New CLIA Waived Tests Effective October 1, 2020

New CLIA Waived Tests Effective October 1, 2020

There are five newly-added waived complexity tests under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). These tests go into effect Oct. 1 and will be implemented by Medicare Administrative Contractors by Oct. 5.

CLIA regulations require a facility to be certified for each test performed. To ensure that Medicare and Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are edited at the CLIA certificate level.

To be considered as waived, the recently approved tests must be reported with the CPT® codes below and modifier QW appended. The latest tests approved by the Food and Drug Administration (FDA) as waived under CLIA include:

CodeEffective DateDescription
87880QW Nov. 26, 2019 Dealmed Medical Supplies LLC, Strep A Rapid Test Kit
82465QW Feb. 26, 2020 Germaine Laboratories Inc. AimStrip Tandem Lipid Profile and Glucose Measuring System
(Germaine Laboratories Inc. AimStrip Tandem Total Cholesterol Test Strips)
84478QW Feb. 26, 2020 Germaine Laboratories Inc. AimStrip Tandem Lipid Profile and Glucose Measuring System
(Germaine Laboratories Inc. AimStrip Tandem Triglycerides Test Strips)
86308QW Mar. 5, 2020 Sekisui Diagnostics, LLC. OSOM Mono Test {Whole blood}
87804QW Apr. 3, 2020 Sekisui Diagnostics, LLC, OSOM Ultra Plus Flu A&B Test {Nasal and Nasopharyngeal Swabs}

For more information, see CMS Transmittal 10230.

Stacy Chaplain

About Has 49 Posts

Stacy Chaplain, MD, CPC, is an executive editor at AAPC. She has worked in medicine for almost 20 years and has more than five years' experience in medical writing & editing. Prior to AAPC, she led a compliance team as director of clinical coding quality for a multispecialty group practice. Chaplain received her Bachelor of Arts in Biology from The University of Texas at Austin and her Medical Doctorate from The University of Texas Medical Branch in Galveston. She is a member of the Beaverton, Ore. local chapter.

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