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

Essentially, the president is arguing that the United States is finding more cases of COVID-19 because we are testing more — and that our increased testing makes it appear the pandemic is worse in the U.S. than in other countries.

This article was first published on Wednesday, June 17, 2020 in Kaiser Health News.

By Shefali Luthra

President Donald Trump sought to downplay the numbers associated with COVID-19 in the United States — which have passed 2 million confirmed cases and are nearing 120,000 lives lost — by arguing that the soaring national count was simply the result of superior testing.“If you don’t test, you don’t have any cases,” Trump said at a June 15 roundtable discussion at the White House. “If we stopped testing right now, we’d have very few cases, if any.”

It’s a talking point the administration is emphasizing. Vice President Mike Pence reiterated it during a phone call to Republican governors that evening, recommending they use the argument as a strategy to quiet public concern about surging case tallies in some states. It’s also a variation on a tweet the president sent earlier in the day.

With that in mind, we wanted to dig deeper. We reached out to the White House for comment or clarification, but we never heard back. Independent researchers told us, though, that the president’s remarks are not only misleading — they’re also counterproductive in terms of thinking through what’s needed to combat the coronavirus pandemic.

The Big Picture

Essentially, the president is arguing that the United States is finding more cases of COVID-19 because we are testing more — and that our increased testing makes it appear the pandemic is worse in the U.S. than in other countries.

“We will show more — more cases when other countries have far more cases than we do; they just don’t talk about it,” he added.

But that isn’t true.

The numbers paint a stark picture. The United States has recorded 2.1 million cases of the novel virus so far, about a quarter of the global total and more than any other country. To Trump’s point, the country is testing more now than it did at the start of the outbreak — per capita, the U.S. is in the top 20% of countries when it comes to cumulative tests run.

This beefed-up testing still likely reflects an undercount in cases, though. The problem is that the U.S. outbreak is worse than that of many other countries — so we need to be testing a higher percentage of our population than do others.

To best understand this, consider the number of tests necessary to identify a positive case. If it’s easier to find a positive case, that suggests the virus has spread further and more testing is necessary to track the spread of COVID-19.

For instance, statistics from the United States and the United Kingdom are fairly similar in terms of how many coronavirus tests are done daily per million people. But those tests yield far more positive cases in the United States. That suggests the outbreak here requires more per capita testing than does the U.K.’s.

“We have a much bigger epidemic, so you have to test more proportionately,” said Jennifer Kates, a senior vice president at KFF.

Put another way, a larger health crisis means — even after controlling for population size — the United States will have to test more people to find out where and how the virus has spread. (KHN is an editorially independent program of KFF, the Kaiser Family Foundation.)

And while the U.S. has ramped up its testing since March, many parts of the country still don’t have sufficient systems in place — from facilities to staff to medical supplies — for diagnosing COVID-19, researchers told us.

What If We Stopped Testing?

And what about the president’s assertion that “if we stopped testing right now, we’d have very few cases” or none at all?

On its literal phrasing, it’s absurd, experts said.

“The implication that not testing makes the problem go away is completely false. It could not be more false,” said Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health in Baltimore. That’s because testing doesn’t create instances of the virus — it is just a way of showing and tracking them. (The president made a similar point during the same White House roundtable event.)

But even if you take it figuratively — the idea that our expanded testing resources have inflated our sense of the epidemic — it’s still misleading.

“We’re seeing a lot of cases because we’re testing? It just doesn’t ring true,” Kates said. “The U.S. has made a lot of progress for sure. But that job is not finished.”

The president’s claim is part of a larger reelection strategy, argued Robert Blendon, a health care pollster at the Harvard T.H. Chan School of Public Health. The idea is to suggest that the health crisis is mostly exaggerated — and that things are getting better, and Americans should feel comfortable going back to work. “If the economy takes off, the president has a chance of reelection,” Blendon said. “If it contracts as a result of expansion of cases, and the only way we know how to respond is restriction of economic activity, he’s gone.”

But the problem, Blendon added, is that COVID-19 counts are still climbing in multiple states. And people are still dying of the virus.

That gets at another point: Diagnostic testing isn’t the only data source to reveal the pandemic’s existence. Let’s not forget about hospitalization rates and death counts. The number of deaths continues to rise, and hospitalizations are higher than they would be in the virus’s absence.

Our Ruling

Trump argued that the nation’s high count of COVID-19 cases is simply a result of our expanded testing capacity. His point is entirely incorrect.

The most relevant data suggests that the U.S. isn’t testing enough to match the severity of the pandemic. Even with our higher testing ratio, we’re probably still undercounting compared with other countries.

Testing doesn’t create the virus. Even without diagnostics, COVID-19 would still pose a problem. We just would know less about it.

And, in fact, eliminating testing may alter the public’s perception of the pandemic but it wouldn’t conceal it. If anything, it would likely worsen the crisis, since the public health system wouldn’t know how to accurately track and prevent the spread of the coronavirus.

