BOULDER, Mont. — Twice a year, Brian Tichenor makes the 1,200-mile drive each way from his home in Kansas to a defunct uranium mine in Montana, where he takes an elevator 85 feet below the surface to sit amid radioactive radon gas to ease the pain from his chronic eye condition.
"I found it like I think a lot of people do," said Tichenor, 67. "It's a point of desperation with conventional treatment."
While radon is commonly known as a hazardous gas removed from basements, people in pain travel to Montana and pay to breathe, drink and bathe in its radioactive particles. The travelers view the radon exposure as low-dose radiation therapy for a long list of health issues. But the Environmental Protection Agency and the World Health Organization, among others, blame the gas as the second-leading cause of lung cancer. Although cancer doctors use radiation as a front-line treatment to destroy dangerous cells, its role in the U.S. in low doses for other ailments is disputed. The pandemic has recharged that debate as clinical trials across the world test whether low doses of radiation can help treat COVID-19 patients.
But radon gas isn't the same radiation U.S. doctors use, radiation experts caution. Radon is just one of the radioactive chemical elements and, because it's a gas, it can be inhaled, making it particularly dangerous. Sitting in a radon-filled room and targeted radiation treatment in a medical facility are as different as "chalk and cheese," said Brian Marples, a professor of radiation oncology at the University of Rochester.
"In clinical therapy, we know exactly what the dose is, we know exactly where it's going," he said.
Marples said much of the argument for radon's therapeutic use relies on historical reports, unlike evidence-based research on clinical radiation. Still, some radiation experts are split on what level of radon should be deemed dangerous and whether it could have positive health effects.
Another concern: The radon treatment in the mines is largely unregulated. The Montana Department of Public Health and Human Services doesn't have the authority to permit or license the mines, though department spokesperson Jon Ebelt said the adverse health risk from exposure is well known. The EPA also doesn't have the power to mandate limits on radon.
Nonetheless, each year travelers head to western Montana, where four inactive mines flush with radon are within 11 miles of one another near the rural communities of Basin and Boulder. Day passes range from $7 to $15. The gas naturally forms when radioactive elements in the mountains' bedrock decay.
Outside the Merry Widow Health Mine, a billboard-like banner announces "Fountain of Youth. FEEL YOUNG AGAIN!" Inside its tunnels, water seeps from the rock walls. Those who want full immersion can slip into a clawfoot tub filled with radon-tainted water. People soak their feet and hands in water or simply sit and work on a puzzle. On a bench sits a printout of a Forbes article on clinical trials that show low-dose radiation could be a treatment for COVID-19.
To owner Chang Kim, 69, his business is a mission, especially for those with chronic medical conditions such as arthritis or diabetes. Those who swear by radon therapy say that, in low doses, a little stress on the body triggers the immune system to readapt and reduces inflammation.
"The people coming to the mines, they're not stupid," Kim said. "People's lives are made better by them."
He learned about the mines 14 years ago when he and his wife, Veronica Kim, lived in Seattle and a connective tissue disease crumpled Veronica's hands and feet. Traditional medicine wasn't working. After two sessions a year in the mines ever since, Veronica smiles when she shows her hands.
"They're not deformed anymore," she said, adding she's been able to cut down on her use of meloxicam, a medication to reduce pain and swelling.
Tichenor said going to a mine with radon over six years has been one of the few things to calm his scleritis, a disorder that causes pain he describes as ice picks stabbing his eyes. As for its potential danger, he said radon treatment is just like any medication: Too much can cause harm.
In the U.S., the EPA maintains that no level of radon exposure is risk-free even though everyone encounters the element in their lives. The agency notes radon is responsible for about 21,000 lung cancer deaths every year. It recommends that homeowners with radon levels of 4 picocuries per liter or more should add a radon-reduction system. By contrast, the owners of Montana's oldest radon therapy mine, Free Enterprise Radon Health Mine, said their mine averages around 1,700.
Monique Mandali said the federal guidelines are "a bunch of baloney." Mandali lives in Helena, about 40 minutes from the mines, and tries to fit in three sessions at Free Enterprise a year — 25 hours of exposure spread out over 10 days for arthritis in her back.
"People say, 'Well, you know, but you could get lung cancer.' And I respond, 'I'm 74. Who cares at this point?'" she said. "I'd rather take my chances with radon in terms of living with arthritis than with other Western medication."
Antone Brooks, formerly a U.S. Department of Energy scientist who studied low-dose radiation, is among those who believe the federal government's no-level-of-radon-exposure stance goes too far. He pointed to research that indicates low doses of radiation potentially turn on pathways within bodies that could be protective. Though what's considered a "low dose" depends on who's talking.
"If you want to go into a radon mine twice a year, I'd say, OK, that's not too much," he said. "If you want to live down there, I'd say that's too much."
In the early 1900s, before antibiotics were popularized, small doses of radiation were used to treat pneumonia with reports it relieved respiratory symptoms. Since then, fear has largely kept the therapeutic potential of low-dose radiation untapped, said Dr. Mohammad Khan, an associate professor with the Winship Cancer Institute at Emory University. But amid the pandemic, healthcare providers struggling to find treatments as hospital patients lie dying have been giving clinical radiation another look.
So far, the trials Khan has led show that patients who received targeted low-dose radiation to their lungs got off oxygen and out of the hospital sooner than those without the treatment. Khan said more research is necessary, but it could eventually expand clinical radiation's role for other illnesses.
"Some people think all radiation is the same thing, that all radiation is like the Hiroshima, Nagasaki bombs, but that's clearly not the case," Khan said. "If you put radiation in the hands of the experts and the right people — we use it wisely, we use it carefully — that balances risk and benefits."
The logo for Free Enterprise Radon Health Mine is a miner skipping with crutches in the air. Roughly 70 years ago, a woman said her bursitis disappeared after visiting the mine several times. Thousands of others followed suit.
"We believe in it," said Leah Lewis, who co-owns the mine with her husband, Ryan Lewis, and has relied on it to help treat her Crohn's disease.
The couple live on-site and grew up in Boulder, going into the tunnels just as their 5-year-old daughter does now. Her husband's great-grandfather owned the mine, and the business has been in the family ever since.
"Not one person has come back and said they've gotten lung cancer here," Ryan Lewis said. "If they did, they would shut us down so fast."
Aside from a billboard outside Helena, the family doesn't really advertise the business. Clients tend to find them. Like many companies, Ryan Lewis said, Free Enterprise took a hit last year as people canceled plans because of the pandemic. Before that, he said, the business broke about even, adding that radon can be "a hard sell."
But he said the family of cattle ranchers plans to keep it running as long as it doesn't cost them money.
"The land is an investment, and we want to keep it in the family," he said. "And there are a lot of people who use this, and there's some responsibility there."
A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices.
This article was published on Thursday, July 29, 2021 in Kaiser Health News.
Three years ago, pharma giant Pfizer paid $24 million to settle federal allegations that it was paying kickbacks and inflating sales by reimbursing Medicare patients for out-of-pocket medication costs.
By making prohibitively expensive medicine essentially free for patients, the company induced them to use Pfizer drugs even as the price of one of those medicines, covered by Medicare and Medicaid, soared 44% to $225,000 a year, the Justice Department alleged.
Now Pfizer is suing Uncle Sam to legalize essentially the same practice it was accused of three years ago — a fighting response to a federal crackdown that has resulted in a dozen drug companies being accused of similar practices.
A Pfizer win could cost taxpayers billions of dollars and erase an important control on pharma marketing after decades of regulatory erosion and soaring drug prices, say health policy analysts. A federal judge's ruling is expected any day.
"If this is legal for Pfizer, Pfizer will not be the only pharmaceutical company to use this, and there will effectively be a gold rush," government lawyer Jacob Lillywhite said in oral arguments last month.
Pfizer's legal argument "is aggressive," said Chris Robertson, a professor of health law at Boston University. "But I think they've got such a political tailwind behind them" because of pocketbook pain over prescription medicine — even though it's caused by pharma manufacturers. Pfizer's message, "'We're just trying to help people afford their drugs,' is pretty attractive," he said.
That's not all that's working in Pfizer's favor. Courts and regulations have been moving pharma's way since the Food and Drug Administration allowed limited TV drug ads in the 1980s. Other companies of all kinds also have gained free speech rights allowing aggressive marketing and political influence that would have been unthinkable decades ago, legal scholars say.
Among other court arguments, Pfizer initially claimed that current regulation violates its speech protections under the First Amendment, essentially saying it should be allowed to communicate freely with third-party charities to direct patient assistance.
"It's infuriating to realize that, as outlandish as they seem, these types of claims are finding a good deal of traction before many courts," said Michelle Mello, a professor of law and medicine at Stanford University. "Drug companies are surely aware that the judicial trend has been toward more expansive recognition of commercial speech rights."
