At issue is the degree to which the virus is airborne ― capable of spreading through tiny aerosol particles lingering in the air ― or primarily transmitted through large, faster-falling droplets.
This article was published on Wednesday, September 23, 2020 in Kaiser Health News.
Front-line healthcare workers are locked in a heated dispute with many infection control specialists and hospital administrators over how the novel coronavirus is spread ― and therefore, what level of protective gear is appropriate.
At issue is the degree to which the virus is airborne ― capable of spreading through tiny aerosol particles lingering in the air ― or primarily transmitted through large, faster-falling droplets from, say, a sneeze or cough. This wonky, seemingly semantic debate has a real-world impact on what sort of protective measures healthcare companies need to take to protect their patients and workers.
The Centers for Disease Control and Prevention injected confusion into the debate Friday with guidance putting new emphasis on airborne transmission and saying the tiny aerosol particles, as well as larger droplets, are the "main way the virus spreads." By Monday that language was gone from its website, and the agency explained that it had posted a "draft version of proposed changes" in error and that experts were still working on updating "recommendations regarding airborne transmission."
KHN and The Guardian are tracking healthcare workers who died from COVID-19 and writing about their lives and what happened in their final days.
Dr. Anthony Fauci, the top U.S. infectious disease expert, addressed the debate head-on in a Sept. 10 webcast for the Harvard Medical School, pointing to scientists specializing in aerosols who argued the CDC had "really gotten it wrong over many, many years."
"Bottom line is, there's much more aerosol [transmission] than we thought," Fauci said.
The topic has been deeply divisive within hospitals, largely because the question of whether an illness spreads by droplets or aerosols drives two different sets of protective practices, touching on everything from airflow within hospital wards to patient isolation to choices of protective gear. Enhanced protections would be expensive and disruptive to a number of industries, but particularly to hospitals, which have fought to keep lower-level "droplet" protections in place.
The hospital administrators and epidemiologists who argue that the virus is mostly droplet-spread cite studies that show it spreads to a small number of people, like a cold or flu. Therefore, N95 respirators and strict patient isolation practices aren't necessary for routine care of COVID-19 patients, those officials say.
On the other side are many occupational safety experts, aerosol scientists, front-line healthcare workers and their unions, who are quick to note that the novel coronavirus is far deadlier than the flu ― and argue that the science suggests that high-quality, and costlier, N95 respirators should be required for routine COVID-19 patient care.
The highly protective respirators have been in short supply nationwide and have soared in price, from about $1 to $7 each. Meanwhile, research has shown high rates of asymptomatic virus transmission, putting N95s in high demand among front-line healthcare workers in virtually every setting.
The debate has come to a head at hospitals from coast to coast, as studies have emerged showing that live virus hangs in COVID-19 patients' hospital rooms even in the absence of "aerosol-generating" procedures (such as intubations or breathing treatments) and has contributed to outbreaks at a nursing home, shuttle bus and choir practice.
KHN and The Guardian U.S. are examining more than 1,200 healthcare worker deaths from COVID-19, including many in which their family or colleagues reported they worked with inadequate personal protective gear.
Yet some front-line workers and managers disagree about exactly how and why healthcare workers are getting sick.
The hospital infection-control and epidemiology leaders cite studies suggesting that many healthcare workers are contracting the virus outside of work and at rates that mirror what's happening in their communities.
A group of Penn Medicine epidemiologists in late July characterized research on aerosol transmission as unconvincing and cited "extensive published evidence from across the globe" showing the "overwhelming majority" of coronavirus spread is "via large respiratory droplets."
Unions, occupational health researchers and aerosol scientists, though, reference another pile of studies showing healthcare workers have been hit far harder than average people ― and a study that showedactive viral particles can drift in the air up to 15 feet from a patient in a hospital room. Such particles can hang in the air for up to three hours.
Backing their concerns, a July 6 letter signed by 239 scientists urged the medical community and World Health Organization to recognize "the potential for airborne spread of Covid-19."
The letter pointed to studies that say talking, exhaling and coughing emit tiny particles that remain suspended in the air far longer than droplets and "pose a risk of exposure."
In one ward of a Dutch nursing home with recirculated air, researchers found that 81% of the residents were diagnosed with COVID-19. Half of the workers on the ward ― who all wore surgical masks during patient care but not during breaks ― also tested positive for the virus.
Although researchers couldn't exclude transmission by another method, the "near-simultaneous detection" of the virus among nearly all the residents pointed to aerosol spread.
The idea that the virus is spread by either droplets or aerosols is an oversimplification, said Dr. Shruti Gohil, associate medical director of epidemiology and infection prevention at the University of California-Irvine School of Medicine.
Gohil said it's more of a spectrum, with the virus being transmitted by some droplets and some large aerosol particles as well.
One metric people in the hospital infection-control field focus on, though, is how many people one sick person infects. For COVID-19, research has shown that the number is about two ― similar to a cold or the flu. For an unequivocally airborne disease like measles, the number is closer to 12 to 18.
Measles is "what airborne [transmission] looks like," Gohil said. "If this was truly a primary aerosol-transmissible disease, we'd be in a world of hurt."
Hospital epidemiologists are also focused on the rate of household spread of the novel coronavirus. With the measles, the risk of an unvaccinated member of a household getting sick is 85%, said Dr. Rachael Lee, a hospital epidemiologist and assistant professor at the University of Alabama-Birmingham. For COVID-19, she said, the risk is closer to 10%.
Though the virus is believed to be spread more by droplets than aerosol particles, Lee said, staffers at UAB University Hospital wear an N95 respirator for an extra layer of protection and because the patients require so many breathing treatments or procedures considered "aerosol-generating."
Such practices are not universal. At the University of Iowa's hospital, healthcare workers use N95s and face shields for aerosol-generating procedures but otherwise use surgical masks and face shields for routine care of COVID patients, said Dr. Daniel Diekema, director of the division of infectious diseases at the university.
He said such "enhanceddroplet precautions" are working. Places where workers are correctly using regular medical masks and face shields are findingno significant spread of the disease among staffers, although one such report focused on the spread from a single patient.
Elsewhere, patients have also been safe on floors where COVID-19 patients and those without the virus have been placed in adjacent rooms ― a practice those concerned about aerosol spread do not endorse.
"It's not an airborne disease the way measles or tuberculosis is," said Dr. Shira Doron, an epidemiologist at Tufts Medical Center in Boston and an assistant professor at Tufts medical school. "We know because we don't see outbreaks that affect multiple patients on a floor."
Origin of the Debate
The CDC helped set the stage for the current debate. In March, the agency issued revised guidance essentially saying it was "acceptable" for healthcare workers to use surgical masks ― instead of N95s ― for routine care. The guidance said respiratory droplets were the most likely source of transmission and recommended N95s only for aerosol-generating procedures.
"The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely," according to the guidance.
The California Hospital Association sent a letter to the state's congressional delegation urging the revised guidance be made permanent.
"We need the CDC to clearly, not conditionally, move from airborne to droplet precautions for patients and healthcare workers," the letter said. Doing so would enable hospitals to preserve PPE supplies and limit the use of special isolation rooms for COVID patients.
An association spokesperson told KHN that the group wasn't weighing in on the science, merely pressing for clarity of the rules.
Christopher Friese, professor of nursing, health management and policy at the University of Michigan, is among the experts who think those rules have endangered healthcare workers.
"We lost a tremendous amount of time and, candidly, lives because the early guidance was to wear N95s only for those specific procedures," Friese said.
Family members and union leaders from Missourito Michigan to Californiahave raised concerns about nurses dying of COVID-19 after caring for virus patients without N95 respirators. In such cases, hospitals have said they followed CDC guidance.
Friese echoed some occupational safety experts who suggested stronger guidance from the CDC early on calling the disease airborne might have had an impact ― perhaps pressuring President Donald Trump to invoke the Defense Production Act to boost supplies of N95s so "we might have the supply we need everywhere we need," Friese said.
Surveys across the country show there's still a shortage of personal protective equipment at many healthcare facilities.
The CDC guidance posted Friday would have put pressure on some hospitals to bolster their protective measures, something they have reportedly resisted. It said the virus can spread when a person sings, talks or breathes.
"These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection," the site said. "This is thought to be the main way the virus spreads."
By Monday morning, the website was back to saying the virus mainly spreads through droplets, noting that draft language had been posted in error.
The University of Nebraska Medical Center has been taking so-called airborne precautions from the start. There, Dr. James Lawler, a physician and director of the Global Center for Health Security at the university, said his colleagues documented that the virus can drift in the air and live on surfaces at an extensive distance from patients.
He said the hospital tests all admitted patients for the virus and keeps COVID-19 patients apart from the general population. He said they pay close attention to cleaning shared spaces and monitoring airflow within the restricted-access unit. Workers also had N95 respirators or PAPRS, which are fitted hoods with filtered air pumped in.
All of it has added up to a "very low" rate of healthcare worker infections.
Amid uncertainty about the virus, and as an unprecedented number of healthcare workers are dying, adopting the "highest possible" forms of protection seems the best course, said Betsy Marville, nurse organizer for the 1199SEIU United Healthcare Workers East union in Florida.
