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.
The patient described it as the worst headache of her life. She didn't go to the hospital, though. Instead, the Washington state resident waited almost a week.
When Dr. Abhineet Chowdhary finally saw her, he discovered she had a brain bleed that had gone untreated.
The neurosurgeon did his best, but it was too late.
"As a result, she had multiple other strokes and ended up passing away," said Chowdhary, director of the Overlake Neuroscience Institute in Bellevue, Washington. "This is something that most of the time we're able to prevent."
Chowdhary said the patient, a stroke survivor in her mid-50s, had told him she was frightened of the hospital.
She was afraid of the coronavirus.
The fallout from such fear has concerned U.S. doctors for weeks while they have tracked a worrying trend: As the COVID-19 pandemic took hold, the number of patients showing up at hospitals with serious cardiovascular emergencies such as strokes and heart attacks shrank dramatically.
Across the U.S., doctors call the drop-off staggering, unlike anything they've seen. And they worry a new wave of patients is headed their way — people who have delayed care and will be sicker and whose injuries will be exacerbated by the time they finally arrive in emergency rooms.
It has alarmed certain medical groups, such as the American College of Cardiology and the American Heart Association. The latter is running ads to urge people to call 911 when they're having symptoms of a heart attack or stroke.
"I haven't seen anything like it, ever," he said. "We anticipated, actually, higher volumes."
But doctors say once-busy emergency rooms have slowed to an eerie calm.
"It was very scary because it was so quiet," Dr. David Tashman, medical director of the ER at USC Verdugo Hills Hospital in Glendale, California, said about the early days of the outbreak.
"We normally see 100 patients a day, and then, you know, overnight, we were down to 30 or 40."
Some of that decrease in normal patient volume was deliberate.
As hospitals prepared for a surge of COVID patients, officials advised people to avoid emergency rooms if at all possible. Tashman said he wasn't surprised to see fewer trauma patients, because the roads were emptier. But soon he and other ER physicians noticed that even truly urgent cases were not coming in.
"We know the number of heart attacks isn't going to go down in a pandemic. It really shouldn't," Tashman said.
Dr. Larry Stock, an ER doctor at Antelope Valley Hospital in Lancaster, California, thought the same thing.
"I mean, we've all been scratching our heads — where are all these patients?" Stock said. "They're at home, and we're starting to get … the tip of the iceberg of this phenomenon."
One studycollected data from nine hospitals across the country, focusing on a crucial procedure used to reopen a blocked cardiac artery after a heart attack. The hospitals performed 38% fewer of those procedures in March than in previous months.
At Harborview Medical Center in Seattle, Dr. Malveeka Sharma has tracked a 60% decline in stroke admissions in the first half of April compared with the previous year.
Nationally, 911 call volumes for strokes and heart attacks declined in March through early April, according to data collected by ESO, a software company used by emergency medical service agencies.
In Connecticut, Dr. Kevin Sheth noticed a similar trend at Yale New Haven Hospital.
Sheth started calling other stroke doctors, trying to understand what was happening.
"The numbers had dramatically plummeted almost everywhere," said Sheth, chief of the division of neurocritical care and emergency neurology at Yale School of Medicine. "This is a big deal from a public health perspective."
Sheth said clinical stroke centers have seen an "unprecedented" drop in stroke patients being treated, with decreases from 50% to 70%.
In April, the American Heart and American Stroke associations put out emergency guidance to ensure health care providers keep stroke teams active and ready to treat patients during the pandemic.
Sheth said he worries it could be challenging to care for all the patients who eventually show up at hospitals in even worse shape after delaying care.
"When those stroke numbers come back, we could have serious capacity issues," he said. "We were already bursting at the seams."
"People are in this fear mode," said Dr. John Harold, a cardiologist at Cedars-Sinai Medical Center in Los Angeles and board president of the Los Angeles chapter of the American Heart Association.
Harold said the full public health consequences of people avoiding the hospital aren't yet clear.
"The big question is, are these people dying at home?" he asked.
Patients Fear The Hospital
Patients who are already at higher risk of experiencing medical emergencies describe a mix of fear and confusion about how to get safe and adequate care.
In March, Dustin Domzalski ran out of his epilepsy medication.
The 35-year-old from Bellingham, Washington, had trouble reaching his doctor, whom he would normally see in person, to get a refill.
Within a few days of not taking the medication, he had a major seizure while in the shower. His caregiver called an ambulance, which took him to the ER.
"I woke up and asked where I was and what happened," Domzalski said. "The guy in the next room to me was coughing and doing all kinds of stuff."
The experience was so unnerving that Domzalski now plans to avoid the hospital if at all possible.
"I am not going to the hospital unless I have a seizure and injure myself," he said. "I'd rather stay here than potentially have problems from the virus."
Miami resident Stayc Simpson recalled a frightening ordeal when she went to the ER in mid-March.
Simpson, a cancer survivor with heart failure, woke up with a pounding heart rate that she worried could signal a heart attack.
At the hospital, she was screened for COVID-19 and was soon moved to a unit for suspected cases because she had a cough, even though that is also a symptom of heart failure.
"When the reality hit that I was in the COVID unit, I thought, 'If I didn't have it before, then I probably will now,'" Simpson said.
She spent a day there, wracked with anxiety. Six days later, back at home, she learned she had tested negative for the virus.
Simpson knows the hospitals have made many changes since the early days of the pandemic, but the thought of calling 911 still scares her.
"I have seen news reports that tell me it's safer now. … I don't know if I have full confidence in that right now," she said. "The risk of COVID is terrifying."
Dangerous Risks Of Postponing Care
Some physicians are already glimpsing the consequences of patients putting off care.
"I've never seen the number of delays that I have in the last month or so," said Dr. Andrea Austin, an ER physician in downtown Los Angeles.
She's treating more serious cases because patients are waiting. "That's really one of the tragedies of COVID-19," Austin said. "They're staying at home and trying to diagnose themselves or really playing down their symptoms."
Chowdhary, the neurosurgeon from Bellevue, Washington, said some of his stroke patients have already seen life-altering consequences.
One older man noticed weakness on the left side of his body but avoided the hospital for four days.
"Now, at that point, we couldn't do anything to reverse the stroke," Chowdhary said. "That weakness is permanent."
Because of the stroke damage, the patient could no longer take care of his wife, who has cognitive issues. Eventually, the couple had to leave their home and move into a nursing home.
Jennifer Kurtz, stroke program coordinator at Overlake in Bellevue, said some patients who delayed care are now grappling with the physical and emotional toll.
"They feel so much guilt and regret that they didn't come to the hospital earlier," she said.
A caregiver confessed to Kurtz that she didn't bring her husband to the hospital when she first noticed symptoms of a stroke.
"She can't even tell her daughter [that] … because she is so ashamed," Kurtz said.
Doctors Plead: 'Don't Delay'
Patients must navigate the sometimes conflicting messages from public officials as well as disruptions to their routine medical care.
The surge of COVID-19 patients in hot spots such as New York City and New Orleans led to "the sense of an overstretched health care system without capacity," said Dr. Biykem Bozkurt, president of the Heart Failure Society of America and a cardiologist at Baylor College of Medicine in Houston.
"This may have created a false sentiment that routine care is to be deferred or that there is no capacity for non-COVID patients — this is not the case," Bozkurt said. "We would like our patients to seek care, not wait."
Hospitals are also trying to reassure patients they are taking precautions to keep them safe. Many have set up protocols for admitting suspected COVID-19 patients, such as separate screening areas inside the ER and dedicated areas of the hospital for coronavirus inpatients.
Tashman, the emergency physician at USC Verdugo Hills Hospital, is pleading with patients to come in for help immediately for heart attack and stroke symptoms: "Don't delay. You're not bothering us. You're not imposing on us."
This story is part of a partnership that includes KPCC, NPR and Kaiser Health News.
The fight over social distancing highlights the preexisting political divide in the U.S. that now has taken on more edge given the economic and life-or-death implications for all.
This article was first published on Thursday, May 7, 2020 in Kaiser Health News.
Even as Montana begins a gradual easing of stay-at-home restrictions intended to curb the spread of the coronavirus, the political schism it highlighted is creating reverberations in one community in the northwestern corner of the state.
A Flathead County health board member who led a movement to disparage the protective safety orders and downplay the virus is now the subject of two competing petitions — one to expel her from office and another to keep her.
When the commissioners in this county of about 104,000 people appointed Dr. Annie Bukacek to the health board in January, they might have known they were getting into a political hornet's nest. "Dr. Annie," as she's known in the Flathead Valley, is a well-known and outspoken opponent of vaccinations.
Then, as the coronavirus spread into Montana and the crisis deepened here and across the country, she became a leading voice locally and in this politically purple state against government restrictions to curb its spread.
In a widely circulated video posted on social media, Bukacek cast doubt over official COVID-19 death tolls, saying medical professionals were pressured to attribute non-COVID deaths to the virus. In many communities, such as New York City, though, the deaths from the virus are now believed to have been initially undercounted. Many public health experts say historical comparisons show the counts nationwide are still underestimating the COVID-19 death toll.
On her Facebook page, Bukacek often posted criticisms of Democratic Gov. Steve Bullock's stay-at-home orders, stating they weren't based in science. Bukacek did not respond to requests for comment for this story. But on April 25, just days after the governor announced the state would begin easing restrictions that he credited with flattening the COVID-19 curve, Bukacek wrote, "I fervently pray we stay awake, as governors return freedoms they never had the right to take away in the first place."
All this might seem to be just another fringe backlash against public health regulations, but Bukacek's critics say she has power and authority as a member of the county health board, which manages the local response to disease outbreaks, including quarantine and isolation orders, plus related directives to businesses and schools. They say her actions risk lives.
Her critiques also mirror a growing movement that has mounted protests across the United States. While surveys show an overwhelming majority of Americans have supported stay-at-home directives and other measures to slow the spread of the virus, loud protests have materialized from Montana to Michigan to Kentucky. Health workers and others, in turn, are countering the protesters.
This fight over social distancing highlights the preexisting political divide in our country that now has taken on more edge given the economic and life-or-death implications for all.
The Flathead Valley is a microcosm of this fight. It's a gateway to Glacier National Park, making it a haven for affluent tourists and retirees. It's also a predominantly white populace in a spot bordering two large Native American reservations. And it has been a frequent, often reluctant, haven for political controversy, sometimes branded a haven for white supremacists and anti-government activists.
In 2010, right-wing pastor Chuck Baldwin moved from Florida to the county seat of Kalispell and built a following with his Liberty Fellowship, which defied coronavirus public health orders early on and held in-person church services.
Though Montana has been one of the states hit least hard by COVID-19, with a confirmed caseload of fewer than 500 and 16 deaths as of May 5 in a population of 1 million, Flathead County has had more cases than all but three of the state's 56 counties. As of Tuesday, the county had reported 37 cases.
In Kalispell, where nearly 24,000 people live, many health care workers fear Bukacek's anti-social-distancing movement could be risking their lives and the health of their patients.
Joan Driscoll, a nurse practitioner who has worked in health care in Kalispell for 20 years, said protests and false information spread by Bukacek have created widespread anxiety in the community.
"The danger to our community is that she is in a position of authority, as a physician and a voting member of the board that oversees our community health clinic," said Driscoll. "By ignoring the mandates of staying at home and avoiding crowds, she is with her actions telling people those mandates — that are flattening our curve and keeping our hospitals under control — are wrong. That's harmful to me and all other health care workers as we see more and more people infected with this virus."
Human rights groups fear Bukacek and the backlash against COVID-19 restrictions will recruit new adherents to the far right. Residents of Kalispell have already reported that a new Friday night "community cruise" of cars parading down the main drag has included displays of Confederate flags in a county that borders Canada and wasn't a state during the Civil War.
"For a lot of people, it feels like she's come out of nowhere over the last couple of weeks," said Travis McAdam of the Montana Human Rights Network. "The reality is she has a long history of work in these far-right circles and is a fairly known quantity, especially for organizations who work around the legislature."
Cherilyn DeVries of the Love Lives Here anti-discrimination advocacy group in Whitefish, a smaller community in Flathead County that weathered a white supremacist troll storm, said locals need to speak out against the anti-science, anti-public-health messages being broadcast in the region.
"Right now, she is intentionally creating controversy," DeVries said of Bukacek. "She is trying to pit people against each other. She's trying to get people to see the hospital and the health department as the enemy, when these are the very people who you're going to go to to save your life."
Seattle mourned the news: Elizabeth and Robert Mar died of COVID-19 within a day of each other. They would have celebrated 50 years of marriage in August.
But their deaths at the end of March were not the same. Liz, a vivacious matriarch at 72, died after two weeks sedated on a ventilator. Her analytical engineer husband, Robert, 78, chose no aggressive measures. He was able to communicate with their adult children until nearly the end.
Clinician Darrell Owens helped the Mar family navigate this incredibly difficult time.
Owens, like other palliative care specialists in COVID-19 hot spots around the country, has seen his professional duties transformed by the deadly coronavirus. Patients and their families face abrupt decisions about the kind of care they want, and time for sensitive deliberation is scarce. Conversations once held in person are now over the phone, with all the nuances of nonverbal communication lost. The comfort of family at the bedside of the dying is all but gone.
Owens, like other palliative care specialists in COVID-19 hot spots around the country, has seen his professional
This is the new reality for those who practice palliative medicine — a speciality focused on relieving pain and symptoms, improving quality of life, and providing support to patients and families during severe, chronic or fatal illness.
Doctors and nurses trained in this branch of medicine are in high demand as hospitals treat thousands of terribly ill patients who may end up on life support with only a small chance of survival.
"This is a horrible virus that we don't have a cure for," Owens said. "As much as we are obligated to save people's lives, we are as obligated to save their deaths."
Before the coronavirus, Owens rarely worked in the emergency room. Now he's there regularly, called in whenever a suspected or confirmed coronavirus patient at high risk of complications comes through the doors.
"It is a totally different atmosphere in an emergency room," Owens said. "The conversations are more abbreviated than they would be because you are behind a mask, you are in a loud room, completely gowned up."
Essential Conversations Under Strain
It's a tough way to talk through sensitive and crucial questions about a patient's chance of survival and what they want.
"This is completely unprecedented," said Dr. Diane Meier, director of the Center to Advance Palliative Care and a professor at the Icahn School of Medicine at Mount Sinai.
During the surge of coronavirus patients in New York City, Meier said, her hospital system set up a palliative care hotline for family members of patients.
