Healthcare facilities are pressuring workers who contract COVID-19 to return to work sooner than public health standards suggest it's safe for them, their colleagues or their patients.
This article was published on Wednesday, August 12, 2020 in Kaiser Health News.
The first call in early April was from the testing center, informing the nurse she was positive for COVID-19 and should quarantine for two weeks.
The second call, less than 20 minutes later, was from her employer, as the hospital informed her she could return to her job within two days.
"I slept 20 hours a day," said the nurse, who works at a hospital in New Jersey's Hackensack Meridian Health system and spoke on the condition of anonymity because she is fearful of retaliation by her employer. Though she didn't have a fever, "I was throwing up. I was coughing. I had all the G.I. symptoms you can get," referring to gastrointestinal COVID symptoms like diarrhea and nausea.
"You're telling me, because I don't have a fever, that you think it's safe for me to go take care of patients?" the nurse said. "And they told me yes."
Guidance from public health experts has evolved as they have learned more about the coronavirus, but one message has remained consistent: If you feel sick, stay home.
Yet hospitals, clinics and other healthcare facilities have flouted that simple guidance, pressuring workers who contract COVID-19 to return to work sooner than public health standards suggest it's safe for them, their colleagues or their patients. Some employers have failed to provide adequate paid leave, if any at all, so employees felt they had to return to work — even with coughs and possibly infectious — rather than forfeit the paycheck they need to feed their families.
Unprepared for the pandemic, many hospitals found themselves short-staffed, struggling to find enough caregivers to treat the onslaught of sick patients. That desperate need dovetailed with a deeply entrenched culture in medicine of "presenteeism." Front-line healthcare workers, in particular, follow a brutal ethos of being tough enough to work even when ill under the notion that other "people are sicker," said Andra Blomkalns, who chairs the emergency medicine department at Stanford University.
In a survey of nearly 1,200 health workers who are members of Health Professionals and Allied Employees Union, roughly a third of those who said they had gotten sick responded that they had to return to work while symptomatic.
That pressure not only stresses hospital employees as they are forced to choose between their paychecks and their health or that of their families. The consequences are starker still: An investigation by KHN and The Guardian has identified at least 875 front-line health workers who have died of COVID-19, likely exposed to the virus at work during the pandemic.
But the dilemma also strains health workers' sense of professional responsibility, knowing they may become vectors spreading infectious diseases to the patients they're meant to heal.
Under Pressure
A database of COVID-related complaints made to the Occupational Safety and Health Administration this spring hints at the scope of the problem: a primary care facility in Illinois where symptomatic, COVID-positive employees were required to work; a respiratory clinic in North Carolina where COVID-positive employees were told they would be fired if they stayed home; a veterans hospital in Massachusetts where employees were returning to work sick because they weren't getting paid otherwise.
"What we learned in this pandemic was employees felt disposable," said Debbie White, a registered nurse and president of the Health Professionals and Allied Employees Union. "Employers didn't protect them, and they felt like a commodity."
Indeed, the pressure likely has been even worse than usual during the pandemic because hospitals have lacked backup staffing to deal with high rates of absenteeism caused by a highly infectious and serious virus. Hospitals do not staff for pandemics because in normal times "the cost of maintaining the personnel, the equipment, for something that may never happen" was hard to justify against more certain needs, said Dr. Marsha Rappley, who recently retired as chief executive of the Virginia Commonwealth University Health System in Richmond.
That has left many hospitals scrambling to find skilled staff to tend to waves of patients with COVID-19.
The nurse from Hackensack Meridian, the largest hospital chain in New Jersey, told the hospital's occupational health and safety office that she could not return to work, citing a doctor's instructions to isolate herself. No threat to fire her was made, she said.
But in daily calls from work, she was reminded her colleagues were short-staffed and "suffering."
She also discovered her employer had revoked most of the paid time off she believed she had accumulated.
White said Hackensack Meridian had conducted what it described as a "payroll adjustment" in March and taken leave from many of its employees without explaining its calculations.
A statement provided by a Hackensack Meridian spokesperson, Mary Jo Layton, said the system's occupational health office "has followed the CDC recommendations as it relates to the evaluation, testing and clearance of team members following infection with COVID-19."
Hackensack Meridian adjusted some employees' leave to correct a technical issue that prevented leave from being counted as it was taken, it said, adding workers were provided "an individual PTO reconciliation statement."
"No team members were shorted any PTO that they rightfully earned," Hackensack Meridian's statement said.
Federal officials acknowledge that staffing shortages may require sick healthcare workers to return to work before they recover from COVID-19. The Centers for Disease Control and Prevention even has strategies for it.
The CDC website lists mitigation options for short-staffed facilities, some of which have been implemented widely, such as canceling elective procedures and offering housing to workers who live with high-risk individuals.
But it acknowledges these strategies may not be enough. When all other options are exhausted, the CDC website says, workers who are suspected or confirmed to have COVID-19 (and "who are well enough to work") can care for patients who are not severely immunocompromised — first for those who are also confirmed to have COVID-19, then those with suspected cases.
"As a last resort," the website says, healthcare workers confirmed to have COVID-19 may provide care to patients who do not have the virus.
Like soldiers on the battlefield, Rappley said, front-line workers have been absorbing the consequences of that lack of preparedness on an institutional and societal level.
"This will leave scars for many generations to come," she said.
Dr. Lauren Schleimer, a first-year resident at NewYork-Presbyterian Hospital, exhibited symptoms of the coronavirus after working in a COVID-only intensive care unit. She was instructed to stay home for seven days. She was never tested. Schleimer returned to the ICU symptom-free to treat patients fighting the same virus she suspects she had. (Shelby Knowles for KHN)
Personal Choice or No Choice?
Shenetta White-Ballard carried an oxygen canister in a backpack at work. A nurse at Legacy Nursing and Rehabilitation of Port Allen in Louisiana, she needed the help to breathe after battling a serious respiratory infection two years earlier.
When COVID-19 began to spread, she showed up for work. Her husband, Eddie Ballard, said his paycheck from Walmart was not enough to support their family.
"She kept bringing up, she gotta pay the bills," he said.
White-Ballard died May 1 at age 44.
Legacy Nursing and Rehabilitation did not respond to requests for comment.
Ballard said his wife's employer offered no support for him and their 14-year-old son after her sudden death. "Only thing they said was, 'Come pick up her last check,'" he said.
Liz Stokes, director of the American Nurses Association's Center for Ethics and Human Rights, said immunocompromised workers, in particular, have faced difficult decisions during the pandemic — sometimes made more difficult by pressure from employers.
Stokes recounted the experience of a surgical nurse in Washington with Crohn's disease who took a temporary leave at her doctor's recommendation but was pressured by her bosses and co-workers to return.
"She really expressed severe guilt because she felt like she was abandoning her duties as a nurse," she said. "She felt like she was abandoning her colleagues, her patients."
The Right Thing to Do
Residents, or doctors in training, are among the most vulnerable, as they work on inflexible, tightly packed schedules often assisting in the front-line care of dozens of patients each day.
Not long after one of New York City's first confirmed COVID-19 patients was admitted to NewYork-Presbyterian Hospital, Lauren Schleimer, a first-year surgical resident, reported she had developed a sore throat and a cough. Because she had not been exposed to that patient, she was told she could keep working and to wear a mask if she was coughing.