Pfizer's lawsuit, in the Southern District of New York, seeks a judge's permission to directly reimburse patient expenses for two of its heart-failure drugs each costing $225,000 a year. An outside administrator would use Pfizer contributions to cover Medicare copays, deductibles and coinsurance for those drugs, which otherwise would cost patients about $13,000 a year.
Letting pharma companies put money directly into patients' pockets to pay for their own expensive medicines "does induce people to get a specific product" instead of shopping for a cheaper or more effective alternative, said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University. "It's kind of the definition of a kickback."
Government rule-makers have warned against such payments since the launch of Medicare's Part D drug benefit in 2006. Drug companies routinely help privately insured patients with cost sharing through coupons and other means, but private carriers can negotiate the overall price.
Because Congress gave Medicare no control over prescription drug prices, having patients share at least part of the cost is the only economic force guarding against unlimited price hikes and industry profits at taxpayer expense.
At the same time, however, regulators have allowed the industry to help patients with copays by routing money through outside charities — but only as long as the charities are "bona fide, independent" organizations that don't match drugmaker money with specific drugs.
Several charities have blatantly violated that rule in recent years by colluding with pharma companies to subsidize particular drugs, the Justice Department has alleged. A dozen companies have paid more than $1 billion to settle allegations of kickback violations.
Pfizer set up an internal fund at one of the charities, the Patient Access Network Foundation, to cover patient costs for a heart arrhythmia drug at exactly the same time it was raising the wholesale cost from $220 to $317 for a package of 40 capsules, the Justice Department said. Pfizer referred Medicare patients who needed the drug to the PAN Foundation, the government said.
Under such arrangements, every $1 million channeled through a charity "has the potential to generate up to $21 m[illion] for the sponsor company, funded by the U.S. government," Andrew Baum, a Citi pharma stock analyst, wrote in 2017.
Pfizer settled the case, saying it was not an admission of wrongdoing but resulted from its "desire to put this legal matter behind us."
The PAN Foundation and three othercharities also made deals to resolve allegations that they functioned as disallowed conduits for patient assistance for multiple pharma companies. One organization, the Virginia-based Caring Voice Coalition, shut down after government scrutiny.
PAN's settlement did not mention the alleged Pfizer transactions. Those were described in the separate government deal with Pfizer.
The 2019 PAN agreement related to "legacy matters" and "did not involve any of PAN's current operations or disease funds," organization CEO Dan Klein said via a spokesperson. "Nonprofit patient assistance programs like PAN are necessary to help people access the critical medications they need to stay healthy."
But legal troubles have hardly slowed the pharma-funded patient assistance business.
Four penalized nonprofits agreed to stop directing money to specific drugs, but they continue to accept hundreds of millions of dollars in pharma donations to indirectly cover copays and other patient drug costs, organization reports and IRS filings show. HHS regulators allow the practice because the drug companies are not involved in deciding which patients and which drugs are subsidized.
Donations to six pharma-funded patient assistance charities reached $1.8 billion in 2019, only slightly less than the year before, a KHN analysis of their IRS filings shows. That was nearly 50% higher than the amount from five years previously, before the Justice Department started cracking down.
Last year Pfizer donated $39.7 million to PAN and five other charities helping patients with out-of-pocket drug costs, company disclosures show.
If Pfizer's lawsuit seeking to earmark such donations for its tafamidis heart-failure drugs opens the way for similar practices industrywide, it would drive up Medicare costs through rising prices and numbers of prescriptions, said Gerard Anderson, an economist and health policy professor at Johns Hopkins University's Bloomberg School of Public Health. Such a program for tafamidis alone would increase Medicare costs by $30 billion, the Health and Human Services Department's inspector general estimated.
Pharma companies can "learn which patients are using the drug, and they can market [and offer financial assistance] directly to that patient," Anderson said. "You get a huge return."
Pfizer argues that its proposal, which the HHS inspector general called "highly suspect" in an advisory opinion before the company filed its lawsuit, is legal and sensible.
"Providing copay assistance to middle-income patients who have been prescribed tafamidis is an efficient and equitable way to lower their out-of-pocket costs," company spokesperson Steven Danehy said.
But the real affordability problem for patients is that tafamidis is too expensive, federal attorney Lillywhite said in court arguments last month. (HHS' Office of Inspector General declined to comment.)
Pfizer has "priced itself out of the market," he said. The company is seeking to "do something that's unprecedented, to upend decades of settled law and agency guidance" to boost sales of "what is the most expensive cardiovascular drug ever launched in the United States."
After the oral arguments, Pfizer dropped claims that HHS rules violate its free speech rights. Judge Mary Kay Vyskocil is considering only the company's contention that a dedicated fund for tafamidis would not violate kickback prohibitions because, among other arguments, it is the doctor who decides to prescribe the drug and create revenue for Pfizer, not the patient getting the financial assistance.
But legal analysts still see the case as part of a broad movement toward deregulation and corporate rights.
A 1970s Supreme Court case, viewed as paving the way for an explosion of drug, lawyer and liquor ads as well as corporate campaign donations, was about speech rights for prescription drug sellers in Virginia. In 2011 the court found that the First Amendment allows data miners to buy and sell prescription records from pharmacies, provided the patients aren't identified.
A year later, a federal appeals court cited speech protections when it overturned the conviction of a pharma sales rep who had been promoting a drug for uses not approved by the FDA.
Even if Pfizer loses its case, the climate may be ripe for similar challenges by other drugmakers, especially after the appointment of more than 200 federal judges by business-friendly President Donald Trump, legal scholars said.
The federal kickback law doesn't mention copay assistance charities "and wasn't designed with these programs in mind," said Mello, of Stanford. Pfizer's lawsuit "should be a loud, clanging call to Congress" to explicitly define drug assistance subsidies as illegal kickbacks, she said.
Phil Gaimon paid about $500 a month for his insurance policy with Health Net through Covered California. He also had a secondary health insurance policy with USA Cycling.
This article was published on Thursday, July 29, 2021 in Kaiser Health News.
It was a race in Pennsylvania that could have sent cyclist Phil Gaimon to the Tokyo Olympics; instead, a serious crash landed the Californian in two hospitals on the East Coast.
Gaimon knows accidents are, unfortunately, part of the sport. He had retired from competitive road cycling three years earlier, but a recruiting call came in spring 2019 from a coach of the USA Cycling track team.
The coach needed speed for a four-man event. At the time, Gaimon was making a name for himself, and money, by mountain racing, and he was setting records.
"It was a dream come true," said Gaimon, 35. "A chance at a second career in racing."
But his Olympic dreams were short-lived. In a sprint with a pack of riders at the velodrome track in eastern Pennsylvania, Gaimon sailed over his handlebars after colliding with a fellow racer. Gaimon hit the ground hard. The result: a fractured collarbone, five broken ribs, a partially collapsed lung and a broken scapula — his worst injuries in the 10 years he had raced on pro road teams in the United States and Europe.
An ambulance whisked him to Lehigh Valley Hospital in Allentown, Pennsylvania, which is part of the health system that sponsored the cycling event. Emergency doctors admitted the athlete and he underwent surgery on his collarbone. He needed surgery on his scapula, too, which he said felt "like a collapsed taco." But that surgery would happen days later, after he was discharged from the Pennsylvania hospital and a friend helped him find a surgeon in New York.
He chronicled the whole ordeal on his social media channels, and soon he was recuperating — painfully, but successfully — back home. And then the bills came.
The Patient: Phil Gaimon, 35, a former professional cyclist, YouTuber and blogger who earns most of his income through sponsorships. He paid about $500 a month for his insurance policy with Health Net through Covered California, the state's health insurance exchange. He also had a secondary health insurance policy with USA Cycling.
Total Bills: $151,804 from Lehigh Valley Health Network, and $49,526 from the Hospital for Special Surgery. He had additional bills from various physicians. Health Net has paid approximately $27,000 to Lehigh Valley, according to Gaimon. His secondary insurance, USA Cycling, paid $25,000 to the Hospital for Special Surgery and his surgeon there.
Service Providers: Lehigh Valley Hospital-Cedar Crest in Allentown, Pennsylvania, part of the not-for-profit Lehigh Valley Health Network. The Hospital for Special Surgery, an academic medical center, in Manhattan.
Medical Procedure: Surgery for a fractured collarbone at Lehigh Valley Hospital and surgery for a broken scapula at the Hospital for Special Surgery.
What Gives: Gaimon collided with three health system dangers in this physically and financially painful crash: an out-of-state emergency, out-of-network care and gold-plated prices from both hospitals that treated him. Gaimon said he could sell his house and pay these bills, "but I shouldn't have to. I have insurance."
