Coronavirus patients and their families who believe a doctor, nurse, hospital or other provider made serious mistakes during their care may face a new hurdle if they try to file medical malpractice lawsuits.
This story was first published on Friday, May 15, 2020 in Kaiser Health News.
Coronavirus patients and their families who believe a doctor, nurse, hospital or other provider made serious mistakes during their care may face a new hurdle if they try to file medical malpractice lawsuits.
Under pressure from health provider organizations, governors in Connecticut, Maryland, Illinois and several other states have ordered that most providers be shielded from civil ― and, in some cases, criminal — lawsuits over medical treatment during the COVID-19 health emergency. In New York and New Jersey, immunity is now part of state law. In California, six hospital, physician and long-term care provider groups are pressing Gov. Gavin Newsom to also issue an order assuring immunity.
The efforts are attracting congressional attention as well and threatening to derail the next federal coronavirus stimulus package on Capitol Hill. Senate Majority Leader Mitch McConnell is demanding that Congress include liability protections against COVID-related suits for businesses and health care providers. The contentious issue of legal liability claims in health care has divided congressional Republicans and Democrats for years.
“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” the Kentucky Republican said in the Senate on Tuesday. “This will give our doctors, nurses and other health care providers a lot more security as they clock in every day and risk themselves to care for strangers.”
Some legal experts and seniors’ advocates worry that the state immunity guarantees go too far, leaving patients with no way to hold providers accountable. Supporters argue that health care providers and facilities deserve protection from lawsuits as they battle a deadly virus during an unprecedented public health emergency.
Pennsylvania Gov. Tom Wolf, a Democrat, joined the movement last week, acknowledging that the COVID-19 epidemic has “required our health care providers to broaden their professional responsibilities and experiences like never before.” Like other governors, Wolf included in his order exceptions for the most egregious lapses in care involving intentional misconduct or extreme negligence.
“When you are asking nurses to work around-the-clock and the ICU has 2½ times as many people than it was engineered for, well, my goodness, doesn’t this make common sense?” said Kenneth Raske, president and chief executive officer of the Greater New York Hospital Association, which represents more than 160 hospitals and health systems in New York, New Jersey, Connecticut and Rhode Island.
The group helped draft New York’s immunity measure, said Raske. Supporters also include the American Medical Association, which urged the National Governors Association to use the New York law as a model for other states.
Immunity for providers during the COVID-19 emergency “is good for patients” because it encourages providers to work in extraordinarily tough conditions, said James Hodge, an Arizona State University law professor and regional director at the Network for Public Health Law.
It is an extension of the usual protection for a “good Samaritan” — the doctor or nurse who sees a car accident, for example, and stops to help the injured. The well-intentioned doctor doesn’t have the equipment and support of a hospital and shouldn’t be held to the same standards.
Similarly, some well-intentioned medical providers treating COVID-19 patients work with scarce supplies and overburdened staff and face other conditions often beyond their control.
Since some states offer no virus-related liability protection for long-term care providers — such as skilled nursing facilities, assisted living communities and continuing care retirement communities — during the current crisis, their trade associations are looking to the federal government instead.
“Long-term care workers and centers are on the front line of this pandemic response,” said Cristina Crawford, a spokesperson for the American Health Care Association, “and it is critical that states and the federal government provide the necessary liability protection.”
But Mairead Painter, director of Connecticut’s State Long Term Care Ombudsman Program, said the immunity guarantee could discourage nursing home residents and their families from filing complaints about abuse or neglect, or challenging their transfer to other homes as administrators try to separate residents who have the coronavirus from those without it.
“So they might sort of just let it fall to the wayside, and we don’t want them to do that,” she said.
As infection rates slowly decrease, providers should be expected to follow the usual standard of care, said Barry Furrow, director of Drexel University law school’s health law program in Philadelphia, who has studied hospital corporate negligence.
“These immunity statutes do too much, because now we’re settling back to a more normalized health care situation where we have a new disease vector, which we’re beginning to understand,” he said.
The immunity guarantee covers the duration of the COVID-19 emergency, which could continue for several more months, if not longer, Furrow said, so states are letting providers “off the hook.”
Despite the state immunity guarantees, the Centers for Medicare & Medicaid Services ordered state health inspectors to crack down on nursing homes that don’t follow infection-control requirements, and, starting May 8, required facilities to inform residents or their families by 5 p.m. the day after a new case of COVID-19 is confirmed. And officials in some parts of the country have begun criminal investigations of nursing homes suspected of endangering residents.
The mixed messages are most evident in New York, the coronavirus epicenter in the U.S., which has one of the nation’s most comprehensive COVID-19 shields against medical liability. It protects individual medical professionals as well as health care facilities from both civil and criminal lawsuits involving any patients, regardless of whether they had the virus. There’s an exception for egregious conduct, which Furrow said is a high bar and up to a jury to define.
“This sends a message to the nursing home inspectors to step back,” said Richard Mollot, executive director of the Long Term Care Community Coalition in New York City. “This is an insidious quieting of accountability just when it is needed the most.”
But Dani Lever, a spokesperson for Gov. Andrew Cuomo, said the immunity law “imposes no limitations on the ability of the state to investigate nursing homes.”
About 20% of the 27,450 confirmed and presumed coronavirus deaths in the state by Wednesday have occurred in nursing homes, prompting an investigation by Cuomo and Attorney General Letitia James. When Cuomo described the investigation, he was both sympathetic and critical of nursing homes.
“This is a crisis situation for nursing homes … through no fault of their own,” he said. “Mother Nature brought a virus and the virus attacks old people.” Nonetheless, he added, they must “do their job by the rules and regulations.”
Although scientists and stock markets have celebrated the approval for emergency use of remdesivir to treat COVID-19, a cure for the disease that has killed nearly 260,000 people remains a long way off — and might never arrive.
Hundreds of drugs are being studied around the world, but "I don't see a lot of home runs right now," said Dr. Carlos del Rio, a professor of infectious diseases at the Emory University Rollins School of Public Health. "I see a lot of strikeouts."
Researchers have launched more than 1,250 studies of COVID-19. Pharmaceutical companies are investing billions to develop effective drugs and vaccinesto help end the pandemic.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, was cautious when announcing the results of a clinical trial of remdesivir last week, noting it isn't a "knockout." Although remdesivir helped hospitalized COVID-19 patients recover more quickly, it hasn't been proved to save lives.
"This [drug] is opening the door," Fauci said. "As more companies and investors get involved, it's going to get better and better."
Researchers have already announced that they will combine remdesivir with an anti-inflammatory drug, baricitinib — now used to treat rheumatoid arthritis — in the hope of improving results.
But COVID-19 is an elusive enemy.
Doctors treating COVID patients say they're fighting a war on multiple fronts, battling a virus that batters organs throughout the body, causes killer blood clots and prompts an immune system overreaction called a "cytokine storm."
With so many parts of the body under siege at once, scientists say, improving survival rates will require multiple routes of attack — and more than one drug. While some of the experimental medications target the virus, others aim to prevent the immune system from inflicting collateral damage.
"There are so many pieces of this, and they will all require different therapies," said Dr. Lewis Kaplan, president of the Society of Critical Care Medicine, whose doctors provide intensive care.
Scientists are also taking a fresh look at existing medications that might be repurposed to fight COVID-19. These include antivirals for influenza, arthritis drugs, estrogen patches and even antacids. If repurposed drugs are successful, they could reach patients relatively quickly, because doctors are already familiar with their side effects and safety concerns.
Some doctors are skeptical that drugs for heartburn or hot flashes have any chance of treating a killer like COVID-19.
Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, said he fears that hype over unproven products will harm patients, even if it temporarily boosts company stock prices. Patients who demand antacids or antimalarial drugs being studied in COVID-19 could be harmed by side effects, for example. Those who hoard drugs — on the hope of protecting themselves from COVID-19 — could deprive other patients of medications they need to stay healthy. Some people may refuse to participate in clinical trials because they fear being given a placebo.
