Cigna IVIG/SCIG Coverage & Prior Auth Update

Coverage Criteria for Immune Globulin (IVIG/SCIG)

inv-01: General Medical Necessity — Immune globulin products are considered medically necessary when BOTH of the following are met.

Immune globulin products are considered medically necessary when BOTH of the following are met:

General requirement: 1) Individual meets the Specific Medical Necessity Criteria by Condition (see condition sections I-VIII). 2) Non-Covered Product Criteria is met (refer to Non-Covered Product Table).

Applies to listed IVIG/SCIG products

inv-02: I. Primary Immunodeficiency Disorder (PID) - Hypogammaglobulinemia / CVID — Covered when ALL of the following are met.

Covered when ALL of the following are met:

PID - Hypogammaglobulinemia: Immunologic evaluation including documented serum IgG below the laboratory lower limit on at least two occasions; impaired antibody response defined as EITHER lack of protective antibody titers (tetanus and diphtheria or HiB) measured 3-4 weeks after immunization OR inadequate responsiveness to pneumococcal polysaccharide vaccine (Pneumovax 23) 4-8 weeks after vaccination per age-based thresholds (age <6 years: <50% serotypes protective; age ≥6 years: <70% serotypes protective); history of recurrent bacterial sinopulmonary infections requiring multiple courses or prolonged antibiotic therapy; evidence of management of underlying conditions and supporting diagnostics where applicable.IgG below lab lower limit; pneumococcal response thresholds per age

Includes CVID and related presentations

inv-03: I. PID - Other specific primary immunodeficiencies (IgG subclass deficiency, Selected specific PID, SAD) — Covered when the listed, condition-specific diagnostic and response criteria are met.

Covered when the listed, condition-specific diagnostic and response criteria are met:

IgG Subclass Deficiency: Normal total serum IgG with one or more IgG subclasses (excluding isolated IgG4) below the laboratory lower limit on at least two occasions; impaired antibody response with inadequate pneumococcal polysaccharide vaccine (Pneumovax 23) response per age thresholds (age <6 years: <50% serotypes protective; age ≥6 years: <70% protective); recurrent bacterial sinopulmonary infections requiring multiple courses or prolonged antibiotics; evidence of management of underlying conditions where applicable.subclass below lab lower limit; pneumococcal response thresholds per age

Selected Specific PID: One of the following: agammaglobulinemia defined as serum IgG <200 mg/dL; extremely low (<2%) or absent B cell count (CD19+); documentation of a recognized genetic defect supporting diagnosis; or transient hypogammaglobulinemia of infancy with serum immunoglobulins below age-specific normal range AND recurrent bacterial sinopulmonary infections (IVIG limited to up to 6 months before re-evaluation).IgG <200 mg/dL; B cells <2%

inv-04: II. Secondary Immunodeficiency — Covered when condition-specific criteria are met.

Covered when condition-specific criteria are met:

Acquired immunosuppression: Prevention of infection when severe hypogammaglobulinemia is present (serum IgG <400 mg/dL) and immunosuppression is attributed to major surgery (e.g., cardiac transplant), hematologic malignancy, extensive burns, or collagen-vascular disease.IgG <400 mg/dL

CLL: Treatment when serum IgG <500 mg/dL AND recurrent sinopulmonary infection or history of serious bacterial infection(s).IgG <500 mg/dL

Multiple Myeloma: A. Initial therapy: approve for 6 months if the patient has or is at risk of severe, recurrent infections OR is starting/has received CAR-T or bispecific antibody therapy, and the medication is prescribed by or in consultation with a hematologist/oncologist/infectious disease specialist. B. If currently receiving immune globulin: approve for 1 year.6 months initial; 1 year continuation

inv-05: III. Infectious Disease — Covered when the listed prophylaxis or treatment criteria are met.