The president’s claim has no merit and seriously misrepresents the severity of the public health crisis. We rate it Pants on Fire.

Arizona has emerged as one of the country's newest coronavirus hot spots, with the weekly average of daily cases more than doubling from two weeks ago.

This article was first published on Tuesday, June 16, 2020 in Kaiser Health News.

By Will Stone

With new daily coronavirus cases rising in at least two dozen states, an explosion of new infections in Arizona is stretching some hospitals and alarming public health experts who link the surge in cases to the state’s lifting of a stay-at-home order a month ago.

Arizona has emerged as one of the country's newest coronavirus hot spots, with the weekly average of daily cases more than doubling from two weeks ago. The total number of people hospitalized is climbing, too.

Over the past week, Arizona has seen an average of more than 1,300 new COVID-19 cases each day.

After the state's largest hospital system warned about a shortage of ICU beds, Arizona Gov. Doug Ducey, a Republican, pushed back on claims that the health care system could soon be overwhelmed.

"The entire time we’ve been focused on a possible worst-case scenario with surge capacity for hospital beds, ICU beds and ventilators," Ducey told reporters. "Those are not needed or necessary right now."

While he acknowledged a spike in positive cases, Ducey said a second stay-at-home order was "not under discussion."

"We put the stay-at-home order there so we could prepare for what we are going through," he said.

Some states have reopened more slowly with a set of specific benchmarks for different regions, but Arizona took a more aggressive approach.

The state began easing restrictions on businesses in early May and lifted its statewide lockdown order after May 15. Under Arizona's reopening plan, businesses are advised to follow federal guidance on social distancing.

There is also no requirement for everyone to wear masks in public.

Public health experts agree: The timing of this spike reflects the state’s reopening.

"Perhaps, Arizona will be a warning sign to other areas," said Katherine Ellingson, an epidemiologist at the University of Arizona. "We never had that consistent downward trend that would signal it's time to reopen and we have everything in place to do it safely."

Before Arizona lifted its stay-at-home order, only about 5% of COVID-19 tests registered as positive. On Monday, that number was around 16%.

A slower reopening gives public health agencies time to identify whether cases are rising and then respond with contact tracing and isolating those who are infected.

"With a fast, rapid reopening, we don't have the time to mobilize those resources," said Ellingson.

Maricopa County, home to about 60% of the state’s population, has ramped up contact tracing in recent weeks, but it may not have enough capacity if the surge in cases continues.

Dr. Peter Hotez said the spike in Arizona, as well as in parts of Texas such as Houston, Dallas and Austin, is the consequence of removing restrictions too quickly and without a public health system that can keep pace.

"It was just 'open it up' and then more or less business as usual, with a little bit of window dressing," said Hotez, the dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston. "This is not an abstract number of cases. We're seeing people pile into intensive care units."

Arizona's governor has also faced criticism from the mayors of Arizona's two biggest cities for not putting in place more stringent requirements.

"There is a pandemic and it's spreading uncontrollably," said Tucson Mayor Regina Romero, a Democrat. Ducey, she said, "is just putting up his hands and saying 'the spread is happening and we just have to go about our business.'"

And the governor's executive order forbids local governments from implementing their own extra measures, which adds to Romero's frustration. Texas has a similar measure.

"What he did was pretty much tie the hands of mayors and public health officials," Romero said.

Arizona's hospital industry has tried to tamp down fears that it's on the verge of a crisis. Hospitals are still performing elective surgeries.

"It's very unfortunate because hospitals right now in Arizona are quite busy with elective procedures," said Saskia Popescu, a Phoenix-based epidemiologist with George Mason University. "You throw in increasing cases of COVID, and that's going to very much stress your hospital systems."

Phoenix's triple-digit summer temperatures actually may fuel the spread of the virus. People forgo outdoor activities and retreat to air-conditioned indoor spaces, where the risk of transmitting the virus goes up significantly.

"My concern is we're going to see a lot more people in close quarters for prolonged periods of time," Popescu said.

Since the stay-at-home order was lifted, Popescu and others say they've seen people returning to a pre-pandemic mindset, neglecting to wear masks or maintain social distance. Videos of crowded bars have only propelled these fears.

On Thursday, however, Arizona's top doctor stressed there were also dangers to keeping the state on lockdown, including the mental health effects of loneliness and isolation.

"We know that it's in the community. We are not going to be able to stop the spread. And so we can't stop living as well," said Dr. Cara Christ, health director for the Arizona Department of Health Services.

But Dr. Quinn Snyder, an emergency medicine physician in Mesa, Arizona, said there needs to be more consistent messaging on public health measures like wearing masks.

"Frankly, I just think a wholesale reevaluation of where we're at is critical right now, but I can tell you that we're not doing nearly enough," said Snyder, who has seen the uptick in seriously ill COVID-19 patients firsthand.

"If we continue to head down this path, the virus will press our health care facilities beyond capacity, where we're going to have to be making tough decisions like who gets a ventilator and who doesn't."

This story is part of a reporting partnership between NPR and Kaiser Health News.