ModifiedUnitedHealthcarePolicy CS2026D0035XY

Immune Globulin (IVIG and SCIG)

Medical benefit drug policy governing use of intravenous and subcutaneous immune globulin products for covered indications and product-preference rules for UnitedHealthcare Community Plan; affects providers submitting requests for IVIG/SCIG in applicable states.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy CS2026D0035XY

Change TypeHCPCS code updatestate applicability change

Effective DateApril 1, 2026

Next Review Date

Key ActionSubmit diagnosis, supporting medical records/labs, and prescriber attestation when requesting initial or continuation authorization.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable HCPCS codes to reflect quarterly edits; added J1553.

Removed content/language pertaining to the state of Louisiana.

Archived previous policy version CS2026D0035XX.

~30pages (TOC)

12states with preferred product criteria

12 monthsauth duration max

J1553 addedHCPCS change

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage criteria and medically necessary indications

Intravenous Immune Globulin Preferred Product Criteria

Cutaquig (non-preferred SCIG) is medically necessary when ONE of the following groups is met:

ANY of the following

Both of the following:
- History of a trial of adequate dose and duration of at least one of the following preferred SCIG products, resulting in minimal clinical response (provider must submit information regarding drug, dose, and duration of therapy): Cuvitru, Hizentra, HyQvia, or Xembify.
- Physician attests that, in their clinical opinion, the clinical response with Cutaquig would be expected to be superior to that experienced with the preferred SCIG products.
Both of the following:
- History of contraindication, intolerance, or severe adverse event to all preferred SCIG products not previously tried (provider must submit information regarding drug, dose, and duration of therapy): Cuvitru; and Hizentra; and HyQvia; and Xembify.
- Physician attests that, in their clinical opinion, the same contraindication, intolerance, or severe adverse event would not be expected to occur with Cutaquig.

type":"criteria_group"},{

citations

Alyglo, Asceniv, Panzyga, or Yimmugo (non-preferred IVIG) is medically necessary when ONE of the following groups is met:

ANY of the following

Both of the following:
- History of a trial of adequate dose and duration of at least two other IVIG products, resulting in minimal clinical response. Alternative IVIG options include, but are not limited to, Bivigam, Gammagard, Gamunex, Privigen (provider must submit information regarding drug, dose, and duration of therapy).
- Physician attests that, in their clinical opinion, the clinical response with Alyglo, Asceniv, Panzyga, or Yimmugo would be expected to be superior to that experienced with other IVIG products.
Both of the following:
- History of contraindication, intolerance, or severe adverse event to all other IVIG products not previously tried (alternative IVIG options include, but are not limited to, Bivigam, Gammagard, Gamunex, Privigen) (provider must submit information regarding drug, dose, and duration of therapy).

Immune globulin is proven and medically necessary for the following disease-specific indications when ALL specified criteria are met:

ALL of the following

Dermatology
- Diagnosis of an autoimmune bullous disease (e.g., pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita, pemphigoid gestationis, linear IgA bullous dermatosis).
- Extensive and debilitating disease.
- History of failure, contraindication, or intolerance to systemic corticosteroids with concurrent immunosuppressive treatment (e.g., azathioprine, cyclophosphamide, mycophenolate mofetil).
Hematology
- Feto-neonatal alloimmune thrombocytopenia (AIT): For pregnant women — diagnosis of AIT and one or more of previously affected pregnancy, family history, or platelet alloantibodies on screening; For newborns — diagnosis of AIT and thrombocytopenia that persists after transfusion of antigen‑negative compatible platelets.

Multiple myeloma, prevention of infection in multiple myeloma — Covered when ALL of the following are met

Measles (rubeola) post-exposure prophylaxis — Covered when ALL of the following are met:

ALL of the following

Patient has been exposed to measles (rubeola) less than 6 days previously.
Patient weight is greater than 30 kg (for patients ≤ 30 kg, administer intramuscular immune globulin).
Patient is a nonimmune or severely immunocompromised individual who is not already receiving immune globulin therapy; examples include: pregnant woman without evidence of measles immunity; HSCT recipient who finished immunosuppressive treatment within 12 months; HSCT recipient with chronic GVHD; patient who received CAR T therapy within 12 months; patient with ALL completing or within 6 months of chemotherapy; patient with HIV and severe immunosuppression (CD4% < 15% for all ages or CD4 < 200 cells/mm3 for age > 5); or patient with a primary immunodeficiency.
Request is for an initial, one-time dose not to exceed 400 mg/kg.

Multiple myeloma, prevention of infection in multiple myeloma — Covered when ALL of the following are met:

ALL of the following

Diagnosis of multiple myeloma.
Documented hypogammaglobulinemia (IgG < 500 mg/dL) or history of bacterial infection(s) associated with multiple myeloma.

Post B-cell targeted therapy prevention — Covered when ALL of the following are met:

ALL of the following

Documentation confirming previous treatment with B-cell targeted therapy within the last 100 days (e.g., CAR‑T, rituximab, inotuzumab ozogamicin).
Both of the following: documented hypogammaglobulinemia (IgG < 500 mg/dL); and history of bacterial infection(s) associated with B‑cell depletion.