His situation is a scenario many patients have encountered when they need emergency care outside of their provider's network. It's known in medical jargon as "balance billing." Hospitals and insurance companies without mutual contracts often don't agree on the price of services, and the patient is left to pay the difference.
While at least 33 states have enacted laws intended to protect consumers from balance billing, many don't apply to out-of-state patients, said Maanasa Kona, an assistant research professor at the Center on Health Insurance Reforms at Georgetown University.
For example, in Gaimon's home state of California, state law protects enrollees of state-licensed health plans from balance billing, but their authority is limited to California doctors and hospitals.
"These state laws depend upon the state having jurisdiction over the providers involved," Kona said. "So, nothing is going to stop out-of-state providers from sending bills and hounding the patient. It's a major gap."
In Gaimon's case, the validity of the hospital charges was also questionable. Lehigh Valley Health Network is notorious for big markups on care for out-of-network patients, said Dr. Merrit Quarum, chief executive of WellRithms, which scrutinizes medical bills for self-funded employers and other clients nationwide. "There's no rhyme or reason as to how they're charging compared to their costs," Quarum said.
WellRithms reviewed Gaimon's bills in detail at the request of KHN and determined that a reasonable reimbursement for the care he received would have been $21,000. That's $6,000 less than what Health Net had already paid.
In an email to KHN, Lehigh Valley Health Network spokesperson Brian Downs called the calculations by WellRithms "flawed," and said it is not appropriate to use Medicare-based rates to determine medical costs because they "are not reflective of the actual cost incurred by a provider in rendering any specific medical service." WellRithms didn't use Medicare rates, however. It looked up the amounts Lehigh told Medicare it costs the health system to perform a wide range of services.
One reason cited by WellRithms for Gaimon's high bill: Lehigh Valley Hospital charged him $25,915 for a night in the intensive care unit and $29,785 for a night in the burn unit, according to an explanation of benefits sent to Gaimon by Health Net in January 2020. Gaimon understood he was placed in these specialty units because of a lack of space in other parts of the hospital. But Downs, in his statement, said Gaimon needed the burn unit because of his abrasions and the ICU after his collarbone surgery.
Still, the charges are big markups compared with the costs Lehigh reports to Medicare: $13,038.82 for an ICU patient night and $18,036.92 for a burn ICU patient night, according to WellRithms.
"$25,000 a day for a charge for an ICU is absolutely ridiculous," Quarum said.
Gaimon's $49,526 bill from the Hospital for Special Surgery posed other patient-billing land mines.
He recalled representatives from the hospital and his insurance plan telling him he would be billed as an out-of-network patient, but they assured him he could file an appeal because of the extenuating circumstances. And he had secondary insurance offered by USA Cycling that would cover $25,000 for the shoulder surgery, which it did, according to billing records.
He expected his primary insurer, Health Net, to pay some of the cost, too.
But in an Oct. 19, 2019, letter, Health Net denied Gaimon's appeal because he "self-referred" himself to a surgeon in New York. They also described the surgery as "outpatient" even though he spent the night at the hospital. The letter went on to say the Hospital for Special Surgery had categorized the surgery as elective.
Given his level of pain and the fact surgeons at the first hospital didn't perform the scapula surgery during his stay, he figured there was nothing "elective" about it. "I needed this surgery and no one else could do it," Gaimon said.
Health Net spokesperson Darrel Ng declined to comment, saying it doesn't comment on specific member cases, even though Gaimon gave written permission for his case to be discussed.
A reasonable reimbursement for Gaimon's out-of-network scapula surgery should have been $13,908, according to WellRithms. Historically, the hospital's average charge for that surgery was nearly $11,000 even though it cost only $3,094 to perform in the year Gaimon had his surgery, WellRithms found in the 2019 annual cost report the hospital submitted to the federal government.
Resolution: Battling these bills became Gaimon's full-time job as he recovered from surgery. And, almost two years after the crash, he still faces huge bills from both hospitals despite both hospitals having been paid tens of thousands of dollars through Gaimon's insurance coverage.
After a reporter made inquiries, a representative from the Hospital for Special Surgery called Gaimon, offering to help him apply for financial assistance based on his income.
In a statement, HSS spokesperson Noelle Carnevale said, "We regret Mr. Gaimon's dispute with his insurance provider's classification of the surgery as elective." And she added, "We are optimistic for an easy resolution, and look forward to celebrating his continuing achievements."
Gaimon spent months calling and writing letters to Health Net to persuade them to cover the emergency room visit and the collarbone surgery. So far, he has been unsuccessful.
Congress last December passed legislation intended to protect patients like Gaimon against unexpected bills from out-of-network providers. Starting next year, when the law takes effect, patients can be charged only up to the amount of their deductible or copayment when receiving emergency care at any hospital.
The Takeaway: The federal protections against unforeseen medical bills for emergency care kick in Jan. 1, 2022. So, if you travel out of state this year, you should be aware that many state-based insurance plans might not cover you fully or at all in another state.
If you're in possession of a surprise or balance bill for out-of-state emergency care, contact your health insurance plan and make sure representatives understand it was an emergency. Call the hospital and ask about financial assistance or charity care.
And be aware that the new federal law doesn't cover everything. Should you be taken to the hospital by a ground ambulance service that's not in your insurance plan's network, for example, you could still be on the hook for a large bill.
"There will always be some surprises, because the hospital or the doctors are going to find a way to get you uncovered by the law," said Gerard Anderson, director of the Center for Hospital Finance and Management at Johns Hopkins University Bloomberg School of Public Health. "It's always a game of whack-a-mole."
Stephanie O'Neill contributed the audio profile with this report.
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!
Upon first inspection, the mutations in the highly contagious delta covid variant don’t look that worrisome.
For starters, delta has fewer genetic changes than earlier versions of the coronavirus.
“When people saw that the epidemic in India was driven by delta, they did not suspect it would be so bad or overtake other variants,” said Trevor Bedford, an evolutionary biologist at the Fred Hutchinson Cancer Research Center.
But those expectations were wrong.
Delta has kept some of the most successful mutations found in earlier variants, but also contains new genetic changes that enable it to spread twice as fast.
Delta is more dangerous in many ways. It has an incubation period of four days, rather than six, making people contagious sooner. When the pandemic began, people spread the original coronavirus to an average of two or three people. Today, people infected with delta infect six people, on average.
As of this week, the delta variant had caused at least 92% of the new infections in the United States, according to covariants.org, a research firm in Bern, Switzerland.
Although delta isn’t necessarily any more lethal than other variants, it can kill huge numbers of people simply because it infects so many more, said Dr. Eric Topol, founder and director of the Scripps Research Translational Institute.
Scientists have sequenced delta’s mutations but are still trying to understand their significance, said Angela Rasmussen, a virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization. “When we see the same mutations appearing repeatedly and independently, that suggests they’re important,” Rasmussen said.
Scientists have the best understanding of mutations on the so-called spike protein — which sticks out from the surface of the virus like a club — and which have been studied the most intensely because of its serious ramifications, Rasmussen said. The coronavirus uses the spike protein to enter human cells, and changes in the spike can help the virus evade antibodies.
Scientists believe one of the most important areas of the spike is the receptor-binding domain, the specific part of the protein that allows the virus to latch onto a receptor on the surface of our cells, said Vaughn Cooper, a professor of microbiology and molecular genetics at the University of Pittsburgh. Receptors are like sockets or docking stations that allow proteins to interact with the cell. Once the virus gains entry to the cell, it can cause havoc, hijacking the cell’s genetic machinery and turning it into a virus-making factory.
Delta’s Worrisome Mix
Delta’s rapid spread is particularly surprising given it lacks two mutations that made earlier variants so scary.
Delta doesn’t have the N501Y spike mutation found in the alpha, beta and gamma variants, which enabled them to invade cells more successfully than the original virus. That mutation changed one amino acid — a building block of proteins — in the receptor-binding domain.
Delta also lacks the E484K mutation, which has made the gamma variant so worrisome. This genetic change, sometimes called “Eek,” allows the virus to spread even among vaccinated people.
(Scientists use the Greek alphabet to name variants of concern.)
Vaccines protect people from covid by providing them with antibodies that attach themselves to the spike protein, preventing the virus from entering cells. By dramatically reducing the number of viruses that enter cells, vaccines can prevent people from developing severe disease and make them less infectious to others.
Delta does share mutations with other successful variants. Like all the identified variants in circulation, delta contains a spike mutation called D614G, sometimes known as “Doug,” which became ubiquitous last year.
Delta also has a spike mutation called P681R, which closely resembles a mutation in the alpha variant that appears to produce higher viral loads in patients, Cooper said. People infected with delta have 1,000 times more virus in their respiratory tract, making them more likely to spread the virus when they sneeze, cough or talk.
