Category: From California Healthline.org

When Joshua Martz tested positive for COVID-19 this summer in a Montana jail, guards moved him and nine other inmates with the disease into a pod so cramped that some slept on mattresses on the floor.

Martz, 44, said he suffered through symptoms that included achy joints, a sore throat, fever and an unbearable headache. Jail officials largely avoided interacting with the COVID patients other than by handing out over-the-counter painkillers and cough syrup, he said. Inmates sanitized their hands with a spray bottle containing a blue liquid that Martz suspected was also used to mop the floors. A shivering inmate was denied a request for an extra blanket, so Martz gave him his own.

“None of us expected to be treated like we were in a hospital, like we’re a paying customer. That’s just not how it’s going to be,” said Martz, who has since been released on bail while his case is pending in court. “But we also thought we should have been treated with respect.”

The overcrowded Cascade County Detention Center in Great Falls, where Martz was held, is one of three Montana jails experiencing COVID outbreaks. In the Great Falls jail alone, 140 cases have been confirmed among inmates and guards since spring, with 60 active cases as of mid-September.

When inmate Joshua Martz tested positive for COVID-19 this summer at the Cascade County Detention Center in Great Falls, Montana, guards moved him and nine other inmates with the disease into a pod so cramped that some slept on mattresses on the floor. (Matt Volz/KHN)

By contrast, the Montana state prison system has the second-lowest infection rate in the nation, according to the COVID Prison Project. No confirmed coronavirus cases have been reported at the men’s prison out of 595 inmates tested. The women’s prison had just one confirmed case out of 305 inmates tested, according to Montana Department of Corrections data.

One reason for the high COVID count in jails and the low count in prisons is that Montana for months halted “county intakes,” or the transfer of people from county jails to the state prison system after conviction. Sheriffs in charge of the county jails blame their outbreaks on overcrowding partly caused by that state policy.

Restricting transfers into state prisons is a practice that’s also been instituted elsewhere in the U.S. as a measure to prevent the spread of the coronavirus. Colorado, California, Texas and New Jersey are among the states that suspended inmate intakes from county jails in the spring.

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But it’s also shifted the problem. Space was already a rare commodity in these local jails, and some sheriffs see the halting of transfers as giving the prisons room to improve the health and safety of their inmates at the expense of those in jail, who often haven’t been convicted.

The Cascade County jail was built to hold a maximum of 372 inmates, but the population has regularly exceeded that since the pandemic began, including dozens of Montana Department of Corrections inmates awaiting transfer.

“I’m getting criticized from various judges and citizens saying, ‘Why aren’t you quarantining everybody appropriately and why aren’t you social-distancing them?’” Cascade County Sheriff Jesse Slaughter said. “The truth is, if I didn’t have 40 DOC inmates in my facility I could better do that.”

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Unlike convicted offenders in state prisons, most jail inmates are only accused of a crime. They include a disproportionately high number of poor people who cannot afford to post bail to secure their release before trial or the resolution of their cases. If they do post bail or are released after spending time in a jail with a COVID outbreak, they risk bringing the disease home with them.

Andrew Harris, a professor of criminology and justice studies at the University of Massachusetts Lowell, said he finds it troubling that more attention is not paid to the conditions that lead to COVID outbreaks in jails.

“Jails are part of our communities,” Harris said. “We have people who work in these jails who go back to their families every night, we have people who go in and out of these jails on very short notice, and we have to think about jail populations as community members first and foremost.”

Some states have tried other ways to ensure county inmates don’t bring COVID-19 into prisons. In Colorado, for example, officials lifted their suspension on county intakes and are transferring inmates first to a single prison in Canon City, Department of Corrections spokesperson Annie Skinner said. There, inmates are tested and quarantined in single cells for 14 days before being relocated to other state facilities.

Outbreaks are also occurring in county jails in states that never stopped transferring inmates to state prison. Several jails in Missouri have experienced significant outbreaks, with Greene County reporting in mid-August that 83 inmates and 29 staffers had tested positive. Missouri Department of Corrections spokesperson Karen Pojmann said the state never opted to stop transfers from county jails, likely because of a robust screening and quarantine procedure implemented early in the pandemic.

At least 1,590 inmates and 440 staff members have tested positive for COVID-19 in Missouri’s 22 prison facilities since March, according to state data. The COVID Prison Project ranks Missouri’s case rate 25th among the states — better than some states that halted inmate transfers, including Colorado, Texas and California.

The halting of transfers was a critical part of the response by officials in California, whose prisons have been among the hardest hit by COVID-19. An outbreak at San Quentin State Prison this summer helped spur Democratic Gov. Gavin Newsom to order the early release of 10,000 inmates from prisons statewide.

Stefano Bertozzi, dean emeritus at the University of California-Berkeley School of Public Health, visited San Quentin before the outbreak, and afterward helped pen an urgent memo outlining immediate actions needed to avert disaster. He recommended halting all intakes at the prison and slashing its population of 3,547 inmates in half. At that point, the California Department of Corrections and Rehabilitation was already more than two months into an intake freeze.

Overcrowding has long been an issue for criminal justice reform advocates. But for Bertozzi, the term “overcrowding” needs to be redefined in the context of COVID-19, with an emphasis on exposure risk. Three inmates sharing a cell designed for two is a bad way to live, he said, “especially for the guy who’s on the floor.” But if those cells are enclosed, they offer far better protection from COVID-19 than 20 inmates sharing a congregate dorm designed for 20.

“It’s how many people are breathing the same air,” Bertozzi said.

Some California county jails struggled. In July, inmates in Tulare County’s facility, where 22 cases had been reported, filed a class action suit against Sheriff Mike Boudreaux alleging he’d failed to provide face masks and other safeguards. U.S. District Court Judge Dale Drozd ruled in favor of the inmates in early September, directing Boudreaux to implement official policies requiring face coverings and social distancing.

California resumed county intakes on Aug. 24 following the development of guidelines designed to control transmission risk and prioritize counties with the greatest need for space. But a huge backlog remains: 6,552 state inmates were still being held in county jails as of mid-September, according to corrections officials.

In Montana, the number of inmates at county jails awaiting transfer to prisons and other state corrections facilities was 238 at the beginning of September, according to state data obtained through a public records request.

Montana and county officials butted heads over delays in inmate transfers before the coronavirus, but the pandemic has increased the stakes.

“Once we had the issue with the pandemic and we had to maintain space for quarantining and isolating inmates, then it became even more critical because the space wasn’t really available,” Yellowstone County Sheriff Mike Linder said.

Montana Department of Corrections Director Reginald Michael acknowledged to state lawmakers in August that halting county intakes places a strain on counties but said it was “the right thing to do.”

“This is one of the reasons why I think our prisons are not inundated with the virus spread,” he told the Law and Justice Interim Committee.

Committee Chairman Rep. Barry Usher, a Republican, gave Michael his endorsement: “Sounds like you guys are doing a good job keeping it controlled and out of our prison systems, and everybody in Montana appreciates that.”

Since then, Montana officials have transferred up to 25 inmates a week, but they continue to block transfers from the three counties with outbreaks: Cascade, Yellowstone and Big Horn.

Martz dreaded the thought of COVID-19 following him out of jail. So much so that, after his release in early September, he walked to an RV park, where his wife met him with a tent.

Despite having tested negative for the virus prior to his release, he self-quarantined for a week before going home. The hardest part, he said, was not being able to immediately hug his 5-year-old stepdaughter. It “sucked,” but it’s what he felt he had to do.

“If somebody’s grandpa or grandmother had gotten it because I was careless and they ended up dying because of it, I’d feel horrible,” said Martz, who has returned home. “That’d be a horrible thing to do.”

When it comes to health care, President Donald Trump has promised far more than he has delivered. But that doesn’t mean his administration has had no impact on health issues — including the operation of the Affordable Care Act, prescription drug prices and women’s access to reproductive health services.

In a last-ditch effort to raise his approval rating on an issue on which he trails Democrat Joe Biden in most polls, Trump on Thursday unveiled his “America First Healthcare Plan,” which includes a number of promises with no details and pumps some minor achievements into what the administration calls “monumental steps to improve the efficiency and quality of healthcare in the United States.”

