Covered California Says Health Insurance Just Got Too Cheap to Ignore

KFF Health News, May 4, 2021

If you are uninsured because health coverage seemed too expensive the last time you looked, it's time to look again.

This article was published on Tuesday, May 4, 2021 in Kaiser Health News.

By Bernard J. Wolfson

A new federal law could make it a whole lot cheaper to buy your own insurance if you don't get coverage through an employer or a government insurance program such as Medicare or Medicaid.

The law, the American Rescue Plan, provides billions of federal dollars to reduce premiums for people who buy their coverage through the insurance exchanges established by the Affordable Care Act.

The aid expands a federal tax credit created by the ACA that you can take upfront as a discount on your premium or claim when you file your taxes the following year. It is not available for those who buy individual or family policies in the open market outside an ACA exchange. So, if you are in an off-exchange health plan, you might save a lot of money by switching to one inside the exchange.

Covered California, the state's ACA exchange, opened a special enrollment period on April 12 for people who want to take advantage of the new aid by enrolling or switching coverage. The period runs through December — 4½ months later than the Aug. 15 special enrollment end date on the federally run exchanges.

Covered California estimates the new money will reduce its customers' monthly premium bills by an average of $180 per household. Nearly 90% of Covered California enrollees already get financial aid, and many will now get more. Some enrollees who didn't previously qualify for tax credits may now be eligible.

Darci Gutierrez, an insurance agent in Dublin, California, says a client with a large family saved $425 a month on a Blue Shield PPO at the silver tier — the second-lowest level in the ACA's four-tier system of coverage.

"I was shocked at the amount of reduction in cost. I was like, 'Holy cow,'" Gutierrez says.

The additional federal aid is slated to stop after 2022, which means your insurance could cost you more after that. But there is talk in Congress about extending the enhanced tax credits for longer.

The new law follows the lead of California, which provided groundbreaking state-funded tax credits starting last year to augment the ACA credits and push eligibility for aid well into the middle class. The new federal dollars will provide assistance even further up the income scale.

Covered California estimates 100,000 consumers with incomes too high to qualify for federal or state credits under prior law will now be eligible for subsidies averaging $500 a month per household.

The share of the new money going to California could be about four times as much as those state-funded subsidies and will completely replace them, saving the state about $761 million this fiscal year and next.

The newly enhanced federal tax credits take effect with coverage that starts May 1. To get coverage for the first of any month, you need only sign up by the day before.

If you are currently enrolled in Covered California, you can keep your plan and take the savings, or you could shop around and save even more — or switch to a higher level of coverage without increasing your monthly bill.

"It's critical that anybody who buys coverage as an individual take a look, because they may be leaving hundreds if not thousands of dollars on the table," says Anthony Wright, executive director of Health Access, a Sacramento-based consumer advocacy group.

The new law, signed by President Joe Biden in March, also allocates money to provide virtually premium-free coverage — in 2021 only — for anyone, regardless of income, who receives unemployment benefits at any point during the year.

California is projected to get about $3 billion of the new federal money. Officials at Covered California think the state can get even more, and the exchange is spending more than $20 million on a television, radio and social media advertising blitz to drum up business. It is targeting in particular the approximately 810,000 uninsured Californians who are eligible for federal support under the new law.

"We need to rattle uninsured people to look again and realize this is new and different," says Peter Lee, Covered California's executive director. "If they think it's just the same old same old, they ain't going to check."

Covered California is also marketing itself to an additional 270,000 people who are enrolled in health plans outside the exchange and would qualify for subsidized coverage if they switched to Covered California.

In an example used by Covered California in its promotional campaign, an Oakland couple making $77,580 a year, both 45 years old, pay the full monthly premium of $1,271 for a silver plan outside the exchange. By switching to the same plan in Covered California, they would pay only $550 — a monthly saving of $721.

If you are a current enrollee, Covered California — unlike the federally run exchanges — will automatically calculate your lower premium, and you will see a credit for May on your June bill. You will also reap that saving retroactively for the first four months of 2021 in the form of an additional premium reduction, in equal monthly installments, over the rest of the year.

If you are uninsured or in an off-exchange health plan, however, you need to take action. The money won't just come to you. Research your options and enroll.

To find out if you qualify for federal assistance, log on to www.coveredca.com.

Click the "shop and compare" button to find the health plans available to you in your area, along with the monthly premium you will pay after your tax credit.

You can also click a button to get a call from a licensed health insurance agent who can help you figure it all out — without charging you. If you don't have a computer, call Covered California at 800-300-1506.

In contrast to the federally operated exchanges, Covered California requires that people switching from off-exchange health plans into exchange-based ones be allowed to apply any deductible paid so far this year against the new policy, as long as they don't change insurance companies. That flexibility also applies if you are exchanging one Covered California plan for another, but with more restrictions, so ask your health plan before you make any changes.

If you are coming to Covered California from the open market, it should be easy to keep doctors you like, since most off-exchange plans mirror ones in Covered California and have the same networks. But there are cases in which you would not be able to keep your doctors, so be sure to ask your insurer about it before making a final decision.

Another notable feature of the new federal tax credits is that they no longer carry upper-income limits for eligibility. Instead, the amount people pay in premiums is limited to a fixed percentage of their income, ranging from zero for low-income consumers to 8.5% for the most affluent.

For the 2020 tax year, the new law overrides a requirement that consumers whose incomes exceeded their original estimate pay back any subsidy amounts to which they are not entitled.

Tom Freker, an insurance agent in Huntington Beach, California, says one of his clients made a big profit on a property sale last year, which raised his income to a level that would have required paying back the $10,000 subsidy he received in 2020.

"But the new American Rescue Plan waived that repayment," Freker says. "That's a big deal."

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

Bernard J. Wolfson: bwolfson@kff.org, @bjwolfson

Democrats Disagree About How to Spend Potential Prescription Drug Windfall

KFF Health News, May 4, 2021

The real problem is what to do with the considerable budget savings that would be produced by policies like allowing Medicare to negotiate drug prices.

This article was published on Tuesday, May 4, 2021 in Kaiser Health News.

By Julie Rovner

One of the few surprises in President Joe Biden's social safety-net proposal, the American Families Plan, was something that didn't make it into the final version: any mention of reining in the price of prescription drugs.

The American Families Plan, the second part of Biden's expansive "infrastructure" agenda, includes sweeping programs aimed at boosting access to child care, higher education and paid family leave. But despite White House signals in March that health also would be a major part of the package, the only health proposal was one that would make permanent the temporary subsidy increases, passed as part of the COVID relief bill earlier this spring, on insurance purchased through the Affordable Care Act's health exchanges.

Initial reports suggest that Biden and his aides did not want to pick a fight now with the powerful prescription drug industry, which is riding high in public opinion after producing COVID vaccines in record time. They worry that the industry's impressive lobbying clout could endanger the rest of the program.

But there is likely another big reason Democrats are loath to address drug prices, despite broad bipartisan support. After nearly a year of uncharacteristically being on the same page when it comes to healthcare, Democratic lawmakers are reverting to a more familiar position: They are at loggerheads about what to do next.

Most Democrats agree the time is ripe to tackle high drug prices. In 2019 the Democratic-led House passed a broad drug price bill that was reintroduced just days ago with the backing of Speaker Nancy Pelosi. Senate Democrats have also been working on drug price legislation. There is some difference between liberals and moderates on how far to push the drug industry for savings, but the consensus is that drugs cost too much and the government needs to step in.

The real problem is what to do with the considerable budget savings that would be produced by policies like allowing Medicare to negotiate drug prices. That's something that pits the more liberal Democratic backers of a "Medicare for All" insurance system against moderates who would instead put the savings into expanding the benefits of the Affordable Care Act.

Biden is, for the moment at least, taking both sides. Savings from drug price reforms "can go to strengthen the Affordable Care Act and expand Medicare coverage and benefits — without costing taxpayers one additional penny," he said in his speech to a joint session of Congress on Wednesday night.

But the factions are taking shape in Congress.

On hearing reports that Biden's families plan would leave major health items on the cutting-room floor, Medicare for All sponsor Sen. Bernie Sanders (I-Vt.) and 16 Senate Democratic colleagues urged Biden not just to include Medicare drug price negotiation authority in his package, but also to use the proceeds to lower the Medicare eligibility age (a Biden campaign promise) and add hearing, vision and dental benefits to Medicare. House Democrats in their 2019 bill opted to use the savings to provide those added health benefits to current Medicare beneficiaries. "We have an historic opportunity to make the most significant expansion of Medicare since it was signed into law," wrote the senators. A similar letter went to the president signed by 80 House members, led by Medicare for All backer Rep. Pramila Jayapal (D-Wash.).

But at the same time, more than 50 members of the "New Democrat Coalition," a more moderate group of House Democrats, also wrote to Biden, urging him to use the package to enhance the ACA. "Over a decade after the passage of the Obama-Biden administration's landmark healthcare legislation, we are eager to work with the Biden-Harris administration to fortify and build on the ACA to achieve universal coverage with access to affordable, quality care," they wrote.

This particular disagreement harks back to the 1980s and '90s, when generations were pitted against each other in a sometimes ugly way. Younger Americans, worried about rising rates of the uninsured, accused Medicare beneficiaries who wanted better benefits of being "greedy geezers." A law Congress passed in 1988 that would have boosted Medicare benefits and added a cap on catastrophic expenses caused a backlash when Congress decided wealthier seniors should pay for it themselves via added taxes. Seniors angry that younger people would not help foot the bill rebelled, and the entire program was repealed in 1989 before it ever took effect.

"It's a very American debate," said Jonathan Oberlander, a health policy professor at the University of North Carolina-Chapel Hill who has written extensively about Medicare. "It's a function of the fact that we have a fragmented health insurance system and it's fragmented by age. You don't have this conversation in Canada or France or anywhere else."

Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy, said the obvious next step is to make the new ACA subsidies permanent. "It's simple, it's all winners, and certainly affordable in the context," he said. In other words, there are no deep-pocketed stakeholders, like health insurers or drug companies, who would step in to fight the plan.

But neither plan, she said, gets to the biggest need, which is to help those caught in the "Medicaid gap" — at least 2.2 million people in states that didn't expand Medicaid who are still uninsured. They don't qualify for ACA marketplace coverage, because they earn too little, or for Medicaid, because they earn too much. "My general preference is to create a public program for those folks to enroll," Adler said.

Oberlander and Adler said it's likely this fight will be settled the old-fashioned way: Rather than pick one pathway, lawmakers will do both, expanding the ACA and Medicare. "If you try to do these policies in a somewhat frugal manner, there are some opportunities here," said Adler.

But Oberlander warned that Congress shouldn't spend the drug price bounty before it's passed. In the 1990s the fight was over whether to expand health insurance for younger Americans or provide more long-term care options for seniors. Said Oberlander, "In the end, they did neither."

HealthBent, a regular feature of Kaiser Health News, offers insight and analysis of policies and politics from KHN's chief Washington correspondent, Julie Rovner, who has covered healthcare for more than 30 years.

