US · guidance
CMS Pub. 100-04, ch. 16, § 70.9
HCPCS Subject To and Excluded From CLIA Edits
At this time, all claims submitted for laboratory tests subject to CLIA are edited at the
CLIA certificate level. However, the HCPCS codes that are considered a laboratory test
under CLIA change each year. The CMS identifies the new HCPCS (non-waived, non-provider-performed procedure) codes, including any modifiers that are subject to CLIA
edits by providing an updated listing of these tests to the A/B MACs (A) and (B) on an
annual basis via a Recurring Update Notification. A facility that submits a claim for any
test mentioned in the HCPCS codes that are subject to CLIA edits list must have either a
valid, current CLIA certificate of registration (certificate type 9), a CLIA certificate of
compliance (certificate type 1), or a CLIA certificate of accreditation (certificate type 3).
Information regarding CLIA test complexity categorization can be found by searching the
U.S. Food and Drug Administration website (www.fda.gov).
In addition, the CMS identifies the new HCPCS codes in the 80000 series that are
excluded from CLIA edits by providing an updated listing of these tests to the A/B
MACs (A) and (B) on an annual basis via a Recurring Update Notification. No CLIA
certificate is required for a claim submitted for any test mentioned in the HCPCS codes in
the 80000 series that are excluded from CLIA edits list.
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
b2e13dc9b7f539fb1f505607d1d51738dc01da740979a21acf0f66467c0f0939
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