Her symptoms subsided. But a couple of weeks later, as cases surged and ventilators grew scarce, she was working in a COVID-only intensive care unit when her symptoms returned, worse than before.
The hospital instructed her to stay home for seven days, as health officials were recommending at the time. She was never tested.
A NewYork-Presbyterian Hospital spokesperson said of its front-line workers: "We have been constantly working to give them the support and resources they need to fight for every life while protecting their own health and safety, in accordance with New York State Department of Health and CDC guidelines."
Schleimer returned to the ICU symptom-free at the end of her quarantine, caring for patients fighting the same virus she suspects she had. While she never felt that sick, she worried she could infect someone else — an immunocompromised nurse, a doctor whose age put him at risk, a colleague with a new baby at home.
"This was not the kind of thing I would stay home for," Schleimer said. "But I definitely had some symptoms, and I was just trying to do the right thing."
A review by KHN and The Associated Press finds at least 49 state and local public health leaders have resigned, retired or been fired since April across 23 states.
This article was published on Tuesday, August 11, 2020 in Kaiser Health News.
Vilified, threatened with violence or in some cases suffering from burnout, dozens of state and local public health officials around the U.S. have resigned or have been fired amid the coronavirus outbreak, a testament to how politically combustible masks, lockdowns and infection data have become.
One of the latest departures came Sunday, when California's public health director, Dr. Sonia Angell, was ousted following a technical glitch that caused a delay in reporting virus test results — information used to make decisions about reopening businesses and schools.
Last week, New York City's health commissioner was replaced after months of friction with the police department and City Hall.
A series examining how the U.S. public health front lines have been left understaffed and ill-prepared to save us from the coronavirus pandemic. The project is a collaboration between KHN and the AP.
A review by KHN and The Associated Press finds at least 49 state and local public health leaders have resigned, retired or been fired since April across 23 states. The list has grown by more than 20 people since the AP and KHN started keeping track in June.
Dr. Tom Frieden, former director of the Centers for Disease Control and Prevention, called the numbers stunning. He said they reflect burnout, as well as attacks on public health experts and institutions from the highest levels of government, including from President Donald Trump, who has sidelined the CDC during the pandemic.
"The overall tone toward public health in the U.S. is so hostile that it has kind of emboldened people to make these attacks," Frieden said.
The past few months have been "frustrating and tiring and disheartening" for public health officials, said former West Virginia public health commissioner Dr. Cathy Slemp, who was forced to resign by Republican Gov. Jim Justice in June.
"You care about community, and you're committed to the work you do and societal role that you're given. You feel a duty to serve, and yet it's really hard in the current environment," Slemp said in an interview Monday.
The departures come at a time when public health expertise is needed more than ever, said Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials.
"We're moving at breakneck speed here to stop a pandemic, and you can't afford to hit the pause button and say, 'We're going to change the leadership around here and we'll get back to you after we hire somebody,'" Freeman said.
As of Monday, confirmed infections in the United States stood at over 5 million, with deaths topping 163,000, the highest in the world, according to the count kept by Johns Hopkins University researchers. The confirmed number of coronavirus cases worldwide topped 20 million.
Many of the firings and resignations have to do with conflicts over mask orders or shutdowns to enforce social distancing, Freeman said. Despite the scientific evidence that such measures help prevent transmission of the coronavirus, many politicians and others have argued they are not needed, no matter what health experts tell them.
"It's not a health divide; it's a political divide," Freeman said.
Some health officials said they were stepping down for family reasons, and some left for jobs at other agencies, such as the CDC. Some, like Angell, were ousted because of what higher-ups said was poor leadership or a failure to do their job.
Others have complained that they were overworked, underpaid, unappreciated or thrust into a pressure-cooker environment.
"To me, a lot of the divisiveness and the stress and the resignations that are happening right and left are the consequence of the lack of a real national response plan," said Dr. Matt Willis, health officer for Marin County in Northern California. "And we're all left scrambling at the local and state level to extract resources and improvise solutions."
Public health leaders from Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, down to officials in small communities have reported death threats and intimidation. Some have seen their home addresses published or been the subject of sexist attacks on social media. Fauci has said his wife and daughters have received threats.
In Ohio, the state's health director, Dr. Amy Acton, resigned in June after months of pressure during which Republican lawmakers tried to strip her of her authority and armed protesters showed up at her house.
It was on Acton's advice that GOP Gov. Mike DeWine became the first governor to shut down schools statewide. Acton also called off the state's presidential primary in March just hours before polls were to open, angering those who saw it as an overreaction.
The executive director of Las Animas-Huerfano Counties District Health Department in Colorado, Kim Gonzales, found her car vandalized twice, and a group called Colorado Counties for Freedom ran a radio ad demanding that her authority be reduced. Gonzales has remained on the job.
In West Virginia, the governor forced Slemp's resignation over what he said were discrepancies in the data. Slemp said the department's work had been hurt by outdated technology like fax machines and slow computer networks. Tom Inglesby, director of the UPMC Center for Health Security at Johns Hopkins, said the issue amounted to a clerical error easily fixed.
Inglesby said it was deeply concerning that public health officials who told "uncomfortable truths" to political leaders had been removed.
"That's terrible for the national response because what we need for getting through this, first of all, is the truth. We need data, and we need people to interpret the data and help political leaders make good judgments," Inglesby said.
KHN and The Associated Press sought to understand how decades of cuts to public health departments by federal, state and local governments has affected the system meant to protect the nation's health.
Here are six key takeaways from the KHN-AP investigation.
Since 2010, spending on state public health departments has dropped 16% per capita, and the amount devoted to local health departments has fallen 18%, according to a KHN and AP analysis. At least 38,000 state and local public health jobs have disappeared since the 2008 recession, leaving a skeleton workforce for what was once viewed as one of the world's top public health systems.
Another sudden departure came Monday along the Texas border. Dr. Jose Vazquez, the Starr County health authority, resigned after a proposal to increase his pay from $500 to $10,000 a month was rejected by county commissioners.
Starr County Judge Eloy Vera, a county commissioner who supported the raise, said Vazquez had been working 60 hours per week in the county, one of the poorest in the U.S. and recently one of those hit hardest by the virus.
"He felt it was an insult," Vera said.
In Oklahoma, both the state health commissioner and state epidemiologist have been replaced since the outbreak began in March.
In rural Colorado, Emily Brown was fired in late May as director of the Rio Grande County Public Health Department after clashing with county commissioners over reopening recommendations. The person who replaced her resigned July 9.
The months of nonstop and often unappreciated work are prompting many public health workers to leave, said Theresa Anselmo of the Colorado Association of Local Public Health Officials.
"It will certainly slow down the pandemic response and become less coordinated," she said. "Who's going to want to take on this career if you're confronted with the kinds of political issues that are coming up?"
Weber reported from St. Louis. Associated Press writers Paul Weber, Sean Murphy and Janie Har and California Healthline senior correspondent Anna Maria Barry-Jester contributed reporting.
This story is a collaboration between KHN and The Associated Press.
Given the high and rapidly growing volume, it's easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.
This article was published on Monday, August 10, 2020 in Kaiser Health News.
Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.
"The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid," mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers' compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.
Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible — an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.