Julie Rovner: jrovner@kff.org, @jrovner

COVID 'Doesn't Discriminate by Age': Serious Cases on the Rise in Younger Adults

KFF Health News, May 4, 2021

Younger generations will pay a heavy price if the outbreak is allowed to simmer in communities across the country.

This article was published on Tuesday, May 4, 2021 in Kaiser Health News.

By Will Stone

After spending much of the past year tending to elderly patients, doctors are seeing a clear demographic shift: young and middle-aged adults make up a growing share of the patients in COVID-19 hospital wards.

It's both a sign of the country's success in protecting the elderly through vaccination and an urgent reminder that younger generations will pay a heavy price if the outbreak is allowed to simmer in communities across the country.

"We're now seeing people in their 30s, 40s and 50s — young people who are really sick," said Dr. Vishnu Chundi, a specialist in infectious diseases and chair of the Chicago Medical Society's COVID-19 task force. "Most of them make it, but some do not. … I just lost a 32-year-old with two children, so it's heartbreaking."

Nationally, adults under 50 now account for the most hospitalized COVID patients in the country — about 36% of all hospital admissions. Those ages 50 to 64 account for the second-highest number of hospitalizations, or about 31%. Meanwhile, hospitalizations among adults 65 and older have fallen significantly.

About 32% of the U.S. population is now fully vaccinated, but the vast majority are people older than 65 — a group that was prioritized in the initial phase of the vaccine rollout.

Although new infections are gradually declining nationwide, some regions have contended with a resurgence of the coronavirus in recent months — what some have called a "fourth wave" — propelled by the B.1.1.7 variant, first identified in the United Kingdom, which is estimated to be somewhere between 40% and 70% more contagious.

As many states ditch pandemic precautions, this more virulent strain still has ample room to spread among the younger population, which remains broadly susceptible to the disease.

The emergence of more dangerous strains of the virus in the U.S. — including variants first discovered in South Africa and Brazil — has made the vaccination effort all the more urgent.

"We are in a whole different ballgame," said Judith Malmgren, an epidemiologist at the University of Washington.

Rising infections among young adults create a "reservoir of disease" that eventually "spills over into the rest of society" — one that has yet to reach herd immunity — and portends a broader surge in cases, she said.

Fortunately, the chance of dying of COVID remains very small for people under 50, but this age group can become seriously ill or experience long-term symptoms after the initial infection. People with underlying conditions such as obesity and heart disease are also more likely to become seriously ill.

"B.1.1.7 doesn't discriminate by age, and when it comes to young people, our messaging on this is still too soft," Malmgren said.

Hospitals Filled With Younger, Sicker People

Across the country, the influx of younger patients with COVID has startled clinicians who describe hospital beds filled with patients, many of whom appear sicker than what was seen during previous waves of the pandemic.

"A lot of them are requiring ICU care," said Dr. Michelle Barron, head of infection prevention and control at UCHealth, one of Colorado's large hospital systems, as compared with earlier in the pandemic.

The median age of COVID patients at UCHealth hospitals has dropped by more than 10 years in the past few weeks, from 59 down to about 48 years old, Barron said.

"I think we will continue to see that, especially if there's not a lot of vaccine uptake in these groups," she said.

While most hospitals are far from the onslaught of illness seen during the winter, the explosion of cases in Michigan underscores the potential fallout of loosening restrictions when a large share of adults are not yet vaccinated.

There's strong evidence that all three vaccines being used in the U.S. provide good protection against the U.K. variant.

One study suggests that the B.1.1.7 variant doesn't lead to more severe illness, as was previously thought. However, patients infected with the variant appear more likely to have more of the virus in their bodies than those with the previously dominant strain, which may help explain why it spreads more easily.

"We think that this may be causing more of these hospitalizations in younger people," said Dr. Rachael Lee at the University of Alabama-Birmingham hospital.

Lee's hospital also has observed an uptick in younger patients. As in other Southern states, Alabama has a low rate of vaccine uptake.

But even in Washington state, where much of the population is opting to get the vaccine, hospitalizations have been rising steadily since early March, especially among young people. In the Seattle area, more people in their 20s are now being hospitalized for COVID than people in their 70s, according to Dr. Jeff Duchin, public health chief officer for Seattle and King County.

"We don't yet have enough younger adults vaccinated to counteract the increased ease with which the variants spread," said Duchin at a recent press briefing.

Nationwide, about 32% of people in their 40s are fully vaccinated, compared with 27% of people in their 30s. That share drops to about 18% for 18- to 29-year-olds.

"I'm hopeful that the death curve is not going to rise as fast, but it is putting a strain on the health system," said Dr. Nathaniel Schlicher, an emergency physician and president of the Washington State Medical Association.

Schlicher, also in his late 30s, recalls with horror two of his recent patients — close to his age and previously healthy — who were admitted with new-onset heart failure caused by COVID.

"I've seen that up close and that's what scares the hell out of me," he said.

"I understand young people feeling invincible, but what I would just tell them is — don't be afraid of dying, be afraid of heart failure, lung damage and not being able to do the things that you love to do."

Will Younger Adults Get Vaccinated?

Doctors and public health experts hope that the troubling spike in hospitalizations among the younger demographic will be temporary — one that vaccines will soon counteract. It was only on April 19 that all adults became eligible for a COVID vaccine, although they were available in some states much sooner.

But some concerning national polls indicate a sizable portion of teens and adults in their 20s and 30s don't necessarily have plans to get vaccinated.

"We just need to make it super easy — not inconvenient in any way," said Malmgren, the Washington epidemiologist. "We have to put our minds to it and think a little differently."

As Schools Spend Millions on Air Purifiers, Experts Warn of Overblown Claims and Harm to Children

KFF Health News, May 3, 2021

School officials desperate to calm worried parents bought these devices and others with a flood of federal funds, installing them in more than 2,000 schools across 44 states, a KHN investigation found.

This article was published on Monday, May 3, 2021 in Kaiser Health News.

By Lauren Weber and Christina Jewett

Last summer, Global Plasma Solutions wanted to test whether the company’s air-purifying devices could kill covid-19 virus particles but could find only a lab using a chamber the size of a shoebox for its trials. In the company-funded study, the virus was blasted with 27,000 ions per cubic centimeter.

This story also ran on CNN. It can be republished for free.

In September, the company’s founder incidentally mentioned that the devices being offered for sale actually deliver a lot less ion power — 13 times less — into a full-sized room.

The company nonetheless used the shoebox results — over 99% viral reduction — in marketing its device heavily to schools as something that could combat covid in classrooms far, far larger than a shoebox.

School officials desperate to calm worried parents bought these devices and others with a flood of federal funds, installing them in more than 2,000 schools across 44 states, a KHN investigation found. They use the same technology — ionization, plasma and dry hydrogen peroxide — that the Lancet COVID-19 Commission recently deemed “often unproven” and potential sources of pollution themselves.

In the frenzy, schools are buying technology that academic air-quality experts warn can lull them into a false sense of security or even potentially harm kids. And schools often overlook the fact that their trusted contractors — typically engineering, HVAC or consulting firms — stand to earn big money from the deals, KHN found.

Academic experts are encouraging schools to pump in more fresh air and use tried-and-true filters, like HEPA, to capture the virus. Yet every ion- or hydroxyl-blasting air purifier sale strengthens a firm’s next pitch: The device is doing a great job in the neighboring town.

“It’s a self-fulfilling prophecy. The more people buy these technologies, the more they get legitimacy,” said Jeffrey Siegel, a civil engineering professor at the University of Toronto. “It’s really the complete wild west out there.”

Marwa Zaatari, a member of the American Society of Heating, Refrigerating and Air-Conditioning Engineers’ (ASHRAE) Epidemic Task Force, first compiled a list of schools and districts using such devices.

Schools have been “bombarded with persistent salespersons peddling the latest air and cleaning technologies, including those with minimal evidence to-date supporting safety and efficacy” according to a report released Thursday by the Center for Green Schools and ASHRAE.

Zaatari said she was particularly concerned that officials in New Jersey are buying thousands of devices made by another company that says they emit ozone, which can exacerbate asthma and harm developing lungs, according to decades of research.

“We’re going to live in a world where the air quality in schools is worse after the pandemic, after all of this money,” Zaatari said. “It’s really sickening.”

The sales race is fueled by roughly $193 billion in federal funds allocated to schools for teacher pay and safety upgrades — a giant fund that can be used to buy air cleaners. And Democrats are pushing for $100 billion more that could also be spent on air cleaners.

In April, Global Plasma Solutions said further tests show its devices inactivate covid in the air and on surfaces in larger chambers. The company studies still use about twice the level of ions than its leaders have publicly said the devices can deliver, KHN found.

There is virtually no federal oversight or enforcement of safe air-cleaning technology. Only California bans air cleaners that emit a certain amount of ozone.

U.S. Rep. Robert “Bobby” Scott (D-Va.), chair of the education and labor committee, said the federal government typically is not involved in local decisions of what products to buy, although he hopes for more federal guidance.

In the meantime, “these school systems are dealing with contractors providing all kinds of services,” he said, “so you just have to trust them to get the best expert advice on what to do.”

These go-between contractors — and the air cleaner companies themselves — have a stake in the sales. While their names might appear in school board records, their role in selling the device or commission from the deal is seldom made public, KHN found.

A LinkedIn job ad with the logo for one air purifier company, ActivePure Technology, which employs former Trump adviser Dr. Deborah Birx as its chief medical and science adviser, recruited salespeople this way: “Make Tons of Money with this COVID-killing Technology!!” The commission, the post said, is up to $900 per device.

“We have reps [who] made over 6-figures in 1 month selling to 1 school district,” the ad says. “This could be the biggest opportunity you have seen!”

‘A Tiny Bit of Ozone’

Schools in New Jersey have a particularly easy time buying air cleaners called Odorox: A state education agency lists them on their group-purchasing commodity list, with a large unit selling for more than $5,100. Originally used in home restoration and mold remediation, the devices have become popular in New Jersey schools as the company says its products can inactivate covid.

In Newark, administrators welcomed students back to class last month with more than 3,200 Odorox units, purchased with $7.5 million in federal funds, said Steven Morlino, executive director of Facilities Management for Newark Public Schools.

“I think parents feel pretty comfortable that their children are going to a safe environment,” he said. “And so did the staff.”

Environmental health and air-quality experts, though, are alarmed by the district’s plan.

The Pyure company’s Odorox devices are on California air-quality regulators’ list of “potentially hazardous ozone generators sold as air purifiers” and cannot be sold in the state.

The company’s own research shows that its Boss XL3 device pumps out as much as 77 parts per billion of ozone, a level that exceeds limits set by California lawmakers for the sale of indoor air cleaners and the EPA standard for ground-level ozone — a limit set to protect children from the well-documented harm of ozone to developing lungs.