Covered when the listed prophylaxis or treatment criteria are met:

Measles post-exposure prophylaxis: Prophylaxis when any of: pregnant women without evidence of measles immunity; severe primary immunodeficiency; bone marrow transplant recipients until ≥12 months post-immunosuppression (or longer with GVHD); individuals on ALL treatment within and until at least 6 months post-chemotherapy; AIDS/HIV with severe immunosuppression (CD4% <15% or CD4 <200) and no MMR since ART.CD4% <15% or CD4 <200

Toxic shock syndrome: Acute treatment when infection is refractory to aggressive treatment, has an undrainable focus, or persistent oliguria with pulmonary edema.

Tetanus/Varicella post-exposure: Use when specific immune globulin formulations (tetanus or varicella immune globulin) are unavailable for post-exposure prophylaxis or treatment.

inv-06: IV. Transplantation — Covered when criteria for transplant-related uses are met.

Covered when criteria for transplant-related uses are met:

BK viremia: Treatment of refractory BK viremia in kidney transplant recipients (persistent viral titers despite reduced immunosuppression).

HCT recipients: Prevention of infection in HCT recipients with hypogammaglobulinemia (serum IgG <400 mg/dL) AND either within the first 100 days post-transplant OR after 100 days with recurrent infections or graft-versus-host disease (GVHD).IgG <400 mg/dL; within 100 days or recurrent infections/GVHD

Solid organ transplant - desensitization: Desensitization therapy prior to and immediately after transplantation: authorization up to 2 g/kg monthly for 4 consecutive months; additional infusions at 12 and 24 months may be authorized if transplant not yet occurred.2 g/kg monthly x4 months

inv-07: V. Hematology — Covered when condition-specific criteria are met.

Covered when condition-specific criteria are met:

Anemia from Parvovirus B19: Treatment when severe refractory anemia with evidence of parvovirus B19 viremia in immunosuppressed patients.

Evan's Syndrome: Treatment when failure, contraindication, or intolerance to alternative therapies (azathioprine, cyclophosphamide, cyclosporine, prednisone).

Fetal Alloimmune Thrombocytopenia: Documentation of maternal antibodies to paternal platelet antigen AND one of: previous pregnancy complicated by FAIT (or other listed criteria).

Hepatitis C-associated thrombocytopenia: Treatment for clinically significant bleeding with thrombocytopenia, preoperative treatment prior to major surgery, or receiving antiviral treatment for hepatitis C.

inv-08: VI. Neurology - CIDP (including MADSAM) — Initial authorization: Approve for 3 months when ALL required elements are met.

Initial authorization: Approve for 3 months when ALL required elements are met:

CIDP initial criteria: Progressive or relapsing motor and/or sensory symptoms of more than one limb AND hyporeflexia or areflexia in affected limbs present for at least 2 months as documented by objective measurement; electrophysiologic findings indicating demyelinating neuropathy meeting at least 3 of 4 AAN criteria (partial conduction block in ≥1 motor nerve; reduced conduction velocity in ≥2 motor nerves; prolonged distal latency in ≥2 motor nerves; prolonged or absent F-waves in ≥2 motor nerves); exclusion of other causes of demyelinating neuropathy per EFNS/PNS guidance.symptoms ≥2 months; electrophysiology: 3 of 4 criteria

Definitions of electrophysiologic thresholds provided

inv-09: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) — Initial authorization — Approve for 3 months of treatment when ALL of the following required elements are met.

Approve for 3 months of treatment when ALL of the following required elements are met:

Electrophysiologic criteria: Electrophysiologic testing demonstrates demyelinating neuropathy with at least 3 of the following 4 AAN criteria: partial conduction block (≥1 motor nerve), reduced conduction velocity (≥2 motor nerves), prolonged distal latency (≥2 motor nerves), prolonged or absent F-wave latencies (≥2 motor nerves).3 of 4 electrophysiologic criteria

Includes AAN definitions for measurement thresholds

Exclusion of other causes: Other causes of demyelinating neuropathy have been excluded (examples include Lyme disease, diphtheria, drug/toxin exposure, hereditary demyelinating neuropathy, prominent sphincter disturbance, multifocal motor neuropathy, IgM monoclonal gammopathy with high-titer anti-MAG antibodies).

inv-10: Guillain–Barré Syndrome (GBS) — Acute treatment — Acute treatment when ALL of the following criteria have been met.

