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Resolved Types of CLIA Certificates

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AISHAH_45691

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Good Morning,

According to my research there are five different CLIA Certifications.

What is the difference between each one?
Is a QW Modifier used for all of them when billing CLIA Waived tests or is that only for a Certificate of Waiver?
Where can I find a list of CLIA waived CPT Lab codes?

Thank you in advance!
 
Perhaps this will be helpful to you.

What are the different types of CLIA certificates and how long are they effective?

All types of certificates are generally effective for two years, and the different types of
certificates are:
• Certificate of Waiver (COW): Issued to a laboratory that performs only waived tests.
• Certificate for Provider-performed Microscopy (PPM) procedures: Issued to a laboratory
in which a physician, midlevel practitioner or dentist performs specific microscopy
procedures during the course of a patient’s visit. A limited list of provider-performed
microscopy procedures is included under this certificate type, which are categorized
as moderate complexity testing.
Certificate of Registration*
: Issued to a laboratory to allow the laboratory to conduct
nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed
(inspected) to determine its compliance with the CLIA regulations. Only laboratories
applying for a certificate of compliance or a certificate of accreditation will receive a
certificate of registration.
• Certificate of Compliance (COC): Issued to a laboratory once the State Agency or
CMS surveyors conduct a survey (inspection) and determine that the laboratory is
compliant with the applicable CLIA requirements. This type of certificate is issued to a
laboratory that performs nonwaived (moderate and/or high complexity) testing.
• Certificate of Accreditation (COA): Issued to a laboratory on the basis of the
laboratory’s accreditation by an accreditation organization approved by CMS. This
type of certificate is issued to a laboratory that performs nonwaived (moderate and/or
high complexity) testing.

Where can I find a list of waived tests?
For a list of waived tests sorted by analyte name, visit the FDA website at:
CLIA – Currently Waived Analytes
To view CMS CLIA waived test list, refer to Tests Granted Waived Status Under CLIA.



Modifier QW is used to indicate that the diagnostic lab service is a CLIA (Clinical Laboratory Improvement Amendment) waived test and that the provider holds at least a Certificate of Waiver. The provider must be a certificate holder in order to legally perform clinical laboratory testing.

Modifier QW​

What you need to know​

Modifier QW is defined as a Clinical Laboratory Improvement Amendment (CLIA) waived test. Some things to keep in mind when appending modifier QW to your lab service/s:

The modifier is used to identify waived tests and must be submitted in the first modifier field.
CLIA waived tests requiring the QW modifier are considered simplified analysis tests.
CLIA requires all laboratory testing sites to have one of the following certificates to legally perform clinical laboratory testing:
Certificate of waiver
Certificate of registration
Certificate of accreditation
Certificate for physician-performed microscopy
Certain CLIA certificates that have been issued may limit the holder to perform only certain test; these are:
Certificate of waiver
Certificate of physician performed microscopy procedures (PMPP)
If a provider currently has one Medicare Part B provider number covering more than one clinical lab testing site (e.g., an office on Main Street and an office on Oak Street), both sites require a CLIA number. The provider should use the CLIA number that specifically represents the site where the test(s) was/were performed.
All clinical diagnostic laboratories must include their CLIA numbers on all claims to avoid an unprocessable rejection. The CLIA number must be placed in Item 23 of the CMS-1500 claim form or the electronic equivalent. Note: The CLIA number is not required on the ASC X12 institutional claim data set or its related paper Form CMS-1450.


Note: A CLIA waived test still requires the provider to include their CLIA number on the claim

Appropriate uses:​

Any test on the CMS CLIA waived test list that has a QW beside the procedure code (i.e., 80047QW).

Inappropriate uses:​

Any code that is not on the CLIA waived test list.
Any test on the CMS CLIA waived test list that does not have a QW beside the procedure code.

 
Good Morning,

Thank you for the prompt reply. I tried researching it on my own, the links for the CLIA waived tests were really confusing. I guess I now need to know the different analytes :eek: for the different tests we use in our clinics. Thank you so much this helped clarify what I was reading.
 
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