That level exceeds the industry’s self-imposed limit by more than 10 times and is “unacceptable,” according to William Bahnfleth, an architectural engineering professor at Penn State who studies indoor air quality and leads the ASHRAE Epidemic Task Force.

Jean-Francois “JF” Huc, CEO of the Pyure company, pointed out that the company’s study was done in a space smaller than they would recommend for such a powerful Odorox device. He cautioned that it was done that way to prove that home-restoration workers could be in the room with the device without violating work-safety rules.

“We provide very stringent operating guidelines around the size of room that our different devices should be put in,” he said. But school staffers are often not warned about the problems they could face if a too-powerful device is used in a too-small room, he acknowledged.

You can’t see or smell ozone, but lungs treat it like a “foreign invader,” said Michael Jerrett, who has studied its health effects as director of the UCLA Center for Occupational and Environmental Health.

Lung cells mount an immune-like response, which can trigger asthma complications and divert energy from normal lung function, he said. Chronic exposure has been linked to more emergency room visits and can even cause premature death. Once harmed, Jerrett said, children’s lungs may not regain full function.

“Ozone is a very serious public health problem,” Jerrett said.

Newark has some of the highest childhood asthma rates in the state, affecting 1 in 4 kids. Scholars have linked outdoor ozone levels in Newark to elevated childhood ER visits and asthma is the leading cause of school absenteeism there.

Adding ozone into the classroom is “just nightmarish,” Siegel, of the University of Toronto, said.

Morlino said the district plans to monitor ozone levels in each classroom, based on the federal Occupational Safety and Health Administration level for working adults, which is 100 parts per billion.

“In our research of the product,” he said, “we’ve determined it’s within the guidelines the federal government produces.”

While legal for healthy working adults, the work-safety standard should not apply to developing children, said Michael Kleinman, an air-quality researcher at the UC Irvine School of Medicine. “It’s not a good device to be using in the presence of children,” he said.

But the devices are going into schools throughout the state that will not be monitoring ozone levels, acknowledged Dave Matisoff, owner of Bio-Shine, a New Jersey-based distributor of Odorox. He said the main safeguard is informing schools about the appropriate-size room each device should be deployed to, a factor in ozone concentration.

Huc, the CEO, said his team has measured levels of ozone that are higher outdoors in Newark than inside — with his company’s units running.

“There is a tiny bit of ozone that is introduced, but it’s very, very low,” he said. “And you get the benefit of the antimicrobial effect, you get the benefit of reduction of pathogens, which we’ve demonstrated in a number of studies, and you get the reduction of VOC [volatile organic compounds].”

Meanwhile, despite expert concerns, the devices continue to pop up in classrooms and school nurses’ offices across the state, said Allen Barkkume, an industrial hygienist for the New Jersey teachers union.

He doesn’t blame schools for buying them, as they’re a lot less expensive than overhauling ventilation systems. Teachers often push for the devices in their classrooms, he said, as they see them in the nurses’ offices and think it’ll keep them safe. And superintendents are not well-versed in air quality’s complex scientific concepts.

“Nothing sounds better than something that’s cheap, quiet, small and easy to find, and we can stick them in every classroom,” Barkkume said.

Tested in Shoebox, Sold for Classrooms

While New York officials are “not permitting” the installation of ionization devices due to “potential negative health effects,” schools across the state of New Jersey are installing ionizing devices.

Ten miles away from Newark in Montclair, New Jersey, parents have been raising hell over the new Global Plasma Solutions’ ionizing devices in their children’s classrooms. The company website promises a product that emits ions like those “created with energy from rushing water, crashing waves and even sunlight.”

The devices emit positive and negative ions that are meant to help particles clump together, making them easier to filter out. The company says the ions can also reduce the viral particles that cause covid-19.

But Justin Klabin, a building developer with a background in indoor air quality and two sons in the district, was not convinced.

He spent hours compiling scientific evidence. He created painstaking YouTube videos picking apart the ionizers’ viability and helped organize a petition signed by dozens of parents warning the school board against the installation.

Even so, the district spent $635,900 on installing ionizers, which would go in classrooms serving more than 6,000 kids. The devices are often installed in ducts, an important consideration, the company founder Charles Waddell said, because the ions that are emitted lose their power after 60 seconds.

But the company’s shoebox study and inflated ion blast numbers that helped sell the product last year leave a potential customer with little sense of how the device would perform in a classroom, Zaatari said.

“It’s a high cost for nothing,” Zaatari said. The company has sued her and another air-quality consultant for criticizing their devices. Of the pending case, Zaatari said it is a David-versus-Goliath situation, but she will not be deterred from speaking on behalf of children.

“Size of the [test] chamber has proved not to play a role in efficacy results but rather ion density,” GPS spokesperson Kevin Boyle said in an email. The company notes by its covid-inactivating test results that they “may include … higher-than-average ion concentrations.”

He also said the company is proud to meet the ASHRAE “zero ozone” certification.

Glenn Morrison, a professor of environmental science and engineering at the University of North Carolina, reviewed a March GPS study on a device combating the covid virus in the air. The device appears to reduce virus concentrations, he said in an email, but noted it would not be very effective under normal building conditions, outside a test chamber. “A cheap portable HEPA filter would work many times better and have fewer side effects (possibly ozone or other unwanted chemistry),” he wrote.

Other parents joined Klabin’s campaign, including Melanie Robbins, the mom of a kindergartner and a child in pre-K. Armed with her background in nonprofit advocacy, she reached out to experts. She and other parents spoke at local government meetings about their concerns.

In April, the superintendent told parents the school would turn off the devices, but parents say they haven’t turned them all off.

“As far as I understand, the district has relied only on information from GPS, the manufacturer,” Robbins said during a Montclair Board of Education meeting via Zoom on April 19. “This is like only listening to advice from Philip Morris as to whether smoking is safe or not.”

Dan Daniello, of D&B Building Solutions, an HVAC contracting company, defended GPS products during the meeting. He said they are even in the White House, a selling point the company has made repeatedly.

The catch: A GPS contractor installed its ionization technology in the East Wing of the White House after it was purchased in 2018 — before covid emerged, according to GPS’ Boyle. But the company was still using the White House logo as a marketing image on its website when KHN asked the White House about the advertising in April. It was taken down shortly thereafter.

Boyle said GPS was “recently informed that the White House logo may not be used for marketing purposes, and promptly complied.”

The Montclair school district did not respond to requests for comment.

“I want to bang my head against the wall, it’s so black-and-white,” Robbins said. “Admit this is a poor purchase, the district got played.”

Selling ‘the Big Kahuna’

Academic air-quality experts agree on what’s best for schools: More outside air pumped into classes, MERV 13 filters in heating systems and portable HEPA filters. The solution is time-tested and effective, they say. Yet as common commodities, like a pair of khaki pants, these items are not widely flogged by a sales force chasing big commissions.

After covid hit, Tony Barron said the companies pitched air purifying technology nonstop to the Kansas district where he worked as a facility manager last fall.

Pressure came from inside the school as well. Teachers sent links for air cleaners they saw on the news. His superintendent had him meet with a friend who sold ionization products. He got constant calls, mail and email from mechanical engineering companies.

The hundreds of phone calls from air cleaner pitches were overwhelming, said Chris Crockett, director of facilities for Turner USD 202 in Kansas City, Kansas. While he wanted to trust the contractors he had worked with, he tested four products before deciding to spend several hundred thousands of dollars.

“Custodial supply companies see the writing on the wall, that there’s a lot of money out there,” he said. “And then a lot of money is going to be spent on HVAC systems.”

ActivePure says on its website that its air purifiers are in hundreds of schools. In a press release, the company said they were “sold through a nationwide network of several hundred franchises, 5,000 general contractors/HVAC specialists and thousands of individual distributors.”

Enviro Technology Pros, founded in January, is one company pitching ActivePure to HVAC contractors. In a YouTube video, the founders said contractors can make $950 for each air-cleaning device sold, and some dealers can make up to $30,000 a month. Citing the bounty of the billions in federal relief, another video touted ready-made campaigns to target school principals directly.

After KHN asked ActivePure for comment, the Enviro Technology Pros YouTube videos about ActivePure were no longer accessible publicly.

ActivePure did not respond to requests for comment but has said its devices are effective and one is validated by the Food and Drug Administration.

An Enviro Technology Pros founder, Rod Norman, told KHN the company was asked to take the posts down by Vollara, a company related to ActivePure. He called sales to schools “the big kahuna.”

Shortly after he spoke with KHN, the website for his own company was taken down.

In an Instagram post that also disappeared, the company had asked: “4000 classrooms protected why not your kids?”

Shoshana Dubnow contributed to this report.

As Vaccine Demand Slows, Political Differences Go on Display in California Counties

KFF Health News, May 3, 2021

Infectious disease experts estimate that anywhere from 50% to 85% of the population would need to get vaccinated to put a damper on the spread of the virus.

This article was published on Monday, May 3, 2021 in Kaiser Health News.

By Anna Almendrala

Demand for COVID vaccines is slowing across most of California, but as traffic at vaccination sites eases, the vaccination rates across the state are showing wide disparities.

In Santa Clara County, home to Silicon Valley, nearly 67% of residents 16 and older have had at least one dose as of Wednesday, compared with about 43% in San Bernardino County, east of Los Angeles. Statewide, about 58% of eligible residents have received at least one dose.

The differences reflect regional trends in vaccine hesitancy and resistance that researchers have been tracking for months, said Dean Bonner, associate survey director at the Public Policy Institute of California, a nonpartisan think tank.

In a PPIC survey released Wednesday, only 5% of respondents in the San Francisco Bay Area and 6% of those in Los Angeles said they wouldn't be getting vaccinated. But that share is 19% in the Inland Empire and 20% in the Central Valley.

"More urban areas might be hitting a wall, but their number of shots given is higher," said Bonner. "The rural areas might be hitting a wall maybe even before, but their shots given isn't quite as high."

Infectious disease experts estimate that anywhere from 50% to 85% of the population would need to get vaccinated to put a damper on the spread of the virus. But overall state numbers may mask pockets of unvaccinated Californians, concentrated inland, that will prevent these regions from achieving "herd immunity," the point at which the unvaccinated are protected by the vaccinated. Epidemiologists worry that the virus may continue to circulate in these communities, threatening everyone.

The regional differences could be attributed, at least in part, to political opposition to the vaccine, said Bonner, as about 22% of Republicans and 17% of independents in the survey said they wouldn't be getting the vaccine, compared with 3% of Democrats.

But officials and epidemiologists see some encouraging signs that the state has yet to hit a wall of vaccine refusal. "As a strongly blue state, one would expect that California is less likely than red states to hit a relatively low ceiling of vaccination, assuming that the access is good and the messaging is strong," said Dr. Robert Wachter, chair of the department of medicine at the University of California-San Francisco School of Medicine.

