House Passes Bill to Cover Coronavirus Testing with Emergency Use Authorization

This article has been updated to include a statement from the Association for Molecular Pathology requesting the US Senate to make certain changes to HR 6201.

NEW YORK – The US House of Representatives on Saturday passed HR 6201, the Families First Coronavirus Response Act, aiming to ensure that all testing will be covered by insurers and the costs will not be passed on to patients. 

The bill will now be considered in the US Senate, and President Donald Trump has voiced support for it. 

HR 6201 would provide supplemental appropriations in FY2020 to the US Department of Agriculture and US Department of Health and Human Services for nutrition and food assistance programs, provide unemployment benefits, and among other things, establish requirements for providing coronavirus diagnostic testing at no cost to consumers.

Specifically with regard to SARS-COV-2 testing, the bill instructs insurers offering group and individual health plans to cover diagnostics with Emergency Use Authorization from the US Food and Drug Administration, and waive deductibles, copayments, coinsurance for patients. The bill would lift insurers' prior authorization and other utilization management requirements for such tests. Costs associated with visiting one's doctor, an urgent care center, or an emergency room in order to receive such testing would also be covered.

However, Mary Steele Williams, executive director of the Association for Molecular Pathology, expressed concern that HR 6201 will only waive costs for tests that have received EUA from the FDA. On Feb. 29, the agency issued guidance allowing labs to validate and launch tests and submit EUAs in the subsequent 15 days. The language in the bill, which AMP characterized as a "drafting error" could impose costs on patients who receive lab tests in that interim period between launch and FDA authorization. 

"The restrictive language in HR 6201, if not remedied, will ultimately limit the tests being covered, resulting in many patients receiving surprise bills," Williams said in a statement. "It could also cause patients to not seek testing because they have no way of knowing whether their testing will fall into the gap left by the language introduced in the House."

The bill is now under consideration at the Senate. On Monday morning, AMP drew attention to this "drafting error" in a statement and called on the Senate to "make these changes and follow through on Congress’ commitment to provide free testing for all Americans."