"Of course I will always protect those with preexisting conditions. Always." — U.S. Sen. Martha McSally, in a campaign ad released June 22.

This article was first published on Monday, June 29, 2020 in Kaiser Health News.

By Shefali Luthra

Trailing Democratic challenger Mark Kelly in one of the country’s most hotly contested Senate races, Arizona Sen. Martha McSally is seeking to tie herself to an issue with across-the-aisle appeal: insurance protections for people with preexisting health conditions.

“Of course I will always protect those with preexisting conditions. Always,” the Republican said in a TV ad released June 22.

The ad comes in response to criticisms by Kelly, who has highlighted McSally’s votes to undo the Affordable Care Act. That, he argued, would leave Americans with medical conditions vulnerable to higher-priced insurance.

The Arizona Senate race has attracted national attention and is considered a toss-up, though Kelly is leading in many polls. McSally’s attempt to present herself as a supporter of protecting people with preexisting conditions — a major component of the 2010 health law — is part of a larger pattern in which vulnerable Republican incumbents stake out positions advocating for this protection while also maintaining the GOP’s strong stance against the ACA.

McSally, who was appointed by the governor to take over John McCain’s Senate seat in 2019, used similar messaging in her failed 2018 bid for the state’s other Senate position. And President Donald Trump echoed the declaration at a June 23 rally in Phoenix, saying McSally — along with the rest of the Republican Party — “will always protect people with preexisting conditions.”

With that in mind, we decided to take a closer look. We contacted McSally’s campaign, which cited her support of a different piece of legislation, the Protect Act. But independent experts told us that legislation doesn’t satisfy the standard she sets out.

Past and Present

Only one national law makes sure people with preexisting medical conditions don’t face discrimination or higher prices from insurers. It’s the Affordable Care Act.

Both as a member of the House of Representatives and as a senator, McSally has supported efforts to undo the health law — voting in 2015 to repeal it and in 2017 to replace it with the Republican-backed American Health Care Act, which would have permitted insurers to charge higher premiums for people with complicated medical histories.

“Anyone who voted for that bill was voting to take away the ACA’s preexisting condition protections,” said Jonathan Oberlander, a health policy professor at the University of North Carolina-Chapel Hill. “Sen. McSally is trying to erase history for electoral purposes.”

Especially as COVID-19 cases climb, health care — and, in particular, the ACA — has emerged as a flashpoint in the Arizona election, said Dr. Daniel Derksen, a professor of public health, medicine and nursing at the University of Arizona.

“Martha McSally has in her actions, in her votes, been pretty consistent about cutting back benefits and trying to repeal the ACA without any clear plan in mind that would protect people who gained insurance through the ACA,” Derksen added. “Her words on preexisting condition protections don’t align with any votes I’ve seen.”

McSally’s campaign argued that the ACA is just one strategy, and a flawed one at that. Dylan Lefler, her campaign manager, instead pointed to her support of the Republican-backed Protect Act as evidence to back up her promise. Specifically, it ostensibly bans insurance plans from “impos[ing] any preexisting condition exclusion with respect to … coverage,” per the bill text.

The problem, though, is that simply banning that exclusion isn’t enough, because the law also has to make sure the health insurance plans that cover preexisting conditions remain affordable. The bill, sponsored by Sen. Thom Tillis (R-N.C.), does nothing to provide subsidies or cost-sharing mechanisms — meaning people both with and without preexisting conditions wouldn’t necessarily be able to afford those plans. Without that framework, the act remains a “meaningless promise,” argued Linda Blumberg, a fellow at the Urban Institute, a social policy think tank.

And it has other holes: for instance, permitting insurers to charge women more than men.

“No six-page bill is ever the way of achieving something,” said Thomas Miller, a scholar at the American Enterprise Institute. “This is a check-the-box effort to try to say, ‘We’re [moving] in that direction.’”

It’s not just legislation. There’s also Texas v. Azar, a pending case in which a group of Republican attorneys general are arguing the Supreme Court should strike the entire health law, including its preexisting condition protections. The Trump administration has sided with the Republican states.

McSally has consistently declined to comment on the lawsuit, saying she doesn’t want to weigh in on “a judicial proceeding.” In reporting this fact check, we asked where she stood on the case. The campaign didn’t specifically answer but pointed to her general disapproval of the ACA. Meanwhile, Senate Democrats have called on the administration to reverse its stance.

That context makes McSally’s silence especially relevant, said Sabrina Corlette, a research professor at Georgetown University.

“When given the opportunity, she has declined to oppose this lawsuit, which would essentially eliminate the protections that exist,” Corlette said.

So — big picture? McSally’s record in Washington hasn’t been one of preserving or building on preexisting condition protections.

