CLIA 101

Clueless about what CLIA means for coders? We can help

The Clinical Laboratory Improvement Amendments (CLIA) affects all laboratories and any practice that has an in-office lab. But talk of fancy CLIA requirements can cloud your understanding of the need-to-know basics, such as the three CLIA test categories and the purpose for using modifier -QW.
 
Here our experts explain the CLIA basics to ensure correct and efficient coding in your practice:
 
What Is the Purpose of CLIA? CMS enacted CLIA to establish "quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed," accord- ing to the General Program Description. CMS monitors CLIA compliance with surveys and routine lab inspections.
 
Three CLIA Test Categories: CLIA establishes three categories of lab tests "based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements," CMS states. The three test categories are waived, moderate complexity, and high complexity. Therefore, all labs receive certification as waived labs, moderate-complexity labs, or high-complexity labs, says Joan Logue, BS, MT-ASCP, principal with Health Systems Concepts Inc. in Longwood, Fla.
 
Small in-office labs commonly have a certificate of waiver that allows them to perform and bill only waived tests. When a waived lab receives an order for a complex test that is not on the waived tests list, it will send the order or test to an outside reference lab.
 
Important: If your practice has a waived lab, you should be familiar with the list of CLIA-waived tests (online at www.cms.hhs.gov/clia/waivetbl.pdf) so you know which tests you can bill Medicare for and which tests your lab personnel will send to a reference lab, says William Dettwyler, MT-AMT, president of Codus Medicus, a laboratory coding consulting firm in Salem, Ore. Otherwise you may inappropriately bill for a test your practice is not allowed to perform.
 
Remember to Append Modifier -QW: If your office has a waived lab, you must add modifier -QW (CLIA-waived test) to every waived lab test you report, Dettwyler says. This modifier tells Medicare that your practice has CLIA-waived status and is allowed to bill for the lab code you are reporting.
 
Every CLIA-waived test code is listed twice on the Medicare fee schedule - once by itself and once with modifier -QW to indicate the test is CLIA-waived.
 
Don't be fooled: You can't just report any lab code with modifier -QW and expect to get paid, Dettwyler says. The code you report must be listed on the fee schedule with -QW.

- Published on 2004-08-26