Immune Globulin Subcutaneous, Human – klhw 20% Solution (Xembify®) HCPCS code J3590: Billing Guidelines

Tuesday, May 12, 2020

Effective with date of service Oct. 4, 2019, the Medicaid and NC Health Choice programs cover immune globulin subcutaneous, human – klhw 20% solution (Xembify®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

It is available as a solution containing 0.2 g/mL (200 mg/mL; 20%) protein solution for subcutaneous infusion. Xembify® is indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients two years of age and older.

Recommended Dose (see full prescribing information for details):  
For patients switching from immune globulin intravenous (human), 10% (IVIG) to Xembify®: 

  • Calculate the dose by using a dose adjustment factor (1.37)
  • Weekly: Begin Xembify® one week after last IVIG infusion
  • Establish initial weekly dose by converting the monthly (or every 3 weeks) IVIG dose into an equivalent weekly dose and increasing it using a dose adjustment factor (1.37). Initial weekly dose (grams) = [Prior IVIG dose (in grams) × 1.37 / Number of weeks between IVIG doses]
  • Frequent dosing (2-7 times per week): Divide the calculated weekly dose by the desired number of times per week

For patients switching from immune globulin subcutaneous (human) treatment (IGSC):

  • Weekly dose (grams) should be the same as the weekly dose of prior IGSC treatment (grams)

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are:  D80.0 - Hereditary hypogammaglobulinemia; D80.1 - Nonfamilial hypogammaglobulinemia; D80.2 - Selective deficiency of immunoglobulin A [IgA]; D80.3 - Selective deficiency of immunoglobulin G [IgG] subclasses; D80.4 - Selective deficiency of immunoglobulin M [IgM]; D80.5 - Immunodeficiency with increased immunoglobulin M [IgM]; D80.6 - Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia; D80.7 Transient hypogammaglobulinemia of infancy; D80.8 - Other immunodeficiencies with predominantly antibody defects; D80.9 - Immunodeficiency with predominantly antibody defects, unspecified; D81.0 - Severe combined immunodeficiency [SCID] with reticular dysgenesis; D81.1 - Severe combined immunodeficiency [SCID] with low T- and B-cell numbers; D81.2 - Severe combined immunodeficiency [SCID] with low or normal B-cell numbers; D81.4 - Nezelof's syndrome; D81.5 Purine nucleoside phosphorylase [PNP] deficiency; D81.6 - Major histocompatibility complex class I deficiency; D81.7 - Major histocompatibility complex class II deficiency; D81.89 - Other combined immunodeficiencies; D81.9 - Combined immunodeficiency, unspecified; D82.0 - Wiskott-Aldrich syndrome; D82.1 - Di George's syndrome; D82.2 - Immunodeficiency with short-limbed stature; D82.3 - Immunodeficiency following hereditary defective response to Epstein-Barr virus; D82.4 - Hyperimmunoglobulin E [IgE] syndrome; D82.8 - Immunodeficiency associated with other specified major defects; D82.9 - Immunodeficiency associated with major defect, unspecified; D83.0 - Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function; D83.1 - Common variable immunodeficiency with predominant immunoregulatory T-cell disorders; D83.2 - Common variable immunodeficiency with autoantibodies to B- or T-cells; D83.8 - Other common variable immunodeficiencies; D83.9 - Common variable immunodeficiency, unspecified
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid and NC Health Choice unit of coverage is:100 mg 
  • The maximum reimbursement rate per unit is: $18.47
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 13533-0810-05, 13533-0810-06, 13533-0810-10, 13533-0810-11, 13533-0810-20, 13533-0810-21, 13533-0810-50, 13533-0810-51
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update
  • For additional information regarding NDC claim requirements related to the PADP, refer to the 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


Medicaid Contact Center: 888-245-0179