CurrentCignaPolicy N/A

Psychiatry – Spravato - (IP0220)

Cigna coverage policy for Spravato (esketamine nasal spray) including prior authorization requirements, FDA‑approved indications (MDD with acute suicidal ideation/behavior and treatment‑resistant depression), dosing, duration of approvals, documentation requirements, REMS requirements, and coding for billing.

Policy Summary

PayerCigna

PolicyPsychiatry – Spravato - (IP0220)

Policy CodePolicy N/A

Change TypeMultiple material revisions (dosing, durations, coding, documentation, coverage)

Effective DateAug 15, 2024

Next Review Date

Key ActionPrior Authorization is required for Spravato; follow documented criteria, dosing, documentation and REMS administration requirements for approvals and durations.

SourceLink

POLICY UPDATE CHANGES

Updated initial approval duration to 2 months for MDD with Acute Suicidal Ideation or Behavior and 6 months for Treatment‑Resistant Depression; Effective Date = 08/15/2024; Review Date = 6/13/2024.

Added dosing indication for all FDA Approved Indications and added documentation instruction requiring documentation where noted in the criteria.

Removed conditions not covered entries for Anesthetic Use, Bipolar Disorder, Pain Syndromes, and PTSD.

Removed requirement that TRD therapy must be concomitant with an oral antidepressant to reflect FDA approval for monotherapy in TRD.

Continuation requirements added for TRD patients who have received ≥ 6 months of therapy: 1‑year approval if beneficial response and PDMP check performed; must be prescribed by or in consultation with psychiatrist or mental health provider. (Effective 2026‑06‑01)

Added HCPCS code J0013 effective 1/1/2026 and updated S0013 description to indicate effective until 12/31/2025.

Changed prescriber requirement for MDD with acute suicidal ideation/behavior from 'by a psychiatrist' to 'by or in consultation with a psychiatrist or a mental health provider' (12/4/2025 and reaffirmed 2/1/2026).

Several documentation requirements were removed in later revisions (dates referenced) for certain prescriber‑stated items and antidepressant dosing documentation.

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Covered FDA Indications

2 moInitial approval (MDD acute SI/B)

6 moInitial approval (TRD)

1 yrContinuation approval (TRD ≥6 mo)

2026-01-01Added HCPCS J0013 effective

Coverage Summary & Indications

Cigna coverage policy: Spravato (esketamine) nasal spray is covered with criteria for the FDA‑approved indications of major depressive disorder (MDD) with acute suicidal ideation/behavior (when used with an oral antidepressant) and treatment‑resistant depression (TRD) (as monotherapy or with an oral antidepressant). Prior authorization and REMS requirements apply. Policy effective date: 2024-08-15; last review date: 2026-06-01.

Major Depressive Disorder (MDD) with Acute Suicidal Ideation or Behavior - FDA‑Approved Indication

Approve for 2 months if the patient meets the following (A, B, C, D, and E):

ALL of the following

Patient is ≥ 18 years of age
Patient has major depressive disorder that is considered to be severe, according to the prescriber
[documentation required]
Patient is concomitantly receiving at least one oral antidepressant
[documentation required]
Psychosis history
- No history of psychosis
- History of psychosis and the prescriber believes that the benefits of Spravato outweigh the risks
Medication is prescribed by or in consultation with a psychiatrist or a mental health provider

Treatment‑Resistant Depression (TRD) - Initial Therapy

Approve for 6 months if the patient meets ALL of the following (i–v):

ALL of the following

Patient is ≥ 18 years of age
Prior antidepressant trials
- Patient has demonstrated nonresponse (≤ 25% improvement in depression symptoms or scores) to at least two different antidepressants, each from a different pharmacologic class
  [documentation required]
- Each antidepressant was used at therapeutic dosages for at least 6 weeks in the current episode of depression
  [documentation required]
Psychosis history

Not Medically Necessary / Not Covered

Spravato is considered not medically necessary when used for any other purpose than listed FDA‑approved indications:

Spravato for any other use is considered not medically necessary

Initial Therapy Criteria & Dosing

MDD with Acute Suicidal Ideation or Behavior - Dosing

Dosing to be approved when criteria met:

