americans. Home is where people isolate themselves to avoid transmitting the virus or becoming infected. When local governments issue stay-at-home orders in the name of public health, they presume that residents have a home. For people who have the virus, home is often where they recover from COVID-19’s fever, chills and dry cough — in lieu of, or after, a hospital stay.

But the moratorium is not automatic. Renters have to submit a declaration form to their landlord, agreeing to a series of statements under threat of perjury, including “my housing provider may require payment in full for all payments not made prior to and during the temporary halt, and failure to pay may make me subject to eviction pursuant to state and local laws.”

Confusion surrounding the CDC’s order means some tenants are still being ordered to leave their homes.

A sign inside a Boost Mobile store in Milwaukee prompted Robert Pettigrew to call Community Advocates to ask for help paying rent on the apartment he shares with his wife, daughter and grandson. The Centers for Disease Control and Prevention said stable housing is vital to controlling the coronavirus pandemic. (Coburn Dukehart/Wisconsin Watch)

Princeton University is tracking eviction filings in 17 U.S. cities during the pandemic. As of Sept. 19, landlords in those cities have filed for more than 50,000 evictions since March 15. The tally includes about 11,900 in Houston, 10,900 in Phoenix and 4,100 in Milwaukee.

It’s an incomplete snapshot that excludes some major American cities such as Indianapolis, where local housing advocates said court cases are difficult to track, but landlords have sought to evict thousands of renters.

Children raised in unstable housing are more prone to hospitalization than those with stable housing. Homelessness is associated with delayed childhood development, and mothers in families that lose homes to eviction show higher rates of depression and other health challenges.

Mounting research illustrates that even the threat of eviction can exact a physical and mental toll from tenants.

Nicole MacMillan, 38, lost her job managing vacation rentals in Fort Myers, Florida, in March when the pandemic shut down businesses. Later, she also lost the apartment where she had been living with her two children.

“I actually contacted a doctor, because I thought, mentally, I can’t handle this anymore,” MacMillan said. “I don’t know what I’m going to do or where I’m going to go. And maybe some medication can help me for a little bit.”

But the doctor she reached out to wasn’t accepting new patients.

With few options, MacMillan moved north to live with her grandparents in Grayslake, Illinois. Her children are staying with their fathers while she gets back on her feet. She recently started driving for Uber Eats in the Chicagoland area.

“I need a home for my kids again,” MacMillan said, fighting back tears. The pandemic “has ripped my whole life apart.”

Searching for Assistance to Stay at Home

That store window sign? It directed Pettigrew to Community Advocates, a Milwaukee nonprofit that received $7 million in federal pandemic stimulus funds to help administer a local rental aid program. More than 3,800 applications for assistance have flooded the agency, said Deborah Heffner, its housing strategy director, while tens of thousands more applications have flowed to a separate agency administering the state’s rental relief program in Milwaukee.

Persistence helped the Pettigrews break through the backlog.

“I blew their phone up,” said Stephanie Pettigrew, with a smile.

She qualifies for federal Social Security Disability Insurance, which sends her $400 to $900 in monthly assistance. That income has become increasingly vital since March when Robert left his motel job.

He has since pursued a host of odd jobs to keep food on the table — such as the window-washing he was doing when he saw the rental assistance sign — work where he can limit his exposure to the virus. He brings home $40 on a good day, he said, $10 on a bad one. Before they qualified for rent assistance, February had been the last time the Pettigrews could fully pay their $600 monthly rent bill.

Robert and Stephanie Pettigrew embrace outside their two-bedroom rental apartment in Milwaukee on Sept. 4. In August, local group Community Advocates covered more than $4,700 in the Pettigrews’ rental payments, late charges, utility bills and court fees, and is now helping them look for a more affordable place to live. (Coburn Dukehart/Wisconsin Watch)

Just as their finances tightened and their housing situation became less stable, the couple welcomed more family members. Heavenly, Robert’s adult daughter, arrived in May from St. Louis after the child care center where she worked shut down because of concerns over the coronavirus. She brought along her 3-year-old son.

