Texas Form 3225 and CLIA in Texas

Texas is one of the simpler states in which to open a testing site. Texas Health and Human Services (HHSC) says it plainly on its CLIA page: "Laboratories are not state licensed." There is no Texas lab registration, permit or license fee layered on top of the federal certificate. There is, however, one Texas form that trips up first-time applicants: Form 3225, Application for Certification, Supplement to CMS 116.

What is Form 3225?

HHSC's forms page describes it this way: "Form 3225 is used as a supplement to the Centers for Medicare & Medicaid Services (CMS) Form CMS-116 to apply for a Clinical Laboratory Improvement Amendments of 1988 (CLIA) program certificate." HHSC, "on behalf of the CMS CLIA program, uses Form 3225 to process CLIA certificate applications." In its list of what each certificate needs, the same page calls it "Form 3225, Disclosure of Ownership." The current version is dated 4/2021.

It is not optional. "Applicants must forward a completed Form 3225 to their appropriate CLIA State Agency regional office for HHSC to accept and process their CLIA application." And: "An application will not be processed until all requested information is received and approved by this office." A CMS-116 that arrives alone waits.

Where does the Texas packet go?

Unlike most states, Texas splits its CLIA work across five regional offices. CMS's State Agency list (updated May 2026) and the HHSC page both name them:

• Arlington Region (HHSC regions 2 and 3): CLIA.Arlington@hhs.texas.gov
• San Antonio Region (8 and 11): CLIA.SanAntonio@hhs.texas.gov
• Houston Region (6): CLIA.Houston@hhs.texas.gov
• Tyler Region (4 and 5): CLIA.Tyler@hhs.texas.gov
• Austin Region, which includes West Texas (1, 7, 9 and 10): CLIA.Austin@hhs.texas.gov

HHSC: "All initial CLIA applications for laboratories located in Texas are processed by HHSC CLIA regional offices." Phone numbers on the two lists do not all match (the San Antonio number differs), so confirm the region against HHSC's regional map before you call. The region depends on where the testing site sits, which matters for a group opening sites in several metro areas: one company can be dealing with three regional offices at once.

Which documents does a Texas waiver application need?

For a Certificate of Waiver, HHSC lists two items: the CMS-116 and Form 3225. "There are no qualification requirements for the laboratory director or testing personnel of a facility with a Certificate of Waiver," HHSC says, and director qualification documents are required "for all certificates, except Certificates of Waiver."

HHSC also says it "will not process incomplete applications" and that labs "must complete the CMS-116 application entirely." The usual reasons a Texas file stalls are the same as anywhere: a post office box instead of a physical address, a tax ID that does not match the ownership disclosure, a test list that does not match the kits on the shelf, or a missing email address. Our section-by-section CMS-116 guide covers each field.

A PPM certificate adds the director's license. HHSC: "When submitting an application for a PPM certificate, the facility must provide a copy of the facility director's current Texas medical license" or nursing license, as applicable. Compliance and Accreditation applicants add the director's education, credentials and laboratory experience, and Accreditation applicants add an enrollment letter from the accreditation organization.

Who pays what, and to whom?

Nothing goes to Texas. HHSC's forms page: "Do not send payment for CLIA fees to HHSC. Follow the instructions on the user fee coupon generated by CMS to make a payment." Labs pay CMS on pay.gov or by mail to the address on the coupon. The current CMS fee for a Certificate of Waiver, as of October 2026, is $248 for two years (see CLIA fees in 2026).

HHSC also reminds labs that "After March 1, 2026, paper fee coupons and CLIA certificates will no longer be available," and recommends "a business email address, or one that many staffers can access and use." In a Texas chain with a dozen waiver sites, the coupon for each site lands in whatever inbox is on that site's CMS-116. Put a shared business address there, not a consultant's.

How does Texas handle changes after approval?

HHSC's change rules are more specific than most states' pages:

• Thirty-day notices. "All laboratories must notify HHSC CLIA within 30 days of any change to the facility name, location, contact information or ownership." A director change is also due within 30 days for every lab except those with a Certificate of Accreditation.
• Letter or new form. A new, fully completed CMS-116 is required "to add a multiple site exception or make changes to the certificate type, ownership or nonwaived Laboratory Director." Name, tax ID, location, contact and waived-director changes can go by letter with the date, facility name, CLIA number, a description of the change and the "Signature of the Laboratory Director or designee."
• Waiver director changes are light. "Laboratories with a Certificate of Waiver do not need to provide any extra documentation and may request a Director change by sending a letter to HHSC CLIA."

Our post on moving, renaming or selling a CLIA lab walks through which changes are a letter and which are a new application.

Does anything else in Texas apply to a waived site?

Not as a lab license. The state requirements that do matter are the ones attached to the people and the business: who may order the tests under Texas practice law, and how claims are billed. Medicaid and commercial payers look for the CLIA number on lab claims, and adding it to payer files is enrollment work. White Glove Credentialing covers that side; see its guide to becoming a Medicaid provider.

How do we help Texas sites?

We prepare the CMS-116, the test list from each kit's instructions and Form 3225 for each location, and identify the right regional office for each address. Your owner or director reviews and signs; we can send the signed packet to the regional office for you, and the CMS coupon comes to your email for your team to pay on pay.gov. A single site is $399 under our Certificate of Waiver Application; a five-site Texas rollout is $1,599. The Texas requirements page keeps the regional contacts current.