Public Health Watch Archives - California Healthline https://californiahealthline.org/news/tag/public-health-watch/ Tue, 27 Sep 2022 22:23:47 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.2 161476318 California Schools Try to Outrace Covid Outbreaks https://californiahealthline.org/news/article/california-covid-outbreak-mask-mandates-schools/ Wed, 25 May 2022 09:00:00 +0000 https://californiahealthline.org/?post_type=article&p=418133 A fourth-grade camping trip led to one outbreak, a high school prom to another. But even with covid cases rising as schools head into the final stretch of the academic year, most California districts have not moved toward reinstating mask mandates.

That stance has left many parents confused and concerned as they witness or hear about covid outbreaks among students after field trips and proms.

Up and down California, school administrators are running out the clock, hoping to outrace the outbreaks. The Berkeley school system and a few others have reversed their mask-optional policies, and the San Diego district sent letters to parents warning that masks could be reinstated if cases continue to rise. But most districts — including those in Los Angeles, San Francisco, and Oakland — haven’t revisited their guidance as summer draws near.

“I do not plan on making any new recommendations in the final three weeks of school,” Dublin Unified Superintendent Chris Funk told KHN, noting that the Alameda County Public Health Department lifted mandatory masking rules in classrooms more than two months ago.

Among other factors, administrators are reluctant to expose districts to legal challenges. From the start, the attempt to create statewide covid protocols for schools was met with sometimes-fierce resistance. Some districts, many of them rural, ignored California’s school mask mandate. In February, the Roseville Joint Union High School District, which enrolls about 12,000 students in Placer and Sacramento counties, dropped the mask rule even as a statewide mandate remained in effect.

Another reason that schools aren’t rushing back to masking, several administrators told KHN, is that even though cases are rising, most districts follow county guidelines that tie public health precautions to either the number of covid hospitalizations or the strain they would put on local health systems. Hospital admission rates tend to lag positive case rates by two weeks. Still, hospitalizations remain low for now, likely because of the availability of vaccines and antiviral treatments.

“We should be past mask mandates, period,” said Dr. Jeanne Noble, who directs covid emergency response at Zuckerberg San Francisco General Hospital and Trauma Center. She said that the virus no longer poses a significant health risk to young and vaccinated populations and that people need to adjust to living with covid. That means taking a “test-to-treat” approach, she said, rather than trying to prevent transmission. The Biden administration is moving to a model where patients are tested and then treated with antiviral pills such as Pfizer’s Paxlovid or Merck’s molnupiravir to lower their risk of going to the hospital.

“I know my advice sounds scary to many, but covid is here to stay,” Noble said. “That is the endgame.”

That can be a tough sell for some parents.

When 40 out of 100 fourth graders at Deterding Elementary in the San Juan Unified School District in Sacramento County contracted covid after sharing cabins during a sleep-away field trip, the school was overwhelmed by inquiries from parents of students in other grades wondering whether the health rules at school were about to change — and whether the fifth-grade camping trip, scheduled for June 1, would go on.

It will, although the district will monitor local conditions and public health guidance, according to Raj Rai, the district’s communications director.

Some parents were confused or upset by the news that the fifth grade trip would remain on schedule, even though the district was following county health recommendations. Melanie Allen, the Deterding principal, said such confusion has been a common theme during a school year marked by shifting public health guidelines.

“Even though information was posted clearly by the district on the website, parents reached out constantly to school administrators to clarify next steps for exposure or positive results,” the principal wrote in an email to KHN.

The rising case rates forced the Berkeley district to make a late reconsideration — it reinstated mandatory masking in classrooms from May 23 until the end of its school year, on June 3. Superintendent Brent Stephens noted in an update on the district’s website that in addition to the spiking student infection numbers, the district could find substitutes for only about half of its absent teachers. District administrators, he said, are working in classrooms to cover the shifts. The city’s chief public health officer strongly recommended the move back to mandatory masking.

“As we are not a health agency, we must rely on these experts to guide us,” Stephens wrote.

Very few of California’s more than 1,000 school districts have joined the Berkeley system in making such a decision. On May 16, school officials in Pacific Grove, near Monterey, ordered that masks be worn inside all classrooms by its roughly 2,000 students. Katrina Powley, the district nurse, said the district is one of the few that ties its masking policy to case rates in Monterey County. Therefore, when those rates moved from “low” to “moderate” transmission, a mask mandate was triggered.

The board of trustees for the San Mateo Union High School District voted in early May to extend its mask mandate until June 1 and strengthened protocols after a prom that was held in San Francisco in April resulted in an outbreak among 90 of the 600 students in attendance.

Those districts remain in the minority despite the statewide covid surge. Roughly 20 schools in Marin County experienced outbreaks in early May. And the Dublin school district, in the East Bay, saw rates shoot up fivefold from March to April and continue to rise in May. Those schools haven’t revisited their optional mask policies.

Schools in Davis, in Yolo County, have not reinstated mask requirements despite rising cases, in large part because the county health director decoupled mandates from test positivity rates.

“We have sufficient protection against the virus, especially with Paxlovid available at test-to-treat locations,” said John Fout, a spokesperson for the county. Only increased hospitalizations straining the health care system would prompt a change, he added.

At this point, an uptick in serious illnesses may not be recognized until after the school year ends — and that is what many school administrators appear to be counting on.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Rural California Hatches Plan for Engineered Mosquitoes to Battle Stealthy Predator https://californiahealthline.org/news/article/rural-california-hatches-plan-for-engineered-mosquitoes-to-battle-stealthy-predator/ Mon, 09 May 2022 09:00:00 +0000 https://californiahealthline.org/?post_type=article&p=416493 VISALIA, Calif. — Bryan Ruiz moved his family into a newly built home in this Central Valley farming center seven months ago and almost immediately found they were under assault.

Mosquitoes bit and harassed them in broad daylight. He looked around, trying to find a water source where they were breeding, and noticed a freshly dug pipe, meant to drain water from the backyard to the front. He lifted its cap and inside found a small puddle in the drainage line, which didn’t have enough slope to fully empty.

He grabbed a turkey baster and drew water, already knowing what he would find: the larvae of Aedes aegypti, one of the greatest threats to humans on the planet.

Ruiz knew what he was looking for because he is in charge of a newly formed team that spends the summer months traveling around northern Tulare County to combat the invasion of Aedes aegypti, a mosquito capable of infecting humans with the deadly diseases of dengue, chikungunya, yellow fever, and Zika.

Since gaining a foothold in California less than a decade ago, Aedes aegypti has spread quickly across the state, its territory now ranging from the desert terrain of Imperial County at the U.S.-Mexico border to the city of Redding in woody Shasta County, about 750 miles north.

To combat aegypti, mosquito control districts rely on the same tools they were using decades ago — pesticides and rooting out water sources — even as climate change and agricultural practices are allowing the mosquitoes to thrive in places previously uninhabitable.

But Tulare County officials hope the region will soon be a testing ground for a new generation of technology, including a genetically modified mosquito, as they try to prevent the kind of disease outbreaks now common in regions of the Caribbean and Central and South America where Aedes aegypti is widespread.

The most immediate mosquito danger in Tulare County comes from a different genus, Culex, a type that typically bites at dawn and dusk and can carry West Nile virus, St. Louis encephalitis, and western equine encephalomyelitis virus, all of which can be fatal. Over the past decade, California has registered more than 4,000 cases of West Nile and at least 220 deaths. Tulare’s mosquito control districts have poured extensive resources into that battle, including releasing a range of chemicals, maintaining a hatchery for larvae-eating fish, and, most recently, buying a drone to ferry pesticides deep into cornfields.

Aedes aegypti, however, is a growing concern, and much harder to combat.

To understand this fight, you first have to understand just how stealthy Aedes aegypti is. The mosquitoes can lay eggs in spaces as small as a bottle cap, and females spread their eggs across multiple locations — scientists often refer to their “cryptic habitats.” Most other types of mosquito eggs need water to survive, but Aedes aegypti’s can lie dormant for months, springing to life when water eventually does come. And one mosquito can bite many times over, snacking repeatedly on the same human or moving from one to the next. They become a lethal threat if one of those people happens to be carrying dengue or some other virus.

In an increasingly global world, people regularly travel to places where dengue is endemic and bring it back to the U.S. If a mosquito bites them, the illness can spread locally. That’s what happened in the Florida Keys in 2020, and more than 70 people were infected before the outbreak was stopped.

California so far has avoided local outbreaks of the diseases carried by Aedes aegypti. But it does import cases — California has registered seven cases of imported dengue this year — and with the mosquito population growing, experts say it’s likely only a matter of time.

Aedes aegypti is a frequent flyer, traveling the world in cargo. It no doubt has been introduced into California millions of times. But it wasn’t until recently that it took hold, said Chris Barker, an associate professor of pathology, microbiology, and immunology at University of California-Davis. It was first detected in 2013 in three California cities: Menlo Park, Clovis, and Madera.

Today, Aedes aegypti has spread across more than 200 California cities and 22 counties. And it has strained mosquito control districts. “It’s been a lot of extra work, extra staffing, extra financial demand,” said Barker. “And regardless of disease risk, a huge issue is the nuisance biting.”

Because of the threat the mosquitoes pose, when aegypti was detected in 2014 by the Delta Mosquito and Vector Control District, where Ruiz works, the district rushed to stamp out the menace. Its eradication method required searching every nook and cranny of the area where Aedes aegypti had taken up residence and cleaning out water sources multiple times a week. People were so annoyed by the full-court press, said the district’s assistant manager, Mir Bear-Johnson, that nearly five years passed before that community reached out again. Which was a problem, because the district partly relies on reports from residents to know where mosquitoes are.

The eradication was also short-lived. In 2015, Aedes aegypti was reintroduced, and this time the ferocious biters spread out across Visalia, the area’s largest city. Because Aedes aegypti can now be found all around the Central Valley, eradication no longer feels like an option, said Mustapha Debboun, an entomologist who moved from Harris County, Texas, in March 2020 to lead the Delta district.

Aedes aegypti mosquitoes in the area are also broadly resistant to pyrethroids, the family of chemicals most frequently used to kill adult mosquitoes. Pyrethroids are in heavy use among the area’s agricultural companies, likely contributing to what Barker described as nearly 100% resistance.

