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Immune Globulin Intravenous (IVIG), Subcutaneous (SCIG)
MA08.009z

Policy

This policy uses coverage criteria primarily based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents. In the absence of fully established coverage criteria from these Medicare coverage documents for a specific medical service or item, the criterion/indication/service indicated by an asterisk (*) in Attachment B is based on internal coverage criteria developed by the Company in consideration of peer-reviewed medical literature, clinical practice guidelines, regulatory status, and/or expert opinion.​

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

INDEX OF MEDICALLY NECESSARY INDICATIONS   
This policy addresses numerous medically necessary indications for th​e use of Intravenous Immune Globulin (IVIG) and Subcutaneous Immune Globulin (SCIG)​​ (listed in order of appearance within the Policy section). Please see below for the specific medical necessity criteria. (NOTE: Other sections such as Experimental/Investigational and Noncovered section​s below must also be reviewed).

SUBCUTANEOUS IMMUNE GLOBULIN (SCIG)
Neurological and Musculoskeletal Disorders
  • ​Chronic Inflammatory Demyelinating Polyneuritis (CIDP)
Primary Humoral Immunodeficiencies

INTRAVENOUS IMMUNE GLOBULIN (IVIG)
Dermatologic
Autoimmune Mucocutaneous Blistering Diseases
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
Scleromyxedema

Hematologic
Idiopathic Thrombocytopenic Purpura (ITP)
Autoimmune Hemolytic Anemia
Evans Syndrome 
Systemic Capillary Leak Syndrome (SCLS)  

Immunodeficiency Syndromes, Primary and Secondary
Acquired von Willebrand disease  ​
Antibody-Mediated Rejection (AMR)
Chimeric Antigen Receptor (CAR) T-Cell–Related Toxicities 
Chronic Lymphocytic Leukemia (CLL)
Hematopoietic Stem Cell Transplant (HSCT)
Human Immunodeficiency Virus (HIV) Infection
Immune Checkpoint Inhibitor–Related Toxicities 
Lymphomas utilizing B-cell–depleting therapies
Kawasaki disease
Multiple Myeloma
Preterm and/or low-birth-weight neonates as prevention for serious infections with severe hypogammaglobulinemia​ 
Primary Humoral Immunodeficiencies
Solid Organ Transplant
Thyroid Eye Disease (Graves' Disease) ​

Neurological and Musculoskeletal Disorders
Autoimmune Encephalitis 
CIDP
Dermatomyositis
Guillain-Barré Syndrome
Immune-Mediated Necrotizing Myopathy 
Inclusion Body Myositis 
Lambert-Eaton Myasthenic Syndrome
Multifocal Motor Neuropathy
Multiple Sclerosis (MS)
Myasthenia Gravis Syndrome
Myasthenic Crisis
Neuromyelitis optica (NMO) (Devic Syndrome) 
Overlap Syndrome with Myositis including Anti-Synthetase Syndrome 
Polymyositis  ​
Stiff-Person Syndrome
Susac Syndrome 
Systemic Lupus Erythematosus (SLE)​

MEDICALLY NECESSARY   

 SUBCUTANEOUS IMMUNE GLOBULIN (SCIG) ​
Use of subcutaneous immune globulin (SCIG) (Cutaquig, Cuvitru, Hizentra, HyQvia, Xembify) or subcutaneous administration of certain intravenous immune globulin (IVIG) (e.g., Gammagard Liquid, Gammaked, Gamunex-C) therapy is considered medically necessary and, therefore, covered for the following indications when the dosing and frequency requirements listed in Attachment B and the following criteria are met:

Neurological and Musculoskeletal Disorders

Chronic Inflammatory Demyelinating Polyneuritis (CIDP)

SCIG is considered medically necessary and, therefore, covered for CIPD when the individual has a documented diagnosis of CIDP ​that has responded to IVIG treatment. 

Primary Humoral Immunodeficiencies

SCIG is considered medically necessary and, therefore, covered when used as a replacement therapy in individuals with primary immunodeficiencies, in whom severe impairment of antibody capacity is present in the following conditions*:
  • Activated Phosphoinositide 3-kinase Delta Syndrome (APDS)   
  • Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia
  • Cerebellar ataxia with defective DNA repair
  • Combined immunodeficiencies     
  • Common variable immunodeficiency
  • Common variable immunodeficiency with autoantibodies to B- or T-cells      
  • Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function    ​
  • Common variable immunodeficiency with predominant immunoregulatory T-cell disorders
  • Congenital agammaglobulinemia                                       ​
  • DiGeorge syndrome
  • Hereditary hypogammaglobulinemia​                        ​
  • Hyperimmunoglobulin E ​​[IgE] syndrome
  • Immunodeficiency with increased immunoglobulin M (IgM)      ​​
  • Major histocompatibility complex class I or II deficiency         ​​
  • Nezelof Syndrome                                                          ​
  • Nonfamilial hypogammaglobulinemia
  • PNP deficiency
  • Selective deficiency of immunoglobulin A (IgA)
  • Selective deficiency of IgM
  • Selective deficiency of IgG subclasses
  • Severe combined immunodeficiencies (SCIDs)
  • SCID due to adenosine deaminase deficiency                ​
  • Transient hypogammaglobulinemia of infancy
  • Wiskott-Aldrich syndrome
  • X-linked immunodeficiency with hyper-IgM     ​​
*Coverage for primary immunodeficiencies not included in this list may be reviewed for coverage through applicable Part D benefits. Individual benefits must be verified.

INTRAVENOUS IMMUNE GLOBULIN (IVIG)
Use of IVIG therapy (e.g., Alyglo​, Asceniv, Bivigam, Flebogamma​, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam, Panzyga, Privigen) is considered medically necessary and, therefore, covered for the following indications when the dosing and frequency requirements listed in Attachment B and the following criteria are met:

Dermatologic

Autoimmune Mucocutaneous Blistering Diseases

IVIG is considered medically necessary and, therefore, covered for the treatment of any of the following biopsy-proven conditions (i.e., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid [a.k.a. cicatricial pemphigoid], epidermolysis bullosa acquisita), and meets at least one of the following criteria:
  • Failed ​or intolerant of conventional therapy 
  • Conventional therapy is otherwise contraindicated
  • Rapidly progressive disease in which a clinical response could not be effected 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

Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis

IVIG is considered medically necessary and, therefore, covered for the one-time treatment of Stevens-Johnson syndrome or toxic epidermal necrolysis.  ​
​
Scleromyxedema

IVIG is considered medically necessary and, therefore, covered for the treatment of ​severe scleromyxedema. 

Hematologic

Idiopathic Thrombocytopenic Purpura (ITP)

For acute ITP, IVIG is considered medically necessary and, therefore, covered for the following indications:
  • Management of acute bleeding due to severe thrombocytopenia (platelet counts usually <30,000/uL)
  • To increase platelet counts prior to invasive surgical procedures, e.g., splenectomy
  • Severe thrombocytopenia (platelet counts less than 20,000/uL) considered to be at risk for intracerebral hemorrhage
Chronic refractory ITP is considered medically necessary and, therefore, covered for individuals meeting all of the following conditions:
  • Prior treatment with corticosteriods and splenectomy, except when contraindicated
  • Duration of illness >6 months
  • No concurrent illness/disease explaining thrombocytopenia
  • Platelet counts persistently at or below 20,000/uL
Autoimmune Hemolytic Anemia (AIHA)

​IVIG is considered medically necessary and, therefore, covered for individuals with AIHA when other treatment approaches have failed. 