"This rush to get every imaginable treatment into a study, it's not prudent," Nissen said. "It's not good medicine. It's an act of desperation."
Other experts say scientists should cast a wide net.
"I don't think we want to rule anything out because it sounds out of the ordinary," said Dr. Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
Antivirals In The Spotlight
Antivirals such as remdesivir aim to prevent viruses from replicating, said Dr. Peter Hotez, a professor at Baylor College of Medicine in Houston.
That doesn't always work. A small Chinese study of remdesivir, published last month in The Lancet, found no benefit to severely ill COVID-19 patients. Remdesivir had previously failed when tested against Ebola.
Antivirals tend to be most helpful in the early stages of infection, when most of the harm to the patient is caused by the virus itself, rather than the immune system, Hotez said.
Remdesivir is just one of many antivirals being tested against COVID-19.
International researchers are studying the antiviral favipiravir, developed to fight the flu.
A study in the New England Journal of Medicine likewise found no benefit in giving two antivirals used to treat HIV ―a combination of lopinavir and ritonavir, sold as Kaletra— in adults hospitalized with severe COVID-19.
Harnessing The Immune System
One of the therapies generating excitement is also one of the oldest: antibody-rich blood from COVID survivors.
The immune system produces antibodies in response to invaders such as viruses and bacteria, allowing the body to recognize and neutralizethem. Antibodies also recognize and neutralize the virus the next time that person is exposed.
Doctors hope that patients who develop antibodies against the novel coronavirus will become immune, at least for a few years, although this hasn't been proved.
Scientists developing this "convalescent plasma" are studying whether COVID-19 survivors can share this immunity with others by donating their plasma, the liquid part of blood that contains antibodies, said Dr. Shmuel Shoham, an associate professor of medicine at the Johns Hopkins University School of Medicine.
In addition to treating people who are already sick, donated plasma could potentially prevent people exposed to the virus — such as health care workers — from developing symptoms.
Donated antibodies ― and any immunity they might provide — don't last forever, said Dr. William Schaffner, a professor at the Vanderbilt University Medical Center. The body destroys aging antibodies as part of its routine maintenance, he said. In general, half of donated antibodies are eliminated in about three weeks.
The use of convalescent plasma goes back more than a century. It was used during the 1918 flu pandemic and was shown to improve survival during the 2009-10 H1N1 pandemic.
Doctors don't know yet whether convalescent plasma will benefit people with COVID-19.
In general, convalescent plasma is expected to be more effective in preventing illness than in treating it. It may be less likely to help someone in intensive care, Shoham said.
Researchers are also studying the use of prepackaged plasma, called intravenous immunoglobulin, in COVID patients. This product, known as IVIG, is taken from healthy donors in the general population and has long been used to help patients with weakened immune systems fight off infections. Hospitals keep it in stock and some are already using it to treat COVID patients.
Although the antibodies in prepackaged IVIG don't specifically target the coronavirus, researchers hope they will tamp down the immune response.
In a third form of immune therapy, researchers are trying to identify the specific antibodies that are most important for neutralizing the coronavirus, then reproduce them as drugs called monoclonal antibodies. Monoclonal antibodies are already used to treat a variety of conditions, from cancer to rheumatoid arthritis and migraines.
"When we give people an antibody, they are immediately at least partially immune to that specific virus," said Dr. James Crowe, director of the Vanderbilt Vaccine Center, who hopes to have antibodies ready for a clinical trial in a few months. "We're moving the immune system from one person to another."
Ideally, doctors would develop a very potent monoclonal antibody or a cocktail of antibodies for COVID-19 patients, to ensure the best chance of success, Crowe said. But manufacturing these drugs can be complicated, expensive and time-consuming.
"Making two antibodies would be at least twice as complicated as making one," Crowe said. "A cocktail might be preferred, but cocktails are harder to move quickly."
Calming The Immune System
In most cases of COVID-19, the immune system neutralizes the coronavirus and patients recover without going to the hospital.
For reasons that doctors don't totally understand, the immune system of some COVID-19 patients becomes hyperactive, attacking not just the virus but the patient's own cells. A "cytokine storm," in which the immune system floods the body with inflammatory chemicals, can do more damage than the virus itself.
In an effort to calm the immune system, researchers are testing immune-suppressing drugs, including monoclonal antibodies already used to treat autoimmune diseases such as rheumatoid arthritis, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security.
Health care giant Roche is conducting large clinical trials of its drug, Actemra, in the hope of preventing cytokine storms, which can cause organ failure and a life-threatening condition called sepsis. Actemra is designed to lower levels of an inflammatory chemical, interleukin-6, which has been found to be elevated in some COVID-19 patients.
Another immune suppressant from Regeneron and Sanofi, called Kevzara, has had disappointing results in clinical trials. The manufacturers plan to continue studying the drug to see if it can help certain types of patients.
Dr. Anar Yukhayev, a New York OB-GYN who was hospitalized with COVID-19 on March 16, agreed to join a clinical trial of Kevzara.
"I was having so much trouble breathing that I was desperate for anything to help," said Yukhayev, 31, who was treated at Long Island Jewish Medical Center.
About 36 hours after receiving an infusion, as Yukhayev was being treated in intensive care, his symptoms began to improve. He was able to avoid being put on a ventilator. Doctors didn't tell him if he received Kevzara or a placebo, but his liver enzymes also began to rise, suggesting the organ was under stress. Elevated liver enzymes are a known side effect of Kevzara.
Yukhayev made a full recovery and went back to work full time April 13. He donated his plasma to researchers.
Until vaccines and other preventive medicines are developed, the best way to prevent coronavirus infections is to maintain social distancing, Adalja said.
"Social distancing is a blunt tool," he said, "but it's all that we have."
As the COVID-19 pandemic swept into Montana, it spread into the Marias Heritage Center assisted living facility, then flowed into the nearby 21-bed hospital.
Toole County quickly became the state's hot spot for COVID-19 deaths, with more than four times the infection rate of all other counties and the most recorded deaths in the state. Six of the state's 16 COVID deaths through Tuesday have occurred here.
But another danger loomed: What if it got into the prison, less than 4 miles away from the hospital and assisted living facility? The county was nearly overwhelmed as it was. Across rural America, prisons and jails sit in places like Toole County that have minimal intensive care unit beds and ventilators and few additional medical resources. Many hospitals there were strained before the pandemic.
This rural, 5,000-person county tucked under the Canadian border might not have seemed like a breeding ground for the contagion. It is a primarily agricultural community almost twice as large as Rhode Island situated in the Great Plains under a big Montana sky. Some areas of the county don't have cellphone coverage, much less internet, and winters are cold enough that people plug in their cars not because they are electric but because they must heat the engines to keep them from freezing.
"When you look at the per capita infection rate in the county and deaths, unfortunately, in our community, it's very, very staggering," said William Kiefer, CEO of the Marias Medical Center, which is affiliated with the assisted living facility. "And the impact is clearly similar to what's happening in some of the urban areas that have been hit really hard."
The two original cases of COVID-19 at the assisted living facility exposed 63 staffers at the center and the affiliated hospital. Thirteen tested positive, and one was hospitalized. All of them recovered. It took a monumental effort by the entire county to keep the hospital from shuttering.
At the worst point, Kiefer and his CFO were the only original staff members not quarantined and able to work. The Montana National Guard helped wash laundry, former employees came out of retirement to fill in, nurses worked as many as five different roles for weeks on end, and quarantined staff coordinated administrative work from sunup to sundown while isolating from their families.
But, through it all, the dreaded coronavirus hasn't yet crept into the site of one of the community's largest employers, the Crossroads Correctional Center prison. It holds almost 15% of the county's total population with a 712-bed facility for both federal and state inmates.
