Sen. Cory Gardner (R-Colo) said in a tweet on September 15 he authored legislation "to guarantee coverage to people with pre-existing conditions — no matter what happens to Obamacare."
This article was published on Friday, September 18, 2020 in Kaiser Health News.
Sen. Cory Gardner, a Republican running in a tight race for reelection in Colorado, says he wants to protect people with medical conditions.
In a mid-September tweet released by his campaign, he promoted legislation he introduced in August that he says will do just that.
“People like my mother who battle chronic diseases are heroes,” read the tweet. “I authored the bill to guarantee coverage to people with pre-existing conditions — no matter what happens to Obamacare — because some things matter more than politics.”
Gardner has voted repeatedly to repeal the Affordable Care Act, the first federal law to guarantee people with health problems that they could buy insurance when shopping for their own coverage — at the same cost as for healthier consumers.
Polls show broad public support for keeping the ACA’s preexisting condition protections, while also indicating a consistent, if narrow, majority favoring the overall law.
The popularity of those protections has led Gardner, as well as other GOP candidates facing tough challengers, to swear their allegiance to protecting people with medical conditions, despite their records. In previous fact checks, we found Sen. Martha McSally’s promise always to protect preexisting conditions to be False. President Donald Trump also has made related statements, which have ranged from False to Pants on Fire.
That got us thinking: Would Gardner’s legislation, dubbed “The Pre-Existing Conditions Protection Act,” actually guarantee these protections if the ACA didn’t exist? We decided to investigate.
The bill, which was introduced in August, and has no co-sponsors. It’s very short, only 117 words in total.
The main section is a single very long sentence: “A group health plan and a health insurance issuer offering group or individual health insurance coverage may not impose any pre-existing condition exclusion with respect to such plan or coverage, factor health status into premiums or charges, exclude benefits relating to pre-existing conditions from coverage, or otherwise exclude benefits, set limits, or increase charges based on any pre-existing condition or health status.”
We reached out to the Gardner campaign to ask for more information.
A campaign spokesperson reiterated in an email that Gardner’s goal is “to guarantee coverage for individuals with preexisting conditions and ensure they cannot be charged more as a result of their underlying medical conditions.”
Thomas Miller, a resident fellow at the American Enterprise Institute, a think tank in Washington, D.C., quipped that the main goal might be something else entirely.
“It’s probably about 100 words too long,” Miller said. “It could have said, ‘I’m running for election. I’ll do whatever is necessary.’”
Past Votes, Present Messages
Proponents of the ACA emphasized that the law would help people with medical conditions as they worked to get it passed by Congress, which happened in 2010 following a yearlong failed effort by Democrats to win Republican support. Among a host of other provisions, the law bars insurers from rejecting applicants with medical conditions, as they routinely did when considering individual applicants before the law passed. Nor can insurers charge the sick more than the healthy.
Since the law went into effect in 2014, it has faced many efforts by Republicans in Congress, including Gardner, to repeal it.
It has also faced three Supreme Court challenges. It survived the first two, although one ruling allowed states to opt out of its expansion of Medicaid programs for the poor. The still-pending case was first brought in 2018 by 20 states and is supported by the Trump administration. That case could overturn the entire law, although the court won’t hear arguments on the issue before the election. And that brings us back to Gardner’s bill. An obvious difference between that proposal and the ACA is length. Gardner’s bill is one page, while the ACA runs to several hundred.
And Gardner’s claim seems pegged to the legislative language that says insurers can’t impose a “pre-existing condition exclusion,” which sounds fairly straightforward.
But it’s not, experts say.
“It’s an adorable little bill but does not address any of the main issues,” said Linda Blumberg, a fellow at the nonprofit Urban Institute’s Health Policy Center. “You need a package of policies working together in order to create real protections for people to have coverage to meet their health care needs.”
For instance, the bill does not explicitly bar insurers from outright rejecting applicants with medical conditions, something known as “guaranteed issue.”
“‘Guaranteed issue’ is not in the language of the bill,” said Miller at AEI.
Instead, the language may simply prohibit insurers from restricting services related to a medical condition only if they choose to sell an individual insurance in the first place, he said.
Compare that with the ACA, which says every insurer selling individual or group coverage “must accept every employer and individual in the State that applies.”
Also needed in legislation aiming to protect people with medical problems, said Blumberg, are provisions for subsidies to help people of low and moderate income afford their premiums. The ACA has those, along with specific enrollment periods, so that people don’t wait until they are sick to sign up. Without them, mainly those with medical conditions might sign up, driving up costs and premiums. That, in turn, can price people, especially the sick, out of future coverage.
Another way Gardner’s bill differs from the ACA is that it does not list benefits that must be included in a health insurance policy. The ACA requires insurers to cover 10 broad categories of care, including hospitalization, prescription drugs, childbirth, substance abuse treatment and mental health care.
“Without that, insurers could sell products that don’t cover very much, which is what we had prior to 2014,” Blumberg added, which is one way to discourage those who are sick from even applying. “It was difficult to find a product that covered prescription drugs, and we even saw policies that didn’t cover chemotherapy.”
So, What About Costs?
Gardner’s legislation says insurers can’t “factor health status into premiums or charges.”
So insurers could not charge people more simply because they have diabetes, say, or cancer. Still, that leaves open a whole lot of other things that insurers could consider when setting premiums for individuals, such as such as gender or occupation, which could stand in as a proxy for health. Unlike the ACA, it does not bar insurers from setting annual or lifetime dollar limits on coverage, which could disproportionately affect people with costly medical conditions.
The ACA allows insurers to vary premiums for only three reasons: where people live, their age and whether they use tobacco. It sets upper limits, such as charging older folks no more than three times what younger enrollees pay.
Douglas Holtz-Eakin, president of the American Action Forum, who wrote a blog post cited by the Gardner campaign, said the proposed legislation is a starting point — a place holder, if you will. His piece mentioned it near the end of a broader look at the Trump administration’s health platform going into the election.
Responding to questions about Gardner’s legislation, Holtz-Eakin said that if the ACA were to be struck down, Gardner would likely add provisions to it.
“I don’t think it’s intended to be a replacement bill but a provision to make sure people can get coverage,” said Holtz-Eakin. “It’s quite clear on the aim to ensure that people with pre-existing conditions can get insurance, but it doesn’t address every single policy issue that’s out there.”
Health law professor Mark Hall at Wake Forest University said Gardner’s legislation could survive if the ACA were struck down by the Supreme Court, but he noted that Congress would be unlikely to adopt the Gardner bill as written.
“A freestanding protection of pre-existing conditions without any supporting provisions to keep insurance affordable or encourage people to purchase it before they become sick, is almost certain to cause serious harms to the market,” Hall wrote in an email. “Therefore, a lot more is needed to overcome legitimate objections that almost certainly will be made from both sides of the political aisle.”
Our Ruling
Because protecting people with medical conditions requires many moving parts, the brevity of Gardner’s proposal makes it appear to be a fig leaf for a political problem rather than a means to guarantee protections for people with preexisting conditions.
The legislation is unclear on whether it guarantees that people with health problems will be able to buy insurance in the first place. And, even if they can, they may well find it priced out of reach because the legislation does not bar insurers from varying premiums widely on the basis of age, gender or occupation.
Viewed in its most favorable light, Gardner’s 117-word proposal would only serve as a place holder for larger legislation, upon which more protections would have to be layered to bolster the effectiveness of its guarantee.
