Medicare to Reimburse 6 New CLIA-Waived Tests, Starting Oct. 1

The FDA recently approved a half a dozen assays as CLIA-waived tests that Medicare will reimburse when properly billed and coded by CLIA-certified labs. On Aug. 6, CMS sent out coding instructions to Medicare Administrative Contractors. Here’s a rundown of the information that your lab’s billing staff needs to know.

Billing of New CLIA-Waived Tests

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 categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver. The edits ensure that payments for the particular test don’t go through if the lab doesn’t have the proper CLIA certificate of waiver.

QW Modifier Tests: Starting Oct. 1, 2021, Medicare will reimburse the CPT codes for the following new tests, 80305, provided that they have the modifier “QW” to ensure they’re recognized as a waived test: