Procedural Guidance for Clinical Laboratory Improvement Amendments (CLIA) Form CMS-116 Changes that Require a New Form CMS-116 or Written Notification (UPDATED)

This memorandum summarizes what laboratory changes require a new Form CMS-116 to be completed, and when written notification of a change is sufficient. • Form CMS-116s must be retained for at least seven years. • We are also including some updated instructions for Certificate Type Changes. CMS has updated the guidance in Admin Info: 09-09-CLIA to include email addresses and deleted the guidance for potential fraudulent Form CMS-116 applications. The fraudulent Form CMS-116 information is outdated.