Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public.

This article was published on Thursday, September 24, 2020 in Kaiser Health News.

By Rachana Pradhan

Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham.

Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country.

Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson and others. The data and safety monitoring board — known as a DSMB — is supposed to make sure the medicine is safe and it works. It has the power to halt a clinical trial or fast-track it.

Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public, according to multiple clinical trial experts who have served on such panels. That could be especially important in the pressure-cooker environment of COVID vaccine research, fueled by President Donald Trump's promises to deliver a vaccine before Election Day.

As pharmaceutical companies work to produce one as quickly as possible, the board's anonymity has stirred concerns that the cloak of secrecy could, paradoxically, allow undue influence. Whitley, for example, represents the specialized world these experts inhabit — a professor revered in academia who also is paid by the drug industry.

Any political pressure to rush pharmaceutical companies or lean on federal regulators to prematurely greenlight a vaccine would undermine a system put in place to ensure public safety. Calls are growing for companies and the government to be more open about who's involved in reviewing the vaccine trials and whether board members have any conflicts of interest.

"We want to know they're truly independent," said Dr. Eric Topol, director of the Scripps Research Translational Institute and a specialist in clinical trials. "The lack of transparency is exasperating."

Data and safety monitoring boards have existed for decades to vet new drugs and vaccines, acting as a backstop to help ensure unsafe products don't make their way to the public. Typically, there's one board for each product. This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration's Operation Warp Speed or other coronavirus vaccine work. It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters.

"Until they are convinced that there's something there that looks promising, nothing is unblinded and sent to the FDA," Collins said. "I doubt if there have been very many vaccine trials ever that have been subjected to this size and the rigor with which it's being evaluated."

The NIH safety board oversees trials in the U.S. from Moderna, Johnson & Johnson and AstraZeneca, U.S. officials and others involved in Operation Warp Speed said, but not Pfizer, which is fully funding its clinical trial work and established its own five-member safety panel. Pfizer has attested that it can conclusively determine by late October the effectiveness of its vaccine, being jointly developed with German company BioNTech. It secured a $1.95 billion purchase agreement with the Department of Health and Human Services for the first 100 million doses produced. The agreement gives HHS the option to buy an additional 500 million doses.

Moderna, Johnson & Johnson and AstraZeneca, which have either started or are aiming to soon begin large-scale trials in the U.S. involving thousands of patients, collectively have received more than $2 billion in government funds for vaccine development; billions more have been meted out under agreements similar to the HHS contract with Pfizer to buy millions of vaccine doses. Having one safety board oversee multiple trials could allow researchers to better understand the field of products and apply consistency across evaluations, clinical trial experts said in interviews.

One big advantage "could be more standardization," said Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former senior official at the Centers for Disease Control and Prevention. "They can look at that data and look at all the trials instead of just doing one trial."

But it also means that one board has an outsize influence to dictate which coronavirus vaccines eventually succeed or come to a halt, all while most of their identities remain secret. The NIH declined to name them, saying they were "confidential" and could be identified only once a study was complete.

One exception to the mystery is Whitley, who was appointed as chair by Dr. Anthony Fauci, the nation's top infectious disease official. Fauci said that following a "combination of input from us and from him and other colleagues, the people who had the greatest expertise in a variety of areas, including statistics, clinical trials, vaccinology, immunology, clinical work," were selected for the panel.

Whitley's role became public when his university announced it, an unusual move. He is a professor as well as a board member of Gilead Sciences, which recently signed a contract with Pfizer to manufacture remdesivir to treat COVID-19 patients. Whitley, who's been on Gilead's board since 2008, conducted research that led to remdesivir's development.

In 2019, he was paid roughly $430,000 as a Gilead board member, according to documents filed with the Securities and Exchange Commission. That same year, he received more than $7,700 in payments from GlaxoSmithKline for consulting, food and travel, according to a federal database that tracks drug and device company payments to physicians.

GlaxoSmithKline and Sanofi are jointly developing a vaccine that's received $2 billion from the U.S. government under Operation Warp Speed; however, Whitley, through a university spokesperson, said his DSMB has not seen any GlaxoSmithKline COVID protocols. The companies have yet to begin phase 3 trials. Although he chairs a separate GSK data and safety monitoring board for a pediatric vaccine, he was vetted and cleared by the NIH conflict-of-interest committee with its knowledge of his involvement, the spokesperson said.