Chronic inflammatory demyelinating polyneuropathy (CIDP) — Initial therapy covered when ALL of the following are met

ADEM treatment — Covered when BOTH of the following are met:

ALL of the following

Diagnosis of acute disseminated encephalomyelitis (ADEM).
History of failure, contraindication, or intolerance to intravenous glucocorticoids.

paragraphs[]

title":"","type":"criteria_group"},{

citations

Chronic inflammatory demyelinating polyneuropathy (CIDP) — Initial therapy covered when ALL of the following are met:

ALL of the following

Diagnosis of CIDP confirmed by: progressive symptoms present for at least 2 months; symptomatic polyradiculoneuropathy with motor or sensory impairment of more than one limb; and electrodiagnostic findings consistent with EFNS/PNS criteria (e.g., motor distal latency prolongation in 2 nerves; reduction of motor conduction velocity in 2 nerves; prolongation or absence of F‑waves; partial motor conduction block; abnormal temporal dispersion; distal CMAP duration increase).
Prescribed by or in consultation with a neurologist.

Encephalitis, immune checkpoint inhibitor-induced — Covered when ALL of the following are met:

ALL of the following

Diagnosis of encephalitis, immune checkpoint inhibitor–induced, severe or progressive.
History of failure, contraindication, or intolerance to glucocorticoids (e.g., methylprednisolone).
The use of the immune checkpoint inhibitor has been interrupted.
Prescribed by or in consultation with a neurologist.

Guillain-Barré syndrome (GBS) — Covered when ALL of the following are met:

ALL of the following

Diagnosis of Guillain‑Barré syndrome (GBS).
Severe disease requiring aid to walk.
Onset of neuropathic symptoms within the last 4 weeks.
Prescribed by or in consultation with a neurologist.

Lambert-Eaton myasthenic syndrome (LEMS) — Covered when ALL of the following are met:

ALL of the following

Diagnosis of LEMS.
History of failure, contraindication, or intolerance to immunomodulator monotherapy (e.g., azathioprine, corticosteroids).
Concomitant immunomodulator therapy will be used for long‑term management of LEMS unless contraindicated.
Prescribed by or in consultation with a neurologist.

Lennox Gastaut syndrome — Covered when ALL of the following are met:

ALL of the following

History of failure, contraindication, or intolerance to initial treatment with traditional antiepileptic pharmacotherapy (e.g., lamotrigine, phenytoin, valproic acid).
Prescribed by or in consultation with a neurologist.

Relapsing forms of multiple sclerosis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing‑remitting MS, secondary‑progressive MS with relapses, progressive‑relapsing MS with relapses).
Documentation of an MS exacerbation or progression (worsening) of the patient's clinical status from the visit prior to the one prompting the decision to initiate immune globulin therapy.
History of failure, contraindication, or intolerance to at least two of the following agents (used in adequate doses and duration): interferon β‑1a, interferon β‑1b, glatiramer acetate, dimethyl fumarate, teriflunomide, fingolimod, peginterferon beta‑1a, natalizumab, ocrelizumab, rituximab, siponimod, ozanimod, ofatumumab, monomethyl fumarate, cladribine, ublituximab, ponesimod.
Prescribed by or in consultation with a neurologist.

Myasthenia gravis (exacerbation and refractory) — Covered when ALL of the following are met:

Myasthenia gravis — Exacerbation

ALL of the following
- Diagnosis of generalized myasthenia gravis.
- Evidence of myasthenic exacerbation defined by at least one of: difficulty swallowing; acute respiratory failure; major functional disability causing discontinuation of physical activity; or recent immunotherapy with a checkpoint inhibitor.
- Either history of failure/contraindication/intolerance to immunomodulator therapy for long‑term management, or currently receiving immunomodulator therapy for long‑term management.
- Prescribed by or in consultation with a neurologist.
Myasthenia gravis — Refractory

Neuromyelitis optica spectrum disorder (NMOSD) — Initial therapy covered when ALL of the following are met:

ALL of the following

Diagnosis of NMOSD by a neurologist with serologic testing for anti‑aquaporin‑4 immunoglobulin G (AQP4‑IgG)/NMO‑IgG antibodies performed.
Past medical history consistent with NMOSD (if AQP4‑IgG positive one feature; if negative, two features) such as optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy/diencephalic syndrome, or symptomatic cerebral syndrome with NMOSD‑typical lesions; and other diagnoses (e.g., multiple sclerosis) have been ruled out.
History of failure, contraindication, or intolerance to at least three of: azathioprine, corticosteroids, mycophenolate mofetil, complement inhibitors (eculizumab, ravulizumab), anti‑IL6 therapy (tocilizumab, satralizumab), anti‑CD19 therapy (inebilizumab), anti‑CD20 therapy (rituximab).
Patient is not receiving immune globulin in combination with disease‑modifying therapies for MS, complement inhibitors, anti‑IL6, anti‑CD19, or anti‑CD20 therapies.

Rasmussen syndrome — Covered when ANY one of the following is met:

ANY of the following

Short‑term amelioration of encephalitis is needed prior to definitive surgical therapy.
Disease symptoms (e.g., seizures) persist despite surgical treatment.
The patient is not a candidate for surgical treatment.

Stiff‑person syndrome — Initial therapy covered when ALL of the following are met:

ALL of the following

Diagnosis of stiff‑person syndrome.
History of failure, contraindication, or intolerance to GABAergic medication (e.g., baclofen, benzodiazepines).
Prescribed by or in consultation with a neurologist.

Primary immunodeficiency syndromes — Covered when BOTH of the following are met:

ALL of the following

Diagnosis of a primary immunodeficiency (refer to disease list).
Clinically significant functional deficiency of humoral immunity evidenced by documented failure to produce antibodies to specific antigens or history of significant recurrent infections.