The P681R mutation, also found in the kappa variant, is located at the beginning of a part of the genome called the furin cleavage site, Cooper said.
Furin is a naturally occurring human enzyme that gets hijacked by the coronavirus, which uses it to slice the spike protein into the optimal shape for entering the cell, Rasmussen said. The new mutation makes that sculpting more efficient, Rasmussen said.
Another delta mutation — also found in kappa and epsilon — is called L452R. Experiments suggest this mutation, which also affects the receptor-binding domain, acts to prevent antibodies from neutralizing the virus, Cooper said.
These mutations appear to be more formidable as a team than alone.
The genetic changes “are certainly doing something, but why that combination makes the delta variant more fit is not entirely obvious,” Bedford said. “Putting them together seems to matter.”
Delta also has developed genetic changes not seen in other variants.
One such spike mutation is called D950N. “This might be unique,” Cooper said. “We don’t see that anywhere else.”
The D950N mutation is different than other mutations because it’s located outside the receptor-binding domain in an area of the coronavirus genome that helps the virus fuse with human cells, Cooper said. Fusing with human cells allows the coronavirus to dump its genetic material into those cells.
This mutation could affect which types of cells the virus infects, potentially allowing it to harm different organs and tissues. Mutations in this region are also associated with higher viral loads, Cooper said.
Delta also contains mutations in a part of the spike protein called the N-terminal domain, which provides a “supersite” for antibodies to latch onto the virus and prevent it from entering cells, said Dr. Hana Akselrod, an infectious diseases specialist at the George Washington University School of Medicine & Health Sciences.
Mutations in this region make monoclonal antibodies less effective in treating covid and increases the delta variant’s ability to escape vaccine-generated antibodies, Akselrod said. That may explain why vaccinated people are slightly more likely to become infected with delta, causing mostly mild illness but allowing them to transmit the virus.
Delta’s Future Course
Scientists say it’s impossible to predict exactly how delta will behave in the future, although Topol said, “It’s going to get worse.”
Topol noted that delta outbreaks tend to last 10 to 12 weeks, as the virus “burns through” susceptible populations.
If the United States continues to follow a pattern seen in the United Kingdom and the Netherlands, infections could rise from the current seven-day moving average of 42,000 cases to 250,000 a day. Yet Topol said the United States is unlikely to suffer the high death rates seen in India, Tunisia and Indonesia because nearly half the population here is fully vaccinated.
While some studies have concluded that the Johnson & Johnson vaccine stimulates strong and persistent antibodies against delta, a new report found that antibodies elicited by one shot may not be enough to neutralize delta. Authors of that study, from the New York University Grossman School of Medicine, suggested a second dose may be needed.
Two doses of the Pfizer-BioNTech vaccine protect 94% of people from any symptomatic infection by the alpha variant, compared with 88% against the delta variant, according to a new study in the New England Journal of Medicine. Two doses of the AstraZeneca vaccine protect 75% of people from alpha and 67% from delta.
Cooper said covid vaccines offer remarkably good protection. “I will always celebrate these vaccines as the scientific achievements of my lifetime,” he said.
The best way to slow down the evolution of variants is to share vaccines with the world, vaccinating as many people as possible, Bedford said. Because viruses undergo genetic changes only when they spread from one host to another, stopping transmission denies them a chance to mutate.
Whether the coronavirus evolves more deadly variants “is totally in our hands,” Cooper said. “If the number of infections remains high, it’s going to continue to evolve.”
By failing to contain the virus through vaccination, wearing masks and avoiding crowds, people are allowing the coronavirus to morph into increasingly dangerous forms, said Dr. William Haseltine, a former Harvard Medical School professor who helped design treatments for HIV/AIDS.
“It’s getting better, and we’re making it better,” he said. “Having half the population vaccinated and half unvaccinated and unprotected — that is the exact experiment I would design if I were a devil and trying to design a vaccine-busting virus.”
After being laid off from her job as a systems analyst for a specialty chemicals company in December, Gabriela de Pompignan opted to hang on to her former employer's insurance coverage under the federal law known as COBRA. Typically, laid-off workers pick up the total cost of premiums under COBRA, but her company paid roughly 75% of the expense for the first six months, leaving de Pompignan with a $659 monthly bill for the family plan covering her, her husband and their 9-year-old son.
Since both de Pompignan and her husband, a lawyer, were unemployed, her company's temporary financial support was crucial to making their premiums affordable. What de Pompignan didn't realize, however, was that she was eligible for an even better deal. Under the American Rescue Plan Act that President Joe Biden signed in March, COBRA premiums for laid-off workers are covered in full by federal funding for six months from April through September.
Neither her former employer nor the company administering COBRA benefits for her workplace told her about that option.
Under federal rules, she should have been sent a notice by May 31 informing her about the subsidy, which is generally available to people who were involuntarily laid off or whose hours were reduced and who are eligible for continued employer coverage under COBRA.
For people like de Pompignan who lost their jobs before April 1, the window to take advantage of the subsidized coverage is closing. They have 60 days from the date their employer notified them of the COBRA subsidy to sign up for it — that's July 31 if their employer notified them at the end of May. People notified earlier may have already missed their opportunity.
People can sign up for the subsidy even if they didn't elect COBRA coverage earlier, or if they had COBRA earlier and dropped it because it was too expensive or for another reason.
Those laid off or furloughed after April 1 have 60 days to sign up for regular COBRA coverage and the temporary financial assistance.
De Pompignan learned about the subsidy only because she happened upon a news story that described it.
"I don't know their reasons for not communicating this option to us," said de Pompignan, 45, who lives with her family in Mendham, New Jersey. "But I did feel frustrated." She added that many workers who have been laid off "could be struggling to get their health insurance paid for during such difficult times."
In a statement to KHN, Trion Group, the company that administers her former employer's COBRA coverage, said, "As a COBRA administrator, we rely on our clients to provide us information on which of their former employees are eligible for the ARPA subsidy. Once we were notified of the error in Ms. de Pompignan's initial status, we immediately made the change in our system and sent her eligibility notification."
Consumer advocates say they're worried many more people may have been left in the dark about the subsidy since notices weren't required to be sent to former workers until the end of May, two months after the benefit started.
"Even if everybody got the notices out on time, are folks reading them and understanding what they're eligible for and what their options are?" said Katie Keith, an associate research professor at Georgetown University's Center on Health Insurance Reforms.
Karen Pollitz, a senior fellow at KFF, said she talked with some people who were notified promptly, while others weren't informed about the subsidy until the very end of May and had to get reimbursed for the first two months of the subsidized premiums. (KHN is an editorially independent program of KFF.)
The Department of Labor said it has "conducted extensive outreach and education to promote awareness of the available premium assistance" to help workers and employers.
The outreach includes virtual webcasts and webinars, social media, radio and TV public service announcements, billboards and posters, according to Labor officials. They added that consumers or employers with questions can contact the department online or by phone.
Under federal COBRA law, people can generally choose to continue their employer health coverage for up to 18 months after being laid off. They usually have 60 days to decide, though that deadline has been extended while the pandemic continues. The law applies to employers with 20 or more employees.
Without the special federal subsidy, however, it's a pricey benefit: People are usually responsible for the entire premium plus a 2% administrative fee.
People who work at smaller companies — those with fewer than 20 employees — that are located in states that have so-called mini-COBRA coverage continuation laws can also take advantage of the subsidy. But there's a catch: To qualify, workers generally must already have elected COBRA continuation coverage before April 1 or become eligible after that.
Getting the word out was hampered by the program's short time frame. It was challenging for employers to figure out who was eligible for the subsidy and get notices out within such a tight timeline, experts said. The law passed in March, and guidance from the Department of Labor and the IRS about implementing the law came in April and May. Notices to workers were due May 31.
"My sense is that employers were working around the clock to make sure the notices went out," said Katy Johnson, senior counsel for health policy at the American Benefits Council, which represents large employers.
But as de Pompignan's experience illustrates, some people slipped through the cracks.
With her employer subsidy running out in June, de Pompignan called the service center at Trion Group to find out what her coverage options were. The representative who answered the phone suggested de Pompignan look into marketplace plans.
After de Pompignan saw the news story about the COBRA subsidy, she contacted her former employer to ask if she was eligible. The answer was yes, she likely was. It was only then that she received the paperwork.
De Pompignan, who paid her portion of the COBRA premium for April, May and June, said she's been assured she'll be reimbursed.
Because de Pompignan's job loss was initially incorrectly coded as "voluntary" by her employer, Infineum, "[it] caused the Trion system to exclude her from communications regarding the federal subsidy," according to Hedy DiSimoni, the human resources benefits and payroll leader at Infineum. De Pompignan will receive a refund for the first three months of premiums she paid before being notified, DiSimoni said.
