Clinical Laboratory Improvement Amendments Requirements
Provider Type
- Physicians
- Participating Physician Groups (PPG)
- Hospitals
- Ancillary
The Centers for Medicare and Medicaid Services (CMS) regulates laboratory testing through Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA regulations require facilities to be appropriately certified for each test they perform, 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.
CLIA ensures quality laboratory testing and requires all laboratory testing sites to have one of the following certificates to legally perform clinical laboratory testing:
- Certificate of Waiver (COW)
- Certificate of Registration
- Certificate of Accreditation
- Certificate for Physician-Performed Microscopy Procedures (PPMP)
- Certificate of Compliance
CLIA CERTIFICATION NUMBER
Providers must include the CLIA certification number when submitting laboratory claims with applicable HCPCS codes to Health Net in order for claims to be paid. For some clinical waived laboratory tests, providers must submit unique HCPCS procedure codes with a modifier QW, which denotes a CLIA waiver.
HCPCS codes for clinical laboratory tests under CLIA regulations change each year. CMS provides an updated listing of new HCPCS codes that are subject to CLIA edits, waived from CLIA edits and discontinued. A current listing of HCPCS codes is available online at CMS.