Through its order, the CDC hopes to curtail evictions, which can add family members and friends to already stressed households. The federal order notes that “household contacts are estimated to be 6 times more likely to become infected by [a person with] COVID-19 than other close contacts.”

“That’s where that couch surfing issue comes up — people going from place to place every few nights, not trying to burden anybody in particular, but possibly at risk of spreading around the risk of coronavirus,” said Andrew Bradley of Prosperity Indiana, a nonprofit focusing on community development.

The Pettigrews’ Milwaukee apartment — a kitchen, a front room, two bedrooms and one bathroom — is tight for the three generations now sharing it.

“But it’s our home,” Robert said. “We’ve got a roof over our head. I can’t complain.”

Housing Loss Hits Black and Latino Communities

A U.S. Census Bureau survey conducted before the federal eviction moratorium was announced found that 5.5 million of American adults feared they were either somewhat or very likely to face eviction or foreclosure in the next two months.

State and local governments nationwide are offering a patchwork of help for those people.

In Massachusetts, the governor extended the state’s pause on evictions and foreclosures until Oct. 17. Landlords are challenging that move both in state and federal court, but both courts have let the ban stand while the lawsuits proceed.

“Access to stable housing is a crucial component of containing COVID-19 for every citizen of Massachusetts,” Judge Paul Wilson wrote in a state court ruling. “The balance of harms and the public interest favor upholding the law to protect the public health and economic well-being of tenants and the public in general during this health and economic emergency.”

The cases from Massachusetts may offer a glimpse of how federal challenges to the CDC order could play out.

By contrast, in Wisconsin, Gov. Tony Evers was one of the first governors to lift a state moratorium on evictions during the pandemic — thereby enabling about 8,000 eviction filings from late May to early September, according to a search of an online database of Wisconsin circuit courts.

Milwaukee, Wisconsin’s most populous city, has seen nearly half of those filings, which have largely hit the city’s Black-majority neighborhoods, according to an Eviction Lab analysis.

In other states, housing advocates note similar disparities.

“Poor neighborhoods, neighborhoods of color, have higher rates of asthma and blood pressure — which, of course, are all health issues that the COVID pandemic is then being impacted by,” said Amy Nelson, executive director of the Fair Housing Center of Central Indiana.

“This deadly virus is killing people disproportionately in Black and brown communities at alarming rates,” said Dee Ross, founder of the Indianapolis Tenants Rights Union. “And disproportionately, Black and brown people are the ones being evicted at the highest rate in Indiana.”

Across the country, officials at various levels of government have set aside millions in federal pandemic aid for housing assistance for struggling renters and homeowners. That includes $240 million earmarked in Florida, between state and county governments, $100 million in Los Angeles County and $18 million in Mississippi.

In Wisconsin, residents report that a range of barriers — from application backlogs to onerous paperwork requirements — have limited their access to aid.

In Indiana, more than 36,000 people applied for that state’s $40 million rental assistance program before the application deadline. Marion County, home to Indianapolis, had a separate $25 million program, but it cut off applications after just three days because of overwhelming demand. About 25,000 people sat on the county’s waiting list in late August.

Of that massive need, Bradley, who works in economic development in Indiana, said: “We’re not confident that the people who need the help most even know about the program — that there’s been enough proactive outreach to get to the households that are most impacted.”

After Milwaukeean Robert Pettigrew saw that sign in the store window and reached out to the nonprofit Community Advocates, the group covered more than $4,700 of the Pettigrews’ rental payments, late charges, utility bills and court fees. The nonprofit also referred the couple to a pro-bono lawyer, who helped seal their eviction case — that means it can’t hurt the Pettigrews’ ability to rent in the future, and ensures the family will have housing at least through September. The CDC moratorium has added to that security.

