Proposed coverage for COVID-19 diagnostics runs counter to FDA Emergency Use Authorization provisions
Newswise — The Families First Coronavirus Response Act (H.R. 6201) represents swift action by the House of Representatives to bolster federal responses to the spread of coronavirus and aims to reduce the pandemic’s impacts on Americans’ safety and financial security, while addressing an ongoing COVID-19 testing backlog.
The Infectious Diseases Society of America, however, is alarmed that the bill only allows coverage for in vitro diagnostic test kits and laboratory developed tests that have already received Emergency Use Authorization by the U.S. Food and Drug Administration, excluding tests from developers that are in the process of finalizing EUA applications. This runs counter to the updated Feb. 29 policy allowing immediate use of tests that have been validated by developers, reduces patient access to urgently needed diagnostic tools and leaves patients open to surprise billing for tests administered under current policy.
The current bill language will potentially exclude thousands of tests that can be used to identify transmission and stanch the outbreak. With the bill now heading to the Senate, IDSA strongly encourages Congress to provide accessible testing for all Americans who require it by amending the current bill language to cover tests that have been validated in accordance with existing policy. This will ensure broad and sustained rollout of lifesaving testing, even in the event of delays in the EUA process.