That would mean a departure from CDC guidelines that now say healthcare workers need an N95 respirator only for "aerosol-generating" procedures, like intubations or other breathing treatments. She said the rule has left the nurses she represents in Florida scrambling for protective gear ― or unprotected ― when patients need such treatments urgently.
"You don't leave your patient in distress and go looking for a mask," she said. "That's crazy."
If the executive branch were to overrule the FDA's scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
This article was published on Monday, September 21, 2020 inKaiser Health News.
In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.
It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.
If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.
Vaccines are typically approved by the FDA. Alternatively, Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.
“Yes, this scenario is certainly possible legally and politically,” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”
Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.
Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.
After this story was published, an HHS official said that Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.
“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.
White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.
Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.
Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.
The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.
Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.
Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.
“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”
In an opinion piece published in The Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”
But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.
Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.
A senior FDA official who oversees vaccine approvals, Dr. Peter Marks, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.
“I think there would be an outcry from the public health community second to none, which is my worst nightmare — my worst nightmare — because we will so confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.
Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”
But Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.
Also, he noted that Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”
Officially, the total repayment of the loan is due this month. Otherwise, federal regulators will stop reimbursing the hospitals for Medicare patients' treatments until the loan is repaid in full.
This article was published on Tuesday, September 22, 2020 in Kaiser Health News.
Note to Readers: Sarah Jane Tribble spent more than a year and halfreporting on a small town in Kansas that lost its only hospital. This month, KHN and St. Louis Public Radio will launch "Where It Hurts," a podcast exploring the often painful cracks growing in America's health system that leave people vulnerable — and without the care they need. Season One is "No Mercy," focusing on the hospital closure in Fort Scott, Kansas — and what happens to the people left behind, surviving the best way they know how. You can listen to Episode One on Tuesday, Sept. 29.
David Usher is sitting on $1.7 million he's scared to spend.
The money lent from the federal government is meant to help hospitals and other healthcare providers weather the COVID-19 pandemic. Yet some hospital administrators have called it a payday loan program that is now, brutally, due for repayment at a time when they still need help.
Coronavirus cases have "picked up recently and it's quite worrying," said Usher, chief financial officer at the 12-bed Edwards County Medical Center in rural western Kansas. Usher said he would like to use the money to build a negative-pressure room, a common strategy to keep contagious patients apart from those in the rest of the hospital.
But he's not sure it's safe to spend that cash. Officially, the total repayment of the loan is due this month. Otherwise, according to the loan's terms, federal regulators will stop reimbursing the hospitals for Medicare patients' treatments until the loan is repaid in full.
The federal Centers for Medicare & Medicaid Services has not yet begun trying to recoup its money, with the coronavirus still affecting communities nationwide, but hospital leaders fear it may come calling for repayment any day now.
Hospital leaders across the country said there has been no communication from CMS on whether or when they will adjust the repayment deadline. A CMS spokesperson had not responded to questions by press time.
"It's great having the money," Usher said. "But if I don't know how much I get to keep, I don't get to spend the money wisely and effectively on the facility."
Usher took out the loan from Medicare's Accelerated and Advance Payments program. The program, which existed long before the pandemic, was generally used sparingly by hospitals faced with emergencies such as hurricanes or tornadoes. It was expanded for use during the coronavirus pandemic — part of billions approved in federal relief funds for healthcare providers this spring.
A full repayment of a hospital's loan is technically due 120 days after it was received. If it is not paid, Medicare will stop reimbursing claims until it recoups the money it is owed — a point spelled out in the program's rules. Medicare reimburses nearly $60 billion in payments to healthcare providers nationwide under Medicare's Part A program, which makes payments to hospitals.
More than 65% of the nation's small, rural hospitals — many of which were operating at a deficit before the pandemic — jumped at the Medicare loans when the pandemic hit because they were the first funds available, said Maggie Elehwany, former vice president of government affairs for the National Rural Health Association.
CMS halted new loan applications to the program at the end of April.
"The pandemic has simply gone on longer than anyone anticipated back in March," said Joanna Hiatt Kim, vice president of payment policy and analysis for the American Hospital Association. The trade association sent a letter to CMS in late July asking for a delay in the recoupment.
On Monday, the House Appropriations Committee included partial relief for all hospitals in a new government funding plan. The committee's proposal would extend the start of the repayment period for hospitals and the amount of time they are allowed to take to repay.
The continuing resolution that includes this language about relief for hospitals (among many, many other things) is still being hammered out, though it does face its own deadline: It must be approved by the House and the Senate within the next nine days or the federal government faces a shutdown.
Tom Nickels, executive vice president at the AHA, said his organization appreciates the House committee's effort to address the loans in the new bill, but full forgiveness of the loans is still needed.
Sen. Jeanne Shaheen (D-N.H.) has called for changes to the loan repayment period for months and said Monday "our work is far from over."
"We are still in the middle of this crisis — from both health and economic standpoints," Shaheen said.
Meanwhile, hospital administrators like Peter Wright are holding their breath, waiting to see if, in order to settle the debt, Medicare will stop making payments to hospitals, even as facilities continue to grapple with coronavirus in their communities.
"The feds, if you owe them money, they just take it," said Wright, who oversees two small hospitals for Central Maine Healthcare in Bridgton, Maine. He said his healthcare system took the money because "we had no other choice; it was a cash flow issue."
For many hospitals, Medicare payments make up 40% or more of their revenue. Not being reimbursed by Medicare would be crippling — akin to a household losing nearly half its income.
"We have no idea what we're going to do if we have to pay it back as quickly as they say," Wright said.
In rural Kentucky, hospital executive Sheila Currans said she "vacillated" for about a week or so trying to decide whether to tap the loan program for her hospital — she knew it would have to be repaid and worried that could prove difficult.
"It was a desperate time," said Currans, chief executive of Harrison Memorial Hospital in Cynthiana, Kentucky. Harrison Memorial was the first hospital in Kentucky to treat a COVID-19 patient in early March, she said.
The hospital immediately quarantined dozens of staff members and shut down elective procedures. And with COVID confirmed in the community, there was a "horrible fear," Currans said, of getting infected that kept people from seeking outpatient care as well.
"Through March and April and most of May, I was in a complete spiral," Currans said. By the end of April, Currans said, her hospital was losing millions of dollars. To cope with the pandemic, she furloughed staff and turned one wing of the hospital into a "cough clinic" to be used exclusively by patients whose symptoms suggested they might be infected with the coronavirus.
Currans said the hospital is still seeing COVID cases, but patients are beginning to return for other services, such as outpatient clinics.
In terms of the hospital's finances, "it's still not a wonderful time," Currans said. The Medicare loan "as well as all the other support from the federal government helped us at least — for now — survive it."
She's hoping the repayment demand will be pushed back to 2021 or, perhaps the loan will be forgiven.
"I know it's a pipe dream," Currans said. "But this has been a historic event."
As drug prices spiral upward, politicians in Washington, D.C., and in state governments have sought to address the problem in limited ways, focusing mostly on one drug: insulin.
This article was published on Tuesday, September 22, 2020 in Kaiser Health News.
Michael Costanzo, a Colorado farmer diagnosed with multiple sclerosis in 2016, has a well-honed ritual: Every six months, he takes an IV infusion of a medicine, Rituxan, to manage his disease, which has no cure. Then he figures out how to manage the bill, which costs thousands of dollars.
For a time, the routine held steady: The price billed to his health insurance for one infusion would cost $6,201 to $6,841. Costanzo's health insurance covered most of it, and he paid the rest out-of-pocket.
But last fall the cost for the same 20-year-old drug and dosage jumped to $10,320, even though he was covered by the same insurance.
"Why does it have to increase in price all of a sudden?" wondered Costanzo, who lives in a small town about 50 miles north of Denver.
"I think greed is a huge problem," he said.
As drug prices spiral upward, politicians in Washington, D.C., and in state governments across the country have sought to address the problem in limited ways, focusing mostly on one drug: insulin, a drug more than 7 million Americans rely on to manage diabetes and whose price tag more than doubled from 2012 to 2017.
With comprehensive drug price legislation stalled in Washington during the COVID-19 state of emergency, seven states in the midst of the pandemic enacted insulin payment caps of less than $100 per month, bringing the total to eight; five more have proposed legislation. In March, President Donald Trump's health officials announced a Medicare test project limiting seniors' monthly out-of-pocket costs to $35. In July, he signed four executive actions targeting insulin and a handful of other medications, boasting, "It's going to have an incredible impact."
Insulin took center stage last year, after moving demonstrations by mothers who caravanned to Canada to buy lifesaving medicine for their children at a tenth of the U.S. price; they swarmed the halls of Congress.
The measures that have resulted so far have not solved a far more widespread problem: escalating drug prices across the board — a problem that voters, left and right, say Congress must fix.
Underlying the problem is that lawmakers spent much of last year at loggerheads about whether the federal government should have the power to set prices or limit price increases. Prospects of comprehensive legislation already in the works slipped away this spring as Congress turned its focus to the COVID-19 pandemic that has killed more than 150,000 Americans and tanked the country's economy.
