What happens if my CLIA certificate expires?

What the law and regulations say

• The CLIA statute: “No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary” (42 U.S.C. 263a(b)).
• The regulations: a lab “will be cited as out of compliance” with the statute unless it has “a current, unrevoked or unsuspended” CLIA certificate for the testing it performs, or is CLIA-exempt (42 CFR 493.3(a)).
• CMS’s instructions to State Agencies: “A laboratory cannot perform testing or claim Medicare and/or Medicaid payment for services performed without a CLIA certificate and/or valid CLIA identification number” (SOM Ch. 6, §6006).
• CMS’s CLIA page: “all laboratories must be properly certified to receive Medicare or Medicaid payments” (CMS CLIA page).

If a lab keeps testing without a certificate

CMS tells State Agencies what to do when a lab operates without a CLIA certificate. The State Agency or CMS notifies the lab that it is violating CLIA and warns it of the consequences. The lab gets 14 days to respond. If it does not respond, or does not stop testing without a certificate within 30 days of the notice, CMS notifies the HHS Office of Inspector General (OIG) (SOM Ch. 6, §6036).

How CLIA certificates usually lapse

• A missed fee coupon. The certificate is not issued until the fees are paid (42 CFR 493.655(a)). CMS warns that labs without a valid email address on file can face “lapsed certification due to missed payments” and “denied Medicare or Medicaid payments” (CMS paperless FAQ).
• A Compliance survey with deficiencies. CMS says “you won’t get your certificate until you’ve fixed the deficiencies, you’re in compliance, and paid your fee” (CMS CLIA Certification brochure).
• Lost accreditation. A Certificate of Accreditation is renewed after payment “unless CMS is notified by the accreditation organization of a laboratory’s loss of accreditation status” (SOM Ch. 6, §6006.5).
• Unpaid assessed fees. For certain fees, such as follow-up visit fees and the validation fee for accredited labs, the regulations say HHS revokes the certificate for failure to pay (42 CFR 493.643(d); 42 CFR 493.645(a)).

What to do if your certificate has lapsed or is about to

1. Confirm the status on QCOR. QCOR’s CLIA laboratory search covers active laboratories only (QCOR). If you can’t find your lab, ask your State Agency. See how to look up your CLIA certificate expiration date.
2. Find the CMS email. Fee coupons come from noreply-cms-ccsq@ccsq.cms.hhs.gov, so check your spam folder. If it isn’t there, CMS says to contact your State Agency (CMS paperless FAQ). Pay CLIA fees only through pay.gov (CMS CLIA page).
3. Call your State Agency, or your accreditation organization if you are accredited. CMS directs labs to their State Agency for CLIA fees, payment and certificate status, and accredited labs to their accreditation organization (CMS CLIA page; State Agency contacts).
4. Ask what it takes to restore the certificate. CMS lists “Reinstatement of CLIA certificate” among the changes that require a new Form CMS-116, while a “Reinstatement – Activate without Gap” can be handled with written notification (SOM Ch. 6, §6016.1). CLIA fees cover the “reinstatement of a terminated certificate with a gap in service” (42 CFR 493.638(a)).
5. Don’t pay look-alike invoices. CMS warned on October 7, 2026 that third-party solicitations “styled as bills or invoices” were reaching labs, and that official CLIA communications come only from CMS or your State Survey Agency (CMS QSSAM-27-01-CLIA).

To keep this from happening, know which renewal clock your certificate is on: see when to submit your CLIA renewal and how long a CLIA certificate is valid.

The Deadline Desk is an independent service, not CMS, HHS, a State Agency or an accreditation organization. This page summarizes public sources and is not legal or regulatory advice. Your State Agency or accreditation organization has the final word for your lab.