Q. I am a physician who performs urine dip sticks and finger sticks for blood glucose in my office as part of the patient’s visit. Am I considered to have a laboratory, and do I need a CLIA certificate?

A. Yes, the testing you perform qualifies as waived laboratory testing, and you need a CLIA Certificate of Waiver. This testing requires a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances. The Food and Drug Administration (FDA) determines which tests are waived tests (i.e., simple with a low risk of error) and thus fall under the purview of the certificate.

 The FDA recently added 36 new tests to the list. You can view the full list:

• Sorted by analyte name, and
• Sorted by the test categorization date and by the test system name.

More information is available here:

• TMA website,
• FDA website, and
• How to Obtain a CLIA Certificate of Waiver (PDF) from the Centers for Medicare & Medicaid Services.

Note that when billing Medicare, the CPT codes for the new tests must have the modifier QW to be recognized as a waived test. However, CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013 and 85651 do not require a QW modifier to be recognized as a waived test. Check with commercial health plans for their coding requirements.

Published Oct. 17, 2012

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