So state lawmakers played whack-a-mole, targeting the drug with the most notoriety, and tackled insulin's cost to patients. But patients like Costanzo — among the millions who rely on other vital drugs — struggle evermore to afford unchecked price increases for everything from HIV/AIDS and depression to asthma, autoimmune disorders and Type 2 diabetes.
A 2019 survey from the Scripps Research Translational Institute published in the Journal of the American Medical Association found that the costs of 17 top-selling brand-name drugs more than doubled from 2012 to 2017. Many of the drugs that made the list are household names: Lipitor and Zetia for high cholesterol, Advair and Symbicort for asthma, Lyrica for pain and Chantix for smoking cessation.
"The general public doesn't realize this is happening with all sorts of drugs," Costanzo said. "We're all suffering from increased prices."
Insulin was a natural poster child for pharmaceutical greed, encapsulating America's problem with high drug prices in a neat package that few, if any, other medications do as effectively.
"You have an illustration of the problem — politics gone awry and capitalism gone awry," said Celinda Lake, a veteran Democratic pollster. "They think of it as being emblematic of everything that's going on with the system."
Three pharmaceutical companies dominate the market for the diabetes treatment that has essentially the same formula as when it was introduced in the 1920s. Not taking insulin can quickly turn fatal. In 2017, Minnesota resident Alec Smith died at age 26 after rationing his insulin because he couldn't afford it.
People dying "is what it takes for Congress to actually commit money and act, and then we solve these problems eventually," said Andy Slavitt, who was acting head of the U.S. Centers for Medicare & Medicaid Services in the Obama administration.
Yet proponents of lowering drug costs say an effort centered on a single drug could backfire, and it did when COVID captured center stage.
"Everywhere in this country people are angry about their drug prices," said David Mitchell, founder of Patients for Affordable Drugs Now, a Washington, D.C.-based group that lobbies Congress and runs campaign ads in support of lower prices. "The people with cancer, the people with autoimmune problems, the people with multiple sclerosis, the people who are taking a variety of drugs that are wildly overpriced, are going to say, 'Now, wait a minute, what about me?'"
In early March, University of Pittsburgh researchers published research finding that, without discounts, list prices of brand-name drugs were rising about 9% a year. Late last year, House Democrats passed a bill that would let the federal government set prices for hundreds of drugs and cap seniors' out-of-pocket costs for medication at $2,000. Trump opposed the bill, calling on Congress to send him a drug pricing bill that has bipartisan support.
"Let's be clear — these price hikes aren't because the medicines got better or there was a significant increase in research and development," said Sen. Chuck Grassley (R-Iowa) in a March 5 floor speech. The chairman of the Senate's powerful Finance Committee spearheaded a bipartisan drug pricing bill with Oregon Sen. Ron Wyden, a Democrat. "No, this was because the pharmaceutical companies could do it and get away with it."
While Congress dithers and the topic periodically becomes the subject of a presidential tweet, patients continue to fend for themselves.
Tara Terminiello has seen the total underlying cost of her son's anti-seizure medication, Topamax, skyrocket to about $1,300 a month, hundreds more than when he started taking it over a decade ago.
In Texas, Joseph Fabian, a public school teacher in San Antonio with health insurance through his job, has relied on inhalers since childhood to manage his allergy-induced asthma. In February 2019, he paid $330.98 for a three-pack of Symbicort inhalers, which he typically uses twice a day but more frequently during allergy season.
A year later and after a change in his health insurance plan, Fabian's costs tripled, to $348.95 for a single inhaler, he said in an interview. According to the Scripps' drug pricing study, the median cost of Symbicort rose from $225 in January 2012 to $308 in December 2017.
"There's no way I can keep working out $350 every month and a half," Fabian said.
Chances that Congress will pass comprehensive drug pricing legislation before the 2020 election have slipped away as lawmakers focus on additional COVID-19 relief. Moreover, the Trump administration, Congress and the public are now hoping for pandemic deliverance by the very same drug companies that have been raising prices as they develop potential virus treatments and vaccines. PhRMA, the powerful industry trade group, has seized the moment with ad campaigns emphasizing the sector's enormous value.
The stalemate provides little solace for patients like Costanzo, whose medicine, Rituxan, made by Genentech, was first approved by the Food and Drug Administration in 1997 to treat lymphoma and can be used off-label for MS. It is one of seven medications with price increases unsupported by new clinical evidence, according to a report from the Institute for Clinical and Economic Review. ICER noted that over 24 months, the net price — the price after any discounts from drug companies are factored in — "increased by almost 14%, which results in an estimated increase in drug spending of approximately $549 million."
In a statement, Genentech spokesperson Priscilla White said ICER's analysis was "significantly limited" because it didn't account for "meaningful, high-quality, and peer-reviewed evidence supporting the clinical and economic benefits of Rituxan." White said the company did not increase Rituxan's price during the period in which Costanzo's bill rose and wouldn't speculate on the change without knowing "other factors" that may have contributed.
"We take decisions related to the prices of our medicines very seriously, taking into consideration their value to patients and society, the investments required to continue discovering new treatments, and the need for broad access," she said.
Costanzo was prescribed the drug by two neurologists and hasn't had any acute relapses since he started the infusions. He eventually did get a financial reprieve, not thanks to Washington, but by enrolling in a patient discount program operated by the very drug company that sets Rituxan's price, a program he said was an "absolute lifesaver" financially.
Genentech said its patient foundation provides free medicine to more than 50,000 patients each year. Costanzo got his first free dose in July.
Ginsburg's absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.
This article was published on Monday, September 21, 2020 in Kaiser Health News.
By Julie Rovner On Feb. 27, 2018, I got an email from the Heritage Foundation, alerting me to a news conference that afternoon held by Republican attorneys general of Texas and other states. It was referred to only as a "discussion about the Affordable Care Act lawsuit."
I sent the following note to my editor: "I'm off to the Hill anyway. I could stop by this. You never know what it might morph into."
Few people took that case very seriously — barely a handful of reporters attended the news conference. But it has now "morphed into" the latest existential threat against the Affordable Care Act, scheduled for oral arguments at the Supreme Court a week after the general election in November. And with the death of Justice Ruth Bader Ginsburg on Friday, that case could well morph into the threat that brings down the law in its entirety.
Democrats are raising alarms about the future of the law without Ginsburg. House Speaker Nancy Pelosi, speaking on ABC's "This Week" Sunday morning, said that part of the strategy by President Donald Trump and Senate Republicans to quickly fill her seat was to help undermine the ACA.
"The president is rushing to make some kind of a decision because … Nov. 10 is when the arguments begin on the Affordable Care Act," she said. "He doesn't want to crush the virus. He wants to crush the Affordable Care Act."
Ginsburg's death throws an already chaotic general election campaign during a pandemic into more turmoil. But in the longer term, her absence from the bench could accelerate a trend underway to get cases to the Supreme Court toward invalidating the ACA and rolling back reproductive freedoms for women.
Let's take them one at a time.
The ACA Under Fire — Again
The GOP attorneys general argued in February 2018 that the Republican-sponsored tax cut bill Congress passed two months earlier had rendered the ACA unconstitutional by reducing to zero the ACA's penalty for not having insurance. They based their argument on Chief Justice John Roberts' 2012 conclusion that the ACA was valid, interpreting that penalty as a constitutionally appropriate tax.
Most legal scholars, including several who challenged the law before the Supreme Court in 2012 and again in 2015, find the argument that the entire law should fall to be unconvincing. "If courts invalidate an entire law merely because Congress eliminates or revises one part, as happened here, that may well inhibit necessary reform of federal legislation in the future by turning it into an 'all or nothing' proposition," wrote a group of conservative and liberal law professors in a brief filed in the case.
Still, in December 2018, U.S. District Judge Reed O'Connor in Texas accepted the GOP argument and declared the law unconstitutional. In December 2019, a three-judge 5th Circuit appeals court panel in New Orleans agreed that without the penalty the requirement to buy insurance is unconstitutional. But it sent the case back to O'Connor to suggest that perhaps the entire law need not fall.
Not wanting to wait the months or years that reconsideration would take, Democratic attorneys general defending the ACA asked the Supreme Court to hear the case this year. (Democrats are defending the law in court because the Trump administration decided to support the GOP attorneys general's case.) The court agreed to take the case but scheduled arguments for the week after the November election.
While the fate of the ACA was and is a live political issue, few legal observers were terribly worried about the legal outcome of the case now known as Texas v. California, if only because the case seemed much weaker than the 2012 and 2015 cases in which Roberts joined the court's four liberals. In the 2015 case, which challenged the validity of federal tax subsidies helping millions of Americans buy health insurance on the ACA's marketplaces, both Roberts and now-retired Justice Anthony Kennedy voted to uphold the law.
But without Ginsburg, the case could wind up in a 4-4 tie, even if Roberts supports the law's constitutionality. That could let the lower-court ruling stand, although it would not be binding on other courts outside of the 5th Circuit. The court could also put off the arguments or, if the Republican Senate replaces Ginsburg with another conservative justice before arguments are heard, Republicans could secure a 5-4 ruling against the law. Some court observers argue that Justice Brett Kavanaugh has not favored invalidating an entire statute if only part of it is flawed and might not approve overturning the ACA. Still, what started out as an effort to energize Republican voters for the 2018 midterms after Congress failed to "repeal and replace" the health law in 2017 could end up throwing the nation's entire health system into chaos.