Acute treatment when ALL of the following criteria have been met:

GBS initial criteria: Initial treatment within 4 weeks of onset of symptoms; no concomitant use of plasmapheresis for the same treatment course; treatment may be repeated once but treatment courses should not extend beyond 8 weeks from symptom onset when repeated.initial treatment within 4 weeks; total treatment <= 8 weeks if repeated

inv-11: Myasthenia Gravis (MG) — Indications for treatment — Treatment when ANY of the following is present.

Treatment when ANY of the following is present:

MG indications: IVIG is indicated for: before planned thymectomy or during the post-operative period; during an acute crisis (e.g., significant dysphagia, respiratory failure) — treatment duration should not exceed 5 days; during initiation of immunosuppressive treatment; and for initial treatment of refractory myasthenia gravis when ALL prior therapy failures/intolerances are documented (pyridostigmine, corticosteroid maintenance failure/intolerance, failure of at least one nonsteroidal immunosuppressive agent, and failure/contraindication to thymectomy if AChR-positive).as specified

Refractory MG requires documented prior therapy failures

inv-12: Dermatomyositis/Polymyositis and Autoimmune Mucocutaneous Blistering Diseases — Condition-specific criteria for treatment.

Dermatomyositis/Polymyositis: Treatment when BOTH of the following are present; Autoimmune mucocutaneous blistering diseases: Treatment when EITHER criterion is met

Dermatomyositis/Polymyositis: Documented dermatomyositis or polymyositis established by biopsy AND either failure of standard medical therapy (corticosteroids AND immunosuppressives) OR profound, rapidly progressive and/or potentially life-threatening muscle weakness.

Octagam 10% has FDA indication for dermatomyositis in adults in described circumstances

Autoimmune mucocutaneous blistering diseases: Failure, contraindication, or intolerance of conventional therapy (corticosteroids, azathioprine, cyclophosphamide, mycophenolate mofetil) OR rapidly progressive disease where conventional agents cannot act quickly enough; IVIG limited to short-term therapy (no longer than 6 consecutive months) in these situations.max duration 6 months for IVIG

inv-13: Relapsing-Remitting Multiple Sclerosis (RRMS) — Treatment as a single agent when there is failure to any TWO of the following products.

Treatment as a single agent when there is failure to any TWO of the following products:

RRMS prior therapy failure: Failure to any two listed disease-modifying therapies (dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta-1a or beta-1b, natalizumab, teriflunomide).failure to 2 agents

IVIG considered after these failures; reserved per step therapy guidance

inv-14: Kawasaki disease — Acute treatment criteria.

Acute treatment

Kawasaki acute therapy: IVIG given in conjunction with aspirin within ten days of onset of symptoms; recommended initial single IV dose of 2 g/kg (AHA/AAP guidance).within 10 days of onset; dose 2 g/kg

inv-15: Reauthorization Criteria (general) — Continuation of immune globulin therapy is considered medically necessary when ALL of the following are met.

Continuation of immune globulin therapy is considered medically necessary when ALL of the following are met:

Reauthorization general: 1) Initial medical necessity criteria were met prior to therapy initiation; 2) Condition not fully resolved and treatment duration has not exceeded applicable limits; 3) Sustained beneficial response documented by treatment notes or clinical narrative; 4) Requested frequency and dose supported by evidence-based literature; 5) Where appropriate, titration to the minimum effective dose and frequency has been attempted.

Applies to all covered diagnoses

inv-16: IVIG for prevention of infections in HCT recipients — Covered when ALL of the following are met.