Which is why Debboun and colleagues are interested in the genetically modified mosquito. Their hope is that the engineered mosquitoes reduce the number of wild Aedes aegypti as they interbreed and produce short-lived offspring.

The U.S. Environmental Protection Agency recently approved a trial in Tulare of the engineered mosquito, which is made by a company called Oxitec. The company says its latest product releases only male mosquitoes, which unlike females do not bite. The mosquitoes are genetically modified to carry a “self-limiting” gene that is passed on during breeding and theoretically prevents the offspring from surviving to adulthood. They have been released in several places, including Brazil and the Cayman Islands.

They also were released in the Florida Keys last year. There, Oxitec faced pushback from some homeowners concerned about the unanticipated risks of releasing genetically modified pests into the wild. Local officials put the issue on the 2016 ballot, and county residents, who by then had confronted both dengue and Zika, voted to go forward.

Now, Oxitec and the Delta mosquito district are waiting for permission from the California Department of Pesticide Regulation to launch the insects. The work would be funded by Oxitec, Debboun said, with operational assistance from his staff.

The goal is to build on the earlier research, which shows that the modified Aedes aegypti temporarily reduces the wild mosquito population but has left scientists with questions about the broader effects on the environment and how well the effort works in the long run to reduce disease. Among the unknowns is whether the Oxitec mosquitoes are indeed incapable of producing viable offspring with wild females.

Another question, said Barker, the UC-Davis expert, is what happens when Oxitec’s mosquitoes encounter tetracycline in the wild. Tetracycline is an antibiotic commonly used to control infection in livestock and agriculture, both of which are found in abundance in the Central Valley. Oxitec mosquitoes are bred with a sort of off-switch that shuts down the self-limiting gene when they come into contact with tetracycline. In the lab, this off-switch allows the company to breed the engineered mosquitoes. If it is triggered in the wild, the concern is that the mosquitoes’ offspring wouldn’t die out.

On a broader level, Barker said, he hopes California will independently track the experiment. He is among the researchers concerned about leaving that analysis in the hands of a private company that stands to benefit. “If an independent source and the company are in agreement when all the results are done, that has much more power and much more potential for the future,” Barker said.

Rajeev Vaidyanathan, director of U.S. operations for Oxitec, said Tulare’s Delta Mosquito and Vector Control District was among several districts interested in hosting the trial. Among the selling points was Debboun’s enthusiasm for new technologies.

Debboun previously helped run a trial in Houston of a product called MosquitoMate, which releases male mosquitoes infected with the bacteria Wolbachia. When the MosquitoMate mosquitoes breed with wild females, they produce eggs that do not hatch. Those mosquitoes were also tested in Fresno County in 2018 and 2019 and led to a 95% reduction in female Aedes aegypti, according to a study on the trial. Even so, that mosquito district told The Fresno Bee it didn’t have the money to continue the project on its own.

“These are the fantastic, glittery options,” said Eva Buckner, a University of Florida assistant professor who advises Florida’s mosquito control districts. “I think they have a lot of potential.” She wants to know what the cost-benefit ratio would be for widespread use by government agencies compared with other interventions — a question the Tulare research could help determine. And regardless of price, she cautioned, there’s not going to be a silver bullet for mosquitoes, which have endured on Earth for millions of years.

Oxitec wanted to test its technology in arid Central California, Vaidyanathan said, because it could show it can work throughout the Aedes aegypti-invaded Southwest. Oxitec hopes its mosquitoes eventually will be sold to mosquito control districts in the U.S., and directly to American consumers. That option is already available in Brazil, via a consumer subscription service that costs $10 to $30 a month. In the U.S. prototype, the mosquitoes would come in a hexagonal box decorated with playful insects. If all goes as planned, consumers would just add water, and the mosquitoes would spring to life.

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Can a Monthly Injection Be the Key to Curbing Addiction? These Experts Say Yes https://californiahealthline.org/news/article/monthly-injectable-opioid-addiction-treatment/ Thu, 05 May 2022 09:00:00 +0000 https://californiahealthline.org/?post_type=article&p=415821 OAKLAND — Dr. Andrew Herring has a clear goal walking into every appointment with patients seeking medication to treat an opioid use disorder: persuade them to get an injection of extended-release buprenorphine.

At his addiction clinic at Highland Hospital, a bustling public facility in the heart of Oakland, Herring promotes administering a shot of buprenorphine in the belly to provide a month of addiction treatment rather than prescribing oral versions that must be taken daily. For him, the shots’ longer-acting protection is a “game changer” and may be his only chance to help a vulnerable patient at risk of overdose.

“At any point in time, they’re just a balloon that’s going to go,” Herring said. “You might only have this one interaction. And the question is, how powerful can you make it?”

In California, where overdose deaths have been rising for years, addiction experts say administering a month’s worth of anti-addiction medication holds great potential, particularly for people without housing or who struggle with other forms of instability. Yet despite its promise, the use of injectable buprenorphine remains fairly limited, especially compared with other forms of addiction medication. Researchers have yet to publish studies comparing different ways to administer buprenorphine.

Buprenorphine, one of three medications approved in the U.S. to treat opioid use disorder, works by binding to opioid receptors in the brain and reducing cravings and withdrawal symptoms. And because it occupies those receptor sites, buprenorphine keeps other opioids from binding and ensures that if a patient takes a high dose of a drug like heroin or fentanyl, they are less likely to overdose. Patients often stay on buprenorphine for years.

If Herring prescribes a supply of buprenorphine as a tablet or film that is placed under the tongue, the patient must commit to taking the medication at least once a day, and many fall out of treatment. He said this is especially true for his patients experiencing homelessness and those who also use methamphetamine.

“It’s like a religious thing — you have to wake up every morning and repeat your vows,” said Herring. “In reality, there are a lot of people who deserve treatment who can’t meet that requirement.”

Oral forms of buprenorphine have been available to treat addiction since 2002 and can be purchased as a generic for less than $100 a month. Injectable buprenorphine, sold under the brand name Sublocade, received FDA approval in 2017. It has a hefty list price of $1,829.05 for a monthly injection. The drugmaker Indivior reported $244 million in revenue from Sublocade last year alone, with a company goal to eventually make $1 billion in annual sales. No generic or competing version of the drug is available.

Most patients won’t pay full price, Indivior says, because most health plans cover the drug. Physicians, however, say the high cost can be a barrier for patients with private health plans, which sometimes resist covering the medication. Medi-Cal, California’s health insurance program for low-income people, covers Sublocade without prior authorization, making the treatment accessible to the majority of Herring’s patients.

Still, addiction experts say, Sublocade use remains limited because of the regulatory hurdles required to dispense it.

Providers must register with the U.S. Drug Enforcement Administration and obtain a waiver to prescribe buprenorphine because it’s considered a controlled substance. In addition, clinics must complete an FDA safety certification program to dispense the medication. And Sublocade can be ordered only by a specialty pharmacy, which must also pass the FDA program.

“At many hospitals, that will mean either a delay in getting this medication on our shelves or just opting out,” said Dr. Rais Vohra, regional director for the California Bridge Network, a state-funded program that supports hospitals in offering treatment for substance use disorders, including Herring’s clinic.

Vohra said Community Regional Medical Center in Fresno, where he works as an emergency physician, is still looking through the documentation requirements to see if the hospital’s pharmacy can distribute the medication — which would make it one of the few Central Valley providers to do so.

Oral buprenorphine, by contrast, is a simple prescription that most local drugstores keep in stock.

“All the hoops that clinicians and patients have to jump through to get this medication is crazy. We don’t do that for any other disease,” said Dr. Hannah Snyder, who runs the addiction clinic at Zuckerberg San Francisco General Hospital across the bay.

Several clinicians noted that access remains a problem even with oral forms of buprenorphine. Despite a cascade of studies proving the effectiveness of medication-assisted treatment, many patients across the country struggle to find a provider willing to prescribe buprenorphine in any form — especially in communities of color.

“The most important question isn’t whether long-acting injectable bupe is a better solution than sublingual buprenorphine for opioid use disorder,” said Dr. Michael Ostacher, a professor at Stanford University School of Medicine, who is comparing injectable and oral versions of buprenorphine through Veterans Affairs. “The bigger question is how we increase access to treatment for all people who need [the medication].”

Angela Griffiths is among the patients who say Sublocade has changed their lives. Griffiths, 41, of San Francisco, used heroin for 18 years. When she was pregnant with her daughter in 2016, doctors put her on methadone, which made her feel “miserable.” Three years ago, she said, she switched to buprenorphine films, but carrying the strips with her everywhere still made her feel tied to her addiction.

“The ritual of taking something every day plays something in your mind,” Griffiths said.

When doctors at the SF General clinic switched her to monthly Sublocade injections, she described the change as “extraordinary.”

“I’m not reaching for my drawer anymore for a fix,” she said. “I have the freedom to wake up and start my day however I want, whether it’s to go to the patio and drink a cup of coffee or to snuggle with my daughter in bed a little longer. It’s there; I don’t have to take anything.”

In states where Medicaid plans may still require prior authorization, waits for Sublocade can stretch into months. Across the border at the Northern Nevada Hopes clinic in Reno, Nevada, for example, Dr. Taylor Tomlinson said she tells patients that between battles for coverage and pharmacy delays, they might have to wait two months for an injection.

“I’m always going to offer it to a patient who I think would be a good candidate, but in the time they have to wait, they get interested in other things,” said Tomlinson. “It creates a barrier to care.”

California’s Medicaid program does not require prior authorization but providing Sublocade is still a challenge. At the Placerville clinic supported by the California Bridge Network, Dr. Juliet La Mers, the director, said a quarter of her buprenorphine patients get injections. Still, they often wait two weeks before Sublocade arrives from the specialty pharmacy.

Herring has been able to cut through some of that red tape at his Oakland clinic by working with the Highland pharmacy to stock and distribute Sublocade. As soon as a patient agrees to an injection, Herring simply calls the pharmacy down the hall and administers it on the spot.

Herring sees urgency — and opportunity — to increase the use of injectable buprenorphine as fentanyl use rises across California. For years, the deadly synthetic opioid was concentrated mostly on the East Coast; in 2018, 88% of deaths from synthetic opioids occurred in the 28 states east of the Mississippi River. But more recently, fentanyl has begun to infiltrate Western states. From 2018 to 2020, deaths from fentanyl overdoses in California quintupled, according to state data.