At least 20 million Americans — and likely many more who sought coverage since the start of the coronavirus pandemic — who buy insurance through the ACA marketplaces or have Medicaid through the law's expansion could lose coverage right away. Many millions more would lose the law's popular protections guaranteeing coverage for people with preexisting health conditions, including those who have had COVID-19.
Adult children under age 26 would no longer be guaranteed the right to remain on their parents' health plans, and Medicare patients would lose enhanced prescription drug coverage. Women would lose guaranteed access to birth control at no out-of-pocket cost.
But a sudden elimination would affect more than just healthcare consumers. Insurance companies, drug companies, hospitals and doctors have all changed the way they do business because of incentives and penalties in the health law. If it's struck down, many of the "rules of the road" would literally be wiped away, including billing and payment mechanisms.
A new Democratic president could not drop the lawsuit, because the Trump administration is not the plaintiff (the GOP attorneys general are). But a Democratic Congress and president could in theory make the entire issue go away by reinstating the penalty for failure to have insurance, even at a minimal amount. However, as far as the health law goes, for now, nothing is a sure thing.
As Nicholas Bagley, a law professor at the University of Michigan who specializes in health issues, tweeted: "Among other things, the Affordable Care Act now dangles from a thread."
Reproductive Rights
A woman's right to abortion — and even to birth control — also has been hanging by a thread at the high court for more than a decade. This past term, Roberts joined the liberals to invalidate a Louisiana law that would have closed most of the state's abortion clinics, but he made it clear it was not a vote for abortion rights. The Louisiana law was too similar to a Texas law the court (without his vote) struck down in 2016, Roberts argued.
Ginsburg had been a stalwart supporter of reproductive freedom for women. In her nearly three decades on the court, she always voted with backers of abortion rights and birth control and led the dissenters in 2007 when the court upheld a federal ban on a specific abortion procedure.
Adding a justice opposed to abortion to the bench — which is what Trump has promised his supporters — would almost certainly tilt the court in favor of far more dramatic restrictions on the procedure and possibly an overturn of the landmark 1973 ruling Roe v. Wade.
But not only is abortion on the line. The court in recent years has repeatedly ruled that employerswith religious objections can refuse to provide contraception.
For Ginsburg, those issues came down to a clear question of a woman's guarantee of equal status under the law.
"Women, it is now acknowledged, have the talent, capacity, and right 'to participate equally in the economic and social life of the Nation,'" she wrote in her dissent in that 2007 abortion case. "Their ability to realize their full potential, the Court recognized, is intimately connected to 'their ability to control their reproductive lives.''
The first five months of the COVID-19 pandemic in California rank among the deadliest in state history, deadlier than any other consecutive five-month period in at least 20 years.
And the grim milestone encompasses thousands of "excess" deaths not accounted for in the state's official COVID death tally: a loss of life concentrated among Blacks, Asians and Latinos, afflicting people who experts say likely didn't get preventive medical care amid the far-reaching shutdowns or who were wrongly excluded from the coronavirus death count.
About 125,000 Californians died from March through July, up by 14,200, or 13%, from the average for the same five months during the prior three years, according to a review of datafrom the state Department of Public Health.
By the end of July, California had logged about 9,200 deaths officially attributed to COVID-19 in county death records. That left about 5,000 "excess" deaths for those months — meaning deaths above the norm not attributed to COVID-19. Deaths tend to increase from year to year as the population grows, but typically not by that much.
A closer look at California's excess deaths during the period reveal a disturbing racial and ethnic variance: All the excess deaths not officially linked to COVID infection were concentrated in minority communities. Latinos make up the vast majority, accounting for 3,350 of those excess deaths, followed by Asians (1,150), Blacks (860) and other Californians of color (350).
The overall number of excess deaths across all races and ethnicities was ultimately tempered because, compared with the three prior years, there were actually 383 fewer deaths among white Californians than would be expected in the absence of COVID-19. In addition, California Healthline adjusted the overall numbers to reflect more than 320 COVID deaths that could not be categorized by race or ethnicity because that information was missing from state records.
Several epidemiologists interviewed said they believe a sizable portion of the excess deaths among people of color did, in fact, stem from COVID infections but went undetected for a variety of reasons. Among them: a shortage of coronavirus tests in the early months of the pandemic; an uneven strategy for how and when to administer those tests, which persists; and inadequate access to healthcare providers in many low-income and immigrant communities.
Dr. Kirsten Bibbins-Domingo, chair of the Department of Epidemiology and Biostatistics at the University of California-San Francisco, is among those who suspect the excess deaths reflect a COVID undercount in minority communities. She noted that several chronic health conditions that disproportionately affect Blacks and Latinos — including diabetes, high blood pressure and heart disease — also place them at higher risk for severe complications from COVID-19.
In addition, Bibbins-Domingo said, the prolonged shutdown of medical offices in the early months of the pandemic — and with them non-urgent surgeries and routine medical care — likely accelerated death among people with those chronic conditions.
"Shutdowns always come at a cost," she said. "It is our most marginalized communities that experience the cost of a shutdown."
According to state Department of Public Health data, deaths in California attributed to diabetes rose 12% from March through July when compared with the average for the same period over the past three years. In addition, deaths attributed to Alzheimer's disease rose 11%.
"Dementia is also a disease where we have racial, ethnic minorities already at greater risk," said Andrea Polonijo, a medical sociologist at the University of California-Riverside. "Now that we have the pandemic, they're more socially isolated. Social isolation we know can cause deeper cognitive decline."
It's hard to determine whether a death is due to COVID-19 if the victim never sought medical care, said Jeffrey Reynoso, executive director of the nonprofit Latino Coalition for a Healthy California. Latinos in California are less likely to have health insurance, he said. They may face language barriers if their medical provider — or contact tracer — does not speak Spanish. Latino immigrants working in the U.S. without authorization may hesitate to visit the doctor.
"Immigration is definitely a driver in creating a fear and a mistrust of systems, and that includes our healthcare system," Reynoso said.
Polonijo said the fact that Latinos make up the bulk of the excess deaths correlates with their dominant role in farming, meat processing, manufacturing and food service, jobs all deemed essential during the pandemic.
"This population is also more likely to live in more crowded conditions," she said. "So not only are they exposed at work, but they are bringing disease home and with it the possibility of spreading it to their family, bringing it to the community."
Bibbins-Domingo noted that, while a major portion of COVID deaths overall have occurred among seniors and nursing home residents, a disproportionate number of the state's excess deaths are of working-age adults.
"The excess deaths that we're seeing in communities of color and in low-income communities are deaths that are occurring at younger ages," she said. "These are deaths that are occurring in these ages from 20 to 60, generally speaking — the ages when people would be out working."
Kathy Ko Chin, president of the Oakland-based Asian & Pacific Islander American Health Forum, said Asian Americans also tend to be overrepresented in essential worker occupations, noting that a large proportion of the state's nurses are Filipino. In addition, she said, government officials have not done enough to translate COVID educational materials into the many languages spoken by California's Asian Americans. The Trump administration's rhetoric on immigration during the past four years, she added, has had a "chilling effect" that has kept many foreign-born Asian Americans from visiting a doctor.
"People were really, really scared," Chin said.
Counties in Southern California and the largely rural Central Valley — places with a high proportion of Latino residents — tended to have high rates of excess deaths from March to July. Among counties with at least 100,000 people, Kings County, an arid expanse north of Los Angeles that is home to industrial-scale agriculture, had the highest rate of excess deaths per capita.
Officials at the Kings County Department of Public Health did not return a message seeking comment.
Bibbins-Domingo and others said it is important for state and county health officials to take a hard look at their excess death numbers. Excess deaths matter, she said, because they expose shortcomings in healthcare delivery. In addition, local and state responses to COVID-19 are grounded in data; if that data is inaccurate, the responses may be misguided.
"Deaths are important because they also help us to understand how much severe COVID is there in the community that we have to worry about," Bibbins-Domingo said. "I think when we undercount that, we both fly blind for the overall pandemic management, and we might fly particularly blind in understanding the impact of the pandemic in particular communities."
Phillip Reese is a data reporting specialist and an assistant professor of journalism at California State University-Sacramento.
Heather Steadman, a nurse at a CSL Plasma donation center near Pittsburgh, was about to enter a tiny closed-door room to administer an exam when the doctor handed her a mask in a translucent wrapper labeled KN95. The folded white mask, visible behind Chinese characters, was all her employer was providing to protect her from COVID-19.
Over a nearly 20-year career, she'd worn certified respirators in intensive care units and cared for patients dying from respiratory disease. That night in late June, she was about to lean into the face of a stranger, checking his throat and peering into his eyes, guarded only by a mask of questionable origin.
"There were just red flags all over it," she said of the mask, which corporate records show was advertised to employees as just as good as the vaunted American-made N95 respirator at stopping the spread of the coronavirus.
She stared at the doctor incredulously, then marched to a nearby storage hutch. She plunged her hand into a blue box of 50 or so masks, then two more boxes, like a kid frantically scrounging through cereal boxes for a magic ring.
