CurrentmhnPolicy CP.PMN.236

Clinical Policy: Amisulpride (Barhemsys)

Defines medical necessity criteria, dosing, coding, and prior authorization requirements for intravenous amisulpride (Barhemsys) for prevention and treatment of postoperative nausea and vomiting (PONV) in adults for Centene-affiliated health plans (commercial, HIM, Medicaid).

Policy Summary

Payermhn

PolicyClinical Policy: Amisulpride (Barhemsys)

Policy CodePolicy CP.PMN.236

Change TypeRevisedAdded coding

Effective Date09.01.20

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J0184 to policy.

Revised initial approval duration wording from 'one time approval' to 'dose' and added age requirement per prescribing information.

Revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy.

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added age requirement (≥18 years) per prescribing information.

2FDA Approved Indications (prevention, treatment of PONV)

18+Age requirement (years)

1Allowed dose administrations (single-dose approval)

J0184

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Coverage Summary & Scope

Scope: Defines medical necessity criteria, dosing, coding, and prior authorization requirements for intravenous amisulpride (Barhemsys) for prevention and treatment of postoperative nausea and vomiting (PONV) in adults for Centene-affiliated health plans (commercial, HIM, Medicaid).

Coverage stance: covered_with_criteria — Barhemsys is covered when the policy's clinical criteria are met (see Initial Approval Criteria for PONV).

FDA-approved indications summary: Prevention and treatment of PONV in adults — Prevention may be used alone or with an antiemetic of a different class; treatment for patients who have or have not received prophylaxis as described in the label.

Age requirement and single-dose approval note: Age ≥ 18 years. Approval is for single-dose administration per indication-specific limits (prevention ≤ 5 mg once; treatment ≤ 10 mg once).

Key thresholds

Age requirement≥ 18 years

Prevention dose limit≤ 5 mg as a single IV dose

Treatment dose limit≤ 10 mg as a single IV dose

Approval duration / Re-authorizationSingle-dose (one dose); re-authorization not permitted

Product vial strengthsSingle‑dose vials: 5 mg/2 mL and 10 mg/4 mL

HCPCS codeJ0184 (Injection, amisulpride, 1 mg)

Initial Therapy Criteria - Postoperative Nausea and Vomiting

Initial Approval Criteria - Postoperative Nausea and Vomiting

Covered when ALL of the following are met:

ALL of the following

Prescribed for the prevention or treatment of postoperative nausea and vomiting (PONV).
Age >= 18 years.
Member is scheduled to undergo surgery.
Member meets one of the following (a or b)
- a. For prevention: For prevention: Failure of one multimodal regimen consisting of two or more formulary agents for PONV, each from different therapeutic classes, at up to maximally indicated dose, unless clinically significant adverse effects are experienced or all are contraindicated.

Continuation / Other Indications

Other diagnoses/indications

Coverage for uses not described above requires meeting one of the following:

ANY of the following

Label change pathway: If drug has had a label change within last 6 months not yet reflected in this policy, follow the no-coverage or non-formulary policy for the relevant line of business (references CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16).
Off-label pathway: If requested use is not specifically listed under section III and criterion 1 above does not apply, refer to off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Diagnoses/Indications Not Authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Applicable Codes

HCPCS code for amisulpride injectionHCPCS

J0184

Injection, amisulpride, 1 mg

Billing reminder: product is supplied as single-dose vials in strengths 5 mg/2 mL and 10 mg/4 mL.

Code usage guidance: report amisulpride injection using HCPCS J0184 (Injection, amisulpride, 1 mg) and ensure J0184 units billed correspond to the administered milligrams.

Prior Authorization, Documentation & Billing

Prior Authorization

Submit documentation to support criteria

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria for amisulpride (Barhemsys). Documentation should demonstrate indication (prevention or treatment of PONV), age ≥18, surgery scheduling, prior therapies or absence of preoperative D2 antagonist as applicable, and that requested dose meets indication-specific limits.

J0184

Step Therapy

Step therapy requirement for prevention

For PONV prevention, coverage requires failure of one multimodal regimen consisting of two or more formulary agents for PONV, each from different therapeutic classes, administered at up to maximally indicated doses, unless clinically significant adverse effects occur or all are contraindicated. Note: Illinois Health Insurance Marketplace (HIM) prior authorization requests are exempt from this step therapy requirement per IL HB 5395 effective 01/01/2026.

IL HIM bypass per IL HB 5395 effective 01/01/2026

Clinical Evidence & References

Evidence: Primary references for this policy are the Barhemsys Prescribing Information (Acacia Pharma; September 2022) and the Fourth Consensus Guidelines for Management of PONV (Anesthesia & Analgesia, 2020).

These sources are cited as the foundational prescribing and guideline references for indications, dosing, and clinical use; no additional trial metrics are provided in the brief.

Background

Background: Amisulpride (Barhemsys) is a dopamine-2 (D2) antagonist approved for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults.

Product presentation: single-dose vials for injection in 5 mg/2 mL and 10 mg/4 mL strengths.

Revision History

10/27/2023code_added

Added HCPCS code J0184 to policy; logged in coding implications.

3Q2024 (05/06/2024)policy_revised

3Q2024 annual review: added age requirement (≥18 years) per prescribing information and revised initial approval duration wording from 'one time approval' to 'dose'; P&T approval date 08.24.

3Q2022 (04/07/2022)policy_revised

3Q2022 annual review: revised initial approval criteria for PONV prophylaxis to require failure of one multimodal combination therapy and updated Appendix B examples and criteria; P&T approval date 08.22.