HCPCS Modifier QW

• Submit this modifier with clinical laboratory tests that are waived from the Clinical Laboratory Improvement Amendments of 1988 (CLIA) list. The Food and Drug Administration (FDA) determines which laboratory tests are waived. Note that not all CLIA-waived tests require HCPCS modifier QW. The CLIA-waived procedures that do not require HCPCS modifier QW include: CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013 and 85651, and HCPCS code G0394.
• This modifier must be submitted in the first modifier field  
• Determine if the CPT code is a waived test by accessing the CMS CLIA web page
• Palmetto GBA will publish information on tests newly classified as waived on our website. The list of CLIA waived tests can be updated as often as quarterly.
• The CLIA certificate number is also required on claims for CLIA waived tests. Submit this information in Loop 2300 or 2400, REF/X4, 02 for electronic claims. For paper claims, submit the CLIA certification number in Item 23 of the CMS-1500 claim form. 

CLIA Background

• The Centers for Medicare & Medicaid Services (CMS) regulates laboratory testing through CLIA. The primary objective of the CLIA program is to ensure quality laboratory testing. CLIA regulations require facilities to be appropriately certified for each test they perform.
• CLIA requires all facilities that perform even one test, including waived tests, on materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings to meet certain federal requirements
• Any facility that performs tests for these purposes, including physician office laboratories, are considered laboratories under CLIA and must apply for and obtain a certificate from the CLIA program
• New waived tests are approved by the FDA on a flow basis, and the tests are valid as soon as they are approved
• Generally, CLIA certification is required for each location where testing is performed. There are exceptions for laboratories that are not at a fixed location and laboratories within a hospital. Refer to CMS CLIA Brochure #5, How to Obtain a CLIA Certificate, (PDF, 1.60 MB) for more details about exceptions to the location rule.