From each, she pulled out a sheet of paper, hoping for evidence that the masks had been cleared as effective by the U.S. government — from the federal Food and Drug Administration, maybe, or the National Institute for Occupational Safety and Health, NIOSH, which certifies N95s that can filter out 95% of particles.
Instead, she read aloud the first line of English: "NOT for medical purpose."
Steadman, 41, had been in a standoff with her employer for months over inadequate personal protective equipment. She'd gone on leave in April, pressing CSL to provide decent masks. She'd complained, without success, to the federal Occupational Safety and Health Administration, which is supposed to ensure safe workplaces. Other CSL employees across the country had made similar complaints. Ten weeks later, though her complaints had been dismissed, she returned because the company said workers now had access to medical-grade masks.
CSL, a leader in the global plasma industry, says it was adhering to federal guidelines to protect front-line workers as it geared up a major national push — endorsed by President Donald Trump — to secure blood plasma donations from recovered COVID-19 patients. The FDA had authorized emergency use of convalescent plasma therapy as a treatment for the severely ill, despite a lack of scientific proof that it saves lives.
Steadman and other blood plasma workers feared a new level of risk as donors came in from the street and attested that they had been symptom-free for 14 days. The workers knew what the studies said: People looking to be paid in exchange for being stuck with a needle are more likely to conceal illness than those without financial incentive.
"These are not people that are going to tell me that they're sick," Steadman told me.
This, on top of the routine flow of non-COVID-19 donors coming in for $40 a draw, mostly poor people in high-risk groups, such as those working "essential" jobs where infections can spread wildly. A plasma donation involves repeated and prolonged contact with staff — in the reception area, in waiting rooms, during physical exams in closed spaces and when blood is drawn.
The company said it was following all federal guidelines, although no agency had quantified the dangers posed to workers like Steadman due to stepped-up plasma donations. Steadman had seen the many reports of counterfeit masks making their way to hospitals, endangering nurses and doctors. Rather than face what she saw as "imminent danger," Steadman told CSL she wouldn't return until she had assurances the company was providing safe masks. She also filed another OSHA complaint.
After weeks of waiting for regulators to act, she contacted ProPublica. She sent correspondence, CSL training materials, internal social media posts and samples of three masks from CSL's stockpile. She'd spent hours trying to track the masks' origins, to see if her colleagues were adequately protected, and none of the Chinese KN95s provided were at the time on the FDA's authorized list of masks that are roughly comparable to U.S.-approved N95s.
"They literally bought some off Amazon," she said, referring to records the company gave to OSHA.
Her story offers a glimpse into the confusion, anxiety and fear wrought by lax government oversight of the coronavirus mask market, where intense demand and low supply bred graft and fraud and left some front-line healthcare workers reliant on face coverings that might or might not work.
I'd spent the last six months delving into the murky world of PPE, tracking foreign vendors and middlemen, and documenting price gouging and questionable contracts. All of it unfolded against a backdrop of confusing and evolving guidance from the federal government.
When Steadman and some other CSL workers agreed to talk, I got in my car and made the windy four-hour drive to the strip mall in McKeesport, Pennsylvania, where they worked.
The parking lot of the Olympia Shopping Center could be artfully rendered in pencil and pastel and slapped on a postcard labeled "Poverty, U.S.A." There's a payday loan store, a Dollar Tree, a Rent-A-Center, a shuttered Payless ShoeSource and in the corner, the glowing red sign of CSL Plasma.
With unemployment at near-record highs, CSL had made donating plasma an attractive option and mobilized workers nationwide to recruit new donors. In McKeesport, it offered a $100 cash bonus to donors who could prove they'd once tested positive for COVID-19 and advertised that regular donors could make about $700 monthly.
As FDA Hypes, OSHA Chills
CSL has more than 260 U.S. plasma donation centers with plans to open dozens more next year. Based in Australia, the company is proud of a history that spans from its early use of plasma to beat diphtheria a century ago to helping develop the swine flu vaccine a decade ago. With $2.2 billion in profits last year, CSL gave out a record dividend to U.S. shareholders.
Its business seems poised to get even better.
An alliance of research institutions, plasma banks and drug companies promotes donations through "The Fight Is In Us" campaign, pitched online and on TV by stars such as Dwayne "The Rock" Johnson and Helen Mirren who urge COVID-19 survivors to visit plasma centers including CSL's. The Trump administration has praised the initiative andrefers donors to the alliance.
Since the pandemic's early days, the administration has been pushing plasma donations and cleared the way for a limited study to see if treatments of concentrated antibodies, derived from the serum surrounding the blood cells of COVID-19 survivors, could help others recover.
In late August, the FDA opened the door for widespread use of convalescent plasma therapy, citing a study that kinda sorta showed the potential upsides of the treatment outweighed the risks. In doing so, FDA Commissioner Stephen Hahn claimed that the treatment could have saved 35 out of 100 patients, a statement he later recanted after scientists called it a gross exaggeration. Still, Alex Azar, secretary of the U.S. Department of Health and Human Services, called the approval of convalescent plasma therapy a "milestone achievement in President Trump's efforts to save lives from COVID-19."
This pushed CSL into high gear.
Weeks earlier, CSL Limited CEO Paul Perreault had made the case for the industry-led race to get antibody-laden plasma in a roundtable appearance with Trump and other federal officials at the American Red Cross headquarters in Washington.
"We need plasma. We need plasma donors. We need them wherever they are," Perreault told Trump.
Aside from the president's support, the company had also enlisted top pharmaceutical lobbyists to press the value of plasma therapy in Washington.
But many unknowns remained. Trump's administration skipped the tedious — and, scientists say, important — step of a randomized controlled study, comparing outcomes of patients who got plasma therapy with those who didn't. And while federal agencies stressed that plasma donation centers should remain open during the pandemic to keep the nation's blood supply flowing, worker safety went largely unmentioned.
Tom Inglesby, a director at Johns Hopkins' Center for Health Security, said the risk to workers in plasma donation centers depends on the spread in each community. The bigger risk, he said, might not be the people who have recovered from COVID-19 but all the other donors who are being let in without prior screening to a place where infections can spread easily.
"If I were working in this type of facility, I would like to have an N95 mask," Inglesby said.
"You'd have to call these people healthcare professionals, for sure. They're drawing blood."
Since March, OSHA has received about a dozen COVID-19-related workplace safety complaints from CSL workers in Pennsylvania, Indiana, Michigan, Minnesota and Texas. Half were about inadequate PPE such as masks, the rest about fear the company wasn't enforcing public health guidelines.
In late May, for instance, a Houston employee reported that a staff member tested positive and "six people working near the infected person were quarantined," according to OSHA data.
"Other staff members are being sent out to work at other locations," that complaint stated, "exacerbating the spread."
Contracts, emails and spreadsheets that Juanita and Dawn Ramos shared with ProPublica detail how domestic and foreign investors, many with marijuana industry ties, seized upon the nation's public health disaster.
Anthony Farina, CSL's spokesman, said OSHA has assessed no penalties based on these complaints.
"CSL Plasma has cooperated promptly with all requests for information, and has routinely shared documentation of our safety practices in place to prevent exposure. The company also investigated the allegations and reviewed our applicable requirements to confirm compliance with appropriate OSHA COVID-19 guidance," his statement said.
All but three of those cases were closed.
Debbie Berkowitz, a former top OSHA official in the Obama administration, said Steadman's journey is part of a larger trend. "OSHA has decided not to enforce the law and has abandoned its mission," she said. "Workers are on their own."
The agency has received more than 33,000 COVID-19-related complaints, according to OSHA data. More than two-thirds of those are closed. Nearly 9,000 complaints were about PPE at work.
She was particularly concerned about a company presentation that told CSL workers that KN95s, approved under Chinese standards, were just as good as N95s, approved by U.S. scientists.
Providing questionable Chinese masks "and sort of implying to workers that this is like an N95 — that is completely deceiving and dangerous because it gives these workers a false sense of security," Berkowitz said.
Afraid at Work
The angst among CSL workers began in March, when corporate guidance stated that "a mask does not adequately protect healthy people from an infection of coronavirus." In fairness, this was around the time U.S. Surgeon General Jerome Adams sent out a tweet he'd later recant:
"Seriously people- STOP BUYING MASKS! They are NOT effective in preventing general public from catching #Coronavirus"
CSL employees, including managers, described an internal tracker on the company's network showing hundreds of employees took leave from March through September because they were either exposed to COVID-19, sick or afraid. None of those workers were able to share raw data. CSL did not directly respond.
Steadman shared emails that hint at concern sweeping through CSL as employee absences shuttered entire centers.
March 17: "Due to staff illness, the Hillsboro [Florida] 126 center will delay opening …"
March 27: "Little Rock [Arkansas] 234 is closed due to staffing issues."
March 30: "... Peoria [Arizona] closed for the day due to staffing issues."
The company shared online presentations outlining evolving pandemic guidelines. On April 10, it told workers that N95 respirators effectively filtered out airborne contaminants. But the company wasn't supplying them and mask use was voluntary.
Later correspondence indicates masks were not required because the company had no OSHA-approved respiratory program, which involves training on how to wear them and fit testing to ensure proper use.
That week, Steadman lodged her first complaint to management, took leave and complained to OSHA.