“No one understands what they’re dealing with,” Herring said of fentanyl’s potency. “This is the time where our greatest deaths are going to occur.”

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.

]]> 415821 Babies Die as Congenital Syphilis Continues a Decade-Long Surge Across the US https://californiahealthline.org/news/article/babies-die-as-congenital-syphilis-continues-a-decade-long-surge-across-the-us/ Tue, 12 Apr 2022 16:01:00 +0000 https://californiahealthline.org/?p=413860&post_type=article&preview_id=413860 For a decade, the number of babies born with syphilis in the U.S. has surged, undeterred. Data released Tuesday by the Centers for Disease Control and Prevention shows just how dire the outbreak has become.

In 2012, 332 babies were born infected with the disease. In 2021, that number had climbed nearly sevenfold, to at least 2,268, according to preliminary estimates. And 166 of those babies died.

About 7% of babies diagnosed with syphilis in recent years have died; thousands of others born with the disease have faced problems that include brain and bone malformations, blindness, and organ damage.

For public health officials, the situation is all the more heartbreaking, considering that congenital syphilis rates reached near-historic modern lows from 2000 to 2012 amid ambitious prevention and education efforts. By 2020, following a sharp erosion in funding and attention, the nationwide case rate was more than seven times that of 2012.

“The really depressing thing about it is we had this thing virtually eradicated back in the year 2000,” said William Andrews, a public information officer for Oklahoma’s sexual health and harm reduction service. “Now it’s back with a vengeance. We are really trying to get the message out that sexual health is health. It’s nothing to be ashamed of.”

Even as caseloads soar, the CDC budget for sexually transmitted disease prevention — the primary funding source for most public health departments — has been largely stagnant for two decades, its purchasing power dragged even lower by inflation.

Tuesday’s CDC report on STD trends provides official data on congenital syphilis cases for 2020, as well as preliminary case counts for 2021 that are expected to increase. CDC data shows that congenital syphilis rates in 2020 continued to climb in already overwhelmed states like Texas, California, and Nevada and that the disease is now present in almost every state in the nation. All but three states — Maine, New Hampshire, and Vermont — reported congenital syphilis cases in 2020.

From 2011 through 2020, congenital syphilis resulted in 633 documented stillbirths and infant deaths, according to the new CDC data.

Preventing congenital syphilis — the term used when syphilis is transferred to a fetus in utero — is from a medical standpoint exceedingly simple: If a pregnant woman is diagnosed at least a month before giving birth, just a few shots of penicillin have a near-perfect cure rate for mother and baby. But funding cuts and competing priorities in the nation’s fragmented public health care system have vastly narrowed access to such services.

The reasons pregnant people with syphilis go undiagnosed or untreated vary geographically, according to data collected by states and analyzed by the CDC.

In Western states, the largest share of cases involve women who have received little to no prenatal care and aren’t tested for syphilis until they give birth. Many have substance use disorders, primarily related to methamphetamines. “They’ve felt a lot of judgment and stigma by the medical community,” said Dr. Stephanie Pierce, a maternal fetal medicine specialist at the University of Oklahoma who runs a clinic for women with high-risk pregnancies.

In Southern states, a CDC study of 2018 data found that the largest share of congenital syphilis cases were among women who had been tested and diagnosed but hadn’t received treatment. That year, among Black moms who gave birth to a baby with syphilis, 37% had not been treated adequately even though they’d received a timely diagnosis. Among white moms, that number was 24%. Long-standing racism in medical care, poverty, transportation issues, poorly funded public health departments, and crowded clinics whose employees are too overworked to follow up with patients all contribute to the problem, according to infectious disease experts.

Doctors are also noticing a growing number of women who are treated for syphilis but reinfected during pregnancy. Amid rising cases and stagnant resources, some states have focused disease investigations on pregnant women of childbearing age; they can no longer prioritize treating sexual partners who are also infected.

Dr. Eric McGrath, a pediatric infectious disease specialist at Wayne State University School of Medicine in Detroit, said that he’d seen several newborns in recent years whose mothers had been treated for syphilis but then were reexposed during pregnancy by partners who hadn’t been treated.

Treating a newborn baby for syphilis isn’t trivial. Penicillin carries little risk, but delivering it to a baby often involves a lumbar puncture and other painful procedures. And treatment typically means keeping the baby in the hospital for 10 days, interrupting an important time for family bonding.

McGrath has seen a couple of babies in his career who weren’t diagnosed or treated at birth and later came to him with full-blown syphilis complications, including full-body rashes and inflamed livers. It was an awful experience he doesn’t want to repeat. The preferred course, he said, is to spare the baby the ordeal and treat parents early in the pregnancy.

But in some places, providers aren’t routinely testing for syphilis. Although most states mandate testing at some point during pregnancy, as of last year just 14 required it for everyone in the third trimester. The CDC recommends third-trimester testing in areas with high rates of syphilis, a growing share of the U.S.

After Arizona declared a statewide outbreak in 2018, state health officials wanted to know whether widespread testing in the third trimester could have prevented infections. Looking at 18 months of data, analysts found that nearly three-quarters of the more than 200 pregnant women diagnosed with syphilis in 2017 and the first half of 2018 got treatment. That left 57 babies born with syphilis, nine of whom died. The analysts estimated that a third of the infections could have been prevented with testing in the third trimester.

Based on the numbers they saw in those 18 months, officials estimated that screening all women on Medicaid in the third trimester would cost the state $113,300 annually, and that treating all cases of syphilis that screening would catch could be done for just $113. Factoring in the hospitalization costs for infected infants, the officials concluded the additional testing would save the state money.

And yet prevention money has been hard to come by. Taking inflation into account, CDC prevention funding for STDs has fallen 41% since 2003, according to an analysis by the National Coalition of STD Directors. That’s even as cases have risen, leaving public health departments saddled with more work and far less money.

Janine Waters, STD program manager for the state of New Mexico, has watched the unraveling. When Waters started her career more than 20 years ago, she and her colleagues followed up on every case of chlamydia, gonorrhea, and syphilis reported, not only making sure that people got treatment but also getting in touch with their sexual partners, with the aim of stopping the spread of infection. In a 2019 interview with KHN, she said her team was struggling to keep up with syphilis alone, even as they registered with dread congenital syphilis cases surging in neighboring Texas and Arizona.

By 2020, New Mexico had the highest rate of congenital syphilis in the country.

The covid-19 pandemic drained the remaining resources. Half of health departments across the country discontinued STD fieldwork altogether, diverting their resources to covid. In California, which for years has struggled with high rates of congenital syphilis, three-quarters of local health departments dispatched more than half of their STD staffers to work on covid.

As the pandemic ebbs — at least in the short term — many public health departments are turning their attention back to syphilis and other diseases. And they are doing it with reinforcements. Although the Biden administration’s proposed STD prevention budget for 2023 remains flat, the American Rescue Plan Act included $200 million to help health departments boost contact tracing and surveillance for covid and other infectious diseases. Many departments are funneling that money toward STDs.

The money is an infusion that state health officials say will make a difference. But when taking inflation into account, it essentially brings STD prevention funding back to what it was in 2003, said Stephanie Arnold Pang of the National Coalition of STD Directors. And the American Rescue Plan money doesn’t cover some aspects of STD prevention, including clinical services.

The coalition wants to revive dedicated STD clinics, where people can drop in for testing and treatment at little to no cost. Advocates say that would fill a void that has plagued treatment efforts since public clinics closed en masse in the wake of the 2008 recession.

Texas, battling its own pervasive outbreak, will use its share of American Rescue Plan money to fill 94 new positions focused on various aspects of STD prevention. Those hires will bolster a range of measures the state put in place before the pandemic, including an updated data system to track infections, review boards in major cities that examine what went wrong for every case of congenital syphilis, and a requirement that providers test for syphilis during the third trimester of pregnancy. The suite of interventions seems to be working, but it could be a while before cases go down, said Amy Carter, the state’s congenital syphilis coordinator.

“The growth didn't happen overnight,” Carter said. “So our prevention efforts aren't going to have a direct impact overnight either.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Health Officials See Bright Future in Poop Surveillance https://californiahealthline.org/news/article/sewage-surveillance-tracking-covid-infectious-disease-modesto-california/ Tue, 22 Mar 2022 09:00:00 +0000 https://californiahealthline.org/?post_type=article&p=411570 MODESTO, Calif. — One of Patrick Green’s first orders of business each day is to open a tap and fill a bottle with sludge.

A utilities plant operator in Modesto, a city of nearly a quarter-million people in California’s San Joaquin Valley, Green helps keep the city’s sewers flowing and its wastewater treated to acceptable levels of safety. But in recent months, he and his colleagues have added covid-19 sleuthing to their job description.

At the treatment plant where Modesto’s sewer pipes converge, larger items, ranging from not-supposed-to-be-flushed baby wipes to car parts, are filtered out. What remains is ushered into a giant vat, where the solids settle to the bottom. It’s from that 3-feet-deep dark sludge that researchers siphon samples in their search for SARS-CoV-2, the virus that causes covid.

Across the country, academics, private companies, public health departments, and sewage plant operators have been working to hone a new public health tool, one with uses that could reach well beyond covid. Wastewater surveillance is not a new concept, but the scale and scope of the current pandemic have vaulted the technique over the narrow walls of academic research to broader public use as a crucial tool for community-level tracking of covid surges and variants.

Sewage surveillance is proving so useful that many researchers and public health officials say it should become standard practice in tracking infectious diseases, as is already the case in many other countries. But whether that happens — and which communities get access — depends on the nation’s ability to vastly scale up the approach and make it viable in communities rich and poor.

Like many other public health tools, wastewater testing initially took off in big cities and university towns with access to research expertise, equipment, and money. The Modesto project offers a glimpse of the challenges and opportunities involved in making this technology available in communities with more limited resources.

“You should be injecting more resources in places that are underserved since they have the disproportionate burden of disease,” said Colleen Naughton, an engineering professor at the University of California-Merced who is helping set up testing in Merced, Modesto, and surrounding Central Valley farm towns.

William Wong, director of utilities for Modesto, oversees water and sewage operations. Since early in the pandemic, he’s wanted to monitor the city’s sewage for SARS-CoV-2. It’s a natural extension of his work; the safe disposal of excrement is a foundation of both public health and modern society. “We always viewed what we do as protecting the public health,” Wong said.

