BioXcel Therapeutics, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent and product-specific J-Code for IGALMI?? (dexmedetomidine) sublingual film, which is approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults1,2. Under the Healthcare Common Procedure Coding System (HCPCS) process, the IGALMI J-Code J1105 will become effective January 1, 2024. J-codes are permanent codes used by healthcare providers, commercial insurance plans, and government payers to help standardize the reimbursement process.

Compared to a miscellaneous or unlisted product code, a J-code simplifies claims submission, which in turn streamlines the billing and reimbursement process. The J-code for IGALMI has been published online in the CMS HCPCS Application Summaries and Coding recommendations, Third Quarter, 2023 HCPCS Coding Cycle. Agitation is a relatively common and difficult-to-manage symptom associated with bipolar I or II or schizophrenia in adults.

Prompt identification of agitation related to schizophrenia and bipolar disorders can help de-escalate the situation before aggressive or violent behaviors emerge. Expert consensus best-practice guidelines have recommended that agitation should be treated by a combination of behavioral calming techniques, verbal de-escalation, and medications that are voluntarily accepted by patients withoutercion. Medication used in this manner to treat agitation is consistent with the goal to calm the patient enough so they can be assessed, while avoiding unarousable sedation.

In many settings, physical restraints and forcedible injections of heavily sedating medications are used, which can create a hostile and adversarial relationship between clinicians and patients. I-code for IGALMI?? sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.

The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tappingness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.

Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.

everyone is encouraged to report negative side effects of prescription drugs to the FDA.