ModifiedPremera BluecrossPolicy 5.01.609

Spravato (esketamine) Nasal Spray — Coverage Criteria

Defines medical necessity, limitations, and coding for Spravato (esketamine) nasal spray for treatment of major depressive disorder (unipolar) including treatment-resistant depression and acute suicidal ideation/behavior; applies to providers administering Spravato under the pharmacy and medical benefits.

Policy Summary

PayerPremera Bluecross

PolicySpravato (esketamine) Nasal Spray — Coverage Criteria

Policy CodePolicy 5.01.609

Change TypeMaterial updates to dosing, trials, and indication application

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥18, DSM-5 MDD (unipolar), prior antidepressant trial history, and specified induction/maintenance dosing.

SourceLink

POLICY UPDATE CHANGES

Removed separate coverage criteria for MDD with acute suicidal ideation or behavior and aligned MDD criteria to apply regardless of suicidal ideation/behavior.

Clarified that maintenance dose (week 5 and after) is limited to 84 mg once weekly for the rest of the first 12 months and for re-authorization the same limit applies for the next 12 months.

Removed requirement that an oral antidepressant must be used concurrently with Spravato (allowing monotherapy) to align with FDA approval.

Removed stipulation that addition of a second antidepressant to an antidepressant trial is considered augmenting agent rather than a separate antidepressant trial.

Updated Documentation Required to include induction dose and maintenance dose frequency and time period specified.

Added an additional criterion that there is no present or past diagnosis of a bipolar disorder, and no history of any manic or hypomanic episodes.

Modified substance use disorder criterion to require either remission or complete abstinence for at least one month and agreement to remain abstinent; added option for temporary increase in dosing frequency to twice weekly when depression worsens during maintenance.

Coding update: added new HCPCS code J0013 and indicated S0013 has been termed, effective January 1, 2026.

For re-authorization, added that there must be no current psychosis to show depression continues to not be psychotic depression.

June 1, 2026 annual review noted: No changes to policy statements.

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18+min age

84 mgmax maintenance dose

84 mg x2/wkinduction/temporary freq

12 moauth period

G2082, G2083, J0013, S0013HCPCS codes

removedacute suicidality criteria

Coverage and Medical Necessity Criteria

Initial and maintenance coverage criteria

Covered when ALL of the following are met

Age: Individual is aged 18 years or older>=18

Diagnosis: Medical record documents DSM-5 diagnostic criteria for major depressive disorder without psychotic features (unipolar)

Not bipolar

Bipolar exclusion: No present or past diagnosis of a bipolar disorder and no history of any manic or hypomanic episodes

Severity: Current episode is moderate to severe as demonstrated by documentation of symptoms and their severity or by one or more standardized depression rating scalesmoderate or severe

Diagnosis code alone for severity is insufficient; symptom documentation or scale score required

Psychosis exclusion: No current or past psychosis

Substance use: No current substance use disorder unless in remission (complete abstinence >= 3 months) OR complete abstinence >= 1 month and the individual agrees to remain abstinent OR confined 24/7 in a facility preventing access to substances and agrees not to use after discharge while continuing Spravato

Concurrent substance/drug restrictions: No concurrent use of hallucinogens/psychedelics, illicit drugs, illicit/non-prescribed stimulants, or prescribed stimulants in excess of prescribed doses; no prescribed controlled medications that were not prescribed for the individual; if alcohol or marijuana used, individual must cease use while treated or not use within 24 hours before and 24 hours after each treatment

Prior therapy requirements: Tried and failed 3 antidepressants from at least 2 different classes OR tried and failed 2 antidepressants from 2 different classes plus an augmenting agent

Failed trial = not effective, partially effective, lost effectiveness, or intolerable side effects; each failed medication must be identified and reasons specified (per medication or collectively); each failed trial should have documentation of at least 30 continuous days unless stopped for intolerable adverse effects

Dosing - induction: Induction (weeks 1-4) dosing limited to 84 mg twice per week, OR 56 mg on day 1 followed by up to 84 mg twice weekly for 4 weeksmax 84 mg twice/week induction

Dosing - maintenance: Maintenance (week 5 and after) limited to 84 mg once weekly for the rest of the first 12 months of treatment84 mg once weekly

Temporary increase to twice weekly during maintenance allowed per separate criteria when worsening occurs

Temporary increased-frequency (during maintenance)

Temporary increased-frequency during maintenance may be covered when ALL of the following are met

