CLIA Waived Test

January 27, 2017

Listed below are the latest tests approved by the FDA as waived tests under CLIA. CPT codes for the following new tests must have the modifier QW to be recognized as a waived test. CLIA requires that for each test it performs, a laboratory facility must be appropriately certified. To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.

• G0477QW [from July 7, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], July 7, 2016, TransMed Company, CLIA Screen In-Vitro Multi-Drug Urine Test Dip Card

• G0477QW [from July 7, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], July 7, 2016, TransMed Company, CLIA Screen In-Vitro Multi-Drug Urine Test Dip Cup

• 82274QW, G0328QW, July 27, 2016, Pinnacle BioLabs Second Generation FIT Fecal Occult Blood (FOB) Self-Test {Cassette}

• G0477QW [from August 11, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], August 11, 2016, Nobel Medical Inc., AEON Multi-Drug Urine Test Cup

• G0477QW [from August 11, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], Nobel Medical Inc., August 11, 2016, AEON Multi-Drug Urine Test Dip Card

• G0477QW [from August 11, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], August 11, 2016, Nobel Medical Inc., INSTA-SCREEN Multi-Drug Urine Test Dip Card

• 82274QW, G0328QW, September 6, 2016, ProAdvantage Immunochemical Fecal Occult Blood Test

• 87880QW, September 16, 2016, Cardinal Health Strep A Cassette Rapid Test

• G0477QW [from September 16, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], September 16, 2016, Premier Biotech, Inc., MDETOX Multi-Drug Urine Test Cup

• G0477QW [from September 16, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], September 16, 2016, Premier Biotech, Inc., MDETOX Multi-Drug Urine Test Dip Card

• 81003QW, October 7, 2016. Moore Medical LLC mooremedical U120 Urine Analyzer

• 87633QW, October 7, 2016, BioFire Diagnostics, FilmArray 2.0 EZ Configuration Instrument (Viral and Bacterial Nucleic Acids) {Nasopharyngeal Swabs}

• 87804QW, October 7, 2016, BioSign Flu A+B {Nasal and nasopharyngeal swabs}

• G0477QW [from October 24, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], October 24, 2016, Identify BioSciences Inc., Identifi Multi-Panel Drug Test Cups (Urine) {Cup Format}

• G0477QW [from October 25, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], October 25, 2016, UCP Biosciences, Inc. U-Card Drug Test Screen (Urine) {Card Format}

• G0477QW [from October 25, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], October 25, 2016, UCP Biosciences, Inc. U-Cup Drug Test Screen (Urine) {Cup Format}

• G0477QW [from October 26, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], Intrinsic Interventions Inc., Vista Flow

• 87804QW, November 15, 2016, LifeSign LLC, Status Flu A+B

• 87804QW, November 21, 2016, Sekisui Diagnostics LLC, OSOM Ultra Flu A&B Test

• G0477QW [from November 23, 2016, to December 31, 2016], 80305QW [on and after January 1, 2017], November 23, 2016, Medical Distribution Group Inc., Identify Diagnostics Drug Test Cards (UPC Biosciences, Inc.)

• 87804QW, November 25, 2016, OraSure QuickFlu Rapid A+B Test {Nasal and Nasopharyngeal Swabs

HCPCS code 80305QW describes the waived testing previously assigned the code G0477QW. All tests in the attachment that previously had HCPCS G0477QW are now assigned 80305QW.

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3696CP.pdf

CLIA Waived Test

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