Prior authorization required for initiation and reauthorization

Prior authorization is required for initial 28-day administration for TRD and for initiation during hospitalization for MDD with acute suicidal ideation/behavior. Requests must demonstrate all coverage criteria are met (age ≥18, DSM-5 structured interview confirming a major depressive episode, depression severity meeting MADRS ≥28 or HAM-D ≥17, and other criteria specific to the indication). Reauthorization for up to one year requires documented symptomatic improvement on an appropriate depression rating scale and continued compliance with REMS and FDA labeling.

• Initial administration: demonstrate all listed criteria for first 28 days (age, DSM-5 diagnosis by structured interview, MADRS ≥28 or HAM-D ≥17, prior treatment failures for TRD or hospitalization/imminent suicide risk for acute indication).
• Reauthorization: document improvement on a validated depression rating scale and continued REMS compliance; coverage up to 1 year if criteria met.

Prior authorization must verify indication and treatment history

Prior authorization must verify that the indication aligns with FDA-labeled uses and the policy’s evidence-based criteria (TRD or MDD with acute suicidal ideation/behavior) and that the patient’s treatment history supports the request (e.g., prior trial outcomes referenced in trials and regulatory approvals).

• Policy references FDA approvals for TRD (March 6, 2019) and the supplemental approval for MDD with acute suicidal ideation/behavior (July 31, 2020).
• Prior authorization should ensure indication, documented diagnosis, and prior treatment failures align with the policy and evidence summarized (TRANSFORM, SUSTAIN, ASPIRE trials).

Prior authorization / coding note — use listed procedure codes and verify benefits

When submitting prior authorization or claims, reference the procedure and mapping codes listed in the policy; coverage and prior authorization requirements remain subject to member benefit terms and medical necessity determinations.

• Procedure Codes listed: J0013 (with mapped G2082/G2083 per coding table) and historically S0013 noted in policy history.
• Final coverage/payment decisions are subject to the member’s benefit program, eligibility on the date of service, and medical necessity per the policy.

Step therapy precedent — document two failed adequate antidepressant trials

For TRD, prior treatment requirement: patient must have failed two antidepressant agents from two different classes with adequate dose and duration (adequate trial defined as ≥6 weeks at accepted doses and ≥80% adherence) before initiating esketamine.

• Failure of two antidepressant agents from different classes is required to meet the TRD definition used for coverage.
• An adequate trial is defined in the policy as at least 6 weeks at generally accepted doses and ≥80% adherence.

Expect documented prior treatment attempts and modification strategies

Expect documentation that prior antidepressant management included modification or augmentation strategies (dose increase, switch, or augmentation) before labeling the patient treatment-resistant; such strategies should be recorded in the treatment history.

• Policy states management commonly involves modifying current antidepressant therapy or augmenting with non-antidepressant medications (e.g., atypical antipsychotics).
• Document whether higher dose, switching agents, or augmentation strategies were attempted and their durations.

Step therapy — policy notes alignment with REMS but no separate algorithm listed

The policy does not enumerate additional explicit step therapy sequencing beyond the TRD definition, but prior treatment requirements and REMS alignment in policy history imply stepwise verification may be applied during authorization.

• Policy history notes REMS criteria alignment and updates but does not list a separate step therapy algorithm in these chunks.
• Authorization decisions will still require meeting documented criteria for the indication.

Required documentation — diagnosis, severity scores, prior trials, REMS, prescriber

Required documentation for authorization must include patient age, DSM-5 structured interview confirming a major depressive episode, baseline depression severity using MADRS or HAM-D (with threshold MADRS ≥28 or HAM-D ≥17), full history of prior antidepressant trials including adequacy (≥6 weeks at accepted doses and ≥80% adherence), REMS enrollment, and prescriber specialty or specialist consultation.

• Include MADRS or HAM-D scores used to establish severity (policy thresholds: MADRS ≥28 or HAM-D ≥17).
• Provide documentation of prior antidepressant trials with duration and adherence details, REMS enrollment, and treating prescriber specialty or consultation.

Required clinical documentation — diagnosis method and symptom measurement

Providers should document the diagnosis of a major depressive episode per DSM or ICD criteria (by structured assessment) and record the treatment history using either clinical interview or a structured staging tool; baseline and follow-up symptom measures (PHQ-9, CUDOS, QIDS-SR16, MADRS, HAM‑D) are expected to demonstrate severity and response.

• Diagnosis may be established by DSM/ICD clinical evaluation or structured tools (HAM-D, MADRS) as described in the policy.
• Use and document validated scales (PHQ-9, CUDOS, QIDS-SR16, MADRS, HAM‑D) at baseline and during follow-up to support improvement for reauthorization.

Verify eligibility and be prepared to document medical necessity

Before requesting services, providers must confirm member eligibility and benefits for the date of service and be prepared to document medical necessity per the policy and the member’s contract terms.

• Coverage/payment is subject to the member’s benefit program, eligibility on date of service, and contract terms.
• Providers should verify benefits and document medical necessity consistent with policy requirements.

Denial risks — common medical necessity triggers

Denial risks include requests that do not meet medical necessity criteria — examples include inadequate prior antidepressant trials, insufficient documentation of depression severity, active substance use disorder without remission, use outside FDA-labeled indications, or failure to comply with REMS and monitoring requirements.

• Requests lacking documentation of two adequate prior antidepressant trials or missing MADRS/HAM‑D scores at policy thresholds may be denied.
• Use outside the outlined indications or without REMS/safety monitoring requirements is considered investigational and may be denied.

Denial risk — missing diagnosis or treatment history

Lack of documented diagnosis by DSM/ICD or structured assessment and absence of documented history of two or more adequate antidepressant trials (with duration and adherence) are specific documentation gaps that may trigger denial.

• Ensure a structured DSM-5 interview or equivalent documentation confirming a major depressive episode is included.
• Provide evidence of the number, duration (≥6 weeks), and adherence (≥80%) of prior pharmacologic trials or use a validated staging tool to document treatment resistance.

Denial risk — benefits and eligibility limitations

Coverage/payment determinations are subject to member benefit terms and eligibility on the date of service; failure to verify coverage or misalignment with contract terms may result in denial or non-payment.

• Final claim processing depends on the member’s contract, including benefit limitations and exclusions.
• Contact Provider Services or Member Services for benefit or coverage questions prior to initiating treatment.