CMS has updated Form CMS-116, the application for a Clinical Laboratory Improvement Amendments (CLIA) certificate. Nursing homes submitting an application on or after November 9, 2026, should use the updated form. CMS says submissions using the previous version after that date may experience processing delays.
The update is relevant to nursing homes that perform testing under their own CLIA certificate, including facilities with a Certificate of Waiver for point-of-care tests. It does not require every facility with an existing certificate to submit a new application.
The revised form includes space for additional email addresses, requests the owner’s name and telephone number, and asks for the CMS Certification Number (CCN) when the laboratory is located within a CMS-certified health care facility. The additional email address fields are marked optional on the form.
What members should do: If your facility is preparing an initial CLIA application or needs to submit Form CMS-116 for a change, download a fresh copy of the
form and instructions from CMS. Confirm that the facility’s email contact information is current: CMS now sends CLIA certificates and fee notices electronically. Submit the completed application to the appropriate State Agency.