Dexmedetomidine Sublingual Film, for Sublingual or Buccal Use (Igalmi™) HCPCS Code J8499: Billing Guidelines

Effective July 25, 2022, Medicaid and NC Health Choice cover dexmedetomidine sublingual film, for sublingual or buccal use (Igalmi)

Effective with a date of service July 25, 2022, the Medicaid and NC Health Choice programs cover dexmedetomidine sublingual film, for sublingual or buccal use (Igalmi) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J8499 - Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified.

Strength/Package Sizes: Sublingual film: 120 mcg and 180 mcg

Indicated in adults for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.

  • Limitations of Use: The safety and effectiveness of Igalmi has not been established beyond 24 hours from the first dose.

Recommended Dose: 

Initial Doses: 

  • Adults
    • Mild or Moderate Agitation: 120 mcg
    • Severe Agitation: 180 mcg
  • Geriatric Patients (≥ 65 years old)
    • Mild, Moderate, or Severe Agitation: 120 mcg

If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart.

Optional second/third Doses: 

  • Adults
    • Mild or Moderate Agitation: 60 mcg
    • Severe Agitation: 90 mcg
  • Geriatric Patients (≥ 65 years old)
    • Mild, Moderate, or Severe Agitation: 60 mcg

Maximum Recommended Total Daily Dosages:

  • Adults
    • Mild or Moderate Agitation: 240 mcg
    • Severe Agitation: 360 mcg
  • Geriatric Patients (≥ 65 years old) 
    • Mild, Moderate, or Severe Agitation: 240 mcg

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are: 
    • F20.0 - Paranoid schizophrenia; 
    • F20.1 - Disorganized schizophrenia; 
    • F20.2 - Catatonic schizophrenia; 
    • F20.3 - Undifferentiated schizophrenia; 
    • F20.5 - Residual schizophrenia; 
    • F20.89 - Other schizophrenia; 
    • F31.0 - Bipolar disorder, current episode hypomanic; 
    • F31.11 - Bipolar disorder, current episode manic without psychotic features, mild; 
    • F31.12 - Bipolar disorder, current episode manic without psychotic features, moderate; 
    • F31.13 - Bipolar disorder, current episode manic without psychotic features, severe; 
    • F31.2 - Bipolar disorder, current episode manic severe with psychotic features; 
    • F31.31 - Bipolar disorder, current episode depressed, mild; 
    • F31.32 - Bipolar disorder, current episode depressed, moderate; 
    • F31.4 - Bipolar disorder, current episode depressed, severe, without psychotic features; 
    • F31.5 - Bipolar disorder, current episode depressed, severe, with psychotic features; 
    • F31.61 - Bipolar disorder, current episode mixed, mild; 
    • F31.62 - Bipolar disorder, current episode mixed, moderate; 
    • F31.63 - Bipolar disorder, current episode mixed, severe, without psychotic features; 
    • F31.64 - Bipolar disorder, current episode mixed, severe, with psychotic features; 
    • F31.71 - Bipolar disorder, in partial remission, most recent episode hypomanic; 
    • F31.72 - Bipolar disorder, in full remission, most recent episode hypomanic; 
    • F31.73 - Bipolar disorder, in partial remission, most recent episode manic; 
    • F31.74 - Bipolar disorder, in full remission, most recent episode manic; 
    • F31.75 - Bipolar disorder, in partial remission, most recent episode depressed; 
    • F31.76 - Bipolar disorder, in full remission, most recent episode depressed; 
    • F31.77 - Bipolar disorder, in partial remission, most recent episode mixed; 
    • F31.78 - Bipolar disorder, in full remission, most recent episode mixed; 
    • F31.81 - Bipolar II disorder; 
    • F31.89 - Other bipolar disorder
  • Providers must bill with HCPCS code: J8499 - Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified
  • One Medicaid and NC Health Choice unit of coverage is: 1 film (1 dose) 
  • The maximum reimbursement rate per unit is: $113.40 per 1 film (1 dose)
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 81092-1120-01, 81092-1120-03, 81092-1180-01, 81092-1180-03
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs
  • PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PADP is available on Medicaid's PADP web page.

Contact

NCTracks Call Center: 800-688-6696

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