CLIA Made Easy

Clinical laboratory testing is subject to the requirements in the Clinical Laboratory Improvement Amendments (CLIA). All entities that perform clinical laboratory tests, including physician office laboratories, must obtain CLIA certification.

The CLIA program classifies clinical laboratory tests as:

  • Waived tests (Note: Some, but not all, waived tests must be reported with HCPCS modifier QW)
  • Provider-performed microscopy procedures (PPMP)
  • Non-waived and non-PPMP tests that are subject to CLIA edits
  • Tests not subject to CLIA

Follow these steps to ensure that you are submitting the correct information on claims for clinical laboratory tests:

Type of Clinical Lab Test
CLIA Certification Number Required on Claim?
Other Instructions
Waived
Yes
To see if HCPCS modifier QW is required with this CLIA-waived test, refer to the CMS website (PDF, 461 KB).
Provider-performed microscopy procedures (PPMP)
Yes
To access the most current list of PPMP procedures, refer to the CMS website (PDF, 9.38 KB).
Non-waived and non-PPMP
Yes
To access the most current list of non-waived and non-PPMP tests that are subject to CLIA, refer to the CMS website (PDF, 430 KB).
I don’t know
It depends

Access the links in this table for each 'type of clinical laboratory test' to determine whether the test you are submitting is subject to CLIA. If the test falls into one of these categories, follow the instructions above for the specific category.

Tests in the 8xxxx series of CPT codes that are not subject to CLIA are listed in this document (PDF, 94 KB)

Facts about CLIA certification:

  • Even if your facility only performs CLIA-waived tests, you must obtain 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.'
  • The specific CLIA certification number associated with the location where the test was performed must be submitted with each claim for clinical laboratory tests
  • What type of CLIA certificate do you have? Use the CMS Laboratory Demographics Lookup to find out. 

Reference:

  • Instructions for submitting your CLIA number on Medicare claims: CMS Medicare Claims Processing Manual (Pub. 100-04 (PDF, 447 KB)), chapter 16, section 70