CLIA: Laboratory Tests
Denial Reason, Reason/Remark Code(s):
• CO-B7: This provider was not certified/eligible to be paid for this procedure/service on this date of service
• CPT codes include 82947 and 85610
Resolution
• HCPCS modifier QW must be submitted with certain clinical laboratory tests that are waived from the Clinical Laboratory Improvement Amendments of 1988 (CLIA) list. The Food and Drug Administration (FDA) determines which laboratory tests are waived.
• Note: Not all CLIA-waived tests require HCPCS modifier QW
• Determine if the CPT code is a waived test by accessing the CMS CLIA Web page
• Palmetto GBA will publish information on tests newly classified as 'waived' on our website. Please note, the list of CLIA-waived procedures is updated as often as quarterly.
• The CLIA certificate number is also required on claims for CLIA waived tests. Submit this information in Loop 2300 or 2400, REF/X4, 02 for electronic claims. For paper claims, submit the CLIA certification number in Item 23 of the CMS-1500 claim form.
• Access complete instructions for correctly submitting HCPCS modifier QW in the Palmetto GBA Modifier Lookup tool.
Clinical Laboratory Procedures: Duplicate Denials
Denial Reason, Reason/Remark Code(s)
• CO-18 - Duplicate Service(s): Same service submitted for the same patient
• CPT codes: 36415, 80048, 80053, 80061, 83036, 84443, 85610
Resolution/Resources
First: Verify the status of your claim before resubmitting. Use the Palmetto GBA Online Provider Services (OPS) tool or call the Palmetto GBA Interactive Voice Response (IVR) unit.
• All providers that have an EDI Enrollment Agreement on file may register to use this tool. If you haven’t already registered, please consider doing so.
• Access the introductory article to learn more by selecting the 'Introducing Online Provider Services' graphic on the top of any of our main contract Web pages
• Please note: Only one provider administrator per EDI Enrollment Agreement/per PTAN/NPI combination performs the registration process. The provider administrator can then grant permission to additional users related to that PTAN/NPI.
• Billing services and clearinghouses should contact their provider clients to gain access to the system
• Specific instructions for accessing claim status information through OPS are available in the OPS User Manual
CPT modifier 91 may be submitted to identify an identical laboratory test for the same patient on the same date.
• This modifier may not be submitted when tests are rerun to confirm initial results due to testing problems with specimens or equipment, or for any other reason when a normal, one-time, reportable result is all that is required
• This modifier may not be used when other codes describe a series of test results (e.g., glucose tolerance tests)
• For clinical laboratory tests ordered by an ESRD facility: these tests must be submitted with CPT modifier 91 if any single service (same CPT code) is ordered for the same patient, and the specimen is collected more than once in a single day, and the service is medically necessary
o CPT modifier 91 must be submitted with services that meet these criteria, regardless of whether the test is also submitted with HCPCS modifiers CD, CE or EF
o Any line item on a claim that meets these criteria and is submitted with CPT modifier 91 will be included into the calculation of the 50/50 rule
o After calculation of the 50/50 rule, services used to determine the payment amount may not exceed 22
Denial Reason, Reason/Remark Code(s):
• CO-B7: This provider was not certified/eligible to be paid for this procedure/service on this date of service
• CPT codes include 82947 and 85610
Resolution
• HCPCS modifier QW must be submitted with certain clinical laboratory tests that are waived from the Clinical Laboratory Improvement Amendments of 1988 (CLIA) list. The Food and Drug Administration (FDA) determines which laboratory tests are waived.
• Note: Not all CLIA-waived tests require HCPCS modifier QW
• Determine if the CPT code is a waived test by accessing the CMS CLIA Web page
• Palmetto GBA will publish information on tests newly classified as 'waived' on our website. Please note, the list of CLIA-waived procedures is updated as often as quarterly.
• The CLIA certificate number is also required on claims for CLIA waived tests. Submit this information in Loop 2300 or 2400, REF/X4, 02 for electronic claims. For paper claims, submit the CLIA certification number in Item 23 of the CMS-1500 claim form.
• Access complete instructions for correctly submitting HCPCS modifier QW in the Palmetto GBA Modifier Lookup tool.
Clinical Laboratory Procedures: Duplicate Denials
Denial Reason, Reason/Remark Code(s)
• CO-18 - Duplicate Service(s): Same service submitted for the same patient
• CPT codes: 36415, 80048, 80053, 80061, 83036, 84443, 85610
Resolution/Resources
First: Verify the status of your claim before resubmitting. Use the Palmetto GBA Online Provider Services (OPS) tool or call the Palmetto GBA Interactive Voice Response (IVR) unit.
• All providers that have an EDI Enrollment Agreement on file may register to use this tool. If you haven’t already registered, please consider doing so.
• Access the introductory article to learn more by selecting the 'Introducing Online Provider Services' graphic on the top of any of our main contract Web pages
• Please note: Only one provider administrator per EDI Enrollment Agreement/per PTAN/NPI combination performs the registration process. The provider administrator can then grant permission to additional users related to that PTAN/NPI.
• Billing services and clearinghouses should contact their provider clients to gain access to the system
• Specific instructions for accessing claim status information through OPS are available in the OPS User Manual
CPT modifier 91 may be submitted to identify an identical laboratory test for the same patient on the same date.
• This modifier may not be submitted when tests are rerun to confirm initial results due to testing problems with specimens or equipment, or for any other reason when a normal, one-time, reportable result is all that is required
• This modifier may not be used when other codes describe a series of test results (e.g., glucose tolerance tests)
• For clinical laboratory tests ordered by an ESRD facility: these tests must be submitted with CPT modifier 91 if any single service (same CPT code) is ordered for the same patient, and the specimen is collected more than once in a single day, and the service is medically necessary
o CPT modifier 91 must be submitted with services that meet these criteria, regardless of whether the test is also submitted with HCPCS modifiers CD, CE or EF
o Any line item on a claim that meets these criteria and is submitted with CPT modifier 91 will be included into the calculation of the 50/50 rule
o After calculation of the 50/50 rule, services used to determine the payment amount may not exceed 22
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