CLIA: Laboratory Tests - Denial Code CO-B7
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
• 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 Web site. 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:
o Jurisdiction 1: Select 'Articles' on the left side of the Palmetto GBA Web page
o Ohio, South Carolina and West Virginia: Select 'Browse by Topic' on the left side of the Palmetto GBA Web page.
Denial reason code CO/PR B7 FAQ
Q: We received a denial with claim adjustment reason code (CARC) CO/PR B7. What steps can we take to avoid this denial?
Provider was not certified/eligible to be paid for this procedure/service on this date of service.
A: This denial is received when the claim’s date of service is prior to the provider’s Medicare effective date or after his/her termination date, or when a procedure code is beyond the scope of the provider’s Clinical Laboratory Improvement Amendment (CLIA) certification, or a laboratory service is missing a required modifier.
Submit claims for services rendered when the provider had active Medicare billing privileges.
Review the Medicare Remittance Advice (RA), and verify the date of service.
• If the date of service is not correct, follow procedures for correcting claim errors.
• If the date of service is correct, there may be an issue with the provider’s Medicare effective or termination date.
• View enrollment information through the internet-based Provider Enrollment, Chain and Ownership System (PECOS) and confirm provider’s Medicare effective date. Click here external link for more details.
Note: The provider’s Medicare effective date can be retroactive up to 30 days from receipt of application, or a future date, up to 60 days from receipt of application.
Submit claims for laboratory services within the scope of the provider’s CLIA certification.
• Verify service/procedure code is listed as approved under the scope of the provider’s certification.
• Refer to the complete list of downloads of Categorization of Tests external link on the Centers for Medicare & Medicaid Services (CMS) website.
• Refer to the List of Waived Tests external pdf file from the CMS website to determine which codes require the modifier QW (CLIA waived tests). For assistance, you may review the CLIA - CPT codes requiring modifier QW tutorial.
• If the procedure code is not correct, or the procedure code modifier is missing, follow procedures for correcting claim errors.
Make the necessary correction(s), and resubmit the claim. Submit the corrected line only. Resubmitting the entire claim will cause a duplicate claim denial.
CO-B7 This provider was not certified/eligible to be paid for this procedure/service on this date of service. Note: Refer to the 835 Healthcare Policy Identification Segment (loop 2110 Service Payment Information REF), if present.
N570 Missing/incomplete/invalid credentialing data.
Common Reasons for Message
Lab code billed is not within CLIA certification type
CLIA waived test was missing modifier QW
Modifier QW was billed but not required
Verify correct CLIA certification number was submitted on claim
Submit Appeal request to correct CLIA certification number or add/remove QW modifier
See the Appeals webpage for instructions on how to submit a Reopening or Redetermination
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