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?

New York 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. 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, up-to-date information.

Don't forget: You'll have to append modifier QW (CLIA waived test) to codes for most CLIA-waived tests. Watch for whether CMS lists the code with QW on the waived-test list. If you don't see QW with the code on that list, you don't need to use the modifier on your claim. For example, 85013 (Blood count; spun microhematocrit) does not require modifier QW.

Resources: You also can read about Medicare CLIA requirements in chapter 16, section 70, of the Medicare Claims Processing Manual (www.cms.gov/manuals/downloads/clm104c16.pdf). Palmetto offers a "CLIA Made Easy" page. You can find it at www.palmettogba.com/palmetto/providers.nsf/DocsCat/Providers~Jurisdiction%201%20Part%20B~Articles~Lab~8CVNJT5561?open&navmenu=||