Unraveling the Mysterious Mutations That Make Delta the Most Transmissible Covid Virus Yet

KFF Health News, July 28, 2021

 

Delta is more dangerous in many ways. It has an incubation period of four days, rather than six, making people contagious sooner.

This article was posted on Wednesday, July 28, 2021 in Kaiser Health News.

By Liz Szabo

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.)

“The ‘D’ in delta stands for ‘different’ and a ‘detour’ to a different genomic mutation path,” Topol said. “But it doesn’t mean ‘doom,’” he said, noting that existing covid vaccines remain mostly effective against the delta variant.

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.

Scientists think Doug increases the density of spike protein on the surface of viral particles and makes it easier for the virus to enter cells.

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.”

Sign-Up Window for Free COBRA Coverage for Many Laid-Off Workers Closes This Week

KFF Health News, July 28, 2021

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.

This article was published on Wednesday, July 28, 2021 in Kaiser Health News.

By Michelle Andrews

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.

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

Women Say California Insurer Makes It Too Hard to Get Drug for Postpartum Depression

KFF Health News, July 28, 2021

However, California's new law has been hailed by advocates as a national model for mental health reform.

This article was posted on Wednesday, July 28, 2021 in Kaiser Health News.

By April Dembosky, KQED

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.

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

April Dembosky, KQED: @adembosky

How a Doctor Breaks Norms to Treat Refugees and Recent Immigrants

KFF Health News, July 27, 2021

Mango House provides food and clothing assistance, after-school programs, English classes, legal help — and even a Boy Scout troop.

This article was published on Tuesday, July 27, 2021 in Kaiser Health News.

By Markian Hawryluk

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.

"We see the rest of them anyway," he said.

Markian Hawryluk: MarkianH@kff.org, @MarkianHawryluk

Want Fries With That Vaccine? Even at a Fast-Food Restaurant, Pop-Up Clinics See Slow Traffic

KFF Health News, July 27, 2021

Recent polling shows that no matter which tactics are used, a strong majority of unvaccinated people are unlikely to budge on getting a shot.

This article was published on Tuesday, July 27, 2021 in Kaiser Health News.

By Anna Almendrala

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.

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

Anna Almendrala: aalmendrala@kff.org, @annaalmendrala

Watch: More Long-COVID Cases Seen in Kids

KFF Health News, July 26, 2021

Children are increasingly among the COVID "long haulers" and physician concern is growing.

This video was posted on Monday, July 26, 2021 in Kaiser Health News.

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.  

As Holdout Missouri Joins Nation in Monitoring Opioid Prescriptions, Experts Worry

KFF Health News, July 26, 2021

Some in public health now argue that monitoring programs to cut off prescription opiate misuse, will push addicts to use heroin and fentanyl.

This article was published on Monday, July 26, 2021 in Kaiser Health News.

By Eric Berger

Kathi Arbini said she felt elated when Missouri finally caught up to the other 49 states and approved a statewide prescription drug monitoring program this June in an attempt to curb opioid addiction.

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."

The Pandemic Made Telemedicine an Instant Hit. Patients and Providers Feel the Growing Pains.

KFF Health News, July 26, 2021

Video services were not equally prepared for the titanic influx in users.

This article was posted on Monday, July 26, 2021 in Kaiser Health News.

By Hannah Norman

Crystal Joseph pays for two telemedicine video services to ensure that her small therapy practice in Silver Spring, Maryland, can always connect with its clients.

She's been burned before. During one hours-long service outage of SimplePractice in late May, PsycYourMind, which offers mental health counseling and group sessions for Black patients, lost about $600 because of missed appointments. Livid, Joseph requested a small credit from the telemedicine service, which costs $432 monthly for her team of clinicians and trainees. SimplePractice refused, she said.

"What they offer is phenomenal, especially being founded by a therapist," said Joseph, a licensed clinical professional counselor. "But with a private practice, if you don't get paid, you don't eat." For some sessions, she was able to hop onto her backup, VSee, which costs her $49 each month. Some of her peers use Zoom. But even though Joseph keeps links to both her SimplePractice and VSee accounts in her email signature, a last-minute switch-up can feel messy for clients, and she never charges a no-show fee when it's an "act of God."

Major health systems, clinics and private practices alike pivoted swiftly to telemedicine when the COVID-19 pandemic forced the nation to shelter in place and patients could no longer safely venture into healthcare settings. But the video services were not equally prepared for the titanic influx in users, said Kapil Chalil Madathil, an engineering professor at Clemson University who has researched how easy — or difficult — telemedicine platforms are to use.

