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CodeMap® Briefing: 02/13/2025


Editor's Welcome: Today we will be revisiting earlier briefings discussing CLIA waived testing. Many physician office laboratories (POLs) hold a CLIA Certificate of Waiver in order to perform rapid point-of-care tests. Both the FDA and CMS are involved in the process of authorizing waived testing. It is important to understand that while a test can be authorized as waived by the FDA, CMS may have specific coding requirements.


Introduction

As discussed in earlier CodeMap® Briefings, Congress enacted the Clinical Laboratory Improvement Amendments (CLIA) to establish quality standards for laboratory procedures to ensure accuracy, reliability, and timeliness of test results. A provider must be properly certified/registered by CLIA in order to receive reimbursement for laboratory testing from Medicare or Medicaid programs. POLs typically register for a CLIA Certi....

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