Almost 70% of the nation's more than 1,100 prisons are located outside of metropolitan areas, according to 2017 research by John M. Eason, an associate professor in sociology at the University of Wisconsin-Madison. A building boom occurred from 1980 through 1999 as struggling towns eyed prisons as economic salvations.
But in many of those same communities, rural hospitals that would be tasked to care for inmates during a pandemic have since struggled, with more than 120 rural hospitals closing nationwide in the past decade.
"It's going to be a nightmare because rural communities are so disadvantaged," Eason said. "We're going to see a lot of people in prison contract and die of COVID."
It is not just the inmates behind bars, but also the people in the surrounding community, many of whom work at the facilities, who would be at risk. The employees leaving prisons and jails daily could spread the virus to inmates on the inside and community members on the outside. Already such rural communities on average have sicker and older populations than the rest of the country, even before considering the added risk of close-quartered prisons and jails.
"What is at stake is, in some way, always what's been at stake," said Jessica Pishko, the senior legal adviser at the Justice Collaborative, a nonprofit focused on the justice system. "The most vulnerable are already the ones who are the most impacted."
The Justice Collaborative released a report last month finding that 12% of people held in jails are in counties without intensive care unit beds. In Montana, the report said, over a third of jail detainees are in counties without them. And Toole County has none. Jails, which hold people pretrial, often have a higher rate of turnover of inmates moving in and out of the facility than prisons, increasing the chance of spreading the disease. Still, prisons have similar difficulties with COVID-19 prevention inside facilities.
Of course, not all people infected with the coronavirus end up in need of intensive care, but even a small number of serious cases in a small jail or prison could overwhelm limited resources.
"You can't just airlift 10 people to another hospital," Pishko said.
The Marias Medical Center has two ventilators and added a six-bed COVID-19 isolation tent behind the hospital. It has two regular staff nurses. But, like many rural hospitals, it is designed to stabilize patients and then transfer them to other, bigger hospitals, if needed. Those are some 80 and 160 miles away.
COVID-19 has only magnified the existing resource problems of the medical center.
"We almost got pushed to the limit where we didn't have sufficient staff to maintain our emergency room open, and that would be catastrophic to a community," Kiefer said.
In normal times, the facility saw about five of the prison's inmates a month in the emergency room. Now, amid the pandemic, officials from the medical center and county have been coordinating with the company that runs Crossroads to form plans in case a new wave of COVID-19 compromises the facility. Ryan Gustin, a spokesperson for CoreCivic, which runs Crossroads, said they are all sharing information to "strengthen our collective response."
The Montana Department of Corrections also helped the private prison distribute educational materials, such as newsletters detailing information about the virus and prevention. As of Monday, no inmates had tested positive in Montana state-run facilities and three staff had tested positive.
Even so, Toole County Health Department interim director Blair Tomsheck wrote in an email that "any outbreak has the potential to overwhelm our medical resources."
The number of patients seeking care for injuries caused by what's known as penetrating trauma — gunshot wounds or stabbings — appear to be holding steady, straining hospitals already busy fighting COVID-19.
This article was first published on Thursday, May 14, 2020 in Kaiser Health News.
CHICAGO — On an early March day at the beginning of the COVID-19 pandemic, the emergency room at the University of Chicago Medical Center teemed with patients.
But many weren't there because of the coronavirus. They were there because they'd been shot.
Gunshot victims account for most of the 2,600 adult trauma patients a year who come to this hospital on the city's sprawling South Side. And the pandemic hasn't dampened the flow.
"The visible virus of violence continues unabated," said trauma chief Dr. Selwyn Rogers Jr.
The Chicago hospital's experience mirrors what's happening at other metropolitan trauma units around the nation, where the number of patients seeking care for injuries caused by what's known as penetrating trauma — gunshot wounds or stabbings — appear to be holding steady, straining hospitals already busy fighting COVID-19.
The Hyde Park hospital's Level 1 trauma center has been bustling since it launched in May 2018. On that day in March, about a half-dozen gowned staffers in the unit — which is separated from the rest of the ER by a set of double doors — hurriedly worked on a patient who had just been brought in through the ambulance bay.
"We pretty much opened and became one of the busiest trauma centers in the city," Rogers said.
Much of that is because of its location, he said. The South Side of Chicago is home to busy expressways and vast manufacturing plants, but also some of the most violent neighborhoods in the city. About a third of the University of Chicago Medicine's adult trauma patients are gunshot victims, Rogers said.
The volume has remained steady despite the city and state issuing a stay-at-home order March 21 in response to the coronavirus pandemic. In fact, Rogers said, domestic violence incidents appear to be on the rise as people shelter in place.
"It's not surprising that penetrating trauma has kind of stayed stable," said Dr. Kenji Inaba, trauma chief for the Los Angeles County-USC Medical Center. "One could surmise there's a lot of potential for this: people being at home, in close contact with others. There's still potential for that human-on-human interaction to occur."
Trauma Care Affected Everywhere
Overall trauma statistics appear to be on the decline nationally, driven by a decrease in blunt trauma from fewer car crashes as people drive less during the pandemic, said Jennifer Ward, president of the Trauma Center Association of America.
"You would expect that to be down," she said. "Less people are going out. You would expect them to be doing less dangerous things than they're doing on other days, less traffic, things like that."
But injuries from gunshots and stab wounds are not dropping.
"As far as domestic violence, I think communities are in a heightened state of awareness," said Kathleen Martin, a board member for the American Trauma Society. Also "gun sales are up. People are looking at protecting themselves."
These trends are playing out across the nation.
At the Los Angeles trauma center, early spring is generally quieter than other times of year. Inaba, the trauma chief, said the unit usually has about 60 to 70 patients weekly with blunt injuries, such as those caused by car or construction accidents. That number has recently been down to as low as 10 to 25 cases as fewer people are driving and working.
But the number of gunshot and stabbing victims has effectively remained static — and maybe even ticked up a bit — hovering around 10 to 15 cases a week, Inaba said.
"Trauma is an interesting thing," he said. "Here at USC, we have for weeks now stopped all of our elective surgeries. This is one specialty you can't stop. We need to have surgeons available 24/7."
At Houston's Memorial Hermann-Texas Medical Center, which has been called the busiest trauma center in the country, blunt trauma cases dropped by about 5% while penetrating trauma incidents rose by roughly 3% in the three weeks after the city started its March 16 shutdown, according to trauma chief Dr. Michelle McNutt. Although she has anecdotally seen cases of intrafamily violence, she said, it's too early to have solid data showing whether domestic violence is up.
Metropolitan Family Services, a Chicago-area nonprofit with locations on the South Side, has had a steady number of domestic violence victims seeking services, according to spokesperson Bridget Hatch.
"There's just less mobility for victims," said Melanie MacBride, a legal aid attorney with the nonprofit. "People are down to one income or no income. Even when you're in a domestic violence situation, that might make you more reticent to upend your situation."
Renata Stiehl, who supervises domestic violence court advocacy for Metropolitan Family Services, said the stay-at-home orders and economic stress could exacerbate tensions and make it harder to report cases before they escalate.
"It's really like a forced hostage situation," Stiehl said. "When you have these ingredients and you have someone who has the propensity to commit this type of abuse, you're creating the perfect environment for it to thrive."
Stiehl noted that in Cook County, however, accusers are now able to file and have remote court hearings for orders of protection.
And neighbors may be more likely to call the police about a domestic disturbance because they're home to hear it.
Pandemic's Toll On Trauma Staff
As trauma center staffers continue to treat injuries inflicted by violence, they are also being pulled in other directions because of the pandemic.
Trauma surgeons are often certified in critical care, so they're helping pulmonologists with COVID-19 patients. Trauma nurses are assisting in now overwhelmed intensive care units. Trauma data collectors have instead been asked to help compile coronavirus statistics.
