CLIA (Clinical Laboratory) Program

Applications and other helpful information can be found at the following link:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

• Mail: DHSS - Bureau of Diagnostic Services
  CLIA Program
  PO Box 570
  Jefferson City, MO 65102
• E-mail: CLIA@health.mo.gov
• Fax: 573-751-6158

Certificates will arrive in 4-6 weeks.

Costs for CLIA certificates are as follows:

• Certificate of Waiver -- $248 every two years
• PPM -- $297 every two years
• COC and COA costs are based on the number of tests that the lab performs in a year. COA will have an additional cost for accreditation.
  Initial COC and COA CLIA certificates include a $123 registration fee along with a compliance fee that is based upon test volumes.

Don’t send payment with your application. Once the application has been entered into the database, an invoice will be sent to you. Payment should be mailed to:

CLIA Laboratory Program
PO Box 3056
Portland, OR 97208-3056

Include your CLIA number with payment to ensure it is credited properly.

CLIA fees are billed 6 months in advance and the certificate will be mailed 30 days prior to your current expiration date.

It takes approximately 2 weeks for payments to appear in the system. If it doesn’t appear after 3 weeks, please send us a copy of the front and back of your canceled check. Always include your facility name and CLIA number.

Please notify the Missouri CLIA Program by requesting the change on letterhead. Also include the previous federal tax ID number along with the new federal tax ID number.

Requests for name or address changes can be sent to the program on facility letterhead. Be sure to include your CLIA number, previous facility name or previous facility address along with the new information.

• If it is a Certificate of Waiver (COW), send us a letter, fax or email including the CLIA number, the previous lab director and the new lab director’s name.
• If it is for a Provider Performed Microscopy (PPM) Certificate, you must send the following:
  • a copy of the CMS 116 application, and
  • a copy of the Missouri State License of the physician or the mid-level practitioner.
• If it is for a Certificate of Compliance (COC) or Accreditation (COA), you must send the following:
  • a copy of the CMS 116 application
  • a copy of the director's Missouri State License,
  • a copy of the director's resume or credentials, and
  • State Board Certificates or degrees showing the qualification of that person to be the director of a moderate or high complexity lab.

  For an existing Certificate of Accreditation (COA), you must send the above documents to your accrediting organization.

A Certificate of Waiver (COW) is required if you are performing blood glucose, urine dips, or any other simple office test where you obtain a specimen and provide the patient a result that is used for diagnosis or treatment.

No CLIA certificate is required for this type of activity.

Missouri does not have a licensure requirement for laboratories.

Complete a new CMS 116 form and send to the Missouri CLIA Program.

Your CLIA certificate must be current, if it is closed or inactive you will not be paid for tests performed. If your certificate is current and claims are being denied, call your intermediary and check your billing codes to ensure you are using the right code for the type of test that your lab is performing. Be sure that the tests billing code also matches the type of CLIA certificate that the lab is certified for, either Certificate Of Waiver, PPM, Moderate Complexity or High Complexity Certificates. The CLIA state office does not deal with billing issues.