Creator: Patrick Connole

News Now|Clinical|Regulatory

CMS Warns CLIA Labs of Fake Solicitations

Freestyle1 min readOct 7, 2026
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CMS told state survey agencies on Oct. 7 to be aware of phony billing and invoices being sent to CLIA-certified laboratories in several states.

In a special alert sent to state survey agencies on Oct. 7, CMS said it is aware that Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories in several states have received solicitation documents from a third-party entity that are styled as bills or invoices and may be mistaken for official CLIA communications.


The agency said, “CLIA-certified laboratories are encouraged to carefully review any solicitation, invoice, or other correspondence that appears to be an official CMS or government communication, including the sender, purpose of the communication, and any requested fees or payment instructions.”


Laboratories that are unsure whether a communication is associated with the CLIA program should contact their State Agency CLIA office or the CMS CLIA Program, at LabExcellence@cms.hhs.gov, for assistance.


CMS said labs being targeted by the third-party solicitations should know that these documents are not issued by CMS and do not represent an official CLIA fee or government notice. “Official CLIA communications come only from CMS or your State Survey Agency,” the CMS alert said.


Background

The CLIA program is administered by CMS under the Dept. of Health and Human Services. CLIA establishes minimum quality standards for all laboratory testing performed on human specimens to ensure the accuracy, reliability, and timeliness of patient test results.


Any laboratory that performs testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease must hold a valid CLIA certificate issued by CMS.


Comments or questions? Contact Patrick Connole at pconnole@parkplacelive.com.