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How ERs Fail Patients with Addiction: One Patient's Tragic Death

KFF Health News, July 15, 2021

Addicts often fall victim to two huge gaps in the U.S. healthcare system: a paucity of addiction treatment and high medical costs.

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

By Aneri Pattani

Jameson Rybak tried to quit using opioids nearly a dozen times within five years. Each time, he'd wait out the vomiting, sweating and chills from withdrawal in his bedroom.

It was difficult to watch, said his mother, Suzanne Rybak, but she admired his persistence.

On March 11, 2020, though, Suzanne grew worried. Jameson, 30 at the time, was slipping in and out of consciousness and saying he couldn't move his hands.

By 11 p.m., she decided to take him to the emergency room at McLeod Regional Medical Center in Florence, South Carolina. The staff there gave Jameson fluids through an IV to rehydrate, medication to decrease his nausea and potassium supplements to stop his muscle spasms, according to Suzanne and a letter the hospital's administrator later sent her.

But when they recommended admitting him to monitor and manage the withdrawal symptoms, Jameson said no. He'd lost his job the previous month and, with it, his health insurance.

"He kept saying, 'I can't afford this,'" Suzanne recalled, and "not one person [at the hospital] indicated that my son would have had some financial options."

Suzanne doesn't remember any mention of the hospital's financial assistance policy or payment plans, she said. Nor does she remember any discussions of providing Jameson medication to treat opioid use disorder or connecting him to addiction-specialty providers, she said.

"No referrals, no phone numbers, no follow-up information," she later wrote in a complaint letter to the hospital.

Instead, ER staff provided a form saying Jameson was leaving against medical advice. He signed and Suzanne witnessed.

Three months later, Jameson Rybak died of an overdose in his childhood bedroom.

Missed Opportunities

That March night in the emergency room, Jameson Rybak had fallen victim to two huge gaps in the U.S. healthcare system: a paucity of addiction treatment and high medical costs. The two issues — distinct but often intertwined — can come to a head in the ER, where patients and families desperate for addiction treatment often arrive, only to find the facility may not be equipped to deal with substance use. Or, even if they are, the treatment is prohibitively expensive.

Academic and medical experts say patients like Jameson represent a series of missed opportunities — both medical and financial.

"The emergency department is like a door, a really important door patients are walking through for identification of those who might need help," said Marla Oros, a registered nurse and president of the Mosaic Group, a Maryland-based consulting firm that has worked with more than 50 hospitals nationwide to increase addiction treatment services. "We're losing so many patients that could be identified and helped," she said, speaking generally.

A spokesperson for McLeod Regional Medical Center, where Jameson went for care, said they would not comment on an individual's case and declined to answer a detailed list of questions about the hospital's ER and financial assistance policies. But in a statement, the hospital's parent company, McLeod Health, noted that the hospital adhered to federal laws requiring that hospital ERs provide "immediate stabilizing care" for all patients, regardless of their ability to pay.

"Our hospitals attempt to manage the acute symptoms, but we do not treat chronic, underlying addiction," the statement added.

Suzanne said her son needed more than stabilization. He needed immediate help breaking the cycle of addiction.

Jameson had been in and out of treatment for five years, ever since a friend suggested he try opioids to manage his anxiety and insomnia. He had insurance through his jobs in the hotel industry and later as an electrical technician, Suzanne said. But the high-deductible plans often left him paying out-of-pocket: $3,000 for a seven-day rehab stay, $400 for a brief counseling session and a prescription of Suboxone, a medication to treat opioid use disorder.

After he lost his job in February 2020, Jameson tried again to detox at home, Suzanne said. That's what led to the ER trip.

Treating Addiction in the ER

Hospital ERs across the nation have become ground zero for patients struggling with addiction.

A seminal study published in 2015 by researchers at Yale School of Medicine found that giving patients medication to treat opioid use disorder in the ER doubled their chances of being in treatment a month later, compared with those who were given only referrals to addiction treatment.

Yet providing that medication is still not standard practice. A 2017 survey found just 5% of emergency medicine physicians said their department provided medications for opioid use disorder. Instead, many ERs continue to discharge these patients, often with a list of phone numbers for addiction clinics.

ER Resources to Offer Medications for Opioid Use Disorder

Yale School of Medicine, which published pioneering work on the use of these medications in the ER, offers assessment, treatment and discharge resources for providers.

The American College of Emergency Physicians shares resources on treating opioid use disorder in the ER, and teamed up with the American Society of Addiction Medicine to provide a bedside tool for using buprenorphine.

Jameson didn't even get that, Suzanne said. At McLeod Regional, he was not seen by a psychiatrist or addiction specialist and did not get a prescription for Suboxone or even a referral, she said.

After Jameson's death, Suzanne wrote to the hospital: "Can you explain to me, especially with the drug crisis in this country, how the ER was not equipped with personnel and/or any follow-up for treatment?"

Hospital administrator Will McLeod responded to Suzanne, in a letter she shared with KHN, that per Jameson's medical record he'd been evaluated appropriately and that his withdrawal symptoms had been treated. Jameson declined to be admitted to the hospital, the letter said, and could not be involuntarily committed, as he "was not an imminent danger to himself or others."

"Had he been admitted to our hospital that day, he would have been assigned to social workers and case managers who could have assisted with referrals, support, and follow-up treatment," McLeod wrote.

Nationwide, hospitals are working to ramp up the availability of addiction services in the ER. In South Carolina, a state-funded program through the Medical University of South Carolina and the consulting firm Mosaic Group aims to help hospitals create a standardized system to screen patients for addiction, employ individuals who are in recovery to work with those patients and offer medication for opioid use disorder in the ER.

The initiative had worked with seven ERs as of June. It was in discussions to work with McLeod Regional hospital too, program staffers said. However, the hospital backed out.

The hospital declined to comment on its decision.

ER staffs around the country often lack the personnel to launch initiatives or learn about initiating addiction treatment. Sometimes affordable referral options are limited in the area. Even when the initial prescribing does occur, cost can be a problem, since Suboxone and its generic equivalent range in price from $50 to over $500 per prescription, without insurance.

In South Carolina, which has not expanded Medicaid, nearly 11% of the population is uninsured. Among patients in the state's program who have been started on medications for opioid use disorder in ERs, about 75% are uninsured, said Dr. Lindsey Jennings, an emergency medicine physician at MUSC who works on the statewide initiative.

Other parts of the country face similar concerns, said Dr. Alister Martin, an emergency medicine physician who heads a national campaign to encourage the use of these medications in the ER. In Texas, for example, hundreds of doctors have gotten certified to provide the medications, he said, but many patients are uninsured and can't pay for their prescriptions.

"You can't make it effective if people can't afford it," Martin said.

Too Late for Charity Care

Throughout the night at McLeod Regional hospital's ER, Jameson worried about cost, Suzanne said.

She wanted to help, but Jameson's father and younger brother had recently lost their jobs, and the household was running on her salary as a public school librarian.

Suzanne didn't know that nonprofit hospitals, like McLeod, are required by the federal government to have financial assistance policies, which lower or eliminate bills for people without the resources to pay. Often called charity care, this assistance is a condition for nonprofit hospitals to maintain their tax-exempt status.

But "nonprofits are actually doing less charity care than for-profits," said Ge Bai, an associate professor at Johns Hopkins University who published a study this year on the level of charity care provided by different hospitals.

That's in part because they have wide leeway to determine who qualifies and often don't tell patients they may be eligible, despite federal requirements that nonprofit hospitals "widely publicize" their financial assistance policies, including on billing statements and in "conspicuous public displays" in the hospital. One study found that only 50% of hospitals regularly notified patients about eligibility for charity care before initiating debt collection.

McLeod Regional's most recent publicly available tax return states that "uninsured patients are screened at the time of registration" and if they're unable to pay and ineligible for governmental insurance, they're given an application.

Suzanne said she doesn't remember Jameson or herself receiving an application. The hospital declined to comment on the Rybaks' case and whether it provides "conspicuous public displays" of financial assistance.

"Not once did anybody tell us, 'Let's get a financial person down here,' or 'There are grant programs,'" Suzanne said.

