New Waived Tests – MLN Matters Number: MM12204

May 10, 2021

Effective Date: July 1, 2021

The CPT codes for the new tests we list below must have the modifier QW to be recognized as a waived test.

The CPT code, effective date, and description for the latest tests FDA-approved waived tests under CLIA are:

80305QW, August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Cup
80305QW, August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Dip
80305QW, September 23, 2020, Axium BioResearchInc.DrugExam Multi Drug Screen Test
80305QW, October 9, 2020, American Screening LLC Discover Panel Dip Card Tests MOR 300
80305QW, October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 300
80305QW, October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 2000
80305QW, October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 300
80305QW, October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 2000
80305QW, October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 300
80305QW, October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 2000
80305QW, October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR300
80305QW, October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR2000
80305QW, October 9, 2020, American Screening LLC Reveal Panel Dip Card Tests MOR2000
80305QW, October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR300
80305QW, October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR2000

CR Transmittal Number: R10721CP

Also, CR 12204 gives the following HSPCS code description changes, effective October 6, 2020:

Source: https://www.cms.gov/files/document/mm12204.pdf