The cost of joint replacement surgery varies widely — though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it's easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.
The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projectionspublished last year in the Journal of Rheumatology.
Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March — and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.
"Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective," said Stephen Thome, a principal in healthcare consulting at Grant Thornton, an advisory, audit and tax firm.
It's impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.
But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.
That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.
If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.
The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year's end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.
Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.
At the NYU Langone Orthopedic Hospital in New York City, "people are starting to come in and you see the operating rooms full again," said Dr. Claudette Lajam, chief orthopedic safety officer.
At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May — cautiously at first, but volume is "very close to pre-pandemic levels at this point," said Dr. Kevin Khajavi, chairman of the hospital's orthopedic surgery department. However, "we are constantly monitoring the situation to determine if we have to scale back once again," he said.
In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.
The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are "at the bottom of the totem pole," Spangehl said.
In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.
The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.
It's also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers — especially on younger, healthier patients who don't require hospitalization.
The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.
"[G]enerally the savings should be very good — but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money — $100,000 wouldn't be too much," said WellRithm's Weintraub, who co-owned such a surgery center in Portland.
Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, D.C., was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.
"That was key to me — avoiding an overnight hospital stay to minimize my exposure," Davis said. "These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30."
Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.
However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.
"The whole marketing of healthcare is so manipulative to the consuming public," said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. "People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition."
McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem. "I asked the surgeon, 'You didn't do it, did you?' And he said, 'Of course I did. He would just have gone to somebody else.'"
As the coronavirus pandemic paralyzed most nonemergency medical practices this spring, the dialysis business, vital to the survival of patients with kidney disease, rolled ahead and in some cases grew.
Yet when the Trump administration sent billions in federal relief funds to medical organizations, at least $259 million went to dialysis providers, a KHN analysis of federal records found. Of that, kidney care behemoth Fresenius Medical Care accepted more than half, at least $137 million, despite acknowledging it had ample financial resources, the analysis showed.
The full amount going to Fresenius and many other dialysis providers is far higher than what KHN could confirm. The analysis was limited to the portion of grants disclosed by the federal government. And the analysis counted only grants going to organizations whose primary purpose was providing dialysis. In a securities filing last month, Fresenius disclosed it received a total of $277 million in relief funds under the Coronavirus Aid, Relief and Economic Security (CARES) Act.
Funding to giant dialysis providers would have been greater if DaVita, the other multinational corporation that dominates dialysis care in the U.S., had not turned down $240 million in aid, saying other medical providers needed it more. Fresenius and DaVita each own more than 2,600 dialysis centers nationwide.
Headquartered in Germany, Fresenius Medical Care is focused on patients with kidney failure who need blood-purifying dialysis treatment three times a week to stay alive, billing itself as the world's largest provider of dialysis and related services, equipment and drugs. Fresenius treated about 350,000 people worldwide and earned last year about $1.4 billion. The company announced second-quarter profits exceeding $400 million, up more than a third over last year, due to a 14% operating margin.
"From what we know today, the net impact of COVID-19 on our earnings is not so significant," Helen Giza, Fresenius' chief financial officer, told analysts.
With scores of COVID-19 patients developing major kidney damage, the pandemic caused unexpected demand for dialysis treatment. Chronic kidney disease and kidney failure were common among people hospitalized with COVID-19, accounting for 13% of all such patients nationally from January to March, when the extent of the virus's spread in the U.S. was just coming to light, according to FAIR Health, a health data nonprofit that analyzes insurance bills.
Little Drop-Off in Business
The bailouts to Fresenius and other dialysis operations provide one of the bluntest examples yet of how the Department of Health and Human Services failed to direct taxpayer-supported bailout funds only to providers in crisis. Massive assistance payments from the $175 billion Provider Relief Fund allotted by Congress went to well-financed corporations and segments of the healthcare industry like dialysis that were financially stable, or to businesses with ample financial reserves.
For instance, HCA Healthcare, the for-profit hospital chain,posted a $1.1 billion second-quarter profit that included $590 million in government rescue funds. "We've seen billions flow to wealthy hospital systems and healthcare corporations that may not need the money," said Kyle Herrig, president of Accountable.US, a government watchdog group and frequent critic of the Trump administration. "We should have designed a program that was most likely to help those that actually needed the help."
Harder-hit segments of the healthcare industry reported the relief funds were insufficient to cover all COVID-related costs and losses. Some doctors' offices and dentists struggled to stay afloat after having to forgo visits and procedures that are the main part of their businesses. Unlike the services hospitals provide, noted Ge Bai, associate professor of accounting and health policy at Johns Hopkins University in Baltimore, dialysis is "much more resistant to the pandemic in terms of revenue."
Dialysis clinics said their drop-off in business was minimal.
"For the most part, patients actually came," said Dr. Mihran Naljayan, medical director of Louisiana State University's peritoneal dialysis program in New Orleans, one of the country's earliest COVID-19 hot spots. "We didn't see a decrease in the number of visits." Instead, when the virus rapidly spread in the New Orleans metro area in late March, the number of inpatient dialysis treatments jumped 47% and continuous renal replacement therapy — dialysis for critically ill patients that is performed for a prolonged time — rose by 260%.
HHS defended its approach for distributing funds, noting that other options would have taken much longer to implement. Congress also did not instruct the department to determine the financial strength of each provider when allocating the money.
"HHS is acutely aware of the financial hardship many facilities and providers are facing. That is why HHS has and will make targeted distributions to facilities and providers that have been disproportionately impacted by the coronavirus pandemic," the department said in a statement.
Covering Unexpected Expenses
In explaining their need for federal money, dialysis clinics large and small said they faced unexpected costs to protect patients from COVID-19. They noted that defraying those costs was an explicit goal Congress set in creating the bailout fund and that their allotments did not cover those expenses.
Brad Puffer, a spokesperson for Fresenius Medical Care North America, which recorded about $41 billion in sales last year, said the money helped dialysis centers equip workers with protective equipment such as gowns, segregate COVID-positive patients, give emergency pay and child care stipends for workers, cover the costs of COVID testing and enact a telehealth system to conduct virtual visits.
"We believe our early and aggressive actions, and the vigilance with which our employees have implemented those actions, have successfully reduced the risks to our patients and employees," Puffer said in an email.
Congress provided the money but largely left to federal health officials the specifics on how these grants, which don't have to be repaid, should be distributed. In its haste to prop up providers, and after lobbying by hospitals and other sectors to quickly get money out the door, HHS meted out the first $50 billion based on past Medicare payments and overall patient revenue. Subsequent funding was steered to COVID-19 hot spots, nursing homes, providers in rural areas and safety-net institutions that care for higher numbers of the uninsured and other vulnerable groups.
The money is available to hospitals, physician practices, dialysis clinics and other medical entities regardless of financial strength; providers had only to agree the money would be used either to replace income lost because of the pandemic or to cover COVID-related expenses that weren't reimbursed through other means.
In April, DaVita, a Fortune 500 company based in Denver that saw $11 billion in revenue and $1 billion in net income last year, indicated it would keep the $240 million the government sent. But a month later, CEO Javier Rodriguez told analysts DaVita decided to return the payments even though the company had incurred extra costs because of the pandemic.
"From our perspective, they were a safety net," he said. "And they were to be used for people that needed that money, because the economic damage was so severe, that they couldn't keep their doors open."