Videoconferencing vendors, including Zoom, tech giants like Microsoft and Cisco, and a host of telemedicine startups absorbed an explosion of demand over the past pandemic months. PitchBook estimates that revenue from the global telehealth market will hit $312.3 billion in 2026, up from $65.5 billion in 2019. But beyond connectivity issues, some services seemed designed for dissatisfaction. They required patients to download a desktop application or made them click through multiple steps to log in. "On an iPhone, I can click one button to see my grandkids," Madathil said. "Can we not make telemedicine systems as easy as that?"

Providers often were locked in with telemedicine options from services they were already using — or what they could afford. Joseph was already paying SimplePractice to house her practice's electronic health records, so moving to another platform would have been time-consuming and costly, she said.

Practitioners have depended on telemedicine to keep their businesses afloat in the pandemic, and Joseph plans to keep a portion of her sessions virtual. A one-stop shop for private practice clinicians, SimplePractice offers scheduling, an electronic medical records system and insurance claims filing along with its video services. The company said it hosted 17 million telehealth appointments last year.

"The expectations are rising," said Diana Stepner, a SimplePractice vice president. "Individuals want screen sharing, they want grid views, so we've added new capabilities since the pandemic began and will continue to do so."

Zoom became an overnight poster child for staying connected as employees in every line of business across the country worked from home. Its revenue jumped 326% in the fiscal year that ended on Jan. 31, 2021, over the previous year's. Even before the pandemic, the Silicon Valley company offered a service tailored for healthcare practitioners that complied with the Health Insurance Portability and Accountability Act, which protects patient privacy, and could be synced with Epic Systems electronic medical records.

"It was 'all bets are off' once the pandemic hit," said Heidi West, who heads the healthcare division at Zoom. West pointed to the CARES Act and the loosening of telehealth regulations, which allowed doctors to be reimbursed for telemedicine at the same rate as for in-office visits.

UCSF Health, which had contracted with Zoom for virtual visits since 2016, gave every doctor and clinician a personal link for its videoconference line and a separate virtual waiting room. Telemedicine calls for outpatient care within the San Francisco academic medical system spiked from 2% of visits in February 2020 to more than 60% by that April. Doctors were seeing patients — who often used their cellphones — in their homes, in parked cars and in one case on skyscraper scaffolding, where a construction worker stepped away for a quick doctor's visit, said Linda Branagan, director of telehealth at UCSF Health.

Zoom is not immune to glitches, Branagan said, but it seems to bounce back faster than many other vendors and "recovers quite gracefully."

UCSF surveyed its patients and found they were more satisfied with their video visits than their in-person ones. More than a year later, almost one-third of outpatient visits are still conducted virtually.

Elsewhere, the initial transition was rockier. Dr. James McElligott, who runs Medical University of South Carolina's Center for Telehealth, said the hospital could not afford to upgrade its Vidyo conferencing system, so he opted for Doxy.me, which the center already used for research and had an easy-to-use interface.

"We were able to get clever, and many doctors really liked it," McElligott said. The software has a waiting room from which patients can be transferred into virtual rooms with providers. The health system sent patients a text with a direct link for their appointments so that they didn't lose time.

"But we couldn't control quality or solve connectivity issues ourselves," he said. "We did have a lot of patients who, despite it just being a link, were uncomfortable waiting." That led to some patients abandoning visits, he added.

Doxy.me employed just eight people when the video telemedicine service saw an unwieldy increase in users in March 2020. For two weeks straight, the company signed up 20,000 new healthcare providers a day, said founder and CEO Brandon Welch, amassing a backlog of customer service inquiries. One day, Welch recalled, there was a 30-second queue for the website to load because so many people were logging on simultaneously.

"We hired anyone who could walk and chew gum at the same time," joked Welch, noting that many of those early pandemic hires, largely tackling customer service, had been recently laid off from other industries, like restaurants.

Doxy.me automated the sign-up process as quickly as possible. The service ballooned from 80,000 users to 850,000 as it assembled a team of 120 employees. And it is still hiring. Doctors and clinicians can sign up for the basic HIPAA-compliant service — which includes audio, video and a patient waiting room — at no charge. But for enhanced options, like screen sharing or shared rooms, there's a price tag of at least $29 a month.

For many doctors and clinicians, the move to virtual visits may be permanent, even with all the technical hiccups. A survey conducted by SimplePractice of over 2,400 clinicians in February found that 88% expected to continue offering a telehealth option.