As the election nears, here is a brief breakdown of what Trump has done — and has not done — on some key health issues.

Affordable Care Act

Trump has not managed to repeal and replace the Affordable Care Act, despite his claims that the law is dead.

But his administration, and Republicans in Congress, have made changes to weaken the law while not dramatically affecting enrollment in marketplace plans.

Congress failed to rewrite the law in summer 2017, but Republicans who controlled both the House and Senate at the time included in their year-end tax cut bill a provision that reduced the penalty for failing to have health insurance to zero. That change eliminated what was by far the most unpopular provision of the law.

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It also sparked a lawsuit by Republican state attorneys general and governors arguing that the tax change undercuts the law and thus should invalidate it. The case is set to be heard by the Supreme Court the week after the Nov. 3 election. The Trump administration is formally supporting the GOP plaintiffs in that suit.

The administration also used executive and regulatory action to chip away at the law’s efficacy. Trump ended disputed cost-sharing subsidies to help insurers lower out-of-pocket costs for policyholders with low incomes. And the administration shortened the open enrollment period by half and slashed the budget for promoting the plans and paying people to help others navigate the often-confusing process of signing up.

Administration officials have complained that plans sold on the ACA marketplaces are not affordable, so they set new rules that allowed companies to sell competing “short-term” policies that were less expensive than ACA-sanctioned plans. But those plans are not required to provide comprehensive benefits or cover preexisting conditions.

Now, weeks before the election, federal officials are taking credit for premiums coming down, slightly, on ACA plans. “Premiums have gone down across all of our programs, including in healthcare.gov, which had been previously seeing double-digit rate increases,” Seema Verma, who runs Medicare, Medicaid and the ACA exchanges, told reporters in a Sept. 24 conference call.

Premiums have come down this past year, confirmed Sabrina Corlette, who tracks the ACA as co-director of the Center on Health Insurance Reforms at Georgetown University, but only after many of the Trump administration’s changes had driven them even higher. Insurers were spooked by the uncertainty — particularly in 2017, about whether the law would be repealed — and Trump’s cutoff of federal funding for subsidies.

“The bottom line is, rates have gone up under Trump,” Corlette said.

Women’s Reproductive Health

Before he was elected, Trump pledged his allegiance to anti-abortion activists, who in turn urged their supporters to vote for him. But unlike many previous GOP presidents who called themselves “pro-life” but pushed the issue to the back burner, Trump has delivered on many of his promises to abortion foes.

Foremost, Trump has nominated two justices to the Supreme Court who were supported by anti-abortion advocates. With the help of the GOP Senate, Trump has also placed 200 conservative judges on federal district and appeals courts.

While many of the policy proposals advanced by the Trump administration are tied up in court, the sheer volume of activity has been notable, outstripping in less than four years efforts by Presidents Ronald Reagan and George W. Bush over each of their two-term presidencies.

Among those actions is a re-implementation and broadening of the “Mexico City Policy” that restricts foreign aid funding to organizations that “perform or promote” abortion. The administration has also moved to push Planned Parenthood out of the federal family planning program and Medicaid program. In addition, it has moved to make private insurance that covers abortion harder to purchase under the Affordable Care Act.

Trump’s efforts on women’s reproductive health reach beyond abortion to birth control. New rules would make it easier for employers with a “moral or religious objection” to decline to offer birth control as a health insurance benefit. Other rules would make it easier for health workers to decline to participate in any procedure to which they personally object.

COVID-19

Trump often claims that his decision in February to stop most travel from China was a critical factor in keeping the coronavirus pandemic in the U.S. from being worse than it has been. But the “travel ban” not only failed to stop many people from entering the U.S. from China anyway, scientists would later determine that the virus that spread widely in New York and other cities on the East Coast most likely came from Europe.

Although the White House has a coronavirus task force, the administration primarily has allowed states and localities to determine their own restrictions and timetables for closing and opening. The administration also had difficulty distributing medical supplies from a stockpile established for exactly this purpose. The president’s son-in-law and White House adviser, Jared Kushner, said at one point that the purpose of the stockpile was to supplement state supplies, not provide them.

Testing was also a problem. An early test developed by the Centers for Disease Control and Prevention turned out to be faulty, and despite continued promises by administration officials, testing remains less available six months into the pandemic than most experts recommend. Meanwhile, Trump has claimed repeatedly — and falsely — that if the U.S. did less testing there would be fewer cases of the virus.

But many public health observers say the administration’s biggest failing during the pandemic has been the lack of a single national message about the coronavirus and the best ways to prevent its spread.

More than 200,000 people in this country have died. Although the United States has only 4% of the world’s population, it has recorded 21% of the fatalities around the globe.

Prescription Drug Costs

Trump pledged to attack high drug costs as one of his main campaign themes in 2016 and again this year. But he has not had the success he hoped for.

In one of the administration’s biggest moves, the Department of Health and Human Services approved a rule last week that allows states to set up programs to import drugs from Canada, where they are cheaper because the Canadian government limits prices. Yet, it’s unclear if the program will get off the ground, given drug industry opposition and resistance from the Canadian government.

In his health care policy speech Thursday, Trump promised to send each Medicare beneficiary a $200 discount card over the next several months to help them buy prescription drugs. The initiative is being done under a specific innovation program and must not add to the deficit. Administration officials Friday could not answer where they will get the nearly $7 billion to pay for what is perceived by many observers as a last-ditch stunt to win votes from older Americans.

The president previously signed an executive order that seeks to tie the price Medicare pays for drugs to a lower international reference price. The administration, however, hasn’t released formal regulations to implement the policy, which could take years, and the policy is expected to be challenged in court by the drug industry.

In addition, Medicare will cap the price of insulin at $35 per prescription starting in 2021 for people getting coverage through some drug plans. More than 3 million Medicare beneficiaries use insulin to control their diabetes.

Trump also signed a law banning gag clauses used by health plans and pharmacy benefit managers to bar pharmacists from telling consumers about lower-priced drug options.

The administration’s plan to require drug companies to provide prices in pharmaceutical advertising has been beaten back in court.

The administration points to the increased number of generic drugs that have been approved since Trump was elected, but many of those drugs are not on the market. That’s because generic companies sometimes make deals with brand-name manufacturers to delay introducing lower-cost versions of their medicines.

At the same time, several bills the president supported to lower prices have stalled in Congress because of partisan differences and industry opposition.

“I don’t think there has been any meaningful action that has had meaningful effect on drug prices,” said Katie Gudiksen, a senior health policy researcher at The Source on Healthcare Price and Competition, a project of UC Hastings College of the Law in San Francisco.

Yet, she said, it’s possible Trump’s harsh criticism of the industry has had a chilling effect that led to lower prices.

Still, out-of-pocket costs for many individuals continue to climb as private and government insurance shifts more responsibility to the patient via higher cost sharing. Good Rx, an online site that tracks drug prices, noted this month that prescription drug prices have increased by 33% since 2014, faster than any other medical service or product.

Medicaid

The Trump administration has tried — but largely failed — to make many major changes to the state-federal health insurance program that covers more than 70 million low-income Americans.

Efforts by Republicans to repeal the Affordable Care Act would have ended the federal funding for the District of Columbia and the 38 states that expanded their programs for everyone with incomes under 138% of the federal poverty level, or about $17,609 for an individual. About 15 million people have gained coverage through the expansion.

Trump administration officials have argued that Medicaid should be reserved for the most vulnerable Americans, including traditional enrollees such as children, pregnant women and the disabled, and not used for non-disabled adults who gained coverage under the ACA’s expansion. Since Trump took office, seven states have expanded Medicaid — Idaho, Maine, Missouri, Oklahoma, Nebraska, Utah and Virginia.

In 2018, federal officials allowed states for the first time to require some enrollees to work as a condition for Medicaid coverage. The effort resulted in more than 18,000 Medicaid enrollees losing coverage in Arkansas before a federal judge halted implementation in that state and several others. The case has been appealed to the Supreme Court.

The administration also backed a move in Congress to change the way the federal government funds Medicaid. Since Medicaid’s inception in 1966, federal funding has increased with enrollment and health costs. Republicans would like to instead offer states annual block grants that critics say would dramatically reduce state funding but that proponents say would give states more flexibility to meet their needs.