"I continued to work in good faith, despite genuinely believing that imminent danger exists," she wrote in a lengthy letter to CSL management. "However, the policy for 'recovered donors' is a risk I am not willing to take."
The drumbeat of staff absences indicated she was not alone in her fear.
April 17: "Taylor 240 [Pennsylvania] temporarily closed due to staffing issues."
On May 4, soon after the FDA gave emergency use authorization to import masks from 80 little-known Chinese manufacturers, the company announced it wasn't distributing those gold-standard N95s. It was instead providing Chinese KN95s. And 10 days later, a presentation told employees there was "very little difference in certification requirements between a N95 and KN95."
But company records show the three brands of KN95s CSL purchased and distributed were not on the FDA's list of Chinese masks that are roughly comparable to N95s and suitable for healthcare workers. And all three used earloops, which can be less snug than those that wrap around the head.
The move to distribute Chinese KN95s didn't halt the ongoing staff issues.
June 21: "... Homestead [Pennsylvania] unable to open due to staffing."
Meanwhile, CSL continued to aggressively recruit donors who had recovered from COVID-19, with workers posting flyers and hanging signs across the country, according to internal social media posts, some of which show workers improperly wearing KN95s.
Weeks passed, so Steadman called OSHA. She was told to file a new complaint. Too much time had passed. So she did.
In early July, OSHA told the company that regulators wouldn't investigate Steadman's updated complaint, deferring to CSL to look into it.
CSL reported to OSHA that its investigation had found no problem. A July 15 follow-up from corporate headquarters in Boca Raton, Florida, gave details about CSL's masks, including pictures and a snapshot of thousands apparently purchased through Amazon. According to CSL, the masks were sourced by the Utah-based medical equipment company HemaSource. Executives at HemaSource did not respond to messages from ProPublica.
"CSL Plasma has advised me that the hazards you complained about have been investigated. The employer states that the hazards have been corrected," Area Director Christopher Robinson wrote. "With this information, OSHA feels the case can be closed."
Steadman believed the mask details provided to OSHA demanded further inquiry.
"Who's going to make sure people have safe masks if not OSHA?" she said.
She rebutted her employer's response in a document that reads like a prosecutor's exhibit.
"Every certificate provided in this document is easily identifiable as plagiarized, and fits each criterion from the [Centers for Disease Control and Prevention] and NIOSH on identifying counterfeit masks and falsified documents," she wrote on July 19.
Here's where Steadman descended into the maddening vortex that's subsumed my reporting these last six months. After the FDA opened the gates for masks from China, later reversing course as junk masks ended up in healthcare settings, it became pretty dang hard to tell what was what. This is especially true of brands of masks the CDC or a private lab hasn't tested and published findings about, which is the case here.
Steadman went down a Google hole, cross-referencing images, technical data, model numbers and more. All of CSL's KN95s were labeled as not for medical use.
One type of mask connected back to a Chinese diaper company.
Another shipment, apparently from Amazon, came in packages of four (sterile masks typically come individually wrapped). Plus, the "CE" markings claiming they'd passed muster with European regulators were skewed and placed in different spots mask to mask, as if applied by hand with an ink stamp rather than precise machinery.
The third type, the KN95 Steadman was handed that stressful June night, links to a company registered with the FDA as ZK-Best, which sells masks approved by Chinese regulators for working around dust or filtering polluted air. The Chinese manufacturer did not respond to email requests for comment.
But CSL included a technical data sheet for these masks in its submission to OSHA that raises questions. The document purports to show that SGS, a global firm that deploys inspectors to factories to test goods for far-flung buyers, had found the ZK-Best respirator highly effective.
The document looked odd. The date format was month, day, year: "July 1st, 2015." That's an American convention I hadn't seen on other SGS documents. The inspection also appeared to be for a completely different mask model, a so-called PM2.5 mask designed for industrial use.
I reached out to experts who had imported and sold legitimate masks. I also reached out to SGS.
Richie Hecker, director of the medical supply company Traction and Scale, sold PPE to New York City and others. With his help, ProPublica asked a researcher in China to investigate. When the results came back, Hecker said he wouldn't buy these masks because SGS said the report provided to OSHA was fake, a "cut and paste job."
"This is not an original SGS document," SGS also wrote to me. "This document is thus of no value whatsoever and we advise you not to rely on it for any purpose."
Hecker said phony documents are common fare in the PPE market and "the KNs are the dirtiest item on the market." That's why reliable chain-of-custody documents connecting the mask in Steadman's hand to a specific factory are crucial.
When I asked CSL about the fake SGS document, a spokesperson said that the company would investigate and that it takes its responsibility to provide accurate information to federal regulators with "utmost seriousness."
On Sept. 2, just two days after I first asked CSL about the ZK-Best masks, its ZKG 9501 KN95 mask appeared on the FDA's list as allowed under the emergency use authorization. This wasn't the case earlier in my research or during the months Steadman refreshed and refreshed the same website and sent questions to several government agencies.
An FDA official told me that brand of mask was authorized based on testing and approvals from the FDA's European Union counterpart, though the masks CSL distributed and their packaging lack the CE mark. NIOSH has seen multiple instances of counterfeit masks sold using the branding of manufacturers on the list. U.S. regulators have not tested the ZK-Best masks themselves, but anyone worried about masks at their workplace is encouraged to send them to NIOSH for testing, officials said.
A few days later, on Sept. 13, CSL provided new documents it said proved the masks were legitimate, including a new testing document and a letter apparently from a ZK-Best manager named "Chensu," who said the masks had been approved by SGS after all. There was a mixup with the mask models, the letter said, but the masks were good.
I tried to authenticate those documents with the factory but didn't hear back.
I asked a CSL spokesperson for proof the documents came from the factory, perhaps an email thread showing a chain of custody. The company declined but said, "We assure you that we did not alter any of the documentation."
I shared all of this with Steadman, who remains skeptical.
"That Put Me at Risk"
Workers in McKeesport remain on edge because of the masks but also CSL policies they say are conflicting and dangerous.
CSL says workers are safe because the centers don't treat patients who are currently sick with COVID-19.
Donors receive a blood pressure, temperature and pulse check, said Farina, the company spokesman, and COVID-19 survivors "must provide a doctor's note confirming their diagnosis and confirmation that they have recovered from COVID-19."
Yet late last month, two workers were potentially exposed to a donor who later tested positive, according to internal emails and interviews with CSL employees. That donor wasn't properly wearing her mask, employees told me.
Samantha Kelly, 30, was told she had contact with this person. She worked the reception desk and spent several minutes pricking the fingers and taking the blood pressure of walk-in donors. She said the company refused to tell her when that contact occurred, making it impossible to retrace her steps and warn those close to her.
Kelly is the primary caregiver for her mother, who has diabetes and a chronic inflammatory lung disease.
"That put me at risk," she told me. "That put my family at risk, everyone we had come in contact with."
She's technically still a CSL employee, on unpaid leave since Aug. 20, but she said she's not going back.
A CSL spokesperson said the company follows CDC and local guidelines on contact tracing but said patient privacy laws limit what they can tell employees.
Company records show CSL stopped doing temperature readings at the door in June.
CSL employees say the checks detailed by CSL's spokesman happen long after patients enter the centers, sometimes after they've signed in, talked with staff and sat in a waiting room before screening.
Ultimately, CSL staff don't have much but donors' word that they're not sick, employees say and records show.
This month, a woman who said she'd recovered from COVID-19 came into the McKeesport office to sell her plasma, according to CSL staff. Well after she arrived, a staffer found she was running a fever. She was sent home. Employees are still rattled.
CSL employees told me their need for good PPE was heightened by a recent policy change. Employees were told they cannot ask donors who refuse to wear masks to leave, according to corporate instructions sent out in late June.
Responding to Steadman's persistence, OSHA reopened its investigation. That inquiry is ongoing, and the agency won't say more until it's complete, a spokeswoman said in an email.
On Sept. 1, the company launched a COVID-19 antibody testing program in about 30 cities to help identify more potential donors who have recovered from the disease. That same day, the National Institutes of Health said there's no evidence to support convalescent plasma therapy as a standard treatment for COVID-19.
In the end, I found only some answers for Steadman, who remains on leave from CSL. She said she and her co-workers could have avoided heartache if the company had simply addressed her questions and found FDA-authorized masks back in May.
"Why would the company let me flail over here and let me freak out and contact several different agencies if everything is just fine?" she said. "Nothing that you've just told me convinces me that anybody is sure those masks would protect me from COVID — at all."
On a recent warm afternoon, as we talked in front of her parent's long log cabin home, Steadman was wearing scrubs even though she hadn't been to work in weeks. I asked why.
Sen. Cory Gardner (R-Colo) said in a tweet on September 15 he authored legislation "to guarantee coverage to people with pre-existing conditions — no matter what happens to Obamacare."
This article was published on Friday, September 18, 2020 in Kaiser Health News.
Sen. Cory Gardner, a Republican running in a tight race for reelection in Colorado, says he wants to protect people with medical conditions.
In a mid-September tweet released by his campaign, he promoted legislation he introduced in August that he says will do just that.
