New Waived Tests – (CR) Number: 11354 Latest Tests Approved by the FDA as Waived Tests Under CLIA

CR 11354 presents the latest tests approved by the FDA as waived tests under CLIA. The Current Procedural Terminology (CPT) codes for these new tests must have the modifier “QW” to be recognized as a waived test.

Note: The tests mentioned on the first page of the list attached to CR 11354 (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 include:

 • 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

• 87634QW, May 29, 2019, Alere ID NOW Instrument {Nasopharyngeal swabs}, for respiratory syncytial virus

CLIA regulations require a facility to be appropriately certified for each test performed. 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.

CR#11354

Source: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11354.pdf