If the test is CLIA waived, the QW will need to be reported with the CLIA #.
Laboratory claims submitted without the CLIA number are returned as unprocessable. If the CLIA number is submitted on the claim, but is inconsistent with the CLIA format, the carrier returns the claim as unprocessable. If more than one CLIA number is submitted on the claim, except when a reference laboratory is on the same claim, the carrier returns the claim as unprocessable.
The CMS identifies CLIA waived tests by providing an updated list of waived tests to the Medicare contractors on a quarterly basis via a Recurring Update Notification. To be recognized as a waived test, some CLIA waived tests have unique HCPCS procedure codes and some must have a QW modifier.
For a list of specific HCPCS codes subject to CLIA see
In addition, the CMS identifies the new HCPCS codes in the 80000 series that are excluded from CLIA edits by providing an updated listing of these tests to the Medicare contractors on an annual basis via a Recurring Update Notification. No CLIA certificate is required for a claim submitted for any test mentioned in the HCPCS codes in the 80000 series that are excluded from CLIA edits list.
For a list of the specific HCPCS codes in the 80000 series that are excluded from CLIA edits refer to the following Internet site: http://www.cms.hhs.gov/CLIA/downloads/cpt4exc.pdf
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