Mark Rukavina, with the nonprofit health advocacy group Community Catalyst, said most hospitals comply with the letter of the law in publicizing their assistance policy. But "how effective some of that messaging is may be a question," he said. Some hospitals may bury the policy in a dense packet of other information or use signs with vague language.

A KHN investigation in 2019 found that, nationwide, 45% of nonprofit hospital organizations were routinely sending medical bills to patients whose incomes were low enough to qualify for charity care. McLeod Regional hospital reported $1.77 million of debt from sending bills to such patients, which ended up going unpaid, for the fiscal year ending in 2019.

Believing they couldn't afford in-patient admission, the Rybaks left the hospital that night.

After the ER

Afterward, Jameson's withdrawal symptoms passed, Suzanne said. He spent time golfing with his younger brother. Although his application for unemployment benefits was denied, he managed to defer payments on his car and school loans, she said.

But, inside, he must have been struggling, Suzanne now realizes.

Throughout the pandemic, many people with substance use disorder reported feeling isolated and relapsing. Overdose deaths rose nationwide.

On the morning of June 9, 2020, Suzanne opened the door to Jameson's room and found him on the floor. The coroner determined he had died of an overdose. The family later scattered his ashes on Myrtle Beach — Jameson's favorite place, Suzanne said.

In the months following Jameson's death, hospital bills for his night in the ER arrived at the house. He owed $4,928, they said. Suzanne wrote to the hospital that her son was dead but received yet another bill addressed to him after that.

She shredded it and mailed the pieces to the hospital, along with a copy of Jameson's death certificate.

Twelve days later, the health system wrote to her that the bill had been resolved under its charity care program.

What Experts Say Patients Should Know about Hospital Charity Care

Ask for the hospitals' financial assistance policy. Nonprofit hospitals are required to have one and to provide you a copy. Many for-profit hospitals have such policies, too.

Always apply. Don't assume you won't qualify because you're working or have insurance.

Ask about alternatives. Even if you don't qualify for charity care, the hospital may be able to offer discounts or flexible payment plans.

Ask to meet with financial counselors or someone from the hospital's finance office to discuss your options.

Ask about assistance programs in the community. Does the hospital know of any local organizations that could help you enroll in insurance coverage or cover part of your bill through a grant program?

Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!

Aneri Pattani: apattani@kff.org, @aneripattani

Influx of Medical School Students Could Overwhelm Montana Resources, Program Leaders Warn

KFF Health News, July 15, 2021

Two medical schools vie to open in Montana, highlighting the rapid spread of for-profit schools and their previously tarnished business model.

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

By Andrea Halland

Opening two new medical schools in Montana would stretch and possibly overwhelm the state's physicians who provide the clinical training that students need to become doctors, according to leaders of a University of Washington medical school program that relies on those teaching physicians.

The University of Washington School of Medicine's WWAMI program in Montana requires its students who have finished their academic work to complete clerkships and clinical rotations to graduate, and then those graduates must be matched with residencies. WWAMI — an acronym of the five states participating in the program: Washington, Wyoming, Alaska, Montana and Idaho — uses hundreds of Montana physicians for that hands-on training, in addition to physicians in the other four states.

That's why plans by the for-profit Rocky Vista University College of Osteopathic Medicine to build a campus in Billings and the nonprofit Touro College and University System to build an osteopathic medical school in Great Falls have WWAMI officials worried.

"The biggest concern that everyone has is around clinical resources," said Dr. Suzanne Allen, vice dean of academic, rural and regional affairs for UW's School of Medicine. "At some point, there's not enough of those clinical resources to go around for everyone to have a good learning experience."

The University of Washington is an allopathic medical school, whose graduates are doctors of medicine, while the proposed Montana schools would train doctors of osteopathic medicine. Both kinds of doctors are fully licensed physicians. The students study the same curriculum and participate in the same clinical training, but they take different licensing exams, and the schools are accredited by different panels: The Liaison Committee on Medical Education for allopathic schools, and the Commission on Osteopathic College Accreditation for osteopathic schools.

Dr. Jay Erickson, assistant dean for regional affairs and rural health and assistant clinical dean for Montana WWAMI, criticized lax osteopathic school accreditation standards for creating a potential Montana medical student logjam that could affect his program.

"The LCME which accredits allopathic medical schools would never approve two new medical schools in a state of 1 million people with limited clinical teaching opportunities that are largely utilized by Montana WWAMI and the existing residencies," Erickson said in an email.

Rocky Vista, which has schools in Colorado and Utah, announced in May that the Commission on Osteopathic College Accreditation had approved its plan to build a Billings campus. The application by Touro, which has campuses across the country, for a facility in Great Falls is set to be taken up at the commission's August meeting.

Opening new medical schools would provide more slots to in-state students who might otherwise be rejected because of WWAMI's thresholds. Montana WWAMI accepts only 30 students a year. In Alaska and Wyoming, it's 20 students a year. In Idaho, it's 40, and in Washington, it's 160 divided between Seattle and Spokane. All WWAMI students must be residents of the state in which they apply.

Those classroom slots don't necessarily guarantee more training opportunities in the field. Such work accounts for about half of a medical student's education.

For the first two years, students in the WWAMI program receive classroom instruction at affiliated universities, such as Montana State University in Bozeman. Then in their third and fourth years, WWAMI students are required to complete clerkships and clinical rotations with doctors whom the program uses as clinical faculty, or teaching doctors, across the state.

About 230 WWAMI students from all five states participate in Montana clerkships as well as clerkships in the other four states. Other medical schools, including Idaho's College of Osteopathic Medicine and the Pacific Northwest University's College of Osteopathic Medicine, also use Montana for their students' clinical training.

The worry of school officials and some of those teaching doctors is that the flood of students the two new medical schools would bring could lead to increased competition and be harmful to the hands-on education that clinical rotations are designed to provide.

Dr. KayCee Gardner, a 36-year-old WWAMI graduate, practices family medicine in Miles City and trains WWAMI students.

"I just hope with more medical schools being built that there will be enough teachers and enough places for them to get a good rotation and not just be standing in the back observing," Gardner said.

Another point of concern is how the new Montana schools will affect residencies, which all medical school students must complete after graduating to become certified doctors. Residency placements are already very competitive, depending on the hospital and the specialty. WWAMI students are encouraged to seek residencies in the five-state region.

Since many doctors end up staying in the area where they do their residency, it is important to the goal of training doctors for rural and underserved communities, such as Montana and Idaho, for schools to encourage students to complete in-state residencies.

Four years ago, Idaho went through the uncertainty that Montana is going through now. That's when the for-profit Idaho College of Osteopathic Medicine was founded, leading to worries that the school would hamper WWAMI students' clinical training opportunities there.

Dr. Tracy Farnsworth, ICOM's president, said the school created more than 50 clinical affiliations and hundreds of affiliations with private physicians to avoid conflicts.

Now, both Farnsworth and WWAMI's Idaho director, Dr. Jeff Seegmiller, say their schools are united by the goal of boosting Idaho's number of physicians per capita, the second-worst ratio in the nation.

"In our view, we need WWAMI, but we also needed Idaho College of Osteopathic Medicine. To become something other than last in the nation for physicians, you need more resources, more ability to generate physicians," Farnsworth said.

ICOM has 486 students compared with WWAMI Idaho's 160, and about three-quarters of the for-profit school's students are from states outside of Idaho and the region.

Of the more than 800 physicians who have been trained by the Idaho WWAMI program, 51% of graduates return to practice in Idaho, according to Seegmiller.

ICOM's first class will graduate in May 2022, so it is unknown how many of its students will return to the state.

Touro University College of Osteopathic Medicine, which is awaiting approval from accreditation agencies, plans to accept 125 students each year and to educate them with affiliates in Montana as well as sending some students out of state for their clerkships and rotations, according to Dr. Alan Kadish, president of the Touro College and University System.

He said Touro plans to give preference to Montana residents but does not have a quota on how many in-state vs. out-of-state students it will accept.

"With our [osteopathic] model and increased primary care residencies, we believe that we will encourage students to enter primary care and remain in the state," Kadish said.

Red State, Blue State, Twin Outbreak: Behind Wyoming and Colorado's Anomalous COVID Spikes

KFF Health News, July 14, 2021

Many Wyoming residents say the virus that causes COVID has felt more like an inconvenience imposed on them by outsiders than a public threat.

