CurrentColorado Rocky Mountain Health PlansPolicy IEXD0035.18

Immune Globulin (IVIG and SCIG) – Individual Exchange Medical Benefit Drug Policyopen_in_new

Medical benefit drug policy for intravenous and subcutaneous immune globulin products (preferred and non-preferred) applicable to Individual Exchange plans (all states except Nevada) outlining general and diagnosis-specific medical necessity criteria, product preferences, and applicable HCPCS/J-codes and ICD-10 diagnosis codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyImmune Globulin (IVIG and SCIG) – Individual Exchange Medical Benefit Drug Policyopen_in_new

Policy CodePolicy IEXD0035.18

Change TypeRevision / Addition / Quarterly code update

Effective DateApr 1, 2026

Next Review Date

Key ActionWhen requesting initial or continuation authorization, document diagnosis, H&P, supporting labs/diagnostics, and attest dosing aligns with FDA labeling or published evidence; authorizations limited to 12 months.

SourceLink

POLICY UPDATE CHANGES

Removed language indicating this Medical Benefit Drug Policy does not apply to Massachusetts and New York.

Added instruction to refer to the UnitedHealthcare Commercial policy version for the state of Nevada.

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

Archived previous policy version IEXD0035.17.

40+Diagnoses Addressed

ManyJ-codes Listed

8FDA Licensed Indications

1 yrAuthorization Duration (max)

Alyglo/Asceniv/PanzygaNot Medically Necessary (named)

Coverage Summary

This policy addresses medical benefit coverage for intravenous and subcutaneous immune globulin (IVIG and SCIG) products for Individual Exchange plans and is covered with criteria. It establishes general and diagnosis-specific medical necessity requirements across multiple specialties (dermatology, hematology, infectious disease, neurology, rheumatology, transplantation, primary immunodeficiency) and lists preferred products that are covered contingent on criteria, while other named or unlisted products are treated as non-preferred and require additional justification. The brief notes specific products (Alyglo, Asceniv, Panzyga) as not medically necessary per available evidence.

Initial Therapy Criteria

Diagnosis-Specific Requirements (selected examples present in Part 1)

General requirements applicable to all medical necessity requests for immune globulin (IVIG and SCIG). Coverage is contingent on documentation and dosing attestation as described below.

type":"criteria_group","title":"General Requirements (Applicable to All Medical Necessity Requests)"},{

Diagnosis-Specific Requirements (selected examples present in Part 1)

Diagnosis‑specific initial‑therapy requirements for selected proven indications (initial therapy leaf nodes). Immune globulin is considered medically necessary for the diagnoses below when the listed criteria are met. Also included: measles (rubeola) post‑exposure prophylaxis.

ALL of the following

Chronic inflammatory demyelinating polyneuropathy (CIDP) - Initial Therapy: Diagnosis of CIDP confirmed by clinical evaluation and electrodiagnostic testing consistent with CIDP; prescriber attests IVIG is being used in accordance with published dosing or FDA labeling; documentation that alternative first‑line therapies are contraindicated or not tolerated when applicable.
Multifocal motor neuropathy (MMN) - Initial Therapy: Diagnosis of MMN supported by clinical features and electrophysiology; IVIG requested for initial therapy; prescriber attests dosing is in accordance with published evidence or labeling; documentation of disease severity and functional impairment.
Multifocal motor neuropathy (MMN) - Maintenance/Continuation: (Note: continuation criteria require documentation of clinical response to initial IVIG and ongoing dosing attestation.)
Multifocal motor neuropathy (MMN) - Additional: MMN initial therapy is considered proven; monthly maintenance dosing and reassessment required per treating neurologist.

Continuation Therapy Criteria

General Requirements - Continuation of Therapy

For continuation of therapy, all listed requirements must be met (authorization limited to no more than 12 months).

Clinical response: Documentation of positive clinical response to immune globulin therapy
Measured by objective scales where applicable (e.g., Rankin, Modified Rankin, MRC)
Dosing attestation
- FDA dosing: Prescriber attests dosing is in accordance with FDA approved labeling
- Published evidence dosing: For indications without FDA approved dosing, prescriber attests there is published clinical evidence to support the dosing

Preferred Product & Non-preferred Product Criteria

Preferred Product Criteria (when requesting non-preferred product)

Treatment with a non-preferred immune globulin is medically necessary when ONE of the following sets of criteria is met.

Trial + clinical expectation
- Trial of all preferred products: Documentation of a trial of all of the preferred immune globulin products resulting in minimal clinical response to therapy and residual disease activity
- Physician attestation of superiority: Physician attests that in their clinical opinion, the clinical response would be expected to be superior with the requested non-preferred product than experienced with all preferred products
Intolerance/Contraindication

Unproven / Not Medically Necessary Indications

The policy summarizes numerous conditions for which IVIG is considered not recommended, unproven, or without a role due to insufficient or negative evidence. Examples include acquired hemophilia, adrenoleukodystrophy, Alzheimer's disease, amyotrophic lateral sclerosis (ALS), antiphospholipid antibody syndrome in pregnancy, asthma, atopic dermatitis, autism spectrum disorders, autoimmune liver disease, autoimmune neutropenia, and various bone marrow transplant uses (e.g., routine prevention of acute or chronic GVHD or infection after autologous BMT).

Additional evidence-based negative or insufficient findings highlighted include POEMS syndrome and polyneuropathy associated with IgM monoclonal gammopathy (no role or ineffective), rotaviral enterocolitis (only small oral IG studies; IV/SC not studied), chronic or delayed-pressure urticaria (conflicting, low-quality data), and prevention of spontaneous recurrent abortions (cumulative randomized trial evidence does not support IVIG).

