New Waived Tests – MLN Matters Number: MM12504

Effective Date: January 1, 2022

Listed below are the latest tests the FDA approved as waived tests under CLIA. These new tests must have the modifier QW to be recognized as a waived test.

The HCPCS code, effective date and description for these latest tests are:

• 87801QW, March 30, 2021, binx health io Instrument (For use with female vaginal swabs and male urine)
• 86308QW, August 9, 2021, Cardinal Health Mono Rapid Test (Whole blood)
• 87801QW, August 26, 2021, Visby Medical Sexual Health Click Test (For use with self-collected vaginal swabs)

The new HCPCS code 87801QW (Detection test by nucleic acid for multiple organisms, amplified probe(s) technique) was assigned for the waived complexity testing performed by the binx health io Instrument (For use with female vaginal swabs and male urine) and the Visby Medical Sexual Health Click Test (For use with self-collected vaginal swabs). This code is effective March 30, 2021.

HCPCS codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651 don’t require a QW modifier to be recognized as a waived test.

CR:12504

Source: https://www.cms.gov/files/document/mm12504-new-waived-tests.pdf