Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Montana
- Montana licenses people, not labs: anyone performing or supervising moderate or high complexity testing needs an individual state license. Waived testing has no education or experience requirement, and any person may be named director of a Certificate of Waiver.
- The Montana CLIA Program takes the CMS-116 by fax or email, and a site that starts testing and reporting results in Montana needs its own Montana CLIA certificate.
Does Montana require a state lab license on top of CLIA?
Montana has no state laboratory license. The Montana CLIA Program follows the federal CLIA rules and has no additional state laboratory regulations, so a waived site needs only its CLIA Certificate of Waiver.
- Does not reach waived-only labs
Do labs in other states need a Montana license to test its specimens?
Specimens collected in Montana may go to an out-of-state lab without any Montana license; the testing lab needs a CLIA certificate from its own state. A site that only collects and ships specimens needs no Montana CLIA certificate.
Where does a Montana CMS-116 go?
- Montana Department of Public Health and Human Services, Office of Inspector General, Certification Bureau (Montana CLIA Program)
- Email: MTSSAD@mt.gov
- Phone: (406) 444-2099
Opening a testing site in Montana?
We prepare the CMS-116 and any Montana 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.