Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56786 (Billing and Coding: Immune Globulin) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A56786: Billing and Coding: Immune Globulin (Billing and Coding, effective 2026-07-01)
- Covered ICD-10-CM codes
- 108
- 2 groups
- Non-covered ICD-10-CM codes
- 1
- Procedure codes listed
- 18
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C90.00 | — |
| C90.02 | — |
| C91.10 | — |
| C91.12 | — |
| D59.0 | — |
| D59.11 | — |
| D59.12 | — |
| D59.13 | — |
| D59.19 | — |
| D69.3 | — |
| D69.41 | — |
| D80.0 | — |
| D80.1 | — |
| D80.2 | — |
| D80.3 | — |
| D80.4 | — |
| D80.5 | — |
| D80.6 | — |
| D80.7 | — |
| D80.8 | — |
| D81.0 | — |
| D81.1 | — |
| D81.2 | — |
| D81.31 | — |
Procedure codes: J1459 (Injection, Immune Globulin (Privigen), Intravenous, Non-Lyophilized (E.G., Liquid), 500 Mg), J1551 (Injection, Immune Globulin (Cutaquig), 100 Mg), J1552 (Injection, Immune Globulin (Alyglo), 500 Mg), J1553 (Injection, Immune Globulin (Yimmugo), 100 Mg), J1554 (Injection, Immune Globulin (Asceniv), 500 Mg), J1555 (Injection, Immune Globulin (Cuvitru), 100 Mg), J1556 (Injection, Immune Globulin (Bivigam), 500 Mg), J1557 (Injection, Immune Globulin, (Gammaplex), Intravenous, Non-Lyophilized (E.G., Liquid), 500 Mg), J1558 (Injection, Immune Globulin (Xembify), 100 Mg), J1559 (Injection, Immune Globulin (Hizentra), 100 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/Gammagard Liquid Erc), 500 Mg), J1572 (Injection, Immune Globulin, (Flebogamma/Flebogamma Dif), Intravenous, Non-Lyophilized (E.G., Liquid), 500 Mg), J1575 (Injection, Immune Globulin/Hyaluronidase, (Hyqvia), 100 Mg Immuneglobulin), J1576 (Injection, Immune Globulin (Panzyga), Intravenous, Non-Lyophilized (E.G., Liquid), 500 Mg), J1577 (Injection, Immune Globulin (Qivigy), 100 Mg).
Coverage indications, limitations and medical necessity
Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.
History/Background and/or General Information
Immune globulin (also referred to as gamma globulin or immunoglobulin) is a therapeutic compound prepared from pools of plasma obtained from several thousand healthy blood donors that contains antibodies to a wide spectrum of antigens. Immune globulin has been utilized for immune deficiencies identified in individuals with inherited or acquired immunodeficiencies and is used for its capacity in combating infection as a replacement therapy and for its anti-inflammatory and immunomodulating effects. The appropriate use of immune globulin can decrease morbidity and mortality and improve quality of life. 1,2
The focus of this LCD is the United States (U.S.) Food and Drug Administration (FDA) approved indications and the off-label indications for immune globulin where the evidence supports such use. Immune globulin products are not generic drugs and products are not interchangeable. A specific product needs to be matched to patient characteristics to ensure patient safety and a change of product should occur only with the active participation of the prescribing provider. 3
The overall coverage of drugs is addressed in the CMS IOM Publication 100-02, Medicare Benefit Policy Manual , Chapter 15, Sections 50.4.1 and 50.4.2 and includes coverage for FDA-approved drugs and unlabeled use of a drug.
Covered Indications
Immune globulin products will be considered medically reasonable and necessary when administered for treatment of FDA-labeled indications (https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/immune-globulins 4 ).
