Local Coverage Article Billing and Coding

Billing and Coding: Intravenous Immune Globulin

A57778

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

Article Information

General Information

Article ID
A57778

Article Title
Billing and Coding: Intravenous Immune Globulin

Article Type
Billing and Coding

Original Effective Date
10/03/2018

Revision Effective Date
10/01/2020

Revision Ending Date
N/A

Retirement Date
N/A

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CMS National Coverage Policy

Social Security Act (Title XVIII) Standard References:

Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period.

Article Guidance

Article Text

This Billing and Coding Article provides billing and coding guidance for Local Coverage Determination (LCD) L34007 Intravenous Immune Globulin. Please refer to the LCD for reasonable and necessary requirements.

Coding Guidance

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Documentation Requirements

All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.
Medical record documentation maintained by the treating physician must clearly document the medical necessity to initiate intravenous immune globulin therapy and the continued need thereof. Required documentation of medical necessity includes but is not limited to:

History and physical; supporting physician rationale (current within the last 12 months)
Physicians orders not more than 30 days old to date of service specifying dose, frequency, administration route and duration office/progress note(s); that clearly document the necessity for both initiation and continuation of IVIG
Documentation supporting the diagnosis
A copy of applicable lab and procedure test results
An accurate weight in kilograms should be documented prior to each infusion since the dosage is based mg/kg/dosage; and
Prior failed conventional therapies or documentation that conventional therapy is contraindicated
Medication administration records

In addition, medical record documentation maintained by the treating physician for claims billed with a diagnosis of CVID must include the following: the initial presenting IgG levels and evidence that the patient has been vaccinated with Pneumovax and has had pre-and post-vaccine pneumococcal antibody titers performed to demonstrate the lack of ability to produce an antibody response to protein or carbohydrate antigens.
Documentation must include dual diagnoses listed for the underlying condition that demonstrates the medical necessity for intravenous immune globulin therapy.
Documentation must include a statement regarding lack of response to protein antigen.
For patients with HIV disease and ITP the medical record must specifically reflect that the patient has a platelet count of less than 30,000 and is actively bleeding. This must be supported by applicable lab results.
When IVIG is indicated in immunodeficient individuals, with recurrent or chronic bacterial sinusitis, the medical record must document findings diagnostic of, or highly suggestive of, recurrent or chronic bacterial sinus infection. Such findings may include, but are not limited to, fever, unilateral purulent nasal discharge and unilateral facial pain." Absence of these findings will not preclude the use of IVIG, however, documentation will be considered insufficient to justify medical necessity when antibiotic therapy is prescribed routinely during the first few days of symptoms in the absence of these findings, or in the instance where antibiotic therapy is prescribed by phone without the benefit of an examination by a physician (or non-physician practitioner). IVIG is never indicated and therefore not reasonable and necessary for the treatment of simple rhinosinusitis, even in immunodeficient individuals. The medical record must substantiate the use of prolonged and/or recurrent antibiotic therapy in the treatment of these infections. Radiographic documentation of mucosal thickening of the paranasal sinuses, in and of itself, is not specific to bacterial sinusitis and as a sole finding will not be consideration sufficient documentation to support the use of IVIG.
For stiff-man (stiff-person) syndrome, documentation must support that the patient is under the care of a physician who is competent in the diagnosis of the syndrome. The current defined criteria for the diagnosis must be met. Patient would have demonstrated failed conservative treatment (such as benzodiazepines). The record must show the patients response to therapy after initial treatment (0 and 1 month). Documentation must support objective response for continued coverage each month or at longer intervals.

Coding Information

CPT/HCPCS Codes

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Group 1

(12 Codes)

Group 1 Paragraph

J1599 Injection, Panzyga® (immune globulin intravenous, human – IFAS)

C9399 Injection, Panzyga® (immune globulin intravenous, human – IFAS)

Note: Providers are reminded to refer to the long descriptors of the CPT codes in their CPT book.

Group 1 Codes

Code	Description
C9399	Unclassified drugs or biolog
J1459	Inj ivig privigen 500 mg
J1555	Inj cuvitru, 100 mg
J1556	Inj, imm glob bivigam, 500mg
J1557	Gammaplex injection
J1561	Gamunex-c/gammaked
J1566	Immune globulin, powder
J1568	Octagam injection
J1569	Gammagard liquid injection
J1572	Flebogamma injection
J1575	Hyqvia 100mg immuneglobulin
J1599	Ivig non-lyophilized, nos

CPT/HCPCS Modifiers

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

(95 Codes)

Group 1 Paragraph

It is the provider’s responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted.

The following ICD-10-CM codes support medical necessity and provide coverage for HCPCS codes: C9399, J1459, J1555, J1556, J1557, J1561, J1566, J1568, J1569, J1572, J1575, and J1599.

