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), email (mtssad@mt.gov), or mail (Certification Bureau-CLIA Program, 2nd floor DPHHS - QAD, PO BOX 202953, Helena, MT 59620-2953). A bill will be automatically generated and mailed within two to three weeks after the application has been entered into the computer by the Montana CLIA program.

For new CLIA Certificates: A bill will be automatically generated and mailed to you within two to three weeks after your complete application has been entered into the computer by the CMS CLIA program. You will send payment with the return portion of your bill to: CLIA LABORATORY PROGRAM, PO BOX 3056, Portland, OR 97208-3056. DO NOT SEND PAYMENT TO THE MONTANA CLIA OFFICE. We will not forward the payment.

If you prefer electronic payment, you may use PAY.GOV to pay online. Enter ‘CLIA’ in the search box and follow the instructions. This requires your new CLIA ID number which is generated when your application is entered into the computer. To find out what your CLIA number is, call 406-444-2099 after your application has been entered into the computer and ask for the new CLIA number for your facility. Have the facility name and tax ID number ready for identity verification.

For existing CLIA Certificates: A bill will be automatically generated and mailed to you 6 months prior to the expiration date of your certificate. Return the bottom portion of your bill with your payment to: CLIA LABORATORY PROGRAM, PO BOX 3056, Portland, OR 97208-3056. DO NOT SEND PAYMENT TO THE MONTANA CLIA OFFICE. We will not forward your payment.

If you prefer electronic payment, you may use PAY.GOV to pay online. Enter ‘CLIA’ in the search box and follow the instructions. Have your CLIA number ready.

Yes. If you prefer electronic payment, you may use PAY.GOV to pay online for your CLIA certificate. Enter ‘CLIA’ in the search box and follow the instructions. Have your CLIA number ready.
Bills for existing CLIA certificates are automatically printed and mailed 6 months prior to the CLIA certificate expiration date. Make sure to notify the Montana CLIA Program of any changes to the mailing address on file. Written notice is required for all address updates which may be submitted to the Montana CLIA Program via email (mtssad@mt.gov), fax (406-444-3456), or mail (Certification Bureau-CLIA Program, 2nd floor DPHHS - QAD, PO BOX 202953, Helena, MT 59620-2953).
All CLIA certificates are effective for two years.

If payment has processed to renew the CLIA certificate, a new certificate will be automatically printed and mailed three to four weeks prior to the expiration of the current certificate. Please watch for the new certificate to arrive in the mail two to three weeks prior to the expiration on the current certificate.

 

For inquiries regarding the status of a missing CLIA certificate, please contact the Montana CLIA program via email (mtssad@mt.gov), phone (406-444-2099), fax (406-444-3456), or mail (Certification Bureau-CLIA Program, 2nd floor DPHHS - QAD, PO BOX 202953, Helena, MT 59620-2953).

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.

The CMS-116 form may 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. Incomplete CMS-116 forms cannot be entered. Completed CMS-116 forms may be submitted 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).

CLIA defines an authorized person as someone that has specific authorization from the state in which the test is performed.

REF: S&C-10-12-CLIA

D5301
§493.1241 Standard: Test request

(a) The laboratory must have a written or electronic request for patient testing from an authorized person.
Interpretive Guidelines §493.1241(a)
An “authorized person” means an individual authorized under State law to order tests or receive test results, or both. Some states expressly authorize patients to order tests or receive (or give them access to) test results regardless of who ordered the test. In these states a laboratory may release test results directly to a patient as an “authorized person” in accordance with state law.
Patients may also be considered “individuals responsible for using test results” if state law does not expressly prohibit release of test results directly to patients. If the laboratory is requesting payment under Medicare, the laboratory must follow the requirements in the Social Security Act regarding test ordering for Medicare reimbursement.

Montana does not currently have any statutes that define an "authorized person".

However, the Medicare regulation specifies that the "authorized person" must be a doctor with a current state medical license.

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 change to different certificate type, fill out a new CMS-116 form (downloadable from www.cms.gov/CLIA) and submit it to the Montana CLIA Program 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). Please indicate that it is a change in the certificate in the top box.

If changing to a Certificate of PPMP or to a Certificate of Compliance/Accreditation, please provide the Laboratory Director qualifications along with the CMS-116 application for review before the change can be processed. For the required Laboratory Director qualifications, please see www.cms.gov/CLIA.

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.

Facilities
 
Contact Us
Phone: (406) 444-2099
Fax: (406) 444-3456
MTSSAD@mt.gov
PO Box 202953
2401 Colonial Drive 2nd Floor
Helena MT 59620-2953