This article from CMS informs you about the addition of the QW modifier to HCPCS code U0002 and 87635. Medicare will permit the use of codes U0002-QW and 87635-QW for claims submitted by facilities with a valid, current CLIA certificate of waiver with dates of service on or after March 20, 2020. Make sure your billing staffs are aware of these changes.
Currently there is no Food and Drug Administration (FDA)-approved or cleared test to diagnose or detect COVID-19. The FDA has issued several Emergency Use Authorizations (EUAs) for the use of new diagnostic test to detect the SARS-CoV-2 virus.
Policy for Diagnostic Tests for Coronavirus Disease-2019, and generally refer to settings that are equipped with the instrumentation and appropriately trained personnel necessary to perform the test, and may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings.
Those tests listed on the FDA’s EUAs for COVID-19 website: https://www.fda.gov/medicaldevices/emergency-situations-medical-devices/emergency-use-authorizations under the Test Kit Manufacturers and Commercial Laboratories Table that include the terms “patient care settings outside of the clinical laboratory environment,” “near patient testing,” or “point of care” in the EUA can be used by facilities having a current CLIA certificate of waiver.
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