Evans syndrome​ ​

IVIG is considered medically necessary and, therefore, covered ​for individuals with Evans syndrome, with or without corticosteroids. 

Systemic Capillary Leak Syndrome (SCLS)​

IVIG is considered medically necessary and, therefore, covered for individuals with systemic capillary leak syndrome (SCLS).

Immunodeficiency Syndromes, Primary and Secondary

Acquired von Willebrand disease   ​

IVIG is considered medically necessary and, therefore, covered for an individual with ​acquired von Willebrand disease associated with monoclonal gammopathy of undetermined significance of the IgG Class (IgG-MGUS) or antibody-mediated acquired von Willebrand disease​ ​

Antibody-Mediated Rejection (AMR)​

IVIG is considered medically necessary and, therefore, covered for the treatment of antibody-mediated solid organ transplant rejection in combination with rituximab and plasma exchange (PE).

Chimeric Antigen Receptor (CAR) T-Cell–​Related Toxicities 
​
IVIG is considered medically necessary and, therefore, covered after CAR T-cell ​(anti-CD19​) therapy (e.g., axicabtagene ciloleucel [Yescarta], brexucabtagene autoleucel [Tecartus], lisocabtagene maraleucel [Breyanzi], tisagenlecleucel [Kymriah®]) for one of the following: 
  • Hypogammaglobulinemia when the individual has a serum IgG level <400–600 mg/dL and serious or recurrent infections (particularly bacterial) until serum IgG levels normalize and infections resolve​
  • Management of Grade 4 cytokine release syndrome that is refractory to high-dose corticosteroids and anti-IL-6 therapy
Chronic Lymphocytic Leukemia (CLL)

IVIG is considered medically necessary and, therefore, covered when used to prevent recurrent bacterial infections in individuals with B-cell CLL who meet all of the following criteria:
  • Documented diagnosis of CLL
  • An IgG level <600 mg/dL
  • Recent history of serious bacterial infection(s) requiring either oral or parenteral antibiotic therapy
​​ Hematopoietic Stem Cell Transplant (HSCT)

  • IVIG is considered medically necessary and, therefore, covered for recipients of HSCT with SCID or other primary immunodeficiencies who are functionally agammaglobulinemic because of weak B-cell engraftment.
  • IVIG is considered medically necessary and, therefore, covered for recipients of allogeneic HSCT with chronic graft-versus-host disease (GVHD), recurring bacterial infections, and subprotective antibody levels following immunization against diphtheria, tetanus, or pneumococcal infection.
Human Immunodeficiency Virus (HIV) Infection

IVIG is considered medically necessary and, therefore, covered to reduce significant bacterial infection for individuals infected with HIV who meet all of the following conditions:
  • Individual is younger than 14 years of age
  • Evidence of either qualitative or quantitative humoral immunologic defects
  • Current bacterial infections, despite appropriate antimicrobial prophylaxis
Immune Checkpoint Inhibitor–Related Toxicities​

IVIG is considered medically necessary and, therefore, covered for the management of the following immunotherapy-related tox​icities  ​(Note: examples of immune checkpoint inhibitors include, but are not limited to, ipilimumab [Yervoy], PD-1/PD-L1 inhibitors [e.g., atezolizumab [Tecentriq], nivolumab [Opdivo], pembrolizumab [Keytruda])​
  • Myocarditis if no improvement within 24​ to 48 hours of starting pulse-dose methylprednisolone
  • Adjunct to ritiximab for severe (Grade 3) or life-threatening (Grade 4) bullous dermatitis  
  • Stevens-Johnson syndrome, or toxic epidermal necrolysis
  • Moderate or severe or life-threatening steroid-refractory myositis (proximal muscle weakness, neck flexor weakness, with or without myalgias) for significant dysphagia, life-threatening situations, or cases refractory to corticosteroids 
  • Severe (Grade 3-4) myasthenia gravis
  • Moderate (Grade 2) or severe (Grade 3-4) Guillain-Barré syndrome or severe (Grade 3-4) peripheral neuropathy in combination with pulse-dose methylprednisolone
  • Encephalitis in combination with pulse-dose methylprednisolone if severe or progressing symptoms, or if oligoclonal bands present (strongly consider if progressing over 24 hours)​
  • Demyelinating disease (optic neuritis, transverse myelitis, acute demyelinating encephalomyelitis)​
  • Moderate (Grade 3) pneumonitis if no improvement after 48 to 72 hours of corticosteroids or severe (Grades 3-4) pneumonitis if no improvement after 48 hours of methylprednisolone
  • Grade 4 cytokine release syndrome that is refractory to high-dose corticosteroids and anti-IL-6 therapy​
Lymphomas utilizing B-cell–depleting therapies   

​IVIG is considered medically necessary and, therefore, covered​ 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.

Kawasaki disease  ​

IVIG is considered medically necessary and, therefore, covered for an individual with a documented diagnosis of Kawasaki disease.

Multiple Myeloma
IVIG is considered medically necessary and, therefore, covered for an individual with multiple myeloma for recurrent infections with hypogammaglobulinemia and subprotective antibody levels following immunization against diphtheria, tetanus, or pneumococcal infection.

Preterm and/or low-birth-weight neonates as prevention for serious infections

IVIG is considered medically necessary and, therefore, covered for​ preterm and/or low-birth-weight neonates as prevention for serious infections (including sepsis, urinary tract infection, soft-tissue infections or cellulitis) when severe hypogammaglobulinemia (IgG ≤400 mg/dL) is present​.

Primary Humoral Immunodeficiencies

IVIG is considered medically necessary and, therefore, covered when used as a replacement therapy in individuals with primary immunodeficiencies in whom severe impairment of antibody capacity is present in the following conditions*:
  • APDS    
  • Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia
  • Cerebellar ataxia with defective DNA repair
  • Combined immunodeficiencies 
  • Common variable immunodeficiency
  • Common variable immunodeficiency with autoantibodies to B or T cells    ​
  • Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function    
  • Common variable immunodeficiency with predominant immunoregulatory T-cell disorders
  • Congenital agammaglobulinemia    ​
  • DiGeorge syndrome
  • Hereditary hypogammaglobulinemia​                             ​
  • IgE syndrome
  • Immunodeficiency with increased IgM      ​​
  • Major histocompatibility complex class I or II deficiency           ​​
  • Nezelof syndrome                                                                     ​
  • Nonfamilial hypogammaglobulinemia
  • Purine nucleoside phosphorylase [PNP] deficiency
  • Selective deficiency of IgA
  • Selective deficiency of IgM
  • Selective deficiency of IgG subclasses
  • SCIDs
  • SCID due to adenosine deaminase deficiency                ​
  • Transient hypogammaglobulinemia of infancy
  • Wiskott-Aldrich syndrome
  • X-linked immunodeficiency with hyper-IgM                                             
*Coverage for primary immunodeficiencies not included in this list may be reviewed for coverage through applicable Part D benefits. Individual benefits must be verified.
​
Solid Organ Transplant

IVIG is considered medically necessary and, therefore, covered as human leukocyte antigen (HLA) and ABO desensitization protocols for the prevention of acute humoral rejection in renal transplantation.​ 

IVIG is considered medically necessary and, therefore, covered for the treatment of hypogammaglobulinemia in solid organ transplants.