Heavenly Pettigrew and her 3-year-old son moved in with her parents in May after the St. Louis child care center where she’d been working closed because of the pandemic. The two-bedroom, one-bath apartment is tight for three generations, said Heavenly’s father, Robert, “but it’s our home.” (Coburn Dukehart/Wisconsin Watch)

The federal eviction moratorium, if it withstands legal challenges from housing industry groups, “buys critical time” for renters to find assistance through the year’s end, said Emily Benfer, founding director of the Wake Forest Law Health Justice Clinic.

“It’s protecting 30 to 40 million adults and children from eviction and the downward spiral that it causes in long-term, poor health outcomes,” she said.

Doctor: Evictions Akin to ‘Toxic Exposure’

Megan Sandel, a pediatrician at Boston Medical Center, said at least a third of the 14,000 families with children that seek treatment at her medical center have fallen behind on their rent, a figure mirrored in national reports.

Hospital officials worry that evictions during the pandemic will trigger a surge of homeless patients — and patients who lack homes are more challenging and expensive to treat. One study from 2016 found that stable housing reduced Medicaid spending by 12% — and not because members stopped going to the doctor. Primary care use increased 20%, while more expensive emergency room visits dropped by 18%.

A year ago, Boston Medical Center and two area hospitals collaborated to invest $3 million in emergency housing assistance as community organizing focused on affordable housing policies and development. Now the hospitals are looking for additional emergency funds, trying to boost legal resources to prevent evictions and work more closely with public housing authorities and state rental assistance programs.

“We are a safety-net hospital. We don’t have unlimited resources,” Sandel said. “But being able to avert an eviction is like avoiding a toxic exposure.”

Sandel said the real remedy for avoiding an eviction crisis is to offer Americans substantially more emergency rental assistance, along the lines of the $100 billion included in a package proposed by House Democrats in May and dubbed the Heroes Act. Boston Medical Center is among the 26 health care associations and systems that signed a letter urging congressional leaders to agree on rental and homeless assistance as well as a national moratorium on evictions for the entire pandemic.

“Without action from Congress, we are going to see a tsunami of evictions,” the letter stated, “and its fallout will directly impact the health care system and harm the health of families and individuals for years to come.”

Groups representing landlords urge passage of rental assistance, too, although some oppose the CDC order. They point out that property owners must pay bills as well and may lose apartments where renters can’t or won’t pay.

In Milwaukee, Community Advocates is helping the Pettigrews look for a more affordable apartment. Robert Pettigrew continues attending doctors’ appointments for his lungs, searching for safe work. He looks to the future with a sense of resolve — and a request that no one pity his family.

“Life just kicks you in the butt sometimes,” he said. “But I’m the type of person — I’m gonna kick life’s ass back.”

For this story, NPR and KHN partnered with the investigative journalism site Wisconsin Watch, Side Effects Public Media, Wisconsin Public Radio and WBUR.

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.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family 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.

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Thousands of minks at Utah fur farms have died because of the coronavirus in the past 10 days, forcing nine sites in three counties to quarantine, but the state veterinarian said people don’t appear to be at risk from the outbreak.

The COVID-19 infections likely were spread from workers at the mink ranches to the animals, with no sign so far that the animals are spreading it to humans, said Dr. Dean Taylor, the state veterinarian, who is investigating the outbreak.

“We genuinely don’t feel like there is much of a risk going from the mink to the people,” he said Thursday.

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Between 7,000 and 8,000 minks have died since the disease swept through the ranches that produce the animals, valued for their luxurious pelts. So far, no animals in Utah have been euthanized because of the disease, and it doesn’t appear to be necessary, Taylor said.

Fur from the dead infected animals will be processed to remove any traces of the virus and then used for coats and other garments, according to Fur Commission USA, a mink farming trade group. The U.S. produces more than 3 million mink pelts each year.

Taylor declined to name the farms or the counties where the affected minks were found.

With minks, as with humans, COVID-19 is less deadly for the young.

