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.