Updated CMS Form-116: CLIA Application for Certification
The Centers for Medicare & Medicaid Services (CMS) has released an updated Form CMS-116, Application for Certification under the Clinical Laboratory Improvement Amendments (CLIA). The revised form takes effect on November 9, 2026.
Laboratories must use Form CMS-116 to apply for a CLIA certificate, which is required to perform testing on human specimens. The form is available on the CMA CLIA website.
What’s New on the Form
The updated form asks laboratories to:
- Provide more than one valid email address to receive certificates, fee coupons, and other CMS CLIA communications.
- Reminder: CLIA Is Paperless- CMS no longer mails paper CLIA certificates or fee coupons. All certification and survey fees must be paid online, and paper checks are no longer accepted. Keep a valid email address on file to receive your electronic certificates, fee coupons, and other CMS CLIA communications.
- Provide the owner’s name and telephone number.
- Provide the CMS Certification Number (CCN) for any laboratory located within a CMS-certified healthcare facility, marked on the form with an asterisk.
What You Need to Know
- Use the updated Form CMS-116 for any application you submit on or after November 9, 2026.
- Download the updated Form CMS-116 and its instructions from the CMS CLIA website.
- Applications submitted after November 9, 2026, using the previous version may experience processing delays.