Ketalar (Ketamine) and Spravato (Esketamine) — Medical Benefit Drug Policy (NJ)
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Governs medical benefit coverage and medical necessity criteria for Spravato (esketamine) nasal spray and ketamine injection for members in New Jersey; applies to prescribers and provider settings seeking coverage under UnitedHealthcare Community Plan.
Added J0013 and removed S0013 from the list of applicable HCPCS codes.
Coverage and Medical Necessity Criteria
Initial Therapy — TRD
Spravato (esketamine) is covered when ALL of the following are met for TRD (Initial Therapy):
Documentation of prior trials and baseline assessment must be included in submitted medical records.
Continuation Therapy
Continuation therapy for Spravato (covered when ALL are met):
Recent assessment (within 1 month) required to support continuation.
MDD with Acute Suicidal Ideation or Behavior
Spravato for MDD with acute suicidal ideation or behavior is covered when ALL are met:
Policy specifies use with a newly initiated or optimized oral antidepressant and standard of care (ASPIRE trial context).
Not Medically Necessary / Investigational
Not medically necessary / investigational statements:
Policy explicitly lists these non-covered indications.
Ketamine injection is considered medically necessary only for specific anesthesia uses (see separate criteria).
Ketamine injection — covered anesthesia uses
Ketamine injection covered uses (medical necessity):
Coverage restricted to anesthesia uses as specified in policy.
Clinical evidence-based coverage groups
Coverage considerations are informed by RCT evidence demonstrating efficacy in specific populations and contexts.
Rapid effect observed starting at 4 hours; follow-up continued through Day 90.
Trials typically used twice-weekly dosing for 4 weeks during induction.
Controlled trials with longer follow-up are needed to define durability and safety.
Spravato (esketamine) and ketamine injection have defined, separate coverage roles. Spravato is not covered for use as an anesthetic agent, for chronic pain (including nonmalignant pain, fibromyalgia, neuropathic pain, complex regional pain syndrome, and reflex sympathetic dystrophy), or for migraine headaches. Similarly, ketamine injection is considered investigational and not medically necessary for psychiatric disorders (including but not limited to depression, bipolar disorder, and PTSD), chronic pain, or migraine headaches. Ketamine injection coverage is limited to established anesthesia indications described elsewhere in the policy.
Spravato is not approved as an anesthetic agent and its safety and effectiveness in that role have not been established. Because of risks including sedation, dissociation, and potential for abuse or misuse, Spravato is available only through the Spravato REMS program; administration must occur in REMS-certified healthcare settings, patients must be enrolled in the REMS program, and patients must be monitored by a healthcare provider for at least 2 hours after administration. The FDA has additionally warned about safety concerns with compounded ketamine products for psychiatric use.
Off-label or non‑FDA uses of esketamine or ketamine mentioned in the policy are specifically limited. The policy explicitly lists use of Spravato as an anesthetic, for chronic pain, or for migraines as not medically necessary. Likewise, intravenous or other ketamine injections used for psychiatric disorders, chronic pain, or migraine headaches are considered investigational and not medically necessary. Providers should note the FDA communication cautioning about compounded ketamine formulations used for psychiatric treatment when considering off‑label approaches.
Health technology assessments summarize the evidence for ketamine-related psychiatric uses as limited or inconsistent. For example, Hayes assigned ketamine for treatment‑resistant unipolar depression a rating of C (potential but unproven benefit) and rated ketamine for PTSD and for treatment‑resistant bipolar depression as D2 (insufficient evidence). These assessments note small studies, methodological limitations, and lack of long‑term data, supporting the policy’s stance that many ketamine psychiatric uses remain unproven.
Applicable Codes and Coding Notes
| J0013 | Esketamine, nasal spray, 1 mg. |
| J3490 | Unclassified drugs. |
| F33.0 | Major depressive disorder, recurrent, mild. |
| F33.1 | Major depressive disorder, recurrent, moderate. |
| F33.2 | Major depressive disorder, recurrent severe without psychotic features. |
| F33.3 | Major depressive disorder, recurrent, severe with psychotic symptoms. |
| F33.40 | Major depressive disorder, recurrent, in remission, unspecified. |
| F33.41 | Major depressive disorder, recurrent, in partial remission. |
| F33.42 | Major depressive disorder, recurrent, in full remission. |
| F33.8 | Other recurrent depressive disorders. |
| J0013 | Injection, ketorolac tromethamine, per 15 mg (example added HCPCS) (document notes J0013 was added — use payer-specific descriptor) |
| S0013 | Previously listed HCPCS code removed from applicable codes |
Prior Authorization, Documentation, and Billing Actions
Prior authorization required; authorizations limited to ≤12 months
Prior authorization is required for Spravato (esketamine). Initial authorization will be for no longer than 12 months; continuation authorization also is limited to no longer than 12 months and requires documentation of remission or positive clinical response and ongoing REMS-certified administration per FDA labeling.