More than 70,000 residents and staff members in nursing homes and assisted living facilities had died of COVID-19 by mid-August, according to the latest count from Kaiser Family Foundation.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
Older adults are asking this question anew in light of the ongoing toll of the coronavirus pandemic — disrupted lives, social isolation, mounting deaths. Many are changing their minds.
Some people who planned to move to senior housing are now choosing to live independently rather than communally. Others wonder whether transferring to a setting where they can get more assistance might be the right call.
These decisions, hard enough during ordinary times, are now fraught with uncertainty as the economy falters and COVID-19 deaths climb, including tens of thousands in nursing homes and assisted living centers.
Teresa Ignacio Gonzalvo and her husband, Jaime, both 68, chose to build a house rather than move into a continuing care retirement community when they relocate from Virginia Beach, Virginia, to Indianapolis later this year to be closer to their daughters.
Having heard about lockdowns around the country because of the coronavirus, Gonzalvo said, “We’ve realized we’re not ready to lose our independence.”
Alissa Ballot, 64, is planning to leave her 750-square-foot apartment in downtown Chicago and put down roots in a multigenerational cohousing community where neighbors typically share dining and recreation areas and often help one another.
“What I’ve learned during this pandemic is that personal relationships matter most to me, not place,” she said.
Kim Beckman, 64, and her husband, Mike, were ready to give up being homeowners in Victoria, Texas, and join a 55-plus community or rent in an independent living apartment building in northern Texas before COVID-19 hit.
Now, they’re considering buying an even bigger home because “if you’re going to be in the house all the time, you might as well be comfortable,” Beckman said.
“Everyone I know is talking about this,” said Wendl Kornfeld, 71, who lives on the Upper West Side of Manhattan. She has temporarily tabled the prospect of moving into a continuing care retirement community being built in the Bronx.
“My husband and I are going to play it by ear; we want to see how things play out” with the pandemic, she said.
In Kornfeld’s circles, people are more committed than ever to staying in their homes or apartments as long as possible — at least at the moment. Their fear: If they move to a senior living community, they might be more likely to encounter a COVID outbreak.
“All of us have heard about the huge number of deaths in senior facilities,” Kornfeld said. But people who stay in their own homes may have trouble finding affordable help there when needed, she acknowledged.
More than 70,000 residents and staff members in nursing homes and assisted living facilities had died of COVID-19 by mid-August, according to the latest count from KFF (Kaiser Family Foundation). This is an undercount because less than half of states are reporting data for COVID-19 in assisted living. Nor is data reported for people living independently in senior housing. (KHN is an editorially independent program of KFF.)
Nervousness about senior living has spread as a result, and in July, the National Investment Center for Seniors Housing & Care reported the lowest occupancy rates since the research organization started tracking data 14 years ago. Occupancy dropped more in assisted living (a 3.2% decline from April through June, compared with January through March) than in independent living (a 2.4% decline). The organization doesn’t compile data on nursing homes.
The potential for social isolation is especially worrisome, as facilities retain restrictions on family visits and on group dining and activities. (While states have started to allow visits outside at nursing homes and assisted living centers, most facilities don’t yet allow visits inside — a situation that will increase frustration when the weather turns cold.)
Beth Burnham Mace, NIC’s chief economist and director of outreach, emphasized that operators have responded aggressively by instituting new safety and sanitation protocols, moving programming online, helping residents procure groceries and other essential supplies, and communicating regularly about COVID-19, both on-site and in the community at large, much more regularly.
Mary Kazlusky, 76, resides in independent living at Heron’s Key, a continuing care retirement community in Gig Harbor, Washington, which is doing all this and more with a sister facility, Emerald Heights in Redmond, Washington.
“We all feel safe here,” she said. “Even though we’re strongly advised not to go into each other’s apartments, at least we can see each other in the hall and down in the lobby and down on the decks outside. As far as isolation, you’re isolating here with over 200 people: There’s somebody always around.”
One staff member at Heron’s Key tested positive for COVID-19 in August but has recovered. Twenty residents and staff members tested positive at Emerald Heights. Two residents and one staff member died.
Colin Milner, chief executive officer of the International Council on Active Aging, stresses that some communities are doing a better job than others. His organization recently published a report on the future of senior living in light of the pandemic.
It calls on operators to institute a host of changes, including establishing safe visiting areas for families both inside and outside; providing high-speed internet services throughout communities; and ensuring adequate supplies of masks and other forms of personal protective equipment for residents and staff, among other recommendations.
Some families now wish they’d arranged for older relatives to receive care in a more structured environment before the pandemic started. They’re finding that older relatives living independently, especially those who are frail or have mild cognitive impairments, are having difficulty managing on their own.
“I’m hearing from a lot of people — mostly older daughters — that we waited too long to move Mom or Dad, we had our head in the sand, can you help us find a place for them,” said Allie Mazza, who owns Brandywine Concierge Senior Services in Kennett Square, Pennsylvania.
While many operators instituted move-in moratoriums early in the pandemic, most now allow new residents as long as they test negative for COVID-19. Quarantines of up to two weeks are also required before people can circulate in the community.
Many older adults, however, simply don’t have the financial means to make a move. More than half of middle-income seniors — nearly 8 million older adults — can’t afford independent living or assisted living communities, according to a study published last year. And more than 7 million seniors are poor, according to the federal Supplemental Poverty Measure, which includes out-of-pocket medical expenses and other drains on cash reserves.
Questions to Ask
For those able to consider senior housing, experts suggest you ask several questions:
How is the facility communicating with residents and families? Has it had a COVID outbreak? Is it disclosing COVID cases and deaths? Is it sharing the latest guidance from federal, state and local public health authorities?
What protocols have been instituted to ensure safety? “I’d want to know: Do they have a plan in place for disasters — not just the pandemic but also floods, fires, hurricanes, blizzards?” Milner said. “And beyond a plan, do they have supplies in place?”
How does the community engage residents? Is online programming — exercise classes, lectures, interest group meetings — available? Are one-on-one interactions with staffers possible? Are staffers arranging online interactions via FaceTime or Zoom with family? Are family visits allowed? “Social engagement and stimulation are more important than ever,” said David Schless, president of the American Seniors Housing Association.
What’s the company’s financial status and occupancy rate? “Properties with occupancy rates of 90% or higher are going to be able to withstand the pressures of COVID-19 significantly more than properties with occupancy below 80%, in my opinion,” said Mace of the National Investment Center for Seniors Housing & Care. Higher occupancy means more revenues, which allows institutions to better afford extra expenses associated with the pandemic.
The increase in home dialysis has accelerated recently, spurred by social-distancing requirements, increased use of telehealth and remote monitoring technologies — and fear of the virus.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
NIPOMO, Calif. — After Maria Duenas was diagnosed with Type 2 diabetes about a decade ago, she managed the disease with diet and medication.
But Duenas’ kidneys started to fail just as the novel coronavirus established its lethal foothold in the U.S.
On March 19, three days after Duenas, 60, was rushed to the emergency room with dangerously high blood pressure and blood sugar, Gov. Gavin Newsom implemented the nation’s first statewide stay-at-home order.
Less than one week later, Duenas was hooked up to a dialysis machine in the Century City neighborhood of Los Angeles, 160 miles from her Central Coast home, where tubes, pumps and tiny filters cleansed her blood of waste for 3½ hours, doing the work her kidneys could no longer do.
