Viva Health Spravato Coverage & Prior Auth

Coverage Criteria for Intranasal Esketamine (Spravato)

Initial Therapy

Covered when ALL of the following are met:

Universal requirements: Patient is at least 18 years old; baseline assessment documented using a validated depression rating scale (e.g., MADRS, HAM-D, PHQ-9, BDI, QIDS); diagnosis of major depressive disorder (MDD) per current DSM; no history of aneurysmal vascular disease, arteriovenous malformation, intracerebral hemorrhage, or known hypersensitivity to ketamine; and patient is not receiving concomitant ketamine therapy.

Indication-specific: Treatment-Resistant Depression (TRD): Used as monotherapy or in conjunction with an oral antidepressant; patient has tried psychotherapy alone or in combination with an oral antidepressant if available; not receiving concomitant ECT, TMS, VNS, or DBS; and failed trial of at least 2 antidepressants of different classes for >=6 weeks each at adequate dose and adherence (failed trial defined as <=25% reduction in symptom severity on a validated depression rating scale).

FDA-approved indication

Indication-specific: MDD with acute suicidal ideation/behavior: Must be used in conjunction with an oral antidepressant AND the patient is experiencing acute suicidal ideation or behavior OR has been recently discharged from a hospital in which esketamine was initiated.

FDA-approved indication

Renewal Therapy

Renewal covered when ALL of the following are met:

Renewal criteria: Patient continues to meet the universal and indication-specific criteria; absence of unacceptable toxicity (examples include sedation, dissociation, respiratory depression, signs of abuse/dependence, severe cognitive impairment, ulcerative/interstitial cystitis, suicidal thoughts/behavior, severe hypertension); and demonstrated disease improvement or stabilization compared to baseline using a validated depression rating scale.

Coverage excludes patients with structural cerebrovascular abnormalities or a prior intracranial bleed. Specifically, esketamine is not covered for individuals with aneurysmal vascular disease, arteriovenous malformation, or a history of intracerebral hemorrhage. Additionally, patients with a known hypersensitivity to ketamine are excluded. Finally, coverage requires that the patient is not receiving concomitant ketamine therapy.

This appendix and the coverage criteria described are intended for non‑Medicare coverage determinations. For Medicare beneficiaries, applicable CMS policies govern coverage of outpatient Part B drugs: consult the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15 §50 and any relevant NCDs, LCDs, and LCAs. Where Medicare rules apply, those determinations may supersede the payer’s non‑Medicare criteria; use the CMS Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx) to locate applicable documents.

For the Treatment‑Resistant Depression (TRD) indication, concurrent use of esketamine with other neuromodulation therapies is not permitted. Patients must not be receiving concomitant ECT, TMS, VNS, or DBS when receiving esketamine for TRD. Failure to meet this requirement may render the service not medically necessary under the TRD criteria and can affect coverage decisions.

Coding: HCPCS, ICD-10, NDCs and References

HCPCS / billing codesHCPCS

J0013	Esketamine, nasal spray, 1 mg; 1 billable unit = 1 mg (Effective 01/01/2026)
J3490	Unclassified drugs (Discontinue use on 01/01/2026)
C9399	Unclassified drugs or biologicals (Discontinue use on 01/01/2026)
S0013	Esketamine, nasal spray, 1 mg; 1 billable unit = 1 mg (Discontinue use on 01/01/2026)
G2082	Outpatient visit with supervision and provision of up to 56 mg esketamine including 2 hours postadministration observation
G2083	Outpatient visit with supervision and provision of greater than 56 mg esketamine including 2 hours postadministration observation

Covered ICD-10 Diagnosis CodesICD-10Covered

F32.0	Major depressive disorder, single episode, mild
F32.1	Major depressive disorder, single episode, moderate
F32.2	Major depressive disorder, single episode, severe without psychotic features
F32.3	Major depressive disorder, single episode, severe with psychotic features
F32.4	Major depressive disorder, single episode, in partial remission
F32.5	Major depressive disorder, single episode, in full remission
F32.9	Major depressive disorder, single episode, unspecified
F33.0	Major depressive disorder, recurrent, mild
F33.1	Major depressive disorder, recurrent, moderate
F33.2	Major depressive disorder, recurrent severe without psychotic features

1–10 of 17

1/2

NDCsNDC

50458-0028-xx

NDC for 56 mg and 84 mg dose kits (unit-dose cartons containing 28 mg devices)

Referenced NCD/LCA/LCD documentsmixed

A59249	NCD/LCA/LCD Document reference
A59250	NCD/LCA/LCD Document reference

Dosing schedules — induction and maintenance regimens, summarized key-value

TRD induction (weeks 1-4)56 mg or 84 mg intranasally twice weekly

TRD maintenance (weeks 5-8)56 mg or 84 mg intranasally once weekly

TRD maintenance (weeks 9+)56 mg or 84 mg intranasally once every 2 weeks or once weekly (individualize to least frequent dosing to maintain remission/response)

MDD with acute suicidal ideation/behavior (initial 4 weeks)84 mg intranasally twice weekly (may reduce to 56 mg twice weekly for tolerability); evaluate therapeutic benefit after 4 weeks

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization is valid for 6 months and may be renewed annually thereafter.