Covered when ALL of the following are met

HCT prophylaxis: Adult or adolescent HCT recipients (allogeneic or autologous): prevention of infections in those with severe hypogammaglobulinemia (serum IgG <400 mg/dL) during the first 100 days after HCT; pediatric allogeneic HCT recipients with severe hypogammaglobulinemia during first 100 days. For prevention beyond 100 days, IVIG indicated for recipients with serum IgG <400 mg/dL and recurrent infections or GVHD. Dosing individualized to maintain trough IgG >400-500 mg/dL (adult/adolescent 0.5 g/kg per week during first 100 days; pediatric allogeneic 0.4 g/kg per month adjusted to keep IgG >400 mg/dL; >100 days dosing 0.5 g/kg every 3-4 weeks).IgG < 400 mg/dL; target trough >400-500 mg/dL

Adjust dosing to maintain trough IgG >400-500 mg/dL

inv-17: IVIG as adjunctive therapy for CMV pneumonitis — Guideline-based adjunctive use.

Guideline-based adjunctive use

CMV pneumonitis adjunctive therapy: IVIG may be used as adjunctive therapy for CMV pneumonitis in cancer or transplant-related infection per NCCN guidance, typically alongside antiviral agents; IVIG use as an antiviral is controversial and not routinely supported as sole antiviral therapy.

Use alongside antivirals (e.g., ganciclovir, foscarnet)

inv-18: IVIG for Guillain-Barré syndrome (GBS) — Covered when ANY of the following guideline conditions are met.

Covered when ANY of the following guideline conditions are met

GBS indications: IVIG recommended for patients who require aid to walk within 2 or 4 weeks from onset per AAN; EAN/PNS recommends IVIG or plasma exchange up to 4 weeks after onset. Repeated course may be effective for treatment-related fluctuation.<=4 weeks from onset for primary course

For patients >4 weeks and still deteriorating, consider alternate diagnoses

inv-19: IVIG for myasthenia gravis — Covered when ANY of the following conditions are met.

Covered when ANY of the following conditions are met

Myasthenia gravis indications: International consensus guidance supports IVIG for certain MG scenarios: short-term treatment for life-threatening effects (respiratory insufficiency or dysphagia), to prepare for surgery in patients with bulbar dysfunction, when a rapid response is needed, when other treatments are inadequate, or before starting corticosteroids to prevent exacerbation. IVIG may be considered as maintenance in refractory disease or when immunosuppressives are contraindicated. Typical initial dosing example: 2 g/kg divided over 2-5 days; maintenance 0.4–1 g/kg every 4 weeks.

Document prior therapies and indication

inv-20: IVIG for MOGAD (acute and maintenance) — Covered when ALL of the following are met.

Covered when ALL of the following are met

MOGAD treatment: Typical acute IVIG dose is 0.4 g/kg/day for 5 days. Maintenance therapy may be offered for patients with two or more attacks or when needed to prevent further disability; loading dose 0.4 g/kg/day for 5 days followed by maintenance every 4 weeks at 0.4 g/kg to 2 g/kg as clinically indicated. Exclude multiple sclerosis before diagnosing MOGAD.

inv-21: IVIG for passive immunization / post-exposure prophylaxis — Covered when ALL of the following are met.

Covered when ALL of the following are met

Measles post-exposure: IG/IVIG used within 6 days of exposure to prevent or modify measles in nonimmune high-risk patients; IVIG 400 mg/kg is recommended for pregnant women and severely immunocompromised persons.administration within 6 days of exposure; dose 400 mg/kg

Infants 6-11 months may receive MMR within 72 hours instead of IG

Varicella/tetanus post-exposure: VariZIG indicated for high-risk individuals (e.g., HIV-infected children lacking immunity); alternative is oral antivirals or IVIG within 10 days if VariZIG unavailable. If tetanus immune globulin is unavailable, immune globulin 200–400 mg/kg may be used.VariZIG/IVIG within 10 days for varicella; tetanus IG alternative 200-400 mg/kg

inv-22: IVIG for hematologic and immunodeficiency-related thrombocytopenia — Covered when ANY of the following guideline conditions are met.