In the beginning, Duenas said she didn’t understand the severity of COVID-19, or her increased vulnerability to it. “It’s not going to happen to me,” she thought. “We’re in a small little town.”
But she was unable to find a spot in a dialysis clinic in, or near, Nipomo. So, with her husband, Jose, at her side, Duenas made long road trips to Century City for more than two months.
In May, Duenas’ doctor told her she was a good candidate for home dialysis, which would save her drive time and stress — and reduce her exposure to the virus.
Now, Duenas assiduously sterilizes herself and her surroundings five nights a week so she can administer dialysis to herself at home while she sleeps.
“There’s always a chance going in that somebody’s going to have COVID and still need dialysis” in a clinic, Duenas said. “I’m very grateful to have this option.”
The increase in home dialysis has accelerated recently, spurred by social-distancing requirements, increased use of telehealth and remote monitoring technologies — and fear of the virus.
While recent, comprehensive data is hard to come by, experts confirm the trend based on what they’re seeing in their own practices. Fresenius Medical Care North America, one of the country’s two dominant dialysis providers, said it conducted 25% more home dialysis training sessions in the first quarter of 2020 than in the same period last year, according to Renal & Urology News.
“People recognized it would be better if they did it at home,” said Dr. Susan Quaggin, president-elect of the American Society of Nephrology. “And certainly from a health provider’s perspective, we feel it’s a great option.”
Nearly half a million people in the United States are on dialysis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Roughly 85% of them travel to a clinic for their treatments.
Dialysis patients are at higher risk of contracting COVID-19 and getting seriously ill with it, said Dr. Anjay Rastogi, director of the UCLA CORE Kidney Program, where Duenas is a patient.
In an analysis of more than 10,000 deaths in 15 states and New York City, the Centers for Disease Control and Prevention found about 40% of people killed by COVID-19 had diabetes. That percentage rose to half among people under 65.
But people on dialysis are also vulnerable to COVID-19 because they usually visit dialysis clinics two to three times a week for an average of four hours at a time, exposing themselves to other patients and, potentially, the virus, Rastogi said.
“Now even more so, we are strongly urging our patients to consider home dialysis,” he said.
There are two kinds of dialysis: hemodialysis and peritoneal dialysis. In hemodialysis, which is administered in a hospital or clinic, or sometimes at home, a dialysis machine pumps blood out of the body and through a special filter called a dialyzer, which clears waste and extra fluid from the blood before it is returned to the body.
Dialysis treatment centers that offer hemodialysis have intensified their infection-control procedures in response to COVID-19, said Dr. Kevin Stiles, a nephrologist at Kaiser Permanente in Bakersfield. Visitors are no longer allowed to accompany patients, and patients get temperature checks and must wear masks during treatment, he said. (KHN, which produces California Healthline, is not affiliated with Kaiser Permanente.)
In peritoneal dialysis, which is the more popular home option because it is less cumbersome and restrictive, the inside lining of the stomach acts as a natural filter. Dialysis solution cleanses waste from the body as it is washed into and out of the stomach through a catheter in the abdomen.
Not everyone is eligible for home dialysis, which comes with its own challenges.
Home dialysis requires patients or their caregivers to lift bags of dialysis solution that weigh 5 to 10 pounds, Stiles said. Good eyesight and hand dexterity are also critical because patients must be able to maintain sterile environments.
Home patients need dialysis equipment and regular deliveries of supplies such as dialysis fluid, drain bags, tubing, disinfectant and personal protective equipment. In response to COVID-19, some clinics have arranged courier services and contracted with labs to deliver supplies to patients.
Medicare covers almost all patients who receive dialysis treatment, including home dialysis, and patients typically pay 20% as coinsurance.
Medicare, which spends an average of $90,000 per hemodialysis patient annually, spent more than $35 billion on patients with end-stage renal disease in 2016.
Duenas is awaiting a kidney transplant. Until she finds a match, she’ll be administering her own peritoneal dialysis at home.
“To be honest, I didn’t want to do it,” she said of home dialysis. “It was scary having to think about taking care of my own treatment.”
Now, three months later, guided by training and the prompts on the dialysis machine, Duenas feels comfortable, capable and safe.
Looking back, she said, “it was a blessing in disguise.”
While it's long been known that smoke can be dangerous when in the thick of it — triggering asthma attacks, cardiac arrests, hospitalizations and more — the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it's gone.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
SEELEY LAKE, Mont. — When researchers arrived in this town tucked in the Northern Rockies three years ago, they could still smell the smoke a day after it cleared from devastating wildfires. Their plan was to chart how long it took for people to recover from living for seven weeks surrounded by relentless smoke.
They still don’t know, because most residents haven’t recovered. In fact, they’ve gotten worse.
Forest fires had funneled hazardous air into Seeley Lake, a town of fewer than 2,000 people, for 49 days. The air quality was so bad that on some days the monitoring stations couldn’t measure the extent of the pollution. The intensity of the smoke and the length of time residents had been trapped in it were unprecedented, prompting county officials to issue their first evacuation orders due to smoke, not fire risk.
Many people stayed. That made Seeley Lake an ideal place to track the long-term health of people inundated by wildfire pollution.
So far, researchers have found that people’s lung capacity declined in the first two years after the smoke cleared. Chris Migliaccio, an immunologist with the University of Montana, and his team found the percentage of residents whose lung function sank below normal thresholds more than doubled in the first year after the fire and remained low a year after that.
“There’s something wrong there,” Migliaccio said.
While it’s long been known that smoke can be dangerous when in the thick of it — triggering asthma attacks, cardiac arrests, hospitalizations and more — the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it’s gone.
That doesn’t bode well for the 78 million people in the western United States now confronting historic wildfires.
Toxic air from fires has blanketed California and the Pacific Northwest for weeks now, causing some of the world’s worst air quality. California fires have burned roughly 2.3 million acres so far this year, and the wildfire season isn’t over yet. Oregon estimates 500,000 people in the state have been under a notice to either prepare to evacuate or leave. Smoke from the West Coast blazes has drifted as far away as Europe.
Extreme wildfires are predicted to become a regular occurrence due to climate change. And, as more people increasingly settle in fire-prone places, the risks increase. That’s shifted wildfires from being a perennial reality for rural mountain towns to becoming an annual threat for areas across the West.
Dr. Perry Hystad, an associate professor in the College of Health and Human Sciences at Oregon State University, said the Seeley Lake research offers unique insights into wildfire smoke’s impact, which until recently had largely been unexplored. He said similar studies are likely to follow because of this fire season.
“This is the question that everybody is asking,” Hystad said. “‘I’ve been sitting in smoke for two weeks, how concerned should I be?’”
Migliaccio wants to know whether the lung damage he saw in Seeley Lake is reversible — or even treatable. (Think of an inhaler for asthma or other medication that prevents swollen airways.)
But those discoveries will have to wait. The team hasn’t been able to return to Seeley Lake this year because of the coronavirus pandemic.
Migliaccio said more research is needed on whether wildfire smoke damages organs besides the lungs, and whether routine exposure makes people more susceptible to diseases.
“Now you have the combination of flu season and COVID and the wildfires,” Migliaccio said. “How are all these things going to interact come late fall or winter?”
