New Waived Tests Implemented 7/3/2017

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.

• 82465QW, 83718QW, 82947QW, 82950QW, 82951QW, 82952QW, December 22, 2016, Polymer Tech. Systems, Inc., CardioChek Home Test System (CardioChek Home Chol+HDL+Glu test strips)

• 82465QW, 83718QW, December 22, 2016, Polymer Technology Systems, Inc., CardioChek Home Test System (CardioChek Home Chol+HDL test strips)

• 82465QW, 82947QW, 82950QW, 82951QW, 82952QW, December 22, 2016, Polymer Technology Systems, Inc., CardioChek Home Test System (CardioChek Home Chol+Glu test strips)

• 82465QW, 83718QW, 82947QW, 82950QW, 82951QW, 82952QW, December 22, 2016, Polymer Technology Systems, Inc., CardioChek Plus Test System (PTS Panels Chol+HDL+Glu test strips)

• 82465QW, 83718QW, December 22, 2016, Polymer Technology Systems, Inc., CardioChek Plus Test System (PTS Panels Chol+HDL test strips)

• 82465QW, 82947QW, 82950QW, 82951QW, 82952QW December 22, 2016, Polymer Technology Systems, Inc., CardioChek Plus Test System (PTS Panels Chol+Glu test strips)

• 81003QW, January 23, 2017, Germaine Laboratories, Inc. AimStrip Urine Analyzer 2 System (AimStrip Urine Reagent Strips)

• 81003QW, January 23, 2017, Germaine Laboratories, Inc. AimStrip Urine Analyzer 2 System (Fisherbrand Urine Reagent Strips)

• 87804QW, January 23, 2017, LifeSign LLC, Status Flu A+B {Nasal and Nasopharyngeal Swabs}

• 87804QW, January 23, 2017, Sekisui Diagnostics LLC, OSOM Ultra Flu A&B Test {Nasal and Nasopharyngeal Swabs}

• 80305QW, February 2, 2017, Advin Biotech, Inc. ATTEST

• 87801QW, March 6, 2017, Alere i System Respiratory Syncytial Virus

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3771CP.pdf