When the congressional attempt to establish block grants failed, the administration tried through executive action to implement a process allowing states to opt into a block grant. Yet only one state — Oklahoma — applied for a waiver to move to block-grant funding, and it withdrew its request in August, two weeks after voters there narrowly passed a ballot initiative to expand Medicaid to 200,000 residents.

Medicaid enrollment fell from 75 million in January 2017 to about 71 million in March 2018. Then the pandemic took hold and caused millions of people to lose jobs and their health coverage. As of May, Medicaid enrollment nationally was 73.5 million.

The administration’s decision to expand the “public charge” rule, which would allow federal immigration officials to more easily deny permanent residency status to those who depend on certain public benefits, such as Medicaid, has discouraged many people from applying for Medicaid, said Judith Solomon, senior fellow with the Center on Budget and Policy Priorities, a research group based in Washington, D.C. 

Medicare

Seniors were among Trump’s most loyal voters in 2016, and he has promised repeatedly to protect the popular Medicare program. But not all his proposals would help the seniors who depend on it.

For example, invalidating the Affordable Care Act would eliminate new preventive benefits for Medicare enrollees and reopen the notorious “doughnut hole” that subjects many seniors to large out-of-pocket costs for prescription drugs, even if they have insurance.

Trump also signed several pieces of legislation that accelerate the depletion of the Medicare trust fund by cutting taxes that support the program. And his budget for fiscal 2021 proposed Medicare cuts totaling $450 billion.

At the same time, however, the administration implemented policies dramatically expanding payment for telehealth services as well as a kidney care initiative for the millions of patients who qualify for Medicare as a result of advanced kidney disease.

Surprise Billing

Trump in May 2019 promised to end surprise billing, which leaves patients on the hook for often-exorbitant bills from hospitals, doctors and other professionals who provide service not covered by insurance.

The problem typically occurs when patients receive care at health facilities that are part of their insurance network but are treated by practitioners who are not. Other sources of surprise billing include ambulance companies and emergency room physicians and anesthesiologists, among other specialties.

An effort to end the practice stalled in Congress as some industry groups pushed back against legislative proposals.

“The administration was supportive of the pretty consumer-friendly approaches, but obviously it doesn’t have any results to speak of,” said Loren Adler, associate director of the USC-Brookings Schaeffer Initiative for Health Policy in Los Angeles.

“At the end of the day, plenty of people in Congress did not really want to get something done,” he said.

Taking a different route, the administration finalized a rule last November that requires hospitals to provide price information to consumers. The rule will take effect Jan. 1. A federal judge shot down an attempt by hospitals to block the rule, although appeals are expected.

Brian Blase, a former Trump adviser, said this effort could soon help consumers. “Arguably, the No. 1 problem with surprise bills is that people have no idea what prices are before they receive care,” he said.

But Adler said the rule would have a “very minor effect” because most consumers don’t look at prices before deciding where to seek care — especially during emergencies.

Public Health/Opioids

Obesity and the opioid addiction epidemic were two of the nation’s biggest public health threats until the coronavirus pandemic hit this year.

The number of opioid deaths has shown a modest decline after a dramatic increase over the past decade. Overall, overdose death rates fell by 4% from 2017 to 2018 in the United States. New CDC data shows that, over the same period, death rates involving heroin also decreased by 4% and overdose death rates involving prescription drugs decreased by 13.5%.

The administration increased funding to expand treatment programs for people using heroin and expanded access to naloxone, a medication that can reverse an overdose, said Dr. Georges Benjamin, executive director of the American Public Health Association.

Meanwhile, the nation’s obesity epidemic is worsening. Obesity, a risk factor for severe effects of COVID-19, continues to become more common, according to the CDC.

Twelve states — Alabama, Arkansas, Indiana, Kansas, Kentucky, Louisiana, Michigan, Mississippi, Oklahoma, South Carolina, Tennessee and West Virginia — have a self-reported adult obesity prevalence of 35% or more, up from nine states in 2018 and six in 2017.

Benjamin said some of the administration’s other policies, such as reducing access to food stamps and undermining clean air and water regulations, have made improving public health more difficult.

But the pandemic has been the major public health issue this administration has faced.

“We were doing a reasonable job addressing the opioid epidemic until COVID hit,” Benjamin said. “This shows the fragility of our health system, that we cannot manage these three epidemics at the same time.”

STERLING, Colo. — Tonja Jimenez is far from the only person driving an RV down Colorado’s rural highways. But unlike the other rigs, her 34-foot-long motor home is equipped as an addiction treatment clinic on wheels, bringing lifesaving treatment to the northeastern corner of the state, where patients with substance use disorders are often left to fend for themselves.

As in many states, access to addiction treatment remains a challenge in Colorado, so a new state program has transformed six RVs into mobile clinics to reach isolated farming communities and remote mountain hamlets. And, in recent months, they’ve become more crucial: During the coronavirus pandemic, even as brick-and-mortar addiction clinics have closed or stopped taking new patients, these six-wheeled clinics have kept going, except for a pit stop this summer for air conditioning repair.

Their health teams perform in-person testing and counseling. And as broadband access isn’t always a given in these rural spots, the RVs also provide a telehealth bridge to the medical providers back in the big cities. Working from afar, these providers can prescribe medicine to fight addiction and the ever-present risk of overdose, an especially looming concern amid the isolation and stress of the pandemic.

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Mobile health clinics have been around for years, bringing vision tests, asthma treatment and dentistry to places without adequate care. But using health care on wheels to treat addiction isn’t as common. Nor is equipping such motor homes with telehealth capability that expands the reach of prescribing providers to treat hard-to-reach patients in these hard-to-reach rural areas.

“We really believe we bring treatment to our patients and we meet them where they’re at,” said Donna Goldstrom, clinical director for Front Range Clinic, a Fort Collins, Colorado, practice that operates four of the RVs. “So meeting them where they’re at physically is not a long leap from meeting them where they’re at motivationally and psychologically.”

Each RV has a nurse, a counselor and a peer specialist who has personal experience with addiction — and all had to be trained to drive a vehicle that size.

“I never thought when I went to nursing school that I’d be doing this,” Christi Couron, a licensed practical nurse, said as she pumped 52 gallons of diesel fuel into the motor home she works on with Jimenez.

The crew has driven their RV more than 30,000 miles since January, much of it viewed through a cracked windshield courtesy of a summer afternoon hailstorm. Four days a week, they ply the roads from Greeley to the smaller towns near the Nebraska border, as the view goes from mile-high to miles-wide.

Don a Mask, Pee in a Cup

On a dusty lot outside a halfway house in Sterling, Jimenez, the peer specialist, activates the leveling jacks to balance the RV, and the team readies the unit for the day’s slate of patients. The passenger-side captain’s chair flips around to face a table where Jimenez will check in patients. The tabletop is crowded with a printer, a scanner, a laptop and a label-maker. Underneath lie a box of specimen cups and a gallon of windshield washer fluid. The vehicle now has plenty of masks and cleaning supplies on hand, too.

After patients check in, they go to the RV’s snug bathroom to provide a urine sample. With test strips built into the sides of the cup, results show instantly whether any of 13 categories of drugs — from opiates to antidepressants — are in the urine. The sample is later dropped off at a lab to confirm the results and determine which specific drug is involved. The results help the team understand how best to treat the patients and make sure they use the prescriptions they’re given.

Patients then head to a small exam room in the back, where they connect via video to a nurse practitioner or physician assistant in a brick-and-mortar clinic.

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If all goes well, the provider will send over a prescription for Suboxone (a combination medicine containing buprenorphine, which reduces cravings for opioids) or for Vivitrol (a monthly injectable version of naltrexone, which blocks opioid receptors). Once the staffers have the prescription in hand, the RV nurse can give those Vivitrol shots directly and distribute Narcan, a medication that will reverse an opioid overdose. Suboxone prescriptions must be called into a local pharmacy.

Patients also can drop used needles into a sharps container for disposal, but the staffers are not allowed to distribute clean needles. Some patients will talk with counselor Nicky McLean in a room just large enough to fit a table and two chairs.