Worsening from remission/mild: Depression was mild or in remission during maintenance and has worsened to moderate or severe as demonstrated by documentation of symptoms or by one or more standardized depression rating scalesworsened to moderate or severe

Worsening from moderate: Depression was moderate during maintenance and has worsened to severe as demonstrated by documentation of symptoms or by one or more standardized depression rating scalesworsened to severe

Temporary dosing limit: Dose limited to 84 mg twice per week for no more than 8 weeks; dose must then return to maintenance 84 mg once weekly<=8 weeks

New course (re-induction) criteria

New course (re‑induction) may be covered when ALL of the following are met

Prior response: Individual previously met coverage criteria, had a prior course of Spravato, and had a positive response to that course

Time since last treatment must be >30 days

Current episode severity: Current episode is moderate to severe as demonstrated by documentation of symptoms or by one or more standardized depression rating scalesmoderate or severe

No new bipolar/psychosis: No new or previously undisclosed bipolar disorder, no new or previously undisclosed manic or hypomanic episodes, and no current or past psychosis

Investigational / Not covered indications

Investigational uses: All other uses not outlined in this policy are investigational (e.g., chronic pain, bipolar depression, use with neuromodulation such as TMS/ECT/VNS, use with other ketamine formulations, or use with any psychedelic drug); use that does not meet the age or diagnosis requirements is investigational

General medical necessity elements (as referenced)

Covered when ALL of the following are met (elements mentioned in this document portion):

Diagnosis: DSM-5 major depressive disorder without psychotic features (unipolar), or MDD with acute suicidal ideation/behavior when criteria met; DSM-5 documentation required

Prior treatment failure for TRD: Failure to respond to >= 2 different adequate antidepressant trials for the current episode (TRD definition used in trials)>=2 failed antidepressant trials

From clinical trials definition

Concomitant antidepressant (historical requirement): Spravato historically used in conjunction with a named oral antidepressant (must be documented); requirement for concurrent oral antidepressant was removed in 03/01/25 to allow monotherapy per FDA approval

Re-authorization may document oral antidepressant when applicable

MDD (including with acute suicidal ideation/behavior)

Covered when ALL applicable medical necessity criteria for major depressive disorder (MDD) are met; criteria for MDD apply regardless of presence of acute suicidal ideation or behavior.

MDD coverage application: Criteria for coverage of Spravato for major depressive disorder (MDD) apply to individuals with or without acute suicidal ideation or behavior; separate coverage criteria for MDD with acute suicidality were removed

See full Medical Necessity section for detailed requirements

Initial and re-authorization criteria (summary)

Covered when ALL of the following are met

Overall coverage requirements: Patient meets the indication for esketamine for depression; depression is not bipolar disorder; no history of manic or hypomanic episodes; no current psychosis for re-authorization; substance use disorder is in remission or patient is abstinent >=1 month and agrees to remain abstinent; reasons for prior medication failures are documented (per medication or collectively); maintenance dose (week 5 onward) limited to 84 mg once weekly with allowance for temporary increase to twice weekly if depression worsens during maintenance

Derived from policy history and clarifications

Spravato (esketamine) in any formulation other than the FDA‑approved nasal spray (for example, intravenous, intramuscular, subcutaneous, or oral esketamine/ketamine) is considered investigational for the treatment of any symptom or condition.

Use of Spravato that does not meet the policy's age (≥18 years) or documented diagnosis requirements in the Medical Necessity section is considered investigational and may be denied.

The presence of a bipolar disorder diagnosis or a history of any manic or hypomanic episode is exclusionary. For re‑authorization, the policy specifically requires there to be no current psychosis to confirm the depression remains non‑psychotic; failure to meet these exclusions may lead to denial.

Concurrent treatment with Spravato administered by more than one provider, group, or clinic at the same time is considered not medically necessary. Even if age and diagnosis criteria are met, overlapping treatment across multiple providers is not allowed.

If use of Spravato meets the age and diagnosis requirements but does not meet other required policy elements in the Medical Necessity section (for example, prior treatment failure documentation, substance‑use restrictions, dosing limits, or required monitoring), that use is considered not medically necessary.

Use that meets age and diagnosis requirements but fails to satisfy other specified medical necessity criteria (such as adequate documentation of prior antidepressant trials, reasons for failure, dosing or monitoring requirements) is considered not medically necessary.

