N721Remark Code (RARC)Active
Effective 03/01/2014

N721 Remark Code - Clinical Trial Coverage Explanation

The N721 remark code indicates that the billed service is only covered if it is performed as part of a clinical trial. This means that the payer is signaling that the service may not be eligible for reimbursement unless it meets the specific criteria associated with clinical trial participation.

How It Relates to the Denial

The N721 code typically accompanies a Claim Adjustment Reason Code that reflects a denial or adjustment related to services not covered. This combination signals that the service in question requires clinical trial involvement for coverage approval.

Common Scenarios

1A provider submitted a claim for a specific diagnostic test that is sometimes part of a clinical trial. The remittance shows a denial with the accompanying reason code indicating non-coverage.
→ In this case, the N721 remark code clarifies that the test is only reimbursable if it was conducted as part of an approved clinical trial, implying the provider must confirm the trial status.
2A hospital billed for a treatment related to a research study but received an adjustment on the remittance stating the service is not covered.
→ The presence of the N721 remark code suggests the hospital needs to verify that the treatment was indeed part of a clinical trial to secure reimbursement.
3A physician office billed for a procedure that was performed on a patient enrolled in a clinical trial, but the claim was partially denied.
→ The N721 code highlights that the procedure is only eligible for coverage if linked to a clinical trial, prompting the office to check the trial enrollment status.

What to Do

  1. Confirm if the service was performed as part of an approved clinical trial.
  2. Gather documentation that verifies the patient's participation in the clinical trial.
  3. If applicable, resubmit the claim with supporting clinical trial information.

What to Check

  • The clinical trial documentation to confirm participation.
  • The patient's medical record to establish the context of the service.
  • The claim submission details to ensure accurate coding related to the clinical trial.