Covered when ANY of the following guideline conditions are met

Secondary ITP (HIV/HCV): ASH guidelines recommend initial treatment options including corticosteroids, IVIG, or Rh0(D) immune globulin for secondary ITP due to HIV; IVIG is also recommended for secondary ITP associated with Hepatitis C. Document underlying infection and therapies tried or considered.

inv-23: IVIG for other neurologic and neuromuscular conditions — Covered when guideline-recommended conditions are met.

Covered when guideline-recommended conditions are met

Other neurologic and neuromuscular conditions: Guidelines recommend IVIG for CIDP, GBS, and other immune-mediated neuropathies; objective measures (MRC Sum Score, grip strength measured by hand-held dynamometer/Vigorimeter, INCAT sensory sum score) can be used to assess response for reauthorization. IVIG is reserved for conditions per guideline recommendations (e.g., Stiff-Person Syndrome after failure of symptomatic therapy).

MRC range 0-60; INCAT 0-20

inv-24: IVIG for hematologic neoplasm-associated hypogammaglobulinemia and post-CAR-T — Covered when ALL of the following are met.

Covered when ALL of the following are met

Secondary immunodeficiency after B-cell therapies/CAR-T: After B-cell targeted therapies or CAR-T, consider IVIG replacement for patients with serum IgG <400–600 mg/dL and serious or recurrent infections; document CAR-T or B-cell therapy, IgG level, and infection history.IgG <400-600 mg/dL with serious or recurrent infections

Follow specialty guidance (NICE/NHS, NCCN)

inv-25: IVIG for parvovirus B19-related pure red cell aplasia in immunosuppressed patients — Covered when ALL of the following are met.

Covered when ALL of the following are met

Parvovirus B19 (immunosuppressed): In immunosuppressed patients lacking neutralizing antibodies with persistent parvovirus B19 infection causing pure red cell aplasia, IVIG can be used; recommended treatment course per reviews and transplant guidance is 200–400 mg/kg/day for 5–10 days. Document persistent viremia and immunosuppressed status.documented persistent B19 infection and immunosuppression

Document prior specific therapies if applicable

inv-26: Objective measurement and multifocal motor neuropathy diagnostic criteria — Covered when ALL of the following are met for CIDP reauthorization assessment.

Covered when ALL of the following are met for CIDP reauthorization assessment:

Objective measurement documentation: Documented objective measurements demonstrating clinical response or status using validated tools: MRC Sum Score, grip strength measured by hand-held dynamometer (e.g., Jamar, Vigorimeter), and INCAT sensory sum score.MRC range 0-60; INCAT 0-20

These tools have demonstrated good clinimetric properties in immune-mediated polyneuropathies

Multifocal motor neuropathy - definite criteria: Clinical: weakness without objective sensory loss in ≥2 named nerves; Electrophysiology: definite conduction block in ≥2 non-entrapment nerves; normal sensory nerve conduction across same segments; normal sensory nerve conduction studies on all tested nerves (minimum three); absence of upper motor neuron signs.

Used to establish diagnosis supporting IVIG coverage

Multifocal motor neuropathy - probable criteria:

Certain IVIG/SCIG products are treated as non‑covered under Employer Group and Individual and Family Plan rules unless product‑specific criteria are met. For example, for Alyglo and Asceniv the prescriber must document either: (A) a prior trial of three enumerated alternative IVIG/SCIG products (e.g., Bivigam, Flebogamma DIF, Gammagard Liquid, Gammaked, Gammaplex, Gamunex‑C, Octagam, Panzyga, Privigen), or (B) a prescriber‑documented clinical justification such as the need for minimal XIa content or elevated RSV antibody levels. Similar product‑specific step requirements apply for other listed non‑covered products (see Non‑Covered Product Table).

