Local Coverage Article Billing and Coding

Billing and Coding: Immune Globulin Intravenous (IVIg)

A57194

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Contractor Information

Article Information

General Information

Article ID
A57194
Article Title
Billing and Coding: Immune Globulin Intravenous (IVIg)
Article Type
Billing and Coding
Original Effective Date
10/01/2019
Revision Effective Date
10/01/2022
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

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CMS National Coverage Policy

Title XVIII of the Social security Act; Section 1862(a)(1)(A) section allows coverage and payment for only those services that are considered to be reasonable and necessary.

Title XVIII of the Social Security Act; Section 1833(e). This section prohibits Medicare payment for any claim, which lacks the necessary information to process the claim.

CMS Manual, Pub.100-2, Chapter 15, section 50.4 and section 50.4.2. This section addresses coverage of drugs and biologicals.

CMS Manual, Pub.100-3, Chapter 1, Section 250.3. This section describes coverage for IVIg for treatment of Autoimmune Mucocutaneous Blistering Diseases.

"Intravenous immune globulin (IVIg) is a blood product prepared from the pooled plasma of donors. It has been used to treat a variety of autoimmune diseases, including mucocutaneous blistering diseases. It has fewer side effects than steroids or immunosuppressive agents.

Effective October 1, 2002, IVIg is covered for the treatment of biopsy-proven: (1) Pemphigus Vulgaris, (2) Pemphigus Foliaceus, (3) Bullous Pemphigoid, (4) Mucous Membrane Pemphigoid (a.k.a., Cicatricial Pemphigoid), and (5) Epidermolysis Bullosa Acquisita for the following patient subpopulations:
• Patients who have failed conventional therapy. Contractors have the discretion to define what constitutes failure of conventional therapy;
• Patients in whom conventional therapy is otherwise contraindicated. Contractors have the discretion to define what constitutes contraindications to conventional therapy; or
• Patients with rapidly progressive disease in whom a clinical response could not be affected quickly enough using conventional agents. In such situations IVIg therapy would be given along with conventional treatment(s) and the IVIg would be used only until the conventional therapy could take effect.

In addition, IVIg for the treatment of autoimmune mucocutaneous blistering diseases must be used only for short-term therapy and not as a maintenance therapy. Contractors have the discretion to decide what constitutes short-term therapy.
"

See associated article for ICD-10 diagnosis codes.

CMS Manual, Pub. 100-2, Chapter 15, Section 50.6. This section describes coverage of IVIg for the treatment of Primary Autoimmune Deficiency Disease in the home.


"Beginning for dates of service on or after January 1, 2004, The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 provides coverage of intravenous immune globulin (IVIg) for the treatment of primary immune deficiency diseases (ICD-10 diagnosis codes D80.0, D80.2, D80.3, D80.4, D80.5, D80.6, D80.7, D81.0, D81.1, D81.2, D81.5, D81.6, D81.7, D81.89, D81.9, D82.0, D82.1, D82.4, D83.0, D83.1, D83.2, D83.8, D83.9 and G11.3) in the home. The Act defines “intravenous immune globulin” as an approved pooled plasma derivative for the treatment of primary immune deficiency disease. It is covered under this benefit when the patient has a diagnosed primary immune deficiency disease, it is administered in the home of a patient with a diagnosed primary immune deficiency disease, and the physician determines that administration of the derivative in the patient's home is medically appropriate. The benefit does not include coverage for items or services related to the administration of the derivative. For coverage of IVIg under this benefit, it is not necessary for the derivative to be administered through a piece of durable medical equipment."

See associated article for ICD-10 diagnosis codes.

Article Guidance

Article Text

The following billing and coding guidance is to be used with its associated LCD. 

Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate IVIg therapy and the continued need thereof. Required documentation of medical necessity could include:
• History and physical;
• Office/progress note(s);
• Test results with written interpretation; and An accurate weight in kilograms should be documented prior to the infusion since the dosage is based mg/kg/dosage.


Coding Information

CPT/HCPCS Codes

Group 1

(9 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
J1459 INJECTION, IMMUNE GLOBULIN (PRIVIGEN), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG
J1556 INJECTION, IMMUNE GLOBULIN (BIVIGAM), 500 MG
J1557 INJECTION, IMMUNE GLOBULIN, (GAMMAPLEX), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG
J1561 INJECTION, IMMUNE GLOBULIN, (GAMUNEX-C/GAMMAKED), NON-LYOPHILIZED (E.G., LIQUID), 500 MG
J1566 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, LYOPHILIZED (E.G., POWDER), NOT OTHERWISE SPECIFIED, 500 MG
J1568 INJECTION, IMMUNE GLOBULIN, (OCTAGAM), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG
J1569 INJECTION, IMMUNE GLOBULIN, (GAMMAGARD LIQUID), NON-LYOPHILIZED, (E.G., LIQUID), 500 MG
J1572 INJECTION, IMMUNE GLOBULIN, (FLEBOGAMMA/FLEBOGAMMA DIF), INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), 500 MG
J1599 INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, NON-LYOPHILIZED (E.G., LIQUID), NOT OTHERWISE SPECIFIED, 500 MG

