With the Trump administration anxious to “reopen” the U.S. economy and ease the social-distancing measures meant to slow the spread of COVID-19, officials have pointed to antibody testing as a critical tool to accomplish those goals. To that end, the administration on April 11 issued a document clarifying that most private health plans must cover such tests, which detect antibodies against the new coronavirus found in the blood of people who have been infected and now may be immune.
“It’s not exactly a surprise, [but] I don’t know that it was 100% expected,” Jason Karcher, a Milliman Inc. actuary, tells AIS Health regarding the requirement. “It seems like as much a point of clarification rather than a ‘hey, we’re going to require something totally out of the blue.'”
So far, at least serological tests have received an Emergency Use Authorization from the FDA.
Cost information is not as readily available for serological tests as it is for tests that diagnose COVID-19, which cost around $51 until CMS increased the reimbursement rate for “high-throughput” diagnostic tests to $100. Cellex, which makes one of the antibody tests that received emergency authorization by the FDA, did not respond to an inquiry about the price of its test as of press time, but Vox reported that “a serological test can be less than $10.”
William Schaffner, M.D., a professor of preventive medicine and infectious diseases at Vanderbilt University, says there are good reasons to temper expectations about how testing people for COVID-19 antibodies could help the U.S. reopen businesses, schools and events.
Since the FDA is essentially allowing companies to do their own evaluation of serological tests’ effectiveness, that will naturally invite questions about whether their results can be trusted, Schaffner says, suggesting that some tests may be more rigorously evaluated than others. “Then there’s the question of availability of the tests — we’ve been down this road once before, where people were told that the nasal swab test for the virus itself would be widely available, and anybody can have it who wants it,” he says. “Well, we’re still struggling with that, and we would like not to repeat that fiasco.”