Our Ruling

In her new TV ad, McSally claims she will “always protect those with preexisting conditions.”

But nothing in her voting record, which tracks closely with the Republican repeal-and-replace philosophy, supports this claim. And she has continually declined opportunities to oppose a pending legal threat to the ACA, including its provisions related to preexisting conditions, by a group of GOP governors and supported by the Trump administration.

Meanwhile, the legislation her campaign cited to justify her stance falls short in terms of meaningfully protecting Americans with preexisting medical conditions.

McSally has not in the past or present taken actions that back up her statement. We rate it False.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

On "Treatment Tuesdays," as she has dubbed them, Katherine O'Brien makes the trek into Chicago by commuter rail from her home in the suburb of La Grange, Illinois, for chemotherapy.

This article was first published on Thursday, June 25, 2020 in Kaiser Health News.

By Hannah Norman

Three Tuesdays each month, Katherine O’Brien straps on her face mask and journeys about half an hour by Metra rail to Northwestern University’s Lurie Cancer Center.

What were once packed train cars rolling into Chicago are now eerily empty, as those usually commuting to towering skyscrapers weather the pandemic from home. But for O’Brien, the excursion is mandatory. She’s one of millions of Americans battling cancer and depends on chemotherapy to treat the breast cancer that has spread to her bones and liver.

“I was nervous at first about having to go downtown for my treatment,” said O’Brien, who lives in a suburb, La Grange, and worries about contracting the coronavirus. “Family and friends have offered to drive me, but I want to minimize everyone’s exposure.”

While her treatment hasn’t changed since the novel coronavirus spread across the United States, the 54-year-old is at high risk of severe complications should she become infected. Those risks haven’t declined significantly for her despite the Illinois governor’s loosening of COVID-related restrictions.

She’s not alone in fearing the deadly combination of COVID-19 and cancer. One study, which reviewed records of more than 1,000 adult cancer patients who had tested positive for COVID-19, found that 13% had died. That’s compared with the overall U.S. mortality rate of 5.9%, according to Johns Hopkins.

Beyond the concern of cancer patients — with their already depleted immune systems — catching the virus, many doctors worry about people delaying their scans and checkups and missing time-sensitive diagnoses. A KFF poll found that nearly half of Americans had skipped or postponed medical care because of the outbreak. Cancer patients seeking care face an array of obstacles as states reopen, such as heavily restricted in-hospital appointments and new clinical trials on hold. (KHN is an editorially independent program of KFF, the Kaiser Family Foundation.)

“Cancer doesn’t care that there’s a coronavirus pandemic taking place,” said Dr. Robert Figlin, chair in hematology-oncology at Cedars-Sinai in Los Angeles. “We don’t want people who have abnormalities to delay having them evaluated.”

In late March, Megan-Claire Chase, 43, of Dunwoody, Georgia, got laid off from her job as a project manager for a staffing company, losing the health care benefits that came with it. Her chief concern was paying for a diagnostic mammogram and MRI, still on the calendar for two days before her benefits were to end. Currently in remission from stage 2A breast cancer, Chase schedules scans for every six months well in advance at Breast Care Specialists in Atlanta.

“When I got there, it was really unsettling. You almost feel like a leper,” said Chase, noting the socially distanced waiting room and heavily sanitized clipboards. Already hyper-careful since her days of chemotherapy, Chase carries her own pens in her purse, along with gloves and extra masks.

Cancer centers across the country are taking extra precautions. At Northwestern, patients are funneled through a single entryway, where masks are required, and are met by a security guard and a temperature check before signing in with receptionists seated behind plastic shields, O’Brien said. No visitors or accompanying family members are allowed inside the building, and the cafeteria and waiting rooms are devoid of unnecessary germ-spreading agents — no magazines or coffee machine in sight. The cubicle where she receives infusions of Abraxane used to seat four patients; now, only two sit in the space.

Where they can, many doctors are turning to telemedicine to limit cancer patients’ trips to the hospital. In Salt Lake City, Dr. Mark Lewis, director of gastrointestinal oncology for Intermountain Healthcare, a 23-hospital system serving Utah and surrounding states, says about half his patient visits are now virtual. He’s also making some patients’ treatments less intense and less frequent. As at Northwestern, patients must arrive at the hospital solo for appointments unless assistance is physically necessary. It’s a significant shift for Lewis, who’s had up to 30 family members in his office for appointments alongside his patients for mental support.

“We are writing the rules as we go, trying to keep patients’ immune systems up and the cancer at bay,” said Lewis. Still, he’s concerned about a later spike in cancer mortality due to the coronavirus pandemic. The coronavirus aside, the National Cancer Institute estimates over 600,000 Americans will die of cancer this year.

