Background

6000 - Background (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100- 578, amended §353 of the Public Health Service Act (PHSA) (42 U.S.C. 263a), to extend jurisdiction of the Department of Health and Human Services (HHS) to regulate all laboratories that test human specimens for the purpose of providing information for diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. Except as provided at 42 CFR 493.3, entities that meet the definition of a laboratory at 42 CFR 493.2 must meet applicable Federal requirements and have a CLIA certificate in order to operate. Regulations implementing CLIA are codified under 42 CFR Part 493. These regulations require that all laboratories or entities that perform laboratory testing: • Pay user fees as assessed by CMS to finance the entire cost of administering the CLIA program; • Submit specific information to HHS or its designee; • Comply with specific administrative and program requirements; • Submit to surveys to assess compliance with CLIA requirements; • Be subject to specified enforcement actions; and • Apply for CLIA certificates based on the complexity of testing performed in the laboratory or based on accreditation by a CMS-approved accreditation organization; or • Be licensed or approved in accordance with State requirements if located in a State with a CMS approved State laboratory licensure program. Section 6141 of the Omnibus Budget Reconciliation Act of 1989, Public Law 101-239, requires that laboratories participating in the Medicare program comply with CLIA requirements. Therefore, all laboratories, with the exception of laboratories located in and licensed or approved by a State with a CMS-approved State laboratory licensure program (CLIA-exempt laboratories) must obtain a CLIA certificate to operate and to be eligible for payment under Medicare and Medicaid. Although CLIA-exempt laboratories do not need a CLIA certificate to operate, they are assigned a CLIA identification number for Medicare and Medicaid payment purposes.