Archive
API

SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: Immune Globulin

A56786

Expand All | Collapse All
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.
Superseded
To see the currently-in-effect version of this document, go to the section.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A56786
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Immune Globulin
Article Type
Billing and Coding
Original Effective Date
08/08/2019
Revision Effective Date
02/05/2023
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 2023 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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

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) L35093 (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.

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

Expand All | Collapse All

Group 1

(11 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

HCPCS code J1599 for Injection intravenous, Panzyga®

HCPCS code C9399 for Injection intravenous, Panzyga®

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
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
J1599 Ivig non-lyophilized, nos

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
N/A

CPT/HCPCS Modifiers

Expand All | Collapse All

Group 1

Group 1 Paragraph

N/A

 Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Expand All | Collapse All

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: C9399, J1459, J1554, J1556, J1557, J1561, J1566, J1568, J1569, J1572, and J1599.

 

 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 Z28.39.

*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 Z28.39.

*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 Z28.39 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 code J1559 may be reported for ICD-10 code G61.81.
N/A

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

Expand All | Collapse All

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

Expand All | Collapse All

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

Expand All | Collapse All

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
02/05/2023 R7

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

Draft article posted on 08/11/2022.
10/01/2022 R6

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 2 Codes’.
10/01/2022 R5

Article revised and published on 10/20/2022 effective for dates of service on and after 10/01/2022 to reflect the Annual ICD-10-CM Code Updates. The following ICD-10-CM codes have been added to the article: D68.01, D68.020, D68.021, D68.022, D68.023, D68.029, D68.03, D68.04, D68.09 in Group 2 Codes and in the Group 2 Asterisk Note. The following ICD-10-CM code has been deleted and therefore has been removed from the article: D68.0 in Group 2 Codes and in the Group 2 Asterisk Note.
10/01/2020 R4

Article revised and published on 10/01/2020 effective for dates of service on and after 10/01/2020 to reflect the Annual ICD-10-CM Code Updates. The following ICD-10-CM code(s) have been added to the Article: D59.11, D59.12, D59.13, and D59.19 for Group 2 Codes. The following ICD-10 code has been deleted and therefore has been removed from the article: D59.1 for Group 2 Codes. Minor formatting changes have been made throughout the coding section.
02/13/2020 R3

Article revised  and published on 02/13/2020 effective for dates of service on and after 02/13/2020 due to a coding error. Current Procedural Terminology (CPT) codes J2788 and J2790 represent intra muscular (IM) injections and are not applicable based on the LCD language. The LCD is for intravenous immune globulin (IVIG) only and does not include the use of (IM) immune globulin. Therefore, J2788 and J2790 have been removed from CPT code group 1 and the ICD-10 code group 5 paragraph.
11/14/2019 R2

Due to system changes the order of the Coding Section has been revised and new sections for CPT/HCPCS Modifiers and Other Coding Information have been added.
08/13/2019 R1

Article revised and published on 08/22/2019 effective for dates of service on and after 08/13/2019 to add the following ICD-10 codes to ICD-10 Group 2 Codes in response to CMS Change Request 11295: D80.2, D80.4, D80.6, D81.5, D82.1, D82.4, D83.1, and G11.3.
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
03/01/2024 01/12/2024 - N/A Currently in Effect View
07/14/2023 07/01/2023 - 01/11/2024 Superseded View
05/26/2023 02/05/2023 - 06/30/2023 Superseded View
12/16/2022 02/05/2023 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

N/A

Read the Article Disclaimer

Submit Feedback/Ask a Question