New clinical trials have also largely ground to a halt in this new era, when traveling long distances for treatment is less of an option. Linnea Olson, who lives in Amesbury, Massachusetts, and has stage 4 lung cancer, worries there may be far fewer treatment options for her, as trials have been her “lifeline.”

About four months ago, Olson, 60, enrolled in her fourth phase 1 clinical trial at Massachusetts General Hospital’s Termeer Center for Targeted Therapies. The treatment has been accompanied by intense side effects, such as a sore mouth and throat from mucositis, also a sign of COVID-19. Before a recent infusion, nurses with plastic shields ferried Olson up a back entryway for a COVID test. It was negative.

The intensity of her treatment, coupled with the extreme social distancing measures, has left Olson, who lives alone, feeling depressed and unsure if she should continue the trial.

“It’s too much all at once — the isolation and the difficult side effects,” Olson said.

Rudy Fischmann, a brain cancer patient and former true crime TV producer, battles balance issues that started after his first set of surgeries two years ago. Daily walks and physical therapy are part of his treatment regimen. Yet strolls around his Knoxville, Tennessee, neighborhood are already becoming more stressful as the state begins to open up.

“It’s getting harder and harder, with more and more people outside every day,” said Fischmann, 48. “I don’t enjoy walking laps around my kitchen, so I’m finding myself having to change my routes almost daily.”

A father of two young children who are now home round-the-clock, Fischmann finds all the family time draining his limited energy. He also fears what germs they will bring back from school come fall.

“The thought of, if I were to contract the virus, would I get a different standard of care?” he said. “I’m used to staying home and not doing that much, but it’s more nerve-wracking now.”

Oklahoma voters head to the polls June 30 to decide if the state should expand Medicaid. If approved, State Question 802 would allow more than 200,000 residents to gain health coverage.

The article was first published on Wednesday, June 24, 2020 in Kaiser Health News.

By Phil Galewitz

Oklahoma residents going to the polls June 30 have the chance to override state leaders’ decadelong refusal to expand Medicaid, which would cover more than 200,000 low-income adults and bring billions of federal dollars into the state.

But advocates are concerned that turnout for the summer primary election could be hampered by fears of contracting COVID-19 at voting stations and by Republican Gov. Kevin Stitt’s about-face on the issue. Since the supporters got the measure on the ballot in October, the governor has gone from opposing Medicaid expansion to announcing in January he would institute his own expansion plan beginning July 1 that included work requirements and monthly premiums for enrollees. But he turned around and surprised many in May with a veto of state funding for his own proposal.

“It’s been a little nuts,” said Carly Putnam, policy director of the Oklahoma Policy Institute, which supports expansion.

Jim McCarthy, CEO of Community Health Connection, a federally funded community health center in Tulsa, said the governor’s plan “seemed designed to confuse people.”

“There is worry about people getting to the polls,” McCarthy said, noting the concerns over COVID and state’s restrictions on absentee voting. “Turnout will be critical.”

If successful, the Sooner State would be the fifth to use a ballot initiative to extend Medicaid under the 2010 Affordable Care Act. Idaho, Utah, Nebraska and Maine have passed similar measures. Missouri voters will decide on a Medicaid expansion initiative Aug. 4.

The election comes as the coronavirus pandemic has roiled Oklahoma’s economy. More than 200,000 people in the state are out of work, many of whom are likely in need of health coverage.

As of April, Medicaid covers about 820,000 Oklahomans, two-thirds of them children. Parents are covered if their incomes are no higher than 41% of the federal poverty level, or about $8,900 for a family of three. Oklahoma is one of 14 states that offer no coverage for adults without dependent children.

Under the ACA, states were encouraged to let Medicaid cover everyone with annual incomes below 138% of the poverty level, or about $17,600 for an individual or just under $30,000 for a family of three. The expansion led to millions of people gaining health coverage and, until recently, a record-low U.S. uninsured rate. Thirty-six states and the District of Columbia have expanded Medicaid.

Clarence Powell, 62, of Oklahoma City, has been uninsured since 2015, when poor health forced him to go from working full time to part time at a hotel. Without health coverage, he’s relied on the Good Shepherd free clinic for medical care and for free or low-cost medications to treat his heart and lung conditions. But seeing a specialist has been difficult without insurance.

When he went to the hospital last year for a bloody nose, he left with a bill for more than $1,000 that he has no way to pay.

“Having Medicaid would make a big difference,” he said. “We will all be better off.”

Conservative leaders in Oklahoma, which has the second-highest uninsured rate in the country, have balked at expanding Medicaid — even though the federal government would pay 90% of the cost for enrollees in 2020. Republicans, who control the state legislature and executive branch, repeatedly said the budget couldn’t afford the state’s share and they didn’t trust the federal government to keep up its funding.

