M102Remark Code (RARC)Active
M102 Remark Code - Service Not Performed on FDA Approved Equipment
The M102 remark code indicates that the service billed was not performed on equipment that has been approved by the FDA for the specific purpose claimed. This suggests a compliance issue with the equipment used during the procedure, which may affect reimbursement.
How It Relates to the Denial
The M102 remark code typically accompanies an adjustment reason code that reflects a denial or reduction related to the use of non-compliant equipment. The combination signals that while a service was rendered, it did not meet the necessary regulatory standards for reimbursement.
Common Scenarios
1A facility billed for a surgical procedure performed using a laser device that has not received FDA approval for that specific use.
→ The M102 remark code points out that reimbursement is denied because the service was performed using non-FDA approved equipment, indicating a potential violation of compliance standards.
2A physical therapy claim was submitted for treatment using an ultrasound machine that is not FDA-approved for therapeutic use.
→ The appearance of M102 suggests that the payer is denying payment based on the equipment's lack of FDA approval, highlighting the need for compliance with regulatory standards.
3A diagnostic imaging service was billed using an imaging device that has not been validated by the FDA for the specific imaging technique used.
→ The M102 remark code indicates that the payer considers the service ineligible for reimbursement due to the equipment's non-compliance with FDA regulations.
What to Do
- Review the claim to confirm the equipment used during the service and its FDA approval status.
- If the equipment is indeed non-compliant, consider resubmitting the claim with documentation showing compliance or using approved equipment for future services.
What to Check
- The FDA approval documentation for the equipment used in the service.
- The claim submission records to ensure accurate equipment details were provided.
- The accompanying reason code on the remittance to understand the primary reason for adjustment.