CMS Clarifies COVID-19 Over the Counter (OTC) Home Testing and CLIA Applicability

Published: 12/06/2021

  • Centers for Medicare and Medicaid Services
Relevant To:
  • Urgent Care,
  • Medical Office,
  • Home Health,
  • Hospitals,
  • Ambulatory Care,
  • Clinical Lab,
  • Pharmacy,
  • Hospice,
  • Rural Health Clinics

The U.S. Centers for Medicare and Medicaid Services (CMS) recently issued a Frequently Asked Questions Document that clarifies CLIA applicability for homes tests, such as COVID-19 home testing products. According to CMS:

  • Generally if a test is cleared, approved, or authorized specifically for home use by the FDA, that test is not regulated under CLIA when that test is self-administered in accordance with the FDA’s authorization and authorized labeling.
  • However, if f the test is eit

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