Prior Authorization & Documentation Required

Prior authorization is required for Spravato (esketamine) nasal spray. Submit documentation of diagnosis, prior antidepressant treatment failures (medication name, dates, duration), baseline depression assessment scores, and evidence that the prescribing provider and administration site are certified in the Spravato REMS program. Initial and reauthorization approvals are limited to no longer than 12 months.

• Prior authorization required for Spravato for TRD
• Document history of failure of at least two different antidepressants or regimens (each ≥ 8 weeks) including medication name, start/end dates, and duration
• Provide baseline scoring on an approved depression assessment (BDI, HAMD, MADRS, PHQ-9, QIDS) prior to starting Spravato

REMS Certification & Administration Requirements

Spravato must be dispensed and administered only in REMS-certified healthcare settings with patients enrolled in the Spravato REMS program. Administration must be performed under direct observation and the patient monitored for at least 2 hours after dosing. Coverage reviewers should verify REMS enrollment and that the provider/site certification is current.

• Patient must be enrolled in the Spravato REMS program prior to administration
• Administration only in REMS-certified healthcare setting
• Patient monitored ≥ 2 hours post-dose; documentation of monitoring must be submitted

REMS Documentation (What to Submit)

Document REMS-related evidence in the medical record: proof of patient enrollment in Spravato REMS, facility or provider REMS certification, and notes showing direct observation and post-dose monitoring. Failure to meet REMS requirements may result in denial of coverage.

• Attach REMS enrollment confirmation for the patient
• Attach provider/setting REMS certification documentation
• Include nursing/observation notes showing direct observation and monitoring duration

Prior Antidepressant Trial Documentation

Ensure prior antidepressant trial documentation shows failure of at least two different antidepressants or regimens (each ≥ 8 weeks). Include agent/class, dose, dates, reason for discontinuation (lack of efficacy, intolerance), and any augmentation strategies tried.

• List each antidepressant or regimen with start and end dates and duration (≥ 8 weeks each)
• State the reason for treatment failure for each trial (nonresponse, adverse effects, etc.)
• Include trials across classes when applicable (SSRI, SNRI, bupropion, TCA, MAOI, mirtazapine, augmentation with antipsychotic/lithium/thyroid)

Clinical Trial Context for Sequencing

Clinical trial evidence supports use of esketamine as adjunctive therapy to a newly initiated oral antidepressant and as monotherapy in TRD. When documenting sequencing, note whether Spravato is being used adjunctively with a newly started oral antidepressant or as monotherapy and include supporting clinical rationale.

• If used adjunctively, document initiation of the concurrent oral antidepressant and timing relative to Spravato dosing
• If used as monotherapy, document discontinuation of prior antidepressants if applicable and rationale for monotherapy use
• Reference supportive trial endpoints (e.g., MADRS score change at day 28) when relevant

Reference Member-Specific Benefit Plan

Before applying this policy, always check the member-specific benefit plan document and any applicable federal or state mandates. In case of conflict, the member specific benefit plan governs. Coverage reviewers and providers should verify member-specific coverage rules and benefit limits.

• Refer to the member specific benefit plan for coverage determinations
• Confirm any applicable state or federal mandates that may affect coverage
• When in conflict, follow the member specific benefit plan document

Updated Applicable HCPCS Codes

Applicable HCPCS/administrative coding for prior authorization and claims has been updated. Use the payer’s current applicable code list when submitting requests and claims to ensure accurate processing.

• Updated HCPCS: J0013 added
• Removed HCPCS: S0013
• Verify payer-specific code list before submission

Use of External Criteria Tools

This policy may be used alongside third-party utilization management tools (e.g., InterQual) to assist in administering health benefits. Providers should follow any additional documentation or criteria required by those tools or by the payer’s reviewer.

• InterQual or other third-party criteria may be applied in conjunction with this policy
• Follow additional documentation requests from payer reviewers or external criteria tools

Ensure REMS certification of provider/setting

Providers and healthcare settings must be certified in the Spravato REMS program to administer Spravato; ensure site certification is current before scheduling treatment.

• Certification of the administering healthcare setting in the Spravato REMS is required
• Only REMS‑certified settings may dispense and administer Spravato

Administer Spravato in certified setting with direct observation and ≥2‑hour monitoring

Dispense and administer Spravato only in REMS‑certified settings with direct observation of dosing and at least 2 hours of post‑dose monitoring; document these site‑of‑care processes in the patient record.

• Direct observation of dosing by a healthcare provider is required
• Record at least 2 hours of monitoring following each administration

Follow member plan and mandates for site‑of‑care decisions

Follow the member specific benefit plan and applicable mandates when interpreting this informational policy; site‑of‑care rules in the member plan may supersede the guidance here.

• This policy is informational and may apply to Medical Benefit Drug coverage in some plans
• Adhere to member‑specific site‑of‑care requirements and federal/state mandates