Any use of immune globulin not explicitly supported by the policy’s condition‑specific criteria is considered not medically necessary. The policy lists examples of conditions considered not medically necessary for IVIG/SCIG, including Hashimoto encephalopathy, inclusion body myositis, Lyme neuropathy, neonatal sepsis, PANS/PANDAS, primary progressive and secondary progressive multiple sclerosis (including acute MS exacerbations and clinically isolated syndrome), and recurrent pregnancy loss.

Some primary immunodeficiency syndromes do not routinely require IVIG replacement. The policy notes that selected genetic PIDs and related conditions — for example, certain selective IgG subclass deficiencies, transient hypogammaglobulinemia of infancy, and some presentations of SCID or other genetic PIDs — generally do not require IVIG replacement for control of recurrent bacterial infections unless there is documentation of rare clinical susceptibility, abnormal vaccine responses, or a specific short‑term clinical need (e.g., transient hypogammaglobulinemia requiring short‑term IVIG).

Administrative updates to plan‑level product preferences and coding were made in recent revisions. The policy documents removal or modification of certain preferred product requirements (for example, changes affecting HyQvia and Gammagard Liquid) and restates that providers must follow plan‑specific preferred product guidance and exception criteria when selecting products. Refer to the plan’s Preferred Product Table for current requirements.

Claims and authorization requests must include covered diagnosis and procedure codes appropriate for the requested service. Per the policy instructions, services billed without covered diagnosis or procedure codes under this Coverage Policy will be denied as not covered. Use the most appropriate and current codes when submitting claims.

Uses listed under the policy’s 'Conditions Not Covered' section are considered not medically necessary and are subject to denial. Examples include conditions such as Hashimoto encephalopathy, inclusion body myositis, Lyme neuropathy, neonatal sepsis, PANS/PANDAS, progressive forms of multiple sclerosis, and recurrent pregnancy loss. Claims for these indications should not be submitted as covered IVIG/SCIG services.

The policy highlights that use of IVIG as a primary antiviral agent is controversial and is not routinely supported as standalone antiviral therapy. For example, NCCN guidance lists IVIG as an adjunctive therapy for CMV pneumonitis in cancer or transplant patients, but notes that IVIG’s antiviral role is controversial; standard antiviral agents (e.g., ganciclovir, foscarnet) are the mainstay of treatment and IVIG, if used, should be adjunctive. Documentation should support any adjunctive rationale.

Terminology in the policy has been updated: conditions formerly described as 'experimental, investigational, or unproven' are now categorized as not medically necessary. This change aligns coverage language with the policy’s updated exclusion and denial terminology.

Codes and Clinical Thresholds

IVIG/SCIG Products (listed)mixed

Cutaquig	immune globulin subcutaneous 16.5% solution
Cuvitru	immune globulin subcutaneous 20% solution
Gamunex-C	immune globulin injection caprylate/chromatography purified
Hizentra	immune globulin subcutaneous 20% liquid
Xembify	immune globulin subcutaneous 20% solution

Considered Medically Necessary HCPCSHCPCSCovered

90283	Immune globulin (IgIV), human, for intravenous use
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each

Ambulatory Pump and Selected HCPCSHCPCSCovered

E0779	Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater
E0781	Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient

J‑Code Immune Globulin Products (part 1)HCPCSCovered

J1459	Injection, immune globulin (Privigen), intravenous, non-lyophilized, 500 mg
J1551	Injection, immune globulin (Cutaquig), 100 mg
J1552	Injection, immune globulin (Alyglo), 500 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, 500 mg
J1558	Injection, immune globulin (Xembify), 100 mg
J1559	Injection, immune globulin (Hizentra), 100 mg
J1561	Injection, immune globulin (Gamunex/Gamunex-C/Gammaked), non-lyophilized, 500 mg

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J‑Code Immune Globulin Products (part 2)HCPCSCovered

J1568	Injection, immune globulin (Octagam), intravenous, non-lyophilized, 500 mg
J1569	Injection, immune globulin (Gammagard liquid), non-lyophilized, 500 mg
J1572	Injection, immune globulin (Flebogamma/Flebogamma DIF), intravenous, non-lyophilized, 500 mg
J1575	Injection, immune globulin/hyaluronidase, 100 mg immunoglobulin
J1576	Injection, immune globulin (Panzyga), intravenous, non-lyophilized, 500 mg

