Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Minnesota
- MDH says paper fee coupons and certificates ended March 1, 2026, and a lab may start testing once CMS confirms its payment.
Does Minnesota require a state lab license on top of CLIA?
The Minnesota Department of Health's CLIA page covers only the federal program: the CMS fee schedule, the switch to emailed fee coupons and certificates, and State Agency contacts. No separate state laboratory license is described.
- Does not reach waived-only labs
What does Minnesota charge?
No state laboratory fee; MDH lists only the CMS fees, including $248 for a Certificate of Waiver and $297 for PPM.
Do labs in other states need a Minnesota 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 Minnesota CMS-116 go?
- Minnesota Department of Health, CLIA Program
- Email: health.clia@state.mn.us
- Phone: (651) 201-4200
Opening a testing site in Minnesota?
We prepare the CMS-116 and any Minnesota 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.