Medicare Top Ten Denials and Action - CLIA

Action - Denied as CLIA (Clinical Laboratory Improvement Act ) no missing

MRA reason code CO-B7: This provider was not certified/eligible to be paid for this procedure/service on this date of service.

MRA reason code CO-16: Claim lacks information which is needed for adjudication.

· Remark message MA120: Missing/incomplete/invalid Clinical Laboratory Improvement Act (CLIA) certification number.

· Remark message M91: Lab procedures with different CLIA certification numbers must be billed on separate claims.


Effective January 1, 1998, the CLIA number must be included on all claims submitted for laboratory services, including purchased tests. CLIA mandates that virtually all laboratories, including Physician Office Laboratories (POLs), meet applicable federal requirements and have a CLIA certificate in order to receive reimbursement from federal programs.

The CLIA number must be submitted on all claims for laboratory services, including tests granted a “waived” status under CLIA and tests covered under the Provider Performed Microscopy Procedures (PPMP) certificates.

Claims for clinical laboratory services submitted by laboratories that have failed to receive CLIA certification will be denied.

The CLIA number of the billing lab must be reported in Item 23 of the paper CMS-1500 Claim Form or Loop 2300/REF02 (X4) of the electronic claim .

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