Wednesday, July 3, 2024

BioXcel Therapeutics Receives Permanent J-Code for IGALMI™ (dexmedetomidine) Sublingual Film from Centers for Medicare & Medicaid Services

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BioXcel Therapeutics, Inc., a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, 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.

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“Beginning next year, IGALMI will be separately reimbursed under a direct and predictable J-Code for the hospital outpatient setting, which we expect will help remove economic barriers that may have impacted formulary approval decisions and product utilization to date,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Ultimately, we believe this commercial milestone will facilitate additional patient access to this important therapeutic option for the treatment of bipolar disorder- or schizophrenia-associated agitation.”

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 without coercion. 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 forcible injections of heavily sedating medications are used, which can create a hostile and adversarial relationship between clinicians and patients

SOURCE: GlobeNewswire

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