HCPCS coding updatesHCPCS

J1552	Added (effective 1/1/2024) — Alyglo (see revision notes)
J1599	Removed (per revision history)

ICD-10-CM additionsICD-10

T45.AX5A	Added (effective 10/1/2024)
T45.AX5D	Added (effective 10/1/2024)
T45.AX5	Added (effective 10/1/2024)

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for IVIG/SCIG products listed in this policy. Initial authorization duration is generally up to 6 months unless a condition-specific criterion states otherwise (e.g., CIDP initial approval up to 3 months). Reauthorization approvals are generally up to 6 months (up to 12 months for CIDP, primary immunodeficiency disorders, and refractory myasthenia gravis) when reauthorization criteria are met.

Initial authorization: up to 6 months unless otherwise stated (CIDP initial = up to 3 months).
Reauthorization: up to 6 months; up to 12 months for CIDP, PID, and refractory MG.

Denial Risk

Prior Authorization Requirement and Denial Triggers

Prior authorization requests must document the medical indication, relevant supporting guideline recommendation or clinical rationale, and pertinent immunoglobulin laboratory data (see below). Denials may be issued if documentation does not support the requested use or if the request is for an indication listed under 'Conditions Not Covered'.

Background and Scope

Intravenous (IVIG) and subcutaneous (SCIG) immune globulin products are concentrated human immunoglobulin preparations, predominantly IgG, and are used across a broad range of clinical contexts. Indications covered by condition‑specific criteria include primary and secondary immunodeficiency (replacement therapy), prophylaxis or treatment of selected infections (including post‑exposure measles prophylaxis), supportive uses in transplantation (e.g., HCT prophylaxis, desensitization, treatment of antibody‑mediated rejection), hematology indications (e.g., immune thrombocytopenia, parvovirus B19‑related pure red cell aplasia), and a variety of immune‑mediated neurologic and neuromuscular disorders (e.g., Guillain–Barré syndrome, CIDP, myasthenia gravis, MOGAD). The policy specifies laboratory thresholds (for example, serum IgG < 400 mg/dL in certain HCT contexts), vaccine response criteria, objective diagnostic requirements, and condition‑specific authorization durations and dosing considerations.

Definitions and Diagnostic Thresholds

Electrophysiologic definitions (CIDP) — partial conduction block

Partial conduction block — AAN definitionA drop of ≥20% in negative peak area or peak‑to‑peak amplitude with a change of <15% in duration between proximal and distal stimulation sites

Temporal dispersion notePossible conduction block/temporal dispersion = ≥20% drop in negative peak area or amplitude with ≥15% change in duration

Use in CIDP diagnosisPartial conduction block count (≥1 motor nerve) is one of 4 electrophysiologic criteria used to support CIDP diagnosis

Inadequate pneumococcal vaccine response

Inadequate pneumococcal vaccine response — age <6 years<50% of serotypes protective (≥1.3 mcg/mL per serotype) at 4–8 weeks post‑Pneumovax®23

Inadequate pneumococcal vaccine response — age ≥6 years

Policy Update History

2026-03-01Policy revisionLatest

Annual revision with multiple selected updates including prior HCPCS and ICD-10 changes summarized in prior entries; policy effective date set to 2026-03-01.

2025-11-01Preferred product update

Removed preferred product requirements for HyQvia and updated preferred product criteria for Gammagard Liquid in employer and individual/family plans.

2025-10-01

OpenPayer

Immune Globulin (IVIG/SCIG) Coverage Criteria

Coverage Criteria for Immune Globulin (IVIG/SCIG)

Codes and Clinical Thresholds

Provider Requirements, Prior Authorization, and Billing

Background and Scope

Definitions and Diagnostic Thresholds

Policy Update History