Retired - Panzyga® (Immunoglobulin Intravenous (Human), 10%) Correct Coding and Coverage - Revised

DME MAC Joint Publication

Panzyga® (Immunoglobulin Intravenous (Human), 10%) is a sterile liquid preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma which has recently been approved by the FDA on August 2, 2018. Panzyga® is covered for claims with dates of service on or after August 2, 2018 when the criteria discussed below are met.

Medicare Coverage for IVIG

Intravenous immune globulin (IVIG) used for the treatment of primary immunodeficiency is covered under the Intravenous Immune Globulin benefit (IOM 100-2, Ch. 15, §50.6). For a beneficiary's IVIG to be eligible for reimbursement there are specific statutory payment policy requirements, discussed below, that must be met.

Intravenous immune globulin is covered if all the following criteria are met:
1. It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease; and
2. The patient has a diagnosis of primary immune deficiency disease (See Diagnosis Codes that Support Medical Necessity section below); and
3. The IVIG is administered in the home; and
4. The treating physician has determined that administration of the IVIG in the patient's home is medically appropriate.

Diagnosis Codes That Support Medical Necessity

[Excerpted from the DME MAC IVIG LCD Related Policy Article]

D80.0 Hereditary 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
 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
 D81.5 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
 D82.4 Hyperimmunoglobulin E [IgE] syndrome
 D83.0 Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function
 D83.1 Common variable immunodeficiency with predominant 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
 G11.3 Cerebellar ataxia with defective DNA repair

HCPCS Coding

As of the date of publication, a specific HCPCS CODE has not been established for Panzyga®. Claims to Medicare for dates of service on or after August 2, 2018 should be submitted using HCPCS code

J1599 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), NOT OTHERWISE SPECIFIED, 500 MG

If all the criteria are not met and the IVIG is not administered with an infusion pump, the IVIG will be denied as noncovered - no benefit category.

If the criteria are not met and the IVIG is administered with an infusion pump, refer to the Intravenous Immune Globulin LCD.

Coverage under the IVIG benefit is limited to the IVIG itself, not to related supplies and services. If the IVIG is not administered with an infusion pump, related supplies will be denied as noncovered – no benefit category.

Refer to both the Intravenous Immune Globulin and External Infusion Pumps LCDs, LCD-related Policy Articles, and Standard Documentation Article for additional information on coverage, coding, and documentation.