Earlier this week, the FDA updated its guidance on testing for the novel coronavirus (COVID-19), allowing clinical laboratories to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA).1

This updated policy also includes recommendations for test developers who may wish to develop serological tests for use during the COVID-19 outbreak, which measures the number of antibodies or proteins present in the blood when the body is responding to a specific infection.2

However, the FDA’s updated guidelines drew concern from organizations such as the American Association for Clinical Chemistry (AACC), which feels that the Families First Coronavirus Response Act does not provide coverage for COVID-19 testing unless the tests are performed under an EUA.1

The clinical laboratory community has seen a major change in COVID-19 tests, with the EUA requirements for the tests lifted entirely. Labs certified by the Centers for Medicare and Medicaid Services (CMS) will be able to operate as normal before the declaration of a public health emergency, with the freedom to create, validate, and perform tests for COVID-19 without FDA oversight.1

Although this decision will help increase testing capacity for COVID-19, it is important to the clinical lab community that Congress amend language in the Families First Coronavirus Response Act that currently does not provide coverage for COVID-19 tests without EUAs. Organizations such as the AACC are actively working with legislators to correct this oversight, which could result in patients getting billed for COVID-19 testing and deter labs from performing these tests.1

“AACC strongly supports FDA’s decision to allow CMS-certified labs to create and perform their own tests for COVID-19 without pursuing emergency use authorization,” said Carmen L. Wiley, PhD, DABCC, president of AACC, in an email to Pharmacy Times®. “This long-overdue change is crucial to alleviating the US testing shortage. However, this raises another problem now, which is that the Families First Coronavirus Response Act currently only provides insurance coverage for COVID-19 tests that are performed under an (EUA). This clearly runs counter to the FDA’s new guidance, and we at AACC are working intently with legislators to fix this and to ensure that all patients have access to COVID-19 testing.”

  1. AACC urges congress to ensure that all COVID-19 tests are covered by insurance now that FDA has released guidance that will expand testing access [news release]. Washington, D.C.; PR Newswire: March 17, 2020. https://prnmedia.prnewswire.com/news-releases/aacc-urges-congress-to-ensure-that-all-covid-19-tests-are-covered-by-insurance-now-that-fda-has-released-guidance-that-will-expand-testing-access-301025783.html. Accessed March 19, 2020.
  2. Coronavirus (COVID-19) update: FDA provides more regulatory relief during outbreak, continues to help expedite availability of diagnostics [news release]. Silver Spring, MD; FDA: March 16, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help. Accessed March 19, 2020.