Jessica Ehrman, a Santa Monica, California, therapist who plans to keep her practice fully remote, finds telemedicine much easier for scheduling, particularly for kids who have short windows of availability. Still, connectivity issues during that small time frame can tarnish the whole session.

"If you're talking about deep childhood trauma — having your connection time out then? It's really frustrating when we're paying for a service," said Ehrman, who has been suddenly dropped from sessions, experienced lags and even once saw back-end coding pop up in her provider portal. Like Joseph in Maryland, she uses SimplePractice through her agency and personally pays for Zoom's HIPAA-compliant option to head off technical difficulties.

Despite the problems, few healthcare providers want to forsake the technology. "Video visits are cemented," said Branagan. "I will never again have to have a conversation with a physician to convince them that you can do healthcare via video."

Hannah Norman: hannahn@kff.org, @hnorms

Contraception Is Free to Women, Except When It's Not

KFF Health News, July 23, 2021

Despite the ACA's guarantees of free contraception coverage, even for women whose health plans are subject to the law's requirements, obtaining the right product at no cost can be onerous.

This article was posted on Friday, July 23, 2021 in Kaiser Health News.

By Michelle Andrews

For Stephanie Force, finding a birth control method that she likes and can get without paying out-of-pocket has been a struggle, despite the Affordable Care Act's promise of free contraceptives for women and adolescent girls in most health plans.

The 27-year-old physician recruiter in Roanoke, Virginia, was perfectly happy with the NuvaRing, a flexible vaginal ring that women insert monthly to release hormones to prevent pregnancy. But her insurer, Anthem, stopped covering the branded product and switched her to a generic version in early 2020. Force said the new product left her with headaches and feeling irritable and short-tempered.

After talking to her OB-GYN, Force tried an IUD. But that made her feel worse: She had bad cramps, gained 10 pounds and developed severe hormonal acne. Plus, she was charged $248 for an ultrasound her provider used to guide the insertion of the device, a charge she successfully fought.

Force also considered a couple of birth control products approved in recent years: a non-hormonal vaginal gel called Phexxi and a vaginal ring called Annovera that can be used for a year. But Phexxi isn't covered by her employer health plan, and she would owe a $45 copayment for Annovera.

Despite the ACA's guarantees of free contraception coverage, Force's experience illustrates that even for women whose health plans are subject to the law's requirements, obtaining the right product at no cost can be onerous. New types of contraceptives aren't automatically incorporated into the federal list of required methods that insurers use to guide coverage decisions. In addition, some health plans continue to discourage use of even long-established methods like IUDs by requiring providers to get approval from the plan before prescribing them.

Consumer advocates who have studied the issue say a process is spelled out in federal rules for women to get the contraceptive they need, but far too few people know that is an option.

Ultimately, Force went back to the generic version of the NuvaRing, despite the side effects she continues to experience. She'd prefer to be on the branded NuvaRing, which didn't give her problems, and the ping-ponging from method to method has left her exhausted and furious.

"I cannot believe what hoops I have had to jump through between September 2020 and June 2021," Force said, "between switching from the generic NuvaRing to the IUD and then back, fighting my insurance and OB-GYN's office on the ultrasound charge."

In a statement, Anthem said, "Anthem health plans cover 222 contraceptive products at $0 cost share on our ACA Preventive List. We cover at least one product" in each of 18 categories of contraception methods approved by the FDA.

Contraception is a very personal choice, and what meets one woman's needs may not meet another's. If avoiding pregnancy is a woman's top priority, a virtually fail-safe method like an IUD may be the right solution. But for someone who's considering getting pregnant soon, a readily reversible method like a birth control pill might be the best option. Side effects are important to consider as well, since women respond differently to the hormones in various birth control products.

Before the ACA required no-cost birth control coverage, researchers estimate, up to 44% of women's out-of-pocket healthcare spending went toward contraceptives. The ACA required most commercial health plans to cover a comprehensive list of FDA-approved methods without charging women anything. Church plans and religious nonprofits as well as employers and schools that object to contraception are exempt from the coverage requirements. Plans that were grandfathered under the law are also exempt. Uninsured women don't benefit from the mandate either.

But the federal rules do not require health plans to cover every contraceptive. After the ACA passed in 2010, the federal Health Resources & Services Administration developed guidelines for women's preventive services. Those guidelines say women should have access without cost sharing to a list that covers the 18 FDA-approved methods, including oral contraceptives, vaginal rings and cervical caps, IUDs, implantable rods and sterilization. Under federal rules, health plans must cover at least one product in each category.