A Case Study
Seeley Lake has long known smoke. It sits in a narrow valley between vast stretches of thick forests.
On a recent September day, Boyd Gossard stood on his back porch and pointed toward the mountains that were ablaze in 2017.
Gossard, 80, expects to have some summer days veiled in haze. But that year, he said, he could hardly see his neighbor’s house a few hundred feet away.
“I’ve seen a lot of smoke in my career,” said Gossard, who worked in timber management and served as a wildland firefighter. “But having to just live in it like this was very different. It got to you after a while.”
When Missoula County health officials urged people to leave town and flee the hazardous smoke, many residents stayed close to home. Some said their jobs wouldn’t let them leave. Others didn’t have a place to go — or the money to get there.
Health officials warned those who stayed to avoid exercising and breathing too hard, to remain inside and to follow steps to make their homes as smoke-free as possible. The health department also worked to get air filters to those who needed them most.
But when flames got too close, some people had to sleep outside in campsites on the other side of town.
Understanding the Science of Smoke
One of the known dangers of smoke is particulate matter. Smaller than the width of a human hair, it can bypass a body’s defenses, lodging deep into lungs. Lu Hu, an atmospheric chemist with the University of Montana, said air quality reports are based on how much of that pollution is in the air.
“It’s like lead; there’s no safe level, but still we have a safety measure for what’s allowable,” Hu said. “Some things kill you fast and some things kill you slowly.”
While air quality measurements can gauge the overall amount of pollution, they can’t assess which specific toxins people are inhaling. Hu is collaborating with other scientists to better predict how smoke travels and what pollutants people actually breathe.
He said smoke’s chemistry changes based on how far it travels and what’s burning, among other factors.
Over the past few years, teams of researchers drove trucks along fire lines to collect smoke samples. Other scientists boarded cargo planes and flew into smoke plumes to take samples right from a fire’s source. Still others stationed at a mountain lookout captured smoke drifting in from nearby fires. And ground-level machines at a Missoula site logged data over two summers.
Bob Yokelson, a longtime smoke researcher with the University of Montana, said scientists are getting closer to understanding its contents. And, he said, “it’s not all bad news.”
Temperature and sunlight can change some pollutants over time. Some dangerous particles seem to disappear. But others, such as ozone, can increase as smoke ages.
Yokelson said scientists are still a long way from determining a safe level of exposure to the 100-odd pollutants in smoke.
“We can complete the circle by measuring not only what’s in smoke, but measuring what’s happening to the people who breathe it,” Yokelson said. “That’s where the future of health research on smoke is going to go.”
Coping With Nowhere to Flee
In the meantime, those studying wildland smoke hope what they’ve learned so far can better prepare people to live in the haze when evacuation isn’t an option.
Joan Wollan, 82, was one of the Seeley Lake study participants. She stayed put during the 2017 fire because her house at the time sat on a border of the evacuation zone.
The air made her eyes burn and her husband cough. She ordered air filters to create cleaner air inside her home, which helped.
On a recent day, the air in Wollan’s new neighborhood in Missoula turned that familiar gray-orange as traces of fires from elsewhere appeared. Local health officials warned that western Montana could get hit by some of the worst air quality the state had seen since those 2017 fires.
If it got bad enough, Wollan said, she’d get the filters out of storage or look for a way to get to cleaner air — “if there is someplace in Montana that isn’t smoky.”
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan — something that could occur before the November election.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states — Colorado, Florida, Maine, New Hampshire, New Mexico and Vermont — have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida — the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan — something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a Colorado-based health consultant who has worked with Florida on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
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 illegal, the FDA has generally permitted purchases for individual use.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for 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 programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs — including injectable and biologic medicines — were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Maryland, said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
From the moment she learned she was pregnant late last year, TaNefer Camara knew she didn't want to have her baby in a hospital bed.
Already a mother of three and a part-time lactation consultant at Highland Hospital in Oakland, Camara knew a bit about childbirth. She wanted to deliver at home, surrounded by her family, into the hands of an experienced female birth worker, as her female ancestors once did. And she wanted a Black midwife.
It took the COVID-19 pandemic to get her husband on board. "Up until then, he was like, 'You're crazy. We're going to the hospital,'" she said.
As the COVID-19 pandemic has laid bare healthcare inequities, more Black women are looking to home birth as a way not only to avoid the coronavirus but also to shun a health system that has contributed to African American women being three to four times more likely to die of childbirth-related causes than white women, regardless of income or education. Researchers argue that the roots of this disparity — one of the widest in women's healthcare — lie in long-standing social inequities, from lack of safe housing and healthy food to inferior care provided at the hospitals where Black women tend to give birth.
"It feels like we are needed," said midwife Kiki Jordan, who co-owns Birthland, a prenatal practice that opened early this year in a 400-square-foot storefront in Oakland's Temescal neighborhood targeting low-income women of color.
Since the COVID-19 pandemic hit in March, she said, the practice's clientele has more than tripled.
Images of hospitals inundated with coronavirus patients have sparked a flurry of new interest among women of all races in home births, which account for just over 1% of deliveries in the United States. Birth centers and midwives who attend home births say they've been swamped by new clients since the pandemic.
"Every midwife I'm talking to has seen their practice double or sometimes triple in the wake of COVID," said Jamarah Amani, a Florida midwife and co-founder of the National Black Midwives Alliance.
Many Americans think of giving birth at home as backward and scary, or as a quixotic practice of privileged white women, akin to cloth diaper services and home-cooked baby food.
But the growing interest in home births in recent years has fueled a growing Black midwifery movement that harks back to a venerable, if long-forgotten, tradition in the United States.
Jordan's practice is now 98% Black, "something I've never seen before," she said. She provides pre- and postnatal care regardless of where women plan to deliver, though the majority of her clientele choose home births.
African American infants are more than twice as likely to die as white infants, and the risks extend across social class. Tennis superstar Serena Williams' harrowing 2018 account of her own near-death postpartum experience with a blood clot in her lungs and a cascade of life-threatening complications was a sobering reminder that even wealth and fame are no protection from being dismissed or mistreated during one of the most vulnerable moments of a woman's life.
At least three Black women have diedin childbirth since March in New York City, which was hit hard early on by the coronavirus. One of the women, 26-year-old Amber Isaac, had reportedly tried to switch to a home or birth-center delivery after not getting an in-person appointment with her obstetrician as providers abruptly switched to telemedicine in the wake of the shutdown.
For Katrina Ayoola, 29, avoiding unnecessary medical interventions that researcherssay can leadto dangerous maternal complications was a key reason for switching to a home birth. As the coronavirus hit last spring, when Ayoola was around five months pregnant with her first baby, she was already frustrated with her obstetricians in Martinez, California. She didn't like their system of rotating providers, to whom she felt she constantly had to reexplain herself. The last straw was being told to go shopping for a home blood pressure monitor. They were sold out everywhere. "I ended up canceling what would have been an online appointment, and I haven't heard from them since," said Ayoola.
"I did not feel cared for," she said.
On Aug. 1, Ayoola delivered her son, Oluwatayo, at home in Fairfield with her husband, Daré, and her mother at her side following a 29-hour labor supervised by Jordan and her partner, Anjali Sardeshmukh.
"At the hospital, I'd probably have had a C-section," said Ayoola, who said her home birth was "an amazing, empowering experience," worth every penny of the out-of-pocket $4,500 the couple paid for it — a discount, based on their insurance and income, from Birthland's typical $6,500 fee.