Within minutes, a couple, who asked not to be identified by name because of the stigma surrounding addiction, arrive early for their appointments. They’ve brought the staff homemade chicken enchiladas. They had been spending $8,000 a month buying OxyContin on the street, and their lives and finances were a wreck. He lost his house. She needs clean urine tests to see her son. The couple started their addiction treatment only three weeks earlier, after he learned about the RV clinic from a friend.

They no longer have a car, so they walked a half-hour to get to their appointment.

“We would’ve done anything to get our drugs,” she said. “Walking 30 minutes to get better, it’s worth it.”

Even before they’ve finished, another patient is at the door. Spencer Nash, 29, has been using opioids since he was 18. Nine years ago, when his wife got pregnant, the couple decided to get clean, driving two hours each way, six days a week, to a methadone clinic in Fort Collins. Now, he walks to the RV, outside the halfway house where he lives, to get his Suboxone prescription.

Filling the Gaps

A few years ago, Robert Werthwein, director of Colorado’s Office of Behavioral Health, heard about a project using RVs for addiction treatment in rural upstate New York. He thought it would work in his state, too. The agency crunched the numbers to see which regions recorded the highest levels of opioid prescriptions and overdoses but lacked addiction treatment.

“We hear too often that in rural Colorado and the mountain regions of Colorado they don’t have the same access to services as the Denver metro and the Front Range regions,” Werthwein said. The state secured a $10 million federal grant for the program. His team brought in health care providers, such as Front Range Clinic, to staff and operate the RVs.

Once the RVs were ready, the staff had to be trained to drive them, which necessitated “a couple of repairs,” Werthwein said. The vehicles first started rolling out in December, eventually serving six regions — and in a seventh area, a place where narrow mountain roads precluded a large RV, one of Werthwein’s teams travels by SUV.

In some communities, the local doctors and others have been less than thrilled, feeling the RVs would attract drug users to their town.

“We’re hoping to address stigma, not just from a public standpoint, but we’re hoping to show providers ‘there is a demand in your community for medication-assisted treatment,’” Werthwein said.

Once the federal grant runs out in September 2022, Front Range Clinic and the other mobile unit operators will inherit and continue to operate the RVs, billing Medicaid and private insurance as they do now for the appointments.

As the RV crew’s 1 p.m. departure time in Sterling approached, one patient remained. The woman, who asked that her name not be published because she didn’t want to be publicly identified as a drug user, arrived at the mobile clinic without an appointment. But they couldn’t take her as a new patient without a urine sample. For two hours, she was in and out of the bathroom, drinking bottles of water, but unable to fill the little plastic cup. Through the bathroom door, the staffers could hear her crying and cursing at herself.

With the battery power on the RV winding down, they coaxed her out of the bathroom. Perhaps tomorrow would work better, they told her. She could continue to rehydrate through the night and then meet the mobile unit at its next stop, Fort Morgan, some 45 minutes away.

The next day, she was still unable to produce a urine sample, whether because of dehydration from her substance use or simply nerves. They asked her to come back again when the RV returned to Sterling the next week, but she never showed up.

President Donald Trump, outlining his “America First Health Plan” Thursday, announced that his administration will allow the importation of prescription drugs from Canada.

The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.

Florida, the biggest swing state in the presidential election, is one of six states to pass laws seeking federal approval to import drugs. Trump’s announcement came the same day counties in Florida began sending out vote-by-mail ballots.

Florida Gov. Ron DeSantis, a close ally of the president, is a strong advocate of importing drugs. His administration has already advertised for a contractor to run the state program and is expected to announce Tuesday which companies have bid for the three-year, $30 million state contract.

Congress has allowed drug importation since 2000 but only if the secretary of the Department of Health and Human Services certified it is safe. That has never occurred until Secretary Alex Azar did it Wednesday, according to a letter he wrote to congressional leaders.

Implementation under the administration’s final rule “poses no additional risk to the public’s health and safety and will result in a significant reduction in the cost of covered products to the American consumer,” Azar said in the letter KHN obtained Thursday.

Prices are cheaper north of the border because Canada limits how much drugmakers can charge for medicines. The United States lets free market dictate drug prices.

The pharmaceutical industry has long fought efforts on importation, arguing that it would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.

“We are reviewing the final rule and guidance that were released; however, we continue to have grave concerns with drug importation that exposes Americans unnecessarily to the dangers of counterfeit or adulterated drugs,” said a spokesperson for the Pharmaceutical Research and Manufacturers of America, an industry trade group. “It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic.”

Drugmakers have suggested in the past that they might try to stop such a policy through a lawsuit.

Trump has dangled his drug importation plan in campaign speeches over the past year — and again on Thursday in North Carolina during a speech that provided a litany of his promises on health care.

“We will finally allow the safe and legal importation of drugs from Canada,” Trump said. States “can go to Canada and buy your drugs for a fraction of the price” in the U.S.

“This will be a game changer for American seniors,” Trump said. “We’re doing it very, very quickly.”

The administration proposed the regulation in December. The final rule says it takes effect in 60 days.

But individuals will not be allowed to import drugs on their own, Azar said in his letter. Instead, they will have to rely on programs run by states.

For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the internet or using storefronts that connect them to foreign pharmacies. Though the practice is illegal, the FDA has generally permitted purchases for individual use.

About 4 million Americans import medicines for personal use each year, and about 20 million say they or someone in their household has done so because prices are much lower in other countries, according to surveys.

The practice has been especially common in retiree-rich Florida, where more than a dozen stores help consumers make the purchases and where numerous cities, counties and school districts assist employees with the transactions.

The administration envisions a system in which a Canadian-licensed wholesaler buys from a manufacturer of drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.

Florida’s legislation — approved in 2019 — would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the program to save the state about $150 million annually.

The second program would be geared to the broader state population.

The HHS final rule said the government will “in the future” allow pharmacists to import drugs from Canada, a provision that matches the law approved by Florida in 2019.

But pharmacists in Florida and across the country oppose drug importation, saying they don’t think it will ensure that counterfeit drugs are kept out of the U.S. market.

The Canadian government told HHS last spring that the country doesn’t have enough drugs to spare and the Trump plan would only worsen shortages of medicines there.

The final rule said state importation programs will have flexibility to decide which drugs to import and in what quantities.

The rule also makes clear that drug manufacturers will have to provide to importers documentation guaranteeing the medications are the same drugs as those already sold in the United States. HHS could set up regulations that require drugmakers to comply. Importers will have to send drugs to labs to certify their authenticity.

In addition to Florida, the other states seeking federal permission to buy drugs from Canada are Colorado, Maine, New Hampshire, New Mexico and Vermont.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Matthew Fentress was just 25 when he passed out while stuffing cannolis as a cook for a senior living community six years ago. Doctors diagnosed him with viral cardiomyopathy, heart disease that developed after a bout of the flu.

Three years later, the Kentucky man’s condition had worsened, and doctors placed him in a medically induced coma and inserted a pacemaker and defibrillator. Despite having insurance, he couldn’t pay what he owed the hospital. So Baptist Health Louisville sued him and he wound up declaring bankruptcy in his 20s.

“The curse of being sick in America is a lifetime of debt, which means you live a less-than-opportune life,” said Fentress, who still works for the senior facility, providing an essential service throughout the coronavirus pandemic. “The biggest crime you can commit in America is being sick.”

Financial fears reignited this year when his cardiologist suggested he undergo an ablation procedure to restore a normal heart rhythm. He said hospital officials assured him he wouldn’t be on the hook for more than $7,000, a huge stretch on his $30,000 annual salary. But if the procedure could curb the frequent extra heartbeats that filled him with anxiety, he figured the price was worth it.

He had the outpatient procedure in late January and it went well.

Afterward, “I didn’t have the fear I’m gonna drop dead every minute,” he said. “I felt a lot better.”

Then the bill came.

Patient: Matthew Fentress is a 31-year-old cook at Atria Senior Living who lives in Taylor Mill, Kentucky. Through his job, he has UnitedHealthcare insurance with an out-of-pocket maximum of $7,900 — close to the maximum allowed by law.

Total Bill: Fentress owed a balance of $10,092.13 for cardiology, echocardiography and family medicine visits on various dates in 2019 and 2020. UnitedHealthcare had paid $28,920.52 total, including $27,561.37 for the care he received on the day of his procedure.