As of Wednesday, 77% of seniors in California, and 68% of those ages 50 to 64, had received at least one dose of COVID vaccine, according to a KHN analysis. These large percentages reflect the early vaccine eligibility of these age groups and are a hopeful sign considering how difficult it was to get a shot in the beginning of the year, said Rebecca Fielding-Miller, an assistant professor at the University of California-San Diego specializing in infectious diseases and public health.

"I'm very hopeful that addressing access would pick up at least another 10-15% before we need to really start addressing myths and hesitancy issues," she said.

The state could see a new jump in vaccinations as workplaces, schools and event organizers begin to require the shots, Wachter said. For example, the University of California and California State University systems announced April 22 that their 1 million-plus students and staff members will be required to get vaccinated against COVID once the shots are formally licensed by the Food and Drug Administration, likely to occur this summer.

Still, the red-blue political distinction on vaccination is meaningful within California as well as nationally. Despite depressed vaccine demand across the board, counties that lean conservative have lower rates of vaccinations.

In true-blue Los Angeles, 4.5 million first COVID vaccine doses have been administered, meaning that about 55% of eligible Angelenos have gotten at least one shot.

But first-dose appointments at county-run sites were down at least 50% last week, said public health director Barbara Ferrer on Thursday. The county has opened several sites where people can walk in and get vaccinated without an appointment, but these walk-ins don't make up for all of the unfilled spots.

Last week probably marked the first time the county did not administer 95% of the doses distributed to it, she said.

In San Diego and Orange counties, meanwhile, vaccination appointments are going unfilled or taking days to get booked up.

About 20% of appointments in Orange County started going unclaimed on April 25 and the slack has persisted, said Dr. Regina Chinsio-Kwong, deputy health officer.

However, based on survey data from last winter indicating that about 58% of Orange County residents plan to get vaccinated against the coronavirus, the county is still expecting more residents to seek out appointments. As of Sunday, about 49% of residents had received at least one dose.

In San Diego, officials expect all appointments to be filled despite the slowdown, said county spokesperson Michael Workman. About 54% of eligible residents had received at least one dose as of Wednesday.

In San Bernardino, the slowdown started in late March, said county spokesperson David Wert. Only 42% of county residents had gotten at least one dose as of Monday.

Across the state, officials are unclear on the extent to which hesitancy or lack of access to a vaccine are responsible for the slowdown.

Campaigns to educate, convince and reach out to people have started to pick up throughout the country, including targeted messaging for conservatives. Ten GOP doctors in Congress recently issued an ad urging their constituents to get vaccinated.

Santa Clara is shifting most county-run sites to enable walk-ins and expanding evening and weekend hours to make it easier for working people to get a shot. San Diego and San Bernardino are also allowing walk-ins.

Other counties are returning unused doses to the state to be redistributed, a bounty from which Los Angeles County has benefited, according to Barbara Ferrer, director of the county public health department. Representatives from Blue Shield and the California Department of Public Health would not say which counties are sending doses back.

California's good pandemic news, which has enabled counties to reopen many businesses, is one of the challenges to getting less-than-enthusiastic people in for their shots right now, said Wachter of UCSF.

As of Thursday, California has one of the lowest case rates in the U.S. at 31.3 cases per 100,000 and a COVID-test positivity rate of 1.3%.

"My hope is that a strong communication campaign, perhaps coupled with some degree of vaccine requirements, will get some people to jump off the fence," Wachter said.

Anna Almendrala: aalmendrala@kff.org, @annaalmendrala

Detecting Rare Blood Clots Was a Win, But US Vaccine Safety System Still Has Gaps

KFF Health News, May 3, 2021

FDA officials acknowledged that some data analysis won't start for weeks or months, but said the government is watching for vaccine reactions with "state-of-the-art" systems.

This article was published on Monday, May 3, 2021 in Kaiser Health News.

By JoNel Aleccia

The quick detection of an ultra-rare blood clotting reaction in some COVID-19 vaccine recipients showed the power of a federal warning system for vaccine safety issues, but experts worry that blind spots in the program could hamper detection of other unexpected side effects.

Before the pandemic began, the Food and Drug Administration had scaled back a program it used successfully to track adverse events during and after the 2009 H1N1 influenza pandemic, and the agency is still ramping up its replacement, said Dr. Robert Chen, scientific director of the Brighton Collaboration, a nonprofit global vaccine safety network.

"It's purely bad luck they were in between systems when COVID hit," said Chen, who helped create the existing U.S. vaccine safety systems during nearly 30 years at the Centers for Disease Control and Prevention.

FDA officials acknowledged that some data analysis won't start for weeks or months, but said the government is watching for vaccine reactions with "state-of-the-art" systems.

"FDA and CDC have robust safety and effectiveness surveillance systems in place to monitor COVID-19 vaccines authorized for emergency use in the U.S.," Abby Capobianco, an FDA spokesperson, wrote in an email.

No question, the nation's vaccine surveillance system performed as expected this spring when it identified unusual cases of blood clots combined with low platelet counts in 15 people who had received Johnson & Johnson's one-shot COVID vaccine, said Dr. Jesse Goodman, a former chief scientist with the FDA. Three people died.

"The good news for a very rare event is it will pop up on VAERS," Goodman said on a call with reporters, referring to the Vaccine Adverse Event Reporting System jointly run by the FDA and CDC since 1990.

But other potentially dangerous, unanticipated reactions to vaccines may not be so obvious in VAERS, a system that is believed to miss many potential side effects — or in the nation's additional monitoring systems, including the Vaccine Safety Datalink and the CDC's new phone-based tracking program, v-safe.

"It's quite a hodgepodge of different systems of collecting data," said Dr. Katherine Yih, a biologist and epidemiologist who specializes in vaccine surveillance at Harvard Pilgrim Healthcare. "It's worth stating that it's not as good as it could be."

The Vaccine Safety Datalink, though highly regarded, did not include enough vaccinations within its data from nine hospital systems covering 12 million people to catch the J&J issue, CDC officials said. And enrollment in v-safe has been less than expected, with about 6 million people enrolled by the end of March, just 6.4% of those who had been vaccinated at that point.

That means that, at a time when about 100 million Americans have been fully vaccinated against COVID, the U.S. continues to rely on a patchwork network of vaccine monitoring systems that may fail to monitor a large enough swath of the population, experts told KHN.

"I'm very concerned about this," said Goodman, who also led the FDA's Center for Biologics Evaluation and Research, or CBER, and is now a professor of infectious diseases at Georgetown University. "I think we should be seeing that reporting on all of these vaccines. It was promised four months ago that it was happening."

The three vaccines in use in the U.S. — produced by Pfizer, Moderna and Johnson & Johnson — were shown to be safe and effective during clinical trials of tens of thousands of volunteers.

But even the best trials aren't large enough to capture all problems, especially rare ones, if they occur only in certain groups or outside a specific time frame. It's important to track side effects once vaccines are distributed throughout the population — an effort known as pharmacovigilance — to ensure not only safety, but also public confidence.

Vaccine safety experts said they were concerned that the FDA scaled back a system known as the Post-Licensure Rapid Immunization Safety Monitoring network, or PRISM, long regarded as a workhorse of surveillance.

"Prior to PRISM, I felt like we were sort of in the dark ages," Steve Anderson, director of the FDA's Office of Biostatistics and Epidemiology, said at a 2016 workshop. "When PRISM came along, for us it was really a game changer."

PRISM linked four large health plans in different parts of the country with eight state immunization registries. During the H1N1 pandemic, it detected signals for three adverse events possibly linked to the vaccines and was used to rule out the two that weren't related and the one, Guillain-Barré syndrome, that was.

The system included records from nearly 40 million people, said Daniel Salmon, former director of vaccine safety at the National Vaccine Program Office. Having a large volume of records of vaccinated people "really drives your ability to figure out what's going on," he said.

PRISM, which was repurposed for drug safety, now contains data from about 60 million people, but it has not been used to track vaccine reactions during the COVID pandemic, said Salmon, who oversaw safety monitoring for the H1N1 vaccine.

"With PRISM, we tested it in a crisis and it operated for a decade," he said. "I was really surprised when it wasn't used for COVID. That was why we built it."

A newer system, called the Biologics Effectiveness and Safety System, or BEST, was started in 2017, but only recently began monitoring data weekly for 15 pre-specified adverse events among Medicare recipients. It will be expanded to include commercial databases starting by the end of June, according to Capobianco, the FDA spokesperson.

A search for possible cases of the rare condition linked to the J&J vaccine began in mid-April and will be expanded in the next few weeks, she added.

FDA officials said PRISM's capabilities have been incorporated into BEST, which can examine data from 100 million people. Experts told KHN that it has not been used extensively to monitor post-vaccination effects, but Capobianco said: "We disagree."

"BEST is built as a state-of-the-art active surveillance system," she wrote.

The concern is that officials have leaned heavily on VAERS, a "passive" system that relies on reports from patients and healthcare providers to flag issues after vaccination that may or may not be related to the shots. A robust "active" surveillance system can search large volumes of patient care records to compare rates of adverse events in people who received vaccines with those who didn't.

In addition, some vaccine safety experts point to a lack of clear authority in the area. The Trump administration shut down the NVPO, a federal office with expertise in monitoring vaccine safety, merging it into a government agency focused on infectious diseases.

As a result, monitoring of COVID vaccine safety is fragmented among federal agencies, said Salmon, who now directs the Institute for Vaccine Safety at the Johns Hopkins Bloomberg School of Public Health.

"There is no single person in charge," he said. "You need to have somebody in charge."

Biden administration officials have praised the nation's vaccine monitoring system, pointing out that it flagged the Johnson & Johnson problems within weeks of the vaccine's rollout. Federal officials paused distribution to assess additional cases and next steps. (They were helped by the fact that European regulators had found similar problems in another vaccine.)

"VAERS performed exactly as intended in this case," said Dr. Tom Shimabukuro, head of the CDC's COVID-19 Vaccine Task Force.

That's true, said Dr. Steven Black, co-director of the Global Vaccine Data Network. Still, he noted, there's room for improvement, particularly more funding and better collaboration.

"This is a safeguard for our population," Black said. "Whether it's for the flu vaccines or the COVID vaccines, you need to have a viable and strong system. Just because we think they're safe doesn't mean you don't need systems in place to back up that opinion."

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

CVS and Walgreens Have Wasted More Vaccine Doses Than Most States Combined

KFF Health News, May 3, 2021

The CDC recorded 182,874 wasted doses as of late March. Of those, CVS was responsible for nearly half, and Walgreens for 21%, or nearly 128,500 wasted shots combined.

This article was published on Monday, May 3, 2021 in Kaiser Health News.

By Joshua Eaton and Rachana Pradhan

Two national pharmacy chains that the federal government entrusted to inoculate people against COVID-19 account for the lion's share of wasted vaccine doses, according to government data obtained by KHN.

The Centers for Disease Control and Prevention recorded 182,874 wasted doses as of late March, three months into the country's effort to vaccinate the masses against the coronavirus. Of those, CVS was responsible for nearly half, and Walgreens for 21%, or nearly 128,500 wasted shots combined.

