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Analysis: Necessary or Not, Covid Booster Shots Are Probably on the Horizon

KFF Health News, July 21, 2021

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision.

This article was published on Wednesday, July 21, 2021 in Kaiser Health News.

By Elisabeth Rosenthal

The drugmaker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of covid-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now — and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them last week.

This has led to confusion. Should the nearly 60% of adult Americans who have been fully vaccinated seek out a booster or not? Is the protection that has allowed them to see loved ones and go out to dinner fading?

Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective”?

The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior covid shot. The booster is likely to be safe — hundreds of millions have taken the earlier shots — and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.

But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.

What if a booster is safe and effective in one sense but simply not needed — at least for now?

Reliance on the simple “safe and effective” standard — which certainly sounds reasonable — is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.

The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”

In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in covid revenue this year.

The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.

It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and Type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.

In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?

For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness — the health value of a product relative to its price — a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker — like an antibody level — a good enough stand-in for whether a drug will have a significant impact on a patient’s health?

In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the price being offered. But there’s no such automatic process in the U.S.

When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out-of-pocket, decide to get the shot.

To make any recommendation on a booster, government experts say they need more data. They could, for example, as Dr. Anthony Fauci has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.

But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.

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With a Diagnosis at Last, Black Women with ADHD Start Healing

KFF Health News, July 20, 2021

The longer girls with ADHD aren't diagnosed and treated, the more their problems are likely to worsen as they grow into adults.

This article was published on Tuesday, July 20, 2021 in Kaiser Health News.

By Claire Sibonney

Miché Aaron has always been a high achiever. The 29-year-old is in her third year of a planetary sciences doctoral program at Johns Hopkins University, where she researches minerals found on Mars. She's a former NASA space grant scholar and hopes to become an astronaut one day.

But last year, Aaron was barely keeping it together — missing classes, late on assignments and struggling to explain that she understood the required material to pass her qualifying exams. Her academic adviser warned that if she didn't get professional help she would flunk.

"I simply thought I was a lazy student and I needed to try harder," Aaron said, wiping the tears behind her thick, black-framed glasses.

Then she was diagnosed with attention deficit hyperactivity disorder and it all made sense.

For many Black women like Aaron, finally having that answer comes with both relief and grief after years of suffering and being misunderstood. Already subject to unique discrimination at the intersection of gender and race, Black girls with ADHD often remain undiagnosed because their symptoms are mischaracterized. Signs of inattentiveness or impulsivity, two main features of the disorder, could be mistaken for laziness or defiance. And the longer these girls aren't diagnosed and treated, the more their problems are likely to worsen as they grow into adults.

While the 2016 National Survey of Children's Health showed that 6.1 million children ages 2 to 17 in the United States have received a diagnosis for ADHD at some point, millions more adults are estimated to have it, too — either having grown up with a diagnosis or being diagnosed later in life, if at all.

ADHD doesn't discriminate by gender or race, but white boys are still more likely to be diagnosed and treated for the condition than anyone else. Experts and advocates say this leads to an inequity in care that hurts girls of any background and children of color of any gender.

Over the past few decades, mental health experts and researchers have started to understand how ADHD manifests differently depending on gender, as girls with the condition tend to seem more inattentive and forgetful while boys tend to seem more hyperactive and disruptive. The reasons Black children and ethnic minorities are overlooked range from racial bias in schools and lack of access to care, to stigma and distrust of educators and health providers based on past discrimination.

Paul Morgan, director of the Center for Educational Disparities Research at Penn State, is the lead author of multiple studies showing that the disparities in school start early. By kindergarten, Black children in the U.S. are 70% less likely to receive an ADHD diagnosis than otherwise similar white children.

A 2016 study found that by 10th grade white children are nearly twice as likely to receive a diagnosis for ADHD as Black children. Lead author Dr. Tumaini Rucker Coker, head of general pediatrics at Seattle Children's Hospital and a top researcher at its Center for Child Health, Behavior and Development, said that, while her study didn't look at underdiagnosis of Black girls, federal Education Department data shows telling signs of racial and gender discrimination in diagnosing ADHD: Black girls are six times as likely to be suspended from school as white girls.

Behavior as common as talking back in class could have wildly different consequences, depending on how it's interpreted, Coker explained. For Black girls, it's often viewed as "intimidation" of a teacher.

"When there's 'bad behavior' and you're a white girl, you get all the benefit of the doubt," Coker said. "On the opposite spectrum, you get zero benefit of the doubt as a Black girl."

Over time, studies have shown that ADHD, especially in girls, can lead to increased rates of anxiety and depression, risky behavior, drug use, self-harm and suicide attempts. Researchers and therapists said they are especially worried about those undiagnosed or undertreated.

Being diagnosed and treated, on the other hand, has many upsides. Medication and therapy, and even behavioral training for parents of patients, have proven to be highly effective in managing ADHD. However, access to such resources depends not only on a diagnosis, but also trust and buy-in from families.

René Brooks, who lives outside Gettysburg, Pennsylvania, was diagnosed three times — twice as a child, when her school tested her without parental permission. Her mother rejected the idea of her daughter, who is Black, being labeled, distrusting a system she feared wanted to "drug up minority children."

The third time Brooks was diagnosed, she was 25 and on the brink of losing her job at one of the biggest insurers in the state because she couldn't keep up with the workload. After starting medication, 18 years after her first diagnosis, she said her brain felt like it "switched on" and she was able to be more productive than she ever imagined possible.

Still, as a Black woman with ADHD, Brooks felt alone. "It's very isolating to sit at that intersection because no one's there, or so we thought," she said.

She started a blog called "Black Girl, Lost Keys," which educates and empowers Black women with ADHD, and created Unicorn Squad, Black People of Marginalized Genders With ADHD, a private support group on Facebook with more than 2,200 members who share the feelings that come with the diagnosis.

Aaron said finding the Facebook group and talking with other Black women with ADHD during the weekly virtual meetings made it easier to accept her diagnosis. They also commiserate about the all-too-common racialized slights known as microaggressions that she and others face — whether it's being dismissed for showing emotion as an "angry Black woman" or having to fight for accommodations at school or being doubted at pharmacies when trying to fill prescriptions for stimulants that treat ADHD under the assumption they're addicts trying to misuse the controlled substances, sold under brand names such as Adderall, Concerta and Ritalin.

Dr. Loucresie Rupert, a child-adolescent psychiatrist, adult ADHD coach and mental health advocate in Winona, Minnesota, also blogs about her personal experience with ADHD. She recognized her symptoms during medical school — problems studying, missing appointments, forgetting to pay bills — and was officially diagnosed during her medical residency, after failing a two-day-long licensing exam. The latter was a wake-up call. "I've never failed at anything in my life," said Rupert.

As a Black woman, Rupert understands why her Black female patients are so grateful to find her. It's hard enough to find a local psychiatrist who is covered by one's insurance and specializes in ADHD, let alone a Black female psychiatrist who has ADHD herself.

Rupert said she, too, sees a Black female psychiatrist, who shares some of the same experiences and sensitivities, which makes a big difference. "It's taken my healing and my ability to function to the next level, because you don't have to explain as many things." For example, when discussing police brutality, she said, "I don't have to spell out how exhausted or tired or traumatized I am."

Coker and Morgan agreed that culturally and linguistically sensitive screenings are key to getting more people diagnosed. Also critical: culturally relevant groups like the Unicorn Squad.

A year and a half after being diagnosed with ADHD, Aaron said the treatment she's received, including medication, therapy and strategies for learning and organization, has changed her life. She has since found out she also has dyslexia and a language processing disorder, two learning disabilities that commonly occur with ADHD.

Far from flunking out, she's now thriving academically and publishing her research on Martian minerals. She wants to help other Black women going through similar struggles, just as Brooks' Unicorn Squad helped her.

"When you start receiving treatment, the biggest impact is to your self-esteem, because you're no longer concerned that you're just lazy, or that you're just unmotivated," said Brooks. "You know this is a problem, and problems have solutions, whereas character flaws do not."

Sen. Wyden: $3.5T Budget May Have to Trim but It Can Set a Path to 'Ambitious Goals'

KFF Health News, July 20, 2021

Healthcare will account for a large proportion of the cost.

This article was published on Tuesday, July 20, 2021 in Kaiser Health News.

By Michael McAuliff

Exactly what American healthcare will look like if Democrats can pass their $3.5 trillion spending plan is unclear, but the senator negotiating its health-related provisions hopes what emerges will be dramatic: the first complete healthcare system for older Americans and significantly reduced costs for everyone else.

