CMS has instructed its MACs to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective Oct. 1.

On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) instructed its Medicare Administrative Contractors (MACs) to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective October 1, 2022. Here’s a briefing of what your lab billing staff needs to know about the changes to ensure proper billing and coding of the newly waived tests.

Billing of New CLIA-Waived Tests

Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require labs to be appropriately certified for each test they perform. CMS edits lab claims at the CLIA certificate level to ensure that Medicare pays only for lab tests that the FDA approves as waived complexity under CLIA in facilities with a CLIA certificate of waiver. Since such tests are marketed immediately after approval, CMS has to notify its MACs about the new tests to ensure they can process claims accurately.

The New QW Modifier CLIA-Waived Tests

In its Aug. 4 transmittal (Pub. 100-04/Transmittal: 11547/Change Request: 12841), CMS lists the Healthcare Common Procedure Coding System (HCPCS) codes for eight new tests that must be recognized as CLIA-waived tests, provided that they list the QW modifier:

New Non-QW Modifier CLIA-Waived Tests

Also be aware that there are CLIA-waived tests that will be recognized without the QW modifier, all of which are produced by various manufacturers (and thus have a CPT rather than a proprietary HCPCS code associated with a single producer):