“People like my mother who battle chronic diseases are heroes,” read the tweet. “I authored the bill to guarantee coverage to people with pre-existing conditions — no matter what happens to Obamacare — because some things matter more than politics.”
Gardner has voted repeatedly to repeal the Affordable Care Act, the first federal law to guarantee people with health problems that they could buy insurance when shopping for their own coverage — at the same cost as for healthier consumers.
Polls show broad public support for keeping the ACA’s preexisting condition protections, while also indicating a consistent, if narrow, majority favoring the overall law.
The popularity of those protections has led Gardner, as well as other GOP candidates facing tough challengers, to swear their allegiance to protecting people with medical conditions, despite their records. In previous fact checks, we found Sen. Martha McSally’s promise always to protect preexisting conditions to be False. President Donald Trump also has made related statements, which have ranged from False to Pants on Fire.
That got us thinking: Would Gardner’s legislation, dubbed “The Pre-Existing Conditions Protection Act,” actually guarantee these protections if the ACA didn’t exist? We decided to investigate.
The bill, which was introduced in August, and has no co-sponsors. It’s very short, only 117 words in total.
The main section is a single very long sentence: “A group health plan and a health insurance issuer offering group or individual health insurance coverage may not impose any pre-existing condition exclusion with respect to such plan or coverage, factor health status into premiums or charges, exclude benefits relating to pre-existing conditions from coverage, or otherwise exclude benefits, set limits, or increase charges based on any pre-existing condition or health status.”
We reached out to the Gardner campaign to ask for more information.
A campaign spokesperson reiterated in an email that Gardner’s goal is “to guarantee coverage for individuals with preexisting conditions and ensure they cannot be charged more as a result of their underlying medical conditions.”
Thomas Miller, a resident fellow at the American Enterprise Institute, a think tank in Washington, D.C., quipped that the main goal might be something else entirely.
“It’s probably about 100 words too long,” Miller said. “It could have said, ‘I’m running for election. I’ll do whatever is necessary.’”
Past Votes, Present Messages
Proponents of the ACA emphasized that the law would help people with medical conditions as they worked to get it passed by Congress, which happened in 2010 following a yearlong failed effort by Democrats to win Republican support. Among a host of other provisions, the law bars insurers from rejecting applicants with medical conditions, as they routinely did when considering individual applicants before the law passed. Nor can insurers charge the sick more than the healthy.
Since the law went into effect in 2014, it has faced many efforts by Republicans in Congress, including Gardner, to repeal it.
It has also faced three Supreme Court challenges. It survived the first two, although one ruling allowed states to opt out of its expansion of Medicaid programs for the poor. The still-pending case was first brought in 2018 by 20 states and is supported by the Trump administration. That case could overturn the entire law, although the court won’t hear arguments on the issue before the election. And that brings us back to Gardner’s bill. An obvious difference between that proposal and the ACA is length. Gardner’s bill is one page, while the ACA runs to several hundred.
And Gardner’s claim seems pegged to the legislative language that says insurers can’t impose a “pre-existing condition exclusion,” which sounds fairly straightforward.
But it’s not, experts say.
“It’s an adorable little bill but does not address any of the main issues,” said Linda Blumberg, a fellow at the nonprofit Urban Institute’s Health Policy Center. “You need a package of policies working together in order to create real protections for people to have coverage to meet their health care needs.”
For instance, the bill does not explicitly bar insurers from outright rejecting applicants with medical conditions, something known as “guaranteed issue.”
“‘Guaranteed issue’ is not in the language of the bill,” said Miller at AEI.
Instead, the language may simply prohibit insurers from restricting services related to a medical condition only if they choose to sell an individual insurance in the first place, he said.
Compare that with the ACA, which says every insurer selling individual or group coverage “must accept every employer and individual in the State that applies.”
Also needed in legislation aiming to protect people with medical problems, said Blumberg, are provisions for subsidies to help people of low and moderate income afford their premiums. The ACA has those, along with specific enrollment periods, so that people don’t wait until they are sick to sign up. Without them, mainly those with medical conditions might sign up, driving up costs and premiums. That, in turn, can price people, especially the sick, out of future coverage.
Another way Gardner’s bill differs from the ACA is that it does not list benefits that must be included in a health insurance policy. The ACA requires insurers to cover 10 broad categories of care, including hospitalization, prescription drugs, childbirth, substance abuse treatment and mental health care.
“Without that, insurers could sell products that don’t cover very much, which is what we had prior to 2014,” Blumberg added, which is one way to discourage those who are sick from even applying. “It was difficult to find a product that covered prescription drugs, and we even saw policies that didn’t cover chemotherapy.”
So, What About Costs?
Gardner’s legislation says insurers can’t “factor health status into premiums or charges.”
So insurers could not charge people more simply because they have diabetes, say, or cancer. Still, that leaves open a whole lot of other things that insurers could consider when setting premiums for individuals, such as such as gender or occupation, which could stand in as a proxy for health. Unlike the ACA, it does not bar insurers from setting annual or lifetime dollar limits on coverage, which could disproportionately affect people with costly medical conditions.
The ACA allows insurers to vary premiums for only three reasons: where people live, their age and whether they use tobacco. It sets upper limits, such as charging older folks no more than three times what younger enrollees pay.
Douglas Holtz-Eakin, president of the American Action Forum, who wrote a blog post cited by the Gardner campaign, said the proposed legislation is a starting point — a place holder, if you will. His piece mentioned it near the end of a broader look at the Trump administration’s health platform going into the election.
Responding to questions about Gardner’s legislation, Holtz-Eakin said that if the ACA were to be struck down, Gardner would likely add provisions to it.
“I don’t think it’s intended to be a replacement bill but a provision to make sure people can get coverage,” said Holtz-Eakin. “It’s quite clear on the aim to ensure that people with pre-existing conditions can get insurance, but it doesn’t address every single policy issue that’s out there.”
Health law professor Mark Hall at Wake Forest University said Gardner’s legislation could survive if the ACA were struck down by the Supreme Court, but he noted that Congress would be unlikely to adopt the Gardner bill as written.
“A freestanding protection of pre-existing conditions without any supporting provisions to keep insurance affordable or encourage people to purchase it before they become sick, is almost certain to cause serious harms to the market,” Hall wrote in an email. “Therefore, a lot more is needed to overcome legitimate objections that almost certainly will be made from both sides of the political aisle.”
Our Ruling
Because protecting people with medical conditions requires many moving parts, the brevity of Gardner’s proposal makes it appear to be a fig leaf for a political problem rather than a means to guarantee protections for people with preexisting conditions.
The legislation is unclear on whether it guarantees that people with health problems will be able to buy insurance in the first place. And, even if they can, they may well find it priced out of reach because the legislation does not bar insurers from varying premiums widely on the basis of age, gender or occupation.
Viewed in its most favorable light, Gardner’s 117-word proposal would only serve as a place holder for larger legislation, upon which more protections would have to be layered to bolster the effectiveness of its guarantee.
More than 70,000 residents and staff members in nursing homes and assisted living facilities had died of COVID-19 by mid-August, according to the latest count from Kaiser Family Foundation.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
Older adults are asking this question anew in light of the ongoing toll of the coronavirus pandemic — disrupted lives, social isolation, mounting deaths. Many are changing their minds.
Some people who planned to move to senior housing are now choosing to live independently rather than communally. Others wonder whether transferring to a setting where they can get more assistance might be the right call.
These decisions, hard enough during ordinary times, are now fraught with uncertainty as the economy falters and COVID-19 deaths climb, including tens of thousands in nursing homes and assisted living centers.
Teresa Ignacio Gonzalvo and her husband, Jaime, both 68, chose to build a house rather than move into a continuing care retirement community when they relocate from Virginia Beach, Virginia, to Indianapolis later this year to be closer to their daughters.
Having heard about lockdowns around the country because of the coronavirus, Gonzalvo said, “We’ve realized we’re not ready to lose our independence.”
Alissa Ballot, 64, is planning to leave her 750-square-foot apartment in downtown Chicago and put down roots in a multigenerational cohousing community where neighbors typically share dining and recreation areas and often help one another.
“What I’ve learned during this pandemic is that personal relationships matter most to me, not place,” she said.
Kim Beckman, 64, and her husband, Mike, were ready to give up being homeowners in Victoria, Texas, and join a 55-plus community or rent in an independent living apartment building in northern Texas before COVID-19 hit.
Now, they’re considering buying an even bigger home because “if you’re going to be in the house all the time, you might as well be comfortable,” Beckman said.
“Everyone I know is talking about this,” said Wendl Kornfeld, 71, who lives on the Upper West Side of Manhattan. She has temporarily tabled the prospect of moving into a continuing care retirement community being built in the Bronx.
“My husband and I are going to play it by ear; we want to see how things play out” with the pandemic, she said.
In Kornfeld’s circles, people are more committed than ever to staying in their homes or apartments as long as possible — at least at the moment. Their fear: If they move to a senior living community, they might be more likely to encounter a COVID outbreak.
“All of us have heard about the huge number of deaths in senior facilities,” Kornfeld said. But people who stay in their own homes may have trouble finding affordable help there when needed, she acknowledged.