Service Provider: Baptist Health Louisville, part of the nonprofit system Baptist Health.

Medical Service: Fentress underwent cardiac ablation this year on Jan. 23. The outpatient procedure involved inserting catheters into an artery in his groin that were threaded into his heart. He also had related cardiology services, testing and visits to a primary care doctor and a cardiologist before and after the procedure.

What Gives: Fentress said he always made sure to take jobs with health insurance, “so I thought I’d be all right.”

But like nearly half of privately insured Americans under age 65, he has a high-deductible health plan, a type of insurance that experts say often leaves patients in the lurch. When he uses health providers within his insurer’s network, his annual deductible is $1,500 plus coinsurance. His out-of-pocket maximum is $7,900, more than a quarter of his annual salary.

Fentress owed around $5,000 after his 2017 hospitalization and set up a monthly payment plan but said he was sent to collections after missing a $150 payment. He declared bankruptcy after the same hospital sued him.

He faced another bill about a year later, when a panic attack sent him to the emergency room, he said. That time, he received financial aid from the hospital.

When he got the bill for his ablation this spring, he figured he wouldn’t qualify for financial aid a second time. So instead of applying, he tried to set up a payment plan. But hospital representatives said he’d have to pay $500 a month, he said, which was far beyond his means and made him fear another spiral into bankruptcy.

This precarious situation makes him “functionally uninsured,” said author Dave Chase, who defines this as having an insurance deductible greater than your savings. “It’s a lot more frequent than a lot of people realize,” said Chase, founder of Health Rosetta, a firm that advises large employers on health costs. “We’re the undisputed leaders in medical bankruptcy. It’s a sad state of affairs.”

Jennifer Schultz, an economics professor and co-director of the Health Care Management program at the University of Minnesota-Duluth, said Fentress faces a difficult financial road ahead. “Once you declare bankruptcy, your credit rating is destroyed,” she said. “It will be hard for a young person to come back from that.”

A recent survey by the Commonwealth Fund found that just over a quarter of adults 19 to 64 who reported medical bill problems or debt were unable to pay for basic necessities like rent or food sometime in the past two years. Three percent had declared bankruptcy. In the first half of 2020, the survey found, 43% of U.S. adults ages 19 to 64 were inadequately insured. About half of them were underinsured, with deductibles accounting for 5% or more of their household income, or out-of-pocket health costs, excluding premiums, claiming 10% or more of household income over the past year.

In Fentress’ case, the $10,092 he owed the hospital was more than a third of what his insurer paid for his care. The majority of his debt — $8,271.56 — was coinsurance, about 20% of the bill, which he must pay after meeting his deductible. Because the bill covered services spanning two years, he owed more than his annual out-of-pocket maximum. If all his care had been provided during 2019, he would have owed much less and the insurer would have been responsible for more of the bill.

Dr. Kunal Gurav, an Atlanta cardiologist who wrote about medical costs for the American College of Cardiology, said ablation usually costs about $25,000-$30,000, a range also confirmed by other experts.

The insurer’s payment for Fentress’ care that January day — around $27,600 — falls into the typical cost range, Gurav said. Fentress is being asked to pay $9,296, meaning the hospital would get more than $36,000 for the care.

Schultz, a state representative from Minnesota’s Democratic-Farmer-Labor Party, said nonprofit hospitals could potentially waive or reduce costs for needy patients.

“They definitely have a moral responsibility to provide a community benefit,” she said.

Resolution: Charles Colvin, Baptist Health’s vice president for revenue strategy, said hospital officials quoted Fentress an estimated price for the ablation that was within a few dollars of the final amount, although his bill included other services such as tests and office visits on various dates. Colvin said there appeared to be some charges that UnitedHealthcare didn’t process correctly, which could lower his bill slightly.

Maria Gordon Shydlo, communications director for UnitedHealthcare, said Fentress is responsible for 100% of health costs up to his annual, in-network deductible, then pays a percentage of health costs in “coinsurance” until he reaches his out-of-pocket maximum. So he will owe around $7,900 on his bill, she said, and any new in-network care will be fully covered for the rest of the year.

A hospital representative suggested Fentress apply for financial assistance. She followed up by sending him a form, but it went to the wrong address because Fentress was in the process of moving.

In September, he said he was finally going to fill out the form and was optimistic he’d qualify.

The Takeaway: Insurance performs two functions for those lucky enough to have it. First, you get to take advantage of insurers’ negotiated rates. Second, the insurer pays the majority of your medical bills once you’ve met your deductible. It pays nothing before then. High-deductible plans have the lowest premiums, so they are attractive or are the only plans many patients can afford. But understand you will be asked to pay for everything except preventive care until you’ve hit that number. And your deductible may be only part of the picture: “Coinsurance” is the bulk of what Fentress owes.

Out-of-pocket maximums are regulated by federal law. In 2021, the maximum will be $8,550 for single coverage. Try to plan treatment and procedures with an eye on the calendar — people with chronic conditions and this kind of insurance could save a lot of money if they have an expensive surgery in December rather than January.

As always, if you face a big medical bill, ask about payment plans, financial aid and charity care. According to the Baptist Health system’s website, the uninsured and underinsured can get discounts. Those with incomes equivalent to 200%-400% of the federal poverty level — or $25,520-$51,040 for an individual — may be eligible for assistance.

If you don’t qualify for help, negotiate with the hospital anyway. Arm yourself with information about the going rate insurers pay for the care you received by consulting websites like Healthcare Bluebook or Fair Health.

As Fentress tries to move past his latest bill, he’s now worried about something else: racking up new bills if he contracts COVID-19 down the road as an essential worker with existing health problems and the same high-deductible insurance.

“I don’t have hope for a financially stable future,” he said. “It shouldn’t be such a struggle.”

Dan Weissmann, host of “An Arm and a Leg” podcast, reported the radio interview of this story. Joe Neel of NPR produced Sacha Pfeiffer’s interview with KHN Editor-in-Chief Elisabeth Rosenthal on “All Things Considered.”

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

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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The death of Supreme Court Justice Ruth Bader Ginsburg — and the insistence of President Donald Trump and the GOP-led Senate to fill that vacancy this year — could have major implications for health care. The high court will hear yet another case challenging the constitutionality of the Affordable Care Act the week after the November election, and a long list of cases involving women’s reproductive rights, including both abortion and birth control, are working their way through lower federal courts.

Meanwhile, scandals at the Department of Health and Human Services continue to surface, such as the case of a media spokesperson for the National Institutes of Health who criticized his boss’s handling of the pandemic via a conservative website. And the Centers for Disease Control and Prevention continues to struggle with its credibility, after posting and then taking down another set of guidelines, this one concerning whether the COVID-19 virus is spread through aerosol particles.

This week’s panelists are Julie Rovner of Kaiser Health News, Anna Edney of Bloomberg News, Kimberly Leonard of Business Insider and Mary Ellen McIntire of CQ Roll Call.

Among the takeaways from this week’s podcast:

• The Supreme Court’s upcoming ACA case was brought by Republican state officials seeking to invalidate the law based Congress’ elimination of the penalty for not having insurance, a provision that the court once used to uphold the law because it was considered part of Congress’ right to impose taxes.
• Many legal experts believe that even if the high court were to decide that the loss of the penalty invalidates the individual mandate to get insurance, other parts of the law should be able to stand. But it’s not clear conservatives on the court will agree.
• With so much emphasis on the ACA’s insurance marketplace, the expansion of the Medicaid program for low-income people and protections for people with preexisting conditions, many consumers don’t realize that the law touches nearly all aspects of health care, including guarantees of preventive services, insurance practices and even requirements for calorie counts on restaurant menus.
• Ginsburg’s death could also influence efforts to undermine abortion rights. Two cases are already before the court, one involving the ability of doctors to remotely prescribe drugs that can end a pregnancy and a Mississippi ban on abortions after the 15th week of pregnancy.
• As the nation marks more than 200,000 deaths from the coronavirus, the “What the Health?” panel looks at problems in the U.S. effort to fight COVID-19, including flip-flops on the need for masks, inconsistent messaging from different parts of government and the politicization of science.
• The Centers for Disease Control and Prevention’s decision to remove guidance on the coronavirus’s ability to spread through the air created more concerns about the politicization of the federal government’s scientific studies. The controversy over the agency’s work is a stark change from the past, when the CDC was considered among the least politicized parts of the government.
• It may take years after these coronavirus controversies for the CDC to restore its credibility with the public, no matter who is elected president.
• Trump has touted his efforts to lower prescription drug prices, and last week The New York Times reported that the administration tried unsuccessfully to get drugmakers to send a $100 gift card to all seniors to help cover the costs of their medicines. The companies objected because, among other reasons, they were worried the move could be seen as an effort to help the Trump campaign.

