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Dynamic List Data
Title
Procedural Guidance for Clinical Laboratory Improvement Amendments (CLIA) Form CMS-116 Changes that Require a New Form CMS-116 or Written Notification (UPDATED)
Memo #
23-05-CLIA EXPIRED EFFECTIVE: January 17, 2025
Posting Date
2023-03-26
Fiscal Year
2025
Summary
EXPIRED AS OF JANUARY 17, 2025. FOR CURRENT GUIDANCE REFER TO QSO-25-13-CLIA: STATE OPERATIONS MANUAL (SOM), CHAPTER 6-SPECIAL PROCEDURES FOR LABORATORIES
-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 The fraudulent Form CMS-116 information is outdated.
-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 The fraudulent Form CMS-116 information is outdated.