Cost is a major barrier for poor people to access out-of-hospital births. Medicaid, the federal-state health insurance program that covers many low-income pregnant women, pays for home births in only a handful of states. Since 2015 these have included California, but reimbursement is low and bureaucratic requirements make it difficult for most midwives to accept Medi-Cal, California's Medicaid program. A quarter of U.S. states do not even offer midwife licenses, making the practice of home birth effectively illegal.
Jordan led a free-standing birth center in San Rafael that was the first in the state to accept Medi-Cal when it opened in 2016. She and a handful of other Black midwives around the country are leading the effort to make out-of-hospital births more accessible to low-income women, a group that could particularly benefit from community-based midwifery, according to a 2018 study.
Many of these birth workers are struggling to break even, but that's nothing new.
In past generations, Black midwives sometimes walked miles and stayed days with laboring women, massaging their feet, cooking and babysitting, and reading from the Bible in exchange for a few dollars or a chicken, according to historicalaccounts. Immigrants and African Americans dominated midwifery during much of this country's history, and in the South, enslaved women passed from mother to daughter childbirth techniques and remedies brought from West Africa starting in the 1600s.
In certain rural pockets, Black midwives continued to deliver babies for poor Black and white families alike, even into the last century, as modern obstetrics regulated traditional birth attendants virtually out of existence. Midwives delivered half of the nation's babies in 1900 and just over 10% by the 1930s, as physicians launched a campaign to promote hospital birth as safe and hygienic, while dismissing midwives as "relics of barbarism."
But in recent years, with hospital birth as the norm, the United States has registered the poorest birth outcomes in the industrialized world. The numbers haveworsened during the past 25 years even as they've improved in most of the world, largely because of the disproportionate toll on African Americans.
California has led the effort to reverse that trend, cutting its maternal death rate by 55% between 2006 and 2013, though the disparity for Black mothers has persisted.
Researchers have documented countless instances of pregnant African American women being ignored, drug-tested without permission, or sutured without pain medication.
There is a growing consensus among medical researchers and social scientists that discriminationcan result in toxic stress that causes maternal complications or premature births. Respectful, holistic prenatal care can improve outcomes, said Jennie Joseph, a British-trained midwife. Her prenatal clinic in Florida serving mostly low-income women of color has had consistently low rates of maternal complications and premature and low-birth-weight babies.
Joseph believes it matters less where a woman gives birth than how she is treated during the previous nine months, and most of her clients deliver in hospitals.
Groups like Amani's are encouraging more midwives of color to penetrate what she calls the profession's "old girls' network." Just 2% of American midwives are Black, and researchhas shown that Black patients tend to do better with Black providers.
There is evidence that their numbers are growing with demand, however. California now has about half a dozen licensed Black midwifery practices, including three that have opened in the San Francisco Bay Area since 2017.
Camara said she wanted to support them: She's had supportive, competent white birth attendants in the past, "but it wasn't the same," she said. "This is returning to what we did before."
At around 6 on a Saturday morning in mid-August, as a heat wave gripped the Bay Area, she phoned Jordan to tell her she was having contractions. Barely two hours later, the midwives helped her give birth to her son, Esangu, 8 pounds, 6 ounces, on her hands and knees on her living room floor.
Victor Coronado felt lightheaded one morning last month when he stood up to grab an iced tea. The right side of his body suddenly felt heavy. He heard himself slur his words. "That's when I knew I was going to have a stroke," he said.
Coronado was rushed to Mercy Hospital & Medical Center, the hospital nearest his home on Chicago's South Side. Doctors there pumped medicine into his veins to break up the clot that had traveled to his brain.
Coronado may outlive the hospital that saved him. Founded 168 years ago as the city's first hospital, Mercy survived the Great Chicago Fire of 1871 but is succumbing to modern economics, which have underfinanced the hospitals serving the poor. In July, the 412-bed hospital informed state regulators it planned to shutter all inpatient services as soon as February.
"If something else happens, who is to say if the responders can get my husband to the nearest hospital?" said Coronado's wife, Sallie.
While rural hospitals have been closing at a quickening pace over the past two decades, a number of inner-city hospitals now face a similar fate. And experts fear that the economic damage inflicted by the COVID-19 pandemic on safety-net hospitals and the ailing finances of the cities and states that subsidize them are helping push some urban hospitals over the edge.
By the nature of their mission, safety-net hospitals, wherever they are, struggle because they treat a large share of patients who are uninsured — and can't pay bills — or are covered by Medicaid, whose payments don't cover costs. But metropolitan hospitals confront additional threats beyond what rural hospitals do. State-of-the-art hospitals in affluent city neighborhoods are luring more of the safety-net hospitals' best-insured patients.
These combined financial pressures have been exacerbated by the pandemic at a time their role has become more important: Their core patients — the poor and people of color — have been disproportionately stricken by COVID-19 in metropolitan regions like Chicago.
"We've had three hospital closures in the last year or so, all of them Black neighborhoods," said Dr. David Ansell, senior vice president for community health equity at Rush University Medical Center, a teaching hospital on Chicago's West Side. He said the decision to close Mercy "is really criminal in my mind, because people will die as a result."
Mercy is following the same lethal path as did two other hospitals with largely lower-income patient bases that shuttered last year: Hahnemann University Hospital in Philadelphia, and Providence Hospital in Washington, D.C., which ended its inpatient services. Washington's only public hospital, United Medical Center — in the city's poorest ward — is slated to close in 2023 as well, and some services are already curtailed.
Slow Death of Urban Safety Nets
So far, urban hospital closures have remained infrequent compared with the cascading disappearance of their rural counterparts. But the closing of a few could portend problems at others. Even some of those that remain open may cut back crucial specialties like labor and delivery services or trauma care, forcing patients to travel farther for help when minutes can matter.
Nancy Kane, an adjunct professor at Harvard T.H. Chan School of Public Health who has studied urban safety-net hospital changes since 2010, said that "some close, but most of them have tried to get into a bigger system and hang on for a few more years until management closes them."
For much of the 20th century, most cities ran their own hospitals to care for the indigent. But after the creation of Medicare and Medicaid, and as the rising cost of healthcare became a burden for local budgets, many jurisdictions turned away from that model. Today only 498 of 5,230 general hospitals in the country are owned by governments or a public hospital district.
Instead, many hospitals in low-income urban neighborhoods are run by nonprofits — often faith-based — and in some cases, for-profit corporations. In recent years owners have unloaded safety-net hospitals to entities with limited patience for keeping them alive.
In 2018, the for-profit hospital chain Tenet Healthcare Corp. sold Hahnemann to Joel Freedman, a California private equity investor, for $170 million. A year later, Freedman filed for bankruptcy on the hospital, saying its losses were insurmountable, while separating its real estate, including the physical building, into another corporation, which could ease its sale to developers.
In 2018, Tenet sold another safety-net hospital, Westlake Hospital in Melrose Park, Illinois, a suburb west of Chicago, to a private investment company. Two weeks after the sale, the firm announcedit would close the hospital, which ultimately led the owners to pay Melrose Park $1.5 million to settle a lawsuit alleging they had misled local officials by claiming before the sale they would keep it open.
