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LCD Reference Article Billing and Coding Article

Billing and Coding: Immune Globulin

A57778

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A57778
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Immune Globulin
Article Type
Billing and Coding
Original Effective Date
10/03/2018
Revision Effective Date
01/12/2024
Revision Ending Date
N/A
Retirement Date
N/A
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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

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 (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.

The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. Drugs that fall under this category must be billed with the JA modifier for the intravenous infusion of the drug or billed with the JB modifier for the subcutaneous injection of the drug.

HCPCS codes J1561 and J1569 must be billed with either modifier JA for the intravenous formulation or modifier JB for the subcutaneous formulation.

Not Otherwise Classified (NOC) Drug Billing

Office/Clinic

Providers submit NOC codes (e.g., J1599) in the 2400/SV101-2 data element in the 5010 professional claim transaction (837P). When billing an NOC code, providers are required to provide a description in the 2400/SV101-7 data element. The 5010 TR3 Implementation Guide instructs: "Use SV101-7 to describe non-specific procedure codes." (Do not use the 2400 NTE segment to describe non-specific procedure codes with 5010). The SV101-7 data element allows for 80 bytes (i.e., characters, including spaces) of information.

In order for the A/B MAC to correctly reimburse NOC drugs and biologicals, providers must indicate the following in the 2400/SV101-7 data element, or Item 19 of the CMS 1500 form:

  • The name of the drug,
  • The total dosage (plus strength of dosage, if appropriate), and
  • The method of administration.

Important: List one unit of service in the 2400/SV1-04 data element or in item 24G of the CMS 1500 form. Do not quantity-bill NOC drugs and biologicals even if multiple units are provided. Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed.

Claims for NOC drugs and biologicals will reject as unprocessable if any of the information listed above is missing, or if the NOC code is billed with more than one unit of service. (Note: The remittance notice will include remark code M123, "Missing/incomplete/invalid name, strength, or dosage of the drug furnished," even if the rejection is due to the number of units billed).

Ambulatory Surgical Centers (ASCs) and Hospital Outpatient Departments

HCPCS code C9399, Unclassified drug or biological, should be used for new drugs and biologicals that are approved by the United States (U.S.) Food and Drug Administration (FDA) on or after January 1, 2004, for which a specific HCPCS code has not been assigned.

Drug Wastage

When billing for Part B drugs and biologicals (except those provided under a competitive acquisition program [CAP]), the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.

Any amount wasted must be clearly documented in the medical record and should include the date and time, amount of medication wasted, and the reason for the wastage.

The use of the JZ modifier (attesting that there were no discarded amounts) is required on claims to report there are no discarded amounts of unused drugs or biologicals from single use vials or single use packages.

Claims for drugs separately payable under Medicare Part B from single-dose containers are required to report either the JW or JZ modifier, to identify any discarded amounts or to attest that there are no discarded amounts, respectively.

  • The JW and JZ modifier policy does not apply for drugs that are not separately payable, such as packaged OPPS or ASC drugs, or drugs administered in the FQHC or RHC setting.
  • The JW and JZ modifiers do not apply to drugs assigned status indicator N (Items and Services Packaged into APC Rates) under the OPPS. Similarly, the JW and JZ modifiers do not apply to drugs assigned payment indicator “N1” (ASC).


Documentation Requirements

    1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
    2. 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.
    3. 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.
    4. The medical record documentation must support the medical necessity of the services as stated in the LCD.
    5. The information contained in the medical record should include all relevant diagnostic laboratory studies, prior history of bleeding, infection, disease progression, prior medical/surgical therapies, vaccination response, and any other information essential in establishing that the patient meets the coverage indications as set forth in the NCD and LCD.
    6. An accurate weight in kilograms should be documented prior to the infusion since the dosage is based on mg/kg/dosage.

Response To Comments

Number Comment Response
1
N/A

Coding Information

Bill Type Codes

Code Description
999x Not Applicable
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

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Group 1

(10 Codes)
Group 1 Paragraph


Intravenous formulations of immune globulin.

When billing HCPCS code J1561 or J1569, append the JA modifier for the intravenous formulation.

