Retired - ALYGLO® (immune globulin intravenous, human-stwk), 10% Liquid - Correct Coding and Coverage

Joint DME MAC Publication

ALYGLO® (immune globulin intravenous, human-stwk), 10% Liquid (GC Biopharma Corp., Republic of Korea) is a sterile liquid preparation of highly purified and concentrated human immunoglobulin G (IgG) antibodies. The distribution of the IgG subclasses is similar to that of normal human plasma. ALYGLO® received FDA approval on December 15, 2023. ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older.

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
D81.82 Activated Phosphoinositide 3-kinase Delta Syndrome [APDS]
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 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
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 ALYGLO®. Claims to Medicare for dates of service on or after December 15, 2023 should be submitted using the following HCPCS code :

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

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