This article was published on Wednesday, July 14, 2021 in Kaiser Health News.

By Rae Ellen Bichell

WHEATLAND, Wyo. — Brandon Graves said COVID-19 arrived in Wheatland the way new movies do in this High Plains farming town: months after hitting the big cities and without much fanfare.

"It kind of trickled in and it never really exploded here," said Graves, a lifelong resident and mayor of the town of about 3,500, the largest in Platte County.

Many residents say the virus that causes COVID has felt more like an inconvenience imposed on them by outsiders than a public threat. For instance, utility bills came late because the company that prints them is in a city that was hit hard by COVID. And the town is stuck repairing and re-repairing one of its aging trash trucks because the ordered replacement has been delayed by more than a year because of a COVID-induced shortage in microchips.

Then there's the "Colorado Navy," the locals' nickname for the parade of vehicles with boats in tow that cross the state line each summer. Their numbers swelled last year as people searched for lakes and campgrounds open during the pandemic, said Shawna Reichert, executive director of the Platte County Chamber of Commerce.

Campers were packed so tightly around Grayrocks Reservoir, a popular fishing spot outside of town, Reichert said, "it literally looked like a city." The crowds trashed the place, and a rancher lost several cows. Plastic bags were found in their stomachs.

It's no surprise many residents are lukewarm to the idea of COVID vaccines: As of July 6, about 29% of Platte County residents were fully vaccinated, according to the state health department. And Wyoming, a staunchly conservative state, had about 32% of residents fully vaccinated, giving it one of the lowest vaccination rates in the nation. Perhaps also not surprisingly, the state has one of the highest new case rates in the nation.

What might be surprising is that Wyoming's neighbor to the south has recently experienced similar case spikes, too. Colorado is a Democratic-leaning state whose population is about 53% fully vaccinated, placing it in the top 15 states in vaccination rates. It also had the 12th-highest rate of new cases among states as of July 9, ranking a few states lower than Wyoming.

Within Colorado, one of the most vaccinated counties is San Miguel County, which, like Wyoming's Platte County, has a population of a little over 8,000 people. Both counties entered June with high transmission rates and sustained them for several weeks straight, but their vaccination rates are inverses of each other: Fewer than a third of Platte County residents are fully vaccinated, while about a third of San Miguel County residents are not. The common thread in both places: pockets of unvaccinated residents.

Health officials are keeping a close eye on COVID hot spots that have emerged in recent weeks tied to low vaccination rates.

"One of the things that we've been sounding the alarm about is the need for hyper-local data," said Jennifer Nuzzo, an epidemiologist with the Johns Hopkins Bloomberg School of Public Health. "The state could look fine and you can think, like, 'No big deal. We've got this.' But then when you drill down at the county level, you could be seeing a much different story."

The county level might not even be granular enough to show true risk. Small upticks in cases can be meaningful even in sparsely populated counties — and not just because of the potential for transmission to spill across county or state lines.

"Small rises in cases in rural areas can have devastating consequences because, chances are, there's fewer healthcare resources in those places in order to save lives," she said. "There's been good studies that show that, partially, the ability of the virus to kill people depends on the bandwidth in the health system to save people."

After months of reporting few cases, Platte County Public Health posted a warning on Facebook in early June that 14 people had tested positive for COVID in the same number of days, and 12 ended up in the hospital.

That string of cases bumped Platte County into the "red zone" of high transmission rates. "Platte County contact tracing has shown that unvaccinated people are going to work and group gatherings while sick," the post read.

Joan Ivaska, senior director of infection prevention for Banner Health, which runs a 25-bed hospital in Wheatland, confirmed that COVID patients were admitted throughout June, though she declined to say how many. The hospital has only two adult intensive care beds.

She and other health officials continue to emphasize that better vaccine coverage is the only way to get back to normal.

The challenge, said Kim Deti, a spokesperson with the Wyoming health department, isn't just the politicization of the COVID vaccines, which has turned many against them, though that is a factor. It's also that many people have resumed activities and believe the pandemic is behind them.

"We've had relatively low levels of COVID-19 illnesses in most areas of the state for a while now, which affects threat perception," Deti said. "There are many people working very hard and trying everything they can. Wyoming's coverage rate is not for lack of effort."

In San Miguel County, Colorado, people were fired up about getting shots from the outset. "Interest has been very, very impassioned since vaccines became widely available," said county spokesperson Lindsey Mills.

San Miguel County hit President Joe Biden's vaccination goal of getting at least one dose into 70% of adult residents weeks before July 4, the deadline the nation as a whole missed. Yet the county was experiencing a surge in COVID cases similar to that of its Wyoming counterpart. More than 460 days after Colorado declared COVID a disaster emergency, San Miguel County recorded its first COVID death on June 14.

The reason? It turns out not everyone was as enthusiastic about the vaccines as San Miguel County's high rates indicated. Numbers provided by the local health department show that on the county's east side, home to the affluent ski resort community of Telluride, about 80% of eligible residents opted in. On the west side, what residents call the West End, only about half did. That left the county vulnerable to continued spread.

That east-west divide in San Miguel County reflects a preexisting cultural divide, according to Mike Bordogna, the county manager. The sparsely populated west side, which stretches to the Utah line, was historically the county breadbasket, growing crops and livestock that fed mining towns like Telluride, now known for skiing and its film and bluegrass festivals.

A KHN analysis of data provided by San Miguel County shows that, since the beginning of the pandemic, most of the county's COVID cases were on the east side, where most residents live. But in May, the tables turned. While the west side typically recorded less than 10% of the county's cases over the first year of the pandemic, in May and June its share suddenly was more than 64%, aided by the arrival of the delta variant.

In late May, an unvaccinated woman in her late 70s living in the county's West End caught the delta variant at a potluck following a funeral and died after a week in the hospital. Other unvaccinated funeral attendees caught the virus, too.

"Pretty much everybody that was there that was unvaccinated became sick after the fact — either tested positive or just became sick and didn't test," said Amanda Baltzley, contact tracing supervisor for San Miguel County Department of Public Health.

Sheila Grother, an EMT and contact tracer who works with Baltzley and has lived in the West End town of Norwood for more than 30 years, said she's gotten nowhere trying to persuade people to get vaccinated — even though two vaccinated West End residents who contracted the delta variant around the same time as the woman who died, and were also over 70, recovered.

"I've been in people's homes when they're at their worst and I've been with them on their worst possible days," she said. "I thought at one time that people, you know, trusted my judgment to some degree, and I think some do, but there are those that just — they're not going to get the damn vaccine."

But county leaders are holding out hope that some will have a change of heart. Bordogna said health officials are working on plans to set up surreptitious vaccination stations at the upcoming county fair and rodeo to make it easy for people to get inoculated without worrying about being spotted. The goal is to create a system in which attendees can, for example, tell a family member or friend they were heading for the bathroom and get a shot instead.

Back in Wheatland, few people were aware of the hospitalizations that happened in early June. Alice Wichert, who manages the Motel 6 in town, suspects most residents probably weren't aware of a spike in cases at all.

"There wasn't really anybody here who kind of had a strong fear of it," she said. "We just pretty much went on with life."

But that wasn't the case for one temporary motel resident. Angela Brixius is a lab technician from Nebraska working a stint at the local hospital, where, among other things, she processes COVID tests and regularly encounters patients convinced COVID is a hoax.

"I worry about people that aren't vaccinated who are out and about who talk to everybody that they meet about how this is not real," Brixius said. "I meet people at the hospital: 'I don't need a swab. I don't have COVID. It's not real.'"

"People are still dying of COVID. It's still going on, and it should be done," Brixius said before heading out the door for food and fresh air before another 3 p.m.-to-midnight shift in the lab.

Rae Ellen Bichell: rbichell@kff.org, @raelnb

Dying Patients With Rare Diseases Struggle to Get Experimental Therapies

KFF Health News, July 14, 2021

Getting expanded access to unproven therapies for rare diseases is more difficult than for more common illnesses, such as cancer.

This article was published on Wednesday, July 14, 2021 in Kaiser Health News.

By Christina Bennett

At 15, Autumn Fuernisen is dying. She was diagnosed at age 11 with a rare degenerative brain disorder that has no known cure or way to slow it down: juvenile-onset Huntington's disease.

