US · guidance
CMS Pub. 100-04, ch. 16, § 70.10
CLIA Number Submitted on Claims from Independent Labs
Effective with services provided October 1, 1997, any independent laboratory performing
tests covered by CLIA must submit the CLIA number on the claim as provided below.
The CLIA number is reported in:
• ASC X12 837 professional claim format REF segment as REF02, with qualifier
of “X4” in REF01, or
• Field 23 of the paper CMS-1500.
The CLIA number is not required on the ASC X12 institutional claim data set or its
related paper Form CMS-1450.
See Chapter 26 for detailed format instructions for the paper claim CMS-1500.
Laboratory claims submitted without the required CLIA number are returned as
unprocessable. If the CLIA number is submitted on the claim, but is inconsistent with the
CLIA format, the A/B MAC (B) returns the claim as unprocessable. If more than one
CLIA number is submitted on the claim, except when a reference laboratory is on the
same claim, the A/B MAC (B) returns the claim as unprocessable.
If the tests on one claim have been performed in more than one Physician Office
Laboratory (POL) by the same physician, the appropriate CLIA number should be
associated with the test that was performed in each laboratory. In such a case, the
physician must submit a separate claim for each location (CLIA number) where a test
was performed.
History
(Rev. 3014, Issued: 08-06-14, Effective: ICD- 10: Upon Implementation of ICD-10 ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10 ASC X12: 09-08-14)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
79c92cd69343ac1597dd8e9300ba910d99d6af06fe6daf7726478b7ddefac60d
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