Once the subsidy ends in September, de Pompignan said, she's not sure what her family will do if she and her husband are still unemployed.
They could continue their COBRA coverage, paying the full premium. They'll also have an opportunity to sign up for coverage on the state marketplace, under a special enrollment period.
For some people, marketplace coverage may be a better option.
Anyone who received unemployment insurance benefits for even one week this year can receive a silver-level plan without premiums and with cost-sharing assistance, which could dramatically reduce their out-of-pocket costs, said Sabrina Corlette, a research professor at the Georgetown University Center on Health Insurance Reforms.
"It'll probably have a lower deductible than a COBRA plan, and it doesn't turn off after September," Corlette said.
When Miriam McDonald decided she wanted to have another baby at age 44, her doctor told her she had a better chance of winning the lottery. So when she got pregnant right away, she and her husband were thrilled. But within three days of giving birth to their son, in September 2019, everything shifted.
"I was thinking, 'Oh my God, what did I do?' I just brought this baby into this world and I can barely take care of myself right now," she recalled. "I feel exhausted. I haven't slept in three days. I haven't really eaten in three days."
As the weeks went by, her depression got worse. She felt sad, but also indifferent. She didn't want to hold her baby, she didn't want to change him. She says she felt no connection with him.
This confused her — she never felt anything like this after her first two kids — and she worried her mood might hurt her son. Untreated postpartum depression can affect babies' cognitive and social development. For the mother, it can be life or death. Suicide accounts for up to 20% of maternal deaths.
"Every day, I was crying. Every day, I felt like I just wanted to die. Every day, I thought about ending my life," said McDonald, who lives in Vacaville, California, and works as an IT professional at the University of California-Davis.
She went to Kaiser Permanente, her healthcare provider, for help. (KHN is not affiliated with Kaiser Permanente.) She said doctors there put her on a merry-go-round of medication trial and error. The first drug her doctor prescribed made her anxious. Upping the dose of a second drug gave her horrific nightmares. A third drug gave her auditory and visual hallucinations that took seven weeks to go away after she stopped taking it.
Then, her psychiatrist retired. And when McDonald complained to her new psychiatrist that she was still depressed, four months after giving birth, the physician suggested more medications.
"I was desperate," McDonald said. "I was like, 'I'm trying to help myself, but things are just getting worse. So what am I left with?'"Bottom of Form
She did her own research and learned about a new treatment, brexanolone. It's the first and only drug approved by the Food and Drug Administration specifically to treat postpartum depression, which affects 1 in 8 new mothers in the United States. Instead of targeting the serotonin system in the brain, like many antidepressants, brexanolone replenishes a hormone metabolite that gets depleted after childbirth: allopregnanolone. Some doctors call allopregnanolone, which is produced by progesterone, "nature's Valium" because it helps regulate neurotransmitters that affect mood. After giving birth, natural levels of estrogen, progesterone and allopregnanolone all plummet rapidly, making some women vulnerable to postpartum depression. Brexanolone is a synthetic version of allopregnanolone, delivered through an IV infusion over the course of 60 hours. It costs $34,000 per treatment.
In clinical trials, 75% of women who got brexanolone started to feel better immediately after the three-day treatment. Half the women went into remission. In the placebo group, 56% of women responded and a quarter went into remission. In practice, doctors are seeing that the effectiveness of the drug in the field mirrors the trial results.
"People walk out of the hospital, wanting to be with their child, wanting to return home," said Dr. Riah Patterson, who has been treating women with brexanolone at the University of North Carolina-Chapel Hill since it became available in summer 2019. "There is a hopefulness, a brightness. You can really see that transformation in the hospital room over those 60 hours. It's pretty miraculous."
McDonald wanted to try it.
But when she asked her doctor for brexanolone, she was told no. In an email, the doctor wrote that the existing studies were "not very impressive." She added that McDonald did not meet Kaiser Permanente's criteria for the drug: She would first have to try — and fail to improve with — four medications and electroconvulsive therapy (ECT) before she could try brexanolone. And she had to be six months or less postpartum to try it at all. For Miriam, the clock had run out. She wondered, How could anyone qualify?
"This is crazy. By the time you even try one drug, that's like four weeks out," she said, noting that traditional antidepressants take weeks to become effective and weeks to taper off from. "There's just no way."
'Unacceptable Burden' on New Moms
Kaiser Permanente's guidance is an outlier. An analysis of guidelines from a dozen health plans revealed that three of them require women to fail treatment with at least one other medication before trying brexanolone. One plan, California's Medicaid program for low-income women, requires two fails. But KP is the only system analyzed that recommends women first fail four drugs, as well as ECT.
"That's absurd. So I'm assuming no woman will ever have the opportunity to try brexanolone?" said UNC's Patterson, one of several experts on postpartum depression who questioned KP's guidance.
"Asking someone to fail four oral antidepressants is an unacceptable burden that will undoubtedly create more harm than good," said Bethany Sasaki, who runs the Midtown Birth Center in Sacramento, California, and is licensed to administer brexanolone.
Psychiatrist Dr. Shannon Clark, who's been administering brexanolone at UC Davis Medical Center for the past two years, seeing positive results, said there are a lot of reasons new moms may not be candidates for one medication, let alone four: taking pills while breastfeeding could be too anxiety-provoking; some women may not be able to adhere to a daily pill regimen; or they may have a liver condition that contraindicates those medications. Clark called Kaiser Permanente's guidance "terrible."
It could also be illegal, according to some California lawmakers and mental health advocates. Under a California state law that took effect this January, health plans must conform to generally accepted standards of care, including scientific literature and expert consensus, when making decisions about mental health treatment.
"If Kaiser is making it effectively impossible to get a particular, important mental health treatment, that could definitely be a violation of our parity law," said state Sen. Scott Wiener (D-San Francisco), the bill's author.
KP officials responded by saying they always follow the law. They also say its integrated structure — as both the health insurer and the health provider — makes it different from traditional insurers. At KP, a patient's doctor determines whether a medication is appropriate, not the health plan, and the criteria doctors use are recommendations, not requirements or prerequisites that patients need to "exhaust," said Dr. Maria Koshy, KP's chair of psychiatry for Northern California.
"At the end of the day, this is an individual clinical decision by both the provider — the physician — and the patient," she said.
But inside KP, the workplace culture is such that doctors are expected to follow these recommendations, according to former KP clinicians who spoke on background — as well as legislative experts familiar with KP's model. They say that when KP doctors deviate from the recommendations, they can get questioned or face other consequences.
"These physicians know that if they start routinely ignoring these bad recommendations, that that could have impacts on them professionally," said Wiener, who has worked on several bills aimed at regulating KP and other insurers in California. "Whether it's couched as a recommendation or a requirement is almost irrelevant. It has the same effect."
To McDonald, her physician seemed to follow the recommended criteria as if they were requirements when she declined to prescribe brexanolone. Another patient, Yesenia Muñoz, got a similar response when she sought brexanolone treatment. KP's grievance department sent her a letter denying the request because she had not failed enough medications.
"When I talked to the caseworker at Kaiser that had denied the medication, he said that Zulresso was very expensive," said Muñoz, referring to brexanolone's brand name.
In addition to the $34,000 cost for brexanolone, the three-day hospital stay can tack on another $30,000 to a patient's bill. Another complicating factor is the FDA requirement that health centers obtain special certification to infuse brexanolone, because of the risks of excessive sedation or fainting from the drug. KP doesn't have the certifications yet to administer the treatment at its own hospitals, so it must pay outside hospitals to provide it for its patients. KP officials say they have plans to eventually open three of their own certified centers in Northern California.
Muñoz, 35, was devastated by the denial. She was overwhelmed by postpartum depression and anxiety shortly after her daughter was born in August 2020. But none of the medications or therapies KP offered her worked. Four months after giving birth, she still felt suicidal.
"I could get out the door sometimes and take the stroller and go walk, and my mind kept on saying, 'If you just step in front of the car, it's all going to go away," she remembered.
Muñoz got help from family members and co-workers to appeal KP's decision to the state, and after reviewing her medical records, regulators ordered KP to pay for the brexanolone treatment.
Muñoz received the treatment at UC Davis Medical Center, and she started feeling better within the first day.
"The nurse came in and she said something funny and I laughed," Muñoz said. "It was the first time I had laughed in so long."
She started looking through photos and videos of her daughter on her phone and she said it was like she was experiencing those moments for the first time. She started making plans for the future.
"It was like a switch flicked and it made me happy enough to want to live," she said. "It saved my life."