"We are setting very, very ambitious goals," Sen. Ron Wyden (D-Ore.) told KHN. "And that's appropriate because the fact is a lot of challenges have gotten short shrift — and I'm not just talking about the last four years, I'm talking about 10 years."

But the budget plan is highly controversial within the Democratic caucus and on a tight time frame. Senate Majority Leader Chuck Schumer set a Wednesday deadline for Democrats to agree on the broad outlines. Wyden insists that lawmakers from different wings of his party can come together to support a framework to move forward.

"He told us to be ready on Wednesday, and we will be," said Wyden, who chairs the powerful Finance Committee and is also a member of the Budget Committee.

While health policy questions have generally taken a back seat in the recent debate over possible infrastructure and climate provisions in the package, healthcare will account for a large proportion of the cost.

Provisions would include steps to reduce prescription drug costs, to extend the generous federal subsidies for people buying insurance on the Affordable Care Act's marketplaces, to provide coverage for low-income residents in states that did not expand their Medicaid programs and to massively increase healthcare options for older Americans.

Medicare could wind up with new programs to provide people with dental, vision and hearing care for the first time. The plan could realize President Joe Biden's proposal to spend $400 billion so seniors would get home-based and community healthcare to live at home longer instead of moving to nursing homes.

Drug spending would be lowered partly by allowing Medicare to negotiate prices with pharmaceutical companies, thus saving the federal government and consumers money.

In raw dollars, the healthcare components of the plan Democrats announced last week could easily exceed the initial $940 billion cost estimates of the Affordable Care Act.

"I think it's huge," said Paul Ginsburg, a professor of health policy at the University of Southern California and senior fellow at the Brookings Institution.

"Many of these components of the plan on their own would be considered major policy accomplishments, maybe the highlight of a congressional session," Ginsburg said. "This just multiplies it all, puts a number of these programs together, many of which on their own would be major, major accomplishments."

Yet there remain major question marks, as well. For instance, some of the proposals tread into territory that has never been tried before, and policy experts aren't sure how they will work. Ginsburg pointed to the dental, hearing and vision proposals for Medicare, noting there has been relatively little careful analysis related to including those benefits in Medicare.

"Nobody's talked about that. We don't know how to do it," Ginsburg said. "It's very different from medical insurance issues."

The plan is moving through what's known as the budget reconciliation process. First Congress approves budget instructions for bills that affect spending, revenue or debt. Under congressional rules, those bills can then advance on an expedited basis and pass in the Senate with a simple majority, with no threat of a filibuster.

Still, there is no room for error. With just 50 Democrats, Schumer will need every one of them — and Vice President Kamala Harris' tie-breaking vote — if Republicans remain united against the package. In the House, Democrats also have a tiny majority and could likely lose only a handful of members as they try to pass the budget framework.

Wyden and others are trying to help lawmakers reach consensus on a plan. Moderate Democrats have raised concerns about how these initiatives would be paid for, and not all are keen on the drug price measures, including allowing Medicare to negotiate. Progressives, on the other hand, have called for higher spending to cover even more robust initiatives.

Wyden said he is shuttling between the Senate and the House and moderates and progressives, and he intends to stay glued to the Capitol to meet Schumer's deadline.

He cautioned, though, that people should not expect to see every detail in whichever package is released this week. It will be an outline that tells committees to get to work on specifics. More details will come later.

"They will not be bills that people think of as legislation — Section 406-B and paragraph three and the like. This is a general framework. We're kind of flushing this out," Wyden said.

And even though he calls the overall effort ambitious, Wyden prefers to work out the details quietly, and make sure they are acceptable to his colleagues and the Senate parliamentarian, who determines if provisions of the bill qualify for the reconciliation process. "We're putting in the time to do this right," Wyden said, pointing to previous bills he has gotten passed. "That's kind of my style — underpromise and lower the decibel level and focus on getting it done."

That leaves ample wiggle room in terms of what would emerge, probably in the fall if Democrats can pass the budget reconciliation this summer. Lawmakers' tinkering and negotiations over how much each item will cost, how long to fund it and how comprehensive a specific program will be could leave certain elements looking skimpy.

Wyden said Democrats may need to settle for very basic versions of these new programs. But the key, he added, is to get the programs started, and show people what is possible.

"The way we're talking about it — and this is going to be the subject of many, many discussions — is we want to get the architecture of these changes, bold changes," Wyden said.

Exactly how grand each change turns out to be in the short run may not be the most important thing, Wyden suggested.

"There's going to be a discussion — this number of years, that number of years and the like," he said. "But what's really important, and we've talked about it — the Budget Committee's talked about it — if we get the architecture right, we can start serving people and build on it."

Wyden often talks about how he got into politics after spending nearly seven years running the Gray Panthers advocacy organization in Oregon and teaching gerontology. What he's believed for a long time is that Medicare simply is not enough to meet people's needs.

"I would say Medicare is a half a loaf," Wyden said.

He wouldn't quite promise a full baguette when the reconciliation process is done.

"This is going to make a significantly bigger set of healthcare options for seniors. I'm not going to start dividing loaves," Wyden said.

Michael McAuliff: @mmcauliff ‏

California Makes It Easier for Low-Income Residents to Get and Keep Free Health Coverage

KFF Health News, July 20, 2021

A provision in California's newly approved state budget will eliminate the asset test for the 2 million Californians enrolled in both Medi-Cal and Medicare.

This article was published on Tuesday, July 20, 2021 in Kaiser Health News.

By Rachel Bluth

SACRAMENTO, Calif. — Getting clean drinking water cost Ignacio Padilla his health insurance.

The World War II veteran needed to repay the loan for the water pump installed on his 1-acre property in rural Tulare County, the only source of water to his mobile home. He carefully socked away a few thousand dollars so he could make the payoff — only to find that those savings put him over the asset threshold to remain on Medi-Cal, California's Medicaid program for low-income people. He was booted from the health insurance program in 2019.

It wasn't an emergency at the time. Padilla still had coverage from Medicare and the Department of Veterans Affairs, and he could live an independent, if remote, life.

But now Padilla is 95 and has congestive heart failure. His children are trying to get him back on Medi-Cal so it can eventually cover the costs for nursing home care.

His older daughter, Emily Ysais, worries that Padilla's finances — limited though they are — will again disqualify him. He gets $1,100 a month from his pension and Social Security. If Veterans Affairs approves the monthly caregiving stipend she helped her dad apply for, it could tip him over the limit of Medi-Cal's "asset test."

"Our hands are tied," said Ysais, 67. "It's hard to keep figuring out a way to take care of him."

Change is coming, though perhaps not soon enough for Padilla. A provision in California's newly approved state budget will eliminate the asset test for the 2 million Californians enrolled in both Medi-Cal and Medicare, the federal health insurance program for people 65 and older and people under 65 with certain disabilities. Instead, their financial eligibility will be based solely on income, as it is for the millions of other people in Medi-Cal.

The elimination of the test will be a game changer for aging or impaired Californians who need long-term care but are caught in a common conundrum: They don't earn enough to cover the high costs of ongoing nursing home care and can't rely on Medicare, which does not cover extended nursing home stays. They can get that care through Medi-Cal, but they would have to wipe out their savings first.

The 2021-22 state budget deal includes several provisions that will make it easier to get on and stay on Medi-Cal, including the elimination of the asset test. Everyone 50 and over will be eligible, regardless of immigration status. And new mothers will be allowed to remain on Medi-Cal for one year after giving birth, up from 60 days.

The budget also includes $15 million over the next three years, starting this year, to develop online enrollment forms and translate them into multiple languages, and $8 million for counties to help some people who get in-home care stay enrolled.

California has a strong Medi-Cal takeup rate, with 95% of eligible people enrolled, said Laurel Lucia, director of the healthcare program at the Center for Labor Research and Education at the University of California-Berkeley. But of the remaining uninsured people, about 610,000 qualify for Medi-Cal, she said.

"We are doing well, but so many people are eligible and not enrolled," Lucia said. "The barriers to Medi-Cal enrollment and retention are really multifaceted, so the solutions have to be as well."

This is an especially volatile moment for the program, which covers 13.6 million Californians. The state is trying to improve the quality of care by renegotiating its contracts with managed-care insurance companies. At the same time, Gov. Gavin Newsom and the state Department of Healthcare Services are proposing a massive overhaul that would provide more services to homeless people and incarcerated people and boost mental healthcare.

Meanwhile, Medi-Cal enrollment continues to grow: State officials estimate enrollment will balloon to 14.5 million this fiscal year, which began July 1.

The changes to Medi-Cal that were approved in the budget include an expansion that Democratic lawmakers have been seeking for years: California already allows eligible unauthorized immigrants up to age 26 to receive full Medi-Cal benefits. Starting next spring, that will expand to people 50 and up.