Some government-run hospitals are also struggling to stay open. Hoping to stem losses, the District of Columbia outsourced management of United Medical Center to private consulting firms. But far from turning the hospital around, one firm was accused of misusing taxpayer funds, and it oversaw a string of serious patient safety incidents, including violations in its obstetrics ward so egregious that the district was forced to shut the ward down in 2017.
Earlier this year, the district struck a deal with Universal Health Services, a Fortune 500 company with 400 hospitals and $11 billion in revenues, to run a new hospital that would replace United, albeit with a third fewer beds. Universal also operates George Washington University Hospital in the city in partnership with George Washington University. That relationship has been contentious: Last year the university accused the company of diverting $100 million that should have stayed in the medical system. In June, a judge dismissed most of the university's complaint.
No Saviors for Mercy
Chicago has three publicly owned hospitals, but much of the care for low-income patients falls on private safety-net hospitals like Mercy that are near their homes and have strong reputations. These hospitals have been sources of civic pride as well as major providers of jobs in neighborhoods that have few.
Fifty-five percent of Chicagoans living in poverty and 62% of its African American residents live within Mercy's service area, according to Mercy's 2019 community needs assessment, a federally mandated report. The neighborhoods served by Mercy are distinguished by higher rates of death from diabetes, cancer and stroke. Babies are more likely to be born early and at low weight or die in infancy. The nearest hospitals from Mercy can be 15 minutes or more away by car, and many residents don't have cars.
"You're going to have this big gap of about 7 miles where there's no hospital," Ansell said. "It creates a healthcare desert on the South Side."
Dr. Maya Rolfe, who was a resident at Mercy until July, said the loss of the hospital's labor and delivery department would cause substantial harm, especially since African American women suffer from a higher rate of maternal mortality than do white women. "Mercy serves a lot of high-risk women," she said.
Mercy, a nonprofit, has been in financial trouble for a while. In 2012, it joined Trinity Health, a giant nonprofit Roman Catholic health system headquartered in Michigan with operations in 22 states. In the next seven years, Trinity invested $124 million in infrastructure improvements and $112 million in financial support.
During that time, the hospital continued to be battered by headwinds facing hospitals everywhere, including the migration of well-reimbursed surgeries and procedures to outpatient settings. Likewise, patients with private insurance, which provides higher reimbursements than government programs do, departed to Chicago's better-capitalized university hospitals, including Rush, the University of Chicago Medical Center and Northwestern Memorial Hospital. Seventy-five percent of Mercy's revenues come from government insurance programs Medicare and Medicaid.
Only 42% of its beds were occupied on average, according to the most recent state data, from 2018. Mercy told state regulators it is losing $4 million a month and required at least $100 million in additional building upgrades to operate safely.
Trinity said it spent more than a year shopping for a buyer. After that yielded no success, Mercy joined forces with three other struggling South Side hospitals to consolidate into a single health system planning to build one hospital and a handful of outpatient facilities to replace their antiquated buildings. They sought state financial help.
The plan would have cost $1.1 billion over a decade. At the close of the legislative session, Illinois lawmakers — already strapped for funding because of the economic effects of the pandemic — balked at the hospitals' request for the state to cover half the cost. Lamont Robinson, a Democratic state representative whose district includes Mercy Hospital, said that was because the group did not declare where the new hospital would be built.
"We were all supportive of the merger but not with the lack of information," Robinson said.
Mercy said in an email that the location would have been chosen after the hospital organizations combined and chose new leaders. Trinity said in a statement: "We are committed to continuing to serve the Mercy Chicago community through investment in additional ambulatory and community-based services that are driven by high-priority community needs."
Blame for Mercy's closure has been spread widely to include the city and state governments as well as Mercy's owner. Trinity Health had $8.8 billion in cash and liquid investments at the end of March and until the pandemic hit had been running a slight profit. Earlier this year in Philadelphia, Trinity Health announced it would phase out inpatient services at another of its safety-net hospitals, Mercy Catholic Medical Center-Mercy Philadelphia Campus, a 157-bed hospital that has been around since 1918.
"People put their money where they want to," said Rolfe, the former medical resident at Mercy in Chicago. Noting that the city has no qualms about spending large sums to beautify its downtown while other neighborhoods are in danger of losing a major institution, she said: "It shows to me that those patients are not that important as patients that exist in other communities."
So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials — and targeted outreach efforts to recruit more minorities have been slow to launch.
This article was published on Wednesday, September 16, 2020 in Kaiser Health News.
Participation in clinical trials among Black people is low, according to Food and Drug Administration statistics. Still, including them in coronavirus vaccine trials has been a stated priority for the pharmaceutical companies involved, since African American communities, along with those of Latinos, have suffered disproportionately from the pandemic.
The ongoing trials are moving at a pace that is unprecedentedfor medical research, with the Trump administration's vaccine acceleration effort dubbed "Operation Warp Speed." Yet recruiting minority participants requires sensitivity to a mistrust borne of past and current medical mistreatment. Trust-building cannot be rushed.
So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials — and targeted outreach efforts to recruit more minorities have been slow to launch.
Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. At Meharry Medical College in Nashville, Tennessee, researchers have set up in-person meetings with patients they already know. Earlier this month, a half-dozen patients gathered in a cramped conference room on campus. They snacked on turkey sandwiches and potato chips and listened to the pitch from their physician, Dr. Vladimir Berthaud.
"What's the best hope to get rid of this virus?" he asked them.
"Vaccination," they replied.
Then Berthaud followed up: "So raise your hand if you would like to take the vaccine?"
Some hands shot up, but not all.
"I ain't going to be the first one, now," said Lanette Hayes.
Katrina Thompson said she does eventually want to get a shot for protection against the coronavirus. She explained she's especially worried about all the residents of her apartment building who don't seem to be doing the basics of covering their coughs.
"The word 'vaccination' don't scare me," she said. "The word 'trial' do."
Black Americans have reason to be suspicious — stemming beyond the well-known Tuskegee experiments, in which Black men with syphilis were deceived and mistreated as part of an experiment that went on for decades. Many Black Americans report ongoing mistreatment by medical providers today.
Berthaud is recruiting patients for a clinical trial site he will oversee in Nashville, and he would like more than 300 people of color to enroll. Berthaud, who is Black and from Haiti, appeals to his patients' sense of duty.
"If you don't have enough people like you in those vaccine trials, you will not know if it works for you," he told them. "You will not know."
For most of the current coronavirus vaccine trials, recruitment mainly takes place online — which often results in mostly white people enrolling.
That's why Meharry researchers are wooing Black patients with a personal invitation. But they're not recruiting for the phase 3 trials underway. Meharry's first trial, for a vaccine candidate by Novavax, doesn't launch until October.
Other pharmaceutical companies are nearly done recruiting. Moderna said it chose nearly 100 trial sites for their "representative demography."
The company did not respond to requests for comment but publicizes demographic statistics about the clinical volunteers every week. While somewhat more inclusive than the typical clinical trial, it still is not a good representation of the diversity of the U.S.
For the coronavirus vaccine in particular, the National Institutes of Health has suggested minorities should be overrepresented in testing — perhaps at rates that are double their percentage of the U.S. population.
"We say we want to have everybody included, but really the effort for the vaccinations — in a sense — [is] starting the same way they've always been," said Dr. Dominic Mack, of Morehouse School of Medicine in Atlanta.