Sage Therapeutics, the maker of brexanolone, said KP's approach to the new drug reflects "a lack of a sense of urgency for treating mental health." Dr. Steve Kanes, Sage's chief medical officer, said the company is working on making the treatment more accessible. Its biggest challenge has been getting enough health centers certified, across a wide enough geography, to reach women who need it. The company is studying a pill form of allopregnanolone that could eliminate the need for a hospital stay, but Kanes said that is still not close to being commercially available.
Stitching Up Legal Loopholes
In 2008, Congress passed a landmark federal law aimed at correcting disparities between how insurers pay for mental health treatments compared with care for physical health. The Mental Health Parity and Addiction Equity Act was later reinforced by provisions in the Affordable Care Act in 2010. But insurers found loopholes, creating overly restrictive or self-serving criteria that made it easy to deny services for mental healthcare and, as a result, save money.
California's new law, SB 855, aimed to tighten those loopholes and has been hailed by advocates as a national model for mental health reform. It requires health plans to use clinically based, expert-recognized criteria and guidelines in making medical decisions, with the goal of limiting arbitrary or cost-driven denials for treatments of mental health or substance use disorders.
KP operates in eight states and Washington, D.C. In California, it is the largest insurer, and in 2011 held a 40% share of the market, covering 9.2 million patients. KP officials have questioned how the new state law applies to the Kaiser system, given its unique integrated structure as both health insurer and medical provider. For example, Koshy, the KP psychiatrist, said that SB 855's requirement to comply with generally accepted standards of care "does not apply" to its brexanolone recommendations because they were developed and are used by the doctors, not the health plan administrators. When a reporter asked KP to provide the brexanolone policy its health plan uses for grievances or appeals, it said it didn't have one.
"We 100% intended this law to apply to the care people get at Kaiser," said Julie Snyder, government affairs director at the Steinberg Institute, which co-sponsored the law. "There is no place where we say Kaiser is exempt" because of its integrated structure.
Doctors at Kaiser have historically been "gatekeepers" for services in the system, more so than doctors who work with traditional insurers, said Meiram Bendat, an attorney and licensed psychotherapist who also advised legislators as the law was being drafted. It doesn't matter if practice recommendations for brexanolone were written by doctors or administrators, or whether the recommendations are mandatory or optional, Bendat said, they must be in compliance with the law.
"If it's inconsistent with generally accepted standards of care, then it has no place in California," he said.
Some of KP's recommended criteria for brexanolone are aligned with generally accepted standards of care; for example, reserving the drug for women who are six months or less postpartum, which was a criterion used in the clinical trials the FDA relied on when approving the drug.
But the recommendation that patients first try four or five alternative depression treatments before considering brexanolone conflicts with the judgment of half a dozen women's health experts interviewed for this story. They say there just isn't enough time to do that in the postpartum period — and too much is at stake.
Not only are babies at risk of developmental and emotional problems if their mother is depressed, husbands and partners are also at higher risk for depression and anxiety. And because new moms are learning to breastfeed, and figuring out what's part of the new normal and what's not, it can take months just to realize there's a problem, said UNC's Patterson.
"It takes so long for this illness to come to recognition and for someone to actually get into an appointment and actually be seen by a provider," she said.
Despite Run-Around, a Quick Turnaround
Indeed, the FDA fast-tracked the approval of brexanolone, in part, because of how well and how quickly it worked, allowing women to feel better and get back to their families in three days.
"It's new, it's promising," said KP's Koshy, adding that "it's not a benign medication." Six women in the clinical trials felt faint or fainted, which is why the FDA requires women to be continuously monitored in certified health centers when getting the medication.
Also, the safety and efficacy data is limited, Koshy said. The clinical trials compared brexanolone only to placebo, not to alternative treatments. So while the data shows brexanolone works better than nothing, there's no data on whether it works better than drugs like Zoloft, or better than electroconvulsive therapy.
Women who received the placebo in the trials also showed improvement in depressive symptoms — which is common in studies of depression treatments — but more women who received brexanolone showed improvement, and their improvement was more substantial and lasted longer, especially if their depression was more severe before treatment. Women with moderate depression who received the placebo did just as well, 30 days after treatment, as those who received brexanolone, which could be because they felt better on their own, or because other antidepressants they were allowed to take during the trial finally kicked in.
Koshy said KP is always reviewing practice recommendations as new evidence becomes available, but also acknowledged that KP's recommendations for brexanolone have not been updated since they were developed two years ago, in July 2019.
Two weeks after this story first aired in Northern California, Koshy said KP is now reviewing the recommendations.
It is unclear what role California's Department of Managed Healthcare, the state agency that regulates KP, might play in resolving issues of access to the infusion. In a statement, department officials said they will review any criteria or guidelines the KP health plan uses for brexanolone, but the department does not have jurisdiction over physician decisions.
The department also monitors patient complaints when new medications or treatments begin to be used, in order to identify problems with access to care. So far, the department has received two complaints about brexanolone — both filed by KP patients.
One was Yesenia Muñoz. The other was Miriam McDonald.
Before going to the state, McDonald called KP's grievance department to complain about her treatment and the denial of brexanolone. KP responded by sending the cops to her house for a welfare check.
The officers were calm and nice, McDonald said, but when she closed the door, she cried her eyes out.
"It just brought me to a whole new low," she said. "Why didn't my doctor call me and talk to me first? I mean, this is how you treat postpartum mental health? How dare you!"
KP declined to comment on any individual cases, but said that, generally, "we feel deep compassion for any patient experiencing the difficult and serious effects of postpartum depression, and our goal is always to support every patient's safe return to a healthy mental state."
McDonald never got brexanolone; by the time her appeals were heard, she was past the six-month postpartum window.
Still, she continued to fight for relief and eventually got KP to cover a different treatment for severe depression, transcranial magnetic stimulation, which uses an electromagnetic coil to stimulate nerve cells in the brain that control mood. That typically costs about $300 per session, and McDonald went in for the treatment five days a week, for three months. Now she is finally feeling like herself again.
"I can remember I woke up one day and I was excited. I had actual joy," she said. "I got up and I walked into his room and I was like, 'Hey, Nico! Hi! Hey, baby!' And he jumped up from his crib and giggled and put his arms out. And I just swooped him up in my arms and cried. Because I was like, 'I am so proud to be your mom.'"
Now when her son smiles at her, she genuinely smiles back. But it took more than 18 months to feel better. She can't help but grieve all the smiles she didn't return in that time, and how she felt like she was barely present at crucial times, like when her son took his first steps.
"I felt like I've been robbed of all those moments," she said, "of those little milestones, that I'm never going to get back."
This story comes from NPR's health reporting partnership with KQED and Kaiser Health News (KHN).
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.
AURORA, Colo. — Fatumo Osman, a 65-year-old Somali refugee who speaks limited English, was in a bind. She made too much money at a meal prep service job so she no longer qualified for Medicaid. But knee pain kept her from working, so her income had dropped. She could reapply for Medicaid, get her knee fixed and return to work, at which point she'd lose that safety-net health coverage. Her first step was getting a note from a doctor so she wouldn't lose her job.
So, Osman came to Mango House, a clinic in this eastern suburb of Denver that caters primarily to refugees and turns no one away, regardless of their ability to pay. Dr. P.J. Parmar designed the clinic to survive on the Medicaid payments that many doctors across the U.S. reject as too low.
The clinic is just one part of a broader refugee ecosystem that Parmar has built. Mango House provides food and clothing assistance, after-school programs, English classes, legal help — and Parmar even leads a Boy Scout troop there. He leases space to nine stores and six restaurants, all owned and run by refugees. Mango House hosts a dozen religious groups, plus community meetings, weddings and other celebrations. When Parmar needs an interpreter for a patient from any of a dozen languages spoken in the building, he can easily grab one of his tenants.
"This is what I call a medical home," Parmar said.
Although it's not part of the formal U.S. refugee resettlement program, Mango House is in many ways emblematic of refugee healthcare in the U.S. It's a less-than-lucrative field of medicine that often relies on individual physicians willing to eke out a living caring for an underserved and under-resourced population.
Parmar finds creative ways, often flouting norms or skirting rules, to fit his patients' needs. As a result, Mango House looks nothing like the rest of the U.S. healthcare system and, at times, draws the ire of the medical establishment.
"How do you deliver the quality of care necessary, and that they deserve, while still keeping the lights on? It's a struggle for sure," said Jim Sutton, executive director of the Society of Refugee Healthcare Providers. "It's these heroes, these champions out there, these cowboys that are taking this on."
Osman brought her son, Jabarti Yussef, 33, to interpret for her. They have been coming to Mango House for 10 years and said that Parmar opens doors for them when they have trouble accessing care.
"If we ask for an appointment to get Medicaid, P.J. makes the call," Yussef said. "If we call, we're on hold for an hour, and then it hangs up. If we go to the ER, it's a three-hour wait. Here, the majority of people walk in and sit for 30 minutes. It's good for the community."