Dermatomyositis or polymyositis — Covered when ALL of the following are met:

ALL of the following

Diagnosis of dermatomyositis or polymyositis.
History of failure, contraindication, or intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate).

Kawasaki disease — Covered when BOTH of the following are met:

ALL of the following

Diagnosis of Kawasaki disease.
IVIG treatment does not exceed five consecutive days.

Allogeneic bone marrow transplantation (BMT) — Covered when ALL of the following are met:

ALL of the following

One of the following uses: prevention of acute graft‑versus‑host disease (GVHD) or prevention of infection.
Confirmed allogeneic bone marrow transplant within the last 100 days.
Documented severe hypogammaglobulinemia (IgG < 400 mg/dL).

Medically accepted indications — Covered when supported by FDA approval, practice guidelines, evidence reviews, or randomized trials for the following indications and clinical scenarios:

ANY of the following

Infectious and infection‑related indications with supporting guidance (e.g., CMV pneumonitis post‑transplant, prevention of bacterial infections in hypogammaglobulinemia associated with CLL or multiple myeloma, prevention in pediatric HIV).
Neuroimmunologic indications and therapy sequence supported by guidelines or trials (e.g., CIDP, GBS, MMN, LEMS, MG exacerbations, Lennox‑Gastaut, Rasmussen syndrome, stiff‑person syndrome).
Hematology indications supported by guidelines/trials (e.g., fetal‑neonatal alloimmune thrombocytopenia, ITP, posttransfusion purpura, warm AIHA as adjunct).

Post‑exposure prophylaxis and infection prevention — Infection‑related and prophylactic use covered when criteria below are met:

ANY of the following

Measles (rubeola) PEP criteria as specified in the Measles PEP group above.
Prevention of infection in CLL or multiple myeloma with documented hypogammaglobulinemia or history of bacterial infections.
Prevention of infection after recent B‑cell targeted therapy when documented therapy within 100 days, IgG < 500 mg/dL, and history of bacterial infections.

Neuroimmunologic indications and therapy sequence — Neuroimmunologic disease use and sequencing covered when criteria below are met:

ANY of the following

CIDP, GBS, MMN, LEMS, MG exacerbation/refractory, NMOSD initial therapy (as specified above) — all requiring neurologist involvement and prior failure/intolerance to first‑line therapies where noted.
ADEM treatment when steroids are contraindicated or ineffective; encephalitis due to checkpoint inhibitors when steroids fail and checkpoint inhibitor interrupted; Rasmussen short‑term use prior to or in lieu of surgery.

Hematology indications — Covered when supported by diagnosis, severity, or failure of first‑line therapy:

ANY of the following

Fetal‑neonatal alloimmune thrombocytopenia — prenatal and neonatal criteria as above.
ITP acute/chronic criteria as above (platelet thresholds, prior therapies).
Posttransfusion purpura — limited IVIG course (≤2 days).
Warm AIHA — adjunct use after failure of steroids and other agents and ongoing transfusion dependence.

Applicable procedure, HCPCS/J-, and diagnosis codes

Immune globulin product listmixed

Alyglo	IV non-preferred product listed
Asceniv	IV non-preferred product listed
Bivigam	IV product listed
Cutaquig	SC non-preferred product listed
Cuvitru	SC preferred product listed
Flebogamma DIF	IV product listed
Gammagard Liquid	IV/SC product listed
Gammagard S/D	IV product listed
Gammaked	IV/SC product listed
Gammaplex	IV product listed

1–10 of 18

1/2

Applicable CPT CodesCPT

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

Applicable J-codesHCPCS

J1459	Injection, immune globulin (Privigen®), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1551	Injection, immune globulin (Cutaquig), 100 mg.
J1552	Injection, immune globulin (Alyglo), 500 mg.
J1553	Injection, immune globulin (yimmugo), 100 mg.
J1554	Injection, immune globulin (Asceniv™), 500 mg.
J1555	Injection, immune globulin (Cuvitru®), 100mg.
J1556	Injection, immune globulin (Bivigam®), 500 mg.
J1557	Injection, immune globulin (Gammaplex®), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1558	Injection, immune globulin (Xembify®), 100 mg.
J1559	Injection, immune globulin (Hizentra®), 100 mg.

1–10 of 14

1/2

Procedure/CPT codesCPT

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

HCPCS / J-codes for IG productsHCPCS

J1459	Injection, immune globulin (Privigen), intravenous, nonlyophilized (e.g., liquid), 500 mg.
J1551	Injection, immune globulin (Cutaquig), 100 mg.
J1552	Injection, immune globulin (Alyglo), 500 mg.
J1553	Injection, immune globulin (yimmugo), 100 mg.
J1554	Injection, immune globulin (Asceniv), 500 mg.
J1555	Injection, immune globulin (Cuvitru), 100mg.
J1556	Injection, immune globulin (Bivigam), 500 mg.
J1557	Injection, immune globulin (Gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1558	Injection, immune globulin (Xembify), 100 mg.
J1559	Injection, immune globulin (Hizentra), 100 mg.

1–10 of 18

1/2

Listed ICD-10 diagnosis codesICD-10

A48.3	Toxic shock syndrome.
A49.9	Bacterial infection, unspecified.
A87.8	Other viral meningitis.
A87.9	Viral meningitis, unspecified.
A88.8	Other specified viral infections of central nervous system.
B05.0	Measles complicated by encephalitis.
B05.1	Measles complicated by meningitis.
B05.2	Measles complicated by pneumonia.
B05.3	Measles complicated by otitis media.
B05.4	Measles with intestinal complications.

