Pathology/Lab Coding Alert

Question: We are a CLIA waived lab. How can we find out if a specific test kit is something we're approved to use in our lab?

Kansas Subscriber

Answer: You can find a complete online list of approved tests for waived labs under the Clinical Laboratory Improvement Amendments (CLIA). The Food and Drug Administration (FDA) categorizes tests, and makes available a quarterly update of any new tests approved for waived-status labs.

CMS posts the CLIA waived list, which you can find at www.cms.gov/CLIA/10_Categorization_of_Tests.asp#TopOfPage. Click on the link for "List of Waived Tests."

Caution: Test manufacturers may provide information that their kit is CLIA-waived, but you should always check the authoritative FDA list to ensure that you have correct information.

The latest: Your lab will have 16 new tests that you'll be able to report as CLIA-waived, thanks to a recent CMS transmittal on the matter. According to MLN Matters article MM7266, CMS will now consider the following tests CLIA-waived:

• 87880 -- BTNX, Inc. Strep A Rapid Test
• 86308 -- Consult Diagnostics Mononucleosis Cassette (Whole Blood)
• 82274 and G0328 -- BTNX, Inc. Rapid Response Fecal Immunochemical Test
• G0434 -- Amedica Biotech AmediCheck Instant Test Cup
• G0434 -- On the Spot Drug Testing Multi-Drug of Abuse Urine Test.

Don't forget: You'll have to append modifier QW (CLIAwaived test) to these codes, and to codes for most other CLIAwaived tests.

To read the complete list of new CLIA-waived tests, visit www.cms.gov/MLNMattersArticles/Downloads/MM7266.pdf.