HCPCS Subject To and Excluded From CLIA Edits

70.9 - HCPCS Subject To and Excluded From CLIA Edits (Rev. 11463; Issued: 06-23-22; Effective: 07-25-22; Implementation: 07-25-22) 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.