"You can't see their facial expression, all the cues you normally get with face-to-face communication are very hard to pick up over the phone," Meier said.
Nonetheless, she said, these conversations — especially with such a fast-moving and poorly understood virus — are an essential piece of the pandemic response.
"Palliative care specialists are a scarce resource, just like ventilators and ICU beds," she said.
Dr. Hope Wechkin, medical director of EvergreenHealth Hospice and Palliative Care in Kirkland, Washington, said palliative medicine is fundamentally about "being with patients during times of profound uncertainty, and continuing to place comfort and enhanced quality of life front and center."
"We now have this new player [coronavirus] — as we are evaluating a patient's goals of care," she said.
One Family, Two Kinds Of Death
While much of the country was still waking up to the pandemic, siblings Angie Okumoto, Rich Mar and Rob Mar were already navigating these wrenching decisions about their parents' care.
In early March, their mother, Liz, contracted the coronavirus and was admitted to the hospital.
Lively and hardworking, Liz was co-owner of the family's popular Hawaiian restaurant, Kona Kitchen, which she founded with her daughter and son-in-law.
"She was one of those people that quickly made friends and made an impression on everyone," said her son Rich. "Young people would look to her as a grandmother figure."
Known for her warmth, she enjoyed giving customers a hug or word of advice. Angie said that when she and her siblings were growing up, her parents made sure they had family dinners, and her mother brought that same feeling of togetherness to their restaurants.
"She cared for people and wanted to know what was going on in their lives," she said.
Liz had been in good health before contracting the virus. When her oxygen levels fell, her son took her to the ER.
"It was the last time I got to hear a response from her," Rob said. "That was the hardest part — not knowing it would be the last time."
The hospital was still adjusting its operations to account for the wave of COVID-19 patients and wasn't yet specifically screening patients with the coronavirus about their end-of-life wishes.
As she was admitted, the hospital staff asked about what kind of medical interventions she wanted, if necessary. "Do you want CPR? Do you want to be put on life support?"
Their mother was weak but still conscious. She said yes. Her children agreed.
"We just had no idea what this virus was going to do," Angie said. "We were trying to give her the opportunity to fight it."
But their mother's health worsened, and soon she was on a ventilator in the intensive care unit.
"For 14 days on the ventilator, she was alone," Angie said. Her brother Rob adds: "That's the part that hurts the most, and what will haunt me forever."
Near the end, the three children did get to visit their mother one last time.
"We were all gowned up and she was sedated," Rich said. "We were trying to talk to her and let her hear our voices."
Meanwhile, their father, Robert, had also become sick. He had been a civilian operations analyst for the Navy.
"He was on a Ph.D. track and quit his program to support his new son, me," Rob remembered. "My dad was more of the analytical type, he could give you a practical solution for everything."
In the early years of his marriage, Robert was supporting a household of seven, including their grandparents. His children describe him as cerebral, a perfect complement to his more extroverted wife.
"They really meshed well together — it worked for them," Rich said.
Robert was admitted to the same hospital as his wife. He seemed stable the first few days. But then his oxygen levels decreased and he started to decline.
He had been clear about his end-of-life care wishes.
"From Day One, he said he did not want to be on life support," Angie said.
'This Awful, Awful Truth'
Darrell Owens started managing Robert's care. The family talked and texted with Owens. He'd give them regular updates and tell them what to expect.
"He had to deliver this awful, awful truth, but the way he did it was so compassionate," Angie said. "He helped us arrange everything we needed for our dad."
"I appreciated the honesty," Rob said. "I found that the most reassuring and valuable thing."
Because he had decided against aggressive treatment, their father was never moved to the ICU. He was able to have a few in-person visits with his three children. Since he wasn't on a ventilator, they could have a conversation.
Rob said his father's treatment at the end of his life was on his own terms: "That was very important to him."
Owens managed Robert's care to the very end, and ensured that Robert could read the last few text messages from his son.
"They were basically goodbyes," Rich said.
Robert also shared memories with Owens about his wife and children.
"My dad opened up to him about our family," Angie said. "Dr. Owens knew quite a bit about us."
The Mars are deeply grateful to the nurses and doctors who cared for their parents. They understand that hospitals are restricting visitors to minimize the chance of infection and preserve limited supplies of masks and gowns.
Still, it doesn't stop Angie from wondering what might have been different if she had said goodbye to her mother before she was intubated, or had the chance to sit next to her while on the ventilator.
"What if I got to be bedside to my mom earlier, when she wasn't heavily sedated, holding her hand and just being present," Angie said. "That we'll never know."
It's a new way of experiencing death that families are coming to know as the coronavirus keeps them at a distance in these final moments.
This story is part of NPR's reporting partnership with Kaiser Health News.
Months into the spread of the coronavirus in the United States, widespread diagnostic testing still isn't available, and California offers a sobering view of the dysfunction blocking the way.
It's hard to overstate how uneven the access to critical test kits remains in the nation's largest state. Even as some Southern California counties are opening drive-thru sites to make testing available to any resident who wants it, a rural northern county is testing raw sewage to determine whether the coronavirus has infiltrated its communities.
County to county, city to city — even hospital to hospital within a city — testing capacity varies widely, as does the definition of who qualifies for testing.
Testing deserts, stemming from an overwhelmed supply chain and a disjointed public health system, have hit hardest in California's rural north and in lower-income urban neighborhoods with concentrations of residents who already were struggling to get quality medical care. In the absence of a coordinated federal response, local health departments, hospitals and commercial labs across the state have been competing for the same scarce materials. Whether they are "haves" — or have-nots — is determined largely by how deep their pockets are, their connections to suppliers and how the state is allocating emergency supplies.
Compounding these problems is the lack of a state or federal public health infrastructure empowered to acquire and allocate resources on a grand and equitable scale. Hospitals and health systems where many people go for care are, by design, set up to focus resources on their own patients and workers. Their bureaucracies can't readily adapt to do the community outreach and education that could bring testing to the masses; nor are they set up to do the contact tracing that ensures that people who have been exposed to COVID-19 patients are tested and monitored.
Those roles typically fall to county health departments, which in much of California operate on bare-bones budgets that make it a struggle to contain perennial STD outbreaks, let alone a deadly pandemic.
Over the past two months, the state has triaged one testing disaster after another, but it is finally making headway on making tests more widely available, in part by cutting its own deals for supplies and expanding testing sites in underserved areas, said Dr. Bob Kocher, one of three people on a testing task force convened by California Gov. Gavin Newsom.
But conversations with dozens of local health officials, hospital systems, scientists and elected officials reveal just how complicated a task it will be.
Take Lake County, a recreational mecca just over two hours north of San Francisco. With 65,000 residents, it has had so few testing supplies that officials have resorted to buying swabs on Amazon and pilfering chlamydia testing kits for swabs and the liquid used to transport specimens to labs. Through what the county has cobbled together, it has identified six cases of COVID-19, all found via nurses or volunteers who have gone out looking for patients. "We're basically having to do tea leaves to figure out what's going on," said Dr. Gary Pace, the county's health officer.
He knows the county has community transmission, both from the cases they've identified and because they've started running tests on raw sewage to check for the COVID-19 virus; samples from four treatment plants have come back positive. "It is a way to just get more information because we can't do testing," he said. Unlike the diagnostic kits — which make use of supplies every health department in the country is competing for — the sewage sampling is done pro bono by a technology startup.
While announcing an ambitious program to increase testing last week, Newsom highlighted the rural-urban divide. "One of the big struggles we have had in the last few weeks of this pandemic is getting to rural and remote parts of this state and getting up testing sites and making them available," he said.
Newsom is promising to dramatically increase the level of coronavirus testing, with a focus on rural towns and communities of color. California currently tests about 25,000 people a day but has a strategy to raise that to 60,000 to 80,000 per day. The state has opened the first of 86 pop-up testing sites targeted for areas in need. It is launching a program to train 10,000 workers to serve as temporary disease investigators who can do the contact tracing considered fundamental in stemming the spread of the virus.
Pace said he wrote the governor to ask for one of the pop-up sites. "Statewide, there's a situation where there's not enough testing, and if you're trying to demonstrate progress, the way you do that is numbers," he said. "We are interested in equity, though, and in my view, we need some horizontal coverage instead of just lots of numbers."
In Mendocino County, situated along California's rugged North Coast, officials expressed similar frustration. In late April, a health center on the Round Valley Indian Reservation got a rapid test machine made by Abbott Laboratories, distributed via the Indian Health Service. That same day, a tribal member came in feeling sick. That person tested positive for COVID-19, as did five family members. The county previously had identified just five cases, all linked to travel.
Dr. Noemi Doohan, the Mendocino County public health officer, fears a broader outbreak among the six tribes who live on the reservation. The state since has provided 2,000 test kits for people who live or work around the reservation. Doohan's office will have to hire couriers to drive 2½ hours to a public lab in Sonoma County, which also has limited supplies, to get them processed.
It's Every Lab — And County — For Itself
A mix of commercial and public labs are responsible for testing in California, and supply chain limitations have plagued them all. But those with deeper pockets and stronger commercial relationships have been out-competing counties and public labs with limited resources.
Rural Tulare County, spanning the peaks and foothills of the Sierra Nevada, is home to half a million people. It also has one of the highest per capita death counts of COVID-19 in California. Until recently, the local public lab was the only place in the county that could test for the disease. After borrowing staff from another county, buying additional machines, and suspending testing for most other diseases, they are now able to process 85 tests a day. Officials also can send specimens to commercial labs in other parts of the state, but say days-long turnarounds create bottlenecks for tracking patients and finding contacts.
Monterey County, in the heart of the state's "salad bowl" coastal farming region, has relied on donations — and horse-trading — to meet demand. A local hospital found the expensive materials needed to make a missing reagent and mixed a batch for the public lab, said lab director Donna Ferguson. The hospital also gave the county 1,000 swabs, which Ferguson used to barter with Riverside County for extraction kits.
And through the kindness of strangers, she found a stopgap for limits on another important resource: lab workers.
During an interview with a local public radio station in March, Ferguson mused that if one of the three microbiologists working in her lab got sick, it could be disastrous for the county's ability to process tests. The next day, she got a call from a graduate student at Stanford's nearby Hopkins Marine Station. He'd heard the interview. Could he and his colleagues help? The crew of six graduate students from three universities has been volunteering at the lab since, tripling its capacity to 120 tests a day.
Though the supply chain is a concern for labs of all sizes, manufacturers appear to be prioritizing orders from commercial labs and big health systems over public health labs, said Eric Blanks, chief program officer for the Association of Public Health Laboratories, which represents most of the labs run by public health departments in the nation.
Quest Diagnostics, the medical testing giant headquartered in New Jersey, is running 350,000 coronavirus tests a week in its facilities around the nation. But it is being inundated with samples from across the country, and even as it has worked to ease backlogs, counties and private hospitals are waiting days for results.
Kaiser Permanente says it can test 2,000 to 2,500 people throughout the state each week. Sutter Health, a major provider in Northern California, tests around 650 people each day across its hospitals. CommonSpirit Health, which includes Dignity Health hospitals, says it could process 50,000 samples a week if it had to. As of last week, Stanford had run more than 20,000 tests for Bay Area residents. (Kaiser Health News, which produces California Healthline, is not affiliated with Kaiser Permanente.)
But even the giants don't have unlimited supplies. "It really is the manufacturing lines. They're the ones that right now are the limiting factor," said Karen Smith, system vice president of laboratory services at CommonSpirit Health.
Moreover, hospitals are not set up to solve the broader issue of statewide disparities in access. They can generally handle the patients sick enough to seek out their ERs. But it hasn't historically been their role to arrange community-wide supplies and testing.
"You're not going to go to an emergency room if you're asymptomatic. That's the last place in the world you want to be right now," said Dr. Omid Bakhtar, medical director for outreach laboratory services at Sharp HealthCare in San Diego. "It's frustrating for me. I have the ability to do more [specimens], but how do I get them?"
Tests But No Takers
In pockets around the state, some counties have been able to stabilize their flow of supplies, in some cases because they have more financial means, in others because of their relationships with major hospital systems and research institutions.
With more confidence in their supply chains, Los Angeles and Riverside counties say they are ready to offer testing to any resident. Several other counties, including much of the Bay Area, are asking more people, including workers deemed essential without COVID symptoms, to get tested.
But some counties that have managed to ramp up testing are wrestling with yet another problem: not enough people to test. The reasons are twofold. After weeks of being told they shouldn't go for testing because of shortages, the public seems to be adhering to that message even now that more testing is available. And the public health workforce tasked with locating those in need of testing is depleted.
San Francisco can test 4,300 people each day in its publicly supported labs but was receiving just 500 samples a day as of late April. Los Angeles is testing roughly 10,000 people daily but says it needs to double that to lift the shelter-in-place orders. Its focus in coming weeks is to increase testing among the uninsured and those in at-risk living environments such as homeless encampments and skilled nursing facilities.
Health officials say part of the challenge is they aren't getting the word out to poorer residents and communities of color, even as those same groups are being hit harder by the virus in many cities. In San Francisco, for example, Latino residents make up 16% of the population but 25% of COVID-19 cases. In Los Angeles, black people are 9% of the county's population but represent 15% of the deaths from COVID-19 for which race and ethnicity data is available.
Kocher, of the state testing task force, acknowledged the state has more work to do. But, he argued, there's also a sufficient amount of testing capability available today, especially via high-capacity commercial labs where the state says the vast majority of specimens should be processed.
"Right now, we're concerned with not having enough samples collected," he said.
When officials do slowly begin to let people return to work and school, experts agree that cases will go up, creating even more need for labs, testing and contact tracers. Preparing for that future will require even more resources.
"We need money," said Santa Barbara County Health Officer Dr. Henning Ansorg. "Lots of money. Lots and lots of it."
There are 21 sites in Southern California where people can provide a sample by swishing a cotton swab around their mouths, putting it in a tube and dropping it in a receptacle on their way out — all within the comfort of their cars.
This article was first published on Friday, May 1, 2020 in Kaiser Health News.
Coronavirus testing is commonly an unpleasant, even painful experience in which a health care provider pushes a torturously long swab up your nostril. President Donald Trump declared that submitting to the process was “a little bit difficult.”
Since late March, three Southern California jurisdictions ― Los Angeles County, and the cities of L.A. and Long Beach ― have offered a more palatable alternative to this nasopharyngeal sampling, whose very name poses a challenge. At 21 drive-thru sites, anyone can now provide a sample by swishing a cotton swab around their mouths, putting it in a tube and dropping it in a receptacle on their way out — all within the comfort of their cars. Some experts suggest this self-sampling approach may provide an easier way to ramp up massive testing in the U.S.
“I strongly advocate for the oral self-swab,” said Dr. Clayton Kazan, medical director for the L.A. County Fire Department, which is overseeing the county’s drive-thru testing program. “It may or may not be inferior, depending on the study you read, but, logistically, there is no comparison.”
But many public health officials balk at relying on the simpler tests unless scientific data convincingly shows they work as well as the accepted methods.
“I have real concerns about decisions that are made based on studies that have not been peer-reviewed,” said Dr. Richard Besser, CEO of the Robert Wood Johnson Foundation and former acting head of the Centers for Disease Control and Prevention.
“In the middle of this pandemic, we don’t want to compromise, especially if people are going to use that information to decide if they’re going to follow social distancing,” said Dr. Adam Jarrett, chief medical officer at Holy Name Medical Center in Teaneck, New Jersey.
Nasopharyngeal samples have long been standard for diagnosing influenza and other respiratory infections because the pathogens are known to colonize the upper part of the throat behind the nose. In contrast, the simpler method being used in L.A. County — in which patients are asked to cough and then swab their cheeks and the back of their mouths — is based on a limited body of emerging research.
The CDC currently calls nasopharyngeal swabs the “preferred choice” for coronavirus testing. It doesn’t recommend self-collected oral fluids, and the number of jurisdictions pursuing this strategy remains limited.
In early April, Middlesex County, New Jersey, also began to offer symptomatic individuals drive-thru tests using oral samples produced after a cough. On Monday, officials in New York City said they planned to begin offering testing using self-collected oral and nasal samples at public hospitals.
Scientists and public health experts have promoted increased viral testing and surveillance as key to any strategy for safely loosening societal restrictions — and the need to collect nasopharyngeal samples by professionals dressed in protective gear represents a major obstacle. That’s why interest is rising in the use of oral samples as well as nasal swabs that can be self-administered, said Lisa Barcellos, an epidemiologist at the University of California-Berkeley.
“It’s impossible to scale up anything that requires health professionals to do it, and with equipment that’s hard to get,” Barcellos said. The surge in demand for the specialized 6-inch swabs required for the nasopharyngeal procedure has led to critical shortages, she added.
The L.A. County, Los Angeles and Long Beach drive-thru sites — designed for people experiencing symptoms — collectively process about 7,000 oral swab tests a day, with a positive rate of just over 7%, according to Curative, the diagnostics company that provides the tests. Curative is holding discussions with jurisdictions in other areas and last week announced an agreement to test Air Force personnel.
Kazan acknowledged that nasopharyngeal sampling is considered the most trustworthy method but noted recent studies have reported promising results from oral samples. Moreover, he said, relying on self-administered techniques eliminates the danger to health care personnel and minimizes the need for personal protective equipment in short supply, like masks, face shields and protective suits.
Kazan said people who receive the tests are relieved to find that collecting secretions from their mouths is relatively quick and easy.
“I think that a lot of folks envision what they saw on YouTube, people in PPE that look like astronauts putting swabs way up people’s noses,” he said.
But to be useful, diagnostic tests must be accurate. A “false negative,” in which the test fails to detect the coronavirus, could lead someone who is infected to think they are safe and pose no danger to others.
Since the pandemic began, a growing body of research — some of which has not yet undergone peer review — has compared how accurately different sampling techniques detect the virus. “Everybody’s looking for better ways to do this,” said Barcellos, who is involved in a major study of the prevalence of coronavirus infection in the East Bay region.
Both oral and nasal samples can be obtained in more and less invasive ways. Oropharyngeal swabs require the instrument to be inserted down the throat; like nasopharyngeal swabs, they are supposed to be performed by a trained provider because the procedure can be uncomfortable and tends to produce a gag reflex.
And swabs of secretions gathered from just inside the nostril can be self-administered, unlike the nasopharyngeal swabs. A Seattle study of hundreds of coronavirus patients found that self-collected samples were almost as accurate as nasopharyngeal swabs in identifying viral infections. In March, Seattle public health agencies launched a home-testing surveillance project using the nasal self-swab, with local residents registering online.
The emerging research has also investigated oral fluid tests, like those being conducted in L.A. County, with subjects generally required to cough in order to bring up virus-rich saliva before they swab their mouth or spit into a container. A non-peer-reviewed study of 65 patients in China reported that the detection rate of the novel coronavirus was higher in saliva than in other respiratory samples. Other studies have found that oral fluid tests aren’t as accurate when people are not reminded to cough beforehand.
Carey-Ann Burnham, medical director of microbiology at Barnes-Jewish Hospital in St. Louis, said the early research on oral fluids looks “remarkably promising.”
But “a nasopharyngeal swab is a standardized sampling technique that’s been done for decades,” said Burnham, who is also a professor of immunology and pathology at Washington University School of Medicine. “Saliva, oral secretions — that’s not a standard way we’ve looked for respiratory viruses, and right now everyone’s doing it a little bit differently.”
That makes it harder to compare studies and results, she said.
The FDA’s authorization for the Curative test recommends that the self-collection process be “observed by a trained healthcare worker.” Kazan, the fire department medical director, said that trained staffers observe the oral self-swabbing. While acknowledging the limitations of the early data, Kazan insists that the needs of the moment are paramount.
“This is the space between smart people reading medical literature and those of us who are tasked with operationalizing these recommendations,” he said.
Jane Gunter, a nurse practitioner in Tuolumne County, California, has long wanted to specialize in mental health so she can treat patients who have anxiety, depression and more complicated mental illnesses.
Her county, a rural outpost in the Sierra Nevada foothills with a population of about 54,000, has only five psychiatrists — "a huge shortage," she said.
But Gunter, 56, wasn't about to quit her job at the Me-Wuk Indian Health Center in Tuolumne and relocate to some distant campus for two years to get certified as a psychiatric nurse practitioner.
Then, in February, she learned that the University of California was launching a new program to provide that certification online in just one year. She fired off her application, and last month she received an acceptance letter.
"Sometimes I think, 'What are you doing?'" Gunter said, referring to the online classes that will take over her nights and weekends once the program starts. "But I care about the community."
The online certification program, conducted jointly by the nursing schools at the University of California-San Francisco, UCLA and UC-Davis, was scheduled to start in the fall, but it has been postponed until January because the on-site clinical hours required as part of the training are not possible during the COVID-19 shutdown.
Despite the delay, the potential expansion of psychiatric care is opportune given the expected increase in mental health problems due to the social isolation and financial stress stemming from the pandemic.
The need for more mental health nurses is about to be bigger than ever, said E. Alison Holman, a health psychologist at UC-Irvine who studies emotional responses to collective trauma.
"We now have 30 million Americans who have lost their jobs, who have no income — and how are they going to pay rent? How are they going to buy food?" Holman said. "And then you have to stay home. This event is rolling out like a long, chronic stressor."
Even before the current crisis, California faced a serious shortage of mental health professionals, especially in rural areas. California's psychiatrists and psychologists are approaching retirement age in large numbers, and fewer medical students are choosing psychiatry.
A UCSF study projected that the state would have 41% fewer psychiatrists than needed by 2028. More than half of Californians with mental illness receive no treatment, according to a February 2019 reportby the California Future Health Workforce Commission.
UC's online mental health nurse practitioner program is one of the solutions recommended by the commission, a statewide, multisector panel that created a master plan to address the Golden State's shortage of health care workers.
The program is expected to put 300 more mental health NPs into California communities, particularly rural ones, over the next five years. Applicants such as Gunter, who live in underserved rural areas, will be given priority in the hope that they will stay in their communities upon completion of the training, said Deborah Johnson, a UCSF nursing professor who is co-director of the program.
Forty spots are available for the class that begins in January, and not all have been filled yet, Johnson said. Applications are being accepted until June 1, and 65 additional spots will open in fall 2021 and each fall thereafter for three more years, she said.
The UC system received a $1.5 million grant from the California Health Care Foundation to develop, design and launch it. But tuition is expected to make it self-sustaining. (Kaiser Health News, which produces California Healthline, is an editorially independent publication of the foundation.)
Applicants for the new program must already be advanced practice nurses, which means they hold either a master's degree or doctorate in nursing. More than 27,000 NPs now practice in California, but only 1,200 are certified to treat psychiatric patients.
Three hundred more psychiatric NPs won't completely fill the growing mental health care need, but they are expected to treat nearly 400,000 patients over a five-year period.
Though the online program means working nurses won't have to leave their jobs and their lives to relocate, they will still face challenges.
For one thing, their certification will require 500 hours of supervised clinical training with patients in hospitals, jails or schools. And some applicants live in communities where such opportunities may not be available, which could require them to commute long distances to meet the requirement.
Another challenge is that, even after nurse practitioners are certified, state law requires they find a medical doctor to supervise them. Havilyn Kern, a school nurse in Nevada City, California, quit her job two years ago so she could spend three days a week at UCSF — 155 miles away — to train as a psychiatric nurse practitioner.
She graduates in June, so the new online program is too late for her. Kern, who plans to work in her own community, hopes she will find a psychiatrist in the Bay Area willing to tele-supervise her.
"It shouldn't have to be this way," said program co-director Johnson. "California is so archaic. It's the most restrictive state in the western portion of the country."
Twenty-eight states plus Washington, D.C.,allow nurse practitioners to work autonomously. Santa Rosa Assembly member Jim Wood, a Democrat, has introduced a bill, AB-890, that would allow California NPs to practice without doctor supervision. It passed the Assembly in January and is pending in the Senate.
"If AB 890 passes, it will certainly help fill the loss of specialty physicians such as psychiatrists everywhere, including in underserved areas," Wood said.
But that's a big "if."
California's powerful doctors' lobby, which has repeatedly scuttled similar legislation, is aggressively fighting it again. They argue that letting NPs order tests and prescribe medications independently would "dilute care."
Doctors also have a financial incentive to keep things the way they are. It restricts competition, and they bill NPs between $5,000 and $15,000 a year to review their charts and prescriptions every few months, according to a report by the California Health Care Foundation and UCSF.
Johnson suggested it is time for a change.
"We are the workhorses," she said. "Oh, my God, there is so much need. This new program could not come at a more important time."
When President Donald Trump started touting hydroxychloroquine as "one of the biggest game changers" for treating COVID-19, researchers hoped electronic health records could quickly tell them if he was on the right track.
Yet pooling data from the digital records systems in thousands of hospitals has proved a technical nightmare thus far. That's largely because software built by rival technology firms often cannot retrieve and share information to help doctors judge which coronavirus treatments are helping patients recover.
"I'm stunned at EHR vendors' inability to consistently pull data from their systems," said Dale Sanders, chief technology officer of Health Catalyst, a medical data analytics company. "It's absolutely hampering our ability to understand and react to COVID."
Over the past decade, federal officials have spent some $36 billion switching from paper to electronic health records, or EHRs, expecting, among other things, to harness volumes of medical data to reveal which treatments work best.
EHRs document every step doctors or other health care workers take in treating a COVID patient, from medicines prescribed to signs of progress or setbacks. Data collected from large numbers of patients could quickly yield answers about which treatments are succeeding.
But the pandemic is bringing into stark relief just how far the nation is from achieving the promised benefits, critics say.
Dr. Richard Cook, a research scientist and health care safety specialist, traces the data problems to missteps dating to the rollout of EHR, which began in earnest in 2009 and has been controversial ever since because commercial players produced ― and hospitals bought — systems that have proved more suited to billing than public health. "This was a boondoggle from the get-go, and the promoters knew it at the time," Cook said.
Although some health systems are beginning to draw on EHR data to spot coronavirus trends and beneficial treatments, most health organizations around the country cannot readily do so.
"If we had a national database, we'd get a readout quickly about responses to [COVID-19] treatments," said Dr. Eric Topol, director of the Scripps Research Translational Institute.
Medical researchers favor studies that test the efficacy of a drug in a formal clinical trial, and trials are underway for a variety of possible COVID-fighting medicines, including hydroxychloroquine. The results could take months or more, however, and doctors treating critically ill patients have few options in the meantime.
Topol said "real-world" evidence drawn from computerized records of COVID patients, while not as reliable as a clinical trial, is "still very useful" to help guide medical decisions.
Medical data has been hard to tease out because much of it resides in electronic "silos," which government officials have not required technology companies to open up and eliminate.
"We'll see piecemeal readouts of small numbers from individual health systems," Topol said, but "don't have the important data that we need."
Sanders, whose firm is a member of the COVID-19 Healthcare Coalition, a business-sponsored group promoting coronavirus data-sharing and analysis, said federal health officials lost precious time by failing to address this need as early as mid-January.
He said the federal Centers for Disease Control and Prevention, or CDC, should have devised a COVID data-collection plan using standardized terminology so hospitals with incompatible EHRs could compare notes on the fast-paced pandemic.
The CDC did not respond to written requests seeking comment. A spokesman for the Health and Human Services office that coordinates health information technology policy said: "This is a novel disease so the health care system did not know what data we needed to collect ― we are learning that the system needs to build out reporting information on multiple clinical features."
Still, several of the top EHR manufacturers have joined the data-sharing coalition, which is pledging to at least partially fill the information void. The group has access to COVID data from about two dozen health systems and is expecting to add more.
"This is the first attempt at this that I'm aware of where inherently competitive EHR vendors have come together to work together with clinical researchers," said Dr. Brian Anderson, chief digital health physician with the MITRE Corp., a nonprofit technology group that formed the coalition in late March.
Anderson said the coalition is "getting close" to being able to share some results from reports of treating people with convalescent plasma recovered from patients who have survived COVID-19. The group is also examining treatment data on the drug remdesiviras it irons out some of the technical difficulties that complicated its analysis of hydroxychloroquine. Last week, the Food and Drug Administration warnedthat hydroxychloroquine could cause heart problems and should be used only in a hospital or clinical trial.
There are other signs the EHR industry is relaxing its grip on medical data in response to the emergency. Major EHR vendor Cerner Corp. has offered researchers access to some types of COVID-19 data, including "clinical complications and outcomes that could help drive important medical decisions."
And some health systems have begun publishing data drawn from EHRs. One study released this month, for instance, tracked the outcome of 5,700 coronavirus patients treated at 12 hospitals in a New York City health system and found that 88% of patients placed on ventilators had died. All the hospitals shared the same records vendor.