Thyroid eye disease, also referred to as Graves’ disease  

IVIG is considered medically necessary and, therefore, covered for​ the treatment of thyroid eye disease, also referred to as Graves’ disease, in individuals who have failed or have contraindications to treatment with teprotumumab (Tepezza). 

Neurological and Musculoskeletal Disorders

Autoimmune Encephalitis  ​

IVIG is considered medically necessary and, therefore, covered for​ the treatment of autoimmune encephalitis, once infection is ruled out, as an alternative in individuals who fail to respond or do not tolerate other treatments (e.g., high-dose corticosteroids, plasma exchange).

Chronic Inflammatory Demyelinating Polyneuritis (CIDP)

IVIG is considered medically necessary and, therefore, covered for CIPD when the individual has a documented diagnosis of CIDP.

​Dermatomyositis

IVIG is considered medically necessary and, therefore, covered for an individual with a documented diagnosis of dermatomyositis.

Guillain-Barré Syndrome
IVIG is considered medically necessary and, therefore, covered for Guillain-Barré syndrome in adults.  

Immune-Mediated Necrotizing Myopathy 

IVIG is considered medically necessary and, therefore, covered for immune-mediated necrotizing myopathy resistant to treatment with glucocorticosteroids and immunosuppressants.

Inclusion Body Myositis  

 IVIG is considered medically necessary and, therefore, covered for severe forms of inclusion body myositis with dysphagia when individuals are otherwise treatment-resistant.

Lambert-Eaton Myasthenic Syndrome (LEMS)

IVIG is considered medically necessary and, therefore, covered in individuals with LEMS who fail to respond or do not tolerate other treatments.​

Multifocal Motor Neuropathy​

IVIG is considered medically necessary and, therefore, covered as initial therapy in individuals who have progressive, symptomatic, multifocal motor neuropathy that has been diagnosed on the basis of electrophysiologic findings that rule out other possible conditions that may not respond to this treatment.
​
Multiple Sclerosis (MS)

IVIG is considered medically necessary and, therefore, covered in individuals with relapsing-remitting MS.

Myasthenia Gravis Syndrome

IVIG is considered medically necessary and, therefore, covered for moderate to severe myasthenia gravis.

​Myasthenic Crisis​​​

IVIG is considered medically necessary and, therefore, covered for myasthenic crisis (i.e., an acute episode of respiratory muscle weakness) when there is a contraindication to plasma exchange.

Neuromyelitis optica (NMO) (Devic syndrome) 

IVIG is considered medically necessary and, therefore, covered for individuals with NMO who have severe relapses not responding to corticosteroids and who are not candidates for plasma exchange.​

Overlap Syndrome with Myositis including Anti-Synthetase Syndrome     

IVIG is considered medically necessary and, therefore, covered for individuals with​ overlap syndrome with myositis including anti-synthetase syndrome resistant to treatment with glucocorticosteroids and immunosuppressants.

Polymyositis

IVIG is considered medically necessary and, therefore, covered for the treatment of severe forms of polymyositis resistant to treatment with glucocorticosteroids and immunosuppressants.

Stiff-Person Syndrome ​(Stiff-man Syndrome)

IVIG is considered medically necessary and, therefore, covered for individuals with Stiff-Person syndrome​.

Susac Syndrome ​

IVIG is considered medically necessary and, therefore, covered for individuals with Susac syndrome in combination with high-dose intravenous corticosteroids.

Systemic Lupus Erythematosus (SLE)

IVIG is considered medically necessary and, therefore, covered for individuals with severe active systemic lupus erythematosus (SLE) for whom other interventions have been unsuccessful, have become intolerable, or are contraindicated.

EXPERIMENTAL/INVESTIGATIONAL (SCIG, IVIG)

All other uses for SCIG, IVIG are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

NONCOVERED (IVIG)

IVIG is considered not medically necessary and, therefore, noncovered for the following indications:  
  • Routine use in the immediate peritransplantation period for the prevention of infection or GVHD​ following marrow or peripheral blood allogeneic transplantation​
  • Acute GVHD with hematopoietic stem cell transplantation (HSCT) in the immediate posttransplantation phase  
  • HSCT in the immediate posttransplantation phase with a history of sinusoidal obstructive syndrome  
  • Cord blood stem cell transplantation for children or adults  
  • Polyneuropathy associated with IgM monoclonal gammopathy 
  • Idiopathic neuropathies 
  • Brachial plexopathy
  • Adrenoleukodystrophy 
  • Amyotrophic lateral sclerosis 
  • Critical illness polyneuropathy 
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)  ​​
NOT ELIGIBLE FOR REIMBURSEMENT

Carimune NF is no longer manufactured and has been withdrawn from the market; therefore, it is not eligible for reimbursement.

DOSING AND FREQUENCY REQUIREMENTS

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this Policy to ensure consistency with the most recently published recommendations for the use of IVIG and SCIG. Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to, the US Food and Drug Administration (FDA), drug manufacturer’s guidelines, Company-recognized authoritative pharmacology compendia, or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of IVIG and SCIG outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia and criteria for peer-reviewed clinical research, view the policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of these drugs. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct postpayment review and audit procedures for any claims submitted for IVIG and SCIG.

Refer to Attachment B for dosing and frequency requirements for IVIG and SCIG.

REQUIRED DOCUMENTATION

When coverage of IVIG and SCIG is requested outside of the Dosing and Frequency Guidelines listed in thi​s policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

STANDARD WRITTEN ORDER REQUIREMENTS ​
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medial equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES (WHEN APPLICABLE)​
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately ​30 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 10 days before the individual would exhaust their on-hand supply.

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.

The maximum number of supplies that can be dispensed at one time is no more than a 1-month supply.

Guidelines

This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, subcutaneous immune globulin (SCIG) and intravenous immune globulin (IVIG) are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria, dosing and frequency requirements, and precertification/preapproval requirements listed in this medical policy are met.

Certain drugs may be available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending upon how the drug is prescribed and dispensed or administered. This medical policy only addresses instances when IVIG and SCIG may be covered under a member's medical benefit. It does not address instances when IVIG and SCIG may be covered under a member’s pharmacy benefit.

For individuals with primary immunodeficiency, IVIG and SCIG in the home setting may be covered under the medical benefit (Part B benefit). All other clinical indications in the home setting may be covered under the pharmacy benefit (Part D benefit). Refer to the policy entitled "Medicare Part B vs. Part D Crossover Drugs - MA08.007" for appropriate benefit application.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved numerous formulations of SCIG and IVIG.

Description

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.

IVIG can replace missing antibodies and decrease infection in primary immune deficiency and chronic lymphocytic leukemia, increase platelets in idiopathic thrombocytopenic purpura, prevent complications in Kawasaki disease, and possibly decrease morbidity in some other conditions.