Report:

HCPCS code J1566 for Injection intravenous, Carimune® NF and Gammagard® S/D

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

 

 Group 1 Codes
Code Description
J1459 Inj ivig privigen 500 mg
J1554 Inj. asceniv
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
J1576 Inj, panzyga, 500 mg

Group 2

(8 Codes)
Group 2 Paragraph


Subcutaneous formulations of immune globulin.

When billing HCPCS code J1561 or J1569, append the JB modifier for the subcutaneous formulation.

 

 Group 2 Codes
Code Description
J1551 Inj cutaquig 100 mg
J1555 Inj cuvitru, 100 mg
J1558 Inj. xembify, 100 mg
J1559 Hizentra injection
J1561 Gamunex-c/gammaked
J1562 Vivaglobin, inj
J1569 Gammagard liquid injection
J1575 Hyqvia 100mg immuneglobulin
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CPT/HCPCS Modifiers

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Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

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Group 1

(108 Codes)
Group 1 Paragraph


Intravenous formulations of immune globulin.

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 codes support medical necessity and provide coverage for HCPCS codes: J1459, J1554, J1556, J1557, J1561, J1566, J1568, J1569, J1572, and J1576.

 

 Group 1 Codes
Code Description
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
C91.12 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
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
D80.8 Other immunodeficiencies with predominantly antibody defects
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
D81.31 Severe combined immunodeficiency due to adenosine deaminase deficiency
D81.4 Nezelof's syndrome
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
G04.81* Other encephalitis and encephalomyelitis
G11.3 Cerebellar ataxia with defective DNA repair
G25.82 Stiff-man syndrome
G35 Multiple sclerosis
G36.0 Neuromyelitis optica [Devic]
G61.0 Guillain-Barre syndrome
G61.81 Chronic inflammatory demyelinating polyneuritis
G61.82 Multifocal motor neuropathy
G70.00 Myasthenia gravis without (acute) exacerbation
G70.01 Myasthenia gravis with (acute) exacerbation
G70.80 Lambert-Eaton syndrome, unspecified
G70.81 Lambert-Eaton syndrome in disease classified elsewhere
G72.41 Inclusion body myositis [IBM]
G72.81* Critical illness myopathy
G72.89* Other specified myopathies
G73.1 Lambert-Eaton syndrome in neoplastic disease
G73.3 Myasthenic syndromes in other diseases classified elsewhere
G93.49* Other encephalopathy
H05.241* Constant exophthalmos, right eye
H05.242* Constant exophthalmos, left eye
H05.243* Constant exophthalmos, bilateral
I78.8* Other diseases of capillaries
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
L12.35* Other acquired epidermolysis bullosa
L12.8 Other pemphigoid
L12.9 Pemphigoid, unspecified
L13.8 Other specified bullous disorders
L51.1 Stevens-Johnson syndrome
L51.2 Toxic epidermal necrolysis [Lyell]
L51.3 Stevens-Johnson syndrome-toxic epidermal necrolysis overlap syndrome
L98.5* Mucinosis of the skin
M30.3 Mucocutaneous lymph node syndrome [Kawasaki]
M32.11 Endocarditis in systemic lupus erythematosus
M32.12 Pericarditis in systemic lupus erythematosus
M32.13 Lung involvement in systemic lupus erythematosus
M32.14 Glomerular disease in systemic lupus erythematosus
M32.15 Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19 Other organ or system involvement in systemic lupus erythematosus
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
M33.11 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
M33.21 Polymyositis with respiratory involvement
M33.22 Polymyositis with myopathy
M33.29 Polymyositis with other organ involvement
M36.0 Dermato(poly)myositis in neoplastic disease
N18.6* End stage renal disease
T86.01* Bone marrow transplant rejection
T86.11 Kidney transplant rejection
T86.21 Heart transplant rejection
T86.31 Heart-lung transplant rejection
T86.41 Liver transplant rejection
T86.810 Lung transplant rejection
Z51.11* Encounter for antineoplastic chemotherapy
Z51.12* Encounter for antineoplastic immunotherapy
Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*Dual diagnosis requirement: ICD-10 code C90.00 or C90.02 must be reported with ICD-10 code Z91.89 to indicate subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection.

*Report ICD-10 codes D80.7, D81.6, D81.7, D81.9, or D83.9 Only for the diagnosis Primary Immune Deficiency Disease.

*Report ICD-10 code G04.81 for autoimmune encephalitis.

