The Centers for Medicare & Medicaid Services (CMS) has updated the Clinical Laboratory Improvement Amendments (CLIA) certification application form, according to a November 5th CLIA communications update.
Key questions answered:
What changes have been made? Laboratories applying for a CLIA certificate must fill out Form CMS-116. The new form requires multiple valid email addresses for certificate, fee coupon, and communications delivery now that CLIA is paperless. Laboratories must also include the owner’s name and telephone number on the form and mark the CMS Certification Number (CCN) for any laboratory located within a CMS-certified healthcare facility with an asterisk.
When do the changes take effect? The new form will be implemented on November 9, 2026.
Where can I find the new form? The form can be found at the CMS CLIA website under “Apply for CLIA Certification.”
Do I need to submit a new application if my lab has already applied? No, Form CMS-116 is only required for applications submitted on and after November 9.
