When do I have to submit my CLIA renewal?

Renewal timing by certificate type

In practice, CLIA renewal runs on CMS bills, which CMS calls fee coupons or invoices and now sends only by email. This is when each one arrives, according to CMS (CMS paperless FAQ; CMS Quick Start Guide, March 2026):

Sources for the table: CMS paperless FAQ; CMS Quick Start Guide; CMS CLIA Certification brochure; State Operations Manual, Ch. 6, §§6006.2–6006.5; 42 CFR 493.45(e).

What the regulations say: 9 to 12 months

The federal CLIA regulations put a renewal application on a 9-to-12-month clock for three certificate types:

• Certificate of Waiver. A lab seeking to renew must “complete the renewal application prescribed by HHS and return it to HHS not less than 9 months nor more than 1 year before the expiration of the certificate” (42 CFR 493.37(f)(1)).
• Certificate of Compliance. A lab must “complete and return the renewal application to HHS 9 to 12 months prior to the expiration of the certificate of compliance” (42 CFR 493.49(g)(1)).
• Certificate of Accreditation. The same 9-to-12-month wording, plus meeting the accreditation requirements and paying the certificate of accreditation fee (42 CFR 493.61(h)).

The PPM section sets a two-year maximum but has no matching renewal-application sentence (42 CFR 493.47(e)). A Certificate of Registration is “not renewable” (42 CFR 493.45(e)(2)).

The CLIA statute adds one detail for accredited labs: when a lab is accredited, the application to issue or renew its certificate is submitted by “the accreditation body which accredited the laboratory” (42 U.S.C. 263a(d)(1)(A)).

Why you usually don’t file a renewal application

CMS’s instructions to State Agencies describe renewal as following payment, not a separate filing. A Certificate of Waiver or PPM certificate is renewed “for another 2-year period” upon expiration “after payment of appropriate fees.” A Certificate of Compliance is renewed “after recertification and payment of appropriate fees.” 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, §§6006.2–6006.5).

State Agencies tell labs the same thing. South Carolina’s CLIA FAQ answers “Are we required to submit a renewal application?” with “No,” and explains that labs with active certificates receive a renewal bill and the new certificate is generated once the fee is paid (SC DPH CLIA FAQs). Your own State Agency’s instructions control, so confirm with them if anything is unclear (CMS list of State Agency contacts).

Certificate of Compliance: the survey sets the clock

• CMS tells State Agencies to schedule the recertification survey “at least 6 months (180 days) prior to the expiration date of the laboratory’s current certificate, but no earlier than 12 months prior” (SOM Ch. 6, §6102.1).
• When scheduling, the State Agency sends the lab forms to complete, including Form CMS-116 and the personnel report, Form CMS-209 (SOM Ch. 6, §6102.1). CMS lists “Survey, Initial or Recertification” among the situations that require a new Form CMS-116 (SOM Ch. 6, §6016.1), and the form’s instructions say to check “survey” for “an initial survey or for a recertification” (Form CMS-116 instructions).
• If the survey finds 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).

So for a Compliance lab, renewal work starts about a year before expiration, which lines up with the regulation’s 9-to-12-month window.

Certificate of Accreditation: two tracks

An accredited lab renews its CLIA certificate with CMS and keeps its accreditation with its accreditation organization. Those are separate tracks.

• CMS: the certificate fee coupon arrives about 6 months before expiration (CMS paperless FAQ). Every two years, accredited labs pay CMS a validation survey fee and an accreditation certificate fee (CMS CLIA Certification brochure).
• Your accreditation organization: accredited labs are surveyed every two years by their CMS-approved accreditation organization (CMS CLIA Certification brochure), on that organization’s schedule and under its standards. CMS tells accredited labs to contact their accreditation organization for guidance (CMS CLIA page).

That is why Compliance and Accreditation are not on the same practical clock, even though the regulations give both the same 9-to-12-month wording.

Make sure the bill reaches you

• CLIA is paperless. CMS “no longer mails paper certificates or fee coupons” and fees are paid online through pay.gov (CMS CLIA page).
• Fee coupons and certificates come by email from noreply-cms-ccsq@ccsq.cms.hhs.gov, and CMS asks labs to keep that sender out of their spam folder (CMS paperless FAQ).
• CMS warns that a lab without a valid email address on file can face “lapsed certification due to missed payments” and “denied Medicare or Medicaid payments.” Update the email through your State Agency, or through your accreditation organization if you are accredited (CMS paperless FAQ).
• Watch for look-alike bills. On October 7, 2026, CMS warned that labs in several states received third-party solicitations “styled as bills or invoices,” and that official CLIA communications come only from CMS or your State Survey Agency (CMS QSSAM-27-01-CLIA).

To find your certificate type and expiration date, see how to look up your CLIA certificate expiration date. For what happens if a renewal is missed, see what happens if your CLIA certificate expires.

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.