NC Medicaid reminds providers that Clinical Laboratory Improvement Amendments (CLIA) certification is required to perform and bill for laboratory services. The level of CLIA certification held by a provider or laboratory must match the complexity of the tests performed, and claims submitted through NCTracks are subject to automated CLIA certification verification obtained through the Division of Health Service Regulation (DHSR).
CLIA Certification Requirements
- All laboratories and providers performing laboratory testing must maintain a valid CLIA certificate.
- The type of CLIA certificate must align with the level of test complexity (waived, moderate or high complexity).
- NCTracks performs a CLIA certificate match during claim processing. Claims submitted with a procedure code that exceeds the provider’s CLIA certification level will be denied.
Certificate of Waiver
- A Certificate of Waiver permits laboratories to perform only CLIA-waived tests, which are simple and carry a low risk of error (e.g., certain rapid drug screens, pregnancy tests, fingerstick glucose).
- Laboratories holding only a Certificate of Waiver may not perform moderate- or high-complexity tests, including most instrument-based and definitive drug testing procedures.
- When billing for CLIA-waived tests, providers must append the QW modifier to the applicable procedure code. Failure to include the QW modifier will result in claim denial.
Additional CLIA Certificate Types
- Certificate for Provider-Performed Microscopy Procedures (PPMP): Allows certain moderate complexity microscopy tests.
- Certificate of Compliance or Certificate of Accreditation: Required for laboratories performing moderate- or high-complexity testing, including definitive drug tests.
- Certificate of Registration: Temporary, issued while awaiting a survey for compliance or accreditation.
Drug Testing and CLIA Certification
Providers are reminded that drug testing codes are subject to CLIA certification requirements:
- 80305 (presumptive, visual read): May be performed in waiver laboratories when Food and Drug Administration-approved as waived. The QW modifier is required.
- 80306 and 80307 (presumptive, instrument-based): Require a CLIA certificate for moderate- or high-complexity testing. Not permitted in waiver labs.
- G0480–G0483 (definitive drug testing): Always require a CLIA certificate of compliance, accreditation or registration for high-complexity testing. These codes cannot be performed in waiver labs.
- Providers must ensure that their CLIA certification type is appropriate for the level of drug testing performed and that the CLIA number is on file in NCTracks.
Resources
- Providers may review CLIA certification requirements and application processes on the CMS CLIA website
- To apply for or update a CLIA certificate, visit How to Apply for a CLIA Certificate, Including International Laboratories | CMS
Provider Action
- Review your current CLIA certificate to ensure it covers the laboratory tests performed in your practice.
- Verify that your current CLIA information is on file with DHSR and report the correct information when you enroll with NC Medicaid. Any changes to your certification status (e.g. waived to high complexity) must be reported to DHSR directly and updated on your NC Medicaid provider record.
- Submit claims only for laboratory tests that fall within the scope of your CLIA certification.
- Use the QW modifier when billing for CLIA-waived tests to ensure proper adjudication.
Contact
NCTracks 800-688-6696
North Carolina Department of Health and Human Services
Division of Health Service Regulation/CLIA Certification
2713 Mail Service Center
Raleigh, NC 27699-2713
919-855-4620
FAX: 919-733-0176
Email: DHSR.CLIA@dhhs.nc.gov