More than 70,000 residents and staff members in nursing homes and assisted living facilities had died of COVID-19 by mid-August, according to the latest count from KFF (Kaiser Family Foundation). This is an undercount because less than half of states are reporting data for COVID-19 in assisted living. Nor is data reported for people living independently in senior housing. (KHN is an editorially independent program of KFF.)
Nervousness about senior living has spread as a result, and in July, the National Investment Center for Seniors Housing & Care reported the lowest occupancy rates since the research organization started tracking data 14 years ago. Occupancy dropped more in assisted living (a 3.2% decline from April through June, compared with January through March) than in independent living (a 2.4% decline). The organization doesn’t compile data on nursing homes.
The potential for social isolation is especially worrisome, as facilities retain restrictions on family visits and on group dining and activities. (While states have started to allow visits outside at nursing homes and assisted living centers, most facilities don’t yet allow visits inside — a situation that will increase frustration when the weather turns cold.)
Beth Burnham Mace, NIC’s chief economist and director of outreach, emphasized that operators have responded aggressively by instituting new safety and sanitation protocols, moving programming online, helping residents procure groceries and other essential supplies, and communicating regularly about COVID-19, both on-site and in the community at large, much more regularly.
Mary Kazlusky, 76, resides in independent living at Heron’s Key, a continuing care retirement community in Gig Harbor, Washington, which is doing all this and more with a sister facility, Emerald Heights in Redmond, Washington.
“We all feel safe here,” she said. “Even though we’re strongly advised not to go into each other’s apartments, at least we can see each other in the hall and down in the lobby and down on the decks outside. As far as isolation, you’re isolating here with over 200 people: There’s somebody always around.”
One staff member at Heron’s Key tested positive for COVID-19 in August but has recovered. Twenty residents and staff members tested positive at Emerald Heights. Two residents and one staff member died.
Colin Milner, chief executive officer of the International Council on Active Aging, stresses that some communities are doing a better job than others. His organization recently published a report on the future of senior living in light of the pandemic.
It calls on operators to institute a host of changes, including establishing safe visiting areas for families both inside and outside; providing high-speed internet services throughout communities; and ensuring adequate supplies of masks and other forms of personal protective equipment for residents and staff, among other recommendations.
Some families now wish they’d arranged for older relatives to receive care in a more structured environment before the pandemic started. They’re finding that older relatives living independently, especially those who are frail or have mild cognitive impairments, are having difficulty managing on their own.
“I’m hearing from a lot of people — mostly older daughters — that we waited too long to move Mom or Dad, we had our head in the sand, can you help us find a place for them,” said Allie Mazza, who owns Brandywine Concierge Senior Services in Kennett Square, Pennsylvania.
While many operators instituted move-in moratoriums early in the pandemic, most now allow new residents as long as they test negative for COVID-19. Quarantines of up to two weeks are also required before people can circulate in the community.
Many older adults, however, simply don’t have the financial means to make a move. More than half of middle-income seniors — nearly 8 million older adults — can’t afford independent living or assisted living communities, according to a study published last year. And more than 7 million seniors are poor, according to the federal Supplemental Poverty Measure, which includes out-of-pocket medical expenses and other drains on cash reserves.
Questions to Ask
For those able to consider senior housing, experts suggest you ask several questions:
How is the facility communicating with residents and families? Has it had a COVID outbreak? Is it disclosing COVID cases and deaths? Is it sharing the latest guidance from federal, state and local public health authorities?
What protocols have been instituted to ensure safety? “I’d want to know: Do they have a plan in place for disasters — not just the pandemic but also floods, fires, hurricanes, blizzards?” Milner said. “And beyond a plan, do they have supplies in place?”
How does the community engage residents? Is online programming — exercise classes, lectures, interest group meetings — available? Are one-on-one interactions with staffers possible? Are staffers arranging online interactions via FaceTime or Zoom with family? Are family visits allowed? “Social engagement and stimulation are more important than ever,” said David Schless, president of the American Seniors Housing Association.
What’s the company’s financial status and occupancy rate? “Properties with occupancy rates of 90% or higher are going to be able to withstand the pressures of COVID-19 significantly more than properties with occupancy below 80%, in my opinion,” said Mace of the National Investment Center for Seniors Housing & Care. Higher occupancy means more revenues, which allows institutions to better afford extra expenses associated with the pandemic.
The increase in home dialysis has accelerated recently, spurred by social-distancing requirements, increased use of telehealth and remote monitoring technologies — and fear of the virus.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
NIPOMO, Calif. — After Maria Duenas was diagnosed with Type 2 diabetes about a decade ago, she managed the disease with diet and medication.
But Duenas’ kidneys started to fail just as the novel coronavirus established its lethal foothold in the U.S.
On March 19, three days after Duenas, 60, was rushed to the emergency room with dangerously high blood pressure and blood sugar, Gov. Gavin Newsom implemented the nation’s first statewide stay-at-home order.
Less than one week later, Duenas was hooked up to a dialysis machine in the Century City neighborhood of Los Angeles, 160 miles from her Central Coast home, where tubes, pumps and tiny filters cleansed her blood of waste for 3½ hours, doing the work her kidneys could no longer do.
In the beginning, Duenas said she didn’t understand the severity of COVID-19, or her increased vulnerability to it. “It’s not going to happen to me,” she thought. “We’re in a small little town.”
But she was unable to find a spot in a dialysis clinic in, or near, Nipomo. So, with her husband, Jose, at her side, Duenas made long road trips to Century City for more than two months.
In May, Duenas’ doctor told her she was a good candidate for home dialysis, which would save her drive time and stress — and reduce her exposure to the virus.
Now, Duenas assiduously sterilizes herself and her surroundings five nights a week so she can administer dialysis to herself at home while she sleeps.
“There’s always a chance going in that somebody’s going to have COVID and still need dialysis” in a clinic, Duenas said. “I’m very grateful to have this option.”
The increase in home dialysis has accelerated recently, spurred by social-distancing requirements, increased use of telehealth and remote monitoring technologies — and fear of the virus.
While recent, comprehensive data is hard to come by, experts confirm the trend based on what they’re seeing in their own practices. Fresenius Medical Care North America, one of the country’s two dominant dialysis providers, said it conducted 25% more home dialysis training sessions in the first quarter of 2020 than in the same period last year, according to Renal & Urology News.
“People recognized it would be better if they did it at home,” said Dr. Susan Quaggin, president-elect of the American Society of Nephrology. “And certainly from a health provider’s perspective, we feel it’s a great option.”
Nearly half a million people in the United States are on dialysis, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Roughly 85% of them travel to a clinic for their treatments.
Dialysis patients are at higher risk of contracting COVID-19 and getting seriously ill with it, said Dr. Anjay Rastogi, director of the UCLA CORE Kidney Program, where Duenas is a patient.
In an analysis of more than 10,000 deaths in 15 states and New York City, the Centers for Disease Control and Prevention found about 40% of people killed by COVID-19 had diabetes. That percentage rose to half among people under 65.
But people on dialysis are also vulnerable to COVID-19 because they usually visit dialysis clinics two to three times a week for an average of four hours at a time, exposing themselves to other patients and, potentially, the virus, Rastogi said.
“Now even more so, we are strongly urging our patients to consider home dialysis,” he said.
There are two kinds of dialysis: hemodialysis and peritoneal dialysis. In hemodialysis, which is administered in a hospital or clinic, or sometimes at home, a dialysis machine pumps blood out of the body and through a special filter called a dialyzer, which clears waste and extra fluid from the blood before it is returned to the body.
Dialysis treatment centers that offer hemodialysis have intensified their infection-control procedures in response to COVID-19, said Dr. Kevin Stiles, a nephrologist at Kaiser Permanente in Bakersfield. Visitors are no longer allowed to accompany patients, and patients get temperature checks and must wear masks during treatment, he said. (KHN, which produces California Healthline, is not affiliated with Kaiser Permanente.)
In peritoneal dialysis, which is the more popular home option because it is less cumbersome and restrictive, the inside lining of the stomach acts as a natural filter. Dialysis solution cleanses waste from the body as it is washed into and out of the stomach through a catheter in the abdomen.
Not everyone is eligible for home dialysis, which comes with its own challenges.
Home dialysis requires patients or their caregivers to lift bags of dialysis solution that weigh 5 to 10 pounds, Stiles said. Good eyesight and hand dexterity are also critical because patients must be able to maintain sterile environments.
Home patients need dialysis equipment and regular deliveries of supplies such as dialysis fluid, drain bags, tubing, disinfectant and personal protective equipment. In response to COVID-19, some clinics have arranged courier services and contracted with labs to deliver supplies to patients.
Medicare covers almost all patients who receive dialysis treatment, including home dialysis, and patients typically pay 20% as coinsurance.
Medicare, which spends an average of $90,000 per hemodialysis patient annually, spent more than $35 billion on patients with end-stage renal disease in 2016.
Duenas is awaiting a kidney transplant. Until she finds a match, she’ll be administering her own peritoneal dialysis at home.
“To be honest, I didn’t want to do it,” she said of home dialysis. “It was scary having to think about taking care of my own treatment.”
Now, three months later, guided by training and the prompts on the dialysis machine, Duenas feels comfortable, capable and safe.
Looking back, she said, “it was a blessing in disguise.”