Practice Management Alert

Review Tests Before Deciding on CLIA-Waived Status

Question: As part of our practice analysis of ways to bring in additional income by offering ancillary services, our physicians want me to research CLIA waivers. We do not have CLIA-waived status currently but are considering it so we can perform some tests in the office. Is CLIA-waived status a good thing for practices?

Arkansas Subscriber

Answer: Whether or not the waiver is worth it is up to your individual practice. However, a practice is not allowed to perform many basic laboratory services without CLIA-waived status. So if your practice does not get the waiver, you could be missing out on possible pay for some simple screens.

Here are a few of the tests that have CLIA-waived status to help you decide:

• 81002 — Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy
• 81025 — Urine pregnancy test, by visual color comparison methods
• 82270 — Blood, occult, by peroxidase activity (e.g., guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (i.e., patient was provided three cards or single triple card for consecutive collection)
• 82962 — Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use
• 85651 — Sedimentation rate, erythrocyte;
  

non-automated

You can find a complete list of CLIA waived test codes, including a list of the approved commercially marketed tests at www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Categorization_of_Tests.html. Download the list of waived tests for the current list, which is updated quarterly.

If your practice has CLIA-waived status, you can perform (and bill for) these tests and others. For your practice to perform CLIA-waived testing, Medicare requires that you:

• Enroll in the CLIA program by obtaining a certificate pay the certificate fee every two years;
• Follow the manufacturers’ instructions for the waived tests;
• Notify your state agency of any changes in ownership, name, address or director within 30 days, or if you wish to add tests that are more complex; and
• Permit inspections by a CMS agent, such as a surveyor from the state agency. (Your laboratory is not subject to a routine survey or inspection.)

Remember: If your physician-office lab operates with a certificate of waiver from under the CLIA, then you should report the codes with modifier QW (CLIA waived test). Modifier QW indicates that a specific, commercially marketed in vitro diagnostic test has been categorized by the Food and Drug Administration (FDA) as a waived test. That means that the test involves a simple, accurate lab procedure with negligible likelihood of erroneous results that poses no reasonable risk of harm to the patient if performed incorrectly.

For more info: Check out the application for the CLIA waiver at www.cms.hhs.gov/cmsforms/downloads/cms116.pdf.