Clinical Laboratories - New Waived Tests

We have listed below the latest tests approved by the Food and Drug Administration (FDA) as waived tests under The Clinical Laboratory Improvement Amendments of 1988 (CLIA). As defined by CLIA, waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” The Current Procedural Terminology (CPT) codes for the following new tests must be reported with modifier QW, CLIA waived test appended. In addition to the waived tests a new CPT code 86386 was developed by CMS for reporting in 2012. This code would be reported for the...

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Note:  The following article synopsis was NOT provided by the AHA. It was created by Find-A-Code/innoviHealth.

Article Overview

This page covers a list of newly approved waived laboratory tests under CLIA and the associated CPT reporting information. It is aimed at laboratory and coding professionals who need to track testing updates, effective dates, and related billing/reporting changes. The article also notes the addition of a newer CPT code developed for a specific qualitative assay and identifies the modifier used for waived-test reporting.

Why This Topic Matters

Changes in waived test status and CPT reporting affect laboratory billing, claim submission, and compliance. Keeping track of these updates helps coding staff and laboratories report tests accurately and align with current payer and regulatory requirements.

What You Will Learn

  • Which newly approved waived laboratory tests are included in the update
  • How the article organizes tests by effective date
  • Which CPT reporting updates are associated with waived laboratory testing
  • Which laboratory testing topics are highlighted in the waiver update

Who Should Read This

  • Medical coders
  • Laboratory billing staff
  • Compliance professionals
  • Pathology and clinical laboratory teams

Codes Discussed

Modifiers Discussed


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