To soak up the overflow demand, pediatric trauma units are increasing the age limits of patients they treat from the usual 18 to 21. The pandemic has also forced other changes for trauma patients. Family members generally can't visit their traumatically injured loved ones because of the coronavirus. Violence-prevention activities have been limited by the outbreak.
Even though protective gear has been hard to come by, doctors and nurses in the trauma centers are having to outfit themselves with personal protective equipment for every patient. "We have to assume they're COVID-positive until proven otherwise," Martin said. Trauma staffers are so specialized that if any of them get infected, it can set the whole unit back.
Dr. Brian Williams, a University of Chicago trauma surgeon, said he and his colleagues also work to reduce their patients' infection risk, putting masks on them when they arrive and housing them in an ICU separate from the one used for treating COVID-19.
"It's as if nothing has changed as far as the volume and acuity of the traumatic injuries we are seeing," he said. "What has changed is how we approach our job in taking care of patients who come in and making sure patients and health care workers are mutually protected without diminishing the level of care we provide."
Some doctors fear the situation could get worse.
In Cleveland, Dr. Glen Tinkoff, who heads trauma for University Hospitals and sits on the board of the American Trauma Society, said that although his system's trauma volume has been down about 10% lately, he expects that number to go in the opposite direction once sheltering-in-place restrictions begin to be lifted.
"We'll see a spike as desperation, despair and hopelessness increase," he predicted. "There's a lot of people out of work. I fear that. You can sense the desperation around the city right now. People are wandering. You see individuals that are just kind of looking for trouble now on the streets."
A septuagenarian was recently brought to the hospital after being beaten with a baseball bat at an ATM, Tinkoff said.
He noted that while shooting injuries were down initially in Cleveland, he doesn't believe that will continue there or anywhere in America.
"You're going to see many of us be very busy as the spring and summer months start to come upon us," he said. "The aftermath is going to be tough. I hope I'm wrong."
In early March, Madalynn Rucker, then 69, agonized over whether to close her Sacramento consultancy office. On the 16th, she finally succumbed to a barrage of texts and calls from her daughter about the heightened risk of the coronavirus, and told her employees to begin working from home. That was three days before California Gov. Gavin Newsom's statewide stay-at-home order.
Her daughter was right in more ways than one. While Rucker's age alone raised her potential danger of being hospitalized or dying of COVID-19, she and many of her employees share another risk factor: They are black. Rucker wonders if more public health messages targeting African Americans could have helped millions like her better prepare for the disease's onslaught.
Officials and commentators said little about race early in the pandemic, recalled Rucker, now 70 and the executive director of OnTrack, a diversity consulting firm. "Could this have made a difference in some way? Not just in educating ourselves, but in how the pandemic was controlled and managed?"
By late February, doctors in China had published that, in addition to older patients, those with chronic health conditions, particularly hypertension and diabetes, were more likely to have severe cases of COVID-19 that ended in ICU admission, mechanical ventilation or death.
It wouldn't have been difficult, some community leaders say, for officials to make an explicit connection between the coronavirus risk factors and African Americans and Latinos, who are more likely to have chronic diseases, and at younger ages ― and then craft tailored, respectful messages for them.
"The messaging I got from the news was, is that if you're young, you're good, and if you're old, you've got to stay home," said Eddie Anderson, the 30-year-old pastor of McCarty Memorial Christian Church, an African American congregation in South Los Angeles.
When Anderson became ill with what turned out to be another viral infection in early March, he was alarmed by the lack of information about how to get tested for COVID-19. The experience motivated him to bring a physician friend to church the next week to explain the disease to his flock.
"I think targeted messaging to the African American community would have been helpful," he said.
But public health and infectious disease experts say the novelty of the virus, whose targets and mode of attack continue to confound scientists, meant that specific racial disparities weren't a foregone conclusion.
"I don't know that it's fair to say that it would have been something that could be 100% predicted," said California Surgeon General Nadine Burke Harris. She called the novel coronavirus "a little bit of a head-scratcher." For example, it doesn't appear to affect children under age 2 or pregnant women the same way similar viruses would, she noted.
"Sometimes when you predict too strongly, it can have the effect of assuming that's going to be the outcome, and it can come across pejoratively," Burke Harris said.
But the disease has disproportionately hurt blacks. In California, 10% of COVID-19 deaths occurred among African Americans, who make up 6% of the state population. A national Centers for Disease Control and Prevention survey showed that 33% of hospitalized COVID patients were non-Hispanic blacks, though that group represented only 18% of residents in the surveyed communities.
Officials are finding it's still difficult to talk about race and COVID-19. Fear of stigmatization remains high, said Burke Harris, who said she walks a fine line by letting certain groups know about the heightened risks without casting blame on them.
"One of the things I've been dealing with a lot in having conversations with black media and black health researchers, right, is this notion of, well, wait a minute, as this data is coming out, how are we not blaming black and brown communities?" said Burke Harris, who is black. "It's like, 'Oh, are you saying we're sicker?'"
Preexisting conditions aren't the only reason black people are dying at disproportionate rates of COVID-19, said Dr. Sonia Angell, director of the California Department of Public Health.
Despite states' orders to stay at home, entire sectors of "essential" jobs have disproportionately high rates of minority employees, which increases their exposure risk. These workers don't benefit as much from social distancing, Angell said.
"They're the ones that are keeping our care delivery system functioning so that when any of us get sick, we have a place to go," she said. "They're the ones that are keeping our grocery stores running and stocked."
The absence of coordinated, official public messaging in February and early March about the potential racial disparity of COVID-19's impact created a vacuum into which conspiracy theories rushed.
Initially came rumors that black people were somehow resistant to the coronavirus. At the same time, black media outlets like The Philadelphia Tribune (Feb. 4), Essence (March 2), the St. Louis American (March 11) and The Undefeated (March 13) made the connection between the virus and America's preexisting health inequalities, publishing forward-thinking pieces about the virus' potential threat to black Americans because of chronic medical conditions, working and commuting conditions, and a historical lack of access to health care and insurance due to institutionalized racism.
Their predictions soon proved true. Local officials began noting higher death rates for black COVID-19 patients in Milwaukee on March 23. In the first week of April, city officials in Chicago, Los Angeles and New Orleans made similar announcements. The CDC published its first national data on racial disparities on April 8. A recent CDC study, published April 29, found that black people made up 83% of COVID-19 hospitalizations in Georgia, a disproportionate level compared with overall hospitalizations.
Public health messages targeting specific populations should be voiced by trusted community leaders, or at least someone of the same race, on media platforms where they're most likely to be seen or heard, said Dr. Oliver Brooks, president of the National Medical Association, which represents black physicians.
Other targeted messages include Spanish-language public service announcements featuring Burke Harris and LA Galaxy soccer player Javier "Chicharito" Hernández. Those have run on Univision; Radio Bilingüe, a Spanish-language public radio network; and other Spanish-language stations, as well as Instagram and Facebook. In Hernández's clip, he encourages listeners in Spanish to seek medical attention if they have COVID-19 symptoms, no matter what their immigration status is.
Targeted messaging can sometimes offend or insult, even with the best of intentions, said Daniel Schober, assistant professor of public health and behavioral psychology at DePaul University in Chicago.
The city of Chicago offended some with a 2015 flu shot campaign that featured a black baby on a billboard next to the words, "I am an outbreak." It inspired graffiti artists to weigh in with their own message: "I am beautiful."
But the city's COVID-19 campaign, featuring Mayor Lori Lightfoot, who is black, has charmed residents, said Schober. The campaign played off social media memes depicting a no-nonsense Lightfootshutting down iconic Chicago landmarks under shelter-in-place directives. The city's official video showed the mayor baking, learning the guitar and sipping tea while exhorting people to "stay home, save lives."
"That's a great example of a message that isn't necessarily tailored toward specific racial or ethnic groups, but is really meant to be universal in its reach," Schober said.
