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CLIA Program and Medicare Laboratory Services

Guidance about the Clinical Laboratory Improvements Amendments (CLIA) Program and Medicare Laboratory Services. The CLIA Program regulates laboratories that test human specimens and ensures they give accurate, reliable, and timely patient test results regardless of where the test is performed. Topics addressed are program overview, getting CLIA certification, types of laboratory certificates, CLIA Proficiency Testing (PT), test categorization, Medicare laboratory services, and resources.

Download the Guidance Document

Final

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

Issue Date: May 01, 2020

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.