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CLIA Certification Required for Claims

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This is a reminder that all providers of laboratory services must comply with the rules and regulations of the Clinical Laboratory Improvement Amendment (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 appropriate CLIA certification, the Texas Medicaid & Healthcare Partnership (TMHP) will deny reimbursement.

Updating CLIA Certifications in PEMS

Providers must update their CLIA certifications in the Provider Enrollment and Management System (PEMS) under the License/Certification/Accreditation link.

Providers may find more information about updating CLIA certifications in PEMS through the tmhp.com website at https://www.tmhp.com/topics/provider-enrollment/pems/licenses.

CLIA Certification Types

These 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 (PPMP) – This certificate is issued to a laboratory in which a physician, midlevel 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 the entity is determined by survey to be in compliance with the CLIA regulations.
  • Certificate of Compliance – This certificate is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements.
  • Certificate of Accreditation – This is a certificate that 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.