For covid surveillance, wastewater isn’t subject to the tricky inconsistencies that come with testing for the coronavirus in humans. Covid testing shortages have been a persistent problem throughout the pandemic, stemming both from supply-chain shortfalls and wide variation in local governments’ response. Long delays in test results can leave health officials weeks behind in detecting and monitoring infection trends.

More recently, at-home tests, whose results rarely find their way to public health departments, have proliferated. And for people living in lower-resource communities, there are incentives not to test at all, said Dr. Julie Vaishampayan, the health officer for Stanislaus County, where Modesto is located. A positive test can be a huge problem for people who can’t take time off work or keep their kids out of school.

By contrast, sewage surveillance is an effective and relatively low-budget enterprise, less reliant on human whim. Everyone poops, as the saying goes, and around 80% of Americans deposit their solids into a sewer system.

Dozens of research projects around the country have shown that the method can be used to accurately track covid trends over time. And because people shed covid in their feces before they show symptoms, upticks and drop-offs in neighborhood- and community-level infections can appear in sludge several days before they show up in tests.

Other health issues leave their mark in poop as well. Recent research has found that wastewater surveillance is a reliable method for monitoring flu and the common respiratory illness RSV. The Centers for Disease Control and Prevention told KHN it will soon launch pilot studies to see whether sewage can reveal trends in antibiotic-resistant infections, foodborne illnesses, and candida auris, a fungal infection.

There are places where sewage may not be a great way to keep tabs on covid. That includes communities without sewers; areas with industrial sewage, where treatment techniques can mask the virus; and communities with huge fluctuations in population, such as ski towns.

But where available, the data has already proven powerful. During the winter surge caused by omicron, California, Colorado, New York, and Texas first detected the variant via sewage. Central Valley health officials have said that sewage monitoring has assured them that declines in covid cases are real, and not a distorted reflection of declines in reported testing.

In Modesto, wastewater also revealed that the delta variant remained the dominant strain well into January, weeks after omicron had taken over elsewhere. That was important, Vaishampayan said, because some of the available treatments that don’t work for omicron are effective against delta. Her department told local doctors to keep using the full range of medicines, even after other areas had narrowed their treatment arsenal.

Having academic researchers get the program up and running made the endeavor possible, said Kristynn Sullivan, chief epidemiologist for Merced County, where two testing sites are being set up. “We were interested in it theoretically, but absolutely would not have had the resources to pursue it,” said Sullivan. “What this allowed us to do is step into something that is cutting-edge, that is exciting, with fairly limited involvement.”

For the first time in her public health career, Sullivan said, money is not the department’s limitation. What it lacks most is people: In addition to being short-staffed after years of budget cuts, it’s hard to recruit workers to the area, Sullivan said, a problem shared by rural health departments around the nation.

And the setup took considerable effort, said Naughton, the engineering professor helping build surveillance programs around the northern Central Valley. It involved coordinating sampling equipment; arranging for refrigerators, coolers, and ice to preserve the samples; navigating paperwork logjams; coordinating couriers; and the complex analyses needed to transform sludge sampling results into population-level infection data.

In a recently published paper, Naughton and colleagues found that urban areas of California are much more likely to have wastewater monitoring than rural communities. Through the surveillance network she is setting up with colleagues at UC-Davis, encompassing eight new Central Valley sites, Naughton hopes to help change that. The collaboration is paid for with funds from state and federal grants, CARES Act money, and philanthropic donations.

Nearly 700 sites in three-quarters of the states are now reporting data to the National Wastewater Surveillance System set up by the CDC, including more than 30 California sites. In many states, however, the data is sparse and sporadic. And experts worry the CDC’s dashboard can be misinterpreted because it reflects percentage changes in virus detection with only limited context.

Still, having that national network will be critical going forward, said health officials, as researchers translate the raw data into usable information and compare trends across regions. But it will take sustained public will and some upgrades to keep it useful, a reality that has kept them from getting too excited about its prospects.

The CDC program is funded through 2025. The Central Valley initiative has one year of funding, though researchers hope to continue the project through at least 2023.

In Modesto, utility workers said they are happy to tap the poop supply for as long as the funding flows. “I love seeing the data used,” said Ben Koehler, water quality control superintendent and chief plant operator for the city. “People want to know that their work has purpose.”

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One California University Has Unified Town and Gown to Fight Covid. Why Haven’t Others? https://californiahealthline.org/news/article/california-university-community-unified-covid-bubble-model/ Tue, 08 Mar 2022 10:00:00 +0000 https://californiahealthline.org/?post_type=article&p=410307 Once a week, Lori Janich drives down the street from her office and partakes in an ongoing success story. Phone in hand to confirm her appointment, she strolls into the massive Activities and Recreation Center on the University of California-Davis campus, reaches a covid-19 testing station, swirls water in her mouth, spits into a tube, and leaves. Within a day, she receives her test result.

Janich doesn’t live in Davis, but because her job as a licensed dental hygienist brings her there, everything about the covid testing process is free for her. The same goes for all UC-Davis students, faculty members, and staffers; Davis city residents; local workers; and visitors — almost anyone whose life brings them into town. Davis has a population of about 70,000, with an additional 15,000 people living on campus, yet through a joint city-university effort, it has administered more than 740,000 tests.

“It’s always worked out for me,” Janich said. “I strongly recommend it to anyone qualified to use it.”

More than a year and a half in, this experiment — a cooperative project placing a university and its adjoining city inside a single, coordinated health bubble ­— has delivered superior results. Both town and gown have consistently experienced covid infection and test positivity rates markedly lower than those recorded in the surrounding region and statewide, according to reviews of state and local data.

The program, Healthy Davis Together, includes free saliva-based testing, vaccination, masks, and isolation or quarantine housing if needed. As part of the effort, UC researchers are regularly testing city wastewater for signs of SARS-CoV-2, the virus that causes covid, and workers from the program routinely screen children in the local school district. An army of 200-plus UC-Davis undergraduate “health ambassadors” raise awareness in the community, with help from a public relations firm. Even during the omicron surge, the program ramped up in time to prevent runaway infection rates.

So why haven’t lots of other campus-town combinations tried it?

“Initially, I thought, ‘Of course, other people are going to do this,’ but it turns out — at least to our knowledge — that there’s not another community in the country that did,” said Brad Pollock, chair of Public Health Sciences at UC-Davis and the program’s leader. Numerous campuses contacted by KHN, in California and outside the state, had no comment about the Davis program.

“Is this model exportable, or is there something so unique about Davis? I think the answer is ‘yes’ and ‘yes,’” Pollock said.

From the project’s inception, UC-Davis researchers and administrators have aimed to learn what happens when a university stops trying to seal itself off from the community in which it’s embedded and instead extends its health goals to that entire community.

“There is strong data that while universities are somewhat different epidemiologically than their communities, they are intertwined,” said Dr. Sarah Van Orman, who directs student health at the University of Southern California and is past president of the American College Health Association. “There are many other college towns where the university is central to community life and this type of closed bubble makes sense.”

UC-Davis researchers say the model has worked. Davis’ cumulative covid infection rate is lower than all but a handful of California’s 58 counties and is roughly half the statewide average. (Researchers are still compiling figures for hospitalizations.) In January 2021, when California was experiencing a 17% test positivity rate for covid, Davis’ weekly average came in just above 1%, according to data provided by Healthy Davis Together. And this past January, as omicron pushed state positivity rates above 20%, Davis’ weekly average never got above 5%.

“When this all began, we were told that Davis would be one of the unhealthiest cities to be in, because our students come from all over the country and all over the world,” Pollock said. “Instead, we’re one of the healthiest.”

Despite the program’s success, KHN was hard-pressed to find any similar community — a small U.S. city chiefly identified by its association with a college or university — that has followed suit.

In some cases, the roadblocks may be administrative; in others, political. Certainly, the cost of such a wide-scale program can be prohibitive. UC-Davis officials estimate that it will wind up spending $40 million to $50 million, and the city expects to have contributed $1.5 million by the program’s anticipated end in June.

“The Davis experience is a real outlier,” said John Packham, associate dean at the University of Nevada-Reno School of Medicine, who works on statewide health initiatives. “I’m not aware of any place in the U.S. that has that combination of positive factors: plenty of dollars, fidelity to evidence and science-based public health practice, social solidarity, isolation, and public/private commitment.”

The project began in summer 2020 as covid case rates began to take off. Dr. Tom Nesbitt, a senior official at UC Davis Health system, suggested to Pollock that a university-city cooperative might be possible, and Pollock sketched an outline during a weekend at his home in Sacramento. “The scheme was just a big circle with Davis in the middle, and on the periphery were all these things we’d need to do,” Pollock said.

An effective testing system was paramount, and it was delivered by Richard Michelmore, a university plant geneticist who repurposed a $400,000 machine set up to detect DNA variations in crop plants like lettuce. Michelmore engineered it to process large numbers of saliva-based covid tests instead, and it has cranked out as many as 10,000 tests a day.

The university covered costs with philanthropic donations; money from the federal Coronavirus Aid, Relief, and Economic Security Act; and state and federal grants. But it has gained the money back in other ways, Pollock said. “We were losing a lot of money by students not being on campus,” Pollock said. “We lost housing revenue immediately.”

Pollock and his associates are doing modeling to assess the savings in lives, hospitalizations, and economic activity. Davis has had slightly more than 7,900 covid cases since the pandemic began, with 26 deaths. “I think the results [of the program] are very robust,” Pollock said.

The city’s willingness to partner with the university is central to those results. When university officials approached Davis City Manager Mike Webb with the idea of trying to safeguard both entities within a single program, “my immediate response was, ‘We’re in,’” Webb said. “We all knew it was critical.”

The city had no budget for the project, so its initial contribution was in kind: It supplied city staff hours, opened city buildings as testing venues, and deployed its communications specialists to help spread the word. In January, city leaders approved $750,000 in American Rescue Plan Act money to keep the program going, and Webb asked for another $750,000 to see it through to the end of this school year.

Across the country, the relationship between campus and city or town is often strained. Davis’ own history is fractious, with previous university administrations sparring with city leaders over issues like providing adequate housing for the rapidly growing student population. But Gary May’s arrival in 2017 as UC-Davis chancellor has led to more cooperation and coordination, according to several city administrators and local businesses leaders.

