CLIA Goes Paperless

(August 18, 2025) The Centers for Medicare & Medicaid Services (CMS) is transitioning the Clinical Laboratory Improvement Amendments (CLIA) program to a fully electronic system. Effective March 1, 2026, laboratories and providers performing laboratory testing, including point-of-care testing under a CLIA Certificate of Waiver, must adopt email-based notifications to receive CLIA fee coupons and certificates.

This shift eliminates the use of paper-based communications, streamlining operations and improving efficiency across the healthcare laboratory landscape.  After March 1, 2026, CMS will no longer mail paper CLIA fee coupons and CLIA certificates.  Instead, laboratories will receive these documents electronically via email, allowing for faster processing and improved access to certification materials.

To transition to electronic notifications, laboratories must ensure CMS has their most up-to-date email address on file. CMS recommends using a business email address accessible by multiple staff members.

There are three ways to switch:

1. Email your CLIA State Agency with:
   • Laboratory name
   • Laboratory director or owner’s name
   • CLIA number
   • Signature of the director or designee
     CLIA State Agency Contacts (PDF)
2. Contact your Accreditation Organization, if applicable.
3. Submit a new or updated CMS-116 application form, checking the box for electronic notifications.
    

CMS has developed a comprehensive CLIA Partner Toolkit to assist laboratories and providers in navigating this transition. The toolkit includes:

• Fact sheets
• Posters
• FAQs
• Messaging templates for outreach

You can visit the CLIA program page for more information. For additional questions, contact CMS at LabExcellence@cms.hhs.gov.

Contact:  Carrie Mosley, cmosley@leadingageny.org, 518-867-8383 x. 147