CMS releases guide and payment system for CLIA certification

Sept. 28, 2020

The Centers for Medicare & Medicaid Services (CMS) released a quick-start guide and payment system for laboratories seeking certification through the Clinical Laboratory Improvement Amendments (CLIA) program to test for COVID-19, according to a press release from CMS. The agency said the changes are designed to reduce paperwork and authorization delays.

CMS said the quick-start guide helps laboratories with the application process for CLIA certification and includes information on the expedited review process that was implemented at the beginning of the public health emergency. The expedited review process allows labs to start COVID-19 testing before the official paper certificate arrives by mail.

CMS said quick-start guide outlines the steps laboratories must follow to apply for and receive CLIA certification, including ensuring the form is submitted to the correct state agency.

Laboratories also have a new option to pay CLIA certification fees on a CMS CLIA Program website, which is hosted by the Treasury Department, the agency said. CLIA fees are based on the certificate requested by the laboratory (i.e., certificate of waiver, provider-performed microscopy, accreditation, or compliance) and, in some instances, the annual volume and types of testing performed. The CLIA Certificate Fee Schedule contains detailed information on costs, the agency said.

CMS regulates all laboratory testing performed on people in the U.S. through the CLIA program. To become CLIA-certified, laboratories must meet performance and quality assurance requirements aimed at ensuring they are able to deliver reliable and accurate test results for the purpose of proper diagnosis, prevention and treatment of diseases like COVID-19.

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