Article Detail - JE Part A
Common CLIA Number Issues
Noridian's Provider Contact Center receives many calls with questions related to Clinical Laboratory Improvement Amendments (CLIA) numbers. The topics below represent the most common CLIA-related guidance provided to laboratories and other providers during the past six months.
Providers Frequently Omit the CLIA Number on Laboratory Claims
Providers often receive claim denials because they do not include the CLIA number on the claim.
- Enter CLIA number in BOX 23 on paper claims
- Enter CLIA number on electronic claims using qualifier X4
Claim Denials with Claim Adjustment Reason Code (CARC) CO-16 and Remittance Advice Remark Code (RARC) MA120
- CO-16: Claim or service lacks information or has submission or billing error(s) which is needed for adjudication
- MA120: Missing, incomplete, invalid, or not approved CLIA certification number
Providers frequently ask about claim denials with CARC CO-16 combined with RACR MA120. In most cases, this rejection occurs because the:
- CLIA Certificate expired
- Date of service falls outside CLIA certification period
- CLIA number was inactive or invalid on the date of service
- CLIA number format errors
- CLIA number omitted from claim
Providers Often Need to Verify Their CLIA Status
Newly enrolled providers, providers that recently updated their laboratory location, and providers receiving denials indicating no CLIA record exists for a practice location frequently contact the Provider Contact Center to:
- Verify CLIA status
- Confirm that Medicare has the correct CLIA number on file
- Determine whether CLIA records require updating
Providers can verify the following information using the CMS CLIA Laboratory Lookup tool:
- Active status
- Certificate type
- Certificate expiration date
Claim Denials with CARC CO-B7 and RARC N570
- CO-B7: This provider was not certified or eligible to be paid for this procedure or service on this date of service
- N570: Medical test provided is not within a certification category for the laboratory indicated
Providers commonly receive claim denials with CARC CO-B7 combined with RARC N570 when they bill a test that exceeds the complexity level authorized by their CLIA certificate.
To determine whether a laboratory may perform a specific test under its current certification, providers should:
- Identify the test's CLIA complexity classification (waived, moderate complexity, or high complexity).
- Compare the classification to the laboratory's CLIA certificate type.
Providers can use the following Food and Drug Administration (FDA) resources to identify a test's CLIA complexity classification level:
