New Waived Tests Under CLIA

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.

• 87807QW, June 30, 2017, Quidel Sofia 2 {Sofia RSV FIA};

• 82274QW, G0328QW, June 5, 2017, Henry Schein OneStep Pro+FIT (1)

• 80305QW, August 10, 2017, CLIA waived Inc. Instant Drug Test Cup/Card II (IDTC II);

• 80305QW, September 5, 2017, Premier Biotech Inc., Premier UTox Cup;

• 87804QW, September 7, 2017, McKesson Consult Influenza A & B {Nasal and Nasopharyngeal Swabs}; and

• 87804QW, September 8, 2017, PBM Princeton Biomedical Corp. ImmunoCard STAT! Flu A&B {Nasal and Nasopharyngeal Swabs}.

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3902CP.pdf