"When handled responsibly, it is appropriate for physicians to collaborate with external entities," said UAB spokesperson Beena Thannickal, saying the university works with physicians to ensure that industry engagement is appropriate. "It facilitates a critical exchange of knowledge and accelerates and advances clinical treatments and cures, and it fuels discovery."

Multiple experts praised his skill — Dr. Walter Straus, an associate vice president at the drug company Merck & Co., said Whitley is an "éminence grise" in pediatrics whom people trust.

"I actually trust that process, and the fact that they asked Rich to do it makes me feel reassured because he's so good," said Dr. Jeanne Marrazzo, director of the University of Alabama-Birmingham's division of infectious diseases.

Multiple scientists who have participated in data and safety monitoring boards maintain it's important to keep the board anonymous to shield them against pressure or even for their safety. For example, when trials were conducted in San Francisco for HIV/AIDS research, the board was confidential to protect members from patients desperate for treatment, said Susan Ellenberg, a professor of biostatistics, medical ethics and health policy at the University of Pennsylvania who's written extensively on the history of DSMBs.

If approached by a patient, it "would be very hard to tell you, 'Oh I can't help you.' It's an unreasonable burden," said Ellenberg, who said she was involved in coronavirus-related safety boards but would not name them.

As part of a large-scale clinical trial, the DSMB and a statistician or team that prepares data for those individuals are generally the only ones who see unblinded data about the trial, making it clear who is getting what treatment. A firewall is set up between them and executives from the sponsoring company with financial interests in the trial. The companies sponsoring COVID vaccine trials are not part of any closed sessions during which unblinded data is reviewed. Those are limited to members of the DSMB, the NIAID executive secretary and the independent unblinded statistician who is presenting the data, a NIAID spokesperson said.

DSMB members or their family members should have no professional, proprietary or financial relationship with the sponsoring companies, and the NIAID DSMB executive secretary vetted all members for potential conflicts of interest, NIAID said in response to questions from KHN. Members are paid $200 per meeting.

"It's generally done out of a sense of public service," said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center, who is working with NIH officials to oversee the U.S. coronavirus vaccine clinical trials. "You're doing it because of your sense of altruism and obligation to knowing the important role it plays in clinical research and the important role it plays in preserving the scientific integrity of important trials."

Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS' Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.

Moderna and Johnson & Johnson are each aiming for their vaccines to have 60% efficacy, which means there would need to be 60% fewer COVID cases among vaccinated individuals in their trials. AstraZeneca's target is 50%. The FDA has said any coronavirus vaccine must be at least 50% effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.

Pfizer is similarly aiming for its vaccine to be 60% effective. The company allows for four interim reviews of the data starting at 32 cases — a schedule that has been criticized by some researchers who contend it makes it easier for the company to stop the trial prematurely.

Pfizer declined to name the individuals on its monitoring committee, saying only that the group consisted of four people "with extensive experience in pediatric and adult infectious diseases and vaccine safety" and one statistician with a background in vaccine clinical trials. An unblinded team supporting its data-monitoring committee — which includes a medical monitor and statistician — will review severe cases of COVID-19 as they are received and any adverse events associated with the trial at least weekly.

"There is an irresolvable tension between speed and safety," said Dr. Gregory Poland, the head of Mayo Clinic's Vaccine Research Group. "Efficacy is pretty easy to figure out. It's safety that's the issue."

California Healthline editor Arthur Allen contributed to this report.

Rachana Pradhan: rpradhan@kff.org, @rachanadixit

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.

By Robert Lewis and Christina Jewett

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 showed active 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 "enhanced droplet precautions" are working. Places where workers are correctly using regular medical masks and face shields are finding no 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 Missouri to Michigan to California have 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."

Christina Jewett: ChristinaJ@kff.org, @by_cjewett

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.

By Sarah Jane Tribble

Note to Readers: Sarah Jane Tribble spent more than a year and half reporting 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."

Sarah Jane Tribble: sjtribble@kff.org, @SJTribble

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 employers with religious objections can refuse to provide contraception.

And waiting in the lower-court pipeline are cases involving federal funding of Planned Parenthood in both the Medicaid and federal family planning programs, and the ability of individual health workers to decline to participate in abortion and other procedures.

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.''

Julie Rovner: jrovner@kff.org, @jrovner