"There's lots of things that she used to be able to do just fine," said her mom, Londen Tabor, who lives with her daughter in Gillette, Wyoming. Autumn's speech has become slurred and her cognitive skills slower. She needs help with many tasks, such as writing, showering and dressing, and while she can walk, her balance is off.

Autumn has been turned down for clinical trials because she is too young.

"It is so frustrating to me," Tabor said. "I would sell my soul to try to get any type [of treatment] to help my daughter."

For patients like Autumn with serious or immediately life-threatening conditions who do not qualify for clinical trials and have exhausted all treatment options, there may be another option: seeking approval from the Food and Drug Administration for expanded access, or compassionate use, of experimental therapies.

Definitive numbers are hard to find, but studies from researchers, actions by drugmakers and insights from experts suggest that getting expanded access to unproven therapies for rare diseases is more difficult than for more common illnesses, such as cancer.

Even with experimental treatments on the rise, patients with rare diseases frequently face an unwillingness by drug companies to provide them before clinical studies are completed. Developing drugs for these diseases is an especially fragile process because the patient populations are small and often diverse, having different genetics, symptoms and other characteristics, which makes studying the drugs' effects difficult.

Drugmakers believe offering a drug before studies are finished could impair its development and jeopardize FDA approval.

Companies working on therapies for rare diseases, especially smaller ones, could feel those repercussions acutely, said Lisa Kearns, a researcher in the ethics division of New York University's medical school and member of the division's working group on compassionate use and preapproval access. "There's not as much investment in rare diseases, so an [adverse] event could frighten the already limited number of potential investors."

Drugs that were not made available for compassionate use last year until studies were completed include Evrysdi, for spinal muscular atrophy; Enspryng, for an autoimmune disease of the optic nerve and spinal cord called neuromyelitis optica spectrum disorder; and Viltepso, for certain patients with Duchenne muscular dystrophy.

A spokesperson for Roche, which makes Evrysdi and Enspryng and is working on a treatment for Huntington's disease, said the decision was tied not to the type of disease but to company policy: Roche does not set up expanded access programs for any drugs until results are available from a phase 3 clinical trial. (Those phase 3 studies are typically the last testing done before the company seeks drug approval.)

Another company's experimental drug for myasthenia gravis, an autoimmune disease that leads to skeletal muscle weakness, similarly was not available through an expanded access program until research was completed last year, and no programs have started for a therapy being studied in a phase 3 clinical trial for Huntington's disease and for amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease often referred to as Lou Gehrig's disease.

One slight, but notable, deviation: Drugmaker Biogen agreed this year to allow certain ALS patients to receive an experimental drug as early as July 15, after the testing was to be completed but before the results are known.

Dr. Merit Cudkowicz, a neurologist at Massachusetts General Hospital in Boston, has helped patients get therapies through expanded access. Since September 2018, she and colleagues launched 10 programs that seek to match people with ALS therapies being developed by drug companies, but only about 120 patients have received therapies this way. More than 16,000 people in the United States were estimated in 2015 to have ALS and most do not qualify for clinical trials because of the progression of their disease or very strict eligibility requirements.

These examples contrast with some drugs for more common problems. Gleevec, for leukemia, was offered to thousands of patients through expanded access programs before the manufacturer completed the clinical studies that led to FDA approval. Videx, for HIV/AIDS, and Iressa, for the most common type of lung cancer, were similarly offered to large numbers of patients even as clinical trials were ongoing.

Last year, Novartis gave more than 7,000 patients worldwide early access to cancer drugs.

Doctors also report that getting experimental drugs for cancer patients is relatively simple. More than 200 physicians around the country were surveyed, and among those who applied for access, nearly 90% said they had secured drugs still being investigated for patients who were not responding to approved therapies.

California researchers found similar trends in a review of 23 social media campaigns launched by patients between 2005 and 2015 seeking a variety of experimental treatments. While seven of the 19 patients with cancer received early access to requested drugs, no access was allowed for three patients with rare diseases, although one of those patients was allowed to enroll in a clinical trial.

Companies base their decisions on whether to provide a therapy through expanded access on a number of factors, said Jess Rabourn, CEO of WideTrial, which helps pharmaceutical companies run compassionate use programs. In general, there should be evidence that patients can tolerate the treatment and an expectation that any benefit outweighs the risk, he said.

"This idea that you have to wait until the research is done is baloney," he said. "We're talking about patients who are going to die if they're told to wait."

But drugmakers often view it differently, even though evidence suggests that granting early access very rarely disrupts drug approval.

Kearns explained that companies often wait until phase 3, or after, because they can be "relatively" confident of a drug's safety and effectiveness. "They don't want to harm patients, of course, but they also do not want to threaten the drug's eventual regulatory approval with an adverse event in [a] very sick patient population."

Melissa Hogan, who consults on clinical trials for rare diseases and is an FDA patient representative, attributes the lack of access to the high cost of therapies and the tightknit nature of the rare disease community, where patients and their families often set up social media groups and exchange ideas and treatment plans. Companies "know that if one patient gains access, other patients will know" and ask for access, said Hogan, who has a son with mucopolysaccharidosis type II. That could overwhelm small drugmakers with little manufacturing capacity.

These concerns cause "many companies [to] just throw up their hands and take a hard line of no [expanded access] until they reach approval stage," said Hogan.

The 2018 Right to Try law offers another option for some patients. Unlike expanded access, the law applies only to requests for medicines — not medical devices — and does not require approval from the FDA or an institutional review board, a committee that reviews and monitors people participating in research for their protection. The legislation, however, doesn't oblige companies to grant a request.

For Cali Orsulak, expanded access may be her husband's only option. He was diagnosed with ALS in 2019 at age 43.

"We did our best with the skill level we had to search clinical trials all over Canada and the U.S., and then covid hit and it became increasingly difficult," said Orsulak, explaining that they live in Canada but seek medical care in the United States. "Now that my husband has progressed, it's even harder to get into clinical trials."

Christina Bennett: @https://twitter.com/tinabenn12?lang=en

As Congress Wrestles With Plans to Expand Medicare, Becerra Says Any One Will Do

KFF Health News, July 14, 2021

Becerra also said he will support efforts to bring down drug prices, including allowing importation from such countries as Canada and giving Medicare the ability to negotiate prices.

This article was published on Wednesday, July 14, 2021 in Kaiser Health News.

By Julie Rovner

The Biden administration will support whatever expansions to Medicare Congress is willing to make, Health and Human Services Secretary Xavier Becerra said Tuesday.

Democratic lawmakers on Capitol Hill are working on plans both to add benefits to the health program for seniors and to lower its eligibility age from 65 to 60. But the efforts are mired in competing priorities among different wings of the party as they try to push through a spending plan this year that Republicans have vowed to oppose. President Joe Biden called for the change in Medicare age eligibility while campaigning in 2020.

But asked if the administration has a preference on which Medicare provisions Congress takes up, Becerra said, "Our preference is to get it done. What's the 'it'? We'll take everything we can get."

In a wide-ranging sit-down interview for KHN's "What the Health?" podcast, Becerra also said he will support efforts to bring down drug prices, including allowing importation from such countries as Canada that have lower prices and giving Medicare the ability to negotiate prices.

In addition, he said he's looking forward to efforts to expand the Affordable Care Act, now that it has been upheld — again — by the Supreme Court last month.

As California's attorney general for the previous four years, Becerra led a coalition of Democratic state officials that defended the 2010 health law in that case from efforts by Republican state officials and the Trump administration to have it declared unconstitutional.

"Now we're playing offense," he said. "We've got the ball and we've got to march it down the field, and we intend to because there are many Americans who still need good coverage."

Among the top priorities for the ACA, he said, is maintaining the COVID relief law's temporary increases in subsidies for people who purchase coverage on the health law's marketplaces. Those new subsidies, he said, "have made it possible for countless American families to stay on those affordable health plans."

HHS is ready to engage in the fight over prescription drug prices, according to Becerra. "The president has been pretty explicit," he said. "He is supportive of negotiation of drug prices, so when we get a price for our tens of millions of Medicare recipients and our tens of millions of Medicaid recipients, [we know] that it's the best price we could have bargained for." At the same time, Becerra said, Biden "has supported efforts to import the same drug that cost too much here from another country if it costs less, if we can do it safely."