This week, Rovner also interviews KHN’s Sarah Jane Tribble, whose new podcast, “Where It Hurts,” drops Sept. 29. The podcast chronicles what happens to a small rural community in Kansas after its local hospital closes.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: KHN’s “Battle Rages Inside Hospitals Over How COVID Strikes and Kills,” by Robert Lewis and Christina Jewett

Anna Edney: The New Yorker’s “A Young Kennedy, in Kushnerland, Turned Whistle-Blower,” by Jane Mayer

Kimberly Leonard: The Wall Street Journal’s “Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization,” by Stephanie Armour

Mary Ellen McIntire: The New York Times’ “Many Hospitals Charge More Than Twice What Medicare Pays for the Same Care,” by Reed Abelson

Other stories discussed by the panelists this week:

The New York Times’ “A Deal on Drug Prices Undone by White House Insistence on ‘Trump Cards,’” by Jonathan Martin and Maggie Haberman

The Daily Beast’s “A Notorious COVID Troll Actually Works for Dr. Fauci’s Agency,” by Lachlan Markay

Politico’s “Trump Administration Shakes Up HHS Personal Office After Tumultuous Hires,” by Dan Diamond

The Washington Post’s “Pentagon Used Taxpayer Money Meant for Masks and Swabs to Make Jet Engine Parts and Body Armor,” by Aaron Gregg and Yeganeh Torbati

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher, Google Play, Spotify or Pocket Casts.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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SANTA CRUZ, Calif. — California will allow public health officials to participate in a program to keep their home addresses confidential, a protection previously reserved for victims of violence, abuse and stalking and reproductive health care workers.

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The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic. More than a dozen public health leaders have left their jobs amid such harassment over their role in mask rules and stay-at-home orders.

“Our public health officers have all too often faced targeted harassment and stalking,” wrote Secretary of State Alex Padilla in a statement. This “program can help provide more peace of mind to the public health officials who have been on the frontlines of California’s COVID-19 response.”

A community college instructor accused of stalking and threatening Santa Clara health officer Sara Cody was arrested in late August. The Santa Clara County sheriff said it believes the suspect, Alan Viarengo, has ties to the “Boogaloo” movement, a right-wing, anti-government group that promotes violence and is associated with multiple killings, including the murders of a federal security officer and a sheriff deputy in the Bay Area. Thousands of rounds of ammunition, 138 firearms and explosive materials were found in his home, the sheriff’s office said.

In Santa Cruz County, two top health officials have received death threats, including one allegedly signed by a far-right extremist group.

In May, a member of the public read aloud the home address of former Orange County health officer Nichole Quick at a supervisors’ meeting and called for protesters to go to her home. “You have seen firsthand how people have been forced to exercise their First Amendment. Be wise, and do not force the residents of this county into feeling they have no other choice than to exercise their Second Amendment,” said another attendee. Quick later resigned.

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Protesters angry over mask mandates and stay-at-home orders have gone to the homes of health officers in multiple counties, including Orange and Contra Costa.

The executive order would allow health officials to register with the Secretary of State’s Safe at Home program. Those in the program are given an alternative mailing address to use for public records so that their home addresses are not revealed.

Threats of violence have added to the already immense pressure public health officials have experienced since the beginning of the year. Amid chronic underfunding and staffing shortages, they have been working to limit the spread of the coronavirus, while also deflecting political pressure from other officials and anger from the public over business closures and mask mandates.

“California’s local health officers have been working tirelessly since the start of the pandemic, using science to guide policy,” said Kat DeBurgh, the executive director of the Health Officers Association of California. “It is regrettable that this order was necessary — but we are grateful for it nevertheless.”

Nationwide, at least 61 state or local health leaders in 27 states have resigned, retired or been fired since April, according to a review by The Associated Press and KHN, a figure that has doubled since the newsrooms first began tracking the departures in June.

Thirteen of those departures have been in California, including 11 county health officials and the state’s two top public health officials.

Dr. Sonia Angell, former director of the California Department of Public Health and state public health officer, quit in early August after a series of glitches in the state’s infectious disease reporting system caused weeks-long delays in reporting cases of COVID-19.

In Placer County, north of Sacramento, health officer Dr. Aimee Sisson resigned effective Sept. 25 after the county Board of Supervisors voted to end its local COVID-19 health emergency. “It is with a heavy heart that I submit this letter of resignation,” she wrote in her resignation letter. “Today’s action by the Placer County Board of Supervisors made it clear that I can no longer effectively serve in my role.”

Organizations across the state have expressed concern over the treatment of health officials during the pandemic, including the California Medical Association.

“Basic science has become politicized in so many parts of our state, and our country,” wrote California Medical Association president Dr. Peter N. Bretan Jr. in a statement after Sisson’s departure. “Public health officers are public servants who seek to do what their job description states — to protect public health.”

The executive order also directs the state to assess impacts of the pandemic on health care providers and health care service plans, and halts evictions for commercial renters through March 31, 2021, among other pandemic-related matters.

KHN and California Healthline correspondent Angela Hart contributed to this report.

Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham.

Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country.

Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson and others. The data and safety monitoring board — known as a DSMB — is supposed to make sure the medicine is safe and it works. It has the power to halt a clinical trial or fast-track it.

Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public, according to multiple clinical trial experts who have served on such panels. That could be especially important in the pressure-cooker environment of COVID vaccine research, fueled by President Donald Trump’s promises to deliver a vaccine before Election Day.

As pharmaceutical companies work to produce one as quickly as possible, the board’s anonymity has stirred concerns that the cloak of secrecy could, paradoxically, allow undue influence. Whitley, for example, represents the specialized world these experts inhabit — a professor revered in academia who also is paid by the drug industry.

Any political pressure to rush pharmaceutical companies or lean on federal regulators to prematurely greenlight a vaccine would undermine a system put in place to ensure public safety. Calls are growing for companies and the government to be more open about who’s involved in reviewing the vaccine trials and whether board members have any conflicts of interest.

“We want to know they’re truly independent,” said Dr. Eric Topol, director of the Scripps Research Translational Institute and a specialist in clinical trials. “The lack of transparency is exasperating.”

Data and safety monitoring boards have existed for decades to vet new drugs and vaccines, acting as a backstop to help ensure unsafe products don’t make their way to the public. Typically, there’s one board for each product. This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration’s Operation Warp Speed or other coronavirus vaccine work. It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters.

“Until they are convinced that there’s something there that looks promising, nothing is unblinded and sent to the FDA,” Collins said. “I doubt if there have been very many vaccine trials ever that have been subjected to this size and the rigor with which it’s being evaluated.”

The NIH safety board oversees trials in the U.S. from Moderna, Johnson & Johnson and AstraZeneca, U.S. officials and others involved in Operation Warp Speed said, but not Pfizer, which is fully funding its clinical trial work and established its own five-member safety panel. Pfizer has attested that it can conclusively determine by late October the effectiveness of its vaccine, being jointly developed with German company BioNTech. It secured a $1.95 billion purchase agreement with the Department of Health and Human Services for the first 100 million doses produced. The agreement gives HHS the option to buy an additional 500 million doses.

Moderna, Johnson & Johnson and AstraZeneca, which have either started or are aiming to soon begin large-scale trials in the U.S. involving thousands of patients, collectively have received more than $2 billion in government funds for vaccine development; billions more have been meted out under agreements similar to the HHS contract with Pfizer to buy millions of vaccine doses. Having one safety board oversee multiple trials could allow researchers to better understand the field of products and apply consistency across evaluations, clinical trial experts said in interviews.