ALL of the following

Maximum single dose: 84 mg intranasally
Twice weekly dosing for 4 weeks

TRD - Dosing

Dosing to be approved when criteria met:

ALL of the following

Induction phase (Weeks 1 to 4): twice weekly dosing

Continuation Therapy Criteria

Treatment‑Resistant Depression (TRD) - Continuation (Currently Receiving Spravato)

Approve for 1 year if the patient meets ALL of the following (i–iv):

ALL of the following

Patient has already received at least 6 months of therapy with Spravato
According to the prescriber, the patient is having a beneficial response to Spravato
Patient's history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP), according to the prescriber
Medication is prescribed by or in consultation with a psychiatrist or a mental health provider

Policy change: continuation requirements were added for TRD patients who have received ≥ 6 months of Spravato therapy — allowing 1‑year approvals if beneficial response and PDMP check performed; effective 2026-06-01.

Provider Actions, Prior Authorization & Operational Requirements

Prior Authorization

Prior Authorization required

Prior authorization is required for benefit coverage of Spravato. Approvals are provided for specified durations: 2 months for Major Depressive Disorder (MDD) with acute suicidal ideation or behavior, 6 months for Treatment‑Resistant Depression (TRD) initial therapy, and 1 year for TRD continuation when criteria are met. Relevant billing/coding: J0013 (effective 1/1/2026) and legacy S0013 (through 12/31/2025); Medicare Advantage visit codes G2082 and G2083 are also listed for administration/observation.

2 months — MDD with acute suicidal ideation/behavior (initial approval to allow a 4‑week course and scheduling)
6 months — TRD initial therapy (when initial TRD criteria met)
1 year — TRD continuation for patients who have already received ≥ 6 months of Spravato and meet continuation criteria

Documentation Required

Documentation required for key criteria

Documentation is required where noted in the criteria. Examples of required documentation include: prescriber documentation that MDD is severe; documentation of prior antidepressant trials and nonresponse (≤ 25% improvement) to at least two different antidepressants from different pharmacologic classes; documentation that each antidepressant was used at therapeutic dosages for at least 6 weeks in the current episode. Documentation may include chart notes, laboratory tests, claims records, and/or other information and must include patient‑specific identifying information.

Applicable Codes

Medically Necessary HCPCS / J‑code (effective 2026-01-01)HCPCSCovered

J0013

Esketamine, nasal spray, 1 mg (Code effective 1/1/2026)

Legacy HCPCS (through 12/31/2025)HCPCSCovered

S0013

Esketamine, nasal spray, 1 mg (Code effective until 12/31/2025)

Medicare Advantage visit codes for administration and observationHCPCSCovered

G2082	Office/outpatient visit for established patient requiring supervision and provision of up to 56 mg esketamine nasal self‑administration; includes 2 hours post administration observation
G2083	Office/outpatient visit for established patient requiring supervision and provision of greater than 56 mg esketamine nasal self‑administration; includes 2 hours post administration observation

Background & Clinical Evidence

Background: Spravato (esketamine) is an NMDA receptor antagonist indicated for MDD with acute suicidal ideation/behavior (in conjunction with an oral antidepressant) and for treatment‑resistant depression (as monotherapy or with an oral antidepressant). It is a Schedule III controlled substance available only through a REMS program because of risks including sedation, dissociation, respiratory depression, and abuse.

Evidence and guidance: Prescribing information — Janssen Spravato prescribing information, April 2025. Guideline note — VA/DoD 2022 MDD guideline suggests ketamine/esketamine augmentation for nonresponsive MDD.

Definitions (glossary): Nonresponse — ≤ 25% improvement in depression symptoms or scores. PDMP — state prescription drug monitoring program used to check controlled substance prescription history.

Policy Revision History

08/15/2024effective_date_change

Updated initial approval duration to 2 months for MDD with Acute Suicidal Ideation or Behavior and 6 months for Treatment‑Resistant Depression; Effective Date = 08/15/2024 (Review Date = 6/13/2024).

02/27/2025added_documentation_instructions

Added documentation instructions: 'Documentation is required for use of Spravato as noted in the criteria' and updated several criterion statements to require documentation where noted.

