US · guidance
CMS Pub. 100-04, ch. 16, § 70.8
Certificate of Waiver
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).
History
(Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
b888af8948270722f3cc67af1b88f8c9eff5550703d2ba971ea2a2bdd55be707
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