Montana CLIA Frequently Asked Questions:

 

Please complete a CMS-116 application (downloadable from www.cms.gov/CLIA). Return the completed CMS-116 form to the Montana CLIA Program via fax (406-444-3456) or email (mtssad@mt.gov). 

How to Pay CLIA Fees Online

Starting March 1, 2026, laboratories must pay their CLIA fees online. Do not mail a check. Laboratories can pay their CLIA certification fee online through pay.gov, a secure platform hosted by the U.S. Treasury Department. CLIA Fee Coupon will be sent to the email address indicated on the CMS-116 form.

  1. Go to https://www.pay.gov/paygov/
  2. Enter the 'CLIA Fee' in the search box on top right, in the blue bar that say Pay.gov
  3. The first search result should say, 'CLIA Laboratory User Fees.'
  4. Click the Continue button for CLIA Laboratory User Fees
  5. Read the information on the next page and follow instructions to complete form and make payment.

To update your email and Certificate please submit a CMS-116 application and submit to mtssad@mt.gov or michelle.griffin@mt.gov.

Certificate Fee Schedule: CLIA Fee Schedule-Updated 01/27/2024 (PDF)  

 

All CLIA certificates are effective for two years.

Once payment has been processed, a notification with a link to your CLIA Certificate will be sent to the email address indicated on the CMS-116 form.

To Obtain Additional Copies of Your Certificate:

Visit the QCOR CLIA Laboratory Lookup S&C QCOR Home Page (cms.gov) [qcor.cms.gov] and follow these steps:

  1. Enter your CLIA ID and click Search
  2. Click the blue hyperlink for your laboratory
  3. Follow the pop-up link to download your certificate

After payment is processed, the renewal certificates will be released 1-2 weeks before the expiration date listed on your current CLIA certificate. 

If the information is not current on your Certificate, please complete a CMS-116 application and submit to mtssad@mt.gov or michelle.griffin@mt.gov. For changes outside the renewal window, you will have to request a revised certificate and pay a fee.

Certificate Fee Schedule: CLIA Fee Schedule-Updated 01/27/2024 (PDF)  

New certificates may or may not be available for ordering a reprinted copy. Contact the Montana CLIA Program via phone (406-444-2099) or email (mtssad@mt.gov) to inquire about ordering a reprinted certificate. New certificates cannot be ordered if the certificate expiration date is less than six months away.

 

If a new certificate cannot be ordered, an official Letter of Verification can be issued upon request. The Letter of Verification verifies the facility’s current, valid CLIA certificate. Please be ready to provide the CLIA number and tax ID number for identity verification.

D5301
§493.1241 Standard: Test request

(a) The laboratory must have a written or electronic request for patient testing from an authorized person.

CLIA defines an "authorized person" as an individual who is permitted under State law to order laboratory tests, receive test results or both.

Montana Code Annotated 2025

TITLE 37. PROFESSIONS AND OCCUPATIONS

TITLE 37. PROFESSIONS AND OCCUPATIONS - Table of Contents, MCA

The Montana CLIA Program does not define the authorized personnel who can order tests in Montana. Each facility is responsible for determining the facility policy on offering Direct Access Testing to patients. Please note, reimbursement entities may not pay for testing performed without an order from a person meeting the reimbursement entity’s definition of an authorized personnel.

The Montana CLIA Program does not have additional state regulations regarding specimen collection. Laboratory specimens may be drawn/collected in the state of Montana and sent to an out-of-state facility for testing without a Montana CLIA license. The facility performing the laboratory testing must have a CLIA license for the state in which they are operating and provide that CLIA number to each facility drawing specimens in Montana per the federal CLIA regulations.

 

Note: Any facility going beyond specimen collection and performing testing and reporting test results in Montana MUST have a Montana CLIA license.

Facilities that solely collect specimens and send them out of state for testing do not need a Montana CLIA certificate. The Montana CLIA Program does not have additional state regulations regarding specimen collection. The out of state laboratory must have a CLIA certificate in the state where the laboratory is located.

Note: Any facility going beyond specimen collection and performing the testing and reporting results in Montana MUST have a Montana CLIA license.

Requests to terminate your CLIA certificate must be submitted in writing to the Montana CLIA Program. Include laboratory name, CLIA number, name of the laboratory director and/or owner, the reason your certificate should be terminated, the effective date of termination, your laboratory contact information and the signature of the laboratory director or his/her designee. Submit requests to:

E-mail: michelle.griffin@mt.gov or MTSSAD@mt.gov

Or Mail:

Montana CLIA Program
PO Box 202953
2401 Colonial Drive 2nd Floor
Helena MT 59620-2953

To terminate your certificate:

Please provide a written notification that includes the laboratory’s name, CLIA identification number, the name of the laboratory director and owner, a request for voluntary termination of the certificate, the effective date of termination, and the wet or certified electronic signature of the laboratory director or owner.

To change your certificate type:

Please fill out a CMS-116 application in its entirety.

To change your laboratory director:

Please fill out a CMS-116 application in its entirety. For non-waived testing, you will be required to include the laboratory director’s qualification documents.

Please submit to:

E-mail: michelle.griffin@mt.gov or mtssad@mt.gov

Laboratory Director changes must be communicated in writing to the Montana CLIA Program within 30 days of the change by filling out a CMS-116 form per the federal CLIA regulations. The CMS-116 form can be downloaded at www.cms.gov/CLIA under the “How to Apply for a CLIA Certificate, Including International Laboratories” tab on the left side of the screen. Send the completed CMS-116 via fax (406-444-3456), email (mtssad@mt.gov), or mail (Certification Bureau - CLIA Program, 2nd floor DPHHS - QAD, PO BOX 202953, Helena, MT 59620-2953).

 

For any CLIA Certificates of PPMP, Compliance, or Accreditation, please submit the new Laboratory Director qualifications along with the CMS-116 form.

The Montana CLIA Program follows the federal CLIA regulations and does not have any additional state specific laboratory regulations. However, individual licensure is applicable in the State of Montana. Please contact the corresponding Licensure Boards for more information on obtaining an individual license to practice in Montana.
Montana does not have additional licensing for Laboratory Directors but does have state licensing for individuals practicing in health care in the State of Montana. Please contact the corresponding Licensure Boards for more information on individual licensing. A state license is required for all personnel performing or supervising moderate and high complexity testing.
There are no education/experience qualifications to be the Laboratory Director of a Montana Certificate of Waiver. There are education/experience qualifications to be the Laboratory Director of a Certificate of PPMP, Compliance, and Accreditation.
There are no education/experience qualifications to perform a WAIVED test. Any person can perform waived testing. There are education/experience qualifications to perform moderate and high complexity testing in the State of Montana.

Centers for Medicare and Medicaid Services - CLIA and DPHHS - CLIA.

For further CLIA inquiries, contact the Montana CLIA Program via phone (406) 444-2099 or email (mtssad@mt.gov).

For further CLIA inquiries, contact the Montana CLIA Program via phone (406) 444-2099 or email mtssad@mt.gov.

There is also additional information at Centers for Medicare and Medicaid Services - CLIA and DPHHS - CLIA.