Hospital workers around the country report frustrating failures by management to notify them when they have been exposed to co-workers or patients known to be infected with COVID-19.
This article was first published on Wednesday, May 13, 2020 in Kaiser Health News.
Dinah Jimenez assumed a world-class hospital would be better prepared than a chowder house to inform workers when they had been exposed to a deadly virus.
So, when her boyfriend, an employee of a popular seafood restaurant in Seattle, received a call from his boss on a Sunday in late March telling him a co-worker had tested positive for COVID-19 and that he needed to quarantine for 14 days, she said she assumed she'd get a similar call from the University of Washington Medical Center. After all, the infected restaurant employee worked a second job alongside her at the hospital's Plaza Cafe.
That call never came, she said.
America's health care workers are dying from the coronavirus pandemic. These are some of the first tragic cases.
Jimenez, 42, said she returned to her job as a cashier at the hospital cafeteria two days later, and "it was like nothing had happened. They didn't say anything." She said the infected worker, a fellow cashier, was stationed just 2 feet from her during a typical shift and that neither had been wearing a mask. "He was as close to me as the person sitting behind you in an airplane," Jimenez said.
Word slowly spread among the cafeteria crew that a co-worker had the virus, she said. In the days that followed, two more workers fell ill. But communication about the outbreak was not broadly disseminated through the ranks, according to Jimenez and other employees interviewed. It wasn't until April, Jimenez said, that the hospital started providing workers with one mask per day. A few weeks later, workers said, they learned a fourth staff member had tested positive for the virus.
From cafeteria staff to doctors and nurses, hospital workers around the country report frustrating failures by management to notify them when they have been exposed to co-workers or patients known to be infected with COVID-19. Some medical centers do carefully trace the close contacts of every infected patient and worker, alert them to the exposure and offer guidance on the next steps. Others, by policy, do not personally follow up with health workers who unknowingly treated an infected patient or worked with a colleague who later tested positive for the virus.
"It's an enormous issue," said Debbie White, president of the Health Professionals and Allied Employees, a union representing nurses and other health care professionals in New Jersey. "When a patient is positive, our expectation is that the employer would go back and do their due diligence in terms of investigating who was participating in that patient's care."
Instead, she said, union members often report "there is very, very little follow-up" to inform them after an exposure.
The disconnect between hospital policy and worker expectations often centers around the lack of clear, direct communication with individual workers who have been potentially exposed to the coronavirus. And when workers are informed about an infected colleague or patient, some say that the efforts to conceal that person's identity can make it difficult to gauge the level of risk.
Melissa Johnson-Camacho, a nurse at UC Davis Medical Center in Sacramento, California, said she was informed that another nurse in her unit tested positive, but not which one.
"I don't know who that nurse is. I don't know if I had lunch with that nurse. I don't know if I helped that nurse with a patient," said Johnson-Camacho, who is a chief nurse representative for the California Nurses Association.
UC Davis Health spokesperson Charles Casey said federal and state privacy laws prevent the hospital from identifying individuals who test positive. HIPAA, the federal privacy rule, does permit some disclosures of personal health information to health care workers during an outbreak of infectious disease, but only the "minimum necessary," according to recent guidance from the Office for Civil Rights, which is part of the U.S. Department of Health and Human Services.
Other hospitals contend that because community transmission of COVID-19 is so widespread, workers should assume anyone they encounter, inside or outside the hospital, could be infected and adapt their behavior accordingly.
OHSU Health Hillsboro Medical Center, a major provider outside Portland, Oregon, for example, recently sent an email to all employees saying that because COVID-19 is widespread in that community, "you will no longer receive notification from [the Employee Health program] after caring for a patient with COVID-19. Instead, we ask that you serve as our eyes and ears and report any concerns for exposure to Employee Health as soon as possible."
Based on similar reasoning, the federal Centers for Disease Control and Prevention issued updated guidelines in April to say hospitals should consider forgoing contact tracing for their workers — a fundamental of public health work that involves identifying people who have been exposed and asking them to quarantine — in favor of universal masking and screening for symptoms at the beginning of shifts.
While all hospital employees, from food service to custodial staff, are vulnerable to exposure, nurses and other direct-care providers who interact closely with patients are at greatest risk. Informing them of patient exposures is generally less important in intensive care units and wards designated for COVID-19 assessments, where patients are assumed to have the virus and proper protective gear should be used. But when providers care for a patient hospitalized for an unrelated condition who later tests positive, workers say the information can be crucial.
"A lot of nurses are caregivers, too, and we have people at home who are in the high-risk group," said Johnson-Camacho, the UC Davis nurse. "No one wants to take this home to their family or someone they love."
Knowing about an exposure might make the difference when deciding whether to hug your children or move out of the family home, Johnson-Camacho added.
At Stroger Hospital in Chicago, nurse Elizabeth Lalasz said she contracted the coronavirus after spending several hours with a patient who came in with what initially was believed to be a chronic respiratory condition, but who later was sent home with a presumed case of COVID-19. Lalasz said the hospital never followed up with her about the presumed exposure, even though she had not been wearing proper protective gear. She said she subsequently fell ill and tested positive for the virus — and that her co-workers were never informed about her condition.
"The contact-tracing idea didn't even exist," Lalasz said.
Cook County Health, which operates Stroger, did not directly respond to questions about its policies on informing workers about exposure to the virus. But spokesperson Deborah Song said the system is following CDC guidelines.
At UW Medicine in Seattle, where the cafeteria outbreak played out, spokesperson Tina Mankowski said the hospital is not doing contact tracing when workers or patients test positive for COVID-19. She said that is because the medical center is not asking workers to quarantine at home following a potential exposure.
Under current policy, if an employee contracts the virus, that person's manager is notified in general terms, and is supposed to share that information with other staff members. Employees are asked to self-monitor for fever or upper-respiratory symptoms, and to stay home if they are ill.
Mankowski confirmed that four cafeteria employees had tested positive for the virus. She said employees were notified but did not provide specifics about how or when.
"The safety of University of Washington Medical Center patients and employees is our top priority," Mankowski wrote in an email. "If an employee tests positive for COVID-19, the manager is informed that one of their employees has tested positive and then discusses this with the staff in that area."
Jimenez and three other workers said that was not their experience and that communication about the outbreak was muted.
Luis Rios, a cook at the cafeteria for 17 years, said he was not informed after the first colleague tested positive, though he had chatted with the sick cashier in the staff locker room several times, no more than 2 feet away. A few days after that worker was diagnosed, Rios said, he was taste-testing a dish when he noticed his sense of taste was dulled, a symptom of COVID-19. He also felt cold, even in the warm kitchen. He was tested at an area medical clinic, and became the unit's second confirmed case.
"Honestly, I don't know if UW or my managers care about workers' lives," said Rios, 49, who spoke through an interpreter. "They only care if we can go in and work."
Justin Lee, communications director for the Washington Federation of State Employees (WFSE), which represents the cafeteria workers, said supervisors did post a copy of an email from the employee health department to cafeteria directors notifying them in general terms when the first worker tested positive. A printout was tacked near the employees' time clock. But many workers did not see it or may have been unable to understand it because it was written in English, according to Lee. Information shared days later in a small huddle did not reach the whole staff, he said.
In early April, cafeteria workers delivered a petition to hospital management, with the support of WFSE and Service Employees International Union Local 925, with 450 signatures. They requested the hospital close the Plaza Cafe for a deep cleaning, install a temporary protective barrier around the cashiers and bring in a medical professional to educate all cafeteria staff about COVID-19, with translations in other languages.
The cafeteria was not closed, but Mankowski said the hospital has disinfected it and all workstations, and now requires workers throughout the hospital to wear masks. The hospital has declined to install Plexiglas barriers at the cafeteria, she said, because it believes the universal masking offers the necessary safety precautions.