IVIG is the preferred treatment method for patients who require an immediate increase in intravascular immunoglobulin antibody levels and are unable to produce sufficient amounts of immunoglobulin G (IgG) antibodies. The therapeutic effect of IVIG is immediate, well-tolerated, and less likely to produce side effects if infused at the properly indicated rate(s). Sensitivity to these reactions is usually related to the infusion rate. Caution should be exercised in the administration of IVIG; reactions may cause a rapid fall in blood pressure and clinical anaphylaxis.

The US Food and Drug Administration (FDA) has approved the subcutaneous infusion preparation of an immune globulin product (SCIG) for the prevention of serious infections in those with primary immunodeficiency disease (PIDD). SCIG is given under the skin using an infusion pump, usually on a weekly basis, in CIDP and PIDD. SCIG may be an option for individuals who have received IVIG and wish to transition to the subcutaneous infusion route. Subcutaneous infusion of immune globulin allows for an alternative route of administration in those who may have problems with chronic IV administration, and enables individuals to self-administer the product at home.

Note: There are a few formulations of IVIG that may be administered via subcutaneous infusion for the indication of PIDD (e.g., Gammagard Liquid, Gamunex-C, Gammaked).

CLINICAL BENEFITS OF INTERNALLY DEVELOPED COVERAGE CRITERIA 

​In accordance with federal regulations, the plan has determined that the use of this additional criterion is necessary to interpret or supplement Medicare's criteria and that it provides clinical benefits that are highly likely to outweigh any clinical harms, including from delayed or decreased access to items or services, to ensure safe and clinically appropriate dosing and frequency of administration of the products. 
​
OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Alyglo. Immune globulin intravenous, human-stwk. GC Biopharma Corp.Teaneck, NJ. Available at: ALYGLO | FDA.  Accessed December 27, 2023. 

American Hospital Formulary Service (AHFS). Drug Information 2024. Immune Globulin. updated 02/08/2021. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed January 11, 2024.

Bastuji-Garin S, Fouchard N, Bertocchi M, et al. SCORTEN: a severity-of-illness score for toxic epidermal necrolysis. J Invest Dermatol. 2000;115(2):149-153.

Broderick C, Kobayashi S, Suto M, et al. Intravenous immunoglobulin for the treatment of Kawasaki disease. Cochrane Database Syst Rev. 2023;1(1):CD014884.

Centers for Medicare & Medicaid Services (CMS). MM11295 – Update to Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home; effective 08/13/2019.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15 – Covered Medical and Other Health Services. 50.6 – Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home. (Rev.:11693, Issued:11-09-22, Effective: 10-01-22, Implementation: 12-12-22). Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed December 8, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 250.3 NCD for intravenous immune globulin for the treatment of autoimmune mucocutaneous blistering diseases. [CMS Web Site]. 10/01/02. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=158&ncdver=1&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=Immune+Globulin&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA==&. Accessed December 8, 2023.​

Cutaquig. Immune Globulin Subcutaneous (Human), 16.5% Solution. Approval and prescribing information. Octapharma USA INC.:Paramus, NJ. 11/2021. Available at: Subcutaneous Immunoglobulin Therapy for Adult PI | cutaquig® (cutaquigusa.com)​​. Accessed September 27, 2023.

Cuvitru, Immune Globulin Subcutaneous (Human), 20% Solution approval and prescribing information. Baxalta US Inc.: Lexington, MA. 03/2023. Available at: https://www.cuvitru.com/. Accessed January 11, 2024. ​

Elsevier’s Clinical Pharmacology Compendium. Immune Globulin IV, IVIG, IGIV. [Clinical Key Web site]. 12/26/2023. Available at: https://www.clinicalkey.com/pharmacology/monograph/311?sec=monindi [via subscription only]. Accessed January 11, 2024. 
​
Elsevier’s Clinical Pharmacology Compendium. Immune Globulin SC, SCIG, IGSC. [Clinical Key Web site]. 05/11/2023. Available at: https://www.clinicalkey.com/pharmacology/monograph/3470?sec=monindi#233 [via subscription only]. Accessed January 11, 2024. ​​
Gammagard Liquid package insert. Baxalta US Inc.: Westlake, CA. 03/2023. Available at: https://www.gammagard.com/primary-immunodeficiency/patient. Accessed January 11, 2024. ​

Gammaked. Package insert. Grifols Therapeutics Inc. Research Triangle Park, NC​. Revised 06/2018. Available at: http://www.gammaked.com/. Accessed January 11, 2024. ​

Gamunex-C package insert. Research Triangle Park, NC: Grifols Therapeutics LLC. 01/2020. Available at: https://www.gamunex-c.com/en/hcp. Accessed January 11, 2024. ​

Hizentra package insert. Kankakee, IL: CSL Behring LLC. 04/2023. Available at: https://www.hizentra.com/prescribing-information. Accessed June 9, 2023.​

HyQvia. package insert. Takeda Pharmaceuticals USA, Inc.: Lexington, MA. 01/2024. Available at: http://www.hyqvia.com/. Accessed January 26, 2024. ​​

Lexi-Drugs Compendium. Immune Globulin. [Lexicomp Online Web site]. 12/27/2023​. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed January 11, 2024. 
​
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Management of immune checkpoint inhibitor-related toxicities. V.2.2023. 05/09/2023. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/immunotherapy.pdf [via free subscription]. Accessed September 13, 2023.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Immune globulin. [NCCN Web site]. 2023. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed September 13, 2023.​​

Noridian Healthcare Solutions. Local Coverage Determination (LCD and Policy Article). 
L33794: External infusion pumps. Original 10/01/2015, Revised 01/01/2024.
A52507: External infusion pumps. Original 10/01/2015, Revised 10/01/2023.
Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active. Accessed January 11, 2024. 

Noridian Healthcare Solutions. Local Coverage Determination (LCD and Policy Article). 
L33610 Intravenous Immune Globulin. Original 10/01/2015, Revised 01/01/2024.
A52509 Intravenous Immune Globulin. Original 10/01/2015, Revised 01/01/2024.
Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active. Accessed January 11, 2024. ​

Novitas Solutions, Inc. Local Coverage Article (A53127). Self Administered Drug Exclusion List. [Novitas Solutions Web site]. Original 10/01/2015, Revised 10/01/2023. Available at: Article - Self-Administered Drug Exclusion List: (A53127) (cms.gov)​. Accessed January 11, 2024.​

Novitas Solutions, Inc. Local Coverage Article (LCA) A56786 - Billing and Coding: Intravenous Immune Globulin (IVIG). [Novitas Solutions Web site]. Original effective date 08/08/2019. Revision Effective date 01/12/2024. Available at: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=56786&ver=41&​. Accessed March 28, 2024. ​​

Novitas Solutions, Inc. Local Coverage Determination (LCD) L35093 - Intravenous Immune Globulin (IVIG). [Novitas Solutions Web site]. Original 10/01/2015, Revised 02/05/2023. Available at: LCD - Immune Globulin (L35093) (cms.gov). Accessed January 11, 2024.​​​​

Truven Health Analytics Inc. Micromedex® Solutions. DrugDex®. [Internet database]. Immune Globulin. 11/14/2023. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/ [via subscription only]. Accessed January 11, 2024.​

US Food and Drug Administration (FDA). Vaccines, Blood & Biologics. Immune Globulin Intravenous (Human) approved products. Updated: 03/08/2023. [FDA Web site]. Available at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm127589.htm. Accessed January 11, 2024.​​

Wingard JR. Prevention of infections in hematopoietic cell transplant recipients. 01/24/2022 UpToDate Website. Available at: http://www.uptodate.com/contents/prophylaxis-of-infections-in-hematopoietic-cell-transplant-recipients?source=search_result&search=Prophylaxis+of+infections+in+hematopoietic+cell+transplant+recipients&selectedTitle=1~150 [via subscription only]. Accessed September 1, 2023.​​

Xembify. Immune Globulin Subcutaneous, human-klhw, 20% Solution. Approval and prescribing information. Grifols Therapeutics LLC: Research Triangle Park, NJ. 08/2020. Available at: XEMBIFY subcutaneous immune globulin for PIDD | Official HCP Site​. Accessed January 11, 2024.​​

Yimmugo. immune globulin intravenous, human-dira, 10% Solution. Biotest AG. Dreieich, Germany Updated 08/09/2024. Available at: YIMMUGO | FDA . Accessed March 17, 2026. 