1–10 of 171

1/18

Applicable HCPCS Codes (updated)HCPCS

J1553

Added to applicable HCPCS codes (description as per HCPCS file)

Measles post-exposure prophylaxis dose

Measles PEP dose capOne-time dose not to exceed 400 mg/kg.

Weight considerationIV/SC IG preferred for patients >30 kg; IM IG for patients ≤30 kg.

Indication timingAdminister as an initial, one-time dose for eligible exposed, nonimmune or severely immunocompromised individuals.

Platelet count threshold for ITP

Platelet thresholdDocumented platelet count < 50 x 10^9 / L (obtained within the past 30 days).

Acute ITP requirementApplies to acute idiopathic thrombocytopenic purpura when platelet count criterion met.

Chronic ITP pathwayChronic ITP coverage requires history of failure, contraindication, or intolerance to corticosteroids or splenectomy (alternative pathway).

Hypogammaglobulinemia thresholds

CLL / multiple myeloma IgG thresholdDocumented hypogammaglobulinemia: IgG < 500 mg/dL for prevention of infection in CLL or multiple myeloma.

Pediatric HIV IgG thresholdDocumented hypogammaglobulinemia: IgG < 400 mg/dL for prevention of bacterial infection in pediatric HIV (age ≤13 years).

Functional antibody deficiency optionAlternatively, functional antibody deficiency (poor specific antibody titers or recurrent bacterial infections) may qualify when IgG thresholds are not met.

Laboratory and timing thresholds

IgG laboratory thresholdsIgG < 400 mg/dL for some indications; IgG < 500 mg/dL for others (e.g., CLL, multiple myeloma).

Measles exposure timingExposure to measles must be less than 6 days prior to IG administration for PEP; route depends on weight (>30 kg IV/SC; ≤30 kg IM).

Prior B-cell therapy timeframeDocumentation confirming prior B-cell targeted therapy within the last 100 days is required for post–B-cell therapy prevention indications.

Allogeneic BMT timeframeFor some BMT indications, confirmed allogeneic bone marrow transplant within the last 100 days is required; severe hypogammaglobulinemia (IgG < 400 mg/dL) may be specified.

IgG level for considering IG therapy

Consider IG at IgG < 400 mg/dLConsider immune globulin therapy when serum IgG is below 400 mg/dL.

Consider IG at IgG 400–600 mg/dLConsider when IgG is 400–600 mg/dL if accompanied by serious, persistent, unusual, or recurrent infections.

Clinical contextDecision also depends on degree of deficiency, infection history, and recency of immunosuppressive therapies.

Measles PEP timing

PEP administration windowAdminister immune globulin within 6 days of measles (rubeola) exposure for post-exposure prophylaxis.

High‑risk groupsIndicated for infants <12 months, pregnant women without measles immunity, and severely immunocompromised persons per CDC guidance.

Route by weightIM for patients ≤30 kg; IV or SC preferred for patients >30 kg.

Prior authorization, documentation, and billing guidance

Billing Rule

Procedure and coding submission

Prior authorization is required for most IVIG/SCIG requests. Submit accurate procedure and drug J‑codes and CPT/HCPCS procedure codes with the authorization or claim; include clinical documentation described below. Listing of codes in the policy is informational only and does not guarantee coverage — always verify federal, state, and contractual benefit terms.

Include procedure codes 90283 (IVIG) and 90284 (SCIG) when applicable and the specific HCPCS/J‑code for the product requested (see applicable codes list).
Ensure claims/authorizations use the correct J‑code for the product/dose (e.g., J1459, J1551–J1576, J1599) and map units to the code-specific dose (mg per unit).

Prior Authorization

Prior authorization for FDA‑approved and standard‑of‑care transplant uses

Prior authorization will generally be approved for FDA‑approved indications and for standard‑of‑care transplant uses when supporting documentation is provided. For transplant-related uses, document the specific transplant scenario and role of IVIG (e.g., desensitization, treatment of antibody‑mediated rejection, adjunct for AMR prevention in solid organ transplant, or prevention of infection/complications after allogeneic BMT when criteria met).

Document whether request is for desensitization, antibody‑mediated rejection (AMR) treatment, or other transplant indication.
For solid organ AMR, include transplant type, HLA/ABO sensitization status, prior desensitization steps, and concurrent therapies (e.g., corticosteroids, plasmapheresis).
For allogeneic BMT uses, include indication (prevention of infection vs GVHD) and timing relative to transplant.

Billing Rule

Updated applicable HCPCS codes

Use the updated HCPCS/J‑codes when requesting authorization or billing. Providers should reference the policy’s Applicable Codes list and confirm quarterly HCPCS updates prior to submission.

J1553 (yimmugo) has been added — include when applicable.
If a product-specific J‑code is not available, use the appropriate not‑otherwise‑specified J‑code with accompanying clinical documentation.
Code lists are informational — verify plan-specific billing rules and reimbursement units.

Documentation Required

General initial therapy documentation requirements

Requests for initial therapy must include a clear diagnosis, relevant history and physical, and objective diagnostic evidence supporting the indication. Missing required items may delay or result in denial.