Off-label indications for intravenous immune globulin ( IVIG) products will be considered medically reasonable and necessary in the following situations:
• Multiple myeloma for recurrent infections with hypogammaglobulinemia and subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection 1,3,5-7
• Following treatment of lymphoma utilizing B-cell depleting therapies for recurrent infections with hypogammaglobulinemia and subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection 3
• Recipients of hematopoietic stem cell transplants with severe combined immunodeficiency (SCID) or other primary immunodeficiencies who are functionally agammaglobulinemic because of weak B-cell engraftment 3
• Recipients of allogeneic hematopoietic stem cell transplantation with chronic graft versus host disease (GVHD), recurring bacterial infections, and subprotective antibody levels following immunization against diphtheria, tetanus or pneumococcal infection 3
• Human Leukocyte Antigen (HLA) and ABO desensitization protocols for the prevention of acute humoral rejection in renal transplantation 3
• The treatment of antibody mediated solid organ transplant rejection in combination with rituximab and plasma exchange (PE) 3,8
• Treatment of hypogammaglobulinemia in solid organ transplants 3
• Autoimmune hemolytic anemia (AIHA) when other treatment approaches have failed 9-10
• Systemic capillary leak syndrome (SCLS) 11-13
• Guillain-Barré syndrome (GBS) in adults 1,3,14-15
• Moderate to severe myasthenia gravis (MG) 2-3,10,15-18
• Lambert-Eaton myasthenic syndrome (LEMS) in individuals who fail to respond or do not tolerate other treatments 3
• Relapsing-remitting multiple sclerosis (MS) 3,19-22
• Neuromyelitis optica (Devic syndrome) in individuals with severe relapses not responding to corticosteroids and who are not candidates for PE 3
• Stiff-person syndrome (also referred to as stiff-man syndrome) 2-3
• Treatment of autoimmune encephalitis, once infection is ruled out, as an alternative in patients who fail to respond or do not tolerate other treatments 23-27
• Treatment of Susac syndrome in combination with high-dose intravenous corticosteroids 28
• Severe forms of polymyositis resistant to treatment with glucocorticosteroids and immunosuppressants 29-30
• Severe forms of inclusion body myositis with dysphagia and individuals are otherwise treatment-resistant 3,29-33
• Immune mediated necrotizing myopathy resistant to treatment with glucocorticosteroids and immunosuppressants 29-30
• Overlap syndrome with myositis including anti-synthetase syndrome resistant to treatment with glucocorticosteroids and immunosuppressants 29-30
• Severe systemic lupus erythematosus (SLE) in individuals who fail to respond or do not tolerate other treatments 10,30
• Biopsy-proven autoimmune mucocutaneous blistering diseases in individuals who fail to respond or do not tolerate other treatments and individuals with rapidly progressive disease requiring a faster response than conventional therapy (i.e., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid and epidermolysis bullosa acquisita) 3,30,34-39
• Toxic epidermal necrolysis (TEN) 3,30
• Stevens-Johnson syndrome 3,30
• Severe scleromyxedema 3,30,40-41
• Thyroid eye disease, also referred to as Graves’ disease in patients who have failed treatment with teprotumumab or have contraindications to the use of teprotumumab 3,42-45
Limitations
The following are considered not medically reasonable and necessary:
• The off-label use of subcutaneous immune globulin
• The off-label use of intravenous immune globulin not listed above in the covered indications
AND
Immune globulin for the following:
• Routine use in the immediate peri-transplantation period for the prevention of infection or GVHD following marrow or peripheral blood allogeneic transplantation 3,46
• Acute GVHD with hematopoietic stem cell transplantation in the immediate post-transplantation phase 3
• Hematopoietic stem cell transplantation in the immediate post-transplantation phase with a history of sinusoidal obstructive syndrome 3,46
• Cord blood stem cell transplantation for children or adults 3
• Polyneuropathy associated with IgM monoclonal gammopathy 10
• Idiopathic neuropathies 10
• Brachial plexopathy 10
• Adrenoleukodystrophy 10
• Amyotrophic lateral sclerosis 10
• Critical illness polyneuropathy 10
• POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) 10
Please refer to the CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 4, Section 250.3 Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases for additional limitations.
Provider Qualifications
Services will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the provider’s professional licensure; and when all procedures are performed by appropriately trained providers in the appropriate setting.
Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.
Summary of evidence (opening)
A literature search was conducted for evidence-based guidelines and appropriate use criteria for immune globulin. The literature search was filtered to locate articles within five-ten years, full-text articles, clinical trials, and systematic reviews.
Multiple guidelines and appropriate use criteria are available for utilization of immune globulin. The goal of immune globulin therapy is to improve health outcomes of patients. In general, improved health outcomes of interest include patient mortality and morbidity, as well as patient quality of life and function.
History/Background
Immunoglobulins (also referred to as immune globulin or gamma globulin) are antibodies produced by differentiated B cells called plasma cells. The immunoglobulin molecule has a distinctive structure that has the ability to recognize specific antigenic determinants. The immune globulin formulations are generated from the pooled human plasma of thousands of healthy donors, which allows the immune globulin formulations to include a large and diverse antibody collection. The supply of immune globulin is limited as it depends on donated plasma. Therefore, it is imperative for healthcare providers to understand current levels of evidence to support immune globulin therapy as the appropriate use of immune globulin can decrease morbidity and mortality and improve quality of life. Immune globulin is a key component in the treatment for individuals with primary immunodeficiency disease affecting the humoral immune system. Intravenous formulations are significant in the treatment of other conditions as well, some for which have no available alternative treatments. 1-2
The contractor cites 61 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2015-10-01
- Current revision effective
- 2023-02-05
- MCD version
- 114
- Derived from
- L32712
The contractor lists one National Coverage Determination as related: NCD 250.3 Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases. Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Other related documents: A59283 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Novitas Solutions, Inc. hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L35093 cover?
Immune globulin (also referred to as gamma globulin or immunoglobulin) is a therapeutic compound prepared from pools of plasma obtained from several thousand healthy blood donors that contains antibodies to a wide spectrum of antigens. Immune globulin has been utilized for immune deficiencies identified in individuals with inherited or acquired immunodeficiencies and is used for its capacity in combating infection… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L35093 apply to?
Novitas Solutions, Inc. applies it to Medicare claims in AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L35093?
The companion billing and coding article A56786 lists 108 ICD-10-CM codes in 2 groups that support medical necessity and 1 that do not; the first 24 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L35093?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.