CDC data suggests that the companies have wasted more doses than states, U.S. territories and federal agencies combined. Pfizer's vaccine, which in December was the first to be deployed and initially required storage at ultracold temperatures, represented nearly 60% of tossed doses.

It's not completely clear from the CDC data why the two chains wasted so much more vaccine than states and federal agencies. Some critics have pointed to poor planning early in the rollout, when the Trump administration leaned heavily on CVS and Walgreens to vaccinate residents and staff members of long-term care facilities. In response to questions, CVS said "nearly all" of its reported vaccine waste occurred during that effort. Walgreens did not specify how many wasted doses were from the long-term care program.

One thing is clear: Months into the nation's vaccination drive, the CDC has a limited view of how much vaccine is going to waste, where it's wasted and who is wasting it, potentially complicating efforts to direct doses to where they are needed most. Public health experts say having a good handle on waste is crucial for detecting problems that could derail progress and risk lives.

The Pfizer-BioNTech and Moderna vaccines, which come in multidose vials, are fragile and have limited shelf lives. Overall, waste has been minuscule: As of March 30, the U.S. had delivered roughly 189.5 million vaccine doses and administered 147.6 million, including 7.7 million in long-term care facilities, according to the CDC.

Among other things, tracking wasted doses helps to identify bottlenecks where distribution adjustments might be needed, said Dr. Bruce Y. Lee, a professor of health policy and management at the City University of New York. Because the federal government is footing the bill for the country's doses, any waste amounts to "basically throwing [taxpayer] money down the chute," he said. CVS, Walgreens and other retailers don't pay for the vaccine. The government provides it. And under the Medicare program, it pays providers roughly $40 for each dose administered.

Particularly early on, officials didn't adequately assess where there would be demand and set up sites in response, Lee said — something that's especially important when trying to jab as many people as possible as quickly as possible.

"If you think of any business, they're going to determine where the customers are first," he said. "It's not just a matter of loading up vaccine and going to a place."

KHN's survey of vaccine waste is based on public records requests to the CDC and all 50 states, five major cities, Puerto Rico and Washington, D.C. Combined, the records document more than 200,000 wasted doses. However, the data has clear shortcomings. Data from 15 states, the District of Columbia and multiple U.S. territories are not included in the CDC's records. And, in general, waste reporting has been inconsistent.

In addition to the CDC, 33 states and D.C. provided at least some data to KHN in response to those records requests. They reported at least 18,675 additional doses that have been wasted across 10 jurisdictions not represented in the CDC figures. They include 9,229 doses wasted in Texas as of March 26 and 2,384 in New Hampshire as of March 10.

An additional eight states told KHN of more wasted doses than they reported to the CDC.

But no city or state comes close to the waste reported by CVS and Walgreens, whose long-term care vaccination drive was criticized by some officials as slow and ineffective. Among nursing home staffers, a median of 37.5% reported they got a shot in the first month, according to a February CDC study.

"To me, this ultimately correlates with just poor planning," said Dr. Michael Wasserman, immediate past president of the California Association of Long Term Care Medicine and a critic of the corporate effort.

Wasserman said the companies' approach was too restrictive and their unfamiliarity with long-term facilities' needs harmed the effort.

"CVS and Walgreens didn't have a clue when it came to interacting with nursing homes," he said. "Missed opportunities for vaccination in long-term care invariably results in deaths."

A CVS spokesperson, Michael DeAngelis, in an email blamed wasted doses on "issues with transportation restrictions, limitations on redirecting unused doses, and other factors."

"Despite the inherent challenges, our teams were able to limit waste to approximately one dose per onsite vaccination clinic," he added.

Walgreens said its wastage amounted to less than 0.5% of vaccines the company administered through March 29, which totaled 3 million shots in long-term care facilities and 5.2 million more through the federal government's retail pharmacy partnership.

"Our goal has always been ensuring every dose of vaccine is used," company spokesperson Kris Lathan said in an email. Before scheduled clinics, she said, Walgreens would base doses it would need on registrations, "which minimized excess and reduced overestimations."

CDC spokesperson Kate Fowlie said that because the retail pharmacy giants were tasked with administering a large number of doses, "a higher percentage of the overall wastage would not be unexpected, particularly in an early vaccination effort that spanned thousands of locations." Since President Joe Biden took office in January, his administration has directed pharmacies to prioritize vaccinations for teachers and school personnel.

Overall, pharmacies accounted for almost 75% of wasted doses reported to the CDC. States and some large cities accounted for 23.3% of vaccine waste reported, and federal agencies, including the Bureau of Prisons and the Indian Health Service, for just 1.54%. The Virgin Islands — the only U.S. territory in the federal data — was 0.19%.

"Though every effort is made to reduce the volume of wastage in a vaccination program, sometimes it's necessary to identify doses as 'waste' to ensure anyone wanting a vaccine can receive it, as well as to ensure patient safety and vaccine effectiveness," Fowlie said. Even still, the CDC has provided guidance and worked with health departments to train staff members to reduce wastage, and clinic staffers should do "everything possible" to avoid wasting shots, she added.

Vaccine waste could increase in the coming weeks as officials shift tactics to inoculate harder-to-reach populations, public health experts say.

"I think we are getting to a place where, to continue to be successful with vaccination, we're going to have to tolerate some waste," said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. People unwilling to travel to a mass-vaccination site might go to a primary care physician or smaller rural pharmacy that might not be able to use every dose in an open vial, he said.

Claire Hannan, executive director of the Association of Immunization Managers, said concerns about waste should not trump getting shots into arms.

"If someone's there, you need to vaccinate them," she said. "In our efforts not to waste a dose, we may be missing opportunities to vaccinate because we don't have 15 people lined up or 10 people lined up."

CDC Numbers Don't Match State Data

The federal government collects information about vaccine waste through federal systems called VTrckS, which manages ordering and shipments, and Tiberius, a platform run by the Department of Health and Human Services that monitors distribution. VTrckS can exchange data with state and local immunization registries that track who has received a shot, but some states rely on manual data entry, Hannan said.

The 15 states not included in the CDC's data are Alaska, California, Colorado, Kansas, Louisiana, Maine, Maryland, Michigan, Nebraska, Nevada, New Hampshire, Ohio, Oklahoma, Oregon and Texas. The District of Columbia is also missing.

Of those jurisdictions, 11 provided data to KHN: Alaska, Colorado, Kansas, Maryland, Nebraska, Nevada, New Hampshire, Ohio, Oregon, Texas and D.C.

Most of those reported minimal waste to KHN: Colorado, Kansas, Nebraska and D.C. together registered just 1,090 wasted doses.

In others, the numbers are more significant. On March 19, the Maryland Department of Health said it knew of 3,175 wasted doses.

Texas had the most wasted doses of any state in either the CDC's data or the data states provided to KHN. Its records showed 9,229 wasted doses as of March 26, putting it third in overall waste behind CVS and Walgreens.

Fowlie, the CDC spokesperson, said the agency is "working closely" with states that have technical issues to ensure accurate reporting.

Broken Freezers, Bent Needles, No-Shows

The reasons states gave for waste varied, from broken vials and syringes, to provider storage errors, to leftover doses from open vials that couldn't be used.

The largest waste incidents, in which hundreds of doses were lost at a time, tended to be due to freezer malfunctions or workers leaving doses at room temperature too long.

But state records also register the little things that can go wrong.

On Dec. 16, the public health department in Gunnison County, Colorado, lost a single dose of the Pfizer vaccine when someone bumped into a table and a vial spilled. On Jan. 5, the Tri-County Health Department in Westminster, Colorado, reported that it wasted a Moderna dose because a hypodermic needle bent.

Remi Graber is a registered nurse who has vaccinated people at mass sites and community health clinics in Rhode Island. They said it's not uncommon for a vial to have one too many or one too few doses, which can lead to a dose being counted as wasted. There are also sometimes syringe problems that result in waste.

But Graber said the biggest problem is people not showing up. Once a vial is punctured, Pfizer's vaccine must be used within six hours. On April 1, Moderna announced that an opened vaccine vial was good for 12 hours — double what it had been previously.

"What could happen is you get people who just decide, 'You know what? I don't need my vaccine today. I'm not going to show up,'" they said. "Well, now we're scrambling to find somebody to take the vaccine, because we don't want to waste it."

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

Mental Health Services Wane as Insurers Appear to Skirt Parity Rules During Pandemic

KFF Health News, May 1, 2021

Up to 4 in 10 adults on average reported anxiety or depression symptoms during the pandemic.

This article was published on Friday, April 30, 2021 in Kaiser Health News.

By Emmarie Huetteman

Therapists and other behavioral health care providers cut hours, reduced staffs and turned away patients during the pandemic as more Americans experienced depression symptoms and drug overdoses, according to a new report from the Government Accountability Office.

The report on patient access to behavioral health care during the covid-19 crisis also casts doubt on whether insurers are abiding by federal law requiring parity in insurance coverage, which forbids health plans from passing along more of the bill for mental health care to patients than they would for medical or surgical care.

The GAO’s findings are “the tip of the iceberg” in how Americans with mental, emotional and substance use disorders are treated differently than those with physical conditions, said JoAnn Volk, a research professor at Georgetown University’s Center on Health Insurance Reforms who studies mental health coverage.

The GAO report, shared before publication exclusively with KHN, paints a picture of an already strained behavioral health system struggling after the pandemic struck to meet the treatment needs of millions of Americans with conditions like alcohol use disorder and post-traumatic stress disorder.

Up to 4 in 10 adults on average reported anxiety or depression symptoms during the pandemic, the report showed, compared with about 1 in 10 adults in early 2019.

During the first seven months of the pandemic, there were 36% more emergency room visits for drug overdoses, and 26% more visits for suicide attempts, compared with the same period in 2019.

As the need grew, already spotty access to treatment dwindled, the GAO found: A survey of members of the National Council for Behavioral Health, an organization that represents treatment providers, showed 27% reported they laid off employees during the pandemic; 35% reduced hours; and 45% said they closed programs.

Worker shortages have long been an obstacle to accessing behavioral health services, which experts attribute in large part to problems with how providers are paid. Last fall the federal government estimated that more than one-third of Americans live in an area without enough providers available.

Provider groups interviewed by GAO investigators acknowledged staff shortages and some delays in getting patients into treatment. They noted that the pandemic forced them to cut outpatient services and limit inpatient options. They also told the researchers that payment issues are a significant problem that predated the pandemic. In particular, the GAO said, most groups cited problems getting reimbursed by Medicaid more often than any other payer.

Sen. Ron Wyden (D-Ore.), who chairs the Senate Finance Committee, requested the report from GAO after hearing complaints that constituents’ insurance claims for behavioral health care were being denied.

In an interview, Wyden said he plans to embark on a “long-running project” as chairman to make care “easier to find, more affordable, with fewer people falling between the cracks.”