The Occupational Safety and Health Administration has no rule requiring that employers inform workers of exposures to infectious diseases. But Dr. Alyssa Burgart, a bioethicist at Stanford, said hospitals do have an ethical obligation. She acknowledged the challenges: With dozens of employees going in and out of a patient's room each day, tracking every single one can be difficult, particularly with limited resources. Hospitals are trying to figure out in real time exactly what they need to disclose and how to do it.
"Everything is a disaster now, and no one has time to answer anything. So you're seeing organizations fumble when figuring out how to do this in a way that meets their ethical obligation to protect employees but doesn't violate federal privacy laws," Burgart said.
"The typical way these decisions would be made would be over a very long deliberative process, and that is a luxury we do not have right now. Some organizations are going to miss the mark the first time."
For older adults contemplating what might happen to them during this pandemic, ventilators are a fraught symbol, representing a terrifying lack of personal control as well as the fearsome power of technology.
This article was first published on Tuesday, May 12, 2020 inKaiser Health News.
DENVER ― Last month, Minna Buck revised a document specifying her wishes should she become critically ill.
"No intubation," she wrote in large letters on the form, making sure to include the date and her initials.
Buck, 91, had been following the news about COVID-19. She knew her chances of surviving a serious bout of the illness were slim. And she wanted to make sure she wouldn't be put on a ventilator under any circumstances.
"I don't want to put everybody through the anguish," said Buck, who lives in a continuing care retirement community in Denver.
For older adults contemplating what might happen to them during this pandemic, ventilators are a fraught symbol, representing a terrifying lack of personal control as well as the fearsome power of technology.
Used for people with respiratory failure, a signature consequence of severe COVID-19, these machines pump oxygen into a patient's body while he or she lies in bed, typically sedated, with a breathing tube snaked down the windpipe (known as "intubation").
For some seniors, this is their greatest fear: being hooked to a machine, helpless, with the end of life looming. For others, there is hope that the machine might pull them back from the brink, giving them another shot at life.
"I'm a very vital person: I'm very active and busy," said Cecile Cohan, 85, who has no diagnosed medical conditions and lives independently in a house in Denver. If she became critically ill with COVID-19 but had the chance of recovering and being active again, she said, "yes, I would try a ventilator."
What's known about people's chances?
Although several reports have come out of China, Italy and, most recently, the area around New York City, "the data is really scanty," said Dr. Carolyn Calfee, a professor of anesthesia at the University of California-San Francisco.
Initial reports suggested that the survival rate for patients on respirators ranged from 14% (Wuhan, China) to 34% (early data from the United Kingdom). A report from the New York City area appeared more discouraging, with survival listed at only 11.9%.
But the New York data incorporated only patients who died or were discharged from hospitals — a minority of a larger sample. Most ventilator patients were still in the hospital, receiving treatment, making it impossible for researchers to draw reliable conclusions.
Calfee worries that data from these early studies may not apply to U.S. patients treated in hospitals with considerable resources.
"The information we have is largely from settings with tremendous resource gaps and from hospitals that are overwhelmed, where patients may not be treated with optimal ventilator support," she said. "I would be very worried if people used that data to make decisions about whether they wanted mechanical ventilation."
Still, a sobering reality emerges from studies published to date: Older adults, especially those with underlying medical conditions such as heart, kidney or lung disease, are least likely to survive critical illness caused by the coronavirus or treatment with a ventilator.
"Their prognosis is not great," said Dr. Douglas White, a professor of critical care medicine at the University of Pittsburgh. He cautioned, however, that frail older adults shouldn't be lumped together with healthy, robust older adults, whose prospects may be somewhat better.
Like other clinicians, White has observed that older COVID patients are spending considerably longer on ventilators ― two weeks or more — than is the case with other critical illnesses. If they survive, they're likely to be extremely weak, deconditioned, suffering from delirium and in need of months of ongoing care and physical rehabilitation.
"It's a very long, uphill battle to recovery," and many older patients may never regain full functioning, said Dr. Negin Hajizadeh, an associate professor of critical care medicine at the School of Medicine at Hofstra/Northwell on New York's Long Island. "My concern is, who's going to take care of these patients after a prolonged ventilator course ― and where?"
In St. Paul, Minnesota, Joyce Edwards, 61, who is unmarried and lives on her own, has been wondering the same thing.
In late April, Edwards revised her advance directive to specify that "for COVID-19, I do not want to be placed on a ventilator." Previously, she had indicated that she was willing to try a ventilator for a few days but wanted it withdrawn if the treatment was needed for a longer period.
"I have to think about what the quality of my life is going to be," Edwards said. "Could I live independently and take care of myself — the things I value the most? There's no spouse to take care of me or adult children. Who would step into the breach and look after me while I'm in recovery?"
People who've said "give a ventilator a try, but discontinue it if improvement isn't occurring" need to realize that they almost surely won't have time to interact with loved ones if treatment is withdrawn, said Dr. Christopher Cox, an associate professor of medicine at Duke University.
"You may not be able to live for more than a few minutes," he noted.
But the choice isn't as black-and-white as go on a ventilator or die.
"We can give you high-flow oxygen and antibiotics," Cox said. "You can use BiPAP or CPAP machines [which also deliver oxygen] and see how those work. And if things go poorly, we're excellent at keeping you comfortable and trying to make it possible for you to interact with family and friends instead of being knocked out in a coma."
Heather McCrone of Bellevue, Washington, realized she'd had an "all-or-nothing" view of ventilation when her 70-year-old husband developed sepsis — a systemic infection ― last year after problems related to foot surgery.
Over nine hours, McCrone sat in the intensive care unit as her husband was stabilized on a ventilator by nurses and respiratory therapists. "They were absolutely fantastic," McCrone said. After a four-day stay in the hospital, her husband returned home.
"Before that experience, my feeling about ventilators was 'You're a goner and there's no coming back,'" McCrone said. "Now, I know that's not necessarily the case."
She and her husband both have advance directives stating that they want "lifesaving measures taken unless we're in a vegetative state with no possibility of recovery." McCrone said they still need to discuss their wishes with their daughters, including their preference for getting treatment with a ventilator.
These discussions are more important than ever ― and perhaps easier than in the past, experts said.
"People are thinking about what could happen to them and they want to talk about it," said Dr. Rebecca Sudore, a professor of medicine at the UCSF. "It's opened up a lot of conversations."
Rather than focusing on whether to be treated with a ventilator, she advises older adults to discuss what's most important to them — independence? time with family? walking? living as long as possible? ― and what they consider a good quality of life. This will provide essential context for decisions about ventilation.
"Some people may say my life is always worth living no matter what type of serious illness or disability I have," she said. "On the other end of the spectrum, some people may feel there are health situations or experiences that would be so hard that life would not be worth living."
Sudore helped create Prepare for Your Care, a website and a set of tools to guide people through these kinds of conversations. Recently it was updated to include a section on COVID-19, as have sites sponsored by Compassion & Choices and The Conversation Project. And the Colorado Program for Patient Centered Decisions has published a decision aid for COVID patients considering life support, also available in Spanish.
Some older adults have another worry: What if there aren't enough ventilators for all the COVID patients who need them?
In that situation, "I would like to say 'no' because other people need that intervention more than I do and would benefit, in all probability, more than I would," said Larry Churchill, 74, an emeritus professor of medical ethics at Vanderbilt.
"In a non-scarcity situation, I'm not sure what I'd do. I'm in pretty good health, but people my age don't survive as well from any major problem," Churchill said. "Most of us don't want a long, lingering death in a custodial facility where the chances of recovery are small and the quality of life may be one we're not willing to tolerate."
Health care runs a lot like the restaurant industry. When people stop showing up for Sunday brunch — or for elective hip replacements, colonoscopies and face-lifts — the enterprise runs short of cash fast.
This article was first published on Monday, May 11, 2020 in Kaiser Health News.
You've probably noticed that the U.S. economy is crashing. What you might not expect is that almost half of the economic devastation comes from just one sector — health care.