One big advantage “could be more standardization,” said Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former senior official at the Centers for Disease Control and Prevention. “They can look at that data and look at all the trials instead of just doing one trial.”

But it also means that one board has an outsize influence to dictate which coronavirus vaccines eventually succeed or come to a halt, all while most of their identities remain secret. The NIH declined to name them, saying they were “confidential” and could be identified only once a study was complete.

One exception to the mystery is Whitley, who was appointed as chair by Dr. Anthony Fauci, the nation’s top infectious disease official. Fauci said that following a “combination of input from us and from him and other colleagues, the people who had the greatest expertise in a variety of areas, including statistics, clinical trials, vaccinology, immunology, clinical work,” were selected for the panel.

Whitley’s role became public when his university announced it, an unusual move. He is a professor as well as a board member of Gilead Sciences, which recently signed a contract with Pfizer to manufacture remdesivir to treat COVID-19 patients. Whitley, who’s been on Gilead’s board since 2008, conducted research that led to remdesivir’s development.

In 2019, he was paid roughly $430,000 as a Gilead board member, according to documents filed with the Securities and Exchange Commission. That same year, he received more than $7,700 in payments from GlaxoSmithKline for consulting, food and travel, according to a federal database that tracks drug and device company payments to physicians.

GlaxoSmithKline and Sanofi are jointly developing a vaccine that’s received $2 billion from the U.S. government under Operation Warp Speed; however, Whitley, through a university spokesperson, said his DSMB has not seen any GlaxoSmithKline COVID protocols. The companies have yet to begin phase 3 trials. Although he chairs a separate GSK data and safety monitoring board for a pediatric vaccine, he was vetted and cleared by the NIH conflict-of-interest committee with its knowledge of his involvement, the spokesperson said.

“When handled responsibly, it is appropriate for physicians to collaborate with external entities,” said UAB spokesperson Beena Thannickal, saying the university works with physicians to ensure that industry engagement is appropriate. “It facilitates a critical exchange of knowledge and accelerates and advances clinical treatments and cures, and it fuels discovery.”

Multiple experts praised his skill — Dr. Walter Straus, an associate vice president at the drug company Merck & Co., said Whitley is an “éminence grise” in pediatrics whom people trust.

“I actually trust that process, and the fact that they asked Rich to do it makes me feel reassured because he’s so good,” said Dr. Jeanne Marrazzo, director of the University of Alabama-Birmingham’s division of infectious diseases.

Multiple scientists who have participated in data and safety monitoring boards maintain it’s important to keep the board anonymous to shield them against pressure or even for their safety. For example, when trials were conducted in San Francisco for HIV/AIDS research, the board was confidential to protect members from patients desperate for treatment, said Susan Ellenberg, a professor of biostatistics, medical ethics and health policy at the University of Pennsylvania who’s written extensively on the history of DSMBs.

If approached by a patient, it “would be very hard to tell you, ‘Oh I can’t help you.’ It’s an unreasonable burden,” said Ellenberg, who said she was involved in coronavirus-related safety boards but would not name them.

As part of a large-scale clinical trial, the DSMB and a statistician or team that prepares data for those individuals are generally the only ones who see unblinded data about the trial, making it clear who is getting what treatment. A firewall is set up between them and executives from the sponsoring company with financial interests in the trial. The companies sponsoring COVID vaccine trials are not part of any closed sessions during which unblinded data is reviewed. Those are limited to members of the DSMB, the NIAID executive secretary and the independent unblinded statistician who is presenting the data, a NIAID spokesperson said.

DSMB members or their family members should have no professional, proprietary or financial relationship with the sponsoring companies, and the NIAID DSMB executive secretary vetted all members for potential conflicts of interest, NIAID said in response to questions from KHN. Members are paid $200 per meeting.

“It’s generally done out of a sense of public service,” said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center, who is working with NIH officials to oversee the U.S. coronavirus vaccine clinical trials. “You’re doing it because of your sense of altruism and obligation to knowing the important role it plays in clinical research and the important role it plays in preserving the scientific integrity of important trials.”

Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS’ Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.

Moderna and Johnson & Johnson are each aiming for their vaccines to have 60% efficacy, which means there would need to be 60% fewer COVID cases among vaccinated individuals in their trials. AstraZeneca’s target is 50%. The FDA has said any coronavirus vaccine must be at least 50% effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.

Pfizer is similarly aiming for its vaccine to be 60% effective. The company allows for four interim reviews of the data starting at 32 cases — a schedule that has been criticized by some researchers who contend it makes it easier for the company to stop the trial prematurely.

Pfizer declined to name the individuals on its monitoring committee, saying only that the group consisted of four people “with extensive experience in pediatric and adult infectious diseases and vaccine safety” and one statistician with a background in vaccine clinical trials. An unblinded team supporting its data-monitoring committee — which includes a medical monitor and statistician — will review severe cases of COVID-19 as they are received and any adverse events associated with the trial at least weekly.

“There is an irresolvable tension between speed and safety,” said Dr. Gregory Poland, the head of Mayo Clinic’s Vaccine Research Group. “Efficacy is pretty easy to figure out. It’s safety that’s the issue.”

California Healthline editor Arthur Allen contributed to this report.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Working as a fast-food cashier in Los Angeles, Juan Quezada spends a lot of his time these days telling customers how to wear a mask.

“They cover their mouth but not their nose,” he said. “And we’re like, ‘You gotta put your mask on right.’”

Quezada didn’t expect to be enforcing mask-wearing. Six months ago, he was a restaurant manager, making $30 an hour, working full time and saving for retirement. But when Los Angeles County health officials shut down most restaurants in March because of the spreading pandemic, Quezada lost his job. The only work he could find pays a lot less and is part time.

“I only work three hours and four hours rather than eight or 10 or 12 like I used to work,” he said.

Quezada doesn’t know anyone who has gotten COVID-19, but the pandemic has affected nearly every aspect of his life. “I am just draining my savings — draining and draining and draining,” he said. “I have to sell my car. Uber is a luxury.” Mostly, he now bikes or rides the bus to his part-time job.

Quezada is one of hundreds of people who responded in a newly published poll by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. Among other things, the poll, which surveyed people from July 1 to Aug. 3, found that a whopping 71% of Latino households in Los Angeles County have experienced serious financial problems during the pandemic, compared overall with 52% of Black households there and 37% of whites. (Latinos can be of any race or combination of races.)

Like Quezada, many are burning through their savings and are having a hard time paying for necessities such as food. Quezada estimated he has about six months of savings left.

In Los Angeles, more than 35% of households report serious problems with paying credit cards, loans or other bills, while the same percentage report having depleted all or most of their savings. Eleven percent of Angelenos polled said they didn’t have any savings at the start of the outbreak.

Nationally, the picture is similar. In results released last week, the poll found that 72% of Latino households around the country reported they’re facing serious financial problems, double the share of whites who said so. And 46% of Latino households reported they have used up all or most of their savings during the pandemic.

How Poverty Differs for Latinos

Nationally, the poll found that 63% of Latinos reported loss of household income either through reduced hours or wages, furloughs or job loss since the start of the pandemic.

But Latinos have kept working through the crisis, said David Hayes-Bautista, a professor of medicine and public health at UCLA.

“In Washington, the idea is you’re poor because you don’t work. That’s not the issue with Latinos,” he said. “Latinos work. But they’re poor. The problem is, we don’t pay them.”

Latinos have the highest rate of labor force participation of any group in California. In March, when state and local officials shut down many businesses, Latinos lost jobs like everyone else. But Latinos got back to work faster.

“In April, the Latino [labor force participation] rate bounced right back up and actually has continued to increase slowly, whereas the non-Latino rate is dropping,” Hayes-Bautista said. “The reward that Latinos have for their high work ethic is a high rate of poverty.”

That work ethic has also contributed to a much higher rate of COVID-19. Hayes-Bautista pointed out that in California, as in some other regions in the U.S., Latinos tend to hold many of the jobs that have been deemed essential, and that’s made them highly susceptible to the coronavirus. Latinos now account for 60% of COVID-19 cases in California, even though they’re about 40% of the population.

Not only are they getting infected, but there’s been nearly a fivefold increase in working-age Latinos dying from the coronavirus since May.

