Panzyga® (Immunoglobulin Intravenous (Human), 10%) Correct Coding and Coverage - Revised
Joint DME MAC Publication
Panzyga® (Immunoglobulin Intravenous (Human), 10%) is a sterile liquid preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. The FDA approved Panzyga® on August 2, 2018. Panzyga® is covered for claims with dates of service on or after August 2, 2018 when the criteria 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 (Medicare Benefit Policy Manual/Internet Only Manual (IOM) 100-02, 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:
- It is an approved pooled plasma derivative for the treatment of primary immune deficiency disease
- The patient has a diagnosis of primary immune deficiency disease (see “Diagnosis Codes that Support Medical Necessity” section below)
- The IVIG is administered in the home
- The treating physician has determined that administration of the IVIG in the patient's home is medically appropriate
Diagnosis Codes That Support Medical Necessity
[From the IVIG Local Coverage Determination (LCD)-related Policy Article]
|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|
|D82.1||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|
As of the date of this publication, there is not a specific HCPCS code for Panzyga®. Submit Panzyga®-related claims for dates of service on or after August 2, 2018 using the following 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.
|12/21/2018||Published on PDAC website|
|12/04/2019||Revised to add ICD-10 codes D80.2, D80.3, D80.4, D80.6, D80.7, D81.5, D82.1, D82.4, D83.1 and G11.3 per update to Medicare Benefit Policy Manual, Chapter 15, section 50.6|
|11/29/2022||Revised to add ICD-10-CM code D81.82, per update to Medicare Benefit Policy Manual/IOM, 100-02, Ch. 15, Section 50.6|