Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Missouri
- For a Certificate of Waiver, Missouri accepts a director change by letter, fax or email naming the old and new directors; PPM changes need a copy of the new director's Missouri license.
- Name, address and tax ID changes go to the program on facility letterhead.
Does Missouri require a state lab license on top of CLIA?
Missouri's CLIA program answers directly: "Missouri does not have a licensure requirement for laboratories." Labs need only the federal CLIA certificate, which DHSS administers for CMS.
- Does not reach waived-only labs
What does Missouri charge?
No state laboratory fee; DHSS lists the CMS Certificate of Waiver fee as $248 every two years.
Do labs in other states need a Missouri license to test its specimens?
No state laboratory license was found, so a lab in another state needs nothing from this state to test its specimens beyond its own CLIA certificate.
Where does a Missouri CMS-116 go?
- Missouri Department of Health and Senior Services, Bureau of Diagnostic Services, CLIA Laboratory Program
- Email: CLIA@health.mo.gov
- Phone: (573) 751-6318
Opening a testing site in Missouri?
We prepare the CMS-116 and any Missouri filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.