Becerra, who has been on the job since late March, said his top priority as secretary is to work on health equity issues. "I love that President Biden has said he wants everyone to feel treated equally," he said. "There are a whole bunch of Black and brown communities that have never had the kind of access to care that others have. And when they come to the doctor, they come with the kind of conditions that show they didn't have healthcare before."

Within that broader priority, Becerra said he wants to pay particular attention to the Indian Health Service: "It's time we really focus on our tribal communities and let Indian Country know we really are serious about being good partners."

Another priority is maternal mortality, given in the U.S. "there are women dying in childbirth at greater numbers than in developing countries," he said, and African American mothers die "in some cases at three or four times the rate of white mothers."

Still high on Becerra's to-do list is battling COVID and, particularly, vaccine hesitancy in states where new variants are spreading fast. Of the people who are dying, he said, "more than 99% are unvaccinated. I don't know how you can spin that any other way than to say: If you're vaccinated, you're probably going to live. And if you're unvaccinated, you've done yourself and a lot of other folks a disservice."

But Becerra, who drew criticism from conservatives last week after saying "it is absolutely the government's business" to know who has been vaccinated, continued to shrug off the idea of any sort of federal vaccine registry. The secretary has said those comments were taken out of context and on Tuesday added, "We want to work with our state and local partners."

To hear the conversation or see a transcript, go to KHN's "What the Health?" podcast.

Julie Rovner: jrovner@kff.org, @jrovner

Teen Volunteers Get a Foot in the Door for Nursing Home Careers

KFF Health News, July 13, 2021

Six of the top 10 fastest-growing jobs in the decade leading up to 2029 are projected to be in healthcare, including home health and personal care aides.

This article was published on Tuesday, July 13, 2021 in Kaiser Health News.

By Michelle Andrews

Jasmine De Moya, 17, has dreamed for years of working in the medical field, and she yearned to spend time with older people, missing her grandparents, who live in the Dominican Republic. A program sponsored by the New Jewish Home health system in New York City that combines volunteering and free training for entry-level health jobs, career coaching and assistance on her college prep is helping make her hopes come alive.

Over the past three years, Jasmine has learned a lot about caring for older people, from the importance of speaking slowly and being gentle with frail residents who may have hearing or comprehension problems to how to brush their teeth or bathe them.

"We practiced first with mannequins, so when we actually [worked on residents] I was in shock," she said. "Cleaning a body and their private areas, I never expected I would do that. But then I got used to it."

Last summer, Jasmine completed a certified nursing assistant training course. She has also researched and applied for colleges and student loans with help from an organization that the geriatrics career development program provides to volunteers like her. After graduating from high school last month, Jasmine will start nursing school at Lehman College in the Bronx in the fall. She'll be the first in her family to attend college.

Since it launched in 2006, the geriatrics career development program has helped more than 700 high school students from 10 underserved schools in New York City get hands-on experience with geriatric care at the New Jewish Home in Manhattan and the Harry and Jeanette Weinberg Gardens senior living facility in the Bronx. Ninety-nine percent of program participants graduate from high school, and more than 150 have gone on to college.

The advantages of the program are also evident for the New Jewish Home, which operates two nursing homes, senior housing and assisted living facilities and a home care business in the New York City area. By familiarizing young people with geriatric care careers, the system aims to address its growing need for workers as the tide of baby boomers enter their later years.

Six of the top 10 fastest-growing jobs in the decade leading up to 2029 are projected to be in healthcare, according to the federal Bureau of Labor Statistics, including home health and personal care aides.

"One of our biggest challenges is that there aren't enough people who want to work in this industry," said Dr. Jeffrey Farber, president and CEO of the New Jewish Home system. "People don't want to work with older adults."

The New Jewish Home began its career development program for teens 15 years ago with the idea of training and hiring them as nursing assistants, Farber said.

But it has become more than that. Working a few afternoons a week for three years with older adults, students gain insights into aging and develop relationships with residents, some of whom are assigned as mentors. It also gives students assistance with figuring out career goals and putting the pieces in place to get there.

"I think the students would be successful without us, but we provide the structure and resources to help them succeed," said John Cruz, senior director of workforce initiatives at the New Jewish Home, who oversees the program.

Students generally must devote two afternoons after school every week and several weeks during the summer, said Cruz. The program curriculum, developed with Columbia University Teachers College, initially teaches students basics about patient privacy, Medicare/Medicaid and overcoming stereotypes about older people. By the time they're seniors in high school, students can train as certified nursing assistants and work as paid interns supporting the residents on the days they spend at the facility.

As part of the program, students may also become certified in other jobs, including patient care technician, phlebotomist, EKG technician, and medical coding and billing staff.

The pandemic, however, changed things. The New Jewish Home in Manhattan was hit hard, with dozens of COVID deaths at the 514-bed facility.

Since volunteers weren't permitted inside the facility, the home instead hired many of them as part-time employees so they could continue to help seniors. This also gave students a chance to complete the clinical training portion of their certified nursing assistant coursework.

In addition to the program for high school students, the health system created a program in 2014 for people ages 18 to 24 who are unemployed and out of school, training them to become certified home health aides and nursing assistants. Nearly 200 have completed the program and the New Jewish Home has hired three-quarters of them, at a starting wage of $15 to $19 an hour.

Both programs are supported primarily by grants from foundations.

In February, the state announced that nursing homes could accept visitors again, following federal guidelines. But many nursing home residents still rely on virtual visits, and during the spring Jasmine spent her time helping them connect with their families and other loved ones by iPad or phone.

The isolation was hard on the residents, and students provided sorely missed company. Asked how the students helped her, resident Dominga Marquez, 78, said, "Just talk."

"We are lonely," said Marquez. "I have a lot of friends that used to come every week to visit but, with the pandemic, nobody came."

Kennedy Johnson, 17, said helping seniors experience virtual visits with their families during the pandemic made him realize how much he takes for granted.

"With the pandemic and doing the virtual calls, seeing how these families don't get to interact with their loved ones every day, that really opened my eyes," he said.

Working at the New Jewish Home was the first time Kennedy had ever been in a nursing home or seen the kinds of work that staff members do.

In the fall, he will start at Morehouse College in Atlanta and plans to major in political science. His goal: "I want to be a healthcare attorney so I can represent people … like this."

Michelle Andrews: andrews.khn@gmail.com, @mandrews110

California Takes a Nibble at Offering Food Stamps to Undocumented Immigrants

KFF Health News, July 13, 2021

The cost of the proposed expansion, starting in 2023, was put at about $550 million a year.

This article was published on Tuesday, July 13, 2021 in Kaiser Health News.

By Anna Almendrala

SANTA ANA, Calif. — One week the food pantry had frozen crabmeat; other weeks, deli meat or plant-based "meat." The week before the Fourth of July, there was no meat at all, and a reminder that the pantry would be closed the next two weeks.

Even though she never knows exactly what she'll get, Lesli Pastrana is grateful for the Mercado El Sol food pantry. She has frequented it ever since she lost her job in January. On a recent Friday, she walked away with produce, eggs and staples like ramen noodles, pasta and oats.

She and her husband are both in the United States without legal authorization. Before the pandemic, they got by with their wages and the food stamps they received for their two young children — both U.S. citizens.

But now that Pastrana has lost her job at a bowling supplies factory where she worked 10 years, and her husband has been downgraded to part-time work at a warehouse, the couple must save every dollar for their $1,500-a-month, two-bedroom apartment in Tustin. Pastrana is looking for a single room to rent for her family of four. She's worried about her kids.

"I don't want them to focus on the fact that I don't have a job right now," she said. "They don't know the magnitude of the situation, but they can sense the worry."

Additional food stamps could help lighten Pastrana's load and cut down on trips to the food pantry, but like all undocumented immigrants in the U.S., she and her husband are not eligible for these benefits, despite having worked and paid taxes here.

Democrats in the state legislature this year proposed opening California's state-funded food stamp program — which serves about 35,000 authorized immigrants who don't qualify for federal food stamps — to all income-eligible Californians, regardless of immigration status. The cost of the proposed expansion, starting in 2023, was put at about $550 million a year.

