CMS announces new CLIA waived tests and their CPT codes

CMS on July 24 released Transmittal 10230 to inform Medicare contractors of five new Clinical Laboratory Improvement Amendments (CLIA) waived tests approved by the Food and Drug Administration (FDA).

CLIA waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The FDA determines which tests meet these criteria when it reviews manufacturer applications for test system waivers. Notably, Medicare pays only for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver.

Listed below are descriptions of the latest tests approved by FDA as waived tests under CLIA, along with the CPT codes used to report them. The laboratory codes must be reported with modifier -QW to be recognized as a CLIA waived test.

• Dealmed Medical Supplies LLC, Strep A Rapid Test Kit
  • 87880-QW, infectious agent antigen detection by immunoassay with direct optical observation; streptococcus, group A. Effective November 26, 2019.
• Germaine Laboratories Inc. AimStrip Tandem Lipid Profile and Glucose Measuring System (Germaine Laboratories Inc. AimStrip Tandem Total Cholesterol Test Strips)
  • 82465-QW, cholesterol, serum or whole blood, total. Effective February 26, 2020.
• Germaine Laboratories Inc. AimStrip Tandem Lipid Profile and Glucose Measuring System (Germaine Laboratories Inc. AimStrip Tandem Triglycerides Test Strips)
  • 84478-QW, triglycerides. Effective February 26, 2020.
• Sekisui Diagnostics, LLC. OSOM Mono Test (whole blood)
  • 86308-QW, heterophile antibodies; screening. Effective March 5, 2020.
• Sekisui Diagnostics, LLC, OSOM Ultra Plus Flu A&B Test (nasal and nasopharyngeal swabs)
  • 87804-QW, infectious agent antigen detection by immunoassay with direct optical observation; influenza. Effective April 3, 2020.

A complete list of CLIA waived tests and their CPT codes is available in Transmittal 10230.