by Leslie Small
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."
No comments:
Post a Comment