If the individual's depressive episode represents bipolar depression or psychotic depression (or there is new, undisclosed, or past bipolar disorder or manic/hypomanic episodes), treatment with Spravato would not meet the policy's coverage criteria and is considered not medically necessary.

Induction and Initial Treatment Criteria

Induction

Induction (weeks 1-4) coverage criteria and dosing limits

Induction dosing limits: Induction dosing limited to 84 mg twice per week, OR 56 mg on day 1 followed by up to 84 mg twice weekly for first 4 weeks<=84 mg twice/week; 56 mg initial option

Documentation of induction dose and time period required in medical record

Induction eligibility: All general medical necessity elements (age, DSM-5 MDD, bipolar/psychosis exclusions, substance and concurrent drug restrictions, prior antidepressant failure requirements) must be met to initiate induction

Failed trial definition and documentation requirements apply

Initial treatment context

Induction and short-term efficacy evidence and dosing context from trials:

Maintenance, Re-authorization, and Continuation Therapy

Re-authorization / continuation therapy

Re-authorization criteria for continuation therapy up to 12 months

Clinical benefit: Chart notes document improvement in signs and symptoms of major depressive disorder as demonstrated by documentation of individual's symptoms and their severity or by one or more standardized depression rating scales; improvement is being maintained (not wearing off)improvement maintained

Required for re-authorization up to 12 months

No new bipolar/psychosis: No new or previously undisclosed bipolar disorder or manic/hypomanic episodes and no current psychosis

Substance and concurrent med restrictions: No current substance use disorder unless in remission or confined as specified; adherence to concurrent substance/drug restrictions; no serious side-effects

Prior Treatment Requirements and Step Therapy

Step requirement	Details
Must have tried and failed 3 antidepressants from at least 2 different classes OR 2 antidepressants from 2 different classes plus an augmenting agent	Policy requirement appears in the step-therapy and history sections; interim review (10/11/2022) updated criteria to three antidepressants from at least two classes or two antidepressants from two classes plus an augmenting agent.

Step requirement	Details
Must have had ≥2 unsuccessful antidepressant trials (TRD definition used in trials)	Clinical trials defined treatment‑resistant depression (TRD) as failure to respond to ≥2 different antidepressants for the current episode.

Clarification	Policy text / effect on counting
Count of prior antidepressant trials clarified	Policy history (05/01/23 and related updates) revised counting: addition of a second antidepressant to a trial is now counted as a separate antidepressant trial; each failed medication must be individually identified.

Authorization documentation requirement	Required information
Document prior treatment failures and reasons	Medical records must identify each failed medication (or state reasons collectively) and specify the reason(s) for failure; failed trials should document at least 30 continuous days at an adequate dose unless stopped earlier for intolerable adverse effects. Induction and maintenance dosing and time periods should also be documented.

Billing Codes and Coding Updates

HCPCS/Codes for SpravatoHCPCS

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.
J0013	Esketamine, nasal spray (Spravato), 1 mg (new code effective 01/01/26).
S0013	Esketamine, nasal spray (Spravato), 1 mg (code termed effective 01/01/26).

Historical HCPCS additionsHCPCS

G2082	HCPCS code added (documented in history).
G2083	HCPCS code added (documented in history).

Current HCPCS coding updateHCPCS

J0013	New HCPCS code added effective January 1, 2026.
S0013	S0013 was termed and noted in coding update.

HCPCS coding updatesHCPCS

J0013	HCPCS added (document notes addition).
S0013	S0013 has been termed.

MADRS severity thresholds

MADRS scoring ranges0-6: No depression; 7-19: Mild; 20-34: Moderate; 35-60: Severe

Scale description10-item Montgomery-Asberg Depression Rating Scale with total score 0–60

Use in policyUsed to document severity for coverage decisions (moderate or severe required for some criteria)

Maintenance dose limit

Maintenance dosing limit (week 5+)84 mg once weekly for the rest of the first 12 months of treatment

ScopeApplies to maintenance period beginning week 5 after induction

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Spravato (esketamine) nasal spray. Requests must document that all medical necessity criteria are met, including age ≥18 and DSM-5 criteria for major depressive disorder without psychotic features (unipolar). Prior authorization must include documentation of prior antidepressant treatment history consistent with the policy's antidepressant failure requirement and the induction and maintenance dosing plan.