"In crisis, people seek data and authorities demand it," said Cook, the health care safety specialist. But, he said, "it is not possible to build such a system on demand."
Ross Koppel, a professor at the University of Pennsylvania and longtime EHR safety expert, said that the COVID-19 pandemic illustrates both "strengths and disappointments" of the digital systems.
While health systems using a single vendor have been able to pool data, Koppel said, the industry has battled regulators seeking to adopt common standards, a practice known as interoperability.
"That failure to mine these oceans of invaluable data reflects the power of the vendors to prevent government requirements for data standards and interoperability," he said.
Limits in electronic data collection systems also are hindering COVID-19 public health and surveillance efforts.
Officials said they are sometimes required to manually fill out and fax some forms, wasting valuable time. Some information must be printed out from EHRs and reentered by public health authorities because it cannot be sent electronically.
Certain CDC forms, such as Person Under Investigation COVID case reports, can take up to 30 minutes to complete. Other forms exchanged between hospitals and laboratories often are missing critical information, leading to delays in contacting patients and identifying people they had close contact with. In some states, demographic information on race and ethnicity is missing 85% of the time, and patients' addresses, half the time, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.
"We're using yesterday's technology for the biggest public health emergency in our lifetimes," Hamilton said. "COVID has demonstrated for people what we've known all along. You can't leave public health at the end of the line."
The government's health IT chief says a new administrative ruleto promote interoperability and bar EHR manufacturers from impeding the flow of information will take time to change behavior.
"If this were to have happened three or four years in the future when we have interoperability … we would be in a much better spot here. But unfortunately, that's not quite the case, but we're still keeping our work going," Donald Rucker, national coordinator for health information technology, said during an April 15 virtual meeting.
Insurers say that while that falloff in claims for non-COVID care is offsetting for now many insurers' costs associated with the pandemic, the future is far more fraught.
This article was first published on Tuesday, April 28, 2020 in Kaiser Health News.
As doctors and consumers are forced to put most nonemergency procedures on hold, many health insurers foresee strong profits.
So why is the industry looking to Congress for help?
Insurers say that while that falloff in claims for non-COVID care is offsetting for now many insurers' costs associated with the pandemic, the future is far more fraught.
Costs could remain modest or quickly outstrip savings. A recession could drive revenue down. Or the coronavirus could resurge next winter and spike treatment expenses.
All that uncertainty for the companies could trigger far higher premiums for consumers, if insurers hedge their bets. Then again, the current savings insurers are seeing — along with cautions from state regulators about pushing cost-sensitive customers away during an economic downturn — might result in minimal premium increases.
"Insurers are nervous, to be sure," said Michael Kreidler, Washington state's insurance commissioner. "But so far they are telling me they are in good shape. Coronavirus claims have not been that high — yet."
Backing that assessment was a report out last week by credit rating agency Moody's, which looked at a range of pandemic scenarios — from mild to severe — and concluded "U.S. health insurers will nonetheless remain profitable under the most likely scenarios."
Earlier this month, UnitedHealth Group CEO David Wichmann told analysts that cost reductions so far are outstripping expenses for COVID-19 and that revenue is up compared with the previous year. He expects — barring a worsening situation — the rest of the year's earnings to match projections. Other insurers, including Centene, Anthem, Humana and Cigna, are scheduled to release earnings reports this week.
If these results are repeated across the insurance industry, there will be pressure on insurers to hold down rate increases for next year and do more for policyholders, such as constrain the growth in deductibles and other out-of-pocket costs, said consumer advocates, regulators and policy experts.
"The last thing we need is insurers pricing their coverage unnecessarily high at a time like this," said Peter Lee, executive director of Covered California, the health insurance marketplace in that state for people who buy their own coverage because they don't get it through their job.
That prediction comes as tens of millions of Americans have lost their jobs — and often their health insurance.
Those thrown out of work may be able to stay on employer coverage through a federal law called COBRA, but it's expensive and workers have to foot the bill. Insurers and employers have asked Congress for relief legislation to fully cover COBRA costs.
Losing a job is also a qualifying event to enroll in an Affordable Care Act plan — and, again, the industry has asked lawmakers to temporarily boost subsidies to help enrollees pay their premiums. Some states that run their own ACA marketplaces have reopened enrollment to help the uninsured get coverage.
The industry also wants Congress to authorize temporary financial support to help cover insurers that face "extraordinary, unplanned costs in 2020 and 2021," according to a letter sent to lawmakers from America's Health Insurance Plans and the Blue Cross Blue Shield Association.
To help, some states are giving insurers more time this year to submit their planned premium rates for 2021 — based on their expected costs — hoping things may be clearer by summer. California, for instance, is giving insurers until July to draw up their estimates.
One fear is that insurance actuaries, when faced with an unknown risk like the coronavirus, will price higher than needed, said Lee.
Setting premiums for next year is a balancing act. Insurers that calculate incorrectly and go too low will lose profits and may have to dig into their cash reserves to pay claims. If they set rates too high, they may run afoul of a provision in the ACA that requires insurers to issue rebates to policyholders if they don't spend at least 80% of revenue on medical care.
And they don't estimate well even in normal years. Early data for 2019 coverage shows insurers may owea record amount in rebates, which will be paid out this year.
Insurers are not talking about next year's premiums.
"We do not yet know the full scope, severity or duration of this outbreak. So we cannot know the ultimate cost of our members' medical treatment or how long the postponement of non-urgent care will continue," said Justine Handelman, senior vice president at the Blue Cross Blue Shield Association.
Early estimates, including a scary one from Covered California issued in late March, warned that costs associated with the coronavirus could drive premiums up 40% next year without federal help, based on initial models of the number of Americans who might fall seriously ill.
That report, though, did not take into account the effect of the sharp decline in elective care.
Thirty-one states have barred most elective surgeries, part of the effort by governors to promote social distancing to flatten the curve of the epidemic and to help prevent hospitals from being overwhelmed.
"The good news since we published that report is that it looks like efforts to flatten the curve are taking effect," said Lee, so costs are more likely to be in the median rather than high end of the range.
The cost to insurers "all depends on the severity" of the continuing pandemic, said Dean Ungar, a vice president and senior credit officer at Moody's. "On the lower side, the industry will do quite well, and also even in a more median scenario, especially when you factor in the offsetting benefit of delayed procedures."
Moody's estimates that deferred elective procedures may account for as much as 20% to 40% savings on medical costs per month for many insurers as long as elective procedures are barred or patients are unwilling to seek nonemergency care.
Even so, "I don't think the insurance industry as a whole has any intention of making money off this," Ungar said. "There will be rebates or other things to help. Partly that's the right thing to do and partly it's good business."
Former Cigna executive turned industry critic Wendell Potter disagreed. He tweeted earlier this month that UnitedHealth spent $1.7 billion during the first quarter to buy back its own stock — a move that helps the company. "In other words, they're thriving during a pandemic," Potter tweeted. Instead, he said, the insurer should plow that money into premium reductions or other help for policyholders.
For its part, UnitedHealth said it has waived patient cost sharing for COVID care — as have most other insurers — as well as accelerated payments for what it owes to doctors, and is helping provide loans to some clinics.
Some physician groups fear they are being left out, saying some of the savings seen by insurers and self-insured employers should be directed to those struggling after seeing their practices dry up as people avoid medical care or governors bar elective procedures.
