Certificate of Waiver

70.8 - Certificate of Waiver (Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22) Effective September 1, 1992, all laboratory testing sites (except as provided in 42 CFR 493.3(b)) must have either a CLIA certificate of waiver, certificate for provider- performed microscopy procedures, certificate of registration, certificate of compliance, or certificate of accreditation to legally perform clinical laboratory testing on specimens from individuals in the United States. The Food and Drug Administration approves CLIA waived tests on a flow basis. The CMS identifies CLIA waived tests by providing an updated list of waived tests to the A/B MACs (A) and (B) on a quarterly basis via a Recurring Update Notification. To be recognized as a waived test, some CLIA waived tests have unique HCPCS procedure codes and some must have a QW modifier included with the HCPCS code. Information regarding CLIA test complexity categorization can be found by searching the U.S. Food and Drug Administration website (www.fda.gov).