WASHINGTON – On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA). AACC commends this decision, which will help speed the expansion of COVID-19 testing at this crucial time. However, the association remains concerned that the Families First Coronavirus Response Act does not provide coverage for COVID-19 tests unless the tests are performed under an EUA. AACC urges Congress to rectify this problem before passing the bill so that all patients will have access to coronavirus testing.
A major reason why COVID-19 testing in the U.S. has fallen so far behind is that when the coronavirus was first declared a public health emergency, all COVID-19 tests had to receive EUAs from FDA. This meant that CMS-certified labs, which are not typically subject to FDA oversight, had to face new, oftentimes insurmountable regulatory hurdles before introducing their COVID-19 tests. At the end of February, FDA amended this requirement so that these labs could develop and perform COVID-19 tests prior to receiving EUAs, so long as they submitted an EUA request to FDA within 15 days of the tests’ launch. However, this modified requirement still stymied the development of COVID-19 tests since many labs, even with a 15-day grace period, do not have the resources to go through FDA’s cumbersome review process.
In response to concerns from AACC and others in the clinical laboratory community, yesterday the FDA finally lifted its EUA requirements for COVID-19 tests entirely. This means that CMS-certified labs will now be able to operate as they normally would have before the declaration of a public health emergency, and will be able to create, validate, and perform tests for COVID-19 without FDA oversight. AACC applauds FDA’s decision to step back, a move that will undoubtedly help to increase the U.S.’s COVID-19 testing capacity. However, now that more labs are going to be offering tests without EUAs, it is crucial that Congress amend language in the Families First Coronavirus Response Act which, as currently drafted, does not provide coverage for COVID-19 tests without EUAs. The association is actively working with legislators to correct this oversight, which could result in patients getting billed for COVID-19 testing and could continue to deter labs from performing these tests.
“We strongly support FDA’s decision to abolish its EUA requirements for COVID-19 testing, which will enable many more AACC member laboratories to offer these desperately needed tests,” said AACC President Dr. Carmen L. Wiley. “However, we are concerned that insurance will not cover these new tests under the Families First Coronavirus Response Act as it is currently written. AACC will continue our work with legislators to bring this bill in line with FDA’s new guidance, and to ensure that all Americans have coverage for COVID-19 testing.”
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.myadlm.org.