Required items for initial authorization: diagnosis, history & physical documenting severity/frequency (e.g., infection frequency), and relevant laboratory or diagnostic test results (e.g., IgG level, specific antibody responses, electrodiagnostic studies, MRI/CSF when applicable).
Prescriber attestation that dosing follows FDA labeling or published evidence (for non‑FDA dosing) is required.
Initial authorizations are generally limited to a maximum of 12 months.

Documentation Required

Continuation therapy documentation

For continuation of therapy, provide documentation of clinical benefit and attest that dosing follows FDA labeling or published evidence; continuation approvals are typically time‑limited.

Document objective evidence of positive clinical response (e.g., validated scales such as MRC, Modified Rankin, BVAS, CY‑BOCS where applicable; reduction in infection frequency; improved laboratory markers).
Prescriber must attest dosing is per FDA labeling or supported by published clinical evidence for the indication.
Continuation authorizations are generally granted for up to 12 months and must show ongoing benefit.

Documentation Required

Required clinical and prior‑treatment documentation

Submit supporting clinical documentation tailored to the indication: diagnostic tests, prior treatment history, and objective measures of response. Provide records of prior therapy trials, doses, durations, and reasons for failure/intolerance if step therapy is claimed.

For immunodeficiency: IgG levels, vaccine/specific antibody responses, history of recurrent or severe infections, and PID diagnostic documentation when applicable.
For neurologic indications: electrodiagnostic studies for CIDP/MMN per EFNS/PNS criteria, MRI/CSF for ADEM, and objective outcome scales for continuation.
For transplant/desensitization: HLA/ABO sensitization data, antibody titers, prior desensitization steps, and timing relative to transplant.

Documentation Required

Selective IgA deficiency — documentation for IVIG consideration

Document selective IgA deficiency carefully. IVIG is not routinely indicated for isolated IgA deficiency; consider IVIG only when poor specific IgG antibody production or IgG subclass deficiency coexists and clinical history supports replacement. Note anaphylaxis risk if anti‑IgA antibodies present.

Provide testing for specific antibody responses and IgG subclass levels if claiming coexistent deficiency.
Document prior infection history and failed alternatives; note testing for anti‑IgA antibodies or prior infusion reactions.
If IVIG is considered, include prescriber rationale and monitoring plan for infusion reactions.

Documentation Required

Vasculitis — documentation of disease activity

When requesting IVIG for vasculitis or ANCA‑associated disease, include disease activity measures and timelines showing response to prior therapies. Demonstrate why IVIG is indicated as adjunct or alternative therapy.

Include baseline and recent BVAS (or other validated disease activity scores) and CRP/ESR trends.
Document prior immunosuppressive therapy trials, doses, durations, and response; explain contraindication or intolerance if used as alternative.
Provide timeline showing temporal relationship of IVIG to clinical improvement when continuation requested.

Documentation Required

PID diagnostic documentation

For primary immunodeficiency (PID) requests, reference recognized PID diagnoses and provide objective evidence of humoral immune deficiency. Use the IDF/WHO disease lists and include specific diagnostic test results and infection history.

Provide PID diagnosis name from recognized lists (e.g., CVID, X‑linked agammaglobulinemia) and supporting test results (e.g., failure to produce specific antibodies, hypogammaglobulinemia).
Document frequency/severity of infections and prior management.
Prescriber attestation that IVIG is appropriate replacement therapy per FDA labeling or specialty guidance.

Step Therapy

Preferred product step edits

Preferred‑product step edits apply: coverage for non‑preferred IVIG/SCIG products requires documentation of trials (or contraindication/intolerance) of preferred products per the policy’s Preferred Product Criteria.

For Cutaquig (non‑preferred SCIG): submit history of trial of at least one preferred SCIG product (Cuvitru, Hizentra, HyQvia, Xembify) with dose/duration and response, or documentation of contraindication/intolerance to all preferred products.
For non‑preferred IVIG products (Alyglo, Asceniv, Panzyga, Yimmugo): document trials of at least two other IVIG products (dose/duration) or contraindication/intolerance to alternatives, plus physician attestation of expected superior response when required.

Step Therapy

Sequence and step‑therapy expectations for neurologic indications

Many neurologic and neuromuscular indications require failure, contraindication, or intolerance to first‑line therapies before IVIG; document prior treatments and objective nonresponse. For CIDP, IVIG is recommended for induction; maintenance choices should be re‑evaluated if response inadequate.

For CIDP initial therapy: include electrodiagnostic confirmation per EFNS/PNS and neurology consultation; document progressive symptoms ≥2 months.
If claiming failure of first‑line therapy for other neurologic conditions, provide therapy names, doses, durations, and objective evidence of nonresponse or intolerance.
Ocular myasthenia: IVIG/plasmapheresis are not supported for ocular‑only disease — reserve for short‑term severe generalized disease after step requirements met.

Denial Risk

Step therapy considerations for off‑label uses and unproven indications

Some off‑label requests (e.g., chronic urticaria, ANCA‑vasculitis adjunct use, PANS/PANDAS) have limited or low‑quality evidence. Expect stricter review and high‑quality trial justification or enrollment in controlled studies to support coverage.

Provide high‑quality supporting literature or RCT data when available; explain rationale if using IVIG off‑label.
For PANS/PANDAS, current evidence is low quality — requests should include robust justification or trial enrollment.
Denials are possible for indications listed as unproven or not medically necessary (see policy list).