State officials estimate about 175,000 people will enroll in the first year, with an additional 3,600 people signing up every year thereafter, eventually costing the state $1.3 billion annually.

And, starting next July, new mothers will be able to stay on Medi-Cal for up to one year after giving birth. By 2027, the additional coverage is expected to cost the state about $200 million a year.

Assembly Republican Leader Marie Waldron (R-Escondido), who said she supports expanding eligibility for the program in limited circumstances, was the author of a bill to allow incarcerated people to enroll before they're released that was ultimately folded into the budget and will take effect in 2023.

But she said the changes in this year's budget go too far.

"Expensive government-run healthcare doesn't really work, and most voters don't want to pay for it," Waldron said. "But California Democrats seem to think everyone will love it once they are on it, which is not true. It's creeping socialism."

The elimination of the Medi-Cal asset test for older Californians and those with certain disabilities, which takes effect July 1, 2022, marks a dramatic change to the program. Officials estimate it will cost the state roughly $200 million a year once fully implemented because of the increased enrollment.

Right now, these people can't qualify for Medi-Cal if they have saved more than $2,000. For couples, it's $3,000. Complicated rules dictate what counts as an "asset" and what doesn't: A house doesn't count and neither does one car, but a second car does. Engagement rings and heirlooms are fine, but other jewelry counts toward the limit.

Ultimately, the test favors individuals and families who can navigate the rules and find ways to hide money in exempt accounts, said Claire Ramsey, a senior attorney with Justice in Aging.

"You create administrative hurdles, which keeps people artificially off the program," Ramsey said. "If it's hard for the lawyers to understand all the rules, what does that mean for the average person who's just trying to have health insurance?"

The federal Affordable Care Act eliminated the asset test for most Medicaid enrollees, basing financial eligibility exclusively on income, but left out people who qualify for both Medicaid and Medicare.

This is especially important when it comes to expensive long-term care, like nursing homes, which can cost $10,000 a month, said Patricia McGinnis, executive director of California Advocates for Nursing Home Reform.

Medicare covers nursing home care only in limited circumstances and for up to 100 days. After that, patients must find another way to pay, either out-of-pocket or through Medi-Cal. Because many people don't qualify for Medi-Cal if they have too much money or other assets, they have to spend through their savings and shed their belongings before they can get on the program.

"Thousands and thousands of people have become impoverished to afford nursing home care," McGinnis said. "You want free medical care? You're going to have to spend every penny you have to get it."

A state Assembly analysis estimated that 17,802 additional Californians would have become eligible in 2018 if the asset test hadn't been required. Of those, 435 were in long-term care, and over the course of the year, 263 spent their money or gave away their assets to qualify for Medi-Cal.

Assembly member Wendy Carrillo (D-Los Angeles), the author of the asset test bill that was folded into the budget, sees eliminating the requirement as part of a larger movement toward universal coverage, in line with efforts to expand Medi-Cal to older unauthorized immigrants or establish a single-payer system.

"We need to aggressively and proactively work on legislation that gives more people coverage," Carrillo said. "And until we have universal healthcare, these are the steps necessary to ensure that."

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

Rachel Bluth: rbluth@kff.org, @RachelHBluth

Perspective: Grab Your Mask and Notepad, We're Headed Back to California's State Capitol

KFF Health News, July 19, 2021

Masks are back for anyone who works in the building, and unvaccinated employees must be tested in the basement twice a week.

This article was published on Monday, July 19, 2021 in Kaiser Health News.

By Rachel Bluth

SACRAMENTO, Calif. — The best part about returning to the pandemic-besieged state Capitol is that the elected officials are so unused to seeing us reporters after more than a year that some are occasionally extra chatty. The bad part is that the masks make it harder to eavesdrop on the rest of them.

Much like the rest of the state — which is navigating ever-changing COVID rules, such as whether vaccinated people should wear masks or how far apart schoolkids should be (3 vs. 6 feet) — the building is subject to a tangle of shifting requirements. All of us — the lawmakers, their staff, the press and the tourists — are making mistakes.

When I reemerged at the Capitol to cover recent budget negotiations, I immediately committed a cardinal sin of pandemic life: I shook the hand of an Assembly member. It's one of those mistakes you immediately realize you've made, like calling your teacher "Mom."

Thankfully, she brushed it off but returned after our conversation to wordlessly offer me a squirt from a giant bottle of hand sanitizer. Probably best practices for anyone talking to the press.

Resurfacing from our pandemic isolation can get confusing. Most California workplaces no longer require vaccinated workers to be masked, in accordance with the June 17 guidance from the state's Occupational Safety & Health Standards Board. The Capitol, where 85% of members and staffers are fully vaccinated — compared with about 61% of eligible Californians — also dropped its mask mandate for vaccinated employees.

That is, until an outbreak erupted in early July, when nine Assembly staffers — eight from the same office — tested positive. Four of them say they were fully vaccinated.

That's a lot of bad luck, considering so-called breakthrough cases are said to be rare. According to the California Department of Public Health, there have been 10,430 COVID cases out of 20.4 million fully vaccinated people as of July 7, a rate of 0.051% of vaccinated people getting sick.

Some post-vaccination infections are to be expected, said Dr. Kirsten Bibbins-Domingo, who chairs the department of epidemiology and biostatistics at the University of California-San Francisco. And once a positive test pops up, you're bound to find more. In this situation, testing likely uncovered asymptomatic cases that would otherwise have gone unnoticed, she said.

In a letter to staff on July 9, Assembly Speaker Anthony Rendon and Senate leader Toni Atkins implored everyone to get vaccinated. But, so far, inoculation isn't required, even though there should "absolutely be a vaccine mandate" for the Capitol, Bibbins-Domingo said.

Meanwhile, masks are back for anyone who works in the building, and unvaccinated employees must be tested in the basement twice a week.

Visitors face all the security measures you'd expect for anyone entering a government building (metal detectors and TSA-esque bag screenings). They are advised to wear masks with at least two layers of protection and must submit to a temperature check by security guards, who, through thin slits in plexiglass barriers, aim thermometer guns at visitors' foreheads.

As I entered the building one recent morning, a gaggle of tourists loitered outside, staring at their phones trying to figure out what to do — like people hoping to get into an exclusive new club. They had all forgotten their masks and didn't know whether they could get in, but security guards were more than happy to hand out garden-variety surgical masks.

Even "Bacteria Bear," the 800-pound bronze legacy of the Schwarzenegger administration, is masked. However, it's not fully business-as-usual for the bronze statue, which guards the entrance to the governor's offices. He's roped off with strict warnings not to touch. (In hindsight, maybe officials should never have invited hundreds of germy tourists to rub their hands all over him.)

Some semblance of normalcy is creeping back into the building. Small groups of tourists roam the halls to look at exhibits, state police guard the exits and give directions to lost reporters (me), and a handful of staffers shuffle between committee rooms and offices.

Though it's much quieter than usual, and most lawmakers aren't allowing drop-in visits by constituents, the actual work of legislating doesn't look much different.

Lawmakers left town Thursday for a month for summer break, and in the past few days have rushed to pass a few dozen budget bills and wrap up committee hearings. As they deliberated, close talking, back-patting and corner huddling were common. But this time they were masked.

California's state Capitol was not built for a pandemic. Members' desks are arranged with little separation between them, and though the ceilings are high (and ornately decorated), airflow is minimal.

"This building isn't well ventilated," said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee. "It's like an airplane in here; you can't even open the windows."

The novelty of working around people again is producing strange experiences. I'm used to pestering lawmakers and their staffers for interviews, but in the back of the Assembly's mint-green chamber, where reporters have always been quarantined regardless of the pandemic, a member came up to me to introduce herself. It's been so long since she's seen a reporter back here, she said, she just had to come over and say hello.

The state Senate chamber, which favors red and pink, feels a little more COVID-cautious than the lower house down the hall. Although state officials have repeatedly said there will be no "vaccine passports" required in California, they're alive and well for reporters trying to get near senators.

Along with our credentials, journalists need passes, printed on purple paper with the Senate seal, to get onto the chamber floor. The Capitol nurse distributes the passes only after reporters provide proof of vaccination or a recent negative COVID test.

In the Senate's smaller and more intimate chamber, there's plexiglass around the dais up front, a few members' desks and a microphone near the back.

And in the rear of the chamber, a lone "press only" desk is surrounded in clear plastic on three sides. I'm beginning to suspect they think we may be more virulent than the general public.