But after negotiations with Gov. Gavin Newsom's administration, the proposal was pared down to a two-year, $30 million project to update the state food aid program so it can accept applications from some of the more than 2 million undocumented people in California, should the program be extended to them in the future.

A bill under consideration in the legislature would expand the food stamp benefit to the undocumented once the system is updated and the legislature has appropriated funds for the expansion.

For now, the state has not committed to expanding the program. But the legislature's efforts this year put California at the forefront of extending food aid to unauthorized residents. Advocates say the state has a responsibility to help feed them, especially since hundreds of thousands of undocumented farmworkers toil in California's fields, feeding the state and the rest of the country.

"They're working and risking their lives, not just through the pandemic, but right now through a heat wave," said state Sen. Melissa Hurtado (D-Sanger), co-author of the bill, whose district is in the Central Valley. "They're risking their lives to provide food for us. Why wouldn't we invest in them as well?"

The program would be expensive, and the state would have to foot the whole bill. Right now, California is flush with a $76 billion surplus, but state revenue can swing wildly. For instance, the pandemic's economic restrictions had the Newsom administration projecting a $54 billion deficit just the year before.

California has already expanded eligibility to undocumented immigrants for its Medicaid health coverage program. Since last year it has allowed people under age 26 to participate if they meet income guidelines, at a cost of roughly $450 million annually. Starting in 2022, unauthorized immigrants age 50 and over will be eligible, and the state's annual costs are expected to grow to $1.3 billion by fiscal year 2024.

Up to 1 million unauthorized immigrants would meet the income requirements for food stamps, according to advocate Jared Call of Nourish California, which co-sponsored Hurtado's bill. But the program would likely begin by offering the benefit to subgroups such as children and seniors.

To qualify for food stamps in California, most families would have to earn 200% or less of the federal poverty level for their household size. For a family of four, this would mean grossing no more than $4,368 per month.

The governor's office declined to comment on the "Food for All" proposal and its funding, citing ongoing discussions with the legislature to finalize the budget.

Conservatives have expressed caution. Republican state senators voted as a bloc against Hurtado's bill. In an email explaining his "no" vote, Sen. Brian Jones (R-Santee) said it asks California taxpayers to "bear the burden of a chaotic border situation that is a federal responsibility."

In the Assembly, where committees are debating the bill, member Steven Choi (R-Irvine) suggested the program's generosity would compound problems at the U.S.-Mexico border by encouraging people to try to immigrate to California.

Even Democrats, who hold supermajorities in both houses of the state legislature, are wary of making commitments they can't keep. Food for All would need to be phased in incrementally in case revenues lag or other spending increases, according to an Assembly budget report.

The 2021-22 state budget, which Newsom was expected to sign Monday, includes other measures to make food available to poor people, regardless of immigration status, including more investment in food banks and a program to expand free breakfast and lunch to all California public school students, regardless of income.

The crushing demand for emergency food assistance during the pandemic put a spotlight on food insecurity. In California, more than 3 million residents said they went without sufficient food during the first three months of the pandemic lockdown, up 22% from before it began in March 2020, according to a study by researchers at UCLA's Fielding School of Public Health and Luskin School of Public Affairs.

Food banks in response doubled or tripled their food distribution. Schools, closed for classes, kept cafeterias running so families could drop by every week for free breakfasts and lunches. Nonprofits scrambled to organize emergency grocery deliveries for those sick with COVID-19.

But people behind these efforts say charity food giveaways are stopgap solutions that often distribute unhealthy food, result in massive waste and rob people of choice.

"Food banks get — I don't want to say 'hand-me-down food' — but they often get food near its expiration date," said Claudia Keller, chief mission officer of Second Harvest Food Bank in Orange County. "Food that might be high in sugar, salt and fat. And that, to us, is a disservice to the most vulnerable in our community."

Advocates say there is a better solution to hunger: Simply give families cash or stamps to buy their own food.

Vanessa Terán of Mixteco Indígena Community Organizing Project, on California's Central Coast, said this is why her organization, which primarily serves undocumented immigrant farmworkers, switched from organizing food drives to raising money for prepaid grocery cards.

"People are able to buy what they need, and also there's a shopper's dignity," she said. "They can make choices for their own families that best meet their needs."

The same approach was taken by the federal benefits program — known nationally as SNAP and in California as CalFresh and often called food stamps — which mails beneficiaries grocery-usable cash cards that automatically reload each month.

Undocumented immigrants make up an estimated 8.1% of California's workforce, according to a 2019 summary of data from the Center for Migration Studies think tank. A 2019 analysis by the nonpartisan California Budget & Policy Center estimated the state's undocumented immigrants contribute $3.2 billion annually in state and local taxes.

Hurtado praised her colleagues' decision to expand Medi-Cal to more groups of undocumented immigrants, saying "hunger and health go hand in hand."

"The foundation for good health is having access to adequate food, and healthy food," she said. "But I think that something is better than nothing, and I'm happy with the progress that we're making."

This story was produced by KHN (Kaiser Health News), a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Anna Almendrala: aalmendrala@kff.org, @annaalmendrala

Biden Is Caught in the Middle of Polarizing Abortion Politics

KFF Health News, July 12, 2021

Abortion will remain front and center for both parties as the Supreme Court prepares to review a Mississippi law that bans the procedure after 15 weeks and allows no exceptions for cases of rape or incest.

This article was published on Monday, July 12, 2021 in Kaiser Health News.

By Julie Rovner

It took five months for the Biden administration to make a substantive policy change to advance abortion rights. And even that change was buried in a 61-page regulation setting rules for 2022's Affordable Care Act enrollment.

The policy would reverse a Trump administration rule requiring insurers that cover abortion to send separate bills for that coverage. Abortion opponents had hoped the extra paperwork would persuade insurers to stop offering the coverage.

But the new administration's effort also highlights the frustrations abortion-rights advocates have with the slow pace of change from a president they strongly supported — and who courted their votes. "Biden will work to codify Roe v. Wade, and his Justice Department will do everything in its power to stop the rash of state laws that so blatantly violate Roe v. Wade," said his campaign platform.

The late-June action was technically Biden's second move on reproductive rights. Following a recent custom in which presidents taking office from the opposite party have reversed each other's abortion policies, Biden in January gave an initial nod to that campaign promise. He issued an executive order that overturned the so-called Mexico City policy that prohibited U.S. funding of foreign organizations that perform abortions or even lobby for looser abortion laws. It also instructed the Department of Health and Human Services to rewrite a Trump regulation that has effectively shut Planned Parenthood out of the federal family planning program, Title X.

But those Title X changes haven't happened yet, nor has the administration formally moved to undo rules that make it easier for employers to opt out of the ACA mandate to provide no-cost contraception. Also so far unchanged are Trump administration modifications to Medicaid guidance that allow states to ban Planned Parenthood from Medicaid. And abortion rights supporters' concerns are growing after the Supreme Court accepted a Mississippi case that could significantly weaken or even overturn Roe v. Wade, the 1973 ruling that legalized abortion nationwide.

In fact, to the consternation of reproductive rights advocates, Biden has apparently not even uttered the word "abortion" as president. A website is keeping track.

None of that, however, has stopped abortion opponents from painting the president and his administration as pro-abortion crusaders. "Once a supporter of policies that protect the lives of the unborn and their mothers, President Biden today caters to the most extreme voices within his party," said a statement from the Susan B. Anthony List in May. The statement was in response to Biden's keeping a campaign pledge to submit a budget calling for Congress to eliminate the Hyde Amendment, which for years has forbidden most federal abortion funding, particularly affecting low-income women in the Medicaid health program. It's named after former Republican Rep. Henry Hyde of Illinois.

It's true that Biden, a practicing Roman Catholic whose stance is criticized by many U.S. bishops, used to be much less supportive of abortion than he is today. But abortion moderates are a disappearing species in both political parties.

As recently as the 1990s, Democrats and Republicans jointly led "pro-life" and "pro-choice" caucuses in Congress. In 1991 an estimated third of Democrats in the U.S. House voted with anti-abortion advocates. A smaller but still significant minority of Republican House members voted with abortion-rights backers. The Senate was similarly divided. The divisions through the '90s helped explain why Democrats, even when they controlled both houses of Congress and the White House, were unable to eliminate the Hyde Amendment or codify abortion rights (they tried both).

