Clinical Laboratory Improvement Amendments (CLIA)

CMS recently made improvements to the way laboratories pay their CLIA certification fee and get their CLIA certificate. As of 2023, laboratories can use online platforms to speed up the payment and certification process. Plus, your laboratory can “go paperless,” which means CMS will send you important certification information directly to your email.

Spotlight

Update your laboratory's email address

Make sure CMS has your laboratory’s most up-to-date email address on file so you get important updates and information from us. We encourage you to use a business email address or one that many staffers access and use.

Opt in to “go paperless”

When your laboratory opts in, you get:

• Email notifications from CMS.
• Electronic fee coupons (no longer paper coupons).*
• Your CLIA certificate sooner. No need to wait for it to come in the mail.**This does not apply to CLIA exempt states or state licensure.

To update your email address or opt in, you must:

• Provide written notification to your State Agency by email.

-OR-

• Fill out the CMS-116 application form . To opt in, check the box, “Receive notifications including electronic certificates via email.”

Even if your laboratory hasn’t opted in yet, you can still pay your CLIA certification fee online using a secure platform hosted by the U.S. Treasury Department. When you pay online, your payment gets processed overnight – it’s much faster than mailing hard-copy checks, which can take up to 10 business days.

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 320,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

COMPLAINT REPORTING

To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-hand navigation pane in this section. See the Consumer Complaints FAQ (PDF) on how to file a complaint. Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing.

QUESTIONS ABOUT the CLIA PROGRAM

1. For Questions regarding a CLIA certificate or fees: If you have a question related to CLIA fees or payment, CMS-116 applications, demographic updates, certificate status or upgrades, and/or Laboratory Director changes, please call your local State agency for assistance. Select the State agency based on the physical location of the laboratory. The State agency maintains the certificate information for new and existing laboratory providers within their state. For a list of our State agency CLIA contacts (PDF), please visit our website at /Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf (PDF)
2. All other questions about the CLIA program should be submitted to LabExcellence@cms.hhs.gov .

WOULD YOU LIKE TO RECEIVE EMAIL UPDATES FROM CLIA?