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Ordering and billing for Barhemsys

J-Code for Billing: J0184

Effective Janurary 1, 2014

Granted 3-Year Transitional Pass-Through Payment Status

Effective October 1, 2023

Medicare reimbursement

ASP + 6%

The CMS has established the HCPCS Level II code J0184, “Injection, amisulpride, 1 mg,” for Barhemsys, effective January 1, 2024.1

Effective October 1, 2023, Barhemsys has been granted a transitional 3-year pass‑through payment status by the CMS. Pass-through status provides additional payment for Barhemsys (ASP + 6%) for ASCs and HOPDs when billed to Medicare for a period of three years.2

Note: Reimbursement is subject to CMS updates.

Commercial reimbursement

Barhemsys may be reimbursed as a percentage of billed charges.

Commercial payers may have varied payment methodologies for Barhemsys. Please contact the patient's insurer to understand how Barhemsys is reimbursed.

For reimbursement questions, please contact us here: barhemsys.com/request-conversation

Indications

Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for:

  • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis

Important Safety Information

Contraindication

Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation

Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.

Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol.

Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions

Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).

Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.

The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Use in Specific Populations

Pregnancy
Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation
Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.

Barhemsys may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after Barhemsys treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.

To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of Barhemsys.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Drug Interactions

  • Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.
  • ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
  • Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.

To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click to access full Prescribing Information.

BAR HCP ISI 09/2022

Indications

Barhemsys is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist indicated in adults for:

  • prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
  • treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis

Important Safety Information

Contraindication

Barhemsys is contraindicated in patients with known hypersensitivity to amisulpride.

QT Prolongation

Barhemsys causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 mg or 10 mg as a single intravenous (IV) dose infused over 1 to 2 minutes.
Avoid Barhemsys in patients with congenital long QT syndrome and in patients taking droperidol.
Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders, electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Adverse Reactions

Common adverse reactions reported in ≥ 2% of adult patients who received Barhemsys 5 mg (N=748) and at a higher rate than placebo (N=741) in clinical trials for the prevention of PONV were: chills (4% vs. 3%), hypokalemia (4% vs. 2%), procedural hypotension (3% vs. 2%), and abdominal distention (2% vs. 1%).

Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared with 1% (1/166) of placebo-treated patients.

The most common adverse reaction, reported in ≥ 2% of adult patients who received Barhemsys 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV was infusion site pain (6% vs. 4%).

Use in Specific Populations

Pregnancy
Available data with amisulpride use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Lactation
Amisulpride is present in human milk. There are no reports of adverse effects on the breastfed child and no information on the effects of amisulpride on milk production.

Barhemsys may result in an increase in serum prolactin levels, which may lead to a reversible increase in maternal milk production. In a clinical trial, serum prolactin concentrations in females (n=112) increased from a mean of 10 ng/mL at baseline to 32 ng/mL after Barhemsys treatment and from 10 ng/mL to 19 ng/mL in males (n=61). No clinical consequences due to elevated prolactin levels were reported.

To minimize exposure to a breastfed infant, lactating women may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after receiving a dose of Barhemsys.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established.

Geriatric Use
No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Drug Interactions
  • Barhemsys causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid use of Barhemsys in patients taking droperidol.
  • ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
  • Reciprocal antagonism of effects occurs between dopamine agonists (e.g., levodopa) and Barhemsys. Avoid using levodopa with Barhemsys.

To report SUSPECTED ADVERSE REACTIONS, contact Acacia Pharma at 1-877-357-9237 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click to access full Prescribing Information.

BAR HCP ISI 09/2022

ASC=ambulatory surgical center. ASP=average sales price. CMS=Centers for Medicare & Medicaid Services. HCPCS=healthcare common procedure coding system. HOPD=hospital outpatient department. PACU=postanesthesia care unit. PONV=postoperative nausea and vomiting. WAC=wholesale acquisition cost.

References: 1. Centers for Medicare & Medicaid Services. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Recommendations. Third Quarter, 2023 HCPCS Coding Cycle. CMS website. Accessed April 10, 2025. https://www.cms.gov/files/document/2023-hcpcs-application-summary-quarter-3-2023-drugs-and-biologicals-posted-10/17/2023-updated-12/28.pdf 2. Centers for Medicare & Medicaid Services. Addendum B Updates. CMS website. Released October 2023. Accessed April 10, 2025. https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/addendum-b-updates/october-2023-0 3. Barhemsys [package insert]. Indianapolis, IN: Acacia Pharma Inc; 2022.