The results are visible. On a warm February afternoon, the Davis campus was abuzz with activity. Matthew Nissan, a sophomore math major who is up to date on his vaccinations, said he takes a covid test at the Activities and Recreation Center once every two weeks, as required by the school. Unvaccinated students and employees, who account for 2% of the campus population, must be tested at least every four days.

“No problem doing it,” Nissan said. “I spent my freshman year in remote learning. When I finally got to campus last fall, it was like, ‘OK, this is college.’”

Around town, meanwhile, the project is hard to miss. Signs posted on almost every block remind residents to get tested and observe masking rules. People who live in the city receive regular updates about testing hours and sites. The project has expanded to include the rest of Yolo County, with testing and vaccination outreach to agricultural workers in the region’s rural stretches.

Pollock said he and his team are capturing all the information they can and sharing their experiences with colleagues on other campuses, pending publication of their work in a peer-reviewed journal. Although the Davis model appears to be rare, experts said, it may yet spread.

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‘Injections, Injections, Injections’: Troubling Questions Follow Closure of Sprawling Pain Clinic Chain https://californiahealthline.org/news/article/lags-medical-pain-clinic-chain-closure-troubling-questions-opioids-injections/ Tue, 22 Feb 2022 10:00:00 +0000 https://californiahealthline.org/?p=408955&post_type=article&preview_id=408955 HANFORD, Calif. — On May 13 of last year, the cellphones of thousands of California residents undergoing treatment for chronic pain lit up with a terse text message: “Due to unforeseen circumstances, Lags Medical Centers will be closing effective May 19, 2021.”

In a matter of days, Lags Medical, a sprawling network of privately owned pain clinics serving more than 20,000 patients throughout the state’s Central Valley and Central Coast, would shut its doors. Its patients, most of them working-class people reliant on government-funded insurance, were left without ready access to their medical records or handoffs to other physicians. Many patients were dependent on opioids to manage the pain caused by a debilitating disease or injury, according to alerts about the closures that state health officials emailed to area physicians. They were sent off with one final 30-day prescription, and no clear path for how to handle the agony — whether from their underlying conditions or the physical dependency that accompanies long-term use of painkillers — once that prescription ran out.

The closures came on the same day that the California Department of Health Care Services suspended state Medi-Cal reimbursements to 17 of Lags Medical’s 28 locations, citing without detail “potential harm to patients” and an ongoing investigation by the state Department of Justice into “credible allegations of fraud.” In the months since, the state has declined to elaborate on the concerns that prompted its investigation. Patients are still in the dark about what happened with their care and to their bodies.

Even as the government remains largely silent about its investigation, interviews with former Lags Medical patients and employees, as well as KHN analyses of reams of Medicare and Medi-Cal billing data and other court and government documents, suggest the clinics operated based on a markedly high-volume and unorthodox approach to pain management. This includes regularly performing skin biopsies that industry experts describe as out of the norm for pain specialists, as well as notably high rates of other sometimes painful procedures, including nerve ablations and high-end urine tests that screen for an extensive list of drugs.

Those procedures generated millions of dollars in insurer payments in recent years for Lags Medical Centers, an affiliated network of clinics under the ownership of Dr. Francis P. Lagattuta. The clinics’ patients primarily were insured by Medicare, the federally funded program for seniors and people with disabilities, or Medi-Cal, California’s Medicaid program for low-income residents.

Taken individually, the fees for each procedure are not eye-popping. But when performed at high volume, they add up to millions of dollars.

Take, for example, the punch biopsy, a medical procedure in which a circular blade is used to extract a sample of deep skin tissue the size of a pencil eraser. The technique is commonly used in dermatology to diagnose skin cancer but has limited use in pain management medicine, usually involving a referral to a neurologist, according to multiple experts interviewed. These experts said it would be unusual to use the procedure as part of routine pain management.

In Lagattuta’s specialty — physical medicine and rehabilitation, a common pain management field — just six of the nearly 8,000 U.S. physicians treating Medicare patients billed for punch biopsies on more than 10 patients in 2019, the most recent year for which data was available. Four, including Lagattuta, were affiliated with Lags Medical.

Medicare and Medi-Cal data are organized differently, and each provides distinct insights into Lags Medical’s billing practices. For Medicare, KHN’s findings reflect the number of procedures and actual reimbursements billed through Lagattuta’s provider number. But the Medicare figures do not encompass services and billing amounts for other providers across the chain, nor reimbursements for patients enrolled in private Medicare Advantage plans.

KHN used Medi-Cal records to assess the volume of services performed across the entire chain. But the state could not provide totals for how much Lags Medical was reimbursed because of California’s extensive use of managed-care plans, which do not make their reimbursement rates public. Where possible, KHN estimated the worth of Medi-Cal procedures based on the set rates Medi-Cal pays traditional fee-for-service plans, which are public.

Lags Medical clinics performed more than 22,000 punch biopsies on Medi-Cal patients from 2016 through 2019, according to state data. Medi-Cal reimbursement rates for punch biopsies changed over time. In 2019 the state’s reimbursement rate was more than $200 for a set of three biopsies performed on patients in fee-for-service plans.

Laboratory analysis of punch biopsies was worth far more. Lags Medical clinics sent biopsies to a Lags-affiliated lab co-located at a clinic in Santa Maria, according to medical records and employee interviews. From 2016 through 2019, Lags Medical clinics and providers performed tens of thousands of pathology services associated with the preparation and examination of tissue samples from Medi-Cal patients, according to state records. The services would have been worth an estimated $3.9 million using Medi-Cal’s average fee-for-service rates during that period.

In that same period, Medicare reimbursed Lagattuta at least $5.7 million for pathology activities using those same billing codes, federal data shows.

Much of the work at Lags Medical was performed by a relatively small number of nurse practitioners and physician assistants, each juggling dozens of patients a day with sporadic, often remote supervision by the medical doctors affiliated with the clinics, according to interviews with former employees. Lagattuta himself lived in Florida for more than a year while serving as medical director, according to testimony he provided as part of an ongoing malpractice lawsuit that names Lagattuta, Lags Medical, and a former employee as defendants.

Former employees said they were given bonuses if they treated more than 32 patients in a day, a strategy Lagattuta confirmed in his deposition in the malpractice lawsuit. “If they saw over, like, 32 patients, they would get, like, $10 a patient,” Lagattuta testified.

The lawsuit, filed in Fresno County Superior Court, accuses a Lags Medical provider in Fresno of puncturing a patient’s lung during a botched injection for back pain. Lagattuta and the other named defendants have denied the incident was due to negligent treatment, saying, in part, the patient consented to the procedure knowing it carried risks.

Hector Sanchez, the nurse practitioner who performed the injection and is named in the lawsuit, testified in his own deposition that providers at the Lags Medical clinic in Fresno each treated from 30 to 40 patients on a typical workday.

According to Sanchez’s testimony and interviews with two additional former employees, Lags Medical clinics also offered financial bonuses to encourage providers to perform certain medical procedures, including punch biopsies and various injections. “We were incentivized initially to do these things with cash bonuses,” said one former employee, who asked not to be named for fear of retribution. “There was a lot of pressure to get those done, to talk patients into getting these done.”

In his own deposition in the Fresno case, Lagattuta denied paying bonuses for specific medical procedures.

Interviews with 17 former patients revealed common observations at Lags Medical clinics, such as crowded waiting rooms and an assembly-line environment. Many reported feeling pressure to consent to injections and other procedures or risk having their opioid supplies cut off.

Audrey Audelo Ramirez said she had worried for years that the care she was receiving at a Lags Medical clinic in Fresno was subpar. In the past couple of years, she said, there were sometimes so many patients waiting that the line wrapped around the building.

Ramirez, 52, suffers from trigeminal neuralgia, a rare nerve disease that sends shocks of pain across the face so severe it’s known as the “suicide disease.” Over the years, Lags Medical had taken over prescribing almost all her medications. This included not only the opioids and gabapentin she relies on to endure excruciating pain, but also drugs to treat depression, anxiety, and sleep issues.

Ramirez said she often felt pressured to get procedures she didn’t want. “They were always just pushing injections, injections, injections,” she said. She said staffers performed painful punch biopsies on her that resulted in an additional diagnosis of small fiber neuropathy, a nerve disorder that can cause stabbing pain.

She was among numerous patients who said they felt they needed to undergo the recommended procedures if they wanted continued prescriptions for their pain medications. “If you refuse any treatment they say they’re going to give you, you’re considered noncompliant and they stop your medication,” Ramirez said.

She said she eventually agreed to an injection in her face, which she said was administered without adequate sedation. “It was horrible, horrible,” she said. Still, she said, she kept going to the office because there weren’t many other options in her town.

Lagattuta, through his lawyer, declined a request from KHN to respond to questions about the care provided at his clinics, citing the state investigation. “Since there is an active investigation, Dr. Lagattuta cannot comment on it until it is completed,” attorney Matthew Brinegar wrote in an email. Lagattuta’s license remains in good standing, and he said in his deposition in the Fresno lawsuit that he is still seeing patients in California.

Experts interviewed by KHN noted that medical procedures such as injections can have a legitimate role in comprehensive pain management. But they also spoke in general terms about the emergence of a troubling pattern at U.S. pain clinics involving the overuse of procedures. In the 1990s and early 2000s, problematic pain clinics hooked patients on opioids, then demanded cash to continue prescriptions, said Dr. Theodore Parran, who is a professor of medicine at Case Western Reserve University and has served as an expert witness in federal investigations into pain clinics.

“What has replaced them are troubled pain clinics that hook patients with the meds and accept insurance, but overuse procedures which really pay well,” he said. For patients, he added, the consequences are not benign.

“I mean they are painful,” he said. “You’re putting needles into people.”

‘Knee Injections, Hip Injections, Foot Injections’

Before moving to California in 1998, Dr. Francis Lagattuta lived in Illinois and worked as a team doctor for the Chicago Bulls during its 1995-96 championship season. Out West, he opened a clinic in Santa Maria, a Latino-majority city along California’s Central Coast known for its strawberry fields, vineyards, and barbecue. From 2015 to 2020, the chain grew from a couple of clinics in Santa Barbara County to dozens throughout California, largely in rural areas, as well as far-flung locations in Washington state, Delaware, and Florida.