04/01/2025added_dosing_indication_and_removed_conditions

Policy Summary

PayerCigna

PolicyPsychiatry – Spravato - (IP0220)

Policy CodePolicy N/A

Change TypeMultiple material revisions (dosing, durations, coding, documentation, coverage)

Effective DateAug 15, 2024

Next Review Date

Key ActionPrior Authorization is required for Spravato; follow documented criteria, dosing, documentation and REMS administration requirements for approvals and durations.

SourceLink

On This Page

No history of psychosis

History of psychosis and the prescriber believes that the benefits of Spravato outweigh the risks

Patient's history of controlled substance prescriptions has been checked using the state prescription drug monitoring program (PDMP), according to the prescriber

Medication is prescribed by or in consultation with a psychiatrist or a mental health provider

Maintenance phase (Weeks 5 and after): up to once weekly dosing

Maximum single dose: 84 mg intranasally

Key thresholds: patient must be age ≥ 18 years. Nonresponse is defined as ≤ 25% improvement in depression symptoms or scores. Prior antidepressant trials must have been at therapeutic dosages for at least 6 weeks each in the current episode.

Prescriber statement/documentation that MDD is severe (for MDD with acute suicidal ideation/behavior)
Documentation of ≥2 different antidepressant trials from different classes and nonresponse (≤ 25% improvement)
Documentation that each antidepressant was used at therapeutic dosages for ≥ 6 weeks in the current episode
All documentation must include patient identifiers (chart note, lab, claims, etc.)

Documentation Required

PDMP check

The prescriber must check the patient's history of controlled substance prescriptions using the state Prescription Drug Monitoring Program (PDMP) as part of TRD initial therapy criteria and for TRD continuation approvals.

PDMP check required for TRD initial approval (criterion iv)
PDMP check required for TRD continuation (criterion iii for 1‑year approval)

Billing Rule

REMS and administration requirements

REMS enrollment and certified settings are required: Spravato must be dispensed only to healthcare settings certified in the REMS. Administration must be under direct observation by a healthcare provider and patients must be monitored for at least 2 hours after administration.

Patient must be enrolled in REMS and medication dispensed only to REMS‑certified healthcare settings
Administration under direct observation of a healthcare provider
Monitor patients for at least 2 hours after each administration

Documentation Required

Specialist prescribing

Spravato must be prescribed by or in consultation with a psychiatrist or a mental health provider for approvals (required for both MDD with acute suicidal ideation/behavior and TRD criteria and continuation).

Prescribed by or in consultation with a psychiatrist or a mental health provider (required for initial and continuation approvals)

Denial Risk

Coverage denial for non‑listed uses

Claims for Spravato billed for conditions or diagnoses not covered under this policy (any use other than the listed FDA‑approved indications) will be denied as not medically necessary / not covered.

Spravato for any other use is considered not medically necessary and will be denied

Billing Rule

Sample product not acceptable

Receipt of sample product does not satisfy criteria requirements for coverage and will not be accepted in lieu of documentation or billed product.

Samples do not fulfill policy criteria for coverage

Added dosing indication for all FDA‑approved indications and removed Conditions Not Covered entries for Anesthetic Use, Bipolar Disorder, Pain Syndromes, and Post‑traumatic Stress Disorder.

12/04/2025prescriber_requirement_change

Changed prescriber requirement for MDD with acute suicidal ideation/behavior from 'by a psychiatrist' to 'by or in consultation with a psychiatrist or a mental health provider.'

01/01/2026coding_change

Added HCPCS code J0013 (Esketamine, nasal spray, 1 mg) effective 1/1/2026; updated S0013 description to indicate code effective until 12/31/2025.

02/01/2026prescriber_requirement_reaffirmed

Reaffirmed change that medication may be prescribed by or in consultation with a psychiatrist or a mental health provider for MDD with acute suicidal ideation/behavior.

05/14/2026continuation_requirements_added

Added continuation requirements for TRD patients who have received ≥ 6 months of therapy: 1‑year approval if beneficial response and PDMP check performed; medication must be prescribed by or in consultation with a psychiatrist or mental health provider.

06/01/2026continuation_requirements_effectiveLatest

Continuation requirements for TRD (as described) effective 2026-06-01; policy notes effective date in force until updated or retired.