Spurred by how the pandemic has intensified the system’s existing problems, Wyden identified four “essential” targets for lawmakers: denied claims and other billing issues; the workforce shortage; racial inequality; and the effectiveness of existing federal law requiring coverage parity.

For Wyden, the issue is personal: The senator’s late brother had schizophrenia. “Part of this is making sure that vulnerable Americans know that somebody is on their side,” he said.

State and federal officials rely heavily on people’s complaints about delayed or denied insurance claims to alert them to potential violations of federal law. The report cited state officials who said they “routinely” uncover violations, yet they lack the data to understand how widespread the problems may be.

Congress passed legislation in December that requires that health plans provide government officials with internal analyses of their coverage for mental and physical health services upon request.

Part of the problem is that people often do not complain when their insurer refuses to pay for treatment, said Volk, who has been working with state officials on the issue. She advised that anyone who is denied a claim for behavioral care should appeal it to their insurer and report it to their state’s insurance or labor department.

Another obstacle: Shame and fear are often associated with being treated for a mental health disorder, as well as a belief among some patients that inequitable treatment is just the way the system works. “Something goes wrong, and they just expect that’s the way it’s supposed to be,” Volk said.

The GAO report noted other ways the pandemic limited access to care, including how public health guidelines encouraging physical distancing had forced some treatment facilities to cut the number of beds available.

On a positive note, the GAO also reported widespread approval for telehealth among stakeholders like state officials, providers and insurers, who told government investigators that the increased payments and use of virtual appointments had made it easier for patients to access care.

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Addiction Treatment Providers in Pa. Face Little State Scrutiny Despite Harm to Clients

KFF Health News, April 30, 2021

A KHN-Spotlight PA investigation found that Pennsylvania has allowed providers to continue operating despite repeated violations of state regulations and harm to clients.

This article was published on Friday, April 30, 2021 in Kaiser Health News.

By Aneri Pattani and Ed Mahon, Spotlight PA April 30, 2021

This investigation is a joint project of KHN, a national newsroom that produces in-depth journalism about health issues, and Spotlight PA, an independent, collaborative newsroom dedicated to producing investigative journalism for all of Pennsylvania.

When Ian Kalinowski was at work, his mom usually texted him. So when he saw her number show up as an incoming call around lunchtime one Tuesday, he figured it had to be important.

Now, more than seven years later, he remembers her screams, the shock and the questions she asked over and over again.

"Why are they saying this to me? Why are they lying to me?" Ian recalled his mom asking. "They're telling me Adam's dead. Why would they do this to me?"

Adam was Ian's older brother. Growing up, it seemed they spent every second together. Football, hockey and tag filled long days outside their Pittsburgh home. When Ian moved away for college, he and Adam turned to online poker to stay in touch. Adam served as best man at Ian's wedding, and Ian admired his brother's artistic streak. Adam could turn any piece of paper into an origami swan. His mom's home is still full of swans.

Adam's struggle with opioid and alcohol addiction was painful for Ian to watch. The problems began, it seemed to Ian, after Adam dropped out of college and used drugs to deal with his depression. Adam sought treatment, and he relied on methadone for many years, but his problems continued. When he was 32, he typically drank dozens of beers each day. On Feb. 3, 2014, he entered a treatment center run by Addiction Specialists Inc., according to a lawsuit later filed by his family against the facility. The center, in a Fayette County strip mall, was about an hour's drive south of Pittsburgh.

Less than 24 hours after Adam made it to the facility, he was dead, according to expert reports from doctors in the family's wrongful death lawsuit. Ian couldn't understand what went wrong, and neither could his mom, still in denial on the other end of the phone call.

What his family didn't know was that Addiction Specialists, often known as ASI, had a history of violating state rules. In a later federal investigation into the facility's billing and drug distribution practices, a grand jury concluded that a litany of problems occurred at the business many months before and after Adam's arrival.

In the wrongful death suit, a lawyer for the Kalinowski family alleged Adam wasn't evaluated by a physician when he arrived at ASI, didn't receive the medication or treatment he needed, became increasingly uneasy and anxious throughout the night and killed himself. An Allegheny County judge in December 2019 said the business, two of its owners — Rosalind and Sean Sugarmann — and an ASI physician were negligent in caring for Adam. The judge ordered them to pay over $1.6 million in damages, although Ian doubts they ever will.

ASI eventually shut down, two years after Adam died.

In recent interviews with KHN-Spotlight PA, the Sugarmanns denied responsibility for Adam's death and maintained that ASI was a good facility. Rosalind said it helped a lot of people in a rural area with a high drug-overdose rate.

Addiction treatment facilities in Pennsylvania, like ASI, are licensed and regulated by the state to ensure they follow certain rules and keep vulnerable people struggling with addiction safe. Oversight used to fall to the Department of Health. But in 2012, the state created the Department of Drug and Alcohol Programs, a $125 million agency set up to give substance use the attention lawmakers felt it deserved.

At the time of Adam's death in 2014, the department had taken few disciplinary actions against ASI. It had issued citations and required the company to submit plans to correct them. But the Sugarmanns told KHN-Spotlight PA that, at the time, they didn't fear the state would shut them down.

Perhaps for good reason.

A KHN-Spotlight PA investigation found that the department has allowed providers to continue operating despite repeated violations of state regulations and harm to clients. More than 80 interviews and a review of thousands of pages of state government and court records revealed that the department lacks resources and regulatory power, uses an inherently flawed oversight system that does little to ensure high-quality or effective care, and rarely takes strong disciplinary action against facilities when so many Pennsylvanians need services.

The department has no standard criteria for when it should force facilities to serve fewer patients and, as of early April, had revoked just one treatment provider's license in nearly a decade. It doesn't, as a regular practice, compare facilities to see if any stand out for an unusual number of violations or the most client deaths. And since state inspections focus heavily on records, they can be tricked with fraudulent paperwork, former employees in the treatment field said.

This leaves Pennsylvanians — who suffer one of the highest drug overdose death rates in the nation — in the dark about which treatment facilities have troubling track records.

Some advocates point out that overregulating or closing facilities could leave people suffering from addiction without options for care. But in the current system, state and judicial records show, some patients have received inadequate treatment or even died; certain facilities have fraudulently billed insurance companies; and owners rake in federal and state tax dollars, as well as private money from victims of the opioid crisis.

"Many of these rehab facilities are not properly run or supervised, and many are in it for the money," said Peter Friday, an attorney who represented Adam's family in their lawsuit. "These places have been unbridled."

Who Polices the Providers?

Even though the Department of Drug and Alcohol Programs provides the licenses that allow addiction treatment facilities to operate, Jennifer Smith, secretary of the department, said it has limited responsibility for them. Law enforcement agencies are often better positioned to take action against troubled providers, she said, and insurance companies that pay for services also offer oversight.

"It's not our job to really police the providers," Smith said in an interview. "Our function is to really try to enable them to meet the [state's] requirements, and by doing so, enabling them to provide quality services."

Yet, as the regulating body of these treatment facilities, the department collects some of the most critical information necessary to properly police them, including reports of client deaths and physical and sexual assaults.

Smith said most providers are trying to do good work. She said annual inspections ensure facilities meet safety standards, like having enough staff members and a building that's up to code. But inspections are not meant to evaluate quality of care, she said.

The KHN-Spotlight PA investigation found the department makes little of what it knows about troubling facilities accessible to the public. Its website shows if a facility currently has a provisional license — a designation indicating the provider failed to meet several state requirements and will be inspected more frequently until it resolves those concerns — but not whether it ever received such a sanction in the past, for what issues, nor how they were resolved.

The department does not post the reports it collects about deaths and assaults, which represent some of the most concerning events at treatment facilities.

When KHN-Spotlight PA filed a public records request for those reports, the department shared only incidents that it decided did not warrant investigation. It said it could not provide the total number of such events at specific facilities since it doesn't have aggregate data prior to September 2019, when it launched a new electronic reporting system. Even the available data from that new system provides an incomplete picture, as less than a quarter of treatment facilities had enrolled in the voluntary system as of March 2021.

Smith said people should pick facilities the same way they do primary care doctors, based on publicly available information, personal recommendations and discussions with insurers.

One of the main public resources the department offers is a website with reports from its facility inspections. Inspectors write these reports after a site visit, listing any violations of state regulations they found. But these reports provide a limited window into the daily reality for clients, as there's no indication of which violations are more severe than others, and many regulations focus on building conditions and completion of records. One regulation, for example, mandates the temperature at which refrigerated food must be maintained.

In response to each violation inspectors find, the facility submits a plan to address it. If the facility fails to provide a plan or follow through on it, the department has two primary options: force the facility to reduce the number of clients it serves or issue a provisional license. If the department wants to permanently revoke a facility's license, it must go through an administrative court process to get approval.

In nearly a decade before December 2020, the state issued provisional licenses to fewer than 80 facilities — less than 10% of providers— and forced only three to reduce their capacity, according to data from the department. In ASI's case, regulators said multiple times that the company failed to document that it provided required counseling and other services. A department spokesperson said it didn't force ASI to operate under provisional licenses before 2015 because the business submitted plans of correction the department found acceptable. Even if a facility has many violations, the department considers how cooperative it is in working to fix them, Smith said.

After a recent reorganization, the department formed a quality improvement unit with three employees, Smith said. The unit may work directly with treatment facilities but is meant to address broader prevention efforts and other addiction-related programs as well. The department is also working with a national company to provide an online platform where clients can leave reviews of facilities, starting in spring 2022.

But many employees and clients in the treatment field are skeptical of any long-term improvement. For years, they've seen troubled facilities make fixes, only to have the same deficiencies arise in later inspections.

The department's own records show the cycle can persist for years.

Years of Citations, Little Action

At SOAR Corp methadone clinic in Philadelphia, inspectors from the state Department of Health first issued citations for unqualified employees in 2009, before the Department of Drug and Alcohol Programs was created and took over inspections in 2012. Inspectors at the time also found one counselor who was responsible for 40 clients — above the state-mandated maximum of 35.

SOAR Corp responded by saying it had demoted an unqualified counselor, had hired another counselor to lower caseloads and would ensure future hires met the state's requirements.

But state records show that within a year of those 2009 citations, the facility was cited three more times for similar issues: hiring an unqualified project director, overloading counselor caseloads and lacking enough medical personnel. Year after year, state inspectors found the same problems. Yet the state approved SOAR to open additional locations in Lansdowne, Levittown and Warminster in 2010, 2016 and 2018, respectively.

In interviews with KHN-Spotlight PA, a dozen former employees and nearly a dozen current and former clients across multiple SOAR sites complained about poor hiring practices and chronic understaffing as just two symptoms of their much larger concerns. They believed the company relentlessly pursued profits by getting as many clients in the door as possible, with little care for the quality of treatment.

The Philadelphia location has received three provisional licenses from the state, in 2012, 2019 and 2020, putting it among the 10 most frequent recipients of this sanction over nearly the past decade.