He's working with the NIH to make sure people of color are included in COVID-19 research. Mack said there are no shortcuts if medical research is going to reflect the diversity of the U.S. It takes time to build trust and meaningful relationships with people who have endured a history of abuse or neglect by medical providers, and exclusion from biomedical research and decision-making.
"Now, that being said, the only thing we can do is what we're doing," he said — by which he means respectful, unrushed outreach and dialogue.
The primary effort, called theCOVID-19 Prevention Network, taps into four existing clinical trial networks designed to advance HIV research. Those networks are based in Seattle, Atlanta, Los Angeles and Durham, North Carolina.
One project will be led by the Rev. Edwin Sanders II of the Metropolitan Interdenominational Church in Nashville. It will involve seven "faith ambassadors" and 30 "clergy consultants" in the African American community working to dispel myths and increase trust in the clinical trial process. But Sanders cautioned this is not about a hard sell. It's not his job to preach trial participation from the pulpit, he said.
"We are not out beating the drum," he said, acknowledging that congregants may have legitimate concerns. "I am not going to do anything more than make sure people are able to make an informed choice."
The danger in lunging for big diversity goals is that it could spark a backlash, meaning minorities might be even less willing to participate, said associate professor Rachel Hardeman, who studies health equity at the University of Minnesota. It's important that the doctors doing the asking look like the people they're appealing to, she said.
"It's racial concordance," she explained. "It offers this feeling of, 'You know who I am, you know where I come from, you have my best interests at heart.'"
Historically Black medical institutions in the U.S. are uniquely positioned to do this work. While they haven't been on the leading edge of recruitment for vaccine trials, they intend to play an important part. The president of Nashville's Meharry Medical College, Dr. James Hildreth, is an infectious disease researcher. But instead of overseeing the trial site being hosted on his campus, Hildreth has a more modest goal in mind: He plans to participate as a patient, and urge others to join him.
"I think my role is more important in advocating for people to be involved in vaccine studies than to be one of the leaders of the study," he said.
So at Meharry, Berthaud is the principal investigator. As lunch wraps up in the crowded conference room, he has managed to win over some holdouts.
"Where is the line?" asked Robert Smith. "Where do we sign?"
Smith, with his young grandson in tow, didn't raise his hand at first when asked if he'd take the vaccine. But after listening to Berthaud, Smith agreed to participate in the clinical trial — for no other reason than the trust he has in Berthaud, his longtime physician.
"He's not only my doctor; he's proven that he cares about me," Smith said.
Persuading hundreds or thousands of Black Americans to sign up will be difficult. But researchers hope their outreach efforts will at least result in more minorities agreeing to take an approved vaccine when available.
Up and down the West Coast, hospitals and health facilities are reporting an influx of patients with problems most likely related to smoke inhalation.
This article was published on Wednesday, September 16, 2020 in Kaiser Health News.
By Mark Kreidler The patients walk into Dr. Melissa Marshall's community clinics in Northern California with the telltale symptoms. They're having trouble breathing. It may even hurt to inhale. They've got a cough, and the sore throat is definitely there.
A straight case of COVID-19? Not so fast. This is wildfire country.
Up and down the West Coast, hospitals and health facilities are reporting an influx of patients with problems most likely related to smoke inhalation. As fires rage largely uncontrolled amid dry heat and high winds, smoke and ash are billowing and settling on coastal areas like San Francisco and cities and towns hundreds of miles inland as well, turning the sky orange or gray and making even ordinary breathing difficult.
But that, Marshall said, is only part of the challenge. Facilities already strapped for testing supplies and personal protective equipment must first rule out COVID-19 in these patients, because many of the symptoms they present with are the same as those caused by the virus.
"Obviously, there's overlap in the symptoms," said Marshall, the CEO of CommuniCare, a collection of six clinics in Yolo County, near Sacramento, that treats mostly underinsured and uninsured patients. "Any time someone comes in with even some of those symptoms, we ask ourselves, 'Is it COVID?' At the end of the day, clinically speaking, I still want to rule out the virus."
The protocol is to treat the symptoms, whatever their cause, while recommending that the patient quarantine until test results for the virus come back, she said.
It is a scene playing out in numerous hospitals. Administrators and physicians, finely attuned to COVID-19's ability to spread quickly and wreak havoc, simply won't take a chance when they recognize symptoms that could emanate from the virus.
"We've seen an increase in patients presenting to the emergency department with respiratory distress," said Dr. Nanette Mickiewicz, president and CEO of Dominican Hospital in Santa Cruz. "As this can also be a symptom of COVID-19, we're treating these patients as we would any person under investigation for coronavirus until we can rule them out through our screening process." During the workup, symptoms that are more specific to COVID-19, like fever, would become apparent.
For the workers at Dominican, the issue moved to the top of the list quickly. Santa Cruz and San Mateo counties have borne the brunt of the CZU Lightning Complex fires, which as of Sept. 10 had burned more than 86,000 acres, destroying 1,100 structures and threatening more than 7,600 others. Nearly a month after they began, the fires were approximately 84% contained, but thousands of people remained evacuated.
Dominican, a Dignity Health hospital, is "open, safe and providing care," Mickiewicz said. Multiple tents erected outside the building serve as an extension of its ER waiting room. They also are used to perform what has come to be understood as an essential role: separating those with symptoms of COVID-19 from those without.
At the two Solano County hospitals operated by NorthBay Healthcare, the path of some of the wildfires prompted officials to review their evacuation procedures, said spokesperson Steve Huddleston. They ultimately avoided the need to evacuate patients, and new ones arrived with COVID-like symptoms that may actually have been from smoke inhalation.
Huddleston said NorthBay's intake process "calls for anyone with COVID characteristics to be handled as [a] patient under investigation for COVID, which means they're separated, screened and managed by staff in special PPE." At the two hospitals, which have handled nearly 200 COVID cases so far, the protocol is well established.
Hospitals in California, though not under siege in most cases, are dealing with multiple issues they might typically face only sporadically. In Napa County, Adventist Health St. Helena hospital evacuated51 patients on a single August night as a fire approached, moving them to 10 other facilities according to their needs and bed space. After a 10-day closure, the hospital was allowed to reopen as evacuation orders were lifted, the fire having been contained some distance away.
The wildfires are also taking a personal toll on healthcare workers. CommuniCare's Marshall lost her family's home in rural Winters, along with 20 acres of olive trees and other plantings that surrounded it, in the Aug. 19 fires that swept through Solano County.
"They called it a 'firenado,'" Marshall said. An apparent confluence of three fires raged out of control, demolishing thousands of acres. With her family safely accounted for and temporary housing arranged by a friend, she returned to work. "Our clinics interact with a very vulnerable population," she said, "and this is a critical time for them."
While she pondered how her family would rebuild, the CEO was faced with another immediate crisis: the clinic's shortage of supplies. Last month, CommuniCare got down to 19 COVID test kits on hand, and ran so low on swabs "that we were literally turning to our veterinary friends for reinforcements," the doctor said. The clinic's COVID test results, meanwhile, were taking nearly two weeks to be returned from an overwhelmed outside lab, rendering contact tracing almost useless.
Those situations have been addressed, at least temporarily, Marshall said. But although the West Coast is in the most dangerous time of year for wildfires, generally September to December, another complication for health providers lies on the horizon: flu season.
