CLIA Program & Medicare Lab Services
This revised Product comprises Subregulatory Guidance regarding the Clinical Laboratory Improvement Amendments (CLIA) Program and its content is based on publicly available content within https://www.govinfo.gov/content/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf. CMS policy or operation subject matter experts also reviewed/cleared this product. This Product educates Medicare health care providers on how to enroll in the CLIA Program, the types of laboratory certificates, and test method categorization. The previous version of this Product is available to the public and currently posted on the CMS website at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/MLN-Publications-Items/CMS1243307
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: May 12, 2023
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.