Newly Waived Lab Tests

Newly Waived Lab Tests

Clinical diagnostic laboratories submitting claims to Medicare should be aware of 12 new tests recently approved by the FDA. The new Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests are shown in Table 1.

Table 1: New Waived Tests Requiring QW Modifier (MLN Matters MM11231)
CPT® Code Effective Date Description
80305QW September 14, 2018 Walmart Stores, Confirm Biosciences Equate Multi Drug of Abuse Test Cup
87880QW October 26, 2018 BD Diagnostic Systems, BD Veritor System
89300QW November 28, 2018 BonrayBio LensHooke X1 Semen Quality Analyzer
80305QW  November 29, 2018  Foodhold USA, LLC, CAREONE Drug Screen Tests Home Test Kit (OTC Use)
84550QW December 11, 2018 ForaCare, Inc. FORA MD6 Uric Acid Monitoring System (ForaCare, Inc. FORA MD6 Uric Acid Test Strips)
87880QW December 13, 2018 Easy Healthcare Corporation, Areta Strep A Swab Test
87634QW December 18, 2018 Sekisui Inc. Silaris Dock (Silaris RSV Test)
82010QW December 20, 2018 Apex Biotechnology Corp., KET-1 Blood Ketone Monitoring System
80305QW January 3, 2019 Easy Healthcare Corporation, Easy@Home Single Drug Screen Test (THC)
87809QW January 9, 2019 Quidel Corporation, QuickVue Adenoviral Conjunctivitis Test (Tear Fluid)
85018QW February 8, 2019 HemoCue Hb 801 System
80305QW February 13, 2019 Wondfo USA, Ltd. Q-Cup Multi-Drug Urine Tet Cup

These codes must have modifier QW appended in the first modifier field on the claim form (with the exception of CPT® codes 81002, 81025, 82270, 82272,
82962, 83026, 84830, 85013, and 85651).

Medicare only pays for diagnostic lab tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver. A CLIA waived test still requires the provider to include their CLIA number on the claim.

Medicare Administrative Contractors (MACs) will not search their files to either retract payment or retroactively pay claims. MACs will adjustment payments brought to their attention.

See MLN Matters® article MM11231 for complete details.

Renee Dustman
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Renee Dustman

Executive Editor at AAPC
Renee Dustman, BS, AAPC MACRA Proficient, is an executive editor at AAPC. She holds a Bachelor of Science degree in Media Communications - Journalism. Renee has more than 20 years experience in print production and content management. Follow her on Twitter @dustman_aapc.
Renee Dustman
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Renee Dustman, BS, AAPC MACRA Proficient, is an executive editor at AAPC. She holds a Bachelor of Science degree in Media Communications - Journalism. Renee has more than 20 years experience in print production and content management. Follow her on Twitter @dustman_aapc.

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