The Southern Hemisphere, whose influenza trends during our summer months typically predict what's to come for the U.S., has had very little of the disease this year, presumably because of restricted travel, social distancing and face masks. But it's too early to be sure what the U.S. flu season will entail.
"You can start to see some cases of the flu in late October," said Marshall, "and the reality is that it's going to carry a number of characteristics that could also be symptomatic of COVID. And nothing changes: You have to rule it out, just to eliminate the risk."
More than 20 states either don't release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus, which has sickened more than 6 million Americans. The lapses leave officials and the public in the dark about the true scope of the pandemic as untold numbers of cases go uncounted.
The gap will only widen as tens of millions of antigen tests sweep the country. Federal officials are prioritizing the tests to quickly detect COVID-19's spread over slower, but more accurate, PCR tests.
Relying on patchy data on COVID testing carries enormous consequences as officials decide whether to reopen schools and businesses: Go back to normal too quickly and risk even greater outbreaks of disease. Keep people at home too long and risk an even greater economic crisis.
"The absence of information is a very dangerous thing," said Janet Hamilton, executive director of the Council for State and Territorial Epidemiologists, which represents public health officials. "We will be blind to the pandemic. It will be happening around us and we will have no data."
The states that don't report antigen test results or don't count antigen positives as COVID cases are California, Colorado, Georgia, Illinois, Maryland, Minnesota, Missouri, Montana, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and Wyoming, as well as the District of Columbia.
So far, most of the COVID tests given in the U.S. have been PCR tests, which are processed in medical labs and can take days to return results. By contrast, antigen tests offer results in minutes outside of labs, appealing to everyone from medical clinics to sports teams and universities.
Each relies on swabs to test patients. But unlike using tests run through labs, many providers who would use antigen tests don't have an easy way to send data electronically to public health authorities.
Since July, though, the federal government has pushed roughly 5 million antigen tests into nearly 14,000 nursing homes to contain outbreaks among staff members and residents. The Department of Health and Human Services also awarded a $760 million contract to buy 150 million rapid antigen tests from Abbott, the Illinois-based diagnostics behemoth. It plans to send 750,000 of those to nursing homes starting this week, Brett Giroir, the HHS official heading the Trump administration's testing efforts, told industry executives on Sept. 8. Federal officials have not elaborated on how many tests will be sent elsewhere but have suggested many will go to governors to distribute as schools reopen.
The rush of antigen tests, however, won't be particularly useful to officials if the results are not publicly and uniformly reported.
KHN surveyed 50 states and the District of Columbia on their collection of antigen test results and what is reported publicly. Forty-eight responded between Sept. 3 and 10, revealing significant variation over whether people who test positive for COVID-19 with an antigen test are counted as cases and whether states even publicly report antigen data in their testing numbers:
21 states and D.C. do not report all antigen test results.
15 states and D.C. do not count positive results from antigen tests as COVID cases.
Two states do not require antigen test providers to report results, and five others require only positive results to be reported.
Nearly half of states believe their antigen test results are underreported.
Consequently, many state counts of infected people could be artificially low. For instance, the lack of reporting could imply infection rates are declining because the virus isn't spreading as widely — when really more antigen tests are being used and not counted, public health officials and experts say.
"It's going to look like your cases are coming down when they're not," said Jeffrey Morris, a biostatistics professor at the University of Pennsylvania.
HHS recognizes that antigen tests are underreported but maintained that officials are not missing the full scale of the pandemic, an agency spokesperson said.
"There is sufficient testing to achieve all objectives outlined in the testing strategy, including identifying newly emergent outbreaks, supporting public health isolation and contact tracing, protecting the vulnerable, supporting safe reopening of schools and businesses, and enabling state testing plans," spokesperson Mia Heck said.
Part of the problem on antigen test reporting stems from what counts as a COVID case. Guidance from the Centers for Disease Control and Prevention defines a "confirmed" COVID case as one that is determined from a PCR test. Positive results from antigen tests are considered "probable" cases because the tests can be less accurate.
Months after the first COVID antigen test received emergency authorization from the Food and Drug Administration, the CDC revised its COVID case definition in early August to allow a positive antigen test to count as a probable case without assessing whether a person had clinical symptoms or was in close contact with a confirmed infected person.
That prompted many states — including Arkansas, starting Sept. 2 — to adjust how they report cases.
"It's easy for people to think since we use the word 'probable' that maybe it's a case, maybe it isn't. But that's not how we think of it," said Dr. Jennifer Dillaha, medical director for the Arkansas Department of Health. "It is a real case in the same way that a PCR is a real case."
Dr. Karen Landers, an assistant state health officer for the Alabama Department of Public Health, said her biggest concern was the potential undercounting of antigen test results as they continue to grow in popularity. While the state has been trying to work with each urgent care or other medical provider, some struggle to submit the results.
"We can't afford to miss a case," she said.
The CARES Act, which Congress passed in March, requires a broad range of healthcare providers to report any COVID test result to state or local health departments. Nonetheless, two states — Montana and New Jersey — said they weren't requiring antigen test providers to report results, positive or negative. Colorado, Maine, Mississippi, New Hampshire and Wyoming require only positive results to be reported, which can distort the positivity rate.
Sara Mendez, the support services manager for the Brazos County Health Department in Texas, said the department saw an increase of antigen tests being administered as Texas A&M University students returned. Even though the state health department was not including positive COVID cases from antigen tests in its public reports, the local health department felt obligated to do so.
"A lot of the college students will just go and get those done as opposed to the PCR tests," Mendez said, "so we felt like we were missing out."
Indiana University undertook a massive antigen testing operation for students living on campus in August, administering 14,870 antigen tests across four campuses through drive-thrus, according to Graham McKeen, an assistant university director for public health. The test results were delivered while students waited in cars for about 30 minutes, with 159 coming back positive. Each night, a university staff member would manually download the spreadsheet off each of the test machines and securely email it to the state health department.
But Indiana began reporting antigen testing only on Aug. 24, adding over 16,000 antigen tests into its public dashboard that day and saying in a news release that it plans to retroactively add in earlier antigen testing figures.
McKeen said that, even though the state is now reporting some antigen data, tests are still missed under the cumbersome reporting system. The state said some of the data is being sent by fax.
"It doesn't give the community a good handle on the infection in the community," McKeen said.
Heck, the HHS spokesperson, said that federal agencies are working to improve the reporting of results and that problems were likely to be eased in the future, citing that Abbott's antigen test includes an electronic reader for automated reporting. By October, 48 million of those tests will be in circulation each month, she said.
Still, to date, "what this is exposing is the antiquated systems that public health agencies have had for years," said Scott Becker, executive director of the Association of Public Health Laboratories. "So much of the data we've gotten is incomplete."
That data barrier is playing out in nursing homes as well.
Victoria Crenshaw is holding off on using antigen tests to screen residents and staff members at Westminster Canterbury on Chesapeake Bay nursing home in Virginia Beach, Virginia. As senior director, she sees one major holdup: No technology platform is in place to easily send results to health officials. Instead, she and colleagues would need to resort to taping pieces of paper together to deliver details of who was tested, and hope local officials would accept it.
The Trump administration is pushing for nursing homes to use the tests for required screenings at least once a month and as often as twice a week. Under new federal regulations, nursing homes that don't comply with regular testing and reporting requirements are subject to citations or fines.
"We have no technology today to submit this information," Crenshaw said, "which leaves us in a vulnerable position."