Prior authorization required demonstrating ALL coverage criteria are met (age ≥18; DSM-5 diagnosis of major depressive disorder without psychotic features; no present or past bipolar disorder or history of manic/hypomanic episodes; severity documented as moderate–severe; no current psychosis; substance use disorder requirements; no concurrent hallucinogens/psychedelics/illicit drugs or inappropriate stimulant use; induction and maintenance dosing limits).
Initial and re-authorization periods are up to 12 months; prior authorization must document clinical benefit for re-authorization (improvement maintained and not wearing-off).

Documentation Required

REMS Monitoring and Administration Requirements

Administration Setting and REMS Requirements

Step Therapy

Administer only under direct supervision in REMS‑certified setting with observation

Administration must occur under direct supervision of a healthcare provider in a REMS‑certified setting with post‑administration observation; include the office visit and observation billing codes (G2082/G2083) when applicable.

Supervised administration with post‑administration observation required
Use G2082 (≤56 mg) or G2083 (>56 mg) for office/outpatient visit with 2‑hour observation when billing

Prior Authorization

REMS monitoring — monitor at least 2 hours post‑administration

Providers must monitor patients for at least 2 hours after each treatment session per REMS requirements and assess for clinical stability prior to discharge.

2‑hour post‑dose monitoring required; assess clinical stability before departure

Key Definitions and Terms

Treatment-resistant depression (TRD)

Policy applicationTRD definition informs prior treatment failure requirements for authorization

TRD — clinical trial definition

Implication for coveragePolicy references this trial definition when specifying prior antidepressant failure requirements

ContextTRD is used to identify candidates for Spravato when standard antidepressants are ineffective

REMS

REMS requirementEsketamine is available through a REMS program requiring administration by a health care professional

Background and Context

BACKGROUND — Spravato (esketamine) is the S‑isomer of ketamine and acts as an NMDA receptor antagonist. It is indicated for treatment‑resistant major depressive disorder and for major depressive disorder with acute suicidal ideation or behavior (when used per labeling); administration must occur in a REMS‑certified health care setting with monitoring and at least a 2‑hour post‑dose observation.

Policy Summary

PayerPremera Bluecross

PolicySpravato (esketamine) Nasal Spray — Coverage Criteria

Policy CodePolicy 5.01.609

Change TypeMaterial updates to dosing, trials, and indication application

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of age ≥18, DSM-5 MDD (unipolar), prior antidepressant trial history, and specified induction/maintenance dosing.

SourceLink

On This Page

Substance use / contraindications: No current substance use disorder unless in remission (complete abstinence >=3 months) or abstinent >=1 month and agrees to remain abstinent, and no concurrent use of mind-altering substances; contraindications include aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or hypersensitivity to esketamine/ketamine/excipients

Policy updates tightened abstinence/remission requirements and substance restrictions

Administration and monitoring: Administered in a REMS-certified health care setting with monitoring for at least 2 hours post-dose and assessment for clinical stability prior to discharge2 hours monitoring

Observed peak symptoms ~40 minutes; most discharge-ready by 1.5 hours

Trial context: Short-term TRD trials randomized esketamine plus a new oral antidepressant versus placebo plus a new oral antidepressant; suicidal ideation trials used 84 mg twice weekly induction with possible one-time reduction to 56 mg for tolerability; trial dosing informed policy induction options

Clinical trials defined TRD as failure to respond to >=2 antidepressants

Induction

Induction dosing options and trial documentation requirements were updated.

Documentation of failed trials: Each failed medication trial must be individually identified and the reason(s) for failure specified; documentation should include at least 30 continuous days at adequate dose unless stopped sooner for intolerable adverse effects>=30 days documentation unless stopped for adverse effects

Counting of antidepressant trials was clarified (addition of second antidepressant counts as a separate trial)

Induction dosing option: Policy allows option of 56 mg on day 1 then up to 84 mg twice weekly for first 4 weeks as part of induction dosing56 mg initial option; up to 84 mg twice weekly

Added Oct 2024

Initial therapy

Initial selection criteria clarifications

Initial therapy exclusions and substance criteria: No present or past bipolar disorder and no history of manic or hypomanic episodes; substance use disorder must be in remission or abstinent >=1 month and agree to remain abstinent; document reasons for prior medication failures (per medication or collectively)>=1 month abstinent option

Coding and prior authorization requirements apply

Maintenance dosing for re-authorization: Maintenance dose limited to 84 mg once weekly for the next 12 months84 mg once weekly

Temporary increases allowed per policy when criteria met

Re-authorization / continuation

Re-authorization requires continued meeting of medical necessity criteria and documentation.

