Spravato denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for spravato are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Aetna May Issue a "Not FDA-Approved" Denial for Spravato

A "not FDA-approved" denial for esketamine nasal spray (Spravato) almost always reflects a documentation mismatch rather than a factual dispute: Spravato does carry FDA approval, for two specific indications — treatment-resistant depression (TRD) and major depressive disorder with acute suicidal ideation or behavior (MDSI). This type of denial typically occurs when the prior authorization request did not specify the correct on-label indication, when the diagnosis code submitted did not align with the approved indication, or when the request was coded in a way that made the drug appear to be sought for an off-label use.

Because the FDA approval is a matter of public record, this denial is highly correctable on appeal with precise documentation.

## Federal Appeal Framework

• Internal appeal (ACA §2719 / ERISA §503): File within the deadline on your EOB. Aetna must respond within 30 days for prospective requests or 60 days for post-service claims.
• External review: If the internal appeal is denied, an Independent Review Organization (IRO) will independently evaluate whether the denial is clinically appropriate. The external-review window is generally up to four months from the final internal denial.
• Expedited track: Where delay poses serious health risk — including acute suicidal crisis — request 72-hour internal or external expedited review.

## Documentation to Gather

1. FDA approval reference: The prescriber's appeal letter should explicitly cite that Spravato (esketamine) is FDA-approved and identify the specific approved indication that applies to this patient — TRD or MDSI — by name. 2. Diagnosis code alignment: Verify that the ICD-10 code submitted matches the FDA-approved indication and, if necessary, submit a corrected claim or updated authorization with the accurate code. 3. Prescribing information excerpt: Attach or reference the current FDA-approved prescribing label confirming the approved indication, available from the FDA's official database. 4. REMS enrollment confirmation: Providing proof that the prescribing site is a REMS-certified healthcare setting reinforces that the drug is being used in the on-label, approved manner. 5. Clinical documentation: Chart notes confirming the patient carries the correct diagnosis and meets the clinical profile described in the FDA label.

## Criteria-Mapping Structure

In your appeal letter, open with a direct factual rebuttal: state the FDA approval, the approved indication, and the diagnosis code that maps to it. Then attach the supporting clinical documentation in the order the policy lists its criteria. A short, factually precise appeal letter is often more effective for this denial type than a lengthy narrative — the core issue is clarifying the record, not arguing clinical judgment.