Zwiers C, Scheffer-Rath ME, Lopriore E, et al. Immunoglobulin for alloimmune hemolytic disease in neonates. Cochrane Database Syst Rev. 2018;3:CD003313.

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
See Attachment A.
HCPCS Level II Code Number(s)

MEDICALLY NECESSARY

SUBCUTANEOUS IMMUNE GLOBULIN (SCIG)

J1555 Injection, immune globulin (cuvitru), 100 mg

J1558 Injection, immune globulin (xembify), 100 mg

J1559 Injection, immune globulin (Hizentra), 100 mg

J1561 Injection, immune globulin, (Gamunex/Gamunex-C/Gammaked), nonlyophilized (e.g., liquid), 500 mg

J1569 Injection, immune globulin, (gammagard liquid/gammagard liquid erc), non-lyophilized, (e.g., liquid), 500 mg

The following code is used to represent HyQvia:

J1575 Injection, immune globulin/hyaluronidase, 100 mg immuneglobulin

The following code are used to represent Cutaquig:

J1551 Injection, immune globulin (cutaquig), 100 mg


INTRAVENOUS IMMUNE GLOBULIN (IVIG)

J1459 Injection, immune globulin (Privigen), intravenous, non-lyophilized (e.g. liquid), 500 mg

J1552 Injection, immune globulin (alyglo), 500 mg

J1553 Injection, immune globulin (yimmugo), 100 mg

J1554 Injection, immune globulin (asceniv), 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 /Gamunex-C/Gammaked), non-lyophilized (e.g. liquid), 500 mg

J1568 Injection, immune globulin, (Octagam), intravenous, non-lyophilized (e.g. liquid), 500 mg

J1569 Injection, immune globulin, (gammagard liquid/gammagard liquid erc), non-lyophilized, (e.g., liquid), 500 mg

J1572 Injection, immune globulin, (Flebogamma/Flebogamma Dif), intravenous, nonlyophilized (e.g., liquid), 500 mg

J1576 Injection, immune globulin (panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mg

Q2052 Services, supplies and accessories used in the home for the administration of intravenous immune globulin (ivig)

S9338 Home infusion therapy, immunotherapy, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

The following code is used to represent GAMMAGARD S/D:

J1566 Injection, immune globulin, intravenous, lyophilized (e.g. powder), not otherwise specified, 500 mg


NOT ELIGIBLE FOR REIMBURSEMENT

THE FOLLOWING CODE REPRESENTS CARIMUNE NF WHICH IS NO LONGER MANUFACTURED AND HAS BEEN WITHDRAWN FROM THE MARKET:

J1566 Injection, immune globulin, intravenous, lyophilized (e.g. powder), not otherwise specified, 500 mg

Revenue Code Number(s)
N/A



Coding and Billing Requirements

Policy History

Revisions From M​A08.009z:
​​10/28/2026
​This policy has been reissued in accordance with the Company's annual review process. ​
07/01/2026

This version of the policy will become effective 07/01/2026.

The following HCPCS narrative has been revised in this policy:

FROM: J1569 Injection, immune globulin, (gammagard liquid), non-lyophilized, (e.g., liquid), 500 mg

TO: J1569 Injection, immune globulin, (gammagard liquid/gammagard liquid erc), non-lyophilized, (e.g., liquid), 500 mg​


Revisions From M​A08.009y:
04/01/2026

This version of the policy will become effective 04/01/2026​.

The following HCPCS code has been removed from this policy:
J1599 Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500 mg

The following HCPCS code has been added to this policy:
J1553 Injection, immune globulin (yimmugo), 100 mg​

Revisions From M​A08.009x:
01/01/2026

This version of the policy will become effective 01/01/2026.

The following HCPCS codes have been removed from this policy:

J1562 Injection, immune globulin (vivaglobin), 100 mg

J1572 Injection, immune globulin, (flebogamma/flebogamma dif), intravenous, non-lyophilized (e.g., liquid), 500 mg​

-----------------------------------------------------------------------------------------------------------------

On 01/13/2026, the policy was revised in reaction to CMS guidance to NOT delete HCPCS J1572.    

 

This policy has been identified for the HCPCS code update, effective 01/01/2026.

 

Th​e following HCPCS code has been added:

J1572 Injection, immune globulin, (flebogamma/flebogamma dif), intravenous, non-lyophilized (e.g., liquid), 500 mg      


Revisions From MA08.009w:
​12/10/2025
​This policy has been reviewed and reissued to communicate the Company’s continuing position on intravenous immune globulin (IVIG) and subcutaneous immune globulin (SCIG).​​
01/01/2025

This version of the policy will become effective 01/01/2025.


The following Healthcare Common Procedure Coding System (HCPCS) code has been added to this policy:

  • ​J1552 Injection, immune globulin (alyglo), 500 mg​

The following HCPCS code has been removed from this policy, which was used to represent immune globulin intravenous, human-stwk (Alyglo):

  • J1599 Injection, immune globulin, intravenous, nonlyophilized​ (e.g., liquid), not otherwise specified, 500 mg​​​

Revisions From ​MA08.009v:
10/01/2024

​This version of the policy will become effective 10/01/2024.


The following HCPCS codes have been termed (no longer valid codes) and removed from this policy:

C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites
C86.0 Extranodal NK/T-cell lymphoma, nasal type
C86.1 Hepatosplenic T-cell lymphoma
C86.2 Enteropathy-type (intestinal) T-cell lymphoma
C86.3 Subcutaneous panniculitis-like T-cell lymphoma
C86.4 Blastic NK-cell lymphoma
C86.5 Angioimmunoblastic T-cell lymphoma
C86.6 Primary cutaneous CD30-positive T-cell proliferations
C88.0 Waldenstrom macroglobulinemia
C88.2 Heavy chain disease
C88.3 Immunoproliferative small intestinal disease
C88.4 Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT-lymphoma]
C88.8 Other malignant immunoproliferative diseases

The following ICD-10 CM codes have been added to this policy:

C83.390, C83.398, C83.3A, C83.5A, C83.7A, C83.8A, C83.9A, C84.0A, C84.1A, C84.4A, C84.6A, C84.7B, C84.9A, C84.AA, C84.ZA, C85.1A, C85.2A, C85.8A, C85.9A, C86.00, C86.01, C86.10, C86.11, C86.20, C86.21, C86.30, C86.31, C86.40, C86.41, C86.50, C86.51, C86.60, C86.61, C88.00, C88.01, C88.20, C88.21, C88.30, C88.31, C88.40, C88.41, C88.80, C88.81, C88.90, C88.91

Revisions From ​MA08.009u:
05/06/2024

This version of the policy will become effective 05/06/2024​.


