CurrentCignaPolicy IP0220

Psychiatry - Spravato

Cigna coverage policy for Spravato (esketamine nasal spray) defining medical necessity criteria, dosing, monitoring, documentation, coding, and exclusions for FDA-approved indications: Major Depressive Disorder (MDD) with acute suicidal ideation or behavior and Treatment-Resistant Depression (TRD) in adults.

Policy Summary

PayerCigna

PolicyPsychiatry - Spravato

Policy CodePolicy IP0220

Change TypeAnnual revision; targeted updates

Effective DateApr 1, 2025

Next Review Date

Key ActionProvide documentation of diagnosis severity and prior treatments (including chart notes, labs, claims) and ensure prescribing and administration meet REMS and PDMP requirements.

POLICY UPDATE CHANGES

Policy Name changed from 'Esketamine' to 'Psychiatry - Spravato'.

Updated initial approval duration to 2 months for MDD with acute suicidal ideation or behavior and 6 months for Treatment-Resistant Depression.

Added dosing indication for all FDA-approved indications.

Removed 'Anesthetic Use, Bipolar Disorder, Pain Syndromes, and Post-traumatic Stress Disorder' from Conditions Not Covered.

Added requirement: 'Documentation is required for use of Spravato as noted in the criteria.'

For TRD removed requirement that patient be concomitantly receiving an oral antidepressant (reflecting monotherapy indication).

Clarified nonresponse wording to: 'Documentation is provided that the Patient has demonstrated nonresponse (≤ 25% improvement in depression symptoms or scores) to at least two different antidepressants, each from a different pharmacologic class.'

FDA-Approved Indications Covered

18+Minimum Age (years)

84Maximum Single Dose (mg)

2hPost-dose Observation Time

Coverage Summary

Cigna coverage policy for Spravato (esketamine nasal spray) covers the FDA‑approved adult indications: Major Depressive Disorder (MDD) with acute suicidal ideation or behavior (administered in conjunction with an oral antidepressant) and Treatment‑Resistant Depression (TRD) as monotherapy or adjunct. The policy specifies medical necessity criteria, dosing, monitoring, documentation, coding, and exclusions for these indications.

Approvals and durations: for MDD with acute suicidal ideation/behavior approve for 2 months when criteria are met; for TRD approve for 6 months when criteria are met. Patients must be ≥ 18 years, and Spravato must be prescribed by a psychiatrist per the policy.

Safety controls: Spravato is a Schedule III controlled substance and is available only through a REMS program requiring administration in REMS‑certified healthcare settings with required post‑dose observation and monitoring.

Key thresholds

Age>= 18 years

Nonresponse to prior antidepressants≤ 25% improvement to at least two different antidepressants from different pharmacologic classes; each used at therapeutic dosages for ≥ 6 weeks in the current episode

Maximum single dose84 mg intranasally

Monitoring duration post-dose>= 2 hours (monitor under direct supervision in REMS-certified setting)

Initial Therapy — MDD with Acute Suicidal Ideation or Behavior

Medical Necessity — Major Depressive Disorder with Acute Suicidal Ideation or Behavior

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

ALL of the following

ALL of the following
- Patient is ≥ 18 years of age
- Documentation is provided that the patient has major depressive disorder that is considered to be severe, according to the prescriber
- Documentation is provided that the patient is concomitantly receiving at least one oral antidepressant
  Antidepressants may include SSRIs, SNRIs, TCAs, mirtazapine, bupropion, etc.
- Psychosis history

Initial Therapy — Treatment-Resistant Depression (TRD)

Medical Necessity — Treatment-Resistant Depression (TRD)

Approve for 6 months if the patient meets the following criteria (A, B, C, D, and E):

ALL of the following

Patient is ≥ 18 years of age
Nonresponse to prior antidepressants
- Documentation is provided that the patient has demonstrated nonresponse (≤ 25% improvement in depression symptoms or scores) to at least two different antidepressants, each from a different pharmacologic class
  Different pharmacologic classes include SSRIs, SNRIs, TCAs, bupropion, mirtazapine, etc.
- Documentation is provided that each antidepressant was used at therapeutic dosages for at least 6 weeks in the current episode of depression, according to the prescriber

Post-administration Monitoring

Post administration patient monitoring is considered medically necessary when ONE of the above criteria has been met (1 or 2).

ALL of the following

Spravato must be administered under the direct supervision of a healthcare provider
Patients must be monitored by a healthcare provider for at least 2 hours after administration
Healthcare settings and pharmacies must be certified in the REMS program; Spravato dispensed only to certified healthcare settings and administered to patients enrolled in the REMS

Provider Actions & Documentation

Documentation Required

Document diagnosis severity and prior treatments

Documentation is required. Provide documentation that MDD is severe for acute suicidal ideation/behavior or that the patient has demonstrated nonresponse (≤ 25% improvement in depression symptoms or scores) to at least two different antidepressants from different pharmacologic classes, and that each antidepressant was used at therapeutic dosages for at least 6 weeks in the current episode. Acceptable documentation may include chart notes, laboratory tests, claims records, and/or other information.

Billing Rule

Administration and observation coding in REMS-certified setting

Bill drug and administration codes as appropriate and ensure administration/observation occurs in a REMS‑certified setting. Use S0013 for esketamine drug billing. For office/outpatient visits including supervision and 2 hours post‑administration observation, use G2082 for up to 56 mg and G2083 for greater than 56 mg.