Since then, though, both parties have retreated more firmly to their respective corners on reproductive health. Despite some complaints, the 2020 Democratic platform calls for repealing the Hyde Amendment, and the 2016 GOP platform (there was no formal platform in 2020) asserts that "the unborn child has a fundamental right to life which cannot be infringed." Anti-abortion Democrats in each chamber of Congress can be counted on one hand, as can Republican abortion-rights supporters.

The shift clearly has a lot to do with the replacement of Democratic conservatives in the South — many of whom opposed abortion — with Republicans. Along with that came redistricting, which has created more reliably red and blue districts. In a heavily Democratic or Republican district, politicians out of alignment with the majority of their party on issues such as abortion are more likely to draw primary opposition and less likely to raise money from activists.

But it's not just Democrats who are retreating from the middle of the abortion debate. In 1992, the Senate approved a bill by an overwhelming margin that would specifically allow federal funding of research on fetal tissue left over from elective abortions. Among the Republicans who voted for that measure who are still in the Senate are current Minority Leader Mitch McConnell and Chuck Grassley (R-Iowa).

By the time the issue returned to the political agenda in 2015, McConnell and Grassley had changed their positions.

Abortion will remain front and center for both parties as the Supreme Court prepares to review a Mississippi law that bans the procedure after 15 weeks and allows no exceptions for cases of rape or incest.

But Democrats will be tested most immediately. Progressives are determined to vote to eliminate the Hyde Amendment. Yet direct federal abortion funding makes even some abortion-rights backers squeamish, as Biden was until 2020 when, under some duress, he promised to sign the repeal if it came to his desk. As always, abortion remains a political high wire.

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

Government Oversight of COVID Air Cleaners Leaves Gaping Holes

KFF Health News, July 12, 2021

Academic air quality experts say the technology can be ineffective or potentially create harmful byproducts.

This article was posted on Monday, July 12, 2021 in Kaiser Health News.

By Lauren Weber and Christina Jewett

Stephen Matthew Shumaker counted on in-home, in-person demonstrations to drive his water filtration business, which serves the Atlanta area. So when COVID-19 hit and no one was inviting people indoors, he turned to the air-cleaning part of his operation.

He sent cards in the mail advertising air purifiers using ActivePure technology to new homeowners: "KILL COVID-19, CORONAVIRUS IN YOUR HOME!!"

One card landed on the desk of a postal inspector, who called it false and misleading in a court record. Shumaker then told an undercover agent on the phone on April 24, 2020, that the air purifier "kills the Coronavirus Virus on the spot," according to a criminal complaint.

Weeks later, as Shumaker was heading out the door to his daughter's tennis tournament, eight law enforcement officers detained him. In August, he pleaded guilty to distributing "a pesticide device that was misbranded in that the product label was missing an EPA establishment number." In other words, he failed to follow the letter of a little-known law.

Shumaker told KHN he was just a salesperson and the devices were being shipped straight from the manufacturer. "So I don't know — what am I supposed to do?" he asked. "How do I know if there's a sticker on there or not? I don't have a clue."

The company that makes the devices, ActivePure Technologies, said Shumaker was not an authorized or known salesperson of its products.

The sting is a rare example of enforcement in an arena where money is gushing like a geyser but oversight is nearly nonexistent. Electronic air cleaners, heavily marketed to gyms, doctors' offices and hospitals, companies and schools awash in federal COVID relief funds, tend to use high-voltage charges to alter molecules in the air. The companies selling the devices say they can destroy pathogens and clean the air.

But academic air quality experts say the technology can be ineffective or potentially create harmful byproducts. Companies that make the devices are subject to virtually no standardized testing or evaluation of their marketing claims. A KHN investigation this spring found that over 2,000 schools across the country have bought such technology.

"That's one of the reasons these companies thrive, is that there's nobody, nobody checking every aspect of what they do," said Delphine Farmer, a Colorado State University associate professor who specializes in atmospheric and indoor chemistry.

Regulatory Patchwork

An alphabet soup of federal agencies have truth-in-advertising or product medical device oversight powers but have done little about air cleaners or left broad loopholes. That has left a handful of states to take the most decisive action on the industry.

The Centers for Disease Control and Prevention does not regulate the devices but, like academic air quality experts, recommends time-tested portable HEPA filters to clean the air in rooms. In comparison, ionizing and dry hydrogen peroxide air purifiers have a "less-documented track record" in air cleaning, the CDC says.

The CDC also urges consumers to research the technology and "request testing data." Those reports, though, can be difficult to parse. They include arcane terms like "natural decay" and test conditions that only an expert could spot as different from those that prevail in real life.

The Food and Drug Administration regulates medical devices. But only air purifiers for a direct medical use or that make a medical claim, like relieving allergies, qualify. The FDA doesn't consider ads saying a device can kill a microorganism a "medical claim," spokesperson Shirley Simson said in an email.

Instead, the air purifiers fall under the Environmental Protection Agency's authority as devices marketed to destroy "pests," which include bacteria or viruses. But "unlike chemical pesticides, the EPA does not register devices and, therefore, does not routinely review their safety or efficacy," the agency said.

Trying to fill the gaps, California bans the sale of air purifiers that emit more than a certain level of the toxic ozone gas. The New York State Education Department is "not recommending" that schools buy air purifiers it describes as "ion generators" or "corona discharge technology."

Jeffrey Siegel, a University of Toronto civil engineering professor who studies indoor air quality, said more meaningful national regulation might clarify for consumers how the devices would work in an actual room.

"If you get any serious government oversight, a big chunk of this industry will go away," said Siegel.

'I Was Alone'

While "pesticide" might evoke the idea of a roach killer, the EPA applies the term more broadly: A pesticide is any substance that claims to kill or mitigate pests. Technologies that claim to do the same through physical means — including air purifiers that inactivate bacteria and viruses — are considered pesticide devices.

And while the agency requires proof that pesticides such as some types of Clorox wipes are safe and work in its premarket review, it has no such requirement for so-called pesticide devices — such as electronic air cleaners that deploy ions or "reactive oxygen" to purify the air.

Instead, manufacturers need to obtain what's known as an establishment number indicating where the device is made, and then they and their sellers must label their products with it. That's the step Shumaker pleaded guilty to skipping.

"There is no review associated with that," said James Votaw, a lawyer who specializes in chemical regulation law at Keller and Heckman in Washington, D.C. "That is automatic. It's like trying to get license plates for your car."

So Shumaker told KHN he was baffled as to why he was targeted instead of the corporate level, which in this case would be the company, Aerus, which is now ActivePure Technologies. Dr. Deborah Birx, former adviser to President Donald Trump, joined ActivePure in March as chief medical and science adviser.

"I was alone," Shumaker said in an interview about facing charges. "Nobody backed me up."

Joe Urso, CEO of ActivePure Technologies, told KHN that its studies showing its devices inactivate the virus that causes COVID were not completed until the fall, long after the postcards were sent. Urso said in a statement that his company's devices do have establishment numbers, and that he supports the ruling against Shumaker.

Federal Trade Commission officials have written warning letters to some air cleaner companies during the pandemic. The commission requires claims about a product's safety and efficacy to be supported with "competent and reliable scientific evidence."

One of the last high-profile actions the FTC took against an air purifier company was in 1997, when the Justice Department filed an action on its behalf against Alpine Industries, which made ozone-generating air purifiers. In 2001, a judge fined Alpine $1.49 million for failing to stop making unsubstantiated claims about its devices, which it had said relieved allergies and removed indoor pollutants.

Alpine is a related company to EcoQuest International, according to the FTC. And a majority of EcoQuest International assets were bought in 2009 by ActivePure Technologies, according to its 2021 press kit. ActivePure makes the device Shumaker got into trouble for selling.

Siegel, of the University of Toronto, consulted with U.S. government agencies targeting the misleading marketing claims of some air-cleaner companies about 10 years ago. He finds the company-by-company approach to be a game of "whack-a-mole."

"A company goes away because they have regulatory scrutiny and reinvent themselves a few months later," he said. "The only solution I see to this problem is a government agency really takes ownership of this — the information dissemination to consumers and the claims by manufacturers. I see no other path forward."

