New Waived Tests Under CLIA

Listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA. The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. However, CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651 do not require a QW modifier to be recognized as a waived test.

The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are the following:

• 80305QW, December 13, 2018, Continental Pharmaceuticals, New Choice Home Drug Test Marijuana {Test Strip};
• 80305QW, December 13, 2018, Shenzhen Bioeasy Biotechnology Co., Ltd, BIOEASY Multi-Drug Test Cup;
• 80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Cup;
• 80305QW, April 18, 2019, Mercedes Scientific Inc., Platinum+ Multi-Drug Urine Test Dip Card;
• 87880QW, May 9, 2019, McKesson Consult Strep A Test Cassette;
• 87502QW, May 28, 2019, Alere ID NOW Instrument {Nasal and Nasopharyngeal swabs}, for Influenza A/B; and
• 87634QW, May 29, 2019, Alere ID NOW Instrument {Nasopharyngeal swabs}, for respiratory syncytial virus.

CR Transmittal Number: R4336CP

Source: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4336CP.pdf