"It's a huge hit," said Tom Banning, CEO and executive vice president of the Texas Academy of Family Physicians.
Lee agreed, warning that struggling front-line physicians, and especially family and primary care doctors, will need financial help.
"A bad outcome of all this will be if thousands of providers can't make it financially and their practices get bought up by hospitals or private entities — creating more consolidation in health care, which is already driving costs up," said Lee. "Lawmakers should be thinking about helping primary providers out."
Relying on surgical masks — which are considerably less protective than N95 respirators — is almost certainly fueling illness among frontline health workers.
This article was first published on Tuesday, April 28, 2020 inKaiser Health News.
With medical supplies in high demand, federal authorities say health workers can wear surgical masks for protection while treating COVID-19 patients — but growing evidence suggests the practice is putting workers in jeopardy.
The Centers for Disease Control and Prevention recently said lower-grade surgical masks are "an acceptable alternative" to N95 masks unless workers are performing an intubation or another procedure on a COVID patient that could unleash a high volume of virus particles.
America's health care workers are dying from the coronavirus pandemic. These are some of the first tragic cases.
But scholars, nonprofit leaders and former regulators in the specialized field of occupational safety say relying on surgical masks — which are considerably less protective than N95 respirators — is almost certainly fueling illness among front-line health workers, who likely make up about 11% of all known COVID-19 cases.
"There's no doubt in my mind that that's one of the reasons that so many health care workers are getting sick and many are dying," said Jonathan Rosen, a health and safety expert who advises unions, states and the federal government.
As of April 23, more than 21,800 health care workers had gotten the coronavirus and 71 had died, according to a House Education and Labor Committee staffer briefed by the CDC.
The CDC's advice contrasts with another CDC webpage that says a surgical mask does "NOT provide the wearer with a reliable level of protection from inhaling smaller airborne particles and is not considered respiratory protection."
Put simply, in worker safety, "a surgical mask is not PPE," or personal protective equipment, said Amber Mitchell, president and executive director of the International Safety Center and immediate past chair of the occupational health and safety section of the American Public Health Association.
The allowance for surgical masks made more sense when scientists initially thought the virus was spread by large droplets. But a growing body of research shows it's spread by minuscule viral particles that can linger in the air as long as 16 hours.
A properly fitted N95 will block 95% of tiny air particles — down to three-tenths of a micron in diameter, which is the hardest to catch — from reaching the wearer's face. But surgical masks, designed to protect patients from a surgeon's respiratory droplets, aren't effective at blocking particles smaller than 100 microns, according to mask maker 3M Corp.
A COVID-19 particle is about 1 to 4 microns, according to recent research.
Research from early April, examining two hospitals in South Korea, found surgical masks "seem to be ineffective in preventing the dissemination" of coronavirus particles. A 2013 Chinese study found that twice as many health workers, 17%, got a respiratory illness if they wore a surgical mask treating sick patients, compared with 7% of those who continuously used an N95, per the American Journal of Respiratory and Critical Care Medicine.
"My personal opinion would be, since there's evidence of aerosol transmission, [at least] an N95 should be used for direct care of suspect or COVID-confirmed patients," said Dr. Robert Harrison, a physician and professor at the University of California-San Francisco medical school who founded UCSF Occupational Health Services.
In an emailed statement, the CDC suggested that its guidance is meant to conserve scarce resources and applies primarily to shortage situations.
Surgical masks should be used when N95s "are so limited that routinely practiced standards of care … are no longer possible," said Martha Sharan, an agency spokesperson. "N95 respirators beyond their manufacture-designated shelf life, when available, are preferable to use of facemasks."
Yet many health facilities — citing the CDC guidelines and scarce supply — are providing N95s in only limited medical settings.
Earlier this month, the national Teamsters union reported that 64% of its health care worker membership — which includes people working in nursing homes, hospitals and other medical facilities — could not get N95 masks.
At Michigan Medicine, the University of Michigan's medical center, employees don't get N95s except for performing specific procedures on COVID-positive patients — such as intubation or a bronchoscopy — or treating them in the intensive care unit, said Katie Scott, a registered nurse at the hospital and vice president of the Michigan Nurses Association. Employees who otherwise treat COVID-19 patients receive surgical masks.
That matches CDC protocol but leaves nurses like Scott — who has read the research on surgical masks versus N95s — feeling exposed.
"We are at a risk of getting this virus, and we are at a risk of bringing it home to our families," Scott said. "It's clear these surgical mask guidelines aren't working."
Nearly 3,000 health workers in the Detroit area — which includes Ann Arbor, the home of Michigan Medicine — have suspected or confirmed COVID-19 infections, according to recent news reports.
At Michigan Medicine, employees cannot bring in their own protective equipment, according to a complaint the nurses union filed with the Michigan Occupational Safety and Health Administration. Scott has PPE that her friends and family have mailed her, including N95 masks. It sits at home while she cares for patients.
"To think I'm going to work and am leaving this mask at home on my kitchen table because the employer won't let me wear it," Scott said. "You feel sacrificial in a way."
News reports from Kentucky to Florida toCalifornia have documented nurses facing retaliation or pressure to step down when they've brought their own N95 respirators.
A spokesperson for Michigan Medicine declined to answer questions about the hospital's protective equipment protocols. The American Hospital Association does not have a stance on letting employees bring their own N95s to work, said Robyn Begley, the trade group's senior vice president and chief nursing officer.
In New York, the epicenter of the nation's coronavirus outbreak, nurses across the state report receiving surgical masks, not N95s, to wear when treating COVID-19 patients, according to a court affidavit submitted by Lisa Baum, the lead occupational health and safety representative for the New York State Nurses Association.
"A surgical mask is not a form of PPE. … [If you] cough or sneeze, it catches some of the virus. It does not protect the wearer," Baum said in an interview with Kaiser Health News.
So far, at least 16 NYSNA members have died from the coronavirus, at least 94 have been hospitalized and more than 1,000 have tested positive, according to union estimates.
National Nurses United has pushed Washington lawmakers to pass legislation that would ramp up production of N95s by compelling the White House to invoke the Defense Production Act, a Korean War-era law that allows the federal government, in an emergency, to direct private business in the production and distribution of goods.
It is also calling on Congress to require that the Occupational Safety and Health Administration put forth an emergency temporary standard to mandate that employers provide health care workers with protective equipment, including N95 masks, when they interact with patients suspected to have COVID-19.
"The employer has a responsibility to protect their employees," said Amirah Sequeira, the union's lead legislative advocate. "At the same time, when you have a crisis at this scale, the federal government also has a responsibility to ensure the very increase in purchasing, and, if not purchasing, production."
The AHA has lobbied against a mandate that would expand use of N95s. Begley acknowledged that "supplies are inadequate" and said heightened global demand makes getting N95s much more difficult.
"If we fail to conserve already limited supplies, there will be no N95s remaining for health care staff performing aerosolizing procedures," Begley said.
But the failure to get more and better protective gear to health workers could cost more lives, union leaders warned in a recent teleconference about the dangerous conditions workers are facing.
"Nurses are not afraid to care for our patients if we have the right protections," said Bonnie Castillo, the executive director of National Nurses United, "but we're not martyrs sacrificing our lives because our government and our employers didn't do their job."