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

Rachel Bluth: rbluth@kff.org, @RachelHBluth

Novavax's Effort to Vaccinate the World, From Zero to Not Quite Warp Speed

KFF Health News, July 19, 2021

Novavax's quest to scale up operations underscores how difficult it can be to launch a vaccine ― even with the formula and technology in hand.

This article was published on Monday, July 19, 2021 in Kaiser Health News.

By Sarah Jane Tribble and Rachana Pradhan

On a sweltering June morning, Novavax CEO and COVID vaccine maker Stanley Erck stood on a stage unmasked and did something that would have been unthinkable six months ago: He shook hands with Maryland's governor.

Erck was with Gov. Larry Hogan to announce Novavax's global vaccine headquarters ― a campus expected to house laboratories and more than 800 employees. Hogan called Novavax's future "bright" and marveled that more than 71% of the state's adults had received at least one shot.

None of those was a Novavax vaccine, which is still unavailable for the American public due to delayed clinical trial results and other difficulties. Hogan, for his part, received his first vaccine dose ― made by fellow biotech upstart Moderna ― in January.

"As you can imagine, we're eager to receive our own," said John Trizzino, Novavax's chief commercial officer and interim chief financial officer. Its two-dose COVID vaccine, which showed overall 90.4% efficacy in key U.S. and Mexico trials, has yet to be authorized. "In the meantime," Trizzino said, "we've had to use one of the existing licensed vaccines and we look forward to the booster" made by Novavax.

Looking forward has kept Novavax afloat for decades ― along with its deep ties to grant makers and federal agencies. With its focus on developing vaccines, including for the SARS and MERS pandemics, Erck argues Novavax is "built for this moment." Still, the 34-year-old startup has never brought one to market.

Novavax's quest to scale up operations underscores how difficult it can be to launch a vaccine ― even with the formula and technology in hand. So what happened? It has had the financial backing of the U.S. government and full faith of international agencies. Everything took longer than expected: hiring necessary researchers and scientists, getting supplies and transferring its vaccine technology. It didn't move at warp speed.

America is awash with vaccine options, and Novavax does not plan to file for regulatory authorizations until late July at the earliest. The delay could have dire consequences for people across the globe awaiting a vaccine.

"We're not making aspirin," Trizzino said. "We're making a very complicated biological."

A Moonshot Goal

A year before the COVID pandemic hit, Novavax had a failed late-stage trial on a potential respiratory virus vaccine, after which it cut its workforce and sold off all its manufacturing capabilities. So, when more than $2 billion in federal and international funding landed at its doorstep, Novavax found itself developing both "a vaccine and a company" in 12 months, said Dr. Gregory Glenn, president of research and development.

Novavax's proprietary secret ingredient is Matrix-M, an immune booster. Executives say the additive ― derived from Chilean soapbark trees ― works so well that less of an antibody-producing antigen would be needed with it in a vaccine. One financial filing said Matrix-M "has the potential to be of immense value."

Equipped with its recombinant nanoparticle vaccine mixed with Matrix-M, Novavax deployed a core team of employees, dubbed "SuperNOVAs," to crisscross the globe. They assembled a manufacturing network and shared vaccine technology in India, South Korea, Spain, Japan and the Czech Republic as well as in the United States ― about 20 contract manufacturing and test sites in all.

"This takes time and expertise," Trizzino said. "You just simply can't hand over the recipe and then walk away from it and expect you're going to have a high-quality product."

Novavax is contracted to form the backbone of the COVAX initiative, having promised 1.1 billion doses starting this year for developing countries. And while President Joe Biden announced the U.S. would donate 500 million doses of the Pfizer-BioNTech vaccine abroad, Novavax is still seen as vital to urgent efforts worldwide to battle the virus and its variants.

Novavax's moonshot goal of producing 2 billion shots a year increasingly looks like a pipe dream for 2021. "It is very hard to accept that they will make 2 billion doses as they had originally committed. I'm very skeptical," said Prashant Yadav, a healthcare supply chain expert and senior fellow at Harvard's Center for Global Development.

One of Novavax's biggest challenges, Yadav said, is relying on "so many sites" that aren't fully under its control, while other manufacturers own their plants. The more places Novavax produces the vaccine, the more challenging it is to make sure the vaccine and its elements are comparable in every place.

When Novavax executives announced another delay in May, the company's stock plummeted to $121 a share ― down 62% from a high of about $319 in February. As the company's fortunes rose last year, Novavax executives cashed out tens of millions of dollars in common stock, according to securities filings. Last year, after the company benefited from grants and government contracts, CEO Erck sold $9.3 million in company shares, Glenn sold $14 million, and Trizzino sold $11.3 million.

Those top executives continued selling in 2021. Erck sold more than $22.5 million worth of common stock in early July.

Novavax executives use trading plans, and the sales often appear at the same time each month. In June, after Novavax announced its long-awaited U.S. and Mexico clinical trial results, Glenn sold more than 8,000 shares for $1.5 million. As a measure of the company's spectacular rise in the pandemic, Glenn purchased 1,000 shares of stock in December 2016 for the price tag of just $1,446.

Novavax spokesperson Amy Speak said the company has programs in place to ensure best practices on stock sales. "Most people, including our executives, sell stock for a wide variety of reasons," she said, adding that Novavax's executives have "generally sold a fraction of their overall holdings in the company."

Charles Duncan, a biotechnology research analyst at Cantor Fitzgerald, called Novavax a "show me" investment in May. "It's one thing to have a place to make it," he said. "It's another thing to be able to make it there and get it certified."

'Hadn't Heard of COVID-19'

John Kutney, Novavax's senior director of manufacturing, joined a BioBuzz video in December, in an effort to recruit urgently needed talent. Kutney described the technology transfer as taking a recipe and teaching it to others. With that mission, he has traveled to the Czech Republic, Spain and the United Kingdom as well as Texas, North Carolina and New England.

When Novavax began work on its vaccine in January 2020, "most of us hadn't heard of COVID-19 and we were only beginning to become aware of what was happening in China," Kutney said. Novavax adapted its established vaccine platform to the new virus and then had to scale and transfer it to larger manufacturing sites, build a global supply chain and develop a regulatory strategy for emergency use.

"These steps would normally take years," he said.

The key step of transferring Novavax's vaccine technology can take three to six months, depending on the quality of the partner's team. Once equipment and raw materials are secured, the teams start with small batches ― first with a 50-liter bioreactor, then a 200-liter and eventually a 2,000-liter bioreactor, checking to make sure the partner operators know the process every step of the way.

"What we're trying to do here is not easy," said Fred Shemer, Novavax's vice president of quality systems and compliance, in the video: "It's a challenging situation."

In March 2020, Novavax received the first $4 million of nearly $400 million pledged by the Coalition for Epidemic Preparedness Innovations. CEPI is a global alliance backed by the Bill and Melinda Gates Foundation, which previously supported Novavax with $89 million for a vaccine for a common respiratory virus.

CEPI's investment jump-started Novavax's technology transfer to plants across Europe and Asia. It helped Novavax partner with SK bioscience in South Korea and paid for ramping up production at Praha Vaccines, which Novavax eventually bought, in the Czech Republic. It also supported scaling up production of Matrix-M at facilities in Sweden and Denmark.

Operation Warp Speed awarded $1.6 billion in July 2020 to Novavax so it would produce 100 million doses ― one of the largest awards from the Trump administration's vaccine incubator. It was "kind of a stunning number for us," Trizzino said. In December, officials bumped the total to $1.74 billion with no changes to the previous contract. Novavax also has a $60 million contract with the Department of Defense for 10 million doses.

Paul Mango, a former senior official at the Department of Health and Human Services, said it wasn't a "big concern" for the Trump administration that Novavax had no successful vaccine. After all, that was also true for Moderna, which went on to launch its wildly successful mRNA vaccine.

Operation Warp Speed's personnel resources and financial support would help carry the day. "We thought we could do it," Mango said.

At the time, Trump officials invested in several vaccine platforms to hedge bets because it wasn't known what would work, if any. "We didn't want to put all our eggs in mRNA," he said. "We didn't want to put all our eggs in viral vector," the platform used by Johnson & Johnson and AstraZeneca. Novavax's technology uses a more established process with a baculovirus grown inside insect cells in a bioreactor.

"It was very important to have that array of technologies," Mango said. "We had to pick the ones that had the best early results and the ones we thought could go through clinical trials before the spring of 2021."

Novavax scientists have spent years collaborating with officials at federal agencies such as the National Institutes of Health, National Institute of Standards and Technology, and Walter Reed National Military Center ― sometimes hiring from their ranks. In 2011, Novavax signed a $179 million contract to develop a seasonal and pandemic influenza vaccine with BARDA, the Biomedical Advanced Research and Development Authority.