'It's Just Buyer Beware'

The Federal Insecticide, Fungicide, and Rodenticide Act, which regulates pesticide devices, was written decades ago and applied to things such as flypaper, long before anyone anticipated machines that would blast ions to clean the air.

"We're just pushing EPA to try and get updated," said Patrick Jones, president of the Association of American Pesticide Control Officials. "It's just buyer beware."

Even before the COVID pandemic, Jones' group was ringing the alarm over the increasing public health claims around pesticide devices. The pesticide control association wrote in a 2019 public comment to the EPA of its concern about the growing use in healthcare facilities of "non-government evaluated pesticide devices that make unsubstantiated human health claims … with no scientific data being submitted to EPA to prove their effectiveness."

EPA spokesperson Tim Carroll said in an email that the agency is developing more outreach materials for schools on air purifiers.

But as few independent authorities assess the effectiveness of the devices, school officials have been snapping them up.

Last summer, the private St. Thomas More School in Kansas City, Missouri, bought ionizing air purifiers to fight COVID. Scott Dulle, the director of building and grounds, said he went with technology he saw health leaders buying.

"We followed the doctors and the hospitals and the government," he said. "They would not put their patients and staff in harm's way."

AAPCO's Jones said changes to federal oversight are needed to better deal with the flood of devices. His solution: If a pesticide device makes a public health claim, it should be evaluated with the same rigor used for pesticides like ant spray.

But to alter the law fundamentally would take congressional action, EPA's Carroll said.

The EPA can prosecute pesticide device companies and sellers under existing laws if a product makes misleading or false claims — and fines can reach into the millions, according to Brandon Neuschafer, a lawyer who specializes in agricultural regulations at the St. Louis-based firm Bryan Cave Leighton Paisner. He noted companies are often turned in by their competitors.

Last fiscal year, Carroll said, the agency issued 19 import refusal notices and sent six advisory letters for COVID-related air-purifying products — a small fraction of its 2020 pesticide actions. Carroll said such investigations are ongoing and a high priority.

But EPA's resources were not the same as they were many years ago, Neuschafer said, as the agency is working with smaller staffing and budgets.

'Worse Indoor Air Quality'

Almost a decade before COVID emerged, New York's education department asked state health officials to test an AtmosAir bipolar ionization unit to see if it would improve the air quality.

During a test in an empty classroom, they found that levels of harmful ozone gas and "ultrafine particles" that can cause cardiovascular problems were elevated, indicating "worse indoor air quality when the AtmosAir Bipolar ionization unit is operating," the 2013 state Bureau of Toxic Substance Assessment report said.

New York State Department of Health officials released the study in response to a KHN public records request about the education department's COVID-era guidance, which urges schools not to buy ionizers.

AtmosAir spokesperson Sarah Berman said the device studied in 2013 is discontinued and "all current products have no affiliation to" it. She also said in an email that tests by third-party labs found that "our bipolar ionization products do not contribute to unacceptable levels" of volatile organic compounds, which are potentially harmful substances.

The California Department of Public Health advised in September against using "air cleaning devices that generate harmful pollutants (i.e., ionization devices or ozone generators)" on the third page of a single-spaced, 44-page document. That guidance was widely overlooked. Districts from Berkeley to Fontana to Culver City bought ionization systems.

But the state does have a one-of-a-kind law: It bans air purifiers that emit anything above a certain level of ozone.

New Jersey doesn't have the same kind of regulation: KHN reported that a public school district there bought thousands of ozone-emitting Odorox devices on the California Air Resources Board's list of "potentially hazardous" air purifiers. Since then, the New Jersey health department posted guidance warning schools about the air purifiers "that may harm health," listing the specific hazards of ozone to children's health.

Back in Georgia, Shumaker was fined more than $9,000 and is on two years' probation.

And the postcards that got him into trouble? Those led to only a handful of sales.

"So it was just like setting money on fire," he said.

Lauren Weber: LaurenW@kff.org, @LaurenWeberHP

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

Opinion: Why We May Never Know Whether the $56K-a-Year Alzheimer's Drug Actually Works

KFF Health News, July 12, 2021

Though patients will start taking it, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.

This article was published on Monday, July 12, 2021 in Kaiser Health News.

By Elisabeth Rosenthal

The Food and Drug Administration's approval in June of a drug purporting to slow the progression of Alzheimer's disease was widely celebrated, but it also touched off alarms. There were worries in the scientific community about the drug's mixed results in studies — the FDA's own expert advisory panel was nearly unanimous in opposing its approval. And the annual $56,000 price tag of the infusion drug, Aduhelm, was decried for potentially adding costs in the tens of billions of dollars to Medicare and Medicaid.

But lost in this discussion is the underlying problem with using the FDA's "accelerated" pathway to approve drugs for conditions such as Alzheimer's, a slow, degenerative disease. Though patients will start taking it, if the past is any guide, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.

The accelerated approval process, begun in 1992, is an outgrowth of the HIV/AIDS crisis. The process was designed to approve for sale — temporarily — drugs that studies had shown might be promising but that had not yet met the agency's gold standard of "safe and effective," in situations where the drug offered potential benefit and where there was no other option.

Unfortunately, the process has too often amounted to a commercial end run around the agency.

The FDA explained its controversial decision to greenlight the Biogen pharmaceutical company's latest product: Families are desperate, and there is no other Alzheimer's treatment. Also, importantly, when drugs receive this type of fast-track approval, manufacturers are required to do further controlled studies "to verify the drug's clinical benefit." If those studies fail "to verify clinical benefit, the FDA may" — may — withdraw them.

But those subsequent studies have often taken years to complete, if they are finished at all. That's in part because of the FDA's notoriously lax follow-up and in part because drugmakers tend to drag their feet. When the drug is in use and profits are good, why would a manufacturer want to find out that a lucrative blockbuster is a failure?

Historically, so far, most of the new drugs that have received accelerated approval treat serious malignancies.

And follow-up studies are far easier to complete when the disease is cancer, not a neurodegenerative disease such as Alzheimer's. In cancer, "no benefit" means tumor progression and death. The mental decline of Alzheimer's often takes years and is much harder to measure. So years, possibly decades, later, Aduhelm studies might not yield a clear answer, even if Biogen manages to enroll a significant number of patients in follow-up trials.

Now that Aduhelm is shipping into the marketplace, enrollment in the required follow-up trials is likely to be difficult, if not impossible. If your loved one has Alzheimer's, with its relentless diminution of mental function, you would want the drug treatment to start right now. How likely would you be to enroll and risk placement in a placebo group?

The FDA gave Biogen nine years for follow-up studies but acknowledged that the timeline was "conservative."

Even when the required additional studies are performed, the FDA historically has been slow to respond to disappointing results.

In a 2015 study of 36 cancer drugs approved by the FDA, only five ultimately showed evidence of extending life. But making that determination took more than four years, and over that time the drugs had been sold, at a handsome profit, to treat countless patients. Few drugs are removed.

It took 17 years after initial approval via the accelerated process for Mylotarg, a drug to treat a form of leukemia, to be removed from the market after subsequent trials failed to show clinical benefit and suggested possible harm. (The FDA permitted the drug to be sold at a lower dose, with less toxicity.)

Avastin received fast-track approval as a breast cancer treatment in 2008, but three years later the FDA revoked the approval after studies showed the drug did more harm than good in that use. (It is still approved for other, generally less common cancers.)

In April, the FDA said it would be a better policeman of cancer drugs that had come to markets via accelerated approval. But time — as in delays — means money to drug manufacturers.

A few years ago, when I was writing a book about the business of U.S. medicine, a consultant who had worked with pharmaceutical companies on marketing drug treatments for hemophilia told me the industry referred to that serious bleeding disorder as a "high-value disease state," since the medicines to treat it can top $1 million a year for a single patient.

Aduhelm, at $56,000 a year, is a relative bargain — but hemophilia is a rare disease, and Alzheimer's is terrifyingly common. Drugs to combat it will be sold and taken. The crucial studies that will define their true benefit will take many years or may never be successfully completed. And from a business perspective, that doesn't really matter.

Elisabeth Rosenthal: erosenthal@kff.org, @rosenthalhealth

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'Worse Indoor Air Quality'

Though patients will start taking it, the world may have to wait many years to find out whether Aduhelm is actually effective — and may never know for sure.

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