Nevada offers key lessons in challenge to U.S. virus tests for nursing homes

covidtestswab-282x300The federal agency that regulates nursing homes and other long-term care facilities not only has cracked down on them with tough new requirements for coronavirus testing of their staff. The Centers for Medicaid and Medicare Services also has flogged its plan to provide facilities with testing equipment and sample tests.

While owners and operators have grumbled about the whole process, the state of Nevada has gone a step further: Enough, its health officials have decided. They briefly halted as unacceptable the CMS tests for the virus because they say they are flawed and may put nursing home residents at risk.

Besides casting yet more doubt on CMS’s poor pandemic response with long-term care facilities,  Nevada’s balk — rescinded abruptly after federal threat — may offer an important take-away to members of the public, already flooded with findings about the novel coronavirus:

Yes, testing for the disease matters — a ton. But federal regulators have opened the door to different types of tests made by a growing array of firms. The tests work in different ways and tell the savvy different things and failing to reckon with this can create a whole lot of ned.

The CMS-blessed tests are of the rapid variety, “portable, simple and speedy, producing results in as little as 15 minutes and bypassing the need to send samples to a laboratory,” as the New York Times reported. But as the newspaper also noted of these quick kits, endorsed by federal regulators for use in thousands of nursing homes and other long-term care facilities across the country:

“Shortly after the tests were rolled out across the state this summer, nursing homes began to report that people who had been evaluated by both the rapid tests and a more accurate laboratory test were receiving conflicting results. Whereas laboratory tests often rely on a highly reliable if slower technique called polymerase chain reaction, or PCR, that can detect very small amounts of coronavirus RNA, rapid tests… look for bits of coronavirus protein, or antigens, and more often make mistakes. Among 39 positive antigen test results [in Nevada], 23 were found by PCR to be negative — an error rate of nearly 60%. The results, which were collected from a dozen facilities where thousands of tests had been performed, prompted the state to pivot away from antigen tests to viral RNA tests such as PCR.”

To be fair, the companies that make the tests that CMS is promoting stand by their products and question the accuracy of the lab tests. This could lead to a dizzying back-and-forth among product specialists.

But there’s a more fundamental testing issue involved, as explained by Susan Butler-Wu, a clinical microbiologist at the University of Southern California. She argued that CMS has pushed an “off-label use of tests that are designed and validated for certain populations, but that are then administered to others.” As the newspaper reported:

“Both … tests [promoted by CMS] received clearance [from the federal Food and Drug Administration] for use ‘within the first five days of the onset of symptoms.’ The instructions that come with [one of the tests] have noted that [its] ‘performance … has not been evaluated for use in patients without signs and symptoms of respiratory infection and performance may differ in asymptomatic individuals.

“In late August, [federal officials] began requiring nursing homes to routinely test their residents and staff, including people without symptoms. Days later, the agency extended coverage under the Public Readiness and Emergency Preparedness Act to include screening for infections in asymptomatic people in nursing homes and other congregate facilities. The measures were implemented to quash outbreaks among nursing home residents, who tend to be at high risk for infection and serious symptoms if exposed to the virus.

“But experts have repeatedly warned that in the absence of data demonstrating that the tests can accurately evaluate people with no symptoms, results should not be taken as definitive. Nevada’s recent testing woes reaffirm ‘why you can’t take something that’s approved for symptomatic use and apply it to an asymptomatic population,’ Dr. Butler-Wu said.”

The federal bungling on tests

Public health experts have ripped the Trump Administration from early in the pandemic for its bungled efforts on coronavirus testing, notably for the federal failure to set and enforce a national strategy and see it carried out properly. The Centers for Disease Control and Prevention inexplicably insisted initially on a United States-only version of a Covid-19 test but gaffed up its delivery, causing a deadly delay. The CDC also sowed confusion with its narrow and rigid rules on which patients could be tested, when, and why.

The FDA has drawn fire since for going in an opposite direction, seeming to critics to be racing tests by many makers to market.

Federal officials also created a chaos in the messaging about tests and testing, with President Trump and other White Officials providing prime examples of how to damage a fundamental way to deal with infectious diseases.

The administration has sought to discourage testing, arguing in logic-free fashion that it politically harmed the president by showing Covid-19’s terrible toll — which is ripping toward 220,000 deaths and more than 7.7 million infections. (Really? Fewer cancer tests would mean fewer cases of cancer? C’mon, man.)

That narrative then gave way to a White House endorsement of rapid testing as a bulwark not of infection detection but — go figure — prevention and deterrence. The president, his staff, and supporters in steady fashion have gone out of their way to denigrate, deny, downplay, and defy public health recommendations, such as distancing and face covering — all while blithely believing that rapid coronavirus and temperature testing would suffice.

Now, the president has contracted the disease and required hospitalization, while dozens in his orbit have tested positive and many have been sickened. Thousands may have been exposed.

Has the critical importance of testing itself been debased beyond repair?

Testing’s core and undeniable value

Members of the public have been forced by the pandemic to process a vast and shifting amount of medical and scientific dissemination. Some of it, issued as the best knowledge at the time, hasn’t held up and has been put away.

The core importance of testing needs to be widely promoted — and conveyed in understandable fashion, especially in how different types of tests work and can be useful. In guy talk, a ball peen hammer isn’t right for carpentry work, especially if lots of nail pulling is required. It is the pick for metal working.

Coronavirus testing can point public health officials and doctors to infected individuals, so they can receive appropriate care. It provides important information where the disease is and where it is and may be spreading. Testing can push experts and people to needed interventions — including isolation of the ill, further testing, and information campaigns to protect and prevent an outbreak from growing. Testing can have its limits due to the nature of the coronavirus: Individuals may be asymptomatic but have the disease and, for a time, still test negative. That is because their viral load has not reached detectable levels. Individuals also may test negative one day and the next be ill and positive as the virus burgeons in them.

As with all matters medical, testing involves trade-offs. Is it important for this tool to produce results fast, with lesser accuracy the known trade-off, for example by measuring antigens as opposed to coronavirus RNA? Or is greater accuracy at less speed the key, with waiting for more complex lab tests to be run? Is it vital that the test use less resources (testers and personal protective equipment) and rely on lower front-line expertise, so that “spit” versus nasal swab tests will work?

Experts, for now, say the lab-run RNA tests may be the “gold standard” in coronavirus screening. But its expense, timing, and resource demands may be such that it cannot be the only option. Cheaper, faster, and yes, less accurate tests may be the choice where public health officials need to screen large groups of people to quicky find and isolate the highly infectious. Repeat screenings, with this swifter and more affordable choice, may reduce the chances that a less accurate test misses an infected individual.

But if the leader of the free world wants to embark on a hectic hopscotching across the country to mass events to seek re-election, while also governing the world’s No. 1 super power, shouldn’t he take the most rigorous test around — and wait for its outcomes and analysis by medical experts?

In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles with costly, complex, and uncertain tests, treatments, and prescription medications, too many of which turn out to be dangerous drugs. Over testing, over diagnosis, misdiagnosis, and over treatment pose significant risks and add needless costs in the U.S. health care system.

But the United States will not shed its shameful status as the Covid-19 hot spot of the planet without aggressive testing, contact tracing, and isolating of the sick. We all may wish to recommit to preventive measures, including robust hand washing, distancing, face covering, and staying home rather than hitting bars, restaurants, stores, and night clubs with abandon. It’s not fun. We’re all weary, including of getting overwhelmed with the coronavirus’ accompanying “infodemic.”

We don’t have a choice, however. We need to research and think with rigor, and act with care and common sense. Vote, please, as if your life depended on it, because, these days, it does.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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