“It’s going through the breeding colonies and wiping out the older mink and leaving the younger mink unscathed,” Taylor said. Most of the deaths have been in minks between the ages of 1 and 4 years.

In addition to the minks, more than 50 animals in the U.S. had tested positive for the coronavirus as of Sept. 2, according to the U.S. Department of Agriculture. The infections have been detected in pet cats and dogs, as well as lions and tigers at a New York zoo.

Minks seem particularly susceptible to COVID-19, likely because of a protein in their lungs, the ACE2 receptor, which binds to the virus and appears to predict vulnerability to the infection, according to Wageningen University & Research in the Netherlands. Humans also have this protein in their lungs.

The COVID outbreak in Utah has surged since mid-August, when the first cases of the disease in the animals were confirmed by the USDA.

Minks were discovered to be susceptible to the SARS-CoV-2 virus, which causes COVID-19, in April, after outbreaks at several farms in the Netherlands, followed by outbreaks in Denmark and Spain. More than 1 million animals were culled in those countries, according to the Associated Press.

Several workers at the Utah mink farms have tested positive for COVID-19, including some who had no symptoms.

“Some of our mink ranchers have more than one facility, and that’s probably how it spread,” Taylor said.

A study in the Netherlands found that the virus appeared to jump back and forth between people and minks, but the data so far remains limited.

After the initial U.S. cases were confirmed, mink farms across Utah and the rest of the country implemented strict measures to prevent the disease from spreading, such as restricting access, conducting health checks on workers and disinfecting surfaces. The USDA and the Centers for Disease Control and Prevention have issued guidelines for farmed minks and other mustelids, a family of animals that also includes weasels and badgers.

“Obviously, it’s very concerning to have a species that is this susceptible with this high of a death rate,” Taylor said.

The outbreak has led to the quarantine of a quarter of Utah’s three dozen mink ranches and raised concerns across the state, said Clayton Beckstead, regional manager for the Utah Farm Bureau and a fourth-generation mink farmer.

“We’re certainly worried, but I think everybody’s taking pretty extreme biosecurity measures,” said Beckstead, whose own farm has not been affected.

Utah is one of the nation’s top mink producers. Overall, there are 245 fur farms in 22 states, part of an industry valued at $82.6 million a year, according to Fur Commission USA.

Investigating an outbreak of a novel virus in a new species is “daunting,” Taylor said.

“We’re learning as quick as we can,” he said. “We’re scrambling to help these animals and protect this industry.”

The first minutes of Tuesday’s presidential debate immediately turned to how President Donald Trump’s Supreme Court nominee to replace Justice Ruth Bader Ginsburg could undo the Affordable Care Act and its protections for people with preexisting conditions.

“There’s 100 million people that have preexisting conditions,” said former Vice President Joe Biden, the Democratic nominee, arguing that those patients could lose coverage protections if the federal health law were declared unconstitutional by the high court.

Protecting guarantees of coverage for people with medical issues is a key campaign issue. It’s among the ACA’s most popular provisions, and polling indicates that most Americans support keeping these protections in place.

Biden, who worked with then-President Barack Obama on the ACA’s enactment, is a strong supporter of the law. Trump, meanwhile, has called repeatedly for the law to be repealed and is backing a lawsuit by a group of Republican state attorneys generals trying to overturn it. The Supreme Court will hear oral arguments in the case Nov. 10.

The ACA guarantees that those with preexisting conditions cannot be denied coverage by health insurers. Despite promises that he will protect people with medical issues, Trump has not offered an alternative proposal to do so. He issued an executive order on health care Sept. 24 that included a commitment to preserving that safeguard, but legal experts said the executive order holds no enforcement power.

After Biden’s comment at the debate, Trump retorted, “There aren’t a hundred million people with preexisting conditions.”

We thought it was important to figure out if this number was right, especially as the ACA’s future hangs in the balance.

