Remark code M61 indicates a claim denial because the FDA clinical trial approval period has lapsed, preventing payment.
Remark code M61 indicates that the claim submitted cannot be reimbursed because the period of approval for the Food and Drug Administration (FDA) clinical trial, which is necessary for coverage, has expired. This suggests that the service or treatment was provided in connection with a clinical trial that no longer has valid authorization from the FDA for the timeframe in which the service was rendered.
Common causes of code M61 are:
1. The claim was submitted for a service or procedure that was part of an FDA clinical trial, and the claim was filed after the trial's approval period had ended.
2. There may have been an administrative oversight where the approval period dates were not correctly tracked or communicated, leading to a claim submission outside the designated timeframe.
3. The provider may have been unaware of the expiration of the clinical trial approval period, possibly due to a lack of proper notification from the trial sponsor or a misunderstanding of the trial timeline.
4. The claim could have been delayed in processing internally before submission, causing it to be received by the payer after the expiration of the FDA clinical trial approval period.
5. There might have been a mistake in coding or documentation that incorrectly indicated the service as part of an expired clinical trial when it should have been billed differently.
6. The payer's system may have incorrectly flagged the claim as outside the approval period due to a system error or incorrect information in their database regarding the trial dates.
Ways to mitigate code M61 include ensuring that the FDA clinical trial approval is current before providing services. Regularly check the expiration dates of all clinical trials and set up alerts to renew approvals well in advance. Additionally, maintain open communication with trial sponsors to receive timely updates on the trial status and any extensions or renewals of the approval period. Implement a system to verify trial approval status during the patient intake process and before claim submission to avoid this issue.
The steps to address code M61 involve several key actions:
- Verify the FDA clinical trial approval dates by reviewing the trial documentation and the patient's consent forms to ensure that the service date falls within the approved period.
- If the service was indeed provided within the trial's approved period, gather all necessary documentation that supports this, such as the Notice of Approval from the FDA, and resubmit the claim with this evidence attached.
- In the case that the service was provided outside the approved period, check if there has been an extension or renewal of the trial approval that was not updated in the billing system. If an extension exists, update the system with the new approval period and resubmit the claim with the appropriate documentation.
- If no extension or renewal is applicable, and the service was erroneously billed under the clinical trial, reprocess the claim without the clinical trial code and with the correct billing codes that reflect the standard care provided.
- Communicate with the clinical trial's administrative team to ensure that all future services are billed correctly according to the FDA's approval timeline to prevent recurrence of this issue.
- If necessary, appeal the denial by providing a detailed explanation and any additional information that justifies the claim, if you believe that the denial was made in error.
- Update your RCM system to flag claims related to FDA clinical trials, prompting a verification of approval periods before submission to avoid similar denials in the future.
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