Denial Risk

Post‑autologous BMT infection prevention

Post‑autologous BMT prophylactic IVIG is not routinely recommended. For autologous BMT recipients, reference CDC guidance and provide strong justification and specific clinical rationale if requesting IVIG for infection prevention.

Routine prophylactic IVIG after autologous BMT is generally not supported and may be denied per CDC guidance.
If requesting IVIG post‑autologous BMT, include specific infection risk factors, immunologic testing, prior infection history, and rationale for deviation from guideline recommendations.

Note

Reference governing benefit terms

Coverage decisions must follow the member’s governing benefit terms. Always check federal, state, and contractual plan requirements before applying this policy; in the event of conflict, the benefit terms govern.

This policy interprets UnitedHealthcare standard benefit plans — it does not override federal/state/contractual coverage mandates.
Verify plan language for exclusions, prior authorization requirements, medical necessity definitions, and any state‑specific mandates before submitting requests.

Background, definitions, and scope

Intravenous (IVIG) and subcutaneous (SCIG) immune globulin products are sterile, purified human immunoglobulin G preparations derived from pooled plasma. They are used either as replacement therapy in patients with primary immunodeficiency or as an immunomodulatory therapy in selected autoimmune, hematologic, infectious, neurologic, and dermatologic conditions when evidence, guidelines, or regulatory approvals support their use.

This policy organizes indications and product‑preference rules around those accepted uses and provides condition‑specific criteria (including laboratory thresholds, timing, and prior‑therapy requirements) to inform medical‑necessity determinations.

IVIG definition and example products

IVIG definitionIntravenous immune globulin (IVIG) — sterile, purified human IgG derived from pooled plasma, administered intravenously as replacement or immunomodulatory therapy.

Example IVIG productsExamples include Privigen, Gammaplex, Gamunex-C, Gammagard, Flebogamma DIF, Octagam, Panzyga, Bivigam, Alyglo, Asceniv, Yimmugo.

Regulatory noteSeveral IVIG products are FDA‑approved for specific indications; FDA approvals are informational and not sole basis for coverage decisions.

SCIG definition and example products

SCIG definitionSubcutaneous immune globulin (SCIG) — human IgG preparations administered subcutaneously for replacement therapy in primary immunodeficiency.

Example SCIG productsExamples include Hizentra, Cuvitru, HyQvia, Xembify, Cutaquig (Cutaquig noted as non‑preferred SCIG in policy).

IndicationsSCIG products are FDA‑approved for treatment of primary immunodeficiency conditions and used for ongoing replacement therapy.

Documented hypogammaglobulinemia definition (IgG thresholds)

Documented hypogammaglobulinemiaSerum IgG below specified thresholds (e.g., IgG < 400 mg/dL for some indications; IgG < 500 mg/dL for others) as required by indication-specific criteria.

Functional antibody deficiencyFunctional antibody deficiency (poor specific antibody titers or recurrent bacterial infections) may substitute for low IgG in some indications.

Evidence requirementRelevant laboratory evidence (IgG level, specific antibody testing) must be provided within specified timeframes as part of authorization documentation.

Recent B-cell targeted therapy/allogeneic BMT timeframe (100-day window)

B-cell therapy/BMT timeframePrior receipt of B-cell targeted therapy or allogeneic bone marrow transplant within the last 100 days is relevant for certain prevention indications.

IgG requirement after B-cell therapy/BMTDocumented severe hypogammaglobulinemia (e.g., IgG < 400 mg/dL or <500 mg/dL as specified) is required for some post‑therapy indications.

Use casesExamples include post–B-cell targeted therapy infection prevention and allogeneic BMT uses for prevention of infection or acute GVHD when criteria met.

IVIG / Immune globulin description

Immune globulin descriptionSterile, purified human immunoglobulin G derived from pooled plasma providing immunomodulating peptides and antibodies; used IV or SC for replacement or immunomodulation.

Clinical rolesUsed as replacement therapy in primary immunodeficiency and as immunomodulatory therapy across multiple autoimmune, hematologic, infectious, neurologic, and dermatologic conditions.

Product variabilityMultiple IV and SC products exist with differing formulations and route‑specific approvals; product choice may be subject to preferred product criteria.

Postexposure prophylaxis (PEP) for measles — definition and timing

PEP for measles definitionAdministration of immune globulin within six days of measles exposure to provide protection or modify disease course in high‑risk or nonimmune individuals.

Eligible populationsInfants <12 months, pregnant women without measles immunity, severely immunocompromised persons (per CDC definitions) are priority candidates for PEP.

Route and timingFor patients >30 kg IV/SC IG is preferred; for ≤30 kg IM IG is indicated; must be given within 6 days of exposure to be effective.

CIDP electrodiagnostic criteria (definition reference)

CIDP electrodiagnostic criteria referenceElectrodiagnostic findings consistent with EFNS/PNS criteria (specific nerve conduction abnormalities) are required to support CIDP diagnosis and IVIG initiation.

Clinical contextDiagnosis typically requires progressive symptoms ≥2 months and polyradiculoneuropathy affecting more than one limb; neurologist involvement advised.

Continuation evidenceContinuation of IVIG for CIDP requires documented objective clinical response (e.g., Rankin or MRC scales).

Isolated IgA deficiency — definition and applicability

Isolated IgA deficiency definitionSelective IgA deficiency: low or absent IgA with normal other immunoglobulins; not an indication for IVIG replacement unless accompanied by poor specific IgG antibody production or IgG subclass deficiency.