This policy has been revised to communicate the coverage position of intravenous immune globulin (IVIG) and subcutaneous immune globulin (SCIG).


New product, immune globulin intravenous, human-stwk​ (Alyglo) was added, represented by HCPCS code: J1599 Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500 mg​


Language regarding refill requirements for supplies was added to the Required Documentation Section of the Policy, per Noridian Medicare Local Coverage Determination (LCD): Intravenous Immune Globulin (L33610) effective 01/01/2024. ​


Attachment A: ICD-10 Diagnosis Codes

The following ICD-10 Diagnosis Codes have been added to this policy for IVIG:

E05.00  Thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm
E05.10  Thyrotoxicosis with toxic single thyroid nodule without thyrotoxic crisis or storm
E05.80  Other thyrotoxicosis without thyrotoxic crisis or storm
E05.81  Other thyrotoxicosis with thyrotoxic crisis or storm
E05.90  Thyrotoxicosis, unspecified without thyrotoxic crisis or storm
E05.91  Thyrotoxicosis, unspecified with thyrotoxic crisis or storm

​​

Attachment B: Dosing and Frequency: Added a new reference #242 from UpToDate.


Revisions From ​MA08.009t:
01/01/2024

This version of the policy will become effective 01/01/2024.


The following HCPCS code has been added to this policy:
Q2052 Services, supplies and accessories used in the home for the administration of intravenous immune globulin (ivig)

Revisions From ​MA08.009s:​
​01/01/2024

​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
02/05/2023

This version of the policy is retro-effective to 02/05/2023.


This policy has been revised to communicate the coverage position of intravenous immune globulin (IVIG) and subcutaneous immune globulin (SCIG), in accordance with Novitas Solutions, Inc.


  • Local Coverage Article (LCA) A56786 - Billing and Coding: Intravenous Immune Globulin (IVIG). Effective date 07/01/2023.
  • Local Coverage Determination (LCD) L35093 - Intravenous Immune Globulin (IVIG). [Novitas Solutions Web site]. Original 10/01/2015, Revised 02/05/2023.

The following ICD-10 CM codes have been added to this policy as Medically Necessary for IVIG AND SCIG:

D80.8 Other immunodeficiencies with predominantly antibody defects

D81.31 Severe combined immunodeficiency due to adenosine deaminase deficiency

D81.4 Nezelof's syndrome


The following ICD-10 CM codes have been added to this policy as Medically Necessary for IVIG:

C81.00, C81.01, C81.02, C81.03, C81.04,C81.05,C81.06, C81.07,C81.08, C81.09, C81.10, C81.11, C81.12, C81.13, C81.14, C81.15, C81.16, C81.17, C81.18, C81.19, C81.20, C81.21, C81.22, C81.23, C81.24, C81.25, C81.26, C81.27, C81.28, C81.29, C81.30, C81.31, C81.32, C81.33, C81.34, C81.35, C81.36, C81.37, C81.38, C81.39, C81.40, C81.41, C81.42, C81.43, C81.44, C81.45, C81.46, C81.47, C81.48, C81.49, C81.70, C81.71, C81.72, C81.73, C81.74, C81.75, C81.76, C81.77, C81.78, C81.79, C81.90, C81.91, C81.92, C81.93, C81.94, C81.95, C81.96, C81.97, C81.98, C81.99, C82.00, C82.01, C82.02, C82.03, C82.04, C82.05, C82.06, C82.07, C82.08, C82.09, C82.10, C82.11, C82.12, C82.13, C82.14, C82.15, C82.16, C82.17, C82.18, C82.19, C82.20, C82.21, C82.22, C82.23, C82.24, C82.25, C82.26, C82.27, C82.28, C82.29, C82.30, C82.31, C82.32, C82.33, C82.34, C82.35, C82.36, C82.37, C82.38, C82.39, C82.40, C82.41, C82.42, C82.43, C82.44, C82.45, C82.46, C82.47, C82.48, C82.49, C82.50, C82.51, C82.52, C82.53, C82.54, C82.55, C82.56, C82.57, C82.58, C82.59, C82.60, C82.61, C82.62, C82.63, C82.64, C82.65, C82.66, C82.67, C82.68, C82.69, C82.80, C82.81, C82.82, C82.83, C82.84, C82.85, C82.86, C82.87, C82.88, C82.89, C82.90, C82.91, C82.92, C82.93, C82.94, C82.95, C82.96, C82.97, C82.98, C82.99, C83.00, C83.01, C83.02, C83.03, C83.04, C83.05, C83.06, C83.07, C83.08, C83.09, C83.10, C83.11, C83.12, C83.13, C83.14, C83.15, C83.16, C83.17, C83.18, C83.19, C83.30, C83.31, C83.32, C83.33, C83.34, C83.35, C83.36, C83.37, C83.38, C83.39, C83.50, C83. 51, C83.52, C83.53, C83.54, C83.55, C83.56, C83.57, C83.58,C83.59, C83.70, C83.71, C83.72, C83.73, C83.74, C83.75, C83.76, C83.77, C83.78, C83.79, C83.80, C83.81, C83.82, C83.83, C83.84, C83.85, C83.86, C83.87, C83.88, C83.89, C83.90, C83.91, C83.92, C83.93, C83.94, C83.95, C83.96, C83.97, C83.98, C83.99, C84.00, C84.01, C84.02, C84.03, C84.04, C84.05, C84.06, C84.07, C84.08, C84.09, C84.10, C84.11, C84.12, C84.13, C84.14, C84.15, C84.16, C84.17, C84.18, C84.19, C84.40, C84.41, C84.42, C84.43, C84.44, C84.45, C84.46, C84.47, C84.48, C84.49, C84.60, C84.61, C84.62, C84.63, C84.64, C84.65, C84.66, C84.67, C84.68, C84.69, C84.70, C84.71, C84.72, C84.73, C84.74, C84.75, C84.76, C84.77, C84.78, C84.79, C84.7A, C84.A0, C84.A1, C84.A2, C84.A3, C84.A4, C84.A5, C84.A6, C84.A7, C84.A8, C84.A9, C84.Z0, C84.Z1, C84.Z2, C84.Z3, C84.Z4, C84.Z5, C84.Z6, C84.Z7, C84.Z8, C84.Z9, C84.90, C84.91, C84.92, C84.93, C84.94, C84.95, C84.96, C84.97, C84.98, C84.99, C85.11, C85.12, C85.13, C85.14, C85.15, C85.16, C85.17, C85.18, C85.19, C85.20, C85.21, C85.22, C85.23, C85.24, C85.25, C85.26, C85.27, C85.28, C85.29, C85.80, C85.81, C85.82, C85.83, C85.84, C85.85, C85.86, C85.87, C85.88, C85.89, C85.90, C85.91, C85.92, C85.93, C85.94, C85.95, C85.96, C85.97, C85.98, C85.99, C86.0, C86.1, C86.2, C86.3, C86.4, C86.5, C86.6, C88.0, C88.2, C88.3, C88.4, C88.8, D59.12, D59.13, D59.19, D89.834, G36.0, G72.81, G72.89, G93.49, H05.241, H05.242, H05.243, H46.9, I40.8, I40.9, L12.35, M32.11, M32.12, M32.13, M32.14, M32.15, M32.19, M33.03, M33.13, Z28.39, Z51.11, Z51.12, Z91.89, Z99.2