Continued response and documentation: Members continuing use must meet medical necessity criteria including documentation of effectiveness and continued concomitant oral antidepressant when applicable; medical record should document induction dose and maintenance dose frequency and time period

Documentation requirements clarified

Maintenance / Re-authorization

Maintenance and re-authorization dosing and response expectations.

Maintenance dosing limits: Maintenance dose prescribed (week 5 and after) is limited to 84 mg once weekly for the rest of the first 12 months of treatment; for re-authorization, maintenance dose is limited to 84 mg once weekly for the next 12 months84 mg once weekly

Policy allows temporary increase to twice weekly if depression worsens during maintenance per separate criteria

Maintenance therapy

Maintenance dosing and re-authorization rules

Maintenance dosing and restrictions: Maintenance dose prescribed (week 5 and after) is limited to 84 mg once weekly for the rest of the first 12 months of treatment; for re-authorization, maintenance dose limited to 84 mg once weekly for the next 12 months; temporary twice-weekly dosing allowed for up to 8 weeks when worsening criteria are met84 mg once weekly; temporary <=8 weeks twice weekly

Re-authorization noteSame 84 mg once weekly limit applies for the next 12 months upon re-authorization (clarified in history)

Maintenance dose limit

Maintenance dosing limit (week 5 and after)84 mg once weekly

Temporary increase allowancePolicy allows temporary increase to twice weekly when criteria for worsening during maintenance are met (separate criteria apply)

Documentation requirementInduction and maintenance dose frequency and time period must be documented in medical records

Substance abstinence duration

Minimum abstinence period>= 1 month (complete abstinence for at least one month)

Alternative remission definitionRemission may be defined as complete abstinence for at least three months per earlier history clarification

Agreement to remain abstinentIndividual must agree to continue to remain abstinent while on treatment

Spravato (esketamine) nasal spray (J0013) — dosing/coding notes

HCPCS and J-code dosing thresholdG2082 covers provision of up to 56 mg per administration; G2083 covers >56 mg per administration; J0013 is the unit-based esketamine code (1 mg)

Dose per administration contextInduction and maintenance schedules reference per-administration amounts (56 mg and 84 mg thresholds reflected in billing guidance)

Coding updatesJ0013 added effective 01/01/26; S0013 termed as of 01/01/26

REMS/observation linkBoth G2082/G2083 descriptions include 2 hours post-administration observation requirement

Esketamine (Spravato) is available only through the FDA REMS program. Prior authorization submissions must confirm that the prescriber and administering site will comply with REMS requirements, that treatments will be administered by a healthcare professional in a certified healthcare setting, and that the patient will be monitored for at least 2 hours after each session with documented assessment of clinical stability prior to discharge.

REMS monitoring required: 2-hour observation after each treatment, assessment for sedation and dissociation prior to discharge.
Documentation that the site and staff are REMS-certified and that monitoring protocols are in place should be available on request.

Billing Rule

Prior Authorization and Coding/Dosing Details

Prior authorization must include operational coding and dosing details. Authorization requests and claims should reflect current HCPCS/HCPCS-like and J-code updates and specify induction and maintenance dosing regimens consistent with policy limits.

Induction dosing documented (weeks 1–4): limited to 84 mg twice weekly, or option of 56 mg on day 1 followed by up to 84 mg twice weekly for 4 weeks.
Maintenance dosing (week 5 onward): limited to 84 mg once weekly for the remainder of the first 12 months (and for the next 12-month re-authorization period).
Coding updates: include applicable HCPCS/HCPCS-like and J-codes per payer billing guidance (policy history notes addition/terminology changes effective Jan 1, 2026).
Specify dosing frequency and time period in the request to align with 12-month authorization windows.

Denial Risk

Investigational and Not Medically Necessary Uses

Use of Spravato for any indication not specified as medically necessary in this policy is considered investigational or not medically necessary as detailed. Concurrent treatment with more than one provider/group/clinic at the same time is considered not medically necessary. Non‑Spravato formulations of esketamine or ketamine (e.g., IV, IM, subcutaneous, oral) are investigational.

Investigational uses include, but are not limited to: chronic pain, bipolar depression, use with neuromodulation modalities (TMS, ECT, VNS), use with other ketamine formulations or psychedelics.
Spravato use that does not meet age or DSM-5 diagnosis requirements is investigational; use that meets age/diagnosis but not other policy criteria is considered not medically necessary.
Concurrent treatment by more than one provider/group/clinic simultaneously = Not medically necessary.
Spravato/esketamine in formulations other than the approved nasal spray is investigational for any indication.