But neither the HRSA guidelines nor a birth control chart published by the FDA addresses newer methods, including the gel Phexxi, which regulates vaginal acidity to reduce the odds a sperm reaches an egg. It was approved by the FDA last year.

Nor do they incorporate fertility-awareness mobile apps the FDA approved in recent years such as Natural Cycles, which tracks a woman's temperature and menstrual cycle to avoid pregnancy.

"There's a real need for new guidance that keeps up with new methods," said Mara Gandal-Powers, director of birth control access at the National Women's Law Center.

Many insurers have balked at covering Phexxi, said Rameshwari Gupta, director of strategic markets for Evofem Biosciences, which markets Phexxi. A box of 12 single-use applicators — consumers use one before having sex — costs $267.50 without insurance, she said.

"When I started talking to payers, they all said, 'Where are you on this FDA chart?'" she said.

According to an FDA spokesperson, the birth control chart is for consumer education purposes only and "was not created with the intent of driving coverage decisions." The agency is in the process of updating it.

In a statement, HRSA said it is reviewing the evidence on contraceptives and expects to complete its review late this year. If it opts to make revisions, it will publish draft recommendations to update the women's preventive services guidelines. These will be finalized after a public comment period and become effective a year later.

At this point, health plans consider Phexxi a spermicide and are required to cover only one type of spermicide without cost sharing, said Kristine Grow, a senior vice president at AHIP, a health insurance trade organization.

"If Phexxi is indeed considered a new 'method' of contraception, both the FDA and HRSA would need to make this clear," she added.

The vaginal ring Annovera, approved by the FDA in 2018, is typically covered by health plans, according to Grow, though it may not be available without cost sharing. The average retail price is $2,457 a year, according to GoodRx.

One way plans have made it difficult for women to access certain contraceptives, even those on the list of approved methods, is by requiring that their providers get approval from the insurer first, often by providing documentation that the product is medically necessary.

Under UnitedHealthcare's coverage policy for Phexxi, for example, before coverage will be authorized, members must have documented reasons that they are unable to use eight other contraceptive methods, including oral contraceptives, the contraceptive patch, a vaginal ring, injections and spermicides. Providers also must attest that they have counseled patients that Phexxi is less effective at preventing pregnancy than some other methods.

In a statement, UHC said it covers "a broad array" of generic and brand-name options, and it follows scientific evidence to develop its list.

Yet consumers have a way to get the specific drug that is most appropriate for them, according to a report by the National Women's Law Center.

Under federal rules, if a doctor or other healthcare provider determines that a patient needs a particular contraceptive, even if it's not on the list of approved products for the patient's plan, the insurer is required to have an expedient process for the patient to seek a waiver.

"It's not up to the insurance company whether to cover that method; it's up to the provider," said Adam Sonfield, executive editor for policy analysis at the Guttmacher Institute, a research and advocacy organization focused on women's reproductive health.

But according to the National Women's Law Center report, many insurers, patients and their providers aren't aware of the requirement, and state agencies don't enforce these so-called exceptions policies.

If patients run into trouble getting the method they want, "we typically recommend filing an appeal with their insurance provider," said Gretchen Borchelt, vice president for reproductive rights and health at the National Women's Law Center.

Stephanie Force said she was unaware of any process she could have used to get the NuvaRing covered without cost sharing. Neither her healthcare provider nor the insurer mentioned the possibility.

She recently had an appointment with a new provider, who she hopes will be a better advocate for her.

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

After 18 Months, Sutter Antitrust Settlement Finally Poised for Formal Approval

KFF Health News, July 23, 2021

Numerous twists and turns have slowed the court's approval of the settlement in late 2019.

This article was published on Friday, July 23, 2021 in Kaiser Health News.

By Jenny Gold

More than 18 months after Sutter Health agreed to a tentative settlement in a closely watched antitrust case joined by the California Attorney General's Office, the judge presiding over the case indicated she would sign off on the terms, pending agreement on attorney fees. The nonprofit healthcare giant, based in Sacramento, stood accused of violating California's antitrust laws by using its market dominance to drive up prices. 

The settlement is expected to have nationwide implications on how hospital systems negotiate prices with insurers. 

"These plaintiffs are among the first, but will not be the last, to successfully challenge dominant healthcare systems who undertake land grabs to mark up prices at the expense of patients and employers," Leemore Dafny, a Harvard Business School professor who studies the industry, wrote in an email. "This settlement has provided a marker for the rest of the nation." 

