Physician Office Laboratories and the Clinical Laboratory Improvement Amendments (CLIA)

Published 02/13/2018

Background: Clinical Laboratory Improvement Amendments of 1988 (CLIA)
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.

Facts You Should Know
  • 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
  • Laboratory tests are classified for CLIA purposes according to complexity. CLIA certificates that are issued correspond to the complexity of tests performed and are categorized as follows:
    • CLIA waived tests: 'simple laboratory examinations and procedures that have an insignificant risk of erroneous result'
      • A Certificate of Waiver (COW) is required for submitting claims for CLIA waived tests
      • New waived tests are approved by the FDA on a flow basis, and the tests are valid as soon as they are approved
    • Provider-performed microscopy procedures (PPMP)
    • Nonwaived (moderate and/or high complexity) tests
Submitting Claims for CLIA-waived Procedures
Failure to submit CLIA-waived tests correctly is one of the primary causes of claims being 'returned as unprocessable.' These claims are identified with remark code MA130 and have no appeal rights. These claims must be corrected and resubmitted.
  • CLIA-waived tests may only be submitted by providers that have obtained a CLIA Certificate of Waiver
  • A complete list of CLIA-waived tests is available on the CMS website
  • Most CLIA-waived tests must be submitted with HCPCS modifier QW
  • CLIA-waived tests that do not require HCPCS modifier QW are CPT codes 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013 and 85651
  • Submit your CLIA certification number 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.
  • Submit the CLIA certification number issued for the specific location where the test was performed. CLIA certificates are site-specific, and a separate certificate is required for each location.
Obtaining CLIA Certification
  • 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, 1.83 MB), for more details about exceptions to the 'location rule'
  • CLIA certification is granted by state agencies


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