CLIA Certification Number Required

Remark Code/ Message Number

• MA120: Missing/incomplete/invalid CLIA certification number

Resolution

• Entities that perform clinical laboratory tests must obtain certification through the state department of health. This is known as Clinical Laboratory Improvement Amendments of 1998 (CLIA) certification.
• Your CLIA number must be submitted on claims for clinical laboratory tests, including tests that are classified as 'CLIA-waived.' 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.
  • Some clinical laboratory tests must also be submitted with HCPCS modifier QW. The Food and Drug Administration (FDA) determines which laboratory tests are waived. Please note that not all CLIA-waived tests require HCPCS modifier QW. 
• Determine if the CPT code is a waived test by accessing the Centers for Medicare & Medicaid (CMS) CLIA CMS Web page
• Palmetto GBA will publish information on tests newly classified as 'waived' on our website
• Submit your corrected claim as a new claim. Claims that are missing required CLIA certification numbers are rejected as 'billing errors' and must be submitted as new claims.

CLIA Background

• 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 named How to Obtain a CLIA Certificate CMS Web page for more details about exceptions to the 'location rule'.

Tools/Resources

• Clinical Laboratory Improvement Amendments (CLIA) CMS web page