New Waived Tests – MLN Matters Number: MM11982

Listed below are the latest tests approved by the 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.

(See the Official Instruction for CR11982 https://www.cms.gov/files/document/r10381CP.pdf  in the Additional Information section for the 26 page list of Tests Granted Waived Status Under CLIA)

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

CPT Code – Effective Date – Description:

86308QW March 5, 2020 Henry Schein One Step + Ultra MonoTest Kit (Whole Blood)

87804QW April 21, 2020 Henry Schein One Step + Ultra Flu Test Kit (Sekisui Diagnostics)

87804QW July 15, 2020 Fisher Healthcare, Sure-Vue Signature Influenza A & B Test

80305QW July 22, 2020 Medline Industries, Inc. Medline Drug Test Cup

80305QW August 18, 2020 Micro Distributing II, Ltd., STATTEST Wondfo Home Drug Test

Note: MACs will not search their files to either retract payment or retroactively pay claims, however, MACs should adjust claims if you bring those claims to their attention.

CR Transmittal Number: R10381CP

Source: https://www.cms.gov/files/document/mm11982.pdf