The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.


The Centers for Medicare & Medicaid Services (CMS) has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification Form, CMS-116. This form should be completed and mailed to the address of the local State Agency for the state in which your laboratory resides. Refer to the State Agency & Regional Office CLIA Contacts page located on the left navigation bar to obtain the appropriate state agency address. The CMS-116 form and its instructions are found as a download in the Related Link Inside CMS section below and contain the following information:

  • The CLIA application form, CMS-116;
  • Instructions for completing the CMS-116;
  • Guidelines for counting tests for CLIA; and
  • Tests commonly performed and their corresponding laboratory specialties/subspecialties.

CLIA requires all entities that perform even one test, including waived test on … “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” to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.

The CLIA application collects information about a laboratory’s operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.