That's according to a first-quarter 2020 estimate of U.S. gross domestic product from the Bureau of Economic Analysis, which pundits later shared on social media.
Much of the slowdown came after hospitals postponed elective surgeries and as Americans skip routine medical care to avoid potential exposure to the coronavirus.
The episode includes interviews with Kaiser Health News senior correspondent Jenny Gold, who spoke with struggling pediatricians; and ProPublica reporter Isaac Arnsdorf, who found that even emergency room docs fighting COVID-19 aren't immune to the economic downturn.
As a society, we need health care workers like never before to fight COVID-19, but many medical professionals are feeling the financial pinch because of the way we pay for health care in this country.
Health care runs a lot like the restaurant industry. When people stop showing up for Sunday brunch — or for elective hip replacements, colonoscopies and face-lifts — the enterprise runs short of cash fast.
Episode 5 explores the COVID downturn, how health care is fueling the recession and what that could mean for our wallets.
“SEASON-19” of “An Arm and a Leg” is a co-production of Kaiser Health News and Public Road Productions.
For-profit companies that typically pay $50 per donation of plasma used in other lifesaving therapies are advertising aggressively — and significantly bumping up their rates for COVID donors.
This article was first published on Monday, May 11, 2020 in Kaiser Health News.
Diana Berrent learned she had tested positive for COVID-19 on a Wednesday in mid-March. Within a day, she had received 30 emails from people urging her to donate blood.
Friends and acquaintances, aware of her diagnosis, passed along a pressing request from New York's Mount Sinai Health System, one of the first centers to seek plasma, a blood component, to be used in a therapy that might fight the deadly disease. Berrent, 45, said she immediately recognized the need for the precious plasma — and the demand that would follow.
"When I saw that email going around, I saw what was going to happen in the landscape," said Berrent, a photographer and mother of two who lives on Long Island. She went on to found Survivor Corps, a grassroots clearinghouse that connects people who have recovered from COVID-19 with organizations eager to collect their blood.
"What I saw was going to emerge was a free market where survivors were a commodity."
Nearly two months later, Berrent's prediction is coming true. The coronavirus has infected more than 1.2 million people in the U.S., and now government scientists, academic researchers and for-profit pharmaceutical firms all are scrambling for blood plasma from COVID-19 survivors in hopes of developing a range of potential treatments.
In Minnesota, a program coordinated by the Mayo Clinic has collected plasma from more than 12,000 COVID survivors for transfusion into more than 7,000 gravely ill patients, the result of a massive public appeal led by government leaders and nonprofit groups like the Red Cross.
Meanwhile, for-profit companies that typically pay $50 per donation of plasma used in other lifesaving therapies are advertising aggressively — and significantly bumping up their rates for COVID donors.
In Utah, John and Melanie Haering, who contracted COVID-19 aboard the ill-fated Diamond Princess cruise ship, received gift cards worth $800 after making two donations apiece at a Takeda Pharmaceuticals BioLife Plasma Services center. BioLife runs several of the more than 800 paid-plasma collection sites in the U.S., part of an industry that produces plasma protein
"Given the urgency and importance of collecting convalescent plasma from the small population of recovered COVID-19 patients, BioLife is currently offering an added incentive for the first two donations from recovered COVID-19 patients," Takeda spokesperson Julia Ellwanger said in an email.
The money was "a nice surprise" for the Haerings, though they said they were motivated more by the opportunity to prevent others from suffering.
"If we could help anybody, we'd go every day," said John Haering, 63, a retired railroad manager who spent two weeks in a hospital in Japan after testing positive for the virus.
Donors like Berrent and the Haerings are needed to supply the building blocks of potentially lifesaving treatments. Rich with antibodies, convalescent plasma from COVID-19 patients is being tested as apossible therapy to promote recovery in people who are critically ill with the disease.
It's also being collected to create a concentrated antibody serum known as hyperimmune globulin that may prevent or halt infection in the future. Similar products are used to treat rabies and illnesses like infant botulism. If plasma from COVID-19 donors is shown to halt the disease, coming up with an antidote could offer companies the prospect of making millions of dollars.
And there's the possibility of a third treatment, monoclonal antibody therapy, which would use antibody-producing cells from high-antibody donors to create lab-produced molecules to fight the disease.
All three therapies are promising, but all three require human blood plasma, said Dr. Michael Busch, a professor of laboratory medicine at the University of California-San Francisco and director of the Vitalant Research Institute, one of the largest blood center-based transfusion medicine research programs in the U.S.
"At some level, they're all competing with the regular blood banks like mine," Busch said.
Only a fraction of those infected with COVID-19 have recovered sufficiently to donate,though more are eligible every day. But as demand for donors has grown, so has the need to wrangle the supply, ensuring that competition for plasma doesn't undercut the larger mission, said Dr. Michael Joyner, who heads the Mayo Clinic program.
"We're going to get it all worked out," he said. "It's in everybody's enlightened self-interest to do this in an intelligent way."
To avoid what Joyner described as a "range war" for COVID-19 plasma, he's spearheading an effort that calls for unprecedented collaboration to distribute separate streams of plasma among producers of therapies in a global market estimated toreach $35.5 billion by 2023.
"It's like the oil market," he said. "You send oil that needs one type of refining to one market and oil that needs another type of refining to another market."
His plan — floated last month to a group that included representatives from philanthropic organizations along with executives from for-profit and nonprofit blood collectors — relies in part on blood plasma from up to 10,000 Hasidic women in New York City, where the Orthodox Jewish community has been hit hard by the disease.
Tens of thousands of people have fallen ill with the virus in the city's Hasidic neighborhoods, and more than 700 have died. In recent weeks, thousands of men in the community who have recovered from COVID-19 have rushed to donate plasma. Chaim Lebovits, 45, who has helped organize the effort, said the donations are an act of faith.
"We have an obligation to protect and save lives," Lebovits said.
So far, however, many women in the Hasidic community have been unable to participate. Hasidic families are often large, and women who have had several children may have high levels of certain antibodies that are sometimes produced during a pregnancy. Rarely, such antibodies can cause a dangerous reaction — transfusion-related acute lung injury — in some recipients of plasma from women who have been pregnant. In COVID-19 patients, battling a virus that targets the lungs, such reactions could be deadly.
Given the risk, many Hasidic mothers who want to join the men in donating have been deferred from providing plasma for immediate transfusion, Joyner said. But those women could be an ideal and ongoing source of plasma for hyperimmune globulin, which is processed in a way that dilutes or removes the antibodies.
Roughly 10,000 women could donate up to four times each, generating some 30,000 liters of COVID-19 plasma that could be directed to the for-profit collectors to make hyperimmune globulin, Joyner estimated. That's enough for the companies to get started.
"This is the basis of a true win-win," Joyner said.
In the future, other groups deemed ineligible to provide convalescent plasma for transfusion, out of concern about disease transmission, could be diverted for hyperimmune globulin creation, he said.
One key part of the plan will be the ability to identify eligible donors through antibody tests, Joyner said. Mayo Clinic scientists have already conducted more than 5,000 serology tests and identified hundreds of potential plasma donors.
So far, however, neither the nonprofit organizations nor the for-profit firms have agreed to the plan.
"Ways to facilitate these donations and recommendations for how to allocate donors to one donation stream or the other are still in progress," said Natalie de Vane, a spokesperson for CSL Behring, a biopharmaceutical company based in King of Prussia, Pennsylvania.
CSL has joined with Takeda, a Japanese pharmaceutical company, to lead the CoVIg-19 Plasma Alliance, a coalition of six companies developing a single, unbranded hyperimmune globulin product that could treat COVID-19.
Meanwhile, officials with the AABB, an international nonprofit focused on transfusion medicine and cellular therapies, have focused efforts primarily on collecting plasma for immediate use. But they acknowledged that convalescent plasma could end up serving as "bridge therapy" to buy time until the hyperimmune globulin products are available.