The following ICD-10 CM codes have been removed from this policy for IVIG:

C90.01, C91.11, D89.810, M60.80, M60.819, M60.829, M60.839, M60.849, M60.859, M60.869, M60.879, O36.0910, O36.0911, O36.0912, O36.0913, O36.0914, O36.0915, O36.0919, O36.0920, O36.0921, O36.0922, O36.0923, O36.0924, O36.0925, O36.0929, O36.0930, O36.0931, O36.0932, O36.0933, O36.0934, O36.0935, O36.0939, O36.0990, O36.0991, O36.0992, O36.0993, O36.0994, O36.0995, O36.0999


The coverage position for the following ICD-10 CM code has been revised from Noncovered to Medically Necessary for IVIG for:

G72.41 Inclusion body myositis [IBM]


The coverage position for the following ICD-10 CM code has been revised from Medically Necessary to Noncovered for IVIG for the following ICD-10 CM codes:

G62.81 Critical illness polyneuropathy

Z94.81 Bone marrow transplant status

Z94.84 Stem cells transplant status


The following ICD-10 CM codes have been added to this policy as Noncovered for IVIG:

​E71.520, E71.521, E71.522, E71.528, E71.529, D47.9, D89.810, G12.21, G54.0, G60.9, G61.89, G61.9​


Revisions From ​MA08.009r: 
07/01/2023
This version of the policy will become effective 07/01/2023.

The following NOC code has been removed from this policy and is replaced by the following HCPCS code:
  • Removed: J1599 Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500mg
  • Replaced With: J1576 Injection, immune globulin (panzyga), intravenous, non-lyophilized (e.g., liquid), 500 mg​

Revisions From ​MA08.009q:​
10/01/2022

This version of the policy will become effective 10/01/2022.

​
The following ICD-10 CM code has been termed (no longer valid codes) and removed from this policy for IVIG:
D68.0 Von Willebrand's disease

The following ICD-10 CM codes have been added to this policy for IVIG​:
D68.00 Von Willebrand disease, unspecified
D68.01 Von Willebrand disease, type 1
D68.020 Von Willebrand disease, type 2A
D68.021 Von Willebrand disease, type 2B
D68.022 Von Willebrand disease, type 2M
D68.023 Von Willebrand disease, type 2N
D68.029 Von Willebrand disease, type 2, unspecified
D68.03 Von Willebrand disease, type 3
D68.04 Acquired von Willebrand disease
D68.09 Other von Willebrand disease
I77.82 Antineutrophilic cytoplasmic antibody [ANCA] vasculitis

​The following ICD-10 CM code has been added to this policy for IVIG and SCIG: 
D81.82 Activated Phosphoinositide 3-kinase Delta Syndrome (APDS)​​​

Revisions From ​MA08.009p:
07/01/2022

This policy has been identified for the HCPCS code update, effective 07/01/2022.


The following NOC codes have been removed from this policy and are replaced by the following HCPCS code:
REMOVED: 
C9399 Unclassified drugs or biologicals
J7799 NOC drugs, other than inhalation drugs, administered through DME
REPLACED WITH: 
J1551 Injection, immune glo​bulin (cutaquig), 100 mg 

Revisions From ​MA08.009o:
01/31/2022This version of the policy will become effective 01/31/2022​.
​
This policy has been updated to communicate the coverage position for the following:

  • Claims for Carimune NF are not eligible for reimbursement, since it was withdrawn from the market. The HCPCS code will remain set up as eligible, since it also represents GAMMAGARD S/D​. (J1566 Injection, immune globulin, intravenous, lyophilized (e.g. powder), not otherwise specified, 500 mg​)​
  • Indications added per National Comprehensive Cancer Network (NCCN)
    • ​​NCCN Clinical Practice Guidelines in Oncology - Management of immune checkpoint inhibitor-related toxicities. V.3.2021. 05/14/2021. 
    • NCCN Drugs & Biologics Compendium. Immune globulin. [NCCN Web site]. 2021. Accessed September 1, 2021.
      • Acquired (secondary) hypogammaglobulinemia in oncologic conditions
      • Management of ​Immune checkpoint inhibitor-related toxicities
  • HIV-infected individuals to reduce baterial infection: timeframe of dosing expanded from every 28 days to every 2-4 weeks. 
  • CIDP policy critieria and Dosing & Frequency were updated in alignment with Noridian ​Medicare and Hizentra FDA labeling
Attachment B: ICD-10 DIAGNOSIS CODES​
The following Header was added: THIS IS NOT AN ALL INCLUSIVE LIST. 

REPORT THE MOST APPROPRIATE DIAGNOSIS CODE FOR TOXICITIES RELATED TO THE MANAGEMENT OF IMMUNE CHECKPOINT INHIBITOR TOXICITIES.


The following ICD-10 CM codes have been added to this policy for IVIG as Medically Necessary:

G04.81 Other encephalitis and encephalomyelitis

G04.89 Other myelitis

G04.90 Encephalitis and encephalomyelitis, unspecified

G04.91 Myelitis, unspecified

G37.3 Acute transverse myelitis in demyelinating disease of central nervous system

L13.9 Bullous disorder, unspecified

M60.80 - M60.89 Other myositis

M60.9   Myositis, unspecified

T80.90XA Unspecified complication following infusion and therapeutic injection, initial encounter

T80.90XD Unspecified complication following infusion and therapeutic injection, subsequent encounter

T80.90XS Unspecified complication following infusion and therapeutic injection, sequela


Revisions From ​MA08.009n:
04/01/2021

This policy has been identified for the HCPCS code update, effective 04/01/2021.


The following HCPCS code has been termed (no longer valid code) from this policy:

C9072 Injection, immune globulin (asceniv), 500 mg


The following HCPCS code has been removed from this policy to represent Asceniv (but will remain in the policy to represent Panzyga):​

J1599 Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500mg 


The following ICD-10 CM code has been added to this policy:

J1554 Injection, immune globulin (asceniv), 500 mg


Revisions From​ MA08.009m:
01/01/2021

This policy has been identified for the HCPCS code update, effective 01/01/2021.


The following ICD-10 CM code has been added to this policy:

C9072 Injection, immune globulin (asceniv), 500 mg​


Revisions From MA08.009l: 
10/12/2020HCPCS "J3590 Unclassified biologics" has been replaced with "J7799 NOC drugs, other than inhalation drugs, administered through DME​" to represent Cutaquig. This is in alignment with Billing Requirements for Medicare contractor, Noridian Healthcare Solutions​​. ​

Revisions From MA08.009k: 
10/01/2020

This policy has been identified for the ICD-10 CM code update, effective 10/01/2020.

