In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

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

By Rachana Pradhan and Lauren Weber and Liz Szabo

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters. 

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within seven days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.  

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.” 

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday — his infection “likely happened five or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when  Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

Experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for three, five, seven, even 10 days after you’re exposed.” 

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them — a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates — including his national security adviser and Secret Service officers — have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

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. 

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 ‏

 

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