Estimates Vary

The Biden campaign provided us with several pieces of evidence to back up the candidate’s 100 million statistic, including a September article in The New York Times, a 2017 issue brief from the Department of Health and Human Services during the Obama administration and a 2018 estimate from Avalere, a health care consulting firm.

We consulted several health policy experts who also pointed us to the HHS brief and the Avalere estimate. They also cited a 2019 analysis from KFF, a nonpartisan health policy organization. (KHN is an editorially independent program of KFF.)

The HHS issue brief, published in January 2017, estimated that between 61 million and 133 million Americans have a preexisting condition.

The number varies based on how a preexisting condition was defined.

In the more conservative estimate of 61 million, a preexisting condition was defined as an illness or condition, such as cancer, cystic fibrosis or heart failure, that would qualify a person for a high-risk insurance pool. High-risk pools were in place before the ACA to help people with serious and expensive-to-treat illnesses gain health coverage. They were operated by some states, as well as by the federal government, but generally covered very few people and were a drain on government budgets.

But that 61 million number doesn’t include everyone who has a preexisting condition, said Linda Blumberg, an institute fellow in the Health Policy Center at the Urban Institute.

“That’s because it’s only capturing the conditions that people had which were in high-risk pools prior to the ACA,” said Blumberg. “We know from a lot of studies that we’ve done that insurance companies would write people up or deny them coverage for conditions that wouldn’t necessarily put you in a high-risk pool.”

Before the ACA, health insurance companies could deny you coverage for a condition as mild as seasonal hay fever.

“Insurance companies had tools they could use to protect themselves from risky people,” said Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University in Washington, D.C. “They would dig through your medical history, and if they found something that might impose additional costs for them, they could do a variety of things.”

Corlette said those tools included the ability to deny coverage outright, charge individuals with preexisting health conditions higher premiums, or decide to offer them health insurance, but not cover the preexisting condition or the body part affected.

With that larger definition, the number HHS offered is 133 million people.

More recent estimates cite similar figures.

A 2018 analysis by Avalere, a health care consulting firm, estimated that 102 million Americans have preexisting conditions. A 2019 analysis by the left-leaning Center for American Progress suggested 135 million people.

And a 2019 analysis by KFF found that 54 million people have a preexisting condition that would likely make them completely uninsurable.

“The 54 million estimate is who wouldn’t have been able to be covered at all,” explained Cynthia Cox, director for the program on the ACA at KFF and one of the authors of the analysis.

“But, I think realistically, there are certainly over 100 million people who have a condition that would have caused them some trouble to get insurance on the individual market,” said Cox. “The 100 million includes both the 54 million who wouldn’t get coverage at all as well as the millions of others who might have had an exclusion or might have had to pay a higher premium.”

Based on the HHS estimate, Blumberg said, she would consider Biden’s 100 million figure conservative.

“If anything, he’s somewhat on the low side,” she said. “I think he was being cautious with range and that is appropriate.”

Why It Matters

While the number of individuals who have a preexisting condition varies based on the analysis, it’s clear that many Americans have a condition that could make it difficult to get comprehensive health insurance — or any insurance at all — if the ACA were overturned, said the experts.

And that’s the real point.

“It’s easy to forget what was common practice before the ACA for insurance companies to use various tactics to dictate coverage,” said Corlette. “So, the 100 million, 133 million, 54 million numbers are almost immaterial. The fact is, a heck of a lot of people will face these tactics from insurance companies if these protections disappear.”

Jonathan Oberlander, a health policy professor at the University of North Carolina-Chapel Hill, agreed that the different numbers shouldn’t obscure the central idea: “The ACA provides strong consumer protections and access to health insurance for persons with preexisting conditions, and if the ACA goes away, so, too, will those protections, jeopardizing health coverage for millions of Americans.”

However, not all think that the ACA will be overturned if Trump is successful in getting his nominee, Amy Coney Barrett, confirmed as a new Supreme Court justice.

