How Familiar Are You with CLIA Waived Tests and Their Codes?

by  Find-A-Code™
Sep 8th, 2023

Pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1998, clinical laboratories must be certified to perform the tests they offer. Each test has an appropriate CPT code that goes along with it. However, these codes change from year to year. You should also note that certain tests are waived in terms of certification requirements. A separate modifier is attached when coding such tests.

The tests and CLIA waived tests changed for coding purposes yet again in 2023. There is no reason to believe that further changes will not be implemented for next year. Here is the point: it's important to stay up to date with the changes if your work involves a lot of lab tests.

Why Certain Tests Are Waived

Federal law requires certification among medical labs due to the propensity for producing erroneous results. In simple terms, regulators want to avoid mistakes with lab tests. Therefore, they require that labs be certified. This demonstrates that they know how to properly perform tests to maximize accuracy.

All that being said, there are certain types of lab tests that come with an exceptionally low risk of producing erroneous results. These are straightforward tests that are difficult to muck up. These are also the types of tests that tend to be waived for certification purposes. A lab that performs them doesn't have to be certified for them.

In order for a lab test to qualify as a CLIA waived test, it must meet the following conditions:

1. It must be straightforward and simple to conduct.
2. Its risk for both false positives and false negatives needs to be comparably low.
3. It must be comparatively reliable and accurate when conducted according to manufacturer instructions.

A pregnancy test based on a urine sample is the perfect example. Labs, OB/GYN practices, and even primary care offices can all conduct these tests without certification. Women can conduct their own tests at home by purchasing an over-the-counter test kit.

No Test Is Perfect

It should be kept in mind that no lab test is perfect. Even the simplest tests can produce inaccurate results. If there is ever any doubt of the accuracy of a CLIA waived test, it doesn't hurt to get a second test performed at a different facility. The same goes for tests performed at home.

Some other things to remember include the following:

• Patients should never make major medical decisions based solely on waived tests.
• Some types of CLIA waived tests are not covered by standard health insurance.
• Most waived tests are not subject to the same level of scrutiny or regulation as non-waived tests.

None of this is to say that waived tests should be avoided. It's not to say that they are junk science or unreliable. The point is that they are only treated differently from non-waived tests for certification and coding purposes.

The Code and Its Modifier

As previously stated, all CLIA wave tests must be coded with an additional modifier: QW. The OSOM Ultra Strep A Test is a good example. Its official CPT code is 87880QW. This particular test has been considered a waived test since 2012.

Last but not least, CPT code changes for 2023 include nine lab test codes that don't have to be coded with the QW modifier to be considered CLIA waived tests. That is a different topic for another post. You can always look online if you are curious.

Remember that waived tests need to be coded correctly so as to avoid delays in payment. If you're not familiar with how to look up said codes, there is no better time to learn than now.