As for Osman's knee pain, Yussef asked Parmar, could they pay cash to get an MRI at the hospital?
"I can almost guarantee it's arthritis," Parmar replied. "You could do an X-ray. That will cost $100. An MRI will cost $500. And if it shows a bigger problem, what are you going to do? It will cost you $100,000."
Parmar said he would connect them with someone who could help Osman enroll in Medicaid but that it's an imperfect solution. "Most orthopedists don't take Medicaid," Parmar said. Older immigrants need to have worked the equivalent of 10 years in the U.S. to qualify for Medicare.
Medicaid, which covers low-income people, generally pays primary healthcare providers a third less than Medicare, which covers seniors and the disabled. And both pay even less than commercial insurance plans. Some doctors paint Medicaid patients as more difficult and less likely to follow instructions, show up on time or speak English.
Parmar said he realized back in medical school that few doctors were motivated to treat Medicaid patients. If he limited his practice to just Medicaid, he said dryly, he'd have guaranteed customers and no competition.
So how does he survive on Medicaid rates? By keeping his overhead low. There are no appointments, so no costs for a receptionist or scheduling software.
He said his patients often like that they can drop in anytime and be seen on a first-come, first-served basis, much like an urgent care clinic, and similar to the way things worked in their native countries.
Because he takes only Medicaid, he knows how to bill the program and doesn't have to hire billing specialists to deal with 10 insurance companies.
It's also more cost-efficient for the health system. Many of his patients would otherwise go to the emergency room, sometimes avoiding care altogether until their problems get much worse and more expensive to fix.
"Really none of our innovations are new or unique; we just put them together in a unique way to help low-income folks, while making money," Parmar said. "And then, instead of taking that money home, I put it back into the refugee community."
The son of Indian immigrants, Parmar, 46, was born in Canada but grew up in Chicago and moved to Colorado after college in 1999, where he did his medical training at the University of Colorado School of Medicine. He opened Mango House 10 years ago, buying a building and renting out space to refugees to cover the cost. Two years ago, he expanded into a vacant J.C. Penney building across the street.
"There's a good three-, four-year dip in the red here, intentionally, as we move from there to here," Parmar said. "But that red is going to go away soon."
The COVID pandemic has helped shore up his finances, as federal incentives and payment increases boosted revenue and allowed him to pay down his debt faster.
Parmar must navigate a host of obstacles while working to overcome financial and language barriers. A Muslim Somali woman needs dental care but is uncomfortable seeing a male dentist. A Nepalese woman needs a prescription refill, but she lives in Denver and so has been assigned by Medicaid to the safety-net hospital, Denver Health. Parmar won't get paid but sees her anyway. Another patient brings paperwork showing he's being sued by a local health system for a year-old emergency room bill he has no way to pay. A Nepalese man with psoriasis doesn't want creams or ointments; good medicine, he believes, comes through a needle.
"A lot of this is, basically, geriatrics," Parmar said. "You have to add 20 years to get their age in refugee years."
When one patient turns away momentarily, Parmar discreetly throws away her bottle of meloxicam, a strong anti-inflammatory he said she shouldn't be taking because of her kidney problems. He began stocking over-the-counter medications after realizing his patients got overwhelmed amid 200 varieties of cough and cold medicines at the drugstore. Some couldn't find what he told them to get, even after he printed flyers showing pictures of the products.
Parmar's creative solutions, however, often rub many in healthcare the wrong way. Some balk at his use of family members or others as informal interpreters. Best practices call for the use of trained interpreters who understand medicine and patient privacy rules. But billing for interpretation isn't possible, so hospitals and clinics must pay interpreters themselves. And that's beyond the capabilities of most refugee clinics, unless they're affiliated with a larger health system that can absorb those costs.
"It's a good thing to have the standards, but it's another thing altogether to implement them," said Dr. Pat Walker, an expert on refugee health at the University of Minnesota.
When Mango House began providing COVID vaccines, residents of more affluent areas of town started showing up. Parmar tried to limit vaccinations only to those patients living in the immediate area, checking ZIP codes on their IDs. The state stepped in to say he could neither require IDs nor turn away any patients, regardless of his refugee-focused mission.
During a recent lull at the clinic, Parmar took stock of that day's inventory of patients. Six were assigned to Denver Health, one patient's Medicaid coverage had expired, and two had high-deductible commercial plans. Chances are he wouldn't get paid for seeing any of them. Of the 25 patients he had seen that day, 14 had Medicaid coverage that Parmar could bill.
SAN BERNARDINO, Calif. — A few months ago, the boxy, teal truck parked outside a McDonald's in this Inland Empire city might have drawn hundreds of people willing to stand in line for hours under the scorching sun.
The truck is San Bernardino County's mobile vaccine unit, which brings COVID-19 vaccines directly to people. But on July 15, only 22 people got a COVID shot during the four hours it sat there.
Roughly 12 feet away, more people were often seen waiting by a red canopy for free, government-subsidized smartphones, intended for low-income people, than were stepping up for the potentially lifesaving shots.
Barry Luque, a 37-year-old car wash worker who visited the red canopy that day for a free phone, was lured by the truck. He had been eligible for a COVID vaccine since April but never got around to making an appointment. Had he not seen the truck in the parking lot on his day off, "this wouldn't have gotten done," he said.
It's Luque's job to guide drivers into the car wash, but his boss won't let him take his mask off unless he can show proof he's vaccinated.
"People come in from different lives, different styles, different moods at different times," he said after getting his first dose of the Pfizer-BioNTech vaccine. "I've got to guide them carefully and gently, and it's kinda hard for them to see the smile on my face."
Luque and the other 21 people who got vaccinated that day — in addition to the scores of others who drove by or waited in the McDonald's drive-thru line without seeking a shot — offer a snapshot of California's stalling vaccination effort.
Some who finally got the shot, like Luque, were motivated by mandates from employers or are tired of wearing masks. Others want to visit other countries, and vaccinations may help ease travel or quarantine requirements. Some were persuaded, at long last, by family and friends.
Those who continued to hold out primarily cited potential side effects and distrust of the medical system.
Recent polling shows that no matter which tactics are used, a strong majority of unvaccinated people are unlikely to budge on getting a shot, creating an increasingly dangerous scenario as the highly contagious delta variant burns through the country. In California, about 2,800 people were hospitalized for COVID or suspected COVID — more than twice the number six weeks earlier — as of Wednesday.
About 61% of Californians age 12 and up were fully vaccinated by then, according to the U.S. Centers for Disease Control and Prevention, ranking the state 18th among other states and the District of Columbia.
But the overall rate masks deep disparities among, and even within, regions. In geographically and ethnically diverse San Bernardino County, about 47% of eligible residents were fully vaccinated as of Wednesday, with the lowest rates among young people, men, Latinos, Blacks and those who live in the poorest and unhealthiest communities. Statewide, the profile of unvaccinated people is largely the same.
One way local and state leaders are trying to get shots into residents' arms is by hosting pop-up clinics that make COVID vaccines more convenient and accessible for those who can't or won't sign up for an appointment.
San Bernardino County is organizing pop-up events at supermarkets, schools, churches and community centers. The state is also funding vaccine clinics, including 155 events at more than 80 McDonald's restaurants in 11 counties as of Wednesday.
The pop-ups require significant resources and are showing diminishing returns. About 2,500 doses have been administered at the McDonald's clinics so far — an average of 16 shots per event. The California Department of Public Health declined to say how much these events cost, saying it varies.
At the McDonald's in San Bernardino, a city of more than 200,000 that serves as the county seat, eight staffers were on hand to check people in, administer shots and watch for side effects from 9 a.m. to 1 p.m. They also scheduled the necessary second dose for another local pop-up event.
Jeisel Estabillo, 36, hadn't been vaccinated, even though she is a registered nurse who sometimes cares for COVID patients at a hospital. She was one of the first people in the county to become eligible for vaccines, in December, but avoided getting a shot because she wanted to wait and see how it would affect others. She also tested positive for COVID during the winter surge.
But Estabillo changed her mind and visited the vaccine clinic with her father and teenage son because they plan to vacation in the Philippines next year and hope vaccination will reduce travel restrictions or quarantines.
Estabillo also likes that vaccinated people can forgo masks in most public places, although that perk may slip away as more California counties respond to the delta surge by calling on residents to mask up again indoors.
But Jasmine Woodson continued to hold out against the vaccine even though she was hired to provide security and direct traffic for the clinic. Woodson, 24, is studying to become a pharmacy technician and has been tracking vaccine news. She said she was alarmed by the brief pause in the administration of the one-shot Johnson & Johnson vaccine over concern about blood clots, and reports of rare heart inflammation linked to the Moderna and Pfizer vaccines. She also knows that no COVID vaccine has been fully approved by the Food and Drug Administration, which puts her on high alert.