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

(98 Codes)
Group 1 Paragraph

N/A

Group 1 Codes
CodeDescription
B20* Human immunodeficiency virus [HIV] disease
B25.0 Cytomegaloviral pneumonitis
B25.1 Cytomegaloviral hepatitis
B25.2 Cytomegaloviral pancreatitis
B25.8 Other cytomegaloviral diseases
C90.00 Multiple myeloma not having achieved remission
C90.02 Multiple myeloma in relapse
C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
C91.11 Chronic lymphocytic leukemia of B-cell type in remission
C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
D59.0 Drug-induced autoimmune hemolytic anemia
D59.11 Warm autoimmune hemolytic anemia
D59.12 Cold autoimmune hemolytic anemia
D59.13 Mixed type autoimmune hemolytic anemia
D59.19 Other autoimmune hemolytic anemia
D61.01* Constitutional (pure) red blood cell aplasia
D69.3 Immune thrombocytopenic purpura
D69.42 Congenital and hereditary thrombocytopenia purpura
D69.49 Other primary thrombocytopenia
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
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
G25.82 Stiff-man syndrome
G35 Multiple sclerosis
G60.3 Idiopathic progressive neuropathy
G61.0 Guillain-Barre syndrome
G61.81* Chronic inflammatory demyelinating polyneuritis
G61.82 Multifocal motor neuropathy
G65.0 Sequelae of Guillain-Barre syndrome
G70.00 Myasthenia gravis without (acute) exacerbation
G70.01 Myasthenia gravis with (acute) exacerbation
G70.81 Lambert-Eaton syndrome in disease classified elsewhere
G73.1 Lambert-Eaton syndrome in neoplastic disease
G73.3 Myasthenic syndromes in other diseases classified elsewhere
I78.8* Other diseases of capillaries
M30.3 Mucocutaneous lymph node syndrome [Kawasaki]
M31.10 Thrombotic microangiopathy, unspecified
M31.19 Other thrombotic microangiopathy
M33.00 Juvenile dermatomyositis, organ involvement unspecified
M33.01 Juvenile dermatomyositis with respiratory involvement
M33.02 Juvenile dermatomyositis with myopathy
M33.09 Juvenile dermatomyositis with other organ involvement
M33.10 Other dermatomyositis, organ involvement unspecified
M33.11 Other dermatomyositis with respiratory involvement
M33.12 Other dermatomyositis with myopathy
M33.19 Other dermatomyositis with other organ involvement
M33.20 Polymyositis, organ involvement unspecified
M33.21 Polymyositis with respiratory involvement
M33.22 Polymyositis with myopathy
M33.29 Polymyositis with other organ involvement
M33.90 Dermatopolymyositis, unspecified, organ involvement unspecified
M33.91 Dermatopolymyositis, unspecified with respiratory involvement
M33.92 Dermatopolymyositis, unspecified with myopathy
M33.99 Dermatopolymyositis, unspecified with other organ involvement
M34.83 Systemic sclerosis with polyneuropathy
M36.0 Dermato(poly)myositis in neoplastic disease
T86.01 Bone marrow transplant rejection
T86.02 Bone marrow transplant failure
T86.09 Other complications of bone marrow transplant
T86.11 Kidney transplant rejection
T86.12 Kidney transplant failure
T86.19 Other complication of kidney transplant
T86.21 Heart transplant rejection
T86.22 Heart transplant failure
T86.298 Other complications of heart transplant
T86.5 Complications of stem cell transplant
Z48.21 Encounter for aftercare following heart transplant
Z48.22 Encounter for aftercare following kidney transplant
Z76.82 Awaiting organ transplant status
Z86.19 Personal history of other infectious and parasitic diseases
Z87.01 Personal history of pneumonia (recurrent)
Z94.0 Kidney transplant status
Z94.1 Heart transplant status
Z94.81 Bone marrow transplant status
Z94.84 Stem cells transplant status
Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*B20 is only payable for children under 13 years of age.
*D61.01 is only to be used when patient has failed all first line therapies.
*G61.81 is not payable when associated with diabetes mellitus, dysproteinemias, renal failure, or malnutrition.
*I78.8 - use only for Idiopathic Systemic Capillary Leak Syndrome (Clarkson's disease).

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph

Any diagnosis codes other than those listed in the covered ICD-10-CM codes of this policy and those in the attached article will be denied as not reasonable and necessary and will be denied provider liable unless a non-coverage notice has been issued to the beneficiary prior to the test. Screening diagnoses will be denied as routine services.

Group 1 Codes

N/A

ICD-10-PCS Codes

N/A

Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

CodeDescription
012x Hospital Inpatient (Medicare Part B only)
013x Hospital Outpatient
022x Skilled Nursing - Inpatient (Medicare Part B only)
023x Skilled Nursing - Outpatient
085x Critical Access Hospital

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

CodeDescription
0636 Pharmacy - Drugs Requiring Detailed Coding

Other Coding Information

N/A

Revision History Information

Revision History DateRevision History NumberRevision History Explanation
10/01/2022 R5

Effective 10/1/22: Per CR12973, added DX D81.82 to Group 1, ICD-10-CM Codes that Support Medical Necessity.

10/01/2021 R4

Effective 10/01/2021 added the following codes to replace the deleted code M31.1 per the ICD-10-CM Annual Updates

  • M31.10 - thrombotic microangiopathy, unspecified
  • M31.19 – Other thrombotic microangiopathy
01/01/2021 R3

1/1/2021-Added C9072 per 2021 CPT/HCPCS Annual Update effective 1/1/2021.

10/01/2020 R2

10/1/2020: DX D59.1 was deleted from Group 1 under "ICD-10 Codes that Support Medical Necessity."

D59.11; D59.12; D59.13; D59.19 were added to Group 1 under "ICD-10 Codes that Support Medical Necessity."

These revisions are due to the Annual ICD-10 Updates effective 10/01/2020.

 

02/01/2020 R1

ICD-10 code I78.8 is added with clarification for its use.

Associated Documents

Statutory Requirements URLs
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Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
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Public Versions
Updated On Effective Dates Status
12/09/2022 10/01/2022 - N/A Currently in Effect You are here
09/10/2021 10/01/2021 - 09/30/2022 Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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