Risk considerationsIVIG can pose anaphylaxis risk in IgA‑deficient patients with anti‑IgA antibodies; document absence of IgE anti‑IgA when possible prior to therapy.

Documentation requiredIf IVIG is considered for IgA‑deficient patients, document poor specific IgG antibody production or IgG subclass deficiency to justify use.

Ocular myasthenia definition

Ocular myasthenia definitionOcular myasthenia: myasthenia gravis limited to ocular muscles (ptosis, diplopia); about half progress to generalized myasthenia gravis.

Therapy implicationIVIG/plasmapheresis are used for short‑term management of severe generalized MG but are not supported for ocular‑only disease as maintenance therapy.

MonitoringTreatment goals include restoring clear vision and preventing progression to generalized disease; standard immunosuppressive treatments are first‑line.

Primary immunodeficiency (PID) definition and scope (>300 disorders)

Primary immunodeficiency scopePrimary immunodeficiency (PID) comprises a heterogeneous group of >300 recognized disorders; many are established indications for immune globulin replacement.

IDF disease listRefer to the Immune Deficiency Foundation (IDF) list for specific PID diagnoses considered proven indications for IG therapy.

Replacement indicationIVIG and SCIG are FDA‑approved and standard therapies for replacement in numerous PIDs (e.g., CVID, X‑linked agammaglobulinemia, Wiskott‑Aldrich syndrome).

Definitions and references

ANCA-associated systemic vasculitis (AASV) definition and trial note

AASV definitionANCA‑associated systemic vasculitis (AASV) includes small‑vessel vasculitides such as Wegener's granulomatosis and microscopic polyangiitis.

Trial evidence noteA randomized placebo‑controlled trial (n=34) evaluated IVIG 400 mg/kg/day x5 days showing higher therapeutic response at 3 months but no difference in disease activity or CRP at 3 months; benefits may be transient.

Clinical use implicationIVIG may be considered as adjunct or alternative in refractory AASV cases, but evidence is limited and additional trials are needed.

References — numbered citations supporting clinical indications and guidelines

Reference list availabilityNumbered literature citations (e.g., 85–104) supporting clinical indications, outcomes, and guidelines for IVIG use are provided in the policy references section.

Key guideline sourcesReferences include CDC measles guidance, FDA informational summaries, IDF resources, and multiple specialty guideline and trial publications.

Use in documentationProviders should reference relevant numbered citations from the reference list when justifying medical necessity where applicable.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG)

Policy CodePolicy CS2026D0035XY

Change TypeHCPCS code updatestate applicability change

Effective DateApril 1, 2026

Next Review Date

Key ActionSubmit diagnosis, supporting medical records/labs, and prescriber attestation when requesting initial or continuation authorization.

SourceLink

On This Page

Physician attests that, in their clinical opinion, the same contraindication, intolerance, or severe adverse event would not be expected to occur with Alyglo, Asceniv, Panzyga, or Yimmugo.

Immune thrombocytopenia (ITP): Acute ITP — diagnosis of acute ITP and documented platelet count < 50 x10^9/L (within past 30 days); Chronic ITP — diagnosis of chronic ITP and history of failure, contraindication, or intolerance to corticosteroids or splenectomy.

Posttransfusion purpura: diagnosis of posttransfusion purpura and IVIG dose does not exceed 2 days.

Thrombocytopenia secondary to HCV, HIV, or pregnancy: diagnosis of thrombocytopenia secondary to HCV with concurrent antiviral therapy unless contraindicated, or secondary to HIV with concurrent antiviral therapy unless contraindicated, or secondary to pregnancy; and documented platelet count < 50 x10^9/L (within past 30 days).

Warm autoimmune hemolytic anemia: diagnosis of warm AIHA; other types ruled out; history of failure/intolerance to glucocorticoids; history of failure/intolerance to rituximab or an immunosuppressive agent; patient still transfusion-dependent at minimum two weeks after initiation of rituximab or a second-line agent; and IG used as adjunct.

Infectious Disease

Chronic lymphocytic leukemia (CLL), prevention of infection: diagnosis of B-cell CLL and documented hypogammaglobulinemia (IgG < 500 mg/dL) or history of bacterial infections associated with CLL.
CMV-induced pneumonitis in solid organ transplants: use consistent with indication.
HIV, prevention of bacterial infection in pediatric HIV: diagnosis of HIV; patient age ≤ 13 years; and documented hypogammaglobulinemia (IgG < 400 mg/dL) or functional antibody deficiency demonstrated by poor specific antibody titers or recurrent bacterial infections.
Measles (rubeola) post-exposure prophylaxis: exposure < 6 days prior; patient weight > 30 kg (≤ 30 kg should receive IM IG); and nonimmune or severely immunocompromised individual not already receiving IG (pregnant woman without immunity; HSCT recipient within 12 months after finishing immunosuppressive treatment; HSCT recipient with chronic GVHD; CAR T therapy within 12 months; ALL completing chemo within 6 months; HIV with severe immunosuppression — CD4% <15% or CD4 <200 for age >5; or primary immunodeficiency). Request is for initial one-time dose not to exceed 400 mg/kg.
Multiple myeloma, prevention of infection: diagnosis of multiple myeloma and documented hypogammaglobulinemia (IgG < 500 mg/dL) or history of bacterial infections associated with multiple myeloma.
Post B-cell targeted therapies: documentation of B-cell targeted therapy within last 100 days and both documented hypogammaglobulinemia (IgG < 500 mg/dL) and history of bacterial infections associated with B-cell depletion.

