CMS Rescinds December 7, 2020, Enforcement Discretion for the Use of SARS-CoV-2 Tests on Asymptomatic Individuals Outside of the Test’s Instructions for Use

Published: 09/28/2022

  • Centers for Medicare and Medicaid Services
Relevant To:
  • Clinical Lab

The U.S. Centers for Medicare and Medicaid Services (CMS) has announced it is rescinding the December 7, 2020 guidance regarding the enforcement discretion under CLIA for the use of tests for SARS-CoV-2 on asymptomatic individuals outside of the test’s authorization, when an Emergency Use Authorization has been granted by the FDA.  According to CMS, because home testing is now widely available and tests can be provided within the parameters designed to ensure accuracy, the original justification

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