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Denied Laboratory Services and Clinical Laboratory Improvement Amendments (CLIA)  

NGS Medicare has been receiving calls from providers regarding denials for laboratory services. Upon research, they found these denials are due to issues with the laboratory CLIA certificate (Clinical Laboratory Improvement Amendments.)  

Your CLIA certificate specifies your laboratory specialties and subspecialties, outlining the tests you are authorized to perform and bill for. These specialties align with the testing scope approved under your CLIA certification and do not require annual renewal. 

If Medicare indicates a specialty is terminated, it may be due to a retired specialty code or a discrepancy between your CLIA and PECOS record. To resolve this, confirm your current specialties with your state CLIA office and update your CLIA and Medicare enrollment records. (Provider Enrollment, Chain and Ownership System)  

Contact your CLIA agency for assistance. You may need to submit a revised CMS Form 116.  

Once your CLIA certificate is updated, submit an enrollment update through PECOS using form CMS-855B or CMS-855I to ensure Medicare reflects your current CLIA information.  

The NGS PCC cannot assist or verify this information.  

Please remember, all CLIA approved laboratories must comply with all applicable CLIA requirements. Refer to 42 U.S.C. §263a and 42 CFR 493 for additional details regarding CLIA. 

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