Pathology/Lab Coding Alert

Reader Questions:

Match Lab Testing to CLIA License

Question:  Our physician office lab is CLIA waived, so if we perform 83009 and 86677, do we need to report the codes with modifier QW?
New Jersey Subscriber

Answer: You mention two tests:

  • 83009 — Helicobacter pylori, blood test analysis for urease activity, non-radioactive isotope (e.g., C-13)
  • 86677 — Antibody; Helicobacter pylori

Neither of these is a CLIA-waived test.

The Clinical Laboratory Improvement Amendments (CLIA) affects all laboratories, and any practice that has an in-office lab, no matter how small.

CLIA establishes three categories of lab tests: waived, moderate complexity, and high complexity. Small, in-office labs commonly have a certificate of waiver that allows them to perform and bill only waived tests. If you operate a lab with a certificate of waiver, you should not perform tests that are not CLIA waived.

Every CLIA-waived test code is listed twice on the Medicare fee schedule — once by itself and once with the QW modifier (CLIA-waived test) to indicate the test is CLIA-waived. If your office has a waived lab, you must add modifier QW to every waived lab test you report. This modifier tells Medicare your practice has CLIA-waived status and is allowed to bill for the lab code you are reporting.

However: You can’t just append modifier QW to any lab code and expect to get paid. The code you report must be listed on the fee schedule with QW. You can find a list of CLIA waived tests on the CMS website under “Regulations and Guidance.”