As concerns about COVID-19 rose, Novavax and BARDA began another negotiation, but Operation Warp Speed officials "stepped over the top," Trizzino said. They asked Novavax what it would take to ramp up large-scale manufacturing, run a 30,000-subject clinical trial and the follow-on trials, and produce millions of doses.

"They said, 'Do all these things in parallel paths. You don't worry about the funding risk. You do the work and we'll pay for those activities,'" Trizzino recalled.

Troubles in Texas

It was a tall order. Novavax had worked with Emergent BioSolutions and signed a contract for manufacturing in early 2020, but BARDA pushed Novavax to partner instead with Fujifilm Diosynth Biotechnologies and its plants in North Carolina, Texas and the U.K.

In retrospect, Trizzino said, Novavax "dodged a bullet." Production problems at Emergent's Baltimore plant led to contamination or suspected contamination of millions of Johnson & Johnson and AstraZeneca doses, and in June federal regulators declared 60 million J&J doses unusable, The New York Times first reported.

Fujifilm's Texas site, like Emergent's plant in Baltimore, was set up in the aftermath of the 2009 H1N1 pandemic to better prepare federal officials for the next one. It received $265 million last July to quickly boost manufacturing capacity, according to a federal contract.

The site began production in January but had to slow the cadence of its manufacturing lines for "troubleshooting" during Novavax's technology transfer process, Fujifilm spokesperson Christine Jackman said. The plant is producing the Novavax vaccine and another undisclosed COVID vaccine.

Trizzino said Fujifilm's site in North Carolina was up and running quickly, but Texas didn't have as much experience so "it's taken us a bit longer to ramp that up." A March inspection by the Food and Drug Administration found overcrowded and unorganized storage areas, a failure to consistently follow cleaning procedures and questions about why there was a backlog of batches, according to documents obtained by KHN in response to a public records request. The backup formed because bulk drug substance was being made faster than the facility could review produced batches, Fujifilm's Jackman said.

FDA inspectors called Fujifilm's operations "sub optimal quality," according to an April response memo written by Gerry Farrell, Fujifilm's chief operating officer for the facility. He said the criticism resonated and promised a thorough review with fixes completed in April and May.

Novavax and Fujifilm work closely to ensure all batches are reviewed and inspected by both companies' quality control teams, said Speak, the Novavax spokesperson. The number of doses produced in Texas to date have not met projections. However, responding to federal inspections in Texas has not delayed Novavax's vaccine development because Fujifilm's North Carolina plant is the primary supplier of vaccine doses for the initial federal approval, Speak said.

Novavax's manufacturing process is complicated because the vaccine is made in steps in different places. One plant makes the protein antigen, and another makes the adjuvant. Then the two components go to a final fill-and-finish facility where they are combined into 10-dose vials.

Its Matrix-M relies on quillaja extract from soapbark trees. The extract is also an additive in root beer and Slurpees. Novavax warned investors in its December 2020 financial filings that an inability to secure enough of the extract could delay production and prevent it from meeting "obligations under our various collaborations and supply agreements." Still, Trizzino said that supply is "not an obstacle to total number of doses."

Supply shortages have plagued the industry. For Novavax, those supplies included 2,000-liter bioreactor bags, used to culture cells; depth filters for the purification process; and the growth media, which is used to feed the cells.

Not having raw materials forced Novavax to trim the number of test batches that manufacturing lines could run. It has also taken longer to create quality control tests, known as assays, to ensure that vaccines are consistent and establish a standard quality for all subsequent batches. Those delays slowed the company's ability to properly train operators, Trizzino said.

Novavax is working to reach "a level of comfort that we're able to produce these batches and then go to full capacity," Trizzino said. Novavax is working to complete the final phases of validating those tests.

Too Late?

At the headquarters event, Glenn acknowledged that Novavax is late to the game. But the global demand is still enormous, he stressed.

"We know that 2 billion people worldwide have received at least one shot," he said, "but there are 6 billion people that need to be inoculated."

The company is working to prove its vaccine will be useful even after the pandemic is contained. With its Matrix-M adjuvant, Novavax is testing a combined flu and COVID vaccine, which is showing strong results in ferrets and hamsters. Novavax is also focused on booster shots.

Novavax joined mix-and-match trials this spring in the U.K. to test whether its vaccine works when paired with Moderna, Pfizer or AstraZeneca's vaccines. Glenn said the results, so far, have been promising that "we're going to be able to use our vaccine after other licensed vaccines."

First, though, "the world has to collectively, as one, really stymie this global pandemic," said Dr. Dawd Siraj, a University of Wisconsin professor specializing in infectious diseases.

Siraj said Novavax's delays shouldn't cast doubt on the quality of the vaccine itself, given the positive trial results it has reported globally.

The shot is a "very good vaccine," he said, that could help turn the tide in developing countries unable to support their own vaccine development.

"Let us never miss the most important point here," Siraj added. "Anyone who is getting a vaccine that is approved, the chances of dying, the chances of requiring ICU care, the chances of requiring a ventilator and high-flow oxygen, they almost disappear."

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

Biden's July Executive Order Includes Drug Pricing Provisions. But Will They Do Enough?

KFF Health News, July 19, 2021

So far, experts generally say the jury is still out on how meaningful these efforts will be.

This article was published on Monday, July 19, 2021 in Kaiser Health News.

By Victoria Knight

President Joe Biden's executive order of July 9 included various steps toward making good on campaign promises to take on pharmaceutical companies by allowing the importation of prescription drugs and curbing the high cost of medicines.

These issues were key to candidate Biden's 2020 healthcare platform, which stated he would "stand up to abuse of power" by drugmakers. Biden promised on his campaign website that he would allow consumers to buy prescription drugs from other countries, as long as the Department of Health and Human Services deemed it safe. In speeches, candidate Biden also pledged to bring down drug costs by 60%.

Nearly six months into his term, Biden issued an executive order on promoting economic competition, which included moves toward fulfilling these promises.

KHN has teamed up with our partners at PolitiFact to analyze Biden's promises during the 2020 presidential campaign — and, so far, experts generally say the jury is still out on how meaningful these efforts will be.

Drug Importation

Promise: "To create more competition for U.S. drug corporations, Biden will allow consumers to import prescription drugs from other countries, as long as the U.S. Department of Health and Human Services has certified that those drugs are safe."

The July 9 executive order directed the Food and Drug Administration commissioner to work with states to develop a program allowing prescription medications to be brought in from other countries, particularly Canada.

However, several drug pricing experts told us that, of all the policy ideas aimed at reducing the cost of drugs, importation seems the least likely to happen.

"Other countries are not interested in facilitating this," said Benedic Ippolito, a senior fellow in economic policy studies at the American Enterprise Institute.

Matthew Fiedler, a fellow with the USC-Brookings Schaeffer Initiative for Health Policy, agreed.

"This policy is unlikely to ever work as intended because Canada is unlikely to allow the export of drugs to the United States," Fiedler wrote in an email.

That's because drug manufacturers would then probably demand higher prices in Canada, since those would become the de facto U.S. prices, he said. "That would cause a big increase in prices in Canada that Canada likely wishes to avoid."

This is not the first time a president has suggested importing drugs, notably from Canada. President Donald Trump put forward the same idea during his time in office. Democrats and Republicans alike have supported similar proposals.

During the Trump administration, a rule was finalized allowing states to seek the FDA's permission to import drugs. Several states then passed laws to that end, but Florida is the only state to have formally applied to the FDA. The agency has yet to make a decision on the request.

The Pharmaceutical Research and Manufacturers of America, the trade industry group representing major pharmaceutical companies, sued HHS in 2020 in an attempt to get this drug importation rule overturned. The litigation is ongoing, though the Biden administration has asked for the case to be dismissed.

In a May court filing, the administration argued the case was pointless because it's unclear whether any state importation plan would be approved anytime soon.

Canada has signaled its concern that exporting drugs to the U.S. could trigger shortages within its borders, and after the Trump-era rule was finalized, the country moved to block bulk exports of medications in short supply.

Still, Rachel Sachs, a law professor and drug pricing expert at Washington University in St. Louis, said Biden's "rehabbed" policy isn't a bad thing.

"Drug pricing has been a big problem for several years now, and there are many policy ideas on the table. We don't lack for policy ideas — we lack for actual implementation of those ideas," Sachs wrote in an email. "So I don't think it's concerning at all if the administration chooses to advance existing policy ideas rather than developing new ones from scratch."

It's also important to remember that Biden has just released an executive order directing that these things happen. It is just a first step in a long line of steps, including issuing rules and allowing time for public comment.