In July, DaVita reported a 14% operating margin, a key measure of its business, for the second quarter. That was down from 16% from the same time last year. The company's net profit was $202 million.
Dan Mendelson, founder of the health consulting firm Avalere and a private equity investor, said the move by DaVita probably helps its image. "They are very attuned to how things look," Mendelson said. "When I saw they were turning it down, I was not surprised."
A Steady Demand
The dialysis industry adapted its care after the pandemic struck. That included segregating patients suspected of having or diagnosed with COVID-19 from uninfected people, limiting staff interaction with patients, hiring additional personnel and bulking up on protective equipment.
But while the pandemic forced other types of providers to close temporarily or significantly limit procedures, there was little impact on dialysis services.
LogistiCare Solutions, which has contracts with multiple state Medicaid programs to provide nonemergency medical transportation to enrollees, saw a steady demand from dialysis patients, while calls for other medical and social services waned because of COVID-induced shutdowns, senior adviser Albert Cortina said. Dialysis patients, who accounted for roughly a fifth of the company's volume before the pandemic, shot up to account for more than 40%.
"It was considered a true essential service," Cortina said.
Some independent dialysis centers said the HHS relief funds were crucial even though they maintained normal patient loads. Northwest Kidney Centers, a nonprofit that runs 19 dialysis centers primarily in Seattle, received $2.6 million. Dr. Suzanne Watnick, the chief medical officer, said that will not cover all of the substantial expenses the center incurred in increasing protection for patients and workers.
"It's important to recognize that what we had to do and stand up was like being in a hospital," she said.
Watnick did not begrudge the large dialysis corporations that accepted the bailout money. "They do have 100 times the number of patients; that seems a reasonable way to allocate," she said. "What do you say? 'You have more of a profit margin, but you get less money'?"
Hispanics have been disproportionately affected by COVID-19. Nationwide, Hispanic patients are hospitalized for COVID-19 at four times the rate of non-Hispanic whites.
This article was published on Friday, August 7, 2020 in Kaiser Health News.
Francisco Bonilla is a pastor in Carthage, Missouri, tending to the spiritual needs of the town’s growing Latino community. He’s also a media personality, broadcasting his voice far beyond the walls of Casa de Sanidad. Bonilla runs a low-power, Spanish-language radio station from the church.
He mainly uses the station to broadcast sermons and religious music. But these days he is also focused on COVID-19: explaining the illness and its symptoms, updating his listeners with the newest case counts and bringing on guests. He has broadcast interviews with a local nurse and with investigators from the Centers for Disease Control and Prevention.
Bonilla and some fellow pastors have closed their churches amid the pandemic. But there are some 30 churches serving the town’s Latino community, and he said other pastors haven’t acted as responsibly. Bonilla said some church leaders may believe that not holding services means they don’t have faith and that they want to show God is in control.
Starting in June, the southwestern corner of Missouri experienced a surge of coronavirus cases, including an outbreak among workers at the Butterball poultry-processing plant in Carthage. Coronavirus infections have been a problem at food-processing plants in many states. The impact has been particularly hard on nearby Latino communities, which often provide the bulk of the workforce at the plants.
Hispanics have been disproportionately affected by COVID-19. Nationwide, Hispanic patients are hospitalized for COVID-19 at four times the rate of non-Hispanic whites. (Hispanics can be of any race or combination of races.)
In Missouri, Hispanics and Latinos make up 4% of the state’s population but 14% of cases in which race or ethnicity is known. In Jasper County, where Carthage is located, they account for almost 40% of the confirmed cases but only 8.5% of the population, according to the Missouri Department of Health and Senior Services.
Many Latin American immigrants came to Carthage to work at the Butterball plant, which employs roughly 800 people in the town of about 15,000. The first to arrive in Carthage were predominantly from Mexico. But those who moved to the area over the past two decades came primarily from Guatemala and El Salvador.
The Butterball plant is half a mile from Carthage’s town square, a straight shot north along Main Street. Along the stretch are small shops and restaurants, many with Spanish-language flyers in the windows. They advertise money transfer services, self-help books and the availability of regional ingredients from Guatemala and El Salvador.
The Butterball plant has always been a sort of anchor for Carthage Councilman Juan Topete. His Mexican American parents worked there in the 1990s, after moving the family to Carthage from Los Angeles. When he was younger, Topete also worked for Butterball.
“My family came from having nothing, whatever we had in our U-Haul and that was it, to owning a restaurant and selling it later and being well established in the community,” Topete explained.
It’s a common story for many of the Latin American immigrants to Carthage, who can find well-paying jobs at the plant without having to speak English.
“When I first moved down here, if you were Hispanic you knew each other,” Topete said. “It was a very tight group and it has expanded tremendously these last few years.”
These days, a third of the people in Carthage are Hispanic, according to the U.S. Census Bureau. In 2016, Topete won a seat on the City Council, the first Latino resident to do so.
Topete said the Latino residents at Butterball and in other essential jobs face pressure on several fronts. Some who test positive for the coronavirus feel they have to keep going to work. They’re afraid of being laid off, or they need the money for their families.
“I do know people that have tested positive,” Topete said. “I try to stay in contact by calling them, following up on them, making sure they’re doing OK.”
A CDC team visited Carthage to investigate the outbreak. They reported the virus made its way into the Butterball plant, infecting workers and spreading through their families. In a statement, Butterball confirmed workers have tested positive but declined to say how many.
Topete said some residents still don’t know much about the disease, so the city is ramping up its outreach.
A Spanish-language public service announcement produced by the Carthage Police Department explains that the Missouri governor’s lifting of the statewide stay-at-home order doesn’t mean the virus is gone. The police department is part of the town’s COVID-19 task force and has helped Topete post Spanish-language flyers.
Such rural health departments face hurdles connecting to immigrant communities, said Lori Freeman, CEO of the National Association of County and City Health Officials. They typically have fewer language resources than their larger, urban counterparts, she said.
“In larger or even medium health departments, there are community health workers that are often bilingual or lingual enough to serve the communities that exist in the demographic area that they serve,” Freeman said.
At La Tiendita Mexican Market, a grocery store and restaurant, owner Jose Alvarado has taken steps to help keep his workers and customers safe. He’s concerned about children being exposed to the virus when their parents bring them in to shop, so he has posted a sign on the door asking that only one member of a family enter at a time. Next to the industrial tortilla maker, he has marked the floor with large X’s, as a visual guide and reminder for customers to stay socially distant from one another.
Topete fears the town’s Latino community could become a scapegoat for the virus. He said many people have the impression that the virus has affected only workers at the Butterball plant, when in reality it has spread throughout town.
Topete said Carthage officials need to keep up their outreach efforts but he sees the educational efforts working: On a recent trip to the store, he noticed more Latino shoppers than before wearing masks — and more of them were wearing masks than were the non-Hispanic shoppers.
This story is part of a partnership that includes KBIA, NPR and Kaiser Health News.
There is widespread public interest in participating in the pivotal, late-stage clinical trials of the first two COVID vaccine candidates in the United States.
Dr. Eric Coe jumped at the chance to help test a COVID-19 vaccine.
At his urging, so did his girlfriend, his son and his daughter-in-law. All received shots last week at a clinical research site in central Florida.