*Report ICD-10 code G72.81 for necrotizing autoimmune myopathy.

*Report ICD-10 code G72.89 for overlap syndrome with myositis including anti-synthetase syndrome.

*Report ICD-10 code G93.49 for Susac syndrome.

*Report ICD-10 code H05.241, H05.242 or H05.243 for thyroid eye disease (TED).

*Report ICD-10 code I78.8 for systemic capillary leak syndrome (SCLS), also referred to as Clarkson Disease.

*Report ICD-10 code L12.35 for epidermolysis bullosa acquisita.

*Report ICD-10 code L98.5 for severe scleromyxedema.

*Triple diagnosis requirement: ICD-10 code N18.6 must be reported with Z51.6 and Z99.2 for HLA and ABO desensitization protocols for prevention of acute renal transplant rejection.

*Triple diagnosis requirement: ICD-10 code T86.01 must be reported with D89.811 and Z91.89 to indicate subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection.

*Triple diagnosis requirement: ICD-10 code Z51.11 or Z51.12 must be reported with an ICD-10 code from C81.00 - C88.8 range and Z91.89 (to indicate subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection) for treatment of lymphoma utilizing B-cell depleting therapies.

Group 2

(30 Codes)
Group 2 Paragraph


Subcutaneous formulations of immune globulin.

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: J1551, J1555, J1558, J1559, J1561, J1562, J1569, and J1575.

 

 Group 2 Codes
Code Description
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
D80.8 Other immunodeficiencies with predominantly antibody defects
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
D81.31 Severe combined immunodeficiency due to adenosine deaminase deficiency
D81.4 Nezelof's syndrome
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
G61.81* Chronic inflammatory demyelinating polyneuritis
Group 2 Medical Necessity ICD-10-CM Codes Asterisk Explanation

*Report ICD-10 codes D80.7, D81.6, D81.7, D81.9, or D83.9 Only for the diagnosis Primary Immune Deficiency Disease.

*Only HCPCS codes J1575 and J1559 may be reported for ICD-10 code G61.81.
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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-CM Codes that Support Medical Necessity” section of this article.

 

 Group 1 Codes
Code Description
XX000 Not Applicable
N/A

ICD-10-PCS Codes

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Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

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.

Code Description
999x Not Applicable
N/A

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
N/A

Other Coding Information

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Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

N/A

Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A N/A
N/A
Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
N/A

Revision History Information

Revision History Date Revision History Number Revision History Explanation
01/12/2024 R7

Article revised and published on 03/07/2024 effective for dates of service on and after 01/12/2024 to revise the asterisk paragraph located at the bottom of the Group 2 ICD-10-CM codes to support medical necessity; “code J1575 and” were added to this paragraph. An asterisk was removed from J1559 that is located at the top of the Group 2 ICD-10 codes. This revision was in response to an inquiry.
07/01/2023 R6

Article revised and published on 07/20/2023 effective for dates of service on and after 07/01/2023 in response to the July Quarterly HCPCS/CPT Code Updates. The following HCPCS code has been added to the Article: J1576 in the CPT/HCPCS Group 1 Codes and the ICD-10-CM Group 1 Paragraph.

The following HCPCS codes have been deleted and therefore have been removed from the article: C9399 and J1599 in the CPT/HCPCS Group 1 Paragraph and Group 1 Codes and the ICD-10-CM Group 1 Paragraph.

Information regarding the JZ modifier has been added to the ‘Drug Wastage’ section of the Article.
02/05/2023 R5

Article revised and published on 06/01/2023 effective for dates of service on and after 02/05/2023 in response to an inquiry. The ‘Group 1 Medical Necessity ICD-10-CM Codes Asterisk Explanation’ section was revised for the 1st, 12th, and 13th Asterisk Notes to change ICD-10 code Z28.39 to Z91.89 to indicate subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection.
02/05/2023 R4

Article effective for dates of service on and after 02/05/2023.

Draft article posted on 08/11/2022.
10/01/2022 R3

Article revised and published on 12/08/2022 effective for dates of service on and after 10/01/2022 in response to the CMS Change Request (CR) 12973. The following ICD-10-CM code has been added to the ‘ICD-10-CM Codes that Support Medical Necessity’ section: D81.82 in ‘Group 1 Codes’.
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.
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