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MLN 13455 – New Waived Tests

December 12, 2023

Listed latest tests approved by the FDA as waived tests under CLIA. The HCPCS codes for the new tests in MLN 13455 must have the modifier QW to be recognized as a waived test.
Clinical Laboratory Improvement Amendments (CLIA) requirements • New CLIA-waived tests approved by the FDA • Use of modifier QW for CLIA-waived tests.
The tests on the attached list to CR 13455 (HCPCS codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) don’t require a QW modifier to be recognized as a waived test.

Source: https://www.cms.gov/files/document/mm13455-new-waived-tests.pdf

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