The settlement, which includes $575 million in damages, was announced on a preliminary basis in December 2019. It marked a dramatic turn in a long-running legal battle initiated in 2014 as a class-action lawsuit filed by the United Food and Commercial Workers International Union & Employers Benefit Trust, representing employers, unions and local governments whose workers use Sutter services. Then-Attorney General Xavier Becerra joined the case in 2018. 

Numerous twists and turns have slowed the court's approval of the settlement in the months since.

San Francisco Superior Court Judge Anne-Christine Massullo had been expected to issue a preliminary approval of the terms in August 2020, but rejected the independent monitor the parties had chosen to oversee the rollout of the agreement. The monitor chosen was neither a woman nor a person of color, and Massullo said the parties' selection process did not properly take into account the court's emphasis on diversity, equity and inclusion. 

More months passed as Sutter argued for further delays and suggested it would push to alter the settlement in light of the potentially dramatic effects of the COVID-19 pandemic on the healthcare system's finances and operations. 

Preliminary approval was eventually granted, but most recently, final approval was postponed because of a dispute between UEBT and their lawyers over attorney fees. The parties had agreed at the outset to plaintiffs' attorneys, led by Richard Grossman of Pillsbury & Coleman, getting 30% of the settlement amount. Given the size of the settlement, that comes to $172.5 million in attorney fees, a figure UEBT argues is unreasonably high. 

An additional 2% in fees will go to the Attorney General's Office. UEBT expects to receive about $15 million, and what is left of the $575 million will be distributed among the rest of the class, made up of other unions and employers who purchase health insurance for their workers. 

Thursday's hearing was largely devoted to a tense back-and-forth over the attorney fees. Ultimately, the hearing concluded without resolution on the issue. But Massullo indicated she would approve the terms of the settlement in a written order once the fees had been sorted out. The timing of that final order was left unclear. 

Sutter has 23 hospitals, 33 surgery centers and 12,000 physicians across Northern California, with $13 billion in operating revenue in 2020. Among other allegations, the state's lawsuit argued Sutter has aggressively bought up hospitals and physician practices throughout the Bay Area and the rest of Northern California, and exploited that market dominance for profit. 

Healthcare costs in Northern California are 20% to 30% higher than in Southern California, even after adjusting for the cost of living, according to a 2018 study from the Nicholas C. Petris Center at the University of California-Berkeley that was cited in the complaint. 

Among other terms, the settlement requires Sutter to: 

  • Limit what it charges patients for out-of-network services. 
     
  • Increase transparency by allowing insurers and employers to give patients pricing information. 
     
  • Cease bundling services and products, and instead offer stand-alone pricing. 

In agreeing to the settlement, Sutter did not admit wrongdoing. Throughout the proceedings, it has maintained that its integrated health system offers tangible benefits for patients, including affordable rates and consistent high-quality care. Sutter spokesperson Amy Thoma Tan said in an email that the settlement would not reduce the quality of patient care. 

"Our commitment to providing high-quality care to our patients is unwavering, and independent data shows that our quality yields better health outcomes and a lower total cost of care," she wrote. "Sutter's quality of care is nationally recognized, with the majority of our hospitals and facilities outperforming state and national averages in nearly every measure of quality." 

Still, under the terms of the settlement, Sutter agreed to end a host of practices that Becerra, who now heads the U.S. Department of Health and Human Services, alleged unfairly stifled competition. Among other conditions, the settlement also requires Sutter to limit what it charges patients for out-of-network services and end its all-or-nothing contracting deals with payers, which demanded that an insurer that wanted to include any one of the Sutter hospitals or clinics in its network must include all of them. 

Sutter has earned an average 42% annual profit margin over the past decade from medical treatments paid for by commercial insurers like the plaintiff companies, according to a recent analysis by Glenn Melnick, a healthcare economist at the University of Southern California.  

Sutter also faces a second federal class-action lawsuit alleging anti-competitive behavior. But while Sutter remains in the crosshairs, its practices are not unique. Experts say negotiating tactics including all-or-nothing contracts and anti-tiering provisions have become widespread among hospital systems nationwide. 

"Any system could change their practices tomorrow. If we have to wait for the courts to force them to not use anti-competitive practices, that's really disappointing," said Elizabeth Mitchell, CEO of the Purchaser Business Group on Health, which represents employers that buy insurance coverage for their workers. 

"What the Sutter case proves is that the people who pay for and receive care can achieve accountability from the healthcare system. But it shouldn't be that hard." 

Jenny Gold: jgold@kff.org, @JennyAGold

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