Neurology

Acute disseminated encephalomyelitis (ADEM): diagnosis of ADEM and history of failure, contraindication, or intolerance to intravenous glucocorticoids.
Chronic inflammatory demyelinating polyneuropathy (CIDP) — Initial therapy: diagnosis confirmed by progressive symptoms ≥ 2 months; symptomatic polyradiculoneuropathy affecting >1 limb; and electrodiagnostic findings consistent with EFNS/PNS criteria (e.g., motor distal latency prolongation, reduced motor conduction velocity, prolonged F-wave latency, absence of F-waves, partial motor conduction block, abnormal temporal dispersion, distal CMAP duration increase). Prescribed by or in consultation with a neurologist. Continuation: documentation of positive clinical response measured by objective scale (e.g., Rankin, Modified Rankin, MRC).
Encephalitis, immune checkpoint inhibitor–induced, severe or progressive: diagnosis; history of failure/intolerance to glucocorticoids; immune checkpoint inhibitor interrupted; and prescribed by or in consultation with a neurologist.
Guillain–Barré syndrome (GBS): diagnosis of GBS; severe disease requiring aid to walk; onset within last 4 weeks; and prescribed by or in consultation with a neurologist.
Lambert–Eaton myasthenic syndrome (LEMS): diagnosis of LEMS; history of failure/intolerance to immunomodulator monotherapy; concomitant immunomodulator therapy will be used for long-term management unless contraindicated; and prescribed by or in consultation with a neurologist.
Lennox–Gastaut syndrome: history of failure/intolerance to initial traditional antiepileptic pharmacotherapy; and prescribed by or in consultation with a neurologist.
Multifocal motor neuropathy (MMN): Initial therapy — diagnosis with weakness >1 month, asymmetric involvement of ≥2 nerves, absence of motor neuron or bulbar signs; and prescribed by or in consultation with a neurologist. Continuation: documentation of positive clinical response measured by objective scale.
Relapsing forms of multiple sclerosis: diagnosis of relapsing forms (e.g., relapsing‑remitting, secondary‑progressive with relapses); documentation of an MS exacerbation or progression from prior visit; history of failure, contraindication, or intolerance to at least two disease‑modifying agents (list includes interferons, glatiramer acetate, dimethyl fumarate, teriflunomide, fingolimod, peginterferon beta‑1a, natalizumab, ocrelizumab, rituximab, siponimod, ozanimod, ofatumumab, cladribine, ublituximab, ponesimod, monomethyl fumarate); and prescribed by or in consultation with a neurologist.

Other Indications

Myasthenia gravis — Exacerbation: diagnosis of generalized myasthenia gravis; evidence of exacerbation (difficulty swallowing, acute respiratory failure, major functional disability, or recent checkpoint inhibitor therapy); and either history of failure/intolerance to immunomodulator therapy for long‑term management or currently receiving immunomodulator therapy for long‑term management. Prescribed by or in consultation with a neurologist.
Myasthenia gravis — Refractory: diagnosis by or in consultation with expertise center; disease unchanged or worsening despite failure/intolerance to corticosteroids and two immunomodulator therapies used in adequate doses/duration; currently receiving immunomodulator therapy for long‑term management; and prescribed by or in consultation with a neurologist.
Neuromyelitis optica spectrum disorder (NMOSD) — Initial therapy: diagnosis by a neurologist with serologic testing for AQP4‑IgG/NMO‑IgG performed; compatible clinical history (optic neuritis, acute myelitis, area postrema syndrome, brainstem syndrome, diencephalic/cerebral syndromes); other diagnoses ruled out; history of failure/intolerance to at least three agents (e.g., azathioprine, corticosteroids, mycophenolate, complement inhibitors, anti‑IL6, anti‑CD19, anti‑CD20); not receiving IG in combination with listed disease‑modifying therapies; and prescribed by or in consultation with a neurologist.
Rasmussen syndrome: short‑term amelioration of encephalitis needed prior to definitive surgical therapy, or persistent disease symptoms despite surgical treatment, or patient not a candidate for surgery.
Stiff‑person syndrome: diagnosis of stiff‑person syndrome; history of failure/intolerance to GABAergic medications; and prescribed by or in consultation with a neurologist.
Primary immunodeficiency syndromes: diagnosis of primary immunodeficiency and clinically significant functional deficiency of humoral immunity demonstrated by failure to produce specific antibodies to antigens or history of significant recurrent infections.
Dermatomyositis or polymyositis: diagnosis and history of failure/intolerance to immunosuppressive therapy (e.g., azathioprine, corticosteroids, cyclophosphamide, methotrexate).
Kawasaki disease: diagnosis of Kawasaki disease and IVIG treatment does not exceed five consecutive days.
Allogeneic bone marrow transplantation (BMT): use for prevention of acute GVHD or prevention of infection; confirmed allogeneic BMT within last 100 days; and documented severe hypogammaglobulinemia (IgG < 400 mg/dL).

title":"","type":"criteria_group"},{

Diagnosis of refractory generalized myasthenia gravis by or in consultation with a physician or center with expertise in MG.

Disease status unchanged or worsening despite failure/contraindication/intolerance to corticosteroids and two immunomodulator therapies used in adequate doses and duration.

Currently receiving immunomodulator therapy (e.g., corticosteroids, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, tacrolimus) for long‑term management.

Prescribed by or in consultation with a neurologist.