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Notification to CMS of an FDA Cleared or Approved Clinical Diagnostic Laboratory Test (CDLT) under the Medicare Clinical Laboratory Fee Schedule (CLFS)

This form is to be used by laboratories or manufacturers to notify the Centers for Medicare & Medicaid Services (CMS) about CDLTs that are cleared or approved by the U.S. Food and Drug Administration (FDA), that are not advanced diagnostic laboratory tests (ADLTs).

Download the Guidance Document


Issued by: Centers for Medicare & Medicaid Services (CMS)

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.