"My main purpose in doing this was so I could spend more time with my family and grandchildren," Coe said, noting that he's seen them only outside and from a distance since March.
"There's a lot less risk to getting the vaccine than contracting the virus," said Coe, 74, a retired cardiologist. "The worst thing that can happen is if I get the placebo."
The Coes' eagerness to offer up their bodies to science reflects the widespread public interest in participating in the pivotal, late-stage clinical trials of the first two COVID vaccine candidates in the United States.
Those trials began rolling out July 27. During the next two months, vaccine makers hope to recruit 60,000 Americans to roll up their sleeves to test the two vaccines, one made by Pfizer and BioNTech, a German company, and the other by biotech startup Moderna. While small tests earlier this year showed the preventives were safe and led to participants developing antibodies against the virus, the final phase 3 testing is designed to prove whether the vaccine reduces the risk of infection.
Amid a pandemic that in the U.S. has caused roughly 5 million infections and nearly 160,000 deaths while decimating the economy, the vaccine trials have drawn far more interest than is typical for a clinical trial, organizers said.
Also, the test sites pay volunteers as much as $2,000 for completing the two-year study.
"We have no shortage of volunteers and we have thousands of people interested in participating," said Dr. Ella Grach, CEO of M3-Wake Research of Raleigh, North Carolina, which is conducting vaccine trials at six sites.
Paul Evans, president of Velocity Clinical Research in Durham, North Carolina, said his company plans to recruit more than 10,000 volunteers in seven states to test COVID vaccines. At least four of Velocity's sites – in Ohio, California and Oregon – have already started injecting volunteers with the Moderna vaccine.
"It's been phenomenal," he said. Patient recruitment is one of the biggest challenges to running trials, but this time patients have been eager to sign up.
"I've been working in this business for 30 years," said Evans. "Outside of a COVID study, you might have to reach out to four or five, up to 10 people to find [one person] who is suitable."
Other vaccine candidates are being tested abroad and more tests will be launched in the U.S. later this year.
People 18 and older are eligible to participate in the trials, and Moderna and Pfizer are pushing to include high-risk individuals such as health workers, the elderly and people with chronic conditions such as diabetes and asthma. Organizers are also seeking to enroll Blacks and Hispanics, groups hit hard by the virus.
The vaccine makers have contracted with dozens of clinical research sites across the country. About 15 have started inoculating, and it will likely take until September for all volunteers to get their first shot. The participants will get a booster shot about a month later. They are asked to keep an electronic diary to record any symptoms. Because the virus is widespread across the country, the studies are expected to be able to note differences between infection rates in those who got the vaccine and those who received a placebo.
Government health experts say they hope to know if the vaccines are working by this fall. If the trials are successful, it would likely take until early next year before a vaccine could gain federal approval to start widespread distribution.
To determine effectiveness, half of the trial participants will receive the vaccine and half a placebo.
Coe, of Leesburg, Florida, said that several hours after getting his shot on Saturday he developed chills and was tired, symptoms that lasted until Sunday afternoon. "I'm virtually certain that I did not get a placebo because normal saline would not do that," he said. His daughter-in-law, Lisa Coe, 46, said she did not have any reaction other than soreness at the injection site.
"We are eager to get the vaccine and get on with the normal course of our lives," she said. "I'm not too worried about my own health, but I am worried about unknowingly transmitting it to anyone at risk."
Dr. Bruce Rankin, a physician investigator at Accel Research Sites in DeLand, Florida, where the Coes got their shots, said more than 1,000 adults have volunteered there already.
Accel recruits on social media sites such as Facebook and Instagram. It prescreens volunteers to make sure they understand what's expected, to learn their basic health history and get other demographic information such as race.
"I thought the opportunity to be part of something like this would be very cool," said Ginny Capiot, 45, of Fayetteville, North Carolina. "I believe it's pretty safe and there wasn't much to lose."
Capiot works in the marketing department at a hospital, where her diabetes puts her at increased risk of serious complications from the coronavirus.
Her visit to the test site last week lasted about three hours. After she filled out paperwork, health workers registered her temperature and other vital signs, gave her a COVID-19 test via a nasal swab and then took some blood. After Capiot was inoculated, she had to wait in a room in case she had any reaction. She did not.
"My arm is not even sore," she said a couple of days after the vaccination.
Volunteers in DeLand are paid as much as $1,200 over the course of the two-year trial. Participants in the Velocity-run trials will each receive $1,962 in compensation for time and travel. But Evans said many are motivated by altruism.
"They understand a couple of things," he said. "This has to happen for us to get a resolution or a solution to the pandemic. They also understand that there's a chance if they get the active vaccine and it works, they will benefit."
Not everyone is excited to test the unproven vaccine.
Dr. Atoya Adams, principal investigator for AB Clinical Trials, which is testing the Moderna vaccine in Las Vegas, said recruiting efforts there found that some people were confused or skeptical. They mistakenly worried they could contract COVID-19 from the vaccine.
The vaccines do not include any live virus. Earlier, smaller studies showed few major safety issues.
Adams has spent a lot of time on the phone, explaining that the vaccine appears safe and that volunteers are needed to see whether it's effective. "I've literally had to tell patients in prescreening, it's something I would feel safe giving to myself or my family," she said.
George Washington University in Washington, D.C., hopes to enroll 500 people at its testing site, and it received inquiries from at least that many in just the first week of recruitment.
"It's been overwhelming and really highlights that everyone understands the need for a vaccine," said Dr. David Diemert, professor of medicine at the GW School of Medicine and Health Sciences.
To gain an ethnically and racially diverse group, the university reached out to food banks, senior living communities and churches looking for volunteers. Participants can get paid nearly $1,100.
In Mississippi, the Hattiesburg Clinic has generated strong interest among potential volunteers, especially among healthcare personnel.
"People who care for these COVID patients have a very healthy fear of this illness," said Rambod Rouhbakhsh, chief investigator with MediSync Clinical Research, whose Moderna vaccine trial site is the only one in Mississippi.
He expects no trouble reaching people who would be at high risk of COVID complications, including those who are obese or have diabetes or heart disease. "In southern Mississippi, there are plenty of people who meet the high-risk categories," he said.
Healthcare workers of color were more likely to care for patients with suspected or confirmed COVID-19, more likely to report using inadequate or reused protective gear, and nearly twice as likely as white colleagues to test positive for the coronavirus, a new study from Harvard Medical School researchers found.
The study also showed that healthcare workers are at least three times more likely than the general public to report a positive COVID test, with risks rising for workers treating COVID patients.
Dr. Andrew Chan, a senior author and an epidemiologist at Massachusetts General Hospital, said the study further highlights the problem of structural racism, this time reflected in the front-line roles and personal protective equipment provided to people of color.
"If you think to yourself, 'Healthcare workers should be on equal footing in the workplace,' our study really showed that's definitely not the case," said Chan, who is also a professor at Harvard Medical School.
The study was based on data from more than 2 million COVID Symptom Study app users in the U.S. and the United Kingdom from March 24 through April 23. The study, done with researchers from King's College London, was published in the journal The Lancet Public Health.
Lost on the Frontline, a project by KHN and The Guardian, has published profiles of 164 healthcare workers who died of COVID-19 and identified more than 900 who reportedly fell victim to the disease. An analysis of the stories showed that 62% of the healthcare workers who died were people of color.
