MLN Matters Number: MM12381 – New Waived Tests Effective Date: October 1, 2021

Listed below are the latest tests the FDA approved as waived tests under CLIA. The CPT codes for the following new tests must have the modifier QW to be recognized as a waived test.

CPT Code	Effective Date	Description
80305QW	October 9, 2021	American Screening LLC Discover Panel Dip Card Tests MOR2000
80305QW	October 9, 2021	American Screening LLC OneScreen Plus Panel Dip Card Tests MOR300
80305QW	October 9, 2021	American Screening LLC OneScreen Plus Panel Dip Card Tests MOR2000
80305QW	October 9, 2021	American Screening LLC Revel Panel Dip Card Tests MOR300
80305QW	October 9, 2021	Lendas UAB EXPLORO Highly Sensitive THC Test
80305QW	October 9, 2021	Clinical Reference Laboratory CRLStat Multi-Drug Urine Test Cup

CR Transmittal Number: R10897CP

Source: https://www.cms.gov/files/document/mm12381.pdf