The California portion of the chain is organized as more than two dozen corporations and limited liability corporations owned by Lagattuta. His son, Francis P. Lagattuta II, was a manager for the company.

On the Lags Medical website and in conversation with employees, the elder Lagattuta claimed he was on the vanguard of diagnosing and treating small fiber neuropathy. Much of the website has now been taken down. But pages available via an archival site claim he had pioneered a three-pronged approach to pain management that made minimal use of opioids and surgeries, instead emphasizing testing, injections, mental health, diet, and exercise. “In keeping with his social justice values, Dr. Lagattuta plans to share these findings to the rest of the world, hopefully to help solve the opioid crisis, and end suffering for millions of people struggling with pain,” touted a biography once highlighted on the website.

Numerous Lags Medical patients interviewed by KHN said that even when they were given punch biopsies and a subsequent diagnosis of neuropathy, their treatment plan continued to involve high doses of opioid medications.

Dr. Victor C. Wang, chief of the division of pain neurology at Brigham and Women’s Hospital in Boston, said punch biopsies are occasionally used in research but are not a standard part of pain medicine. Instead, small fiber neuropathy is usually diagnosed with a simple clinical exam.

“The treatment is going to be the same whether you have a biopsy or not,” said Wang. “I always tell the fellows, you can do this test or that one, but is it really going to change the management of the patient?”

Ruby Avila, a mother of three in Visalia, remembers having the punch biopsies done at least three times during her four years as a Lags Medical patient. “I have scars down my leg,” she said. Each time, she said, providers removed a set of three skin specimens that were used to diagnose her with small fiber neuropathy.

Avila, 37, who has lived with pain since childhood, had found it validating to finally have a diagnosis. But after learning more about how common the biopsies were at Lags Medical, she was shaken. “It’s overwhelming to hear that they were doing it on a lot of people,” she said.

Sanchez, the nurse practitioner named in the Fresno lawsuit, spoke of other procedures that garnered bonuses: “Trigger point injections, knee injections, hip injections, foot injections for plantar fasciitis and elbow injections” all qualified for $10 bonuses, he said in his testimony.

Two former employees, who asked not to be named, echoed Sanchez, saying they were incentivized to do certain procedures, including injections and punch biopsies.

In his testimony in the Fresno case, Lagattuta denied paying bonuses for procedures. “It was only for the patients,” he said. “We never did it based on procedures.”

Incentive systems for a specific procedure are “completely unethical,” said Dr. Michael Barnett, an assistant professor of health policy at Harvard. “It’s like giving police officers a quota for speeding tickets. What do you think they’re going to do? I can’t think of any justification.”

Dr. Carl Johnson, 77, is a pathologist who directed Lags Medical’s Santa Maria lab from 2018 to 2021. Johnson said the only specimens he looked at came from punch biopsies, the first time in his long career as a pathologist that he had been asked to run such an analysis. On an average day, he said, he examined the slides of about 40 patients, searching for signs of small fiber neuropathy. Lagattuta gave him papers to read on peripheral neuropathy and assured him they were on the cutting edge of care for pain patients. Johnson said he “never thought there was anything untoward going on” until he arrived on his last day and was told to pack up his belongings because the entire operation was shutting down.

Lags Medical performed other procedures at rates that also set them apart. From 2015 through 2020 — the span for which KHN had state data — Lags Medical performed more than 24,000 nerve ablations, a procedure in which part of a nerve is destroyed to reduce pain, on Medi-Cal patients. That’s more than 1 in 6 of all nerve ablations billed through Medi-Cal during that period.

An analysis of federal data also shows Lagattuta was an outlier. For example, in 2018 he billed Medicare for nerve ablations more often than 88% of the doctors in his field who performed the procedure.

Lags Medical also used the in-house lab to run drug tests on patients’ urine samples. From 2017 through 2019, Lags Medical facilities often ordered the most extensive — and expensive — set of drug tests, which check for the presence of at least 22 drugs, according to state and federal data.

For perspective, in 2019, more than 23,000 of the most extensive drug tests were ordered on Medi-Cal patients under Lagattuta’s provider number, more than double the number tied to the next highest biller. The next five top billers were all lab companies.

Overall, from 2017 through 2019, nearly 60,000 of the most extensive drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for these tests during that period. Using state fee-for-service rates, the testing billed to Medi-Cal would have been worth an estimated $6.3 million. That doesn’t include less extensive drug screens or those billed under other providers’ numbers.

Pain management experts described the use of extensive screening as unnecessary in routine pain treatment; the overuse of such tests has been the subject of numerous Medicare investigations in recent years.

Private pain clinics like Lags Medical are only loosely regulated and generally are not required to hold a special license from the state. But the physicians who work there are regulated by the Medical Board of California.

In December 2019, a patient who’d visited clinics in both Visalia and the Central Coast filed a complaint against Lagattuta with the medical board claiming, among other things, that she received biopsies that were not properly performed, that she underwent excessive testing, and that positive drug tests had been falsified. The medical board had another pain management doctor review more than 300 pages of documents and found “no deviations from the standard of care” and “did not find any over testing, or improperly performed biopsies.”

He did, however, find some record-keeping problems, including numerous procedures in which patient consent was not documented. He also found instances in which procedures were performed and repeated without documentation that they were effective. The patient who filed the complaint was given a medial branch nerve block in November 2014, followed by a radiofrequency ablation in December, and another in February. No improvements for the patient were ever noted in the charts, the investigating doctor found.

The medical board chalked it up to a record-keeping error and fined Lagattuta $350.

A Halfway-Normal Life

On a warm evening in late July, Leah Munoz drove her power wheelchair around the long plastic tables at the Veterans Memorial Building in Hanford, a dusty farm town in California’s Central Valley. Senior bingo night was crowded with gray-haired players waiting for the game to begin. She found an empty spot and carefully set out $50 worth of bingo cards, alongside her collection of 14 brightly colored daubers.

Munoz, 55 and a mother of six, said she has suffered from a litany of illnesses — thyroid cancer, breast cancer, lupus, osteoarthritis — that leave her in near-constant pain. She’s been playing bingo since she was a little girl, and said it helps distract from the pain and calm her mind. She looks forward to this event all week.

Munoz was a Lags Medical patient for about four years and, while her pain never disappeared, the opioids prescribed provided enough relief for her to continue doing the things she loved. “There’s a difference between addiction and dependence. I need it to live a halfway-normal life,” Munoz said.

After Lags Medical closed in May, her primary care doctor initially refused to refill her opioid prescriptions. She said she called the Lags Medical offices to try to get a copy of her medical records to prove her need, and even showed up in person. But she said she was unable to get them. As the pills dwindled and the pain surged, Munoz said, it became hard to leave her home. “I missed a lot of bingo, a lot of grocery shopping, a lot of going to my grandkids’ birthday parties. You miss out on life,” she said. Ultimately, she said, her primary care doctor referred her to another pain clinic, and she was able to resume her prescription.

Even with pain medications, Munoz said, she never received true relief during her time as a patient at Lags Medical. She said she felt coerced to get several injections, none of which seemed to help. “If I didn’t get the procedures, I didn’t get the pain medication,” she said. Her husband, Ramon, a landscaper who was also a patient, received an injection there that he said left him with permanent stiffness in his neck.

Munoz knows at least five other people at bingo night who were former patients at Lags Medical. One of them, Rick Freeman, came over to her table to chat. He swayed back and forth as he walked, his knees, he explained, swollen after 35 years living with HIV. At Lags Medical, Freeman said, he felt pressured by staff to receive injections if he wanted to continue receiving his opioid prescriptions. “If you don’t cooperate with them, they would reduce your meds down,” he said.

At the front of the room, Gail Soto, who ran the event, sold bingo cards to the latecomers. Soto, 72, said she injured her back while working an administrative job at a construction company years ago and suffers from spinal stenosis, rheumatoid arthritis, and fibromyalgia. She, too, was a patient at Lags Medical for years. In addition to her opioid prescription, Soto said, she received repeated injections and three nerve ablations. At first, the ablations helped, but what staff members didn’t tell her, she said, was that the nerves they destroyed could grow back. Ultimately, she said, the procedures left her in worse pain.

Soto’s biggest concern is the spinal stimulator that she said Lags Medical surgically inserted into her back five years ago. She said the doctors told her the device would work so well that she would no longer need her pain pills. She said they didn’t explain that the device would work only two hours a day, and on one side of her body. She remained in too much pain to give up her meds, she said, and, five years later, the battery is failing.

Soto sleeps in a recliner chair in her three-bedroom mobile home in Lemoore, another small city near Hanford. It’s well kept but humble, and she and her husband keep a collection of wind chimes on the front porch that create a wave of gentle music when a breeze passes by. The couple take good care of each other and their two beloved Chihuahuas, but life has become increasingly difficult for Soto.

As the battery on her spinal stimulator has started to fail, she said, she has sudden electrical pulses that shoot up her body. “My husband says sometimes when I sleep that my body will just jump up in the air,” she said. But now that Lags Medical is closed, she said, she can’t find a doctor willing to remove the device. “Most doctors are telling me right now, ‘We can’t, because we didn’t [put it in]. We don’t want nothing to do with that.’”

Waitlists and Withdrawal

Audrey Audelo Ramirez said she picked up her final refill from Lags Medical on June 4 and by July 4 had no meds left to treat her pain. Ramirez said she called every pain management clinic in Fresno, but none were taking new patients.

“They left us all high and dry,” she said. “Everybody.”

In the weeks that followed the closures, county officials throughout the Central Valley saw a flood of patients on high doses of opioids in search of new providers, they said. Patients couldn’t access their medical records, so other providers had no idea what their treatments had been.

“We had to create a crisis response to it because there was no organized response at that time,” said Dr. Rais Vohra, the interim health officer for Fresno County.

Fresno County’s health system is already lean, Vohra said. Toss in this abrupt closure and you end up in the kind of crisis rarely seen in other fields of medicine: “You’d never do this with a cancer clinic,” he said. “You’d never abruptly stop chemo.”

The state asked Dr. Phillip Coffin, director of substance abuse research for the San Francisco Department of Public Health, to run provider training and persuade doctors to take on new patients. Many practices have rules against taking new patients on opioids, or will refuse to prescribe doses above certain thresholds.