Woodson, who is Black, is also wary because these mobile vaccine events seem to take place only in low-income Black and Latino neighborhoods — a tactic public health officials say is meant to increase uptake in these communities.
"Every day there's always something new. You're not meant to live that long, so if you get it, you get it, and if you don't, you don't," Woodson said of COVID.
Maxine Luna, 69, who came to the nearby red canopy to get a phone, also was not swayed. A longtime smoker whose doctor has been pleading with her to get a COVID shot, she fears side effects, mentioning a friend who battled two weeks of headaches, diarrhea and vomiting after getting vaccinated.
To mitigate her risk, Luna sticks close to her home, which she shares with her brother, who is vaccinated, and her sister and brother-in-law, who are not.
"We're not out and about, we don't go to shows, and we don't go to crowded places," she said.
Concern about side effects is the most common reason holdouts cite for not getting a COVID vaccine, said Ashley Kirzinger, associate director of public opinion and survey research for KFF. (The KHN newsroom is an editorially independent program of KFF.) This is followed by fear that the vaccine is too new or hasn't been tested enough.
Kirzinger said it's important to acknowledge that some people simply can't be persuaded.
"They don't see themselves at risk for COVID, they think that the vaccine is a greater risk to their health than the virus itself, and there's really no incentive, no stick, no message, no messenger that's going to convince these populations," she said. "It's going to be really hard to reach the goals set by public health officials, with the decreasing enthusiasm around the vaccine that we have seen in the past several weeks."
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.
The vast majority of the pandemic's 4.1 million COVID infections in children have been mild. However, doctors are concerned about a growing number of long-haul COVID cases and a rare but dangerous inflammatory disease, particularly among Black and Latino children. KHN correspondent Sarah Varney, in collaboration with PBS NewsHour, reports on the phenomena.
The hairstylist turned activist estimated she made 75 two-hour trips in the past decade from her home in Fenton, a St. Louis suburb, to the state capital, Jefferson City, to convince Republican lawmakers that monitoring how doctors and pharmacists prescribe and dispense controlled substances could help save people like her son, Kevin Mullane.
He was a poet and skateboarder who she said turned to drugs after she and his dad divorced. He started "doctor-shopping" at about age 17 and was able to obtain multiple prescriptions for the pain medication OxyContin. He died in 2009 at 21 from a heroin overdose.
If the state had had a monitoring program, doctors might have detected Mullane's addiction and, Arbini thinks, her son might still be alive. She said it's been embarrassing that it's taken Missouri so long to agree to add one.
"As a parent, you would stand in front of a train; you would protect your child forever — and if this helps, it helps," said Arbini, 61. "It can't kill more people, I don't think."
But even though Missouri was the lone outlier, it had not been among the states with the highest opioid overdose death rates. Missouri had an average annual rank of 16th among states from 2010 through 2019, as the country descended into an opioid epidemic, according to a KHN analysis of Centers for Disease Control and Prevention data compiled by KFF.
Some in public health now argue that when providers use such monitoring programs to cut off prescription opiate misuse, people who have an addiction instead turn to heroin and fentanyl. That means Missouri's new toll could cause more people to overdose and leave the state with buyer's remorse.
"If we can take any benefit from being last in the country to do this, my hope would be that we have had ample opportunity to learn from others' mistakes and not repeat them," said Rachel Winograd, a psychologist who leads NoMODeaths, a state program aimed at reducing harm from opioid misuse.
Before Missouri's monitoring program was approved, lawmakers and health and law enforcement officials warned that the absence made it easier for Missouri patients to doctor-shop to obtain a particular drug, or for providers to overprescribe opiates in what are known as pill mills.
State Sen. Holly Rehder, a Republican with family members who have struggled with opioid addiction, spent almost a decade pushing legislation to establish a monitoring program but ran into opposition from state Sen. Rob Schaaf, a family physician and fellow Republican who expressed concerns about patient privacy and fears about hacking.
In 2017, Schaaf agreed to stop filibustering the legislation and support it if it required that doctors check the database for other prescriptions before writing new ones for a patient. That, though, sparked fresh opposition from the Missouri State Medical Association, concerned the requirement could expose physicians to malpractice lawsuits if patients overdosed.
The new law does not include such a requirement for prescribers. Pharmacists who dispense controlled substances will be required to enter prescriptions into the database.
Dr. Silvia Martins, an epidemiologist at Columbia University who has studied monitoring programs, said it's important to mandate that prescribers review a patient's information in the database. "We know that the ones that are most effective are the ones where they check it regularly, on a weekly basis, not just on a monthly basis," she said.
But Stephen Wood, a nurse practitioner and visiting substance abuse bioethics researcher at Harvard Law School, said the tool is often punitive because it cuts off access to opioids without offering viable treatment options.
He and his colleagues in the intensive care unit at Carney Hospital in Boston don't use the Massachusetts monitoring program nearly as often as they once did. Instead, he said, they rely on toxicology screens, signs such as injection marks or the patients themselves, who often admit they are addicted.
"Rather than pulling out a piece of paper and being accusatory, I find it's much better to present myself as a caring provider and sit down and have an honest discussion," Wood said.
When Kentucky in 2012 became the first state to require prescribers and dispensers to use the system, the number of opioid prescriptions and overdoses from prescription opioids initially decreased slightly, according to a state study.
But the number of opioid overdose deaths — with the exception of a slight dip in 2018 and 2019 — has since consistently ticked upward, according to a KFF analysis of CDC data. In 2020, Kentucky was estimated to have had the nation's second-largest increase in drug overdose deaths.
When efforts to establish Missouri's statewide monitoring program stalled, St. Louis County established one in 2017 that 75 local jurisdictions agreed to participate in, covering 85% of the state, according to the county health department. The county now plans to move its program into the state one, which is scheduled to launch in 2023.
Dr. Faisal Khan, director of the county department, said he has no doubt that the St. Louis program has "saved lives across the state." Opioid prescriptions decreased dramatically once the county established the monitoring program. In 2016, Missouri averaged 80.4 opioid prescriptions per 100 people; in 2019, it was down to 58.3 prescriptions, according to the CDC.
The overall drug overdose death rate in Missouri has steadily increased since 2016, though, with the CDC reporting an initial count of 1,921 people dying from overdoses of all kinds of drugs in 2020.
Khan acknowledged that a monitoring program can lead to an increase in overdose deaths in the years immediately following its establishment because people addicted to prescription opioids suddenly can't obtain them and instead buy street drugs that are more potent and contain impurities.
But he said a monitoring program can also help a physician intervene before someone becomes addicted. Doctors who flag a patient using the monitoring program must then also be able to easily refer them to treatment, Khan and others said.
"We absolutely are not prepared for that in Missouri," said Winograd, of NoMODeaths. "Substance use treatment providers will frequently tell you that they are at max capacity."
Uninsured people in rural areas may have to wait five weeks for inpatient or outpatient treatment at state-funded centers, according to PreventEd, a St. Louis-based nonprofit that aims to reduce harm from alcohol and drug use.
For example, the waiting list for residential treatment at the Preferred Family Healthcare clinic in Trenton is typically two weeks during the summer and one month in winter, according to Melanie Tipton, who directs clinical services at the center, which mostly serves uninsured clients in rural northern Missouri.
Tipton, who has worked at the clinic for 17 years, said that before the COVID-19 pandemic, people struggling with opioid addiction mainly used prescription pills; now it's mostly heroin and fentanyl, because they are cheaper. Fentanyl is a synthetic opioid that is 50 to 100 times more potent than morphine, according to the National Institute on Drug Abuse.
Still, Tipton said her clients continue to find providers who overprescribe opiates, so she thinks a statewide monitoring program could help.
Inez Davis, diversion program manager for the Drug Enforcement Administration's St. Louis division, also said in an email that the program will benefit Missouri and neighboring states because "doctor shoppers and those who commit prescription fraud now have one less avenue."
Winograd said it's possible that if the state had more opioid prescription pill mills, it would have a lower overdose death rate. "I don't think that's the answer," she said. "We need to move in the direction of decriminalization and a regulated drug supply." Specifically, she'd rather Missouri decriminalize possession of small amounts of hard drugs, even heroin, and institute regulations to ensure the drugs are safe.
State Rep. Justin Hill, a Republican from St. Charles and former narcotics detective, opposed the monitoring program legislation because of his concerns over patient privacy and evidence that the lack of a program has not made Missouri's opioid problem any worse than many other states'. He also worries the monitoring program will lead to an increase in overdose deaths.
"I would love the people that passed this bill to stand by the numbers," Hill said. "And if we see more deaths from overdose, scrap the monitoring program and go back to the drawing board."