CLIA PROGRAM AND
MEDICARE LABORATORY SERVICES
Guidance for all laboratories that examine “materials derived from the human body for the purpose
of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” (42 Code of Federal Regulations [CFR] § 493.2).
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.