The former counselors felt that expectations to maximize "billable hours" led to their burnout. And they saw high turnover among staffers. The former and current clients said they sometimes went weeks without therapy or were switched from one overwhelmed counselor to another every few months.

Nicole Tihansky was a client at SOAR's Levittown location for about a year until last fall. She said she waited more than a month before getting her first counseling session, and then was assigned about five counselors, one after the other.

"It makes you just want to get in and out of the session quickly, because you know you'll get another counselor in a month," she said.

Understaffing is a problem across the treatment industry, according to employees in the field. But former SOAR employees who have worked for multiple companies said SOAR stood out in their experiences for its high staff turnover and inadequate therapy.

"It's not about therapy or addressing the needs of clients," said Esther Kirshenbaum, a counselor who worked at the Philadelphia location from 2017 to 2019. "The attitude is to just get clients in here and make sure we get paid."

In a statement, SOAR CEO Richard Mangano said the company "makes every effort to comply with local, State, and Federal regulations."

KHN-Spotlight PA shared with SOAR a detailed list of more than a dozen allegations from their reporting, including violations of state regulations and putting profits over patient care. Mangano did not address them specifically.

"Soar Corp categorically denies any allegation or suggestion of wrongdoing. … Soar Corp has and will continue to work with DDAP to improve the important services it provides," Mangano wrote, referring to the Department of Drug and Alcohol Programs.

In its responses to state citations in recent years, SOAR explained that clients didn't show up to scheduled counseling sessions, and that services like drug tests and physician evaluations had been provided but simply not documented properly.

The Department of Drug and Alcohol Programs has never forced SOAR to decrease its capacity, nor have state officials initiated the administrative court process to permanently revoke its license.

Former clients and employees said state licensing inspections were announced ahead of time, causing a rush by SOAR employees in the days before a site visit to complete treatment plans, counseling notes and other required paperwork.

Nicholas Cucchiaro was a SOAR counselor from 2017 to 2018. He shared with KHN-Spotlight PA what he reported to the Department of Drug and Alcohol Programs and the Pennsylvania Office of Attorney General after he was fired. He told the agencies that a senior administrator at SOAR instructed him to make up counseling notes for clients who had gone weeks without an assigned therapist.

"These are notes from therapy sessions that never happened," he said, adding he knew it was wrong but feared losing his job if he didn't comply.

About a dozen other former employees and clients described to KHN-Spotlight PA their own experiences of similar practices, ranging from thrusting months' worth of forms upon clients in the days before an inspection to backdating their paperwork.

The Department of Drug and Alcohol Programs and the attorney general's office both agreed to look into the allegations, Cucchiaro said, but he didn't hear of any consequences for SOAR.

The attorney general's office told KHN-Spotlight PA that it reviewed "a small number" of complaints regarding SOAR and referred the matter to the Department of Drug and Alcohol Programs.

Smith, the department head, said that as a general matter it's difficult to prevent facilities from falsifying paperwork, because state regulations require advance notice of licensing inspections. But if the department receives a complaint, it can conduct unannounced inspections, she said, and other facilities have been cited for fraudulent paperwork.

Unannounced site visits were made in response to the complaints at SOAR, according to a department spokesperson, and citations were issued for violations that did not include fraudulent paperwork. SOAR's Philadelphia location received provisional licenses in 2019 and 2020, but as of mid-April all the company's sites were operating on full licenses after remedying the cited issues.

A Growing Industry

One significant limitation on the department's oversight is its inability to impose financial penalties on treatment facilities.

In contrast, the state's environmental protection and health departments can fine polluters and nursing homes for violations.

A 2017 report from the state auditor general's office urged lawmakers to allow the department to charge licensing fees and assess financial penalties, pointing to other states that do so. Smith told KHN-Spotlight PA that fining facilities would help weed out repeat violators.

A bill introduced in the Pennsylvania legislature to allow the department to generate licensing fees went nowhere two years ago. A similar measure was recently referred to the state Senate Health and Human Services Committee.

"I hope that it's considered quickly as ensuring drug treatment facilities are given appropriate oversight is of utmost importance," the bill's sponsor, state Sen. Judy Schwank (D-Berks), said in a statement. 

Meanwhile, with millions of dollars on the line, the treatment industry is growing in Pennsylvania. Over the past four years, the state has seen a net gain of about 40 facilities, the department said, bringing the total to more than 800 treatment providers. State budget documents suggest the industry's client capacity has grown by about 5,000 over a similar period.

The Department of Drug and Alcohol Programs employed 82 people, including two dozen who conduct facility inspections, as of April. That's about half the number of dog wardens employed by the state to inspect kennels.

Smith said there is "adequate staff to perform our current licensing responsibilities."

In December 2018 — the same year the department said it received complaints from former SOAR employees and clients — it approved the company to open a location in Warminster. Inspection surveys at the facility since have found it violated state rules by providing a certain medication without state approval and failing to provide the required hours of therapy to some patients.

A former SOAR supervisor who is still working in the treatment industry and asked not to be named doubts the state will ever take stronger action against the company.

"The state knows the demand for treatment and the demand for medication-assisted treatment," the former supervisor said. "If you took SOAR's license in Northeast Philadelphia and didn't give them a provisional, you could be displacing 500 clients."

The Need for Treatment

The urgency of the opioid crisis puts regulators in a tough position: If they shut down a facility, where will all the patients get treatment?

James McKay, a professor at the University of Pennsylvania's medical school who researches the efficacy of addiction treatments, said facilities that are committing insurance fraud or actively harming patients should be penalized. But the question becomes more complicated when judging how well a facility is serving its clients.

In Philadelphia, where there are many treatment programs, it might make sense to close one that has ineffective interventions, untrained counselors and many clients dropping out, McKay said.

"But if you're out in the middle of the state and there's only one treatment program in any reasonable distance, as long as they're not treating you badly, you're at least going to get some support and meet others in recovery," he said. "So much of this depends on what the other alternatives are."

In western Pennsylvania, an inpatient detox and rehab facility called Clear Day Treatment of Westmoreland has received multiple provisional licenses since it opened in 2018. State inspectors have noted at least six incidents that involved drugs on the premises and have cited the facility at least twice for understaffing, writing that the lack of sufficient staff fails to ensure "efficient and safe operation."

Despite these concerns, the facility is the only one in the county that provides detox services while allowing patients to stay on any of three medications for opioid use disorder. Many patients in the area need that service, said Colleen Hughes, executive director of the Westmoreland Drug and Alcohol Commission. (The commission is one of more than 40 agencies across the state that the Department of Drug and Alcohol Programs contracts with to coordinate substance use services locally.)

The commission determined in 2017 that a lack of residential rehabs in the county was one factor delaying people's treatment. Clear Day responded to a request for proposals to meet that need from companies that manage Medicaid-paid behavioral health for the state in that region. Clear Day has been awarded nearly $750,000 in state Medicaid funds left over from previous years to help with startup costs, according to Southwest Behavioral Health Management, one of the companies that put out the request.

Stephen Devlin, executive director of Clear Day, said in a statement that Southwest Behavioral Health Management closely monitored those funds, which helped the facility provide "much needed" addiction treatment services.

"State auditors have been diligent in ensuring that Clear Day addressed all deficiencies that have been identified during audits," Devlin wrote, "and, further, that Clear Day provides strong and effective treatment to the individuals in our care."

Hughes said her office has addressed the issues of understaffing and drugs on the premises with Clear Day through meetings and training sessions.

Smith, head of the Department of Drug and Alcohol Programs, said: "None of us want to see providers closing. We want them to be successful. We want them to be able to deliver the services for their benefit and for ours."

Waiting for Consequences

In Fayette County, ASI came under fire from state and federal authorities in 2015.

The FBI raided the facility that October. The following January, a federal grand jury indicted one of the owners, Rosalind Sugarmann, and an ASI doctor on multiple counts of illegally distributing a medication to treat opioid addiction.

Nearly three months later, a counselor employed by ASI overdosed while staying at the facility, an attorney for the state later said in an administrative court filing against ASI. Ultimately, a bankruptcy case forced the business to close.

In late 2016, Sugarmann pleaded guilty to illegal drug distribution and healthcare fraud. But that hasn't kept her and her family out of the recovery business. Less than a year after she was released from prison, Sugarmann — who has talked publicly about her own substance use decades ago — announced she was opening a recovery home.

"I'm not going to stop working with addicts ever. That's my calling in life," Sugarmann said in an interview with KHN-Spotlight PA. "Somebody helped me, and I help somebody else."

But two families said Sugarmann failed their loved ones.

There's Adam Kalinowski, who died at ASI in 2014, and there's 37-year-old James Pschirer, who died of an overdose in a recovery home Sugarmann's family operates. These homes offer peer support and often have curfews and rules designed to help people stay away from drugs after they've been discharged from inpatient treatment.

In Kalinowski's case, Sugarmann said ASI reported his death to everyone it was required to. There's no indication from department records that the state cited ASI in connection with his suicide.

(The Department of Drug and Alcohol Programs wouldn't comment on Kalinowski's case specifically but said it worked with the FBI to investigate problems at ASI.)

Neither Sugarmann nor her husband, Sean, mounted a defense against the Kalinowski family's lawsuit in court. In a recent interview with KHN-Spotlight PA, Sean Sugarmann placed the blame for Kalinowski's death elsewhere, saying that the facility was staffed correctly and that, given his eventual suicide, Kalinowski never should have been sent to ASI.

Kalinowski's family also sued UPMC Mercy, the Pittsburgh hospital where he was treated before going to ASI, and affiliated entities, but resolved the claims against them through a private settlement, according to a family attorney. UPMC denied responsibility for Kalinowski's death. In a pretrial court filing, an expert witness for UPMC directed blame at ASI, saying Kalinowski was well enough to be safely discharged to a residential treatment facility. That he wasn't evaluated by a doctor, nurse or professional counselor when he arrived at ASI was a concern, the expert wrote, and "perhaps this tragedy could have been avoided" if ASI had provided a higher level of care.

More recently, Rosalind Sugarmann has faced criticism for her involvement with recovery homes.

In February 2019, while still under federal supervision, Sugarmann announced on a blog that she was "back in commission!!" and would open a men's recovery home called The Second Act outside Pittsburgh.

A 2017 law gave the Department of Drug and Alcohol Programs new power to regulate recovery homes in addition to treatment facilities. The state missed a June 2020 deadline to implement the voluntary licensing process but plans to roll out the program this year.

James Pschirer turned to The Second Act for a place to stay in the fall of 2019. His mom, Andrea Zack, helped him with rent, writing out a $250 check to Sugarmann, according to a photocopy of the check the family provided.

Then, on Nov. 1, 2019, James died inside the home from a fentanyl and cocaine overdose, a photo of the death certificate provided by his family showed.

Andrea and James' sister, Amanda Pschirer, went to The Second Act to collect his clothes and personal items. Andrea kept the coins in his pockets, knowing he had touched them.

It wasn't until after James' death that his family found out about Sugarmann's criminal conviction, they said.