S0013

Applicable Codes

Drug HCPCS (Commercial plans)HCPCSCovered

S0013

Esketamine, nasal spray, 1 mg

Administration / E/M with observationHCPCSCovered

G2082	Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine nasal self-administration, includes 2 hours post administration observation
G2083	Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of greater than 56 mg esketamine nasal self-administration, includes 2 hours post administration observation

Clinical Evidence & Safety

Boxed warning elements include risks of sedation, dissociation, respiratory depression, abuse/misuse, and suicidal thoughts and behaviors in pediatric and young adult patients.

The most common psychological adverse effects reported are dissociative or perceptual changes (including distortion of time, space, illusions, derealization, and depersonalization), occurring in 61% to 84% of treated patients.

Because of these risks, Spravato is only available through a restricted REMS program: healthcare settings and pharmacies must be certified, patients must be enrolled, the medication must be administered under direct supervision of a healthcare provider, and patients must be monitored for at least 2 hours after administration.

Regulatory/control status: Spravato contains esketamine and is a Schedule III controlled substance; assess and monitor patients for abuse/misuse and check PDMP per policy requirements when applicable.

Definitions

TRD (treatment‑resistant depression): FDA considers TRD when a patient with major depressive disorder has not responded to at least two antidepressants given at adequate doses for an adequate duration in the current episode (policy defines nonresponse as ≤ 25% improvement to at least two different antidepressants from different pharmacologic classes, each used at therapeutic dosages for ≥ 6 weeks).

PDMP (prescription drug monitoring program): state prescription drug monitoring program; the policy requires that the patient's history of controlled substance prescriptions be checked using the PDMP for TRD prior to prescribing Spravato.

Revision History

2024-08-15policy_name_change

Policy Name changed from 'Esketamine' to 'Psychiatry - Spravato'.

2024-08-15approval_duration_update

Updated initial approval duration: 2 months for Major Depressive Disorder with acute suicidal ideation or behavior; 6 months for Treatment-Resistant Depression.

2025-04-01documentation_requirement_addedLatest

Added requirement: Documentation is required for use of Spravato as noted in the criteria; acceptable documentation may include chart notes, laboratory tests, claims records, and/or other information.

Policy Summary

PayerCigna

PolicyPsychiatry - Spravato

Policy CodePolicy IP0220

Change TypeAnnual revision; targeted updates

Effective DateApr 1, 2025

Next Review Date

Key ActionProvide documentation of diagnosis severity and prior treatments (including chart notes, labs, claims) and ensure prescribing and administration meet REMS and PDMP requirements.

On This Page

No history of psychosis
History of psychosis and the prescriber believes that the benefits of Spravato outweigh the risks

The medication is prescribed by a psychiatrist

Dosing requirements

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

Prior Authorization

Approval durations and prescriber requirement

For MDD with acute suicidal ideation or behavior, approve for 2 months. Spravato must be prescribed by a psychiatrist.

No history of psychosis
History of psychosis and the prescriber believes that the benefits of Spravato outweigh the risks

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

The medication is prescribed by a psychiatrist

Dosing requirements

Maximum single dose: 84 mg intranasally
Induction phase (Weeks 1 to 4): twice weekly dosing
Maintenance phase (Weeks 5 and after): up to once weekly dosing

Documentation Required

PDMP check for TRD

Check the patient's history of controlled substance prescriptions using the state prescription drug monitoring program (PDMP) prior to prescribing for TRD, per the prescriber.

Prior Authorization

Approval durations and prescriber requirement

For Treatment‑Resistant Depression (TRD), approve for 6 months. Spravato must be prescribed by a psychiatrist.

Billing Rule

REMS-certified setting and observation billing

Ensure administration occurs in a REMS‑certified healthcare setting with at least 2 hours of post‑dose observation. Use HCPCS code S0013 for the drug; use G2082 for visits that include supervision and provision of up to 56 mg (includes 2 hours post administration observation) and G2083 for visits that include supervision and provision of greater than 56 mg (includes 2 hours post administration observation).

S0013 — Esketamine, nasal spray, 1 mg
G2082 — up to 56 mg (includes 2 hours observation)
G2083 — greater than 56 mg (includes 2 hours observation)

G2082 (use for ≤56 mg; includes 2 hours observation)

G2083 (use for >56 mg; includes 2 hours observation)

2025-04-01dosing_addedLatest

Added dosing indications for all FDA-approved indications: maximum single dose 84 mg intranasally; MDD with acute suicidal ideation/behavior — 84 mg (may reduce to 56 mg) twice weekly for 4 weeks; TRD induction Weeks 1–4 twice weekly (56 or 84 mg), Weeks 5–8 once weekly, Week 9+ individualized (56 or 84 mg).

2025-04-01indication_criteria_revisionLatest

For Treatment-Resistant Depression removed the requirement that the patient be concomitantly receiving an oral antidepressant (reflecting monotherapy indication).

2025-04-01nonresponse_wording_clarifiedLatest

Clarified nonresponse documentation to: 'Documentation is provided that the patient has demonstrated nonresponse (≤ 25% improvement in depression symptoms or scores) to at least two different antidepressants, each from a different pharmacologic class'; also requires documentation that each antidepressant was used at therapeutic dosages for at least 6 weeks in the current episode.

2024-08-15conditions_not_covered_update

Removed 'Anesthetic Use, Bipolar Disorder, Pain Syndromes, and Post-traumatic Stress Disorder' from Conditions Not Covered.