Group 1 Codes

Code	Description
B20*	Human immunodeficiency virus [HIV] disease
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
D69.3	Immune thrombocytopenic purpura
D69.41	Evans syndrome
D69.6*	Thrombocytopenia, unspecified
D70.8	Other neutropenia
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
D81.89	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
G61.0	Guillain-Barre syndrome
G61.81	Chronic inflammatory demyelinating polyneuritis
G61.82	Multifocal motor neuropathy
G61.89	Other inflammatory polyneuropathies
G62.89	Other specified polyneuropathies
G64	Other disorders of peripheral nervous system
G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation
H46.8	Other optic neuritis
L10.0	Pemphigus vulgaris
L10.1	Pemphigus vegetans
L10.2	Pemphigus foliaceous
L10.3	Brazilian pemphigus [fogo selvagem]
L10.4	Pemphigus erythematosus
L10.5	Drug-induced pemphigus
L10.81	Paraneoplastic pemphigus
L10.89	Other pemphigus
L10.9	Pemphigus, unspecified
L12.0	Bullous pemphigoid
L12.1	Cicatricial pemphigoid
L12.8	Other pemphigoid
L12.9	Pemphigoid, unspecified
L13.8	Other specified bullous disorders
L14	Bullous disorders in diseases classified elsewhere
L40.1	Generalized pustular psoriasis
M30.3	Mucocutaneous lymph node syndrome [Kawasaki]
M33.00	Juvenile dermatomyositis, organ involvement unspecified
M33.01	Juvenile dermatomyositis with respiratory involvement
M33.02	Juvenile dermatomyositis with myopathy
M33.03	Juvenile dermatomyositis without 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
M33.13	Other dermatomyositis without 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
M33.93	Dermatopolymyositis, unspecified without myopathy
M33.99	Dermatopolymyositis, unspecified with other organ involvement
M36.0	Dermato(poly)myositis in neoplastic disease
T86.00	Unspecified complication of bone marrow transplant
T86.01	Bone marrow transplant rejection
T86.02	Bone marrow transplant failure
T86.03	Bone marrow transplant infection
T86.09	Other complications of bone marrow transplant
T86.11	Kidney transplant rejection
Z78.9*	Other specified health status
Z91.89*	Other specified personal risk factors, not elsewhere classified
Z92.21*	Personal history of antineoplastic chemotherapy

Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

Note: Dual Diagnosis requirement:

For the pediatric population less than thirteen, there is a requirement for a dual diagnosis; B20 Human immunodeficiency virus [HIV] disease plus Z91.89 Other specified personal risk factors, not elsewhere classified OR B20 Human immunodeficiency virus [HIV] disease plus Z78.9 Other specified health status.

For adults ≥ 13 there is a dual diagnosis requirement for administering IVIG for thrombocytopenia associated with HIV disease; primary diagnosis of D69.6 Thrombocytopenia, unspecified and a secondary diagnosis of B20 Human immunodeficiency virus [HIV] disease.

For patients treated for Hypogammaglobulinemia due to non neutropenic infection a dual diagnosis of D80.1 Nonfamilial hypogammaglobulinemia and Z92.21 Personal history of antineoplastic chemotherapy is required.

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

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Group 1

(1 Code)

Group 1 Paragraph

All those not listed under the “ICD-10 Codes that Support Medical Necessity” section of this article.

Group 1 Codes

Code	Description
XX000	Not Applicable

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.

Code	Description
999x	Not Applicable

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.

Code	Description
99999	Not Applicable

Other Coding Information

N/A

Revision History Information

Revision History Date	Revision History Number	Revision History Explanation
10/01/2020	R2	Revision Number: 2 Publication: September 2020 Connection LCR A/B2020-065 Explanation of Revision: Based on CR 11895 and CR 11845 (Annual 2021 ICD-10-CM Update), ICD-10-CM codes D59.11, D59.12, D59.13, and D59.19 have been added to “ICD-10 Codes that Support Medical Necessity/ Group 1 Codes:”. Also, ICD-10-CM code D59.1 was removed from“ICD-10 Codes that Support Medical Necessity/ Group 1 Codes:”. Additional formatting changes have been made throughout the document. The effective date of this revision is for dates of service on or after October 1, 2020.
03/16/2020	R1	Revision Number: 1 Publication: March 2020 Connection LCR A/B2020-016 Explanation of Revision: Based on a review, this billing and coding article was revised to add the new FDA approved drug Panzyga ® (immune globulin intravenous, human – IFAS) (HCPCS codes C9399/J1599) to the “CPT/HCPCS Codes/Group 1 Paragraph:/Group 1Codes:” and “ICD-10 Codes that Support Medical Necessity/Group 1 Paragraph:” sections. The effective date of this revision is for claims processed on or after 03/16/2020, for dates of service on or after August 2, 2018.

Associated Documents

Related Local Coverage Documents
LCDs
L34007 - Intravenous Immune Globulin

Updated On	Effective Dates	Status
09/25/2020	10/01/2020 - N/A	Currently in Effect	You are here
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Keywords

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Billing and Coding: Intravenous Immune Globulin

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Coding Information

CPT/HCPCS Codes

Group 1

CPT/HCPCS Modifiers

ICD-10-CM Codes that Support Medical Necessity

Group 1

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

Group 1

Additional ICD-10 Information

Bill Type Codes

Revenue Codes

Other Coding Information

Revision History Information

Associated Documents

Keywords

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