MM11765 – Addition of the QW Modifier to Healthcare Common Procedure Coding System (HCPCS) Code U0002 and 87635

This article informs you about the addition of the QW modifier to HCPCS code U0002 (2019- nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC) and 87635 [Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique]. Medicare will permit the use of codes U0002QW and 87635QW 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.

The terms “patient care settings outside of the clinical laboratory environment,” “near patient testing,” and “point of care” are mentioned in some EUAs, 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. In cases where these terms are used in EUAs, FDA has deemed such test to be appropriate for use in a CLIA waived setting for the time period of the emergency. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.

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. On March 20, 2020, FDA issued the first EUA containing the previous terms. HCPCS code U0002 and 87635 must have the modifier QW to be recognized as a test that can be performed in a facility having a CLIA certificate of waiver.

Note that MACs will not search their files to adjust claims already processed prior to implementation of CR 11765. They will adjust such claims that you bring to your MAC’s attention.

Source: https://www.cms.gov/files/document/mm11765.pdf