CurrentUnitedHealthcarePolicy CSOH2025D0035.D

Immune Globulin (IVIG and SCIG) (for Ohio Only)

Defines UnitedHealthcare Community Plan medical benefit drug policy for intravenous and subcutaneous immune globulin products for members in Ohio; governs coverage determination and references InterQual criteria for medical necessity.

Policy Summary

PayerUnitedHealthcare

PolicyImmune Globulin (IVIG and SCIG) (for Ohio Only)

Policy CodePolicy CSOH2025D0035.D

Change TypeAdded InterQual referencearchived prior version

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization using the current InterQual guideline for the specific IVIG or SCIG product requested.

SourceLink

POLICY UPDATE CHANGES

Added instruction to refer to the current InterQual® guideline for Alyglo and Yimmugo.

~20products listed

Ohiostate

InterQualcriteria source

Multiplebilling codes

Coverage and Medical Necessity

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Medical Necessity (InterQual-based)

Covered when InterQual criteria for the requested IG product are met.

InterQual product-specific criteria: Medical necessity clinical coverage criteria are determined by the current InterQual guideline corresponding to the requested immune globulin product (IVIG or SCIG).

Providers should reference the InterQual entry for the specific product. Examples of listed products include Alyglo, Asceniv, Bivigam, Cutaquig, Cuvitru, Flebogamma DIF, Gammagard (liquid and S/D), Gammaked, Gammaplex, Gamunex-C, Hizentra, and HyQvia.

If product not listed: If the requested IG product is not listed in the InterQual entries referenced by this policy, coverage determinations will use applicable criteria outlined within this drug policy plus prescribing and dosing information from the product package insert.

Providers must ensure documentation supports InterQual medical necessity decisions and follow the product labeling when product-specific InterQual criteria are not available.

This policy defines UnitedHealthcare Community Plan medical benefit coverage for intravenous and subcutaneous immune globulin (IG) products for members in Ohio. It is intended to assist in interpreting standard benefit plans but does not replace the federal, state (Ohio Administrative Code), or contractual requirements that govern actual benefit coverage. In the event of a conflict, the applicable federal, state (OAC), or contractual requirement controls and should be checked before applying this policy.

This document may be updated as needed. The policy is informational and does not guarantee coverage or claim payment; inclusion of a service or code in this policy is not a guarantee of coverage and does not create a right to reimbursement.

The lists of procedure and J-/HCPCS codes in this policy are provided for reference only. Listing a code does not imply the service is covered or not covered, nor does it guarantee claim payment. Benefit coverage and reimbursement are determined by applicable federal, state, or contractual requirements and other policies that may apply.

Services or uses that are unproven, or that are subject to coverage or quantity limits, will be assessed for medical necessity in accordance with applicable rules (for Ohio, see OAC 5160-1-01) and any relevant UnitedHealthcare guidelines.

Applicable Procedure and Billing Codes

Applicable procedure and J-/HCPCS codesmixed

90283	Immune globulin (IgIV), human, for intravenous use.
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each.
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.
J1554	Injection, immune globulin (Asceniv™), 500 mg.
J1555	Injection, immune globulin (Cuvitru®), 100 mg.
J1556	Injection, immune globulin (Bivigam®), 500 mg.
J1557	Injection, immune globulin (Gammaplex®), intravenous, non-lyophilized (e.g., liquid), 500 mg.
J1558	Injection, immune globulin (Xembify®), 100 mg.

1–10 of 19

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Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and medical necessity determinations will be based on the current InterQual® guideline specific to the prescribed immune globulin product. Providers must obtain prior authorization before initiating therapy per UnitedHealthcare processes.

Prior authorization required and processed using the current InterQual® guideline for the specific IG product.
Click here to view the InterQual® criteria.

Step Therapy

There is no UnitedHealthcare step therapy specified for immune globulin products in this policy. Coverage and utilization are determined by meeting InterQual® medical necessity criteria rather than a step-therapy sequence.

No step therapy specified; InterQual® criteria apply.

Documentation Required

Documentation Requirements

Providers must document clinical information that supports InterQual® determinations and must include dosing, administration route (IVIG vs SCIG), frequency, total dose calculations, patient weight when relevant, and indication-specific clinical findings. Documentation should also reference package insert dosing when a product is not listed in InterQual®.

Ensure documentation supports InterQual® decision points and clinical rationale.
Include product name, dose, route, infusion schedule, weight-based dose calculations, and relevant clinical/laboratory data.

Denial Risk

Denial Triggers and Coverage Limits

Services that are unproven, experimental, or not supported by InterQual® criteria may be denied. Quantity, frequency, duration, and site-of-care limits will be evaluated per InterQual®, Ohio Administrative Code (OAC), and the member's contract; claims exceeding coverage limits or lacking clinical support may be denied.

Denial risk for services unsupported by InterQual® or considered unproven/experimental.
Quantity/frequency/duration and site-of-care evaluated against InterQual®, OAC, and contract terms.

Clinical Background

Intravenous (IVIG) and subcutaneous (SCIG) immune globulin products are used therapeutically to replace or supplement immunoglobulin in patients with primary and secondary immunodeficiency disorders, helping to prevent infections by providing pooled human antibodies. They are also used for certain autoimmune and inflammatory conditions where modulation of immune function is clinically indicated.

This policy refers to FDA‑approved IV and SC products (examples include Alyglo, Asceniv, Cutaquig, Cuvitru, Gammaplex, Hizentra, HyQvia, Privigen, Octagam and others) and directs reviewers to apply the current InterQual product‑specific criteria and the product labeling for clinical indications and dosing guidance.

Products and Terminology

IVIG / SCIG products — examples

AlygloIV immune globulin product listed as FDA‑approved example

AscenivIV immune globulin product listed as FDA‑approved example

CutaquigSC immune globulin product listed as FDA‑approved example

CuvitruSC immune globulin product listed as FDA‑approved example

GammaplexIV immune globulin product listed as FDA‑approved example

Privigen, Panzyga, Gamunex‑C, Gammaked, Octagam, Xembify, Hizentra, HyQvia, Bivigam, Flebogamma DIF, Gammagard S/D, YimmugoAdditional FDA‑approved IV or SC immune globulin products named in the policy