Pathology/Lab Coding Alert

Reader Questions:

Find CLIA-Waived List for Your Lab

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 SubscriberAnswer: 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 [...]
You’ve reached your limit of free articles. Already a subscriber? Log in.
Not a subscriber? Subscribe today to continue reading this article. Plus, you’ll get:
  • Simple explanations of current healthcare regulations and payer programs
  • Real-world reporting scenarios solved by our expert coders
  • Industry news, such as MAC and RAC activities, the OIG Work Plan, and CERT reports
  • Instant access to every article ever published in Revenue Cycle Insider
  • 6 annual AAPC-approved CEUs
  • The latest updates for CPT®, ICD-10-CM, HCPCS Level II, NCCI edits, modifiers, compliance, technology, practice management, and more