“The Supreme Court isn’t going to overturn the ACA,” said Joseph Antos, a health policy scholar at the right-leaning American Enterprise Institute. “The Supreme Court has an unbroken history since the 1700s of not expanding upon the specific case that is brought before them, so the idea that somehow preexisting condition protections will be tossed out by the Supreme Court is fairly absurd.”

Whoever is elected Nov. 3 will have to deal with the court’s decision. Although the arguments come next month, it’s unlikely a ruling will be issued until 2021.

Our Ruling

The experts all agreed that Biden was certainly in the ballpark with his estimate of 100 million people having preexisting conditions. His figure was even a little low based on a range provided in an HHS report, said one expert.

But a wide range of people — from 54 million to 135 million — could be affected, according to our reporting. Also, it is unclear how many people with preexisting conditions would be at risk of losing their insurance entirely, or facing higher costs or having their conditions excluded from coverage. Though Biden’s number is certainly within this range, he would need to provide more detail to support such a definitive number.

We rate Biden’s claim Mostly True.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family 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.

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Voters say health issues — from the Affordable Care Act to COVID-19 to prescription drug prices — are important considerations in the November general election. But which issues are truly moving voters to participate in a year as politically polarized as 2020?

Former Vice President Joe Biden says he wants to expand the Affordable Care Act if he’s elected and Democrats win the Senate. President Donald Trump says he will find a way to protect people with preexisting conditions if his Supreme Court nominee helps strike down the ACA. And both candidates insist they will successfully control the coronavirus pandemic.

This week’s panelists are Julie Rovner of Kaiser Health News, Margot Sanger-Katz of The New York Times, Joanne Kenen of Politico and Rebecca Adams of CQ Roll Call.

Among the takeaways from this week’s podcast:

• The presidential debate Tuesday night didn’t illuminate much about health care for voters. Biden, the Democratic candidate, wasn’t incisive about his plan and mischaracterized a key provision, the public option he hopes to add to the Affordable Care Act. Trump, a Republican, misrepresented much of the information he offered about his efforts on health care.
• Nonetheless, the debate did portray the growing interest among partisans to use health care as a critical issue in the final weeks of the campaign and brought the fate of the ACA back to the top of Democrats’ talking points.
• Trump and other Republicans who want to get rid of the ACA often promise to protect health coverage for people with preexisting medical issues, even though they have not offered any evidence of how they would accomplish that. Recent polls suggest that GOP voters believe they will follow through on that pledge. The health law made guarantees to insurers that, if they accepted those expensive customers, the costs would be covered because they would have more people buying insurance.
• Although protections for preexisting conditions are popular, Democrats are finding it somewhat challenging to get voters excited about the issue because they don’t think Republicans would actually get rid of the popular provision. In addition, many people have forgotten the difficulty that patients had getting insurance before the ACA became law.
• The coronavirus pandemic will play a role in voters’ decisions, but it might play out in different ways. Some people are concerned that the federal effort hasn’t worked effectively, while others are concerned about the economic meltdown the outbreak caused. At the same time, people are overwhelmed by the magnitude of the catastrophe and finding it hard to process that 800 to 1,000 people are dying daily from the disease.
• The health care topic that seems to have truly galvanized the president — ever since his first campaign — is high drug prices. Although he has pushed hard on the issue, to make any progress he needs legislation from Congress, and Republicans on Capitol Hill have not been willing to follow him on policies that are directly opposed by drugmakers and, in some cases, may involve price- setting.
• If Biden were elected, his plans to expand the ACA through a public option or even to lower the eligibility age for Medicare would face a tough time in Congress, even if Democrats win back the Senate.

This week, Rovner also interviews KHN’s Laura Ungar, who wrote the latest installment of KHN-NPR’s “Bill of the Month.” This month’s patient, Matthew Fentress, had insurance but still received a giant bill because he is among those Americans whose insurance is not considered adequate. If you have an enormous medical bill you would like to share with us, you can do that here.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: The Washington Post’s “7 former FDA commissioners: The Trump Administration Is Undermining the Credibility of the FDA,” by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach

Joanne Kenen: The New York Times’ “How Trump Voters View His Position on Pre-existing Conditions,” by Sarah Kliff and Margot Sanger-Katz

Margot Sanger-Katz: The New York Times’ “Immigrants Say They Were Pressured Into Unneeded Surgeries,” by Caitlin Dickerson, Seth Freed Wessler and Miriam Jordan

Rebecca Adams: ProPublica’s “Investors Extracted $400 Million From a Hospital Chain That Sometimes Couldn’t Pay for Medical Supplies or Gas for Ambulances,” by Peter Elkind with Doris Burke

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher, Google Play, Spotify, or Pocket Casts.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family 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.

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

When Democratic Gov. Gavin Newsom concluded the chaotic legislative year Wednesday — his deadline to sign or veto bills — what emerged wasn’t the sweeping platform he and state lawmakers had outlined at the beginning of the year. But the dozens of health care 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 health care 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 health care workers.

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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 health care 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 health care 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 health care 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 Health Care 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 health care 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 health care 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 health care 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, health care 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 health care 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 health care 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.

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.

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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%.

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 health care 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”?

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family 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.

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Enormous drug company profits are the primary driver of soaring prescription drug prices in America, according to a damning investigation that Democrats on the House Oversight Committee began releasing Wednesday.

The first two reports in the investigation focus on Celgene and Bristol Myers Squibb’s Revlimid cancer treatment, which saw its price hiked 23 times since 2005, and Teva’s multiple sclerosis drug Copaxone, which went up in price 27 times since 2007.

Those costs have little to do with research and development or industry efforts to help people afford medication, as drug companies often claim, according to the probe.

“It’s true, many of these pharmaceutical industries have come up with lifesaving and pain-relieving medications, but they’re killing us with the prices they charge,” said Rep. Peter Welch (D-Vt.) as the hearings began Wednesday. He added that “uninhibited pricing power has transformed America’s pain into pharma’s profit.”

The top Republican on the committee, Rep. James Comer of Kentucky, called the investigation a partisan attack. “These hearings seem designed simply to vilify and publicly shame pharmaceutical company executives,” Comer said.

Much of the drug industry’s profits come at the expense of taxpayers and the Medicare program, are used to pay generous executive bonuses and are guarded by aggressive lobbying and efforts to block competition, regulation or systemic change in the United States while the rest of the world pays less, the reports say.

“The drug companies are bringing in tens of billions of dollars in revenues, making astronomical profits, and rewarding their executives with lavish compensation packages — all without any apparent limit on what they can charge,” committee chair Rep. Carolyn Maloney (D-N.Y.) wrote in a letter attached to the first two staff reports.

Rep. Elijah Cummings (D-Md.), the former committee chairperson who died last October, had launched the probe more than a year ago. It has since produced more than a million documents. CEOs of Teva Pharmaceutical Industries, Celgene and Bristol Myers Squibb were testifying Wednesday.

Amgen, Mallinckrodt Pharmaceuticals and Novartis were scheduled to appear Thursday.

Celgene CEO Mark Alles verified the accuracy of the documents obtained by the committee but stuck with the standard explanations that the company’s pricing is entirely aboveboard and merited.

“The pricing decisions for our medicines were guided by a set of long-held principles that reflected our commitment to patient access, the value of a medicine to patients in the health care system, the continuous efforts to discover new medicines and new uses for existing medicines and the need for financial flexibility,” Alles said. He said that in 2018 Celgene “committed to full pricing transparency by limiting price increases to no more than once per year,” pegged to Centers for Medicare & Medicaid Services’ projected national health expenditures.

Teva CEO Kåre Schultz demurred from addressing specific questions about much of the report, saying he took over only in 2017, in part to repair a company suffering after its Copaxone patent finally expired.

He also sounded the familiar refrain that prices are justified by research costs.