"AABB recognizes the importance of ensuring that convalescent plasma is available as a transfusion therapy for patients today, as well as to develop future treatments," the agency said in a statement.
Representatives from all sides agree that the most pressing need is to increase the pool of COVID-19 survivors willing to donate plasma. They downplay talk of jockeying for donors in the nonprofit and for-profit worlds.
"We don't view it as competition," said Chris Healey, president of corporate affairs at Grifols, a Spanish pharmaceutical company that has receivednearly $13 million in funding from the U.S. Department of Defense to develop its own hyperimmune globulin product. "We're all pointed in the same direction."
One solution may be groups like Berrent's nonprofit Survivor Corps, which started in late March with a Facebook group that's grown to 42,000 members and now includes international partnerships and a pro bono advertising campaign,A Call to Arms.
Berrent has given plasma four times now, including to a biotech firm that sent a phlebotomist to her home and gave her a $100 Amazon card for her trouble.
Survivor Corps aims to function as a "one-stop shop" for donors interested in giving COVID-19 plasma, said Berrent. And, she said, it also could serve as a single source for recruitment, freeing scientists in government, academia and industry to focus on finding answers, not scouting survivors.
"Free markets work beautifully in many, many situations," said Berrent. "During a global pandemic, during a time of crisis, we need collaboration and efficiency."
The Trump administration has sent hundreds of millions of dollars in pandemic-related bailouts to health care providers with checkered histories, including a Florida-based cancer center that agreed to pay a $100 million criminal penalty as part of a federal antitrust investigation.
This article was first published on Saturday, May 9, 2020 in Kaiser Health News.
The Trump administration has sent hundreds of millions of dollars in pandemic-related bailouts to health care providers with checkered histories, including a Florida-based cancer center that agreed to pay a $100 million criminal penalty as part of a federal antitrust investigation.
At least half of the top 10 recipients, part of a group that received $20 billion in emergency funding from the Department of Health and Human Services, have paid millions in recent years either in criminal penalties or to settle allegations related to improper billing and other practices, a Kaiser Health News review of government records shows.
They include Florida Cancer Specialists & Research Institute, one of the nation’s largest U.S. oncology practices, which in late April said it would pay a $100 million penalty for engaging in a nearly two-decade-long antitrust scheme to suppress competition. A top Justice Department lawyer described the plot as “limiting treatment options available to cancer patients in order to line their pockets.” The company, which is required to pay the first $40 million in penalties by June 1, received more than $67 million in HHS bailout funds.
HHS distributed emergency funding to hospitals and other providers to help offset revenue losses or expenses related to COVID-19. In April, it distributed the first $50 billion based on providers’ net patient revenue, a calculation that gives more money to bigger systems or institutions charging higher prices.
Companies that have attested to receiving payments as of May 4 collectively received roughly $20 billion. The list is likely to change in the coming days as other companies confirm they’ve received money.
In total, the CARES Act, signed into law by President Donald Trump in March, provides $100 billion in emergency funding. Subsequent coronavirus relief legislation added another $75 billion. Money has also been steered to hot spots with high numbers of COVID-19 patients, rural health care providers and the Indian Health Service.
Of the companies documented to date, other top recipients ― including Dignity Health in Phoenix, the Cleveland Clinic, Houston’s Memorial Hermann Health System and Massachusetts General Hospital in Boston — have paid millions in recent years to resolve allegations related to improper billing in federal health programs, false claims to increase their payments or lax oversight that enabled employees to steal prescription painkillers.
Dignity Health, one of the largest hospital systems in the West, received $180.3 million in HHS bailout funds, making it the top recipient listed. It has settled civil accusations by DOJ that it submitted false claims to Medicare and TriCare, the military health care program.
The Cleveland Clinic, which in 2015 paid $1.74 million to settle federal allegations that it mischarged Medicare for costly spinal procedures to increase their billings and has entered into other similar settlements, received $103.3 million from HHS, the second-largest amount.
Memorial Hermann Health System and Massachusetts General Hospital received more than $93 million and $58 million, respectively. In 2018, Memorial Hermann paid nearly $2 million to the government to settle allegations that it improperly billed government health care programs by charging for higher-cost services when patients only needed lower-cost outpatient services.
Massachusetts General Hospital in 2015 paid the federal government $2.3 million to settle allegations that lax oversight enabled hospital employees to steal thousands of prescription medications, mostly addictive painkillers, for personal use.
Malcolm Sparrow, a professor at the Harvard John F. Kennedy School of Government, said the HHS methodology for its general distribution of relief funds is “a little bit worrying.”
“If you peg the amount based on historical volume and you’ve got good reason to believe that historical volume is inflated due to fraud and abuse, the irony is that they get more money because they’re more dishonest,” Sparrow said. “But you can’t prove that in a short period of time.”
Public tolerance for fraud and abuse naturally rises during times of emergency, Sparrow said, and now is not the time to revisit historical decisions to determine which companies are entitled to federal relief based on legal issues.
“I think that’s a tough case to make,” he said.
HHS has criteria for disqualifying providers from receiving bailout money. But even the strongest condition carries a broad caveat: None of the funds may be used for grants to any corporation convicted of a felony criminal violation within the preceding two years ― unless officials have decided that it is not necessary to prohibit them from doing business with the federal government.
“It’s sort of a high bar” for someone to be disqualified for this money, said Roger Cohen, a health care lawyer at Goodwin who specializes in fraud and anti-kickback law.
The Florida oncology provider has been charged with a felony and admitted to an antitrust crime, however federal prosecutors agreed to defer any prosecution and trial because a criminal conviction would have “significant collateral consequences” for its patients, the DOJ said.
Beyond that, HHS in its terms states that providers have to certify that they are not excluded from participating in federal health care programs like Medicare and Medicaid and have not had their Medicare billing privileges revoked.
The HHS Inspector General has the authority to exclude practitioners and health care companies for a wide variety of reasons — including a conviction of fraud ― but it’s highly unusual for the federal government to do so with large institutions, experts say.
“I imagine there would be hesitancy to exclude the provider,” Cohen said. “I think you’d have concerns about interrupting access to care.”
An HHS spokesperson declined to comment on its existing allocations but said the department has rules in place to recoup funds and address fraudulent activity if necessary.
“Failure to comply with any term or condition is grounds for HHS to recoup some or all of the payment from the provider,” the spokesperson said.
In a statement, Florida Cancer Specialists signaled it intended to use the funding.
“During this health crisis, we have continued to keep the doors of our more than 80 facilities open to ensure that cancer patients have access to care and treatment,” Thomas Clark, the company’s chief legal officer, wrote in an email. “We plan to use these funds, if needed, in accordance with government guidelines to continue providing affordable, safe and high-quality cancer care.”
Dignity Health said, “We have had to bear significant costs to prepare for and manage the pandemic in our communities even as patient volumes have been dramatically reduced across our hospitals.”
In October 2014, Dignity agreed to pay $37 million after the Department of Justice alleged it admitted patients to 13 of its hospitals in California, Nevada and Arizona who could have been treated on a “less costly, outpatient basis.” The civil case involved patients treated for elective heart procedures, such as pacemakers and stents, and other conditions. The company did not acknowledge wrongdoing in settling the case.
“Charging the government for higher-cost inpatient services that patients do not need wastes the country’s vital health care dollars,” acting Assistant Attorney General Joyce Branda for the Justice Department’s Civil Division said at the time. “This department will continue its work to stop abuses of the nation’s health care resources and to ensure patients receive the most appropriate care.”
Dignity said that independent annual audits were conducted after the False Claims Act settlement in 2014 and “no additional concerns were raised related to this issue.”
Massachusetts General Hospital and Memorial Hermann did not respond to requests for comment. The Cleveland Clinic confirmed the amount of money received from HHS but declined to comment further.