Documentation Required

Required Clinical Documentation for Prior Authorization

Prior authorization submissions must include complete clinical documentation. Medical records should demonstrate that medical necessity criteria are met and must include office visit notes with diagnosis, relevant history, physical evaluation, and comprehensive medication history.

Office visit notes with DSM-5 diagnostic criteria for major depressive disorder without psychotic features and documentation that depression is unipolar (not bipolar).
Documentation of symptom severity (clinical narrative and/or standardized depression rating scale scores) to support moderate–severe episode.
For each failed medication trial, include dates and duration, reason for failure, and evidence of at least 30 continuous days at an adequate dose unless stopped sooner for intolerable adverse effects.

Step Therapy

Antidepressant Trial and Failure Documentation

Detailed documentation of prior antidepressant trials and reasons for failure is required. The policy defines treatment-resistant depression and specifies how antidepressant failures are counted for authorization decisions.

Antidepressant failure requirement: generally defined as failure of ≥2 different antidepressants for the current episode (TRD definition used in trials); policy also includes an option requiring failure of 3 antidepressants from at least 2 classes OR 2 antidepressants from 2 classes plus an augmenting agent depending on criteria in effect — prior authorization must document which counting rule is being applied per policy version.
Each failed medication must be individually identified; reasons for failure must be specified either per medication or collectively for all failed medications.
For each failed medication trial, documentation should show at least 30 continuous days with no or inadequate improvement unless discontinued sooner due to intolerable adverse effects.
If an augmentation strategy was used, document the augmenting agent and the rationale and duration.

Note

Operational and Exclusion Notes

Additional operational notes that affect authorization decisions and clinical monitoring.

Temporary increase in maintenance frequency (to 84 mg twice weekly) may be considered medically necessary for up to 8 weeks when depression has worsened during maintenance, with documentation of symptom worsening and a required return to 84 mg once weekly.
For re-authorization, include documentation that there is no new or previously undisclosed bipolar disorder or manic/hypomanic episodes, no current psychosis, and no current substance use disorder unless in remission per policy.
Specify the name of any oral antidepressant when used in conjunction with Spravato (policy history: requirement removed for monotherapy consistency with FDA changes; if an oral antidepressant is part of the treatment plan, name it).

Denial Risk

No concurrent use with other ketamine formulations or psychedelics (investigational)

Do not administer Spravato concurrently with any other formulation of ketamine or with any psychedelic drug; other formulations of ketamine are considered investigational.

No concurrent use of IV/IM/oral/subcutaneous ketamine formulations
Spravato only in its FDA‑approved nasal spray formulation

Note

Site‑of‑care: supervised REMS administration under medical/pharmacy benefit

The policy affirms administration setting considerations: Spravato is managed under pharmacy and medical benefits and must be administered under supervision; there is no additional site‑of‑care restriction beyond REMS‑certified supervised administration.

Managed via pharmacy and medical benefit; supervised administration required
No policy‑level site‑of‑care restriction beyond REMS supervision and observation

Post-dose monitoringIndividuals must be monitored for 2 hours after each treatment session and assessed for clinical stability before departure

Safety rationaleREMS in place due to risks including sedation, dissociation, abuse/misuse, and increased suicidal thoughts/behavior

TRD / MDD (policy context)

Policy linkage to TRD/MDDTRD definition and requirements are referenced across the policy and linked to requirements for documenting failed antidepressant trials and DSM-5 MDD diagnosis

Bipolar and psychosis exclusionsPolicy clarifies depression must not be bipolar and re-authorization requires no current psychosis

Documentation expectationsMedical records should document DSM-5 MDD criteria, prior failed antidepressant trials, and dosing details

Maintenance dose (week 5 and after)

Maintenance dose limit (week 5 onwards)84 mg once weekly for the rest of the first 12 months (and for the next 12 months upon re-authorization)

Temporary increased-frequency optionTemporary increase to 84 mg twice weekly allowed when depression worsens during maintenance under specified criteria

Documentation requirementInduction dose and maintenance frequency/time period must be recorded in the medical record

Substance use requirement

Earlier remission definitionHistory notes also defined remission as complete abstinence for at least three months in a prior update

Facility-confined exceptionIf confined 24/7 in a facility preventing access, individual must agree not to use after discharge while on Spravato