They include Roger Liddell, 64, a Black hospital supply manager in Michigan, who sought but was denied an N95 respirator when his work required him to go into COVID-positive patients' rooms, according to his labor union. Sandra Oldfield, 53, a Latina, worked at a California hospital where workers sought N95s as well. She was wearing a less-protective surgical mask when she cared for a COVID-positive patient before she got the virus and died.
The study findings follow other research showing that minority healthcare workers are likely to care for minority patients in their own communities, often in facilities with fewer resources, said Dr. Utibe Essien, a physician and core investigator for the Center for Health Equity Research and Promotion in the VA Pittsburgh Healthcare System.
Those workers may also see a higher share of sick patients, as federal data shows minority patients were disproportionately testing positive and being hospitalized with the virus, said Essien, an assistant professor of medicine with the University of Pittsburgh.
"I'm not surprised by these findings," he said, "but I'm disappointed by the result."
Dr. Fola May, a UCLA physician and researcher, said the study also reflects the fact that Black and Latino healthcare workers may live – or visit family – in minority communities that are hardest-hit by the pandemic because so many work on the front lines of all industries.
The study showed that healthcare workers of color were five times more likely than the general population to test positive for COVID-19.
Their workplace experience also diverged from that of whites alone. The study found that workers of color were 20% more likely than white workers to care for suspected or confirmed-positive COVID patients. The rate went up to 30% for Black workers specifically.
Black and Latino people overall have been three times as likely as whites to get the virus, a New York Times analysis of Centers for Disease Control and Prevention data shows. (Latinos can be of any race or combination of races.)
Healthcare workers of color were also more likely to report inadequate or reused PPE, at a rate 50% higher than what white workers reported. For Latinos, the rate was double that of white workers.
"It's upsetting," said Fiana Tulip, the daughter of a Texas respiratory therapist who died of COVID-19 on July 4. Tulip said her mother, Isabelle Papadimitriou, a Latina, told her stories of facing discrimination over the years.
Jim Mangia, chief executive of St. John's Well Child and Family Center in south Los Angeles, said his clinics care for low-income people, mostly of color. They were testing about 600 people a day and seeing a 30% positive test rate in June and July. He said they saw high positive rates at nursing homes where a mobile clinic did testing.
He said seven full-time workers scoured the U.S. and globe to secure PPE for his staff, at one point getting a shipment of N95 respirators two days before they would have run out. "It was literally touch-and-go," he said.
All healthcare workers who reported inadequate or reused PPE saw higher risks of infection. Those with inadequate or reused gear who saw COVID patients were more than five times as likely to get the virus as workers with adequate PPE who did not see COVID patients.
The study said reuse could pose a risk of self-contamination or breakdown of materials, but noted that the findings are from March and April, before widespread efforts to decontaminate used PPE.
Chan said even healthcare workers reporting adequate PPE and seeing COVID patients were far more likely to get the virus than workers not seeing COVID patients — nearly five times as likely. That finding suggests a need for more training in putting on and taking off protective gear safely and additional research into how healthcare workers are getting sick.
For a world crippled by the coronavirus, salvation hinges on a vaccine.
But in the United States, where at least 4.6 million people have been infected and nearly 155,000 have died, the promise of that vaccine is hampered by a vexing epidemic that long preceded COVID-19: obesity.
Scientists know that vaccines engineered to protect the public from influenza, hepatitis B, tetanus and rabies can be less effective in obese adults than in the general population, leaving them more vulnerable to infection and illness. There is little reason to believe, obesity researchers say, that COVID-19 vaccines will be any different.
"Will we have a COVID vaccine next year tailored to the obese? No way," said Raz Shaikh, an associate professor of nutrition at the University of North Carolina-Chapel Hill.
"Will it still work in the obese? Our prediction is no."
More than 107 million American adults are obese, and their ability to return safely to work, care for their families and resume daily life could be curtailed if the coronavirus vaccine delivers weak immunity for them.
In March, still early in the global pandemic, a little-noticed study from China found that heavier Chinese patients afflicted with COVID-19 were more likely to die than leaner ones, suggesting a perilous future awaited the U.S., whose population is among the heaviest in the world.
And then that future arrived.
As intensive care units in New York, New Jersey and elsewhere filled with patients, the federal Centers for Disease Control and Prevention warned that obese people with a body mass index of 40 or more — known as morbid obesity or about 100 pounds overweight — were among the groups at highest risk of becoming severely ill with COVID-19. About 9% of American adults are in that category.
As weeks passed and a clearer picture of who was being hospitalized came into focus, federal health officials expanded their warning to include people with a body mass index of 30 or more. That vastly expanded the ranks of those considered vulnerable to the most severe cases of infection, to 42.4% of American adults.
Obesity has long been known to be a significant risk factor for death from cardiovascular disease and cancer. But scientists in the emerging field of immunometabolism are finding obesity also interferes with the body's immune response, putting obese people at greater risk of infection from pathogens such as influenza and the novel coronavirus. In the case of influenza, obesity has emerged as a factor making it more difficult to vaccinate adults against infection. The question is whether that will hold true for COVID-19.
A healthy immune system turns inflammation on and off as needed, calling on white blood cells and sending out proteins to fight infection. Vaccines harness that inflammatory response. But blood tests show that obese people and people with related metabolic risk factors such as high blood pressure and elevated blood sugar levels experience a state of chronic mild inflammation; the inflammation turns on and stays on.
Adipose tissue — or fat — in the belly, the liver and other organs is not inert; it contains specialized cells that send out molecules, like the hormone leptin, that scientists suspect induces this chronic state of inflammation. While the exact biological mechanisms are still being investigated, chronic inflammation seems to interfere with the immune response to vaccines, possibly subjecting obese people to preventable illnesses even after vaccination.
An effective vaccine fuels a controlled burn inside the body, searing into cellular memory a mock invasion that never truly happened.
Evidence that obese people have a blunted response to common vaccines was first observed in 1985 when obese hospital employees who received the hepatitis B vaccine showed a significant decline in protection 11 months later that was not observed in non-obese employees. The finding was replicated in a follow-up study that used longer needles to ensure the vaccine was injected into muscle and not fat.
Researchers found similar problems with the hepatitis A vaccine, and other studies have found significant declines in the antibody protection induced by tetanus and rabies vaccines in obese people.
"Obesity is a serious global problem, and the suboptimal vaccine-induced immune responses observed in the obese population cannot be ignored," pleaded researchers from the Mayo Clinic's Vaccine Research Group in a 2015 study published in the journal Vaccine.
Vaccines also are known to be less effective in older adults, which is why those 65 and older receive a supercharged annual influenza vaccine that contains far more flu virus antigens to help juice up their immune response.
By contrast, the diminished protection of the obese population — both adults and children — has been largely ignored.
"I'm not entirely sure why vaccine efficacy in this population hasn't been more well reported," said Catherine Andersen, an assistant professor of biology at Fairfield University who studies obesity and metabolic diseases. "It's a missed opportunity for greater public health intervention."
In 2017, scientists at UNC-Chapel Hill provided a critical clue about the limitations of the influenza vaccine. In a paper published in the International Journal of Obesity, they showed for the first time that vaccinated obese adults were twice as likely as adults of a healthy weight to develop influenza or flu-like illness.
