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Reminder: CLIA Certification Required for Claims

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Reminder: All providers of laboratory services must comply with the rules and regulations of the Clinical Laboratory Improvement Amendments (CLIA). Providers must submit their CLIA certifications and can bill only for services for which they have an appropriate CLIA certification on file. Providers that do not comply with CLIA are not reimbursed for laboratory services.

All providers that bill laboratory services must have CLIA certification for the procedure code being billed. If a provider bills for a procedure without the appropriate CLIA certification, the reimbursement will be denied.

Updating CLIA Certifications in PEMS

Providers must update their CLIA certifications on the License/Certification/Accreditations web page in the Provider Enrollment and Management System (PEMS). This web page provides more information about updating CLIA certifications in PEMS.

CLIA Certification Types

The following items are the current CLIA certification types published by the Centers for Medicare & Medicaid Services (CMS):

  • Certificate of Waiver – This certificate is issued to a laboratory to perform only waived tests.
  • Certificate for Provider – Performed Microscopy Procedures (PPMPs) – This certificate is issued to a laboratory in which a physician, mid-level practitioner, or dentist performs no tests other than microscopy procedures. This certificate also permits the laboratory to perform waived tests.
  • Certificate of Registration – This certificate is issued to a laboratory that enables the entity to conduct moderate- or high-complexity laboratory testing, or both, until a survey determines the entity is compliant with the CLIA regulations.
  • Certificate of Compliance – This certificate is issued to a laboratory after an inspection finds the laboratory to be compliant with all applicable CLIA requirements.
  • Certificate of Accreditation – This certificate is issued to a laboratory on the basis of the laboratory's accreditation by an accreditation organization approved by CMS.

For more information, call the TMHP Contact Center at 800-925-9126.