Application and Certificate Process

6006 - Application and Certificate Process (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) It is the responsibility of the laboratory to obtain and submit the CLIA application (Form CMS- 116, Exhibit 125) and necessary personnel information for a CLIA certificate. The CLIA application collects information about a laboratory’s operation that is necessary to determine the fees to be assessed, to establish baseline data and to fulfill the statutory requirements for CLIA. The information will provide an overview of a facility’s laboratory operation. A laboratory cannot perform testing or claim Medicare and/or Medicaid payment for services performed without a CLIA certificate and/or valid CLIA identification number. (See Chapter 2, section 2005, for additional information pertaining to “Medicare Health Care Provider/Supplier Enrollment.”) CMS (directly or through its agents or contractors) is responsible for providing, collecting, and processing CLIA applications; generating fee coupons; collecting certificate and inspection fees; and entering application and fee data into the CLIA database. A CMS contractor issues the CLIA certificate through the Quality, Certification and Oversight Reports (QCOR).