Amanda knows her brother chose to use drugs, but she thinks he could still be alive if he had stayed in another home with better oversight. And she's angry that nothing stopped Sugarmann from being involved with one.

"I am worried that someone else will die under her care," Amanda said.

In interviews, Rosalind and Sean Sugarmann downplayed their involvement with The Second Act. "My kids are involved in the recovery homes," Rosalind told KHN-Spotlight PA. "I'm not an owner there." The business is registered in their children's names, and Rosalind said she's lived in Los Angeles since early 2020.

Still, Sean Sugarmann acknowledged helping his adult children manage the business, and said in March he was living in the men's home at that time. One of his daughters referred questions about The Second Act to Sean. Rosalind promotes the business on social media accounts, encouraging people to move in. She told KHN-Spotlight PA, "I'm not gonna deny that I'm a consultant."

Sean said an overdose death "could have happened anywhere, and I think it happens everywhere."

Last fall, Amanda Pschirer reached out to state officials with concerns about recovery homes. But she said she didn't receive a response for four months. The department said a computer glitch with an online form, discovered in January, caused the delay in responding to her submission and about 260 others.

Ian Kalinowski, whose brother died at ASI seven years ago, has followed Rosalind's posts online and saw that she's still involved in the recovery business. He's outraged.

He and his family are still grieving Adam's loss. Ian wishes his young children had gotten to meet their uncle. He doubts the ASI defendants will ever provide the $1.6 million-plus that the judge said they owe.

Ian recognizes that ASI's leaders faced some consequences for problems at the business.

"But there have still been no repercussions for what happened to my brother," he said of the Sugarmanns.

He's not optimistic there ever will be.

Methodology: How We Investigated Pennsylvania's Addiction Treatment Industry and Found Weak Oversight of Providers

Pennsylvania is at the epicenter of the nation's opioid crisis, ranking among the top five states for overdose death rates and top 10 for number of adults suffering from substance use disorder in recent years, according to national data. And the addiction treatment industry there is growing.

Federal grants, state initiatives and Medicaid pump millions of taxpayer dollars into the field annually. The state has seen a net gain of about 40 licensed treatment facilities over the past four years, bringing the total to more than 800.

But an investigation by Spotlight PA and KHN found the Pennsylvania Department of Drug and Alcohol Programs — which licenses these facilities — provides weak oversight and lacks the resources and regulatory power to police them, allowing providers to continue operating despite repeated violations and harm to clients. The department has no standard criteria to determine when it should force facilities to serve fewer patients and, in nearly a decade, has revoked just one provider's license.

Spotlight PA, an independent, collaborative newsroom reporting on the Pennsylvania state government and statewide issues, began investigating the oversight of addiction treatment facilities shortly after its launch in late 2019. The newsroom later partnered with KHN, a national organization that produces in-depth journalism about health issues.

Our team began by scraping thousands of facility inspection reports from the Department of Drug and Alcohol Programs' website. We then analyzed them to find the most egregious citations: ones that mentioned a failure to report patient deaths and assault, that noted medication errors or that revealed unsafe staffing ratios.

We also requested from the department historical data about which facilities had received provisional licenses — designations indicating that facilities have failed to meet several state requirements and will be inspected more frequently until they resolve those concerns. The department didn't have an automated system to gather this data but agreed to compile it manually. It provided the information with the following caveat: "Due to incorrect data entered into the licensing database, the attached report may not include all provisional licenses since 2012. It is as close to accurate as we can determine base[d] on the available data."

Additionally, the team filed an open records request for reports of unusual incidents. These are certain serious events that the department requires facilities to report, including client deaths and incidents of physical and sexual abuse, among others. The department provided reports of only those incidents that it decided did not warrant investigation. It said it could not provide the total number of such events because it doesn't have facility-specific aggregate data prior to September 2019, when it launched a new electronic reporting system. Even available data from that new system provides an incomplete picture, as less than a quarter of treatment facilities had enrolled in the voluntary system as of March 2021.

Reporters also reviewed the department's administrative court history to see cases in which the state had initiated legal action against a facility.

To further inform our reporting, Spotlight PA launched a public callout for readers to send in tips and concerns about facilities.

Using a combination of these sources — facility inspection surveys, provisional license history, administrative court cases, limited reports of unusual incidents and tips from the public — we compiled a list of 34 facilities that appeared to have the most troubling track records.

From the short list of facilities, Spotlight PA and KHN reporters then reached out to current and former employees and clients at various locations. The interviews helped establish whether people's firsthand experiences matched the concerns that arose in the data.

Our reporters also reviewed the licensing applications that these facilities had submitted to the state, as well as lawsuits filed by clients and employees against the facilities. We interviewed former employees of the Department of Drug and Alcohol Programs to understand the oversight system and challenges within the agency.

The final story was based on interviews with more than 80 people and a review of thousands of pages of state government and court records.

Spotlight PA is powered by The Philadelphia Inquirer in partnership with PennLive/The Patriot-News, TribLIVE/Pittsburgh Tribune-Review, and WITF Public Media. The independent, nonpartisan newsroom is funded by foundations and readers like you who are committed to accountability journalism that gets results: spotlightpa.org/donate

Aneri Pattani: apattani@kff.org, @aneripattani

The Vulnerable Homebound Are Left Behind on Vaccination

KFF Health News, April 30, 2021

Even as the nation has moved on to vaccinating everyone 16 and older, the vast majority of homebound people have not yet been vaccinated.

This article was published on Friday, April 30, 2021 in Kaiser Health News.

By Jenny Gold

It was April, more than three months into the vaccination campaign against COVID-19, and Jim Freeman, 83, still had not gotten his first dose.

Freeman had been eligible for months as part of the 75-and-older target group deemed most vulnerable to death and serious illness in the pandemic. But he could not leave his home to make the journey to one of the mass-vaccination sites in San Mateo County. Freeman, who has Parkinson's disease, has extremely limited mobility and no longer can walk.

"He watches TV at night and sees all these people in line getting vaccines, but he couldn't do it," said his daughter Beth Freeman, 58. "It was really frustrating." She contacted the county and state public health departments and even her local congresswoman for help, but none had a solution.

Finally, after weeks of failed attempts to get someone to vaccinate her father at their home, Beth spent $700 to rent a special wheelchair-accessible van and, with the help of a home health aide, nervously drove her father to the county's mass-vaccination site.

Even as the nation has moved on to vaccinating everyone 16 and older, the vast majority of homebound people have not yet been vaccinated, said Kelly Buckland, executive director of the National Council on Independent Living. "As far as I can tell, no one's really doing it. Maybe a few places in the country, but not on the mass scale it needs to be."

Across the nation, an estimated 4 million Americans are homebound by age, disability or frailty, unable to easily leave their homes to receive a COVID vaccine.

Buckland noted that, while homebound people are not out in public where the virus is circulating, they don't live in a bubble. Most rely for care on family members or a rotating staff of home health aides who come and go and often have their own homes and families. "For people with disabilities, you can't close yourself off. You don't have the option. People have to come into your home every day to give you services."

The Biden administration in late March dedicated $100 million to help vulnerable older adults and people with disabilities get vaccinations. But many caregivers and homebound people say they aren't yet feeling the impact of that effort.

California, where tens of thousands of residents like Jim Freeman are still waiting their turn for vaccination, offers a sharp lens on the challenges.

Marta Green, a California official helping oversee vaccine distribution, said during an April meeting of the state's Community Vaccine Advisory Committee that California is "working on a partnership" to send ambulances to vaccinate homebound people where they live. In response to questions about how many homebound people had been vaccinated so far, a spokesperson for the California Department of Public Health said the effort was "just beginning" and estimates were not available.

As part of a $15 million no-bid contract with California to administer the state's vaccination program, Blue Shield of California is obligated to provide vaccine access to homebound people. The company, nonetheless, declined to provide responses to specific questions about such efforts. Spokesperson Erika Conner said the company has "diligently explored opportunities for this work" and recommended that homebound people contact their local public health departments or healthcare providers.

The logistics of inoculating homebound people with a vaccine that requires cold storage is not simple. Once thawed, a vial of Pfizer-BioNTech vaccine contains six doses that must be delivered within six hours, while a Moderna vaccine vial contains 10 to 15 doses to be used within 12 hours. With each vaccination visit lasting about an hour plus the travel time, there isn't much room for error, especially in rural areas where residents may live far apart. The one-dose Johnson & Johnson vaccine offers more flexibility, but the pause due to safety concerns resulted in delays.

"Yeah, it's not easy. If it were easy, we'd already have done it," said Dr. Mike Wasserman, a geriatrician and member of the California vaccine advisory committee. "But that's not an excuse. These are the folks who if they get the virus they're going to die. I don't accept it."

Wasserman said he'd give the state a "D" for its efforts to reach the homebound for vaccination. For some, he added, it might already be too late. "If you're 80 years old and you live in a 1,000-square-foot home with 10 other people, you're probably dead already."

In the absence of a coordinated state-driven effort, California counties are attempting a patchwork of approaches.

In Los Angeles County, the public health department has partnered with the sheriff's department and 15 fire departments to vaccinate homebound residents, with some success. Health officials projected that 50% of the county's 10,000 homebound residents will have received one dose by the end of April.

In Fresno County, with more than a million residents, health officials said they are compiling a list of homebound people who want help getting a vaccine. So far, fewer than 20 people in that category have been contacted and received the vaccine.

In San Mateo County, where Freeman lives, the health department has identified at least 1,000 individuals who are homebound and in need of the vaccine; so far, 100 have been vaccinated.

Before she resorted to renting the $700 mobility van for her father, Beth Freeman contacted county workers. They offered to send a bus to pick up her father and take him to a vaccination site, but she couldn't imagine how that would work for him, both in terms of the physical logistics and the risk of exposure. She asked the nurses who visited her father twice a week through Sutter Health's care-at-home program for help — after all, they had given him the flu shot. But no luck. The nurses said they were not allowed to offer the COVID vaccine.

Finally, on April 6, Beth made the difficult decision to transport her father despite his limited mobility. "I did not want to take him out of the house for this. It was risky for his health. But at some point I realized it wasn't going to happen any other way," she said. "He wanted to see members of his family and time was ticking."

She said her father was up all night worrying, and his body was stiff. But with help from a home health aide, she used a special lift to hoist him into a wheelchair and wheeled him down two ramps and into the rented van, where she strapped him to the chair. They drove 20 minutes to the San Mateo County Event Center, her eyes darting from the road to the rearview mirror to check on her father, and then waited 40 minutes in the drive-thru line.

"When I rolled down the window, the nurses were like, What the hell? Why is he only coming to us now?" she said. The experience was so stressful for her father, she added, that he slept on and off for the next two days.

This week, they repeated the ordeal for his second dose — including laying out another $700 for the rental van. "All this, while he sees nurses at home twice a week?" Beth Freeman said. "What a missed opportunity."

Jenny Gold: jgold@kff.org, @JennyAGold

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