“We know that when you stop prescribing opioids, some people end up with death from suicide, overdose, increased illicit opioid use, pain exacerbations. It’s really important to have a continuity, and that is not really possible in the current opioid-prescribing culture,” Coffin said. The threat to patients is so severe that the FDA issued a warning in 2019 against cutting patients off from prescription opioids.

Gina, a retired nurse who asked to be identified by only her first name for fear she’d be discriminated against by other doctors, had been a Lags Medical patient for six years. She said she called every practice she could find in her Central Coast town, and was put on a waiting list at one. Suffering from a severe case of scoliosis, she started rationing the pain pills she had come to rely on.

When she finally secured an appointment, she said, she was told by the doctor she was on “some very strong meds” and he would fill only one of her two prescriptions. “You’re like a criminal,” she said. “You’re branded as ‘we don’t trust you.’”

She started experiencing withdrawal symptoms — sweating, lost appetite, sleeplessness, anxiety. Worst of all, her pain “came back with a vengeance,” she said.

“I think about this, what I’d have been like if I’d never gone through pain management. I sometimes wonder if I’d be better off.”

As for Ramirez, her primary care doctor finally secured an appointment for her at another pain clinic, she said. It was in the same space as the old Lags Medical clinic, and she said she recognized many of the staff members. But now there was a new name: Central California Pain Management. From her perspective, it was as if nothing had changed. And she still doesn’t know whether she needs to worry about the care she received during more than four years at Lags Medical.

The new clinic’s owner, Dr. Ashok Parmar, said that he is leasing the space and that Lagattuta is his landlord. Parmar said he doesn’t do punch biopsies, nor does he diagnose small fiber neuropathy. After all, he said, he would treat the pain the same way, with or without the diagnosis.

How We Did This

KHN evaluated the billing practices of physicians and clinics associated with Lags Medical Centers using data from both Medicare and Medi-Cal.

KHN did multiple analyses using Medicare Part B records that show, for each medical practitioner or lab, every procedure or service billed to the federal government, along with the number of times a procedure was performed, the number of Medicare beneficiaries who received specific services, and how much Medicare reimbursed. The Part B records include billings from 2015 through 2019, the most recent years available. The records are limited to beneficiaries who have traditional fee-for-service Medicare rather than private Medicare Advantage plans. Medicare suppressed data in cases in which a provider performed a procedure on 10 or fewer beneficiaries in a year.

KHN analyzed Medicare billing records for a range of specific procedures, comparing Dr. Francis P. Lagattuta’s billings with those of other practitioners who also identified themselves in the records as Physical Medicine and Rehabilitation specialists.

Through a public records request, KHN also obtained data from the California Department of Health Care Services for a range of specific medical procedures performed on state Medi-Cal recipients by all California providers from 2015 through 2020, as well as every service rendered through Medi-Cal under Lagattuta’s provider number during that time. The Medi-Cal data is organized to show both the rendering and billing provider for a procedure, allowing KHN to look across the network of Lags Medical clinics. To calculate services provided at Lags Medical Centers, KHN included services performed under Lagattuta’s provider number, as well as active provider numbers of organizations with a mailing address associated with Lags Medical clinics that listed Dr. Francis P. Lagattuta or another Lags employee as their authorized official. DHCS suppressed data for instances in which a provider performed a procedure fewer than 11 times on Medi-Cal patients in a year.

The Medi-Cal data did not include reimbursement amounts for procedures, so KHN obtained historical reimbursement amounts from DHCS to calculate the value of the services based on the fee-for-service reimbursement rate in July of each year. Care received by patients with Medi-Cal is generally reimbursed by the state in one of two ways: a fee-for-service model, in which physicians are reimbursed for services according to a set fee schedule that is public; or a managed-care model, in which the state pays insurers a monthly fee per patient, and the insurers reimburse providers amounts that are not public. Only a small percentage of Lags Medical services were reimbursed through fee-for-service plans during the years reviewed. As a result, the values of procedures calculated by KHN are meant to convey a general estimate of their worth. All estimates are calculated using the Basic Rate.

KHN senior correspondent Jordan Rau and Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

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.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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‘Somebody Is Gonna Die’: Medi-Cal Patients Struggle to Fill Prescriptions https://californiahealthline.org/news/article/california-medicaid-patients-struggle-to-fill-prescriptions-medi-cal-rx/ Wed, 09 Feb 2022 10:00:00 +0000 https://californiahealthline.org/?post_type=article&p=407732 SACRAMENTO — A month into its debut, California’s new Medicaid prescription drug program is riddled with problems, leaving thousands of patients without medications — often after languishing on hold for up to eight hours on call center phone lines.

On Jan. 1, the state handed control of its Medicaid drug program, known as Medi-Cal Rx, to Magellan Health, which is administering prescription drug coverage for California’s 14 million Medicaid patients, most of whom previously got their medications from about two dozen managed-care plans.

But Magellan has tripped up implementation. It didn’t anticipate that calls to its help center would take so long, and a large number of its call center workers have been sickened during the omicron surge — with 100 of 220 absent during the first two weeks of January, state officials said. Magellan also didn’t get some data it needed from managed-care plans.

This has left Californians from Redding to Oceanside without their medications for days, sometimes weeks.  

“We’ve had many, many patients who are sort of in this limbo,” said Dr. James Schultz, chief medical officer of Neighborhood Healthcare, which operates 17 clinics in Riverside and San Diego counties. 

“Somebody is gonna die if they haven’t already,” added Schultz, who said some of his clinics’ patients have experienced delays getting life-saving medications such as antibiotics or those used to prevent seizures and blood clots. “That’s why we’re fighting so hard.”

Officials from the California Department of Health Care Services, which administers Medi-Cal, California’s Medicaid program for low-income people, called the problems “unacceptable.” The department and Magellan Health are scrambling to find missing patient data, fix improper claim denials, add call center staffers, and provide pharmacists with codes to override prescription denials. 

Handing over Medi-Cal’s drug program to a single pharmacy benefit manager is one of Gov. Gavin Newsom’s big health care initiatives. His administration estimates it will save the state $414 million in the 2022-23 budget year alone, in part by getting bigger discounts on drugs than the managed-care insurance plans did.

But the massive transfer has been rocky for many providers, pharmacists, and patients, especially patients who use medications their doctors consider medically necessary but require prior authorizations from Medi-Cal Rx and are generally not on the state’s approved drug list. Magellan has received more than 95,000 prior authorization requests since it took over, state officials said. 

In the months leading up to the switch, patients and doctors were told all their medications would be grandfathered into the new system for 180 days, but that hasn’t always been the case.  

Marilyn Bloomer of Oceanside had gone nearly a week without a specialty histamine prescription that she takes to regulate an overactive allergic response in her body, a condition known as mast cell activation syndrome, because her pharmacist and Magellan said it was no longer covered. When she finally reached someone at the Magellan call center last week — six hours after she placed the call — a supervisor gave her a code the pharmacist could use to override the denial. 

But the pharmacy wouldn’t accept it. 

On Monday, Bloomer’s health plan secured an emergency five-day supply for her, but she doesn’t know what will happen when it runs out. Without the medication, called ketotifen, Bloomer gets bright red, patchy hives all over her face. 

“I’m getting the runaround, and I’m getting confused,” said Bloomer, 57, who said her face had been beginning to swell. “It’s beyond frustrating.”

State officials said Magellan representatives had answered more than 81,000 calls at the 24-hour, 7-day-a-week call center as of Feb. 1 and paid 11 million prescription claims totaling approximately $1.3 billion as of Feb. 4.

“As we sit here, clearly five weeks into operations, Magellan, our contractor, has really struggled with some service operations,” Jacey Cooper, the state’s Medicaid director, told lawmakers at an Assembly budget subcommittee hearing Monday.

She said that the Department of Health Care Services is holding daily meetings with Magellan to discuss its management of the program and that the state has provided staffers to help answer calls at the Medi-Cal Rx call center. The immediate goal, Cooper added, is to ensure medications that require prior authorization are approved within 24 hours. In the meantime, she said, the state has given pharmacies the go-ahead to fill emergency prescriptions for up to two weeks. It also has removed prior authorization requirements for some medications.

Magellan referred media questions to the Department of Health Care Services.

After the hearing, Assembly member Joaquin Arambula (D-Fresno), who chairs the Assembly budget subcommittee that oversees Medi-Cal, said he is satisfied with the administration’s plan. “I believe there’s a real path forward to implementing the system successfully,” he told KHN.

Sharon Ng, pharmacy director at the Venice Family Clinic, isn’t as optimistic. Even though state officials say they have given pharmacies authorization to use override codes and fill temporary emergency prescriptions, prescriptions continue to be denied. 

“It’s just chaos,” Ng said. “We just kept getting rejections. It’s been so frustrating because the rejection doesn’t tell you what’s wrong. And then if you finally go through their lines, they don’t help you either. They’re just guessing.”

What Magellan needs, she added, is a dedicated hotline for pharmacists — like the managed-care plans had — so they don’t have to compete with Medi-Cal patients.

Patients and legal advocates say they are confounded by the chaos because both the state and Magellan had plenty of time to prepare for the rollout, since the program was delayed by nearly a year after the health care company Centene announced plans to acquire Magellan.

Medi-Cal Rx finally launched Jan. 1 after state officials ruled in December that Magellan could independently administer the Medi-Cal drug benefit without any conflict of interest with its new owner. 

“Magellan should have come into this understanding fully what the volume and the needs were going to be,” said Jack Dailey, an attorney with the Legal Aid Society of San Diego, which is representing some Medi-Cal enrollees unable to get their medication. “I did not think this is where we would be a month into this process.”

Shah’ada, a mother in Redding, has spent the past two weeks desperately trying to get her 16-year-old son’s birth control medication approved. He is transgender and hadn’t had a period in five years until last week, she said. Without the birth control, he bled for 11 days. 

“Things in our household have started dissolving,” said Shah’ada, who asked that her last name not be published to protect her son’s privacy. “He’s been depressed, unable to go to school for several days, really high anxiety. It’s just very emotional and frustrating.”

When Shah’ada tried to fill the prescription, the pharmacist told her that it was denied because of her son’s gender. 

She dialed the prescription call center every chance she got. Her managed-care plan suggested there was a glitch in the system but didn’t know how to help since it no longer controls prescription drugs for its members. Her son’s doctor tried to submit more paperwork to no avail, and she submitted a grievance to Medi-Cal Rx. 