With his plan dead for now, Stitt opposes the ballot initiative because it would not give the state flexibility to impose restrictions on enrollees and doesn’t include a plan to come up with the state’s funding.

As part of his plan, Stitt asked the Trump administration to approve giving the state a set annual amount of money per newly eligible Medicaid enrollee and agree to evenly split any money the state saves on future Medicaid spending.

Such a funding arrangement would radically alter the traditional system, in which the federal government pays states an unlimited amount based on enrollment and medical expenses.

Oklahoma submitted a request to the federal government for a waiver to implement the governor’s plan, but the Trump administration did not rule on it before Stitt changed his plans.

Carter Kimble, deputy secretary of Health and Mental Health and Stitt’s top aide, said the governor was willing to cap federal funding for Medicaid because it would come with a deal to give the state more flexibility in using Medicaid dollars, including targeting funds for enrollees’ housing and food needs. Currently, Medicaid dollars must be used for health costs.

“We have had unfettered and uncapped federal financing, and we are ranked 48th in health outcomes and 49th in health system performance,” Kimble added. “So where has it got us?”

“We need innovation and change and not to keep doing the same thing,” he said.

In May, the Oklahoma Legislature approved taxing hospitals to pay most of the state’s estimated $150 million annual cost for its share of Medicaid expansion. Kimble said the governor vetoed the bill because he wanted multiple years of funding and the bill included only one year. Stitt has the authority to expand Medicaid on his own, though he needs the legislature to approve funding. Kimble expects the ballot measure to pass.

Several major interest groups, including the state chamber of commerce, Blue Cross and Blue Shield of Oklahoma (the state’s largest insurer), and the Oklahoma Primary Care Association, which represents community health centers that treat thousands of uninsured, have not taken a position on the ballot initiative.

Community Health Connection’s McCarthy said the primary care association board did not want to alienate the Stitt administration, which provides some health center funding.

The pandemic, which has led to more than 11,000 cases in the state and more than 370 deaths as of Tuesday, highlighted the need for expansion, said Patti Davis, president of the Oklahoma Hospital Association.

“The pandemic has put health care front of mind for everybody,” she said.  “People want to know they can get care when they need it and know they will have a hospital to care for them,” she said.

Oklahoma’s slumping economy, which is closely tied to oil, also fueled interest in expanding Medicaid, Davis said.

“Oklahomans are ready to do this, and with the downturn in the economy, people are even more worried about job security and helping low-wage workers get covered by insurance.”

The FDA has now received a total of 106 reports of adverse events for the Abbott test. 

This article was first published on Monday, June 22, 2020 in Kaiser Health News.

By Rachana Pradhan   

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 "adverse event reports" about Abbott's ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher "false negative" rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company's test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was "flawed" and "an outlier," citing studies with higher accuracy rates.

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department's preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

"Everybody was raving about it," a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. "It's an amazing test, but it has limitations which are now being better understood."

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests' "sensitivity" — a metric showing how often a test correctly generates a positive result. They are debating whether it's sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn't likely to miss sicker patients.

"There's no way I would be comfortable missing 2 out of 10 patients," said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it "is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found." Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid's point-of-care tests, according to an agency spokesperson.

"Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19," Dr. Timothy Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. "If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic."

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as "presumptive" negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it's for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott's, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren't as accessible. There's also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials' "general expectation" is that companies' test validation data indicate a sensitivity of at least 95%; however, "based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%."

"Rapid and reliable detection of positive patients can be important for public health," the spokesperson said.

Cepheid would not comment on FDA's 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

"Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance," Dr. David Persing, Cepheid's chief medical and technology officer, said in a statement. "Tests with higher sensitivity have a natural advantage in this setting."

As far as Abbott's test, "there are certainly some elements of it that could be improved, but I think it's a great assay," said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was "flawed" in part because of the number of patients researchers included with such low viral loads that they wouldn't be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA's threshold.

"For them to just say 80%, it lets people game the system," he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

"They really need to fix this issue," Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System's clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

"The difference now," he said, "is that people are so fearful and tolerance for false negatives is just zero."

Abbott's rapid COVID-19 test isn't the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians' offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district's poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city's Department of Forensic Services, which oversees the city's public health lab.

"We test every test before we put it online," she said. "We didn't find the successively high rate of false negatives. In fact, we found we were getting the same results."

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

"Without confirmation of negatives, I wouldn't want to use it in hospitals," said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn't match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient's viral burden isn't high.

Berry's analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott's self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott's stated limit, Polage said: "I'm not sure what they were thinking."

Rachana Pradhan: rpradhan@kff.org, @rachanadixit