The following ICD-10 CM code has been deleted for IVIG:

D59.1 Other autoimmune hemolytic anemias

 

The following ICD-10 CM code has been added for IVIG:

D59.11 Warm autoimmune hemolytic anemia 

​

Revisions From MA08.009j:
07/20/2020This version of the policy will become effective 07/20/2020.

This policy was updated to communicate the removal of the following indications:
    • Benign mucous membrane pemphigoid, with or without mention of ocular movement, due to Centers for Medicare and Medicaid Services (CMS) NCD 250.3.
    • Erythema multiforme major, due to terminology change

Revisions From MA08.009i:
07/01/2020This policy has been identified for the HCPCS code update, effective 07/01/2020.

The following NOC codes have been removed from this policy for Xembify and are replaced by the following HCPCS code:

REMOVED:
C9399 Unclassified drugs or biologicals
J3590 Unclassified biologics

REPLACED WITH:
J1558 Injection, immune globulin (xembify), 100 mg

Revisions From MA08.009h:
10/21/2019This policy was updated to communicate the Company's coverage criteria, including Dosing and Frequency, of the new SCIG product, Xembify.

Per CMS, "MM11295 – Update to Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home", additional primary immune deficiency diseases and codes were added to this policy for IVIG and SCIG.

Revisions From MA08.009g:
06/17/2019This Policy was revised with the following changes:
  • The following new SCIG product was added: Cutaquig
  • The following new IVIG products were added: AscenivTM, Panzyga®.
  • New FDA-approved indication for SCIG (e.g., Hizentra®) for CIDP was added.
  • New indication for IVIG, per Novitas L35093, for Systemic Capillary Leak Syndrome (SCLS) or Clarkson's Disease: IVIG is considered medically necessary and, therefore, covered in individuals with Systemic Capillary Leak Syndrome (SCLS) or Clarkson's Disease when associated with monoclonal gammopathy and used for prophylaxis to increase survival
  • Lambert-Eaton: plasma exchange was added an as example of prior therapies.
The following CPT codes were removed from the policy: 90283, 90284

Attachment B: Dosage and Frequency
    SCIG Section:
    PIDD Induction dosing was expanded from 100-150 mg/kg/weekly to 100-200 mg/kg/weekly.
    PIDD: Cutaquig dosing was added.
    CIDP: New Indication. Hizentra dosing was added.

    IVIG Section: Dosing and Frequency were added/adjusted for the following IVIG indications:
    Scleromyxedema
    Systemic Capillary Leak Syndrome (SCLS) or Clarkson's Disease
    Antibody-Mediated Rejection (AMR)
    Guillain-Barre syndrome
    Myasthenia gravis syndrome

Revisions From MA08.009f:
10/22/2018This version of the policy will become effective 10/22/2018.

This policy has been updated to include coverage changes, per Novitas Solutions, Inc., to:
  • Include the following subtypes of Primary Humoral Immunodeficiencies: Nonfamilial hypogammaglobulinemia, Selective deficiency of IgG subclasses, and Transient hypogammaglobulinemia of infancy
  • Add coverage criteria for antibody-mediated rejection (AMR), multiple myeloma, and Rh and ABO incompatibility
  • Clarify types of solid organs included in transplant coverage.

Revisions From MA08.009e:
01/01/2018This policy has been identified for the HCPCS code update, effective 01/01/2018.

The following NOC code has been removed from this policy and is replaced by the following HCPCS code:

REMOVED: J3590 Unclassified biologics
REPLACED WITH: J1555 Injection, immune globulin (cuvitru), 100 mg

Revisions From MA08.009d:
10/01/2017This policy has been identified for the ICD-10 CM code update, effective 10/01/2017.

The following ICD-10 CM codes have been added to this policy for IVIG only:

M33.03 Juvenile dermatomyositis without myopathy
M33.13 Other dermatomyositis without myopathy
M33.93 Dermatopolymyositis, unspecified without myopathy

The following ICD-10 CM narratives have been revised in this policy for IVIG only:

M33.00
FROM: Juvenile dermatopolymyositis, organ involvement unspecified
TO: Juvenile dermatomyositis, organ involvement unspecified

M33.01
FROM: Juvenile dermatopolymyositis with respiratory involvement
TO: Juvenile dermatomyositis with respiratory involvement

M33.02
FROM: Juvenile dermatopolymyositis with myopathy
TO: Juvenile dermatomyositis with myopathy

M33.09
FROM: Juvenile dermatopolymyositis with other organ involvement
TO: Juvenile dermatomyositis with other organ involvement

M33.10
FROM: Other dermatopolymyositis, organ involvement unspecified
TO: Other dermatomyositis, organ involvement unspecified

M33.11
FROM: Other dermatopolymyositis with respiratory involvement
TO: Other dermatomyositis with respiratory involvement

M33.12
FROM: Other dermatopolymyositis with myopathy
TO: Other dermatomyositis with myopathy

M33.19
FROM: Other dermatopolymyositis with other organ involvement
TO: Other dermatomyositis with other organ involvement

Revisions From MA08.009c:
12/28/2016This policy was updated to reflect current Medicare Policies. The new SCIG product, Cuvitru, was added to the Policy and to the Dosing and Frequency Attachment. In the Dosing and Frequency Attachment, Kawasaki disease was added to this attachment and Scleromyxedema was revised. In addition, extensive coding changes were made to reflect the Policy's covered indications; as such, the following codes have been removed from this policy: D80.3, T86.19, T86.298, T86.39, T86.49, T86.818, T86.898.

Revisions From MA08.009b:
03/01/2016This policy was updated to communicate the following changes:

New indications with Policy and Dosing criteria were added, per Novitas LCD L32712: Erythema multiforme major (Stevens-Johnson syndrome and toxic epidermal necrolysis), Scleromyxedema, and Systemic Lupus Erythematosus (SLE).

Product and Dosing criteria were added/updated per FDA labeling or peer-reviewed literature: Hizentra (SCIG), HyQvia (SCIG), Multiple sclerosis, CLL, and pediatric individuals with dermatomyositis or polymyositis.

Noncovered positions were added for the following indications, per Novitas LCD L35093: Immune Modulation of highly sensitized individuals prior to transplantation and the Treatment of inclusion body myositis.

Policy criteria were updated for the following indications, per Novitas LCD L32712: Multifocal Motor Neuropathy, Dermatomyositis and Polymyositis.

Policy and dosing criteria were updated for the following indications, per Novitas LCD L32712: Chronic refractory ITP and Myasthenia Gravis Syndrome. Antibody-mediated rejection (AMR) was removed as a covered indication.

Policy was updated for Vivaglobin, a SCIG product, that is no longer available; therefore, so longer eligible for reimbursement.

The coding table has been updated to reflect above criteria. ICD-9 codes were removed from this policy since as of 10/01/2015, ICD-10 codes are effective.

SCIG information was added to the Description Section.

The criteria for required documentation that must be kept regarding DME and Home Infusion related supplies was updated.

Revisions From MA08.009a:
01/01/2016This policy has been identified for the HCPCS code update, effective 01/01/2016.

The following HCPCS code has been added to this policy, as Medically Necessary:

J1575 Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immunoglobulin

Revisions From MA08.009:
01/01/2015This is a new policy.

7/1/2026
7/1/2026
10/28/2026
MA08.009
Medical Policy Bulletin
Medicare Advantage
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.