How to code laboratory tests waived by federal regulations

Q: Our office is Clinical Laboratory Improvement Amendments (CLIA)-certified. Can you provide an update on which tests are CLIA-waived?

A: According to CLIA regulations, a facility is required to be appropriately certified for each test performed.

According to the Centers for Medicare and Medicaid Services (CMS), laboratory claims are currently being edited at the CLIA certificate level in order to ensure that the Medicare and Medicaid programs only pay for laboratory tests categorized as waived complexity for those entities that hold a CLIA certificate of waiver.

Listed in the chart to the right are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA.  Modifier QW (CLIA waived test) needs to be appended to the CPT codes for the listed tests with the exception of 82962 (Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use).

CLIA-waived tests are those that are cleared by the FDA for home use. Waived tests must be simple and have a low risk for erroneous results, though the tests are not error-proof. 

The answer to the reader’s question was provided by Renee Stantz, a billing and coding consultant with VEI Consulting Services in Indianapolis, Indiana. Send your practice management questions to [email protected].