That means details of how this importation policy would work are not yet available. The executive order calls for a report to be issued 45 days afterward with a plan outlining specific efforts to reduce prescription drug prices.

"I assume we'll know more then," Sachs said.

The High Cost of Drugs

Promise: "I'm going to lower prescription drugs by 60%, and that's the truth."

On this pledge, the recent executive order outlined the president's vision for how to proceed.

The order included an initiative designed to shore up the approval framework for generic drugs and biosimilars, working with the Federal Trade Commission to address efforts to impede competition for these types of drugs and help Medicare and Medicaid incorporate new payment models to cover them.

Experts so far have offered measured reactions.

The administrative actions outlined in this executive order do have the potential to reduce prescription drug prices, said Fiedler of the USC-Brookings Schaeffer Initiative. But it depends on more than just what the order says.

"In each of these areas, whether prices actually fall will depend on the details of the proposals the administration ultimately puts forward," Fiedler wrote in an email. "However, these are all areas where there are opportunities to make changes that would have a meaningful impact."

Again, more will be known in 45 days, the deadline for the release of the plan to reduce prescription drug prices.

It's important to note that the FTC is an independent agency, so Biden's principal means of influencing drug policy comes from his appointments to the agency, said Fiedler. It does seem likely, though, he added, that the newly appointed FTC chair would be sympathetic to cracking down on market conduct that delays the entry of generic drugs or biosimilars.

Still, reducing drug prices by 60% would require legislation, said the AEI's Ippolito.

"And the most disruptive drug pricing reforms — those that could even sniff that kind of price reduction — are also the most unlikely to pass," Ippolito wrote in an email. "In short, I suspect that this executive order isn't going to make much headway."

Trump also promised last year on the campaign trail that he would lower drug prices by 60%, after repeatedly promising to reduce medication costs during his four years in office. However, little progress was made toward that goal despite several related executive orders in 2020.

While Biden's executive order has a different focus than most of the Trump-era drug pricing orders, the Biden administration has signaled it may still be open to embracing some of those policies.

Trump's directives focused on rebates paid to pharmacy benefit managers being rerouted to beneficiaries, reducing the cost of insulin by compelling federally qualified health centers to make the drugs available at low prices to low-income people, importing drugs from Canada and tying drug prices to the prices paid in other countries.

Three proposed rules that resulted from Trump's orders are being kept around by the Biden administration — at least for the time being. One is the "Most Favored Nation Model." This rule is supposed to match U.S. prices for certain classes of drugs with the lower amounts paid in countries that negotiate drug prices.

According to Politico, the Biden administration's regulatory office received the rule this month, which means there may be a new public comment period before the rule is finalized — though it's likely this would take some time.

And, of course, there's the pending Trump administration rule on drug importation, currently tied up in court.

Trump's rebate rule, meanwhile, has also been delayed. The Biden administration pushed back its effective date to January 2023. Freezing the rule was part of the Biden administration's policy to review any rules finalized in the final months of Trump's term.

No other Trump drug pricing efforts made much headway. Instead, they drew a fair amount of industry pushback.

And it remains to be seen whether Biden's directives will fare any better.

Experts agreed that most likely congressional action would be needed to achieve a 60% reduction in prices. With over three years left in Biden's term, who knows what could still happen?

For now, we rate these promises "In the Works."

Victoria Knight: vknight@kff.org, @victoriaregisk

Fútbol, Flags and Fun: Getting Creative to Reach Unvaccinated Latinos in Colorado

KFF Health News, July 16, 2021

Colorado, and most of the nation, has now moved into a new phase involving targeted efforts and individual interactions and using trusted community influencers to persuade the hesitant to get jabbed.

This article was published on Friday, July 16, 2021 in Kaiser Health News.

By John Daley, Colorado Public Radio

Horns blared and drums pounded a constant beat as fans of the Mexican national soccer team gathered recently at Empower Field at Mile High in Denver for a high-profile international tournament.

But the sounds were muted inside a mobile medical RV parked near the stadium, and the tone was professional. During halftime of Mexico's game against the U.S., soccer fan Oscar Felipe Sanchez rolled up his sleeve to receive the one-dose COVID-19 vaccine.

Sanchez is a house painter in Colorado Springs. After getting sick with COVID a few months ago, he thought he should get the vaccine. But because of the illness, he was advised to wait a few weeks before getting the shot. Asked if he's glad he got it, Sanchez answered through a translator: "Yes! He's more trusting to go out."

Bringing the mobile vaccine program to an international soccer match was the latest effort by the state of Colorado and its local partners to meet unvaccinated residents wherever they are, rather than ask them to find the vaccine themselves.

Long gone are the days in early spring when vaccine appointments were snatched up the instant they became available, and healthcare workers worried about making sure patients were eligible under state and federal criteria for age and health status.

Colorado, and most of the nation, has now moved into a new phase involving targeted efforts and individual interactions and using trusted community influencers to persuade the hesitant to get jabbed.

With about half of Colorado's 5.78 million people now fully immunized, the challenge cuts across all demographic groups. According to the state's vaccination dashboard, men are slightly more hesitant than women and rural residents are more hesitant than urban dwellers. Younger Coloradans have been less likely than their elders to prioritize the shots.

But perhaps no group has been harder to get vaccinated than Coloradans who identify as Hispanic. Despite Hispanics making up more than 20% of the state population, only about 10% of the state's doses have gone to Hispanic residents, according to the state's vaccination dashboard.

The gap is not as wide nationally: Hispanics, or Latinos, make up 17.2% of the U.S. population, and 15.8% of people who have gotten at least one dose — and whose race/ethnicity is known — are Hispanic.

At first, the gap in Colorado seemed to be an issue of inadequate access to healthcare. Nearly 16% of Hispanic Coloradans are uninsured, according to a KFF report. That's more than double the rate for white Coloradans. That disparity may play a role, even though the vaccine itself is free, with no insurance requirement.

Denver has hit the 70% threshold for resident vaccination, but some Latino neighborhoods are getting vaccinated at much lower rates, according to Dr. Lilia Cervantes, an associate professor in the department of medicine at Denver Health.

"There are some very high-risk neighborhoods where most of the community are first-generation or foreign-born individuals," said Cervantes. "And that is where we're seeing the highest disparities."

According to data from Denver's health agencies, about 40% of Latinos older than 12 are vaccinated in Denver County — that's far below the roughly 75% rate for whites.

Latinos make up 29% of the Denver population but represent nearly half of cases and hospitalizations.

If the state hopes to reach broad levels of protection from the virus, Cervantes said, "I think that it is critical that we improve vaccine uptake in our most marginalized groups, including those who are undocumented and those who are Spanish-language dominant." Cervantes added she's concerned the state will keep seeing a higher COVID positivity rate in those marginalized groups, who make up much of the essential workforce. "This past year, I think we have seen stark health inequities in the Latino community."

All this portends a more uneven pandemic, said Dr. Fernando Holguin, a pulmonologist and critical care doctor at the Latino Research & Policy Center at the Colorado School of Public Health.

He worries cases, hospitalizations and deaths will keep flaring up in less vaccinated communities, especially predominantly Hispanic populations in parts of Colorado or other states where overall vaccination rates are poor. "They're at risk, especially moving into the fall of seeing increasing waves of infections. I think it is really critical that people really become vaccinated," Holguin said. Even as parts of Colorado and parts of the U.S. — like the Northeast — are getting vaccinated at high rates, for the mostly unvaccinated "COVID infections in certain communities still will be devastating for them," he said.

He's especially concerned about migrant farmworkers, who often have poor access to the internet and may struggle to find good information about the vaccine and avoiding the virus. "So overcoming those access, cultural, language barriers is important," he said.

When asked what the state has done to reach out to Latino Coloradans, a health department spokesperson pointed to over 1,500 "vaccine equity clinics" in 56 counties; the Workplace Vaccination Program, which partners with businesses and organizations to provide vaccine clinics at worksites; and a Spanish-language Facebook page and COVID website. She said the state's "Power the Comeback" campaign is available in English and Spanish and aims to reach disproportionately affected populations with awareness ads, testimonial videos and animated videos.

About a third of all adults in the U.S. are unvaccinated, a "shrinking pool" that skews younger and includes people more likely to identify as Republican or Republican-leaning, according to a KFF COVID-19 Vaccine Monitor report.

They also tend to be poorer, less educated and more likely to be uninsured. The KFF report found 19% of unvaccinated adults are Hispanic; of that group, 20% said they will "wait and see" about getting vaccinated, and 11% said they'd "definitely not" get it.

Both Cervantes and Holguin credit local, state and community groups with aggressively looking to boost vaccination rates among Latino Coloradans, while also encouraging them to keep recruiting trusted community voices from within, to help deliver the message.

"You know, it's not going to be Dr. [Anthony] Fauci saying something, that someone translates in Spanish, that you need to get vaccinated," Holguin said. "There's going to be people in the community convincing others to get vaccinated."

At Empower Field, soccer fan Diego Montemayor of Denver echoed that sentiment, saying some fans who got shots themselves urged friends who came to the stadium to visit the RV and get one, too. "When they hear people that they trust sharing their experiences, that goes a long way," Montemayor said.

Community health advocate Karimme Quintana agreed. She had come to the game as well to spread the word about the safety and efficacy of the vaccine. She works as a promotora de salud pública, a public health outreach worker, focusing her efforts on Denver's majority-Latino Westwood neighborhood. Quintana said that population may trust someone close to them more than even a doctor.

"They need to be more educated about the COVID because they have a lot of questions," said Quintana, whose button read "¿Tiene preguntas sobre COVID? Pregúnteme." ("Do you have questions about COVID? Ask me.")

"Latino people, they listen [to] the neighbor, they listen [to] my friend," Quintana said.

University of Colorado Health nurse Danica Farrington said the vaccine effort at the soccer tournament was heavily promoted beforehand on billboards and big screens inside the stadium during the game.

"They just plastered it everywhere and said, go get your shot," she said. "That's pretty influential."

The carnival atmosphere at the stadium helped him make the pitch, said Jesus Romero Serrano, a community ambassador with Denver's mayor's office: "It's a Mexico game versus Honduras! So lots of Latinos are here. This is the perfect place to be, to reach the Latin community. Absolutely!"

To capitalize on the playful spirit of the day, Romero Serrano wore a Mexico soccer jersey and a red-and-green luchador wrestling mask. In his work with the city government, he's what you could call a community influencer. He filtered through the tailgate crowd in the parking lot, handing out cards about where to get a vaccine.

As he circulated, he admitted it's sometimes hard for some Latino Coloradans to overcome what they see as years of historical mistreatment or neglect from medical providers. "They don't trust the healthcare system," he said.

Still, Romero Serrano kept wading into the crowd, shaking hands and shouting over the constant din of the drum bands, asking people whether they had gotten a vaccine.

The most common answer he heard was "everybody has it" — but he was skeptical about that, thinking people were just being nice.

A few miles from the stadium is the Tepeyac Community Health Center, in the predominantly Hispanic Globeville neighborhood. That's home base for Dr. Pamela Valenza, a family physician and the chief health officer at the clinic. She tries to address her patients' fears and concerns about the new vaccines, but many have told her they still want to wait and see that people don't have serious side effects.

Valenza's clinic recently held more vaccine events, at more convenient times that didn't interfere with work, like Friday evenings, and offered free grocery cards for the vaccinated. She said she likes the idea of pairing vaccines with fun.

"The Latino culture — food, culture and community — is such a central part of the Latino community," Valenza said. "Making the events maybe a little bit more than just a vaccine might encourage some community members to come out."

This story comes from NPR's health reporting partnership with Colorado Public Radio and Kaiser Health News (KHN).

John Daley, Colorado Public Radio: @CODaleyNews

Hospital 'Trauma Centers' Charge Enormous Fees to Treat Minor Injuries and Send People Home

KFF Health News, July 16, 2021

Tens of thousands of times a year, hospitals charge enormously expensive trauma alert fees for injuries so minor the patient is never admitted.

This article was published on Friday, July 16, 2021 in Kaiser Health News.

By Jay Hancock July 16, 2021

The care was ordinary. A hospital in Modesto, California, treated a 30-year-old man for shoulder and back pain after a car accident. He went home in less than three hours.

The bill was extraordinary. Sutter Health Memorial Medical Center charged $44,914 including an $8,928 "trauma alert" fee, billed for summoning the hospital's top surgical specialists and usually associated with the most severely injured patients.

The case, buried in the records of a 2017 trial, is a rare example of a courtroom challenge to something billing consultants say is increasingly common at U.S. hospitals.

Tens of thousands of times a year, hospitals charge enormously expensive trauma alert fees for injuries so minor the patient is never admitted.

In Florida alone, where the number of trauma centers has exploded, hospitals charged such fees more than 13,000 times in 2019 even though the patient went home the same day, according to a KHN analysis of state data provided by Etienne Pracht, an economist at the University of South Florida. Those cases accounted for more than a quarter of all the state's trauma team activations that year and were more than double the number of similar cases in 2014, according to an all-payer database of hospital claims kept by Florida's Agency for Healthcare Administration.

While false alarms are to be expected, such frequent charges for little if any treatment suggest some hospitals see the alerts as much as a money spigot as a clinical emergency tool, claims consultants say.

"Some hospitals are using it as a revenue generator," Tami Rockholt, a registered nurse and medical claims consultant who appeared as an expert witness in the Sutter Health car-accident trial, said in an interview. "It's being taken advantage of" and such cases are "way more numerous" than a few years ago, she said.

Hospitals can charge trauma activation fees when a crack squad of doctors and nurses assembles after an ambulance crew says it's approaching with a patient who needs trauma care. The idea is that life-threatening injuries need immediate attention and that designated trauma centers should be able to recoup the cost of having a team ready — even if it never swings into action.

Those fees, which can exceed $50,000 per patient, are billed on top of what hospitals charge for emergency medical care.

"We do see quite a bit of non-appropriate trauma charges — more than you'd see five years ago," said Pat Palmer, co-founder of Beacon Healthcare Costs Illuminated, which analyzes thousands of bills for insurers and patients. Recently "we saw a trauma activation fee where the patient walked into the ER" and walked out soon afterward, she said.

The portion of Florida trauma activation cases without an admission rose from 22% in 2012 to 27% last year, according to the data. At one Florida facility, Broward Health Medical Center, there were 1,285 trauma activation cases in 2019 with no admission — almost equal to the number that led to admissions.

"Trauma alerts are activated by EMS [first responders with emergency medical services], not hospitals, and we respond accordingly when EMS activates a trauma alert from the field," said Jennifer Smith, a Broward Health spokesperson.

Florida regulations allow hospitals themselves to declare an "in-hospital trauma alert" for "patients not identified as a trauma alert" in the field, according to standards published by the Florida Department of Health.

At some hospitals, few patients whose cases generate trauma alerts are treated and released the same day.

At Regions Hospital, a Level I trauma center in St. Paul, Minnesota, patients who are not admitted after a trauma team alert are "very rare" — 42 of 828 cases last year, or about 5%, said Dr. Michael McGonigal, the center's director, who blogs at "The Trauma Pro."

"If you're charging an activation fee for all these people who go home, ultimately that's going to be a red flag" for Medicare and insurers, he said.

In the Sutter case in Modesto, the patient sued a driver who struck his vehicle, seeking damages from the driver and her insurer. Patient "looks good," an emergency doctor wrote in the records, which were part of the trial evidence. He prescribed Tylenol with hydrocodone for pain.

"If someone is not going to bleed out, or their heart is not going to stop, or they're not going to quit breathing in the next 30 minutes, they probably do not need a trauma team," Rockholt said in her testimony.

Like other California hospitals with trauma center designations, Sutter Health Memorial Medical Center follows "county-designated criteria" for calling an activation, said Sutter spokesperson Liz Madison: "The goal is to remain in position to address trauma cases at all times — even in the events where a patient is determined healthy enough to be treated and released on the same day."

Trauma centers regularly review and revise their rules for trauma team activation, said Dr. Martin Schreiber, trauma chief at Oregon Health & Science University and board chair at the Trauma Center Association of America, an industry group.

"It is not my impression that trauma centers are using activations to make money," he said. "Activating patients unnecessarily is not considered acceptable in the trauma community."

Hospitals began billing trauma team fees to insurers of all kinds after Medicare authorized them starting in 2008 for cases in which hospitals are notified of severe injuries before a patient arrives. Instead of leaving trauma team alerts to the paramedics, hospitals often call trauma activations themselves based on information from the field, trauma surgeons say.

Reimbursement for trauma activations is complicated. Insurers don't always pay a hospital's trauma fee. Under rules established by Medicare and a committee of insurers and healthcare providers, emergency departments must give 30 minutes of critical care after a trauma alert to be paid for activating the team. For inpatients, the trauma team fee is sometimes folded into other charges, billing consultants say.

But, on the whole, the increase in the size and frequency of trauma team activation fees, including those for non-admitted patients, has helped turn trauma operations, often formerly a financial drain, into profit centers. In recent years, hundreds of hospitals have sought trauma center designation, which is necessary to bill a trauma activation fee.

"There must have been a consultant that ran around the country and said, 'Hey hospitals, why don't you start charging this, because you can,'" said Marc Chapman, founder of Chapman Consulting, which challenges large hospital bills for auto insurers and other payers. "In many of those cases, the patients are never admitted."

The national number of Level I and Level II trauma centers, able to treat the most badly hurt patients, grew from 305 in 2008 to 567 last year, according to the American College of Surgeons. Hundreds of other hospitals have Level III or Level IV trauma centers, which can treat less severe injuries and also bill for trauma team activation, although often at lower rates.

Emergency surgeons say they walk a narrow path between being too cautious and activating a team unnecessarily (known as "overtriage") and endangering patients by failing to call a team when severe injuries are not obvious.

Often "we don't know if patients are seriously injured in the field," said Dr. Craig Newgard, a professor of emergency medicine at Oregon Health & Science University. "The EMS providers are using the best information they have."

Too many badly hurt patients still don't get the care they need from trauma centers and teams, Newgard argues.

"We're trying to do the greatest good for the greatest number of people from a system perspective, recognizing that it's basically impossible to get triage right every time," he said. "You're going to take some patients to major trauma centers who don't really end up having serious injury. And it's going to be a bit more expensive. But the trade-off is optimizing survival."

At Oregon Health & Science, 24% of patients treated under trauma alerts over 12 months ending this spring were not admitted, Schreiber said.

"If this number gets much lower, you could put patients who need activation at risk if they are not activated," he said.

On the other hand, rising numbers of trauma centers and fees boost healthcare costs. The charges are passed on through higher insurance premiums and expenses paid not just by health insurers but also auto insurers, who often are first in line to pay for the care of a crash victim.

Audits are uncommon and often the system is geared to paying claims with little or no scrutiny, billing specialists say. Legal challenges like the one in the Sutter case are extremely rare.

"Most of these insurers, especially auto insurance, do not look at the bill," said Beth Morgan, CEO of Medical Bill Detectives, a consulting firm that helps insurers challenge hospital charges. "They automatically pay it."

And trauma activation charges also can hit patients directly.

"Sometimes the insurance companies will not pay for them. So people could get stuck with that bill," Morgan said.

A few years ago, Zuckerberg San Francisco General Hospital charged a $15,666 trauma response fee to the family of a toddler who had fallen off a hotel bed. He was fine. Treatment was a bottle of formula and a nap. The hospital waived the fee after KHN and Vox wrote about it.

Trauma alert fatigue can add up to a nonfinancial cost for the trauma team itself, McGonigal said.

"Every time that pager goes off, you're peeling a lot of people away from their jobs only to see [patients] go home an hour or two later," he said.

"Some trauma centers are running into problems because they run themselves ragged. And there is probably unneeded expense in all the resources that are needed to evaluate and manage those patients."

Jay Hancock: jhancock@kff.org, @JayHancock1

Can Biden's Plan to Remove Urban Highways Improve the Health of American Cities?

KFF Health News, July 15, 2021

The president's infrastructure plan calls for highway removal to right historical injustices and improve the health of people who live nearby.

This article was published on Thursday, July 15, 2021 in Kaiser Health News.

By Sarah DiGiulio

Mandela Parkway, a four-lane boulevard enhanced by a median with trees and a curving footpath, stretches along a 24-block section of West Oakland. It's the fruit of a grassroots neighborhood campaign to block reconstruction of an elevated freeway leveled by the Loma Prieta earthquake in 1989 and reimagine the thoroughfare to replace it.

Since the parkway's 2005 completion, 168 units of affordable housing have sprung up along its route. The air is measurably freer of pollutants than it was when the Cypress Freeway ran through the area.

A federal report heralded the project as the type of socially minded renovation that can make appropriate, if partial, amends for the devastation wrought on low-income neighborhoods by the freeway-building boom of earlier decades.

"Community involvement was a very important part of the rebuilding process," said the report, which concluded, "West Oakland residents got what they wanted."

Unfortunately, that's not entirely the case.

Although the 1.3-mile strip of land that Mandela Parkway passes through has cleaner air and better amenities than when it was a freeway spur, many of the neighborhood's original residents are no longer there to enjoy it, forced out by rising rents and housing costs. And West Oakland more broadly, bordered by the massive Port of Oakland, is still crisscrossed by elevated freeways where cars and heavy trucks spew hundreds of tons of pollutants every year.

The successes and failures of the Mandela Parkway are emblematic of the challenges faced by a new urban renewal movement that seeks to replace dozens of stretches of elevated urban freeways built in the 1950s, '60s and '70s across the United States. These highways bisected cities, displacing residents and businesses in what were frequently lower-income, working-class, non-white neighborhoods. Pollution and noise plague the health of those who continue to live nearby.

Today, as many of these roadways near or pass the end of their intended lifespans, policymakers, social justice advocates and urban planners have called for them to come down.

President Joe Biden's administration agrees. His infrastructure plan calls for highway removal to right historical injustices and improve the health of people who live nearby. At least four bills in Congress would fund such efforts, though none is assured passage.

But the Cypress Freeway conversion shows how complicated it is to accomplish highway removal in a way that improves the health and well-being of the longtime residents wronged by the roadways' legacy. The effects of neighborhood "greening" can be paradoxical, leading to "green gentrification."

There's abundant evidence that living near highways is bad for human health: Research has linked it to higher rates of hypertension, heart attack, neurological illnesses like Alzheimer's disease and multiple sclerosis, worse birth outcomes, and asthma, especially in kids.

But the evidence is shakier on whether transforming the roadways reverses these problems, said Regan Patterson, a transportation equity research fellow for the Congressional Black Caucus Foundation.

A 2019 study conducted by Patterson and Robert Harley of the University of California-Berkeley's Department of Civil and Environmental Engineering showed that rerouting the Cypress Freeway — Interstate 880 — and building the Mandela Parkway cut nitrogen oxides by an annual average of 38%, and soot by 25%, along the parkway. But West Oakland in general is still heavily polluted by the rerouted I-880, as well as I-580 and I-980.

"You cannot talk about Mandela Parkway if you don't talk about the impact of all three highways," said Margaret Gordon, 74, a founding member of the West Oakland Environmental Indicators Project, an environmental justice organization.

And the very upgrade of the area along Mandela Parkway — coupled with the arrival of Big Tech company offices in the area — has contributed to property values spiking and longtime residents leaving. Black residents, who made up 73% of the population around the expressway in 1990, accounted for only 45% in 2010, according to Patterson's research. Median home values along the parkway jumped by $261,059 in that time frame.

"Green gentrification" is a paradoxical effect of projects intended to support healthier communities, said Jennifer Wolch, a professor of city and regional planning at UC-Berkeley. Her research, focused on the overall public health effects of urban greening, shows that rising housing costs and displacement of longtime residents can also damage their health. Other research has found that residents from marginalized groups reported a lower sense of community after "greening" transformations.

Longtime Latino residents, for example, reported avoiding segments of Chicago's 606 pedestrian trail that run through mostly white neighborhoods because of concerns of discrimination. Well-off white residents were more likely than Black residents to use the Atlanta BeltLine, a 33-mile network of trails and parks.

None of these problems seal an argument against highway removal, say urban activists. The Congress for the New Urbanism, a nonprofit focused on sustainable urban development, has identified 15 highways in major U.S. cities that are ripe for removal in its 2021 "Freeways Without Futures" report.

The lesson, instead, is to pay attention to the wishes of longtime community members in planning these infrastructure projects, said Jonathan Fearn, a member of the Oakland Planning Commission and a founder of ConnectOakland, an advocacy group involved in plans to tear down 2-mile-long I-980 and redesign the area.

Highway removal and neighborhood renewal should focus on making communities less car-dependent, and adding affordable housing and other amenities, said Dr. Richard Jackson, professor emeritus at the Fielding School of Public Health at UCLA and former director of the National Center for Environmental Health at the Centers for Disease Control and Prevention.

For example, creating community land trusts — nonprofits that buy vacant lots in communities and sell them back to residents at reduced rates — can help ensure affordable housing and rent stability.

Some of the congressional bills under consideration have provisions that would require anti-displacement strategies. But the $1.2 trillion Bipartisan Infrastructure Framework put forward by the Biden administration, which includes funding for a $1 billion "reconnecting communities" program, offers few details about ameliorating displacement.

If the projects get done, conversations about whom they benefit should happen early on, said Ben Crowther, program manager for the Congress for the New Urbanism's Highways to Boulevards program. But it's "very encouraging," he said, that federal bills to fund the remakes include strategies for making sure current residents benefit.

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

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