Initial prior authorization duration: 6 months
Renewal: may be renewed annually

Note

Check NCD/LCD/LCA for Medicare Prior-Authorization-like Requirements

When treating Medicare beneficiaries, check for applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) prior to authorization and billing. These Medicare policies may impose additional prior-authorization-like requirements or coverage limits that must be followed for Part B claims.

Search for NCD/LCD/LCA applicable to the service and contractor-specific articles (e.g., Novitas A59249, First Coast A59250)

Administration Setting and Supervision Requirements

Outpatient / Office-based supervised administration

Covered when ALL of the following are met:

Outpatient / Office-based supervised administration: Patient is an adult with MDD meeting universal and indication-specific criteria; baseline assessment documented with a validated depression rating scale; dosing and monitoring will occur in an outpatient/office-based setting with supervision and post-administration observation as required; and continued therapy requires documentation of absence of unacceptable toxicity and evidence of clinical improvement or stabilization compared to baseline.

Administration must follow safety monitoring and observation requirements (see dosing/administration).

Treatment Modalities and Specific Drug Criteria

Esketamine (intranasal)

Esketamine dosing: Treatment-Resistant Depression (TRD): Induction (weeks 1–4) — 56 mg or 84 mg intranasally twice weekly. Maintenance: weeks 5–8 once weekly (56 mg or 84 mg); weeks 9+ once every 2 weeks or once weekly individualized to the least frequent dosing that maintains remission/response. MDD with acute suicidal ideation/behavior: 84 mg intranasally twice weekly for 4 weeks (may reduce to 56 mg twice weekly for tolerability); evaluate therapeutic benefit after 4 weeks to determine need for continued treatment.

Dosing frequency should be individualized to the least frequent dosing necessary to maintain remission/response.

Visit Limits and Unit Examples

HCPCS/HCPCS-equivalent units example — induction twice weekly, maintenance weekly; units per dosing period

HCPCS G2082/G2083 example — TRD induction1 billable unit twice weekly during induction (weeks 1-4)

HCPCS G2082/G2083 example — TRD maintenance1 billable unit once weekly during maintenance (weeks 5+)

HCPCS J0013 units — TRD induction84 billable units twice weekly (J0013 = 1 mg per billable unit; corresponds to 84 mg per dose)

HCPCS J0013 units — TRD maintenance84 billable units once weekly (corresponds to 84 mg per dose)

MDD with acute suicidality — unitsPer chunk 2: 1 billable unit twice weekly; per J0013: 168 billable units weekly (reflecting 84 mg twice weekly dosing as documented)

Definitions

Failed trial — definition and threshold (<=25% reduction despite adequate trial)

DefinitionFailed trial = less than or equal to 25% reduction in symptom severity on a validated depression rating scale despite an adequate trial (generally ≥6 weeks at accepted doses)

Minimum trials for TRDAt least 2 antidepressant trials of different classes with adequate adherence and dose in the current depressive episode (unless contraindicated)

Adequate durationEach antidepressant trial generally at least 6 weeks

NCD / LCD / LCA — definitions of CMS coverage documents

NCDNational Coverage Determination — CMS policy document that defines national Medicare coverage and billing rules for services and Part B drugs

LCD

Background

Esketamine nasal spray (Spravato) is indicated for adults with treatment‑resistant depression (TRD) and for adults with major depressive disorder (MDD) who have acute suicidal ideation or behavior when used in conjunction with an oral antidepressant. Treatment with intranasal esketamine is provided in an observed outpatient setting and consists of an induction phase followed by maintenance dosing. For TRD, an induction regimen during weeks 1–4 uses either 56 mg or 84 mg intranasally twice weekly, with maintenance dosing individualized to once weekly or every 2 weeks thereafter. For MDD with acute suicidal ideation/behavior the regimen uses 84 mg twice weekly for up to 4 weeks (may be reduced to 56 mg twice weekly for tolerability) and must be used with an oral antidepressant. Baseline and follow‑up assessments using a validated depression rating scale are required, and coverage is limited to adults aged 18 and older who meet the policy’s universal and indication‑specific criteria.

Revision History

08/05/2025policy_reviewLatest

Document last reviewed on 08/05/2025 (listed in document header and Dates Reviewed).

02/2025policy_review

Document reviewed in 02/2025 (listed in Dates Reviewed).

08/2024policy_review

Document reviewed in 08/2024 (listed in Dates Reviewed).

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Intranasal esketamine (Spravato) — Coverage Criteria and Prior Authorization