Over the weekend, she finally got approval for her son’s birth control, but she’s worried about refilling the prescription in three months.

Schultz, the San Diego County physician, said his staff is also directed to the call center to ask questions when patients are denied medications. But the appeal form they are asked to fill out is incomplete, he said, lacking a section for the previous medications a patient has tried, for instance, information Medi-Cal Rx requires for approval.

“We’ve got people out with covid. We really don’t have time to sit on hold for eight hours. We have dozens of patients in the same boat,” Schultz said. “Theoretically, all of our staff could be tied up on hold with Magellan. We can’t do it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Clinics Say State’s New Medicaid Drug Program Will Force Them to Cut Services https://californiahealthline.org/news/article/clinics-lawsuit-prescription-drugs-medicaid/ Tue, 11 Jan 2022 02:05:00 +0000 https://californiahealthline.org/?post_type=article&p=404326 SACRAMENTO — California’s sweeping new program to buy prescription drugs for its nearly 14 million Medicaid patients has alarmed health clinics that say they will lose money and have to cut services.

Gov. Gavin Newsom acknowledged Monday that some clinics, which serve the poorest Californians, would lose funding, and he included $105 million for them in the 2022-23 proposed state budget he unveiled in the state capital. 

But the allocation falls far short of what clinic officials say they need to keep critical health care services funded in some of California’s neediest areas. California’s federally qualified health centers, which operate more than 1,000 clinics across the state, have filed a lawsuit in federal court to exempt them from the program, but a judge on Monday denied their request for a temporary reprieve while the lawsuit proceeds.

“People are going to be laid off; services are going to be cut,” said Anthony White, president of the Community Health Center Alliance for Patient Access, a statewide organization of federally qualified health centers. “It’s going to decrease access for our patients.”

The drug program, known as Medi-Cal Rx, debuted Jan. 1 and is one of Newsom’s key health care initiatives. It takes the responsibility for prescription drug coverage in the state’s Medicaid program away from managed-care plans and puts it into the hands of a state contractor.

On his first day in office in 2019, Newsom promised the overhaul would deliver better health care for patients and generate “substantial annual savings” because the state would negotiate lower prices as one of the largest drug purchasers in the country. 

The Newsom administration anticipates the state will save $414 million in the 2022-23 budget year and nearly two times that amount in the next one, said Keely Martin Bosler, director of the California Department of Finance. 

California’s health clinics, however, could lose up to $200 million a year in drug reimbursements, White estimated, money they have been using to care for patients with asthma, HIV and other chronic health problems. The reimbursement money is a key revenue stream for clinics, but they rely primarily on federal grants for their funding, in addition to some patient revenue and private donations.

At issue is money the clinics have received through a federal prescription drug savings program known as “340B.” The 340B program requires drug manufacturers participating in Medicaid to offer deep discounts to certain providers that care for underserved and uninsured people, including health clinics. The health centers, in turn, must use that money to expand health care services. 

Beginning Jan. 1, California started buying prescription drugs for all its low-income and disabled residents enrolled in Medi-Cal, the country’s largest Medicaid program. Because the state expects to get bigger discounts on drugs than the roughly two dozen Medi-Cal managed-care insurance plans did, clinics expect to receive less 340B money. 

The $105 million Newsom earmarked for health clinics in his budget proposal to offset their losses was not intended to fully replace them, said Michelle Baass, director of the state Department of Health Care Services, which administers Medi-Cal, in the state’s Jan. 5 response to the clinics’ lawsuit.

“Plaintiffs have no entitlement to continued profits from selling marked up 340B drugs,” she wrote.

The funding Newsom proposed is not guaranteed. Indeed, it is now subject to the annual budget negotiation process. The legislature has until June 15 to negotiate with Newsom and adopt a deal. The 2022-23 state budget takes effect July 1. 

Mark Ghaly, secretary of the state’s Health and Human Services Agency, said the administration has been working with clinics and is open to further discussions.

“We’re always happy to sit down and try to understand what the conditions are today,” Ghaly said. 

California Healthline’s Angela Hart contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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With Sexually Transmitted Infections Off the Charts, California Pushes At-Home Tests https://californiahealthline.org/news/article/sexually-transmitted-infections-stds-california-at-home-tests/ Tue, 04 Jan 2022 10:00:00 +0000 https://californiahealthline.org/?post_type=article&p=403033 SACRAMENTO — California has become the first state to require health insurance plans to cover at-home tests for sexually transmitted infections such as HIV, chlamydia and syphilis — which could help quell the STI epidemic that has raged nearly unchecked as public health departments have focused on covid-19.

The rule, part of a broader law addressing the STI epidemic, took effect Jan. 1 for people with state-regulated private insurance plans and will kick in sometime later for the millions of low-income Californians enrolled in the state’s Medicaid program.

By making it easier and cheaper for Californians to self-administer tests in the privacy of their homes, the provision could bring better disease monitoring to rural and underserved parts of the state, reduce the stigma patients experience when seeking care and give them more control over their health, say experts on infectious diseases.

“This is the first law of its kind, and I’d say it’s kind of cutting-edge,” said Stephanie Arnold Pang, senior director of policy and government relations for the National Coalition of STD Directors. “We want to bring down every single barrier for someone to get STI testing, and out-of-pocket cost is a huge factor.”

But being first has its downsides. Because the concept of insurance coverage for home STI tests is so new, the state’s Medicaid program, Medi-Cal, could not establish by Jan. 1 the billing codes it needs to start paying for tests. Federal regulators also haven’t approved the tests for home use, which could make labs reluctant to process them. And a state analysis predicts most in-network health care providers won’t start prescribing home tests for at least a year until they adjust their billing and other practices.

Nevertheless, the situation is urgent and requires action, said state Sen. Richard Pan (D-Sacramento), a pediatrician who wrote the law.

“We have children born in California with syphilis,” Pan said. “You’d think that went away in the Victorian era.”

Even before covid, sexually transmitted infections hit all-time highs in the U.S. and California for six years in a row, according to 2019 data from the Centers for Disease Control and Prevention. Rates of congenital syphilis, which babies contract from their mothers, illustrate the severity of the STI epidemic: Cases were up 279% from 2015 to 2019 nationally and 232% in California. Of the 445 cases of congenital syphilis in California in 2019, 37 were stillbirths.

The pandemic only worsened the problem because health departments were overwhelmed responding to the covid emergency, and stay-at-home orders kept people away from clinics.

In surveys of public health programs across the country since May 2020, the National Coalition of STD Directors found that most respondents — up to 78% in one survey — have diverted some of their STI workforces to test and monitor covid. A report that accompanied the most recent survey found that some STIs were “completely unchecked” due to reductions in clinic hours, diversion of resources, shortages of testing kits and staff burnout.

Some at-home STI tests screen for a single disease but other kits can collect and send samples to check for a variety of infections. Depending on the test, patients collect a drop of blood with a lancet, or swab their mouth, vagina, anus or penis.

Some tests require patients to send samples to a lab for analysis, while some oral HIV tests give results at home in a few minutes.

Ivan Beas, a 25-year-old graduate student at UCLA, was getting tested frequently as part of a two-year research study. When clinics closed during the pandemic, researchers sent him a home kit.

The kit, which tests for HIV, hepatitis C, herpes, syphilis, chlamydia, gonorrhea and trichomoniasis, was packaged discreetly and came with easy instructions. It took Beas about 10 minutes to prick his finger, swab his mouth and send the samples to the lab.

Beas wanted to continue screening himself every few months after the study ended, he said, but the kit he used retails for $289, which is out of reach for him.

The last time he went to a clinic in person, “I spent two hours waiting to even be seen by a doctor because of how busy they are,” he said. Until Medi-Cal begins covering home tests, he said, he will have to find time to get tested for free at a Planned Parenthood clinic.

“If insurance were to cover it, I’d definitely do it more,” he said.

Under California’s new law, plans regulated by the state must cover home STI tests when ordered by a health care provider.  

Privately insured Californians can take advantage of the coverage immediately. How much they will owe out-of-pocket for the tests — if anything — depends on the type of plan they have, whether their provider is in-network, and if they fall into a category the federal government has designated for free screening.

Medi-Cal patients almost never face out-of-pocket expenses, but they will have to wait for coverage because the Department of Health Care Services, which administers Medi-Cal, is working with the American Medical Association and the federal government to create billing codes. The reimbursement rates for those codes will then need federal approval.

The state doesn’t know how long that process will take, according to department spokesperson Anthony Cava.

The rule does not apply to the millions of Californians whose job-based health insurance plans are regulated by the federal government.

Other states and organizations have experimented with at-home STI tests. The public health departments in Alabama and the District of Columbia send free kits to residents who request them, but neither jurisdiction requires insurance coverage for them. The National Coalition of STD Directors is sending free kits to people through health departments in Philadelphia; Iowa; Virginia; Indiana; Puerto Rico; and Navajo County, Arizona. The list of recipients is expected to grow this month.

Iwantthekit.org, a project of Johns Hopkins University, has been sending free kits to Maryland residents since 2004, and to Alaskans since 2011. The program is funded by grants and works with local health departments.

Charlotte Gaydos, co-founder of the project, said that requests for test kits during the pandemic nearly tripled — and that she would expand to every state if she could bill insurance the way the California law mandates.

The tests fall into a murky regulatory area. While they have been approved by the Food and Drug Administration, none have been cleared for use at home. Patients are supposed to collect their own samples within the walls of a health facility, and some labs may not analyze samples collected at home.

Public health officials cited other potential challenges: Patients may not have the same access to counseling, treatment or referrals to other services such as food banks that they would receive at clinics. And although patients are supposed to self-report the results of their tests to public health authorities, some people won’t follow through.

Vlad Carrillo, 31, experienced such trade-offs recently. Carrillo used to get tested at a San Francisco clinic, where they could get counseling and other services. But Carrillo lost their apartment during the pandemic and moved about seven hours away to Bishop, the only incorporated city in rural Inyo County.

“Being away from the city, it took me a whole year to find a way to get tested,” Carrillo said.

Carrillo eventually got the kit through the mail, avoiding the stigma of going to the clinic in Bishop, which is “more focused on straight stuff,” like preventing pregnancy. Without the test, Carrillo couldn’t get PrEP, a medication to prevent HIV.

“Going without it for so long was really hard on me,” Carrillo said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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