“These are workers usually in their prime years — peak earning power and everything else,” Hayes-Bautista said. “Latinos between 50 and 69, those are the ones that are being hit the hardest. That’s pretty worrying.”

Exposed — And Often Without Health Insurance

Nationally, according to the poll, 1 in 4 Latino households report serious problems affording medical care during the pandemic.

Many of the essential jobs that Latinos are more likely to perform — farmworker or nursing home aide or other contract work, for example — lack benefits. That means some Latinos are more exposed to the coronavirus and less likely to have health insurance because they don’t get coverage through an employer.

Others, such as Mariel Alvarez, lack health insurance because of citizenship restrictions. She lives with her parents and sisters in Los Angeles County’s San Fernando Valley. Alvarez lost her sales job and her employer-sponsored health insurance when the pandemic hit in March, she said. Then she got sick.

Eventually, her whole family was ill. Alvarez had to pay out-of-pocket to go to a CVS clinic near her home. But after a couple of $50 visits, it got too expensive.

“I just couldn’t afford to continue to go to the doctor,” she said. She suspected it was COVID-19 but was unable to get tested.

Now that she’s recovered, getting a job with health insurance is crucial because she doesn’t qualify for any state or federal support. Alvarez is undocumented and was brought to the U.S. by her parents as a child from Bolivia. She’s one of roughly 640,000 immigrants who has a permit allowing her to work and defer deportation under the Deferred Action for Childhood Arrivals program, or DACA.

“I don’t want to jeopardize that,” Alvarez said. “You’re not supposed to use any of the government assistance when you’re on that. You’re only supposed to work, and that’s it.”

The pandemic has created a big need for one job: contact tracers. So Alvarez completed a free certificate online in the hope it will give her an edge. She’s going through the application process; if she gets hired, she hopes to have benefits again.

In the meantime, she’ll do her best not to get sick.

Jackie Fortiér is a health reporter for KPCC and LAist.com.

This story is part of a partnership that includes KPCC, NPR and KHN, an editorially independent program of KFF.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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This story can be republished for free (details).

Laura Stutzman had no doubts that this year’s Twin Falls County Fair should go on despite the pandemic still raging across the U.S. — and several outbreaks tied to such community fairs.

Though she saw few people wearing masks from her volunteer station in the fair’s hospitality tent in southern Idaho earlier this month, she said she wasn’t concerned. Stutzman, 63, had been attending the fair off and on for 30 years, and she didn’t consider this year that different. People in rural communities know how to respect one another’s space, she said, and don’t have time to “fret and worry” about the coronavirus.

“Common sense is knowing that COVID-19 is in the picture,” she said, yet not allowing fear to “dictate how we live.”

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Hundreds of state and county fairs typically take place across the U.S. each year. They are a centerpiece for the agricultural industry — particularly for the 4-H kids who raise livestock all year to show off at their local events. Thousands of people are drawn to small towns for the concerts, rodeos, races and carnivals that flesh out the experience.

But only about 1 in 5 fairs took place as scheduled this summer, while the rest were dramatically modified or outright canceled because of the pandemic, according to data provided by the International Association of Fairs & Expositions.

Fairs are the economic lifeblood and cultural high point of the year for many rural communities, so the decision to cancel one is especially consequential. Scaling back can have devastating effects on the finances of the fair organizers and local community. And organizers fear that skipping a single year could mean losing a fair permanently.

“With very few exceptions, most fairs get most of their income from one single annual event,” said Marla Calico, president and CEO of the International Association of Fairs & Expositions. “Some fairs are trying to figure out how they will survive after this.”

In pressing on with their events, many organizers cited the fair’s importance to their counties, precisely because of the pandemic — people have been isolated from one another and communities are struggling economically.

One, the Montrose County Fair and Rodeo in Colorado, wanted to give students a chance to show and sell their livestock in person, Montrose County Fairgrounds & Event Center director Emily Sanchez said. Organizers promoted the event on social media with the hashtag #spreadingjoy, which Sanchez said was not intended to be a tongue-in-cheek reference to the pandemic.

“What we noticed was a lot of people saying that this was the worst year,” Sanchez said. “We were just giving people a minute to enjoy the small things.”

Montrose and most other fairs that took place scaled back events and made other changes to try to prevent coronavirus transmission. Fairs posted signs encouraging mask use and social distancing, and some canceled concerts and carnival-type attractions. The Fresno County fair in California, which is scheduled for October and typically draws 600,000 people, has been rebranded as a “series of drive-thru and virtual experiences.”

Often, those precautions haven’t worked, though, as fairgoers shed masks and gathered in large groups to watch rodeos and other attractions.

Health officials have since traced some COVID outbreaks to fairs. For example, Ohio Gov. Mike DeWine announced restrictions to county fairs after at least 22 cases of COVID-19 were traced back to the Pickaway County Fair in June.

Another fair linked to a COVID outbreak is the Phillips County Fair in the vast plains of northeastern Montana. The organizers of the event in Dodson, a small farming community about 40 miles south of the Canadian border, have long proclaimed that theirs was the longest continuously running fair in the state.

Until the fair took place in early August, Phillips County had another unique distinction: It was one of just a handful of Montana’s 56 counties to have no confirmed cases of COVID-19.

By mid-August, an outbreak of COVID-19 occurred — 68 cases within a week in the county of 4,000 people. The county’s small public health team scrambled to perform contact tracing. They concluded the fair and other events held at the same time, including a softball tournament and a large wedding, caused the spread.

“It was really just a perfect storm that led to an outbreak,” said public health nurse Jenny Tollefson.

The number of infections in Phillips County eventually rose to 114, but county officials have since curbed the outbreak. There were no active cases in the county as of mid-September, according to state health officials.

Sue Olsen, chairperson of the Phillips County Fair board, said organizers did everything they could to safely hold a large community event amid a global pandemic. They purchased 500 gallons of hand sanitizer and encouraged attendees to wear masks, although she said few did. They also improved cleaning procedures in the bathrooms.

They canceled events in which social distancing would not be possible, such as the carnival games and rides, face painting and a clown show. The county’s Native American neighbors on the Fort Belknap Reservation disagreed with the decision to hold the fair and canceled the relay races that are a traditional part of the event.

But organizers felt they needed to hold the fair.

“If you don’t have an event one year, you might just lose it,” Olsen said.

The outbreak opened up the county to criticism. Montana Gov. Steve Bullock, a Democrat, called Phillips County an example of how the state hasn’t learned to live with the coronavirus.

Other fair organizers took notice but pressed ahead. Near Montana’s Glacier National Park, Flathead County held the Northwest Montana Rodeo and Fair in mid-August despite 140 local health care professionals writing a letter urging organizers to cancel it. Among the medical community’s chief concerns: Schools were reopening just a week after the fair.

Fair manager Mark Campbell said his team worked closely with local health officials to ensure that the event, which normally attracts upward of 80,000 people, could proceed safely.

“We had a health department that was willing to work with us on a plan when a lot of other counties or states just simply said no to public events,” he said.

Campbell said the fair was different than in past years, with a bigger focus on 4-H and agricultural education. They canceled the carnival and parade, plus ditched the beer garden during the concerts and rodeos. Masks were required to enter the fair and the grandstands, although images posted by a local newspaper that quickly circulated on social media showed many people simply took off their masks once inside.

Interim county health officer Tamalee St. James Robinson said the images of so many maskless people in the grandstands were concerning, and fair organizers should have ensured compliance. Campbell said that the organizers took corrective actions to make sure people did wear masks after the images surfaced but that his staff didn’t have time to constantly remind people.

Two weeks later, contact tracers found seven people with COVID-19 had gone to the fair.

Back in Twin Falls, Idaho, about 3,500 people — half the usual number — showed up at the fair’s opening on Sept. 2, according to news reports. Despite the smaller crowd, the carnival games and rides went ahead and so did the rodeo.

Stutzman said she spent some of her time during the rodeo sanitizing the hospitality tent — but not necessarily because of the coronavirus.

“We were all raised with manners and good hygiene and consideration for others in our neck of the woods,” she said. “So everything pretty much goes on as it always has.”

The fair ended on Sept. 7, and it remains to be seen what effect, if any, it will have on Twin Falls County’s COVID-19 cases.