“In order for any pharmaceutical company to research and develop new drugs, or improve old ones, the price of successful medicines must reflect the significant cost of ongoing research and development projects,” Schultz said. “The public only sees and pays for the drugs that are ultimately approved by the government, like Copaxone, but you have to expend a lot of resources and endure many disappointments before bringing to the market safe and effective medicines.”

Maloney’s letter called the exorbitant price hikes for vital drugs “simply unsustainable,” and said she hopes the investigation spurs change.

Several themes common to pricing practices emerge in both reports, particularly aggressive pricing strategies that depend on the United States market and are divorced from underlying costs of manufacturing or development.

In the case of Revlimid, Celgene hiked the price from $215 per pill to $719 per pill when Bristol Myers Squibb gained the rights to it last year. The drug now costs $763 per pill, or $16,023 for a monthly course — more than three times the original cost in 2005.

In the case of Copaxone, Teva raised its price from less than $10,000 for a yearly course in 1997 to nearly $70,000.

Such price hikes have been predictably profitable. Teva has banked more than $34 billion in net profits in the United States alone, while Revlimid spun off $32 billion from the United States from 2009 to 2018 for Celgene. Medicare alone paid $17.5 billion for Revlimid from 2010 to 2018.

According to emails released with the reports, executives raised prices at will to meet quarterly profit goals, unrelated to costs. In one such case in 2014, then-Celgene executive vice president Mark Alles, who later became CEO, ordered up price hikes simply to juice flagging first-quarter numbers. “I have to consider every legitimate opportunity available to us to improve our Q1 performance,” Alles wrote. The first of two hikes was carried out less than a week later.

The investigation also undercuts the pharmaceutical industry’s claims that increased rebates, discounts and fees paid to pharmacy benefit managers drive prices. In the case of Revlimid, the largest discount Celgene ever paid in the commercial market was 5%, and the drug’s average net price after rebates, discounts and fees rose every year. Celgene’s Revlimid copay program cost just 0.16% of its net U.S. revenue from 2011 to 2018.

The average net price of Teva’s Copaxone similarly spiked every year until 2017 when a generic finally hit the market. Indeed, while Teva touted its patient assistance programs as a cost driver and a way to help people afford the drug, internally it described those efforts as a marketing ploy that spurred sales. For instance, the $70 million Teva spent on “Private Insurance Financial Assistance” yielded a 451% return on investment, internal documents show.

The oft-mentioned R&D also does not account for costs. In the case of Teva, it’s particularly glaring. Teva identified $689 million in development costs since 1989 — only about 2% of its U.S. profits from 2002 to 2019.

For Revlimid, the drug stemmed from basic research done in government-backed studies on thalidomide and related compounds. Celgene swooped in after the research showed the promise of the compound that would become Revlimid. And as it justified price hikes, Celgene’s internal documents cited the value of the drug, not the costs to develop it. To prove the value, it cited numerous research studies, many of which were done by others, including the National Institutes of Health.

While offering spurious rationales for raising prices, the companies worked hard to protect those prices, the investigation found. The most well-known are the aggressive lobbying tactics that the pharma industry deploys.

But there are many others, including using the high cost of the drugs themselves as a deterrent by making it extremely expensive for generic developers to buy enough samples for their own studies. In one case, Celgene used an FDA-required Risk Evaluation and Mitigation Strategy — which limits the distribution of risky drugs — to “prevent or delay 14 generic manufacturers from purchasing sufficient samples of Revlimid to obtain FDA approval,” the report on Celgene said.

The single-greatest step to curb prices, according to the report, would be to allow Medicare to negotiate prices. Both reports note how the companies highlight the noncompetitive U.S. market — specifically Medicare — as the means to ensure high profits.

For instance, the report says, “internal Teva documents warned that the legislative reform that posed the greatest threat to Teva’s future revenue was ‘Medicare Reform: Removal of government non-interference.’”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.