The Bureau of Outpatient Healthcare (BOH) protects the citizens of Missouri by regulating and enforcing standards of care and treatment for individuals utilizing health care services certified by the Centers for Medicare and Medicaid Services (CMS). CMS providers surveyed by the Bureau of Outpatient Healthcare are:

  • End Stage Renal Disease Facilities
  • Certified Rural Health Clinics
  • Clinical Laboratories certified under CLIA

These providers are inspected to determine if Federal standards of care are being met. Inspections are performed as part of an on-going process. Inspections may also become necessary based on complaints received by BOH. Once an inspection has taken place, BOH may cite a facility for deficiencies if it is found to provide substandard care or is not in compliance with federal regulations.

To contact the Bureau of Outpatient Healthcare you may contact us by email at BOH.BOH@health.mo.gov or by telephone at 573-751-6318. Many of the most frequently asked CLIA questions (FAQ) are listed below.

Where do I send my CLIA application?

  • Mail: DHSS - Bureau of Outpatient Healthcare
    CLIA Program
    PO Box 570
    Jefferson City, MO 65102
  • E-mail: BOH.BOH@health.mo.gov
  • Fax: 573-526-3621

How long does it take to receive my certificate?

Certificates will arrive in 4-6 weeks.

How much does a Certificate of Waiver, PPM, COC/COA cost?

Costs for CLIA certificates are as follows:

  • Certificate of Waiver -- $150 every two years
  • PPM -- $200 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 $100 registration fee along with a compliance fee that is based upon test volumes.

Should I send my payment with the application?

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 530882
ATLANTA, GA 30353-0882

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

I paid my fee and I have not received my certificate?

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

I paid my CLIA fee, but it’s not showing as paid in the CMS system. Why is this?

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.

What do I need to do for a change ownership?

Please notify the Bureau of Outpatient Healthcare by requesting the change on letterhead. Also include the previous federal tax ID number along with the new federal tax ID number.

How do I make changes to my certificate - such as name and/or address of facility?

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.

How do I make a lab director change to my CLIA certificate?

  • If it is a Certificate of Waiver (COW), send us a letter, fax or email including the CLIA number with the name of the prior lab director and then the new lab director’s name.
  • If it is for a Provider Performed Microscopy (PPM) Certificate, send 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 also send the following:
    • 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.

I do not have a lab; why am I being billed $150.00 for a waiver?

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.

If I am only drawing blood or collecting specimens do I need a CLIA certificate?

No CLIA certificate is required for this type of activity.

Does Missouri have a licensure requirement for laboratories or to perform testing?

Missouri does not have a licensure requirement for laboratories.

I need to make a status change, what do I do?

Complete a new CMS 116 form and send to the Bureau of Outpatient Healthcare.

My claims are being rejected and not being paid for laboratory test performed?

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.