Curiously, they found that adults with obesity did produce a protective level of antibodies to the influenza vaccine, but they still responded poorly.
"That was the mystery," said Chad Petit, an influenza virologist at the University of Alabama.
One hypothesis, Petit said, is that obesity may trigger a metabolic dysregulation of T cells, white blood cells critical to the immune response. "It's not insurmountable," said Petit, who is researching COVID-19 in obese patients. "We can design better vaccines that might overcome this discrepancy."
Historically, people with high BMIs often have been excluded from drug trials because they frequently have related chronic conditions that might mask the results. The clinical trials underway to test the safety and efficacy of a coronavirus vaccine do not have a BMI exclusion and will include people with obesity, said Dr. Larry Corey, of the Fred Hutchinson Cancer Research Center, who is overseeing the phase 3 trials sponsored by the National Institutes of Health.
Although trial coordinators are not specifically focused on obesity as a potential complication, Corey said, participants' BMI will be documented and results evaluated.
Dr. Timothy Garvey, an endocrinologist and director of diabetes research at the University of Alabama, was among those who stressed that, despite the lingering questions, it is still safer for obese people to get vaccinated than not.
"The influenza vaccine still works in patients with obesity, but just not as well," Garvey said. "We still want them to get vaccinated."
Adm. Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, during an appearance on CNN's "State of the Union" with Jake Tapper, July 26, 2020
In a heated exchange late last month on CNN's State of the Union, host Jake Tapper pressed Adm. Brett Giroir, the Health and Human Services assistant secretary who oversees COVID testing efforts for the Trump administration, on why the government isn't requiring commercial labs to increase testing capacity in order to speed turnaround time.
Giroir's response described a series of steps — some unusual — being taken by the federal government. One focus was on the role veterinary labs, including those with special certification, could play in helping to build capacity. "Five veterinary labs have their CLIA certification to officially test human patients," he said. "There are a lot of labs who are doing surveillance testing that don't need the CLIA certification."
So that got us wondering: Can labs that test cattle, chickens or your pet Fido run tests on humans? And, if so, what role are they playing in the national pandemic, and how much is it helping?
After all, the issue of expanding lab capacity will likely come up repeatedly as demand for testing increases with mounting case counts. Turnaround times at some labs have grown, with results now taking days to more than a week in some areas, frustrating consumers and public health officials. Delays for test results mean delays for contact tracing and quarantining. The administration's pandemic response, including testing issues, is also proving to be a hot topic on the campaign trail.
We reached out to HHS for more information about Giroir's statement.
An HHS spokesperson emailed a list of nine veterinary labs that have received the required certification to do patient-specific human testing, saying Giroir had been mistakenly briefed before the interview that there were only five. A U.S. Department of Agriculture spokesperson said there are 15 National Animal Health Laboratory Network facilities nationwide that have CLIA certification to test human samples. Clearly, there are vet labs in the U.S. with the necessary credentials, but the exact number is a matter of confusion.
As for the surveillance efforts, the HHS spokesperson did not provide specific examples of veterinary labs doing such work but provided a Centers for Medicare & Medicaid Services FAQsaying labs that don't have CLIA certification can do some types of surveillance if results are not given to specific patients.
Similar Science, Same Machines
Our experts all quickly noted that veterinary labs — especially those that focus on food animals, including cows, pigs and chickens, have long tested for diseases, including many kinds of coronaviruses.
They're on the lookout for microbes that can affect food safety, such as salmonella or E. coli, or diseases that can devastate the animals themselves, including avian influenza, hoof and mouth disease or African swine fever.
Hence, a lot of testing goes on in the 63 food-animal testing labs in 33 states and four Canadian provinces accreditedby the American Association of Veterinary Laboratory Diagnosticians, said its executive director, David Zeman.
"In some states, we have more capacity in the vet labs than in the public health labs," he added.
Those vet labs, often affiliated with universities or government agencies, use highly sophisticated equipment, including polymerase chain reaction (PCR) techniques, as do labs focusing on human testing. Many of the COVID tests being done are PCR, which can detect the virus's genetic material.
"It's the same machines, the same science," said Zeman.
However, these are large, full-service labs that deal mainly with farm animals, different from the smaller labs generally found at your neighborhood vet. So, sorry, Fido.
A Different Regulatory Chain of Command
Earlier this year, researchers at Iowa State University found that the testing process for the new coronavirus is similar to that used to test pigs for porcine epidemic diarrhea (PED) virus, a disease that killed thousands of piglets in 2013. Because a lot of labs had updated their equipment and processes so they could check for PED, they were in a good position to help with COVID-19 testing.
Except, of course, it's never that simple.
While the science and technology are the same, the administrative requirements are not.
Veterinary labs must meet standards for accreditation by such groups as the American Association of Veterinary Laboratory Diagnosticians and are overseen by federal and state agricultural agencies.
Human labs also must meet strict standards, including CLIA, and fall under the auspices of other agencies, including the Centers for Medicare & Medicaid Services, the Food and Drug Administration and the Centers for Disease Control and Prevention.
One requirement is that the CLIA lab must have a director who is a medical doctor with specialized experience. Most animal labs are run by, not surprisingly, veterinarians, often ones with Ph.D.s. Some vet labs have formed partnerships with CLIA-certified labs to clear this hurdle. Still, it's a process that can take weeks, so it's not an overnight fix, said Zeman.
Telephone interview with Mark Ackermann, director of the Oregon Veterinary Diagnostic Laboratory, July 28, 2020
Email correspondence with Michelle Forman, manager, Media Association of Public Health Laboratories, July 28, 2020
Email correspondence with Mia Heck, spokesperson for Department of Health and Human Services, July 28 and 29, 2020
Telephone interview with Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security, July 28, 2020
Telephone interview with David Zeman, executive director of the American Association of Veterinary Laboratory Diagnosticians, July 28, 2020
Telephone interview with Thomas Sparkman, senior vice president, government affairs and policy, American Clinical Laboratory Association, July 28, 2020
Email correspondence with Lyndsay Cole, assistant director for public affairs, USDA Animal and Plant Health Inspection Service, July 30, 2020
But can these labs really make a difference in the testing backlog?
A June article on the American Veterinary Medicine Association website quoted an official in May saying that the then-seven CLIA-certified vet labs had the capacity to process 12,000 PCR samples with a 24-hour turnaround.
Zeman said he sent out a survey in July to his 63 members in response to an HHS inquiry and found that, on average, each lab — if CLIA-certified — could process 500 to 1,000 COVID samples a day on top of what it needs to do to monitor animals.
"Multiply that by 60 some labs and you have a rough idea of what they could do," he said. The math adds up to at least 31,500 tests a day.
Currently, more than 700,000 samples are taken daily and sent to all types of labs — mainly large commercial and hospital-based facilities, according to tracking by Johns Hopkins University. The Atlantic's COVID Tracking Project notes similar testing numbers at the end of July.
More vet labs participating "could ease the burden on these labs, but it doesn't sound like a game changer in terms of wait times," said Gigi Gronvall, a senior scholar at Johns Hopkins Center for Health Security.
