
A CLIA lab must notify its State Agency in writing within 30 days of a change in ownership, name or location. The CLIA number survives a sale, a rename or even a move to another state. A revised certificate costs $95 or $150 as of October 2026, and some states, such as California, require a new state application.
Labs move, rebrand and change hands all the time, usually as a side effect of something bigger: a practice relocating, a pharmacy chain acquiring stores, a group selling to a health system. The CLIA certificate is easy to forget in those projects, and the federal deadline is short.
Which changes have to be reported, and how fast?
A waiver lab must notify HHS or its State Agency "Within 30 days of any change(s) in (1) Ownership; (2) Name; (3) Location; or (4) Director" (42 CFR 493.39(b)). PPM, compliance and accreditation labs have the same 30 days (493.53(b), 493.51(a), 493.57(a)(2)), and CMS's Quick Start Guide (March 2026) shows 30 days for ownership, name and location across every certificate type. Notice must be in writing; State Agencies "must not accept oral notices of change or intent to change" (State Operations Manual, Chapter 6, section 6016).
Does the CLIA number change when a lab is sold or moves?
Usually not. CMS's rule for State Agencies: "Once a laboratory is assigned a number, it retains this number even if it withdraws from CLIA, has its certificate revoked, changes its certificate type or ownership, location (i.e., relocates to another State), name, or operator. A CLIA number will not be reassigned to another laboratory" (SOM section 6008).
The first two characters of the number identify "the State in which the laboratory was located when it initially applied," so a lab that moves from Ohio to Indiana keeps a number that starts with Ohio's code. That is expected, and payers should not treat it as an error.
Keeping the number is not the same as keeping everything else. The new owner's details, a new address or a new name still have to reach the State Agency, and payer enrollment files have to be updated separately.
Does each change need a new CMS-116?
CMS sorts changes into two groups (SOM section 6016.1):
- A new CMS-116 is required for: a certificate type change, reinstatement, adding a multiple-site exception, a director change at a PPM or compliance lab, and a change in "Type of Control (Ownership Type)," which is Section IX of the form (for example, a for-profit practice bought by a nonprofit system).
- Written notice is enough for: the lab's name, physical location, mailing and corporate addresses, "Tax ID (EIN)," specialties, test volume, phone and fax, email address, multiple-site details, change of accreditation organization and "Voluntary Closure/Termination."
Written notice "includes an email, fax, or hard copy letter" and must include "the laboratory's name, CLIA number, the name of the Laboratory Director and/or Owner, the change(s) being made, and the signature of the Laboratory Director or designee." A new CMS-116 is always acceptable instead, and "each section of the Form CMS-116 applicable to the certificate type must be completed in its entirety" when one is used.
A sale often touches several items at once: a new EIN, a new name, sometimes a new type of control and a new director. We usually file a complete CMS-116 for a change of ownership so the State Agency has every field in one place.
Before closing, what should a buyer check?
- The certificate's status and type. Look up the lab's certificate and its expiration date. CMS's October 2026 alert notes that survey and certification information is public in CMS's QCOR system "at no cost."
- Whether the lab tested within its certificate. A waiver lab that has been running a nonwaived test carries that history with its number. Performing tests outside the certificate is a ground for revocation (42 CFR 493.1840(a)(2)).
- Who counts as an owner. CMS defines an owner as "any person who owns any interest in a laboratory except for an interest in a laboratory whose stock and/or securities are publicly traded" (CMS-116 instructions).
- The buyer's own history. CMS may act against a lab whose owner or operator "Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked" (493.1840(a)(8)).
- The email address on file. Fee coupons and certificates go only by email since March 1, 2026. If the seller's staff inbox is on the CMS-116, the renewal coupon goes to them.
- State licenses. State registrations and permits often do not transfer the way the CLIA number does. See below.
Moving the lab: what changes besides the address?
The certificate is tied to a physical address; the facility address "must reflect the physical location where the laboratory testing is performed" and "cannot be a Post Office box." Report the new address within 30 days. If the move splits one lab into two sites, the second site needs its own certificate, because only three narrow exceptions allow one certificate for several fixed locations. See one certificate per site.
A move across state lines keeps the CLIA number but brings a new State Agency and the new state's own lab rules. A lab moving into Washington, which replaces CLIA certificates with its own Medical Test Site license, is a separate project. See state requirements.
What does the revised certificate cost?
A revised certificate is one "reissued with changes to one or more fields displayed on the certificate, such as the laboratory's name, address, laboratory director, or approved specialties/subspecialties" (SOM section 6018). As of October 2026 it costs $95 for a waiver or PPM lab and $150 for registration, compliance and accreditation labs, and a plain replacement copy costs $75 (Minnesota Department of Health, applying CMS-3326-F). CMS emails the coupon to the lab, and the lab pays on pay.gov. Look-alike third-party "invoices" circulated in several states in 2026; see look-alike CLIA invoices.
Is closing a lab a change too?
Yes. The CMS-116 instructions list "lab closure" with location and director among the changes reported with an effective date, and CMS accepts written notice of a "Voluntary Closure/Termination" (SOM section 6016.1). Report it even if the practice is only stopping its testing; an open certificate stays on CMS's renewal cycle. The number is retired with the lab, not recycled: a lab "retains this number even if it withdraws from CLIA," and "A CLIA number will not be reassigned to another laboratory" (SOM section 6008). A lab that later restarts testing asks for reinstatement, which CMS lists among the changes needing a new CMS-116.
How do states treat a sale or a move?
California's rule is the strictest we have read. "A clinical laboratory license or registration shall be automatically revoked 30 days from a major change of laboratory directorship or ownership," unless the lab files "a completed application for a new clinical laboratory license or registration within those 30 days." Notice of a change in ownership "shall be the responsibility of both the current and new owners," and both remain responsible to the department until it receives proper notice (Bus. & Prof. Code 1265(e), (g)). A separate registration is required for each location, so a move to a new address is a filing too. See California's registration.
New York's Limited Service Laboratory program has separate change forms for owner information, location and name. See New York. Check every other state on the state requirements index.
Who updates payer files?
Not the CLIA program. A new owner, a new EIN or a new address usually means updating Medicare, Medicaid and commercial enrollment, and claims for lab tests are edited against the CLIA certificate on file. Our sister company handles that; see White Glove Credentialing's post on enrollment mistakes that cause denials.
How do we handle a sale or a move?
We prepare the CMS-116 or written notice, the state change filings, and a checklist of every date that moves with the deal. The owner or director signs; the lab pays CMS and the states directly. A Change of Ownership filing is $299, and a name or address change is a $149 CLIA Change Request. Buyers of several sites can add Renewal and Compliance Tracking at $299 per year for the first lab and $99 for each additional site.
Common questions
- Does a CLIA certificate transfer to a new owner?
- The CLIA number stays with the lab when ownership changes, according to CMS. The State Agency must be notified within 30 days, and state licenses and payer enrollment need their own updates.
- Do we keep our CLIA number if we move to another state?
- Yes. CMS says a lab keeps its number even when it relocates to another state. The new state's own lab rules and State Agency then apply.
- Is a phone call to the State Agency enough to report a change?
- No. CMS tells State Agencies not to accept oral notices. Send written notice by email, fax or letter, or a new CMS-116.
- What happens to a California lab registration after a sale?
- It is automatically revoked 30 days after a major change of ownership unless the lab files a completed new application within those 30 days.
Need Help with Your CLIA Certificate?
We prepare your CMS-116 and any state filing for your owner or director to sign, then track your certificate, changes and renewals.
