Part B Insider (Multispecialty) Coding Alert

Published on Wed Sep 07, 2011 PDF

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?

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. In the CMS List of Waived Tests, watch for whether the code is listed with QW. If QW is not appended to the code on the 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: Palmetto offers a "CLIA Made Easy" page. You can find it by clicking on the March 29, 2011, article at www.palmettogba.com/palmetto/providers.nsf/docsCat/Jurisdiction%201%20Part%20B~Articles~Lab. You also can read about Medicare requirements in chapter 16, section 70, of the Medicare Claims Processing Manual (www.cms.gov/manuals/downloads/clm104c16.pdf).