Some vet labs are working with public health labs to "test a specific segment of the population (university students, routine screening of government workers, etc.)," said Michelle Forman, media manager for the Association of Public Health Laboratories in an email. "So it's not so much taking existing burden off of the public health labs and commercial labs but it is preventing additional burden from being put on them."
Giroir said "lots" of labs that are non-CLIA certified labs are helping by doing research or surveillance, but Zeman was not aware of such efforts by such labs in his organization.
Perhaps Giroir was talking about "pooled testing," in which a number of specimens are tested in a batch, speculated Mark Ackermann, director of the Oregon Veterinary Diagnostic Laboratory in Corvallis, Oregon. Under that method, if any batch tests positive, individual specimens from the batch are then each tested to see who is positive.
Ackermann, whose lab has CLIA certification, pointed to another way vet labs might be helping: Many are making the liquid needed for the vials that hold the swabs taken from patients' nasal passages.
Our Ruling
Giroir was correct in saying there are some veterinary labs helping out with COVID testing.
But even if all 63 accredited food-animal vet labs in the U.S. and Canada were pressed into processing human COVID tests, an industry survey estimates it would increase capacity by between 31,500 to 63,000 samples per day. While helpful, that would still be only a small portion of the more than 700,000 daily tests being conducted, which some experts say falls short of what is needed.
Additionally, while vet labs are helping in some ways, Giroir provided little evidence to back up his assertion that "lots" of labs that lack CLIA certification are assisting in surveillance efforts.
Premiums for health plans sold through Covered California, the state's Affordable Care Act insurance exchange, will rise an average of 0.6% next year — the smallest hike since it started providing coverage in 2014, the agency announced Tuesday.
The modest increase follows an average statewide increase of 0.8% on coverage that started in January of this year, which was the previous record low.
The rate changes will vary across regions, ranging from an average increase of 5.6% in Santa Clara County to reductions of 2.1% in southwestern Los Angeles County and 2.6% in Mono, Inyo and Imperial counties.
Before the announcement, some industry observers had called for rate cuts, given the windfall health plans have reaped so far this year from lower spending on care. The COVID-19 pandemic shut down elective surgeries in the spring and has continued to sharply reduce patient visits to doctors, emergency rooms and outpatient clinics.
But Peter Lee, Covered California's executive director, told California Healthline that lower spending by insurers due to the pandemic had "very, very little" impact on 2021 premiums.
Covered California's insurance carriers "are seeing their healthcare costs rebound and are projecting that for the balance of the year they will catch up on the health expenses they thought they were going to spend for 2020," Lee said. Health plans in the exchange projected increases in non-COVID medical costs of 4% to 8% next year and did not think they needed to budget extra for the pandemic, he said.
The rate increase was modest mainly because of a surge of new, "healthier" enrollees both during the regular enrollment period for 2020 coverage and the current "special" enrollment period — recently extended to Aug. 31 — for people whose coverage has been affected by the pandemic, Lee said. Covered California said an analysis of the medical risk and demographics of these newcomers showed "they are healthier on average than the equivalent cohorts from 2019."
But Kaiser Permanente said in a regulatory filing that it saw no change in the overall health of enrollees, and Anthem Blue Cross expected a less healthy patient mix, pushing costs up about 2.2%,
Covered California said that other factors keeping the average rate hike low include the repeal of a federal tax on health plans, which reduced 2021 premiums by an average of 1.7%, and a cut next year in the "participation" fee health plans pay Covered California, from 3.5% of premiums to 3.25%.
The exchange provides coverage for about 1.5 million Californians who buy their own insurance. About 90% of them receive financial assistance from the federal or state government, or both, to help them pay for their premiums. Another 800,000 Californians buy coverage in the open market, where financial assistance is not available. About 600,000 of that group are in plans that mirror the ones available on the exchange and will see the same rate increase.
Glenn Melnick, a professor of public finance at the University of Southern California's Sol Price School of Public Policy, differed with Lee's view of the medical spending trend, saying health plans will likely continue to benefit from depressed patient volume next year, which will more than offset their assumed 4% to 8% increase in non-Covid costs.
Emergency room visits are lagging pre-pandemic levels by about 20% and outpatient volume is about 5% to 10% down, Melnick said. "I don't see those people coming back unless there's a vaccine – and when there's a spike, more people will stay home."
Michael Johnson, a health insurance industry observer and critic who worked as an executive at Blue Shield of California from 2003 to 2015, said next year's premiums should be lower. "Preliminary indications are that rates for 2020 are way too high, so for 2021 they should be going down, not up," he said.
The average statewide increase among Covered California carriers is smaller than what's been proposed in many other states.
A KFF analysis last month of proposed 2021 rates in the exchanges of 10 states and the District of Columbia showed a median increase of 2.4%, with changes ranging from a hike of 31.8% by a health plan in New Mexico to a cut of 12% by one in Maryland. (Kaiser Health News, which produces California Healthline, is an editorially independent program of KFF.)
This year's rate announcements come as the Affordable Care Act remains under threat from a federal lawsuit by Republican officials in 18 states, joined by the Trump administration, who want to repeal it. If they prevail, more than 20 million people could lose their health coverage and popular consumer protections afforded by the ACA, including the ban on health plan discrimination against people with preexisting medical conditions, could be eliminated.
All 11 insurance companies operating in Covered California this year will remain in 2021, and no new ones will enter the marketplace. But Anthem Blue Cross and Oscar Health Insurance will expand their offerings geographically, the exchange said. Anthem will enter Inyo, Kern, Mono and Orange counties. Oscar will join the competition in San Mateo County. Many of the Covered California health plans are available only in certain regions of the state.
Kaiser Permanente is the largest carrier in the exchange, with about 526,000 enrollees this year, more than one-third of the total. Kaiser is followed by Blue Shield of California, with 392,000, and Health Net, with 232,000.
Kaiser is seeking an average increase of 0.9% in its individual market plans, including those sold in the exchange and outside of it, according to a filing with the state's Department of Managed Healthcare. Last year, Kaiser raised its rates by an average of 0.7%.
Blue Shield of California plans to cut rates by an average of 2.4% statewide, following a hike of 3.6% this year, according to its regulatory filings. One of the main factors in next year's rate cut, it said, is that it set current premiums with a projection of medical costs that was too high.
Rates differ not only from carrier to carrier and region to region, but also by the covered person's age. Premiums also differ by benefit level, from the cheaper "bronze" coverage tier up to the highest, known as "platinum." The lower the premium, the higher the deductibles and coinsurance payments for care.
The individual deductible for the bronze tier in 2021is set at $6,300, unchanged fromthis year. For the silver tier, the second-cheapest level of coverage, the full individual deductible in 2021 will be $4,000, also unchanged from this year. But many silver enrollees are in plans that offer financial aid to reduce their share of medical costs, and that can push the 2021 silver deductible as low as $75.
Moreover, numerous medical services are not subject to the deductible in silver plans, including primary care and specialist visits, lab tests, X-rays and other imaging. In bronze plans, the first three primary care visits are not subject to the deductible.
Covered California said that, on average, exchange enrollees who plan to renew for 2021 can save 7.3% on premiums by switching to the least expensive plan in the same tier of coverage.
The 2021 rates are subject to final review by the Department of Managed Healthcare and the Department of Insurance, but significant changes are unlikely.
The enrollment period for 2021 coverage starts Nov. 1 and runs through Jan. 31.