- Initial authorization ≤ 12 months
- Continuation requires documentation of remission or positive clinical response and REMS-certified setting
Reflect updated HCPCS (J0013 added; S0013 removed) and confirm REMS
Update PA and billing processes to reflect the annual HCPCS edits: J0013 was added and S0013 was removed. Prior authorization reviews must also confirm the provider/setting is certified in the Spravato REMS program and that REMS monitoring requirements are met.
- HCPCS update: Added J0013; Removed S0013
- Confirm provider/setting REMS certification and REMS monitoring (including 2-hour post‑dose monitoring)
Document ≥2 prior antidepressant trials (each ≥3 weeks) for TRD
For TRD, document history of failure of at least two different antidepressants or treatment regimens, with each trial lasting at least 3 weeks; include medication name, dates, and duration of each trial in submitted records.
- At least two different antidepressant trials documented
- Each trial ≥ 3 weeks with medication, date, and duration noted
No mandated sequencing beyond trial requirements
This policy does not mandate a specific sequencing beyond the requirement for prior antidepressant trials; clinical trials described include newly initiated or optimized oral antidepressant with esketamine or esketamine monotherapy.
- No mandated sequencing specified in policy text
- Evidence includes trials with newly initiated/optimized oral antidepressant or esketamine monotherapy
Submit DSM diagnosis and baseline (and recent for continuation) depression scale scores
Submit medical records documenting DSM diagnosis of major depressive disorder and baseline score on an accepted depression scale (BDI, HAMD, MADRS, PHQ‑9, or QIDS). For continuation requests, include baseline and recent (within the last month) assessment scores demonstrating remission or response.
- DSM diagnosis by a mental health professional
- Baseline score on BDI, HAMD, MADRS, PHQ‑9, or QIDS
- For continuation: recent (within 1 month) assessment score showing response/remission
Document REMS-certified administration, REMS enrollment, monitoring, and updated coding
Document that Spravato was dispensed and administered only in a REMS-certified healthcare setting, that the patient is enrolled in the Spravato REMS program, and that monitoring occurred per REMS (patients monitored by a healthcare provider for at least 2 hours after administration). Also ensure applicable HCPCS coding reflects the policy update (J0013 added; S0013 removed).
- Proof of administration in REMS‑certified healthcare setting
- Patient enrollment in Spravato REMS program
- Documentation of ≥2‑hour post‑dose monitoring
- Use updated HCPCS code (J0013) and remove S0013
Denial risk: missing diagnosis, assessment scores, or prior trial documentation
Claims or prior authorization may be denied if required documentation is missing — for example, absence of the DSM diagnosis, missing baseline or follow-up depression scale scores, or failure to document at least two prior antidepressant trials of adequate duration.
- Missing DSM diagnosis or baseline/ follow‑up assessment scores
- No documentation of ≥2 prior antidepressant trials of adequate dose/duration
- Use of ketamine injection for psychiatric indications (investigational) may lead to noncoverage
Denial risk for REMS noncompliance (dispensing/administering outside certified settings or lack of monitoring)
Failure to comply with Spravato REMS requirements — including dispensing or administering Spravato outside certified healthcare settings, administering to patients not enrolled in the REMS program, or not monitoring patients for at least 2 hours post‑administration — can trigger denial or noncoverage.
- Dispensing/administering outside REMS‑certified settings
- Patient not enrolled in Spravato REMS program
- Failure to monitor patient for ≥2 hours after administration
Clinical Background and Context
Major depressive disorder (MDD) is a common, potentially severe condition associated with substantial morbidity and mortality. A meaningful subset of patients—commonly estimated at approximately 30–40%—do not respond adequately to first‑line treatments and are considered treatment‑resistant after failure of at least two adequate antidepressant trials. Esketamine (Spravato) is an NMDA receptor antagonist approved for treatment‑resistant depression and for depressive symptoms in MDD with acute suicidal ideation or behavior (when used with an oral antidepressant); IV ketamine is an anesthetic with studied off‑label rapid antidepressant effects but lacks FDA approval for psychiatric indications.
Key Definitions
Setting and Administration Level Criteria
Inpatient/Acute and Outpatient administration under REMS-certified settings
Initiation in suicidal patients may occur in inpatient/acute settings; outpatient administration requires REMS-certified settings and monitoring.
Documentation of REMS enrollment and monitoring should be maintained for authorization.
Therapies and Administration
Esketamine (Spravato)
Provides context for expected dosing frequency, monitoring, and response timing.
Esketamine (intranasal), Ketamine (IV)
Efficacy demonstrated in multiple RCTs and meta-analyses with rapid onset.
Systematic reviews suggest repeat infusions may provide greater effect than single infusion.
Dosing Frequency and Visit Limits
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