Applicable Codes

HCPCS/CPT codes (administration/reference)CPT

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

J-codes for specific immune globulin products (covered contingent on criteria)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.
J1553	Injection, immune globulin (Yimmugo), 100 mg.
J1554	Injection, immune globulin (Asceniv), 500 mg.
J1555	Injection, immune globulin (Cuvitru), 100 mg.
J1556	Injection, immune globulin (Bivigam), 500 mg.
J1557	Injection, immune globulin (Gammaplex), intravenous, non-lyophilized, 500 mg.
J1558	Injection, immune globulin (Xembify), 100 mg.
J1559	Injection, immune globulin (Hizentra), 100 mg.

1–10 of 18

1/2

ICD-10 diagnosis codes referencedICD-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 85

1/9

Applicable ICD-10 Diagnosis Codes (listed in this part)ICD-10

G62.9	Polyneuropathy, unspecified
G65.0	Sequelae of Guillain-Barre syndrome
G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation
G70.80	Lambert-Eaton syndrome, unspecified
G70.81	Lambert-Eaton syndrome in disease classified elsewhere
G73.1	Lambert-Eaton syndrome in neoplastic disease
L10.0	Pemphigus vulgaris
L10.2	Pemphigus foliaceous
L12.0	Bullous pemphigoid

1–10 of 84

1/9

Applicable HCPCS / J-codes (updated quarterly; J1553 added)HCPCS

J1553

Immune globulin, human, 500 mg

Provider Actions & Billing Requirements

Prior Authorization

Authorization duration and requirements

Initial and continuation authorizations are required and will be limited to ≤12 months. Requests must document the diagnosis, a recent history & physical (H&P), relevant laboratory results, and an attestation that dosing follows FDA‑approved labeling or published clinical evidence where no FDA dosing exists.

Initial authorization: ≤ 12 months; must include diagnosis, H&P, labs, and prescriber attestation of dosing.
Continuation authorization: ≤ 12 months; must include documentation of positive clinical response, H&P, labs, and prescriber attestation of dosing.

Documentation Required

Clinical documentation for requests

Provide complete clinical documentation with each request. Required elements include a recent history & physical exam describing disease severity and course, relevant laboratory results (e.g., IgG level when applicable), and objective scales or infection history when relevant to the indication.

Clinical Evidence & Guideline Summaries

DermatomyositisRCT (ProDERM): IVIG improved dermatologic symptoms vs placebo

CIDPEFNS/PNS guideline: Level A recommendation for IVIG induction in disabling sensory/motor CIDP

BMT (Allo)Allogeneic BMT RCT: no benefit of IVIG vs placebo for infection/GVHD (200-patient trial)

ANCA VasculitisRandomized trial: IVIG (400 mg/kg/day x5) ↑therapeutic response at 3 months (14/17 vs 6/17; OR 8.56, p=0.015) but no sustained difference in activity

Clinical-indication summaries: the policy lists numerous indications where IVIG/SCIG is considered beneficial or standard-of-care (or accepted by evidence/guidelines). These include immune thrombocytopenic purpura (ITP), dermatomyositis and polymyositis, Kawasaki disease (initial treatment), chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barré syndrome (GBS), multifocal motor neuropathy (MMN), Lambert-Eaton myasthenic syndrome (LEMS), paraproteinemic neuropathies, stiff-person syndrome, myasthenia gravis (including refractory disease and crisis), fetal-neonatal alloimmune thrombocytopenia and hemolytic disease of the newborn, HIV-associated thrombocytopenia in children, posttransfusion purpura, CMV pneumonitis in transplant, prevention of bacterial infections in hypogammaglobulinemia and selected patients with CLL or multiple myeloma, and prevention of infections after B-cell targeted therapies when criteria (e.g., IgG thresholds, timing) are met.

Background & Definitions

Background: the policy lists and differentiates preferred and non-preferred immune globulin products and provides medical necessity criteria across specialties (dermatology, hematology, infectious disease, neurology, rheumatology, transplantation, primary immunodeficiency). It notes that coverage of preferred products is contingent on meeting General and Diagnosis-Specific Requirements and explicitly states that certain named products (Alyglo, Asceniv, Panzyga) are considered not medically necessary based on available evidence.

Definitions:

Preferred products: Named immune globulin products (e.g., Bivigam, Cutaquig, Cuvitru, Flebogamma DIF, Gammagard Liquid/S-D, Gammaked, Gammaplex, Gamunex-C, Hizentra, HyQvia, Octagam, Privigen, Xembify) that are preferred for coverage subject to the policy's criteria.

Non-preferred product criteria: Clinical justification required via either a documented trial and inadequate response to all preferred products with physician attestation of expected superiority of the requested non-preferred product, or documentation of intolerance/contraindication/adverse event to all preferred products plus physician attestation that the same issue would not be expected with the requested non-preferred product.

IVIG: Intravenous immune globulin, pooled human IgG preparation for IV administration.

SCIG: Subcutaneous immune globulin preparations for subcutaneous administration.

AMR: Antibody-mediated rejection (transplant).

Revision History

04/01/2026applicability_updateLatest

Applicable States updated: removed prior exclusion for Massachusetts and New York (policy now applies to those states); Nevada guidance added instructing to refer to the UnitedHealthcare Commercial Medical Benefit Drug Policy for Nevada.

04/01/2026codes_updateLatest

Applicable HCPCS/J-code list updated to reflect quarterly edits; J1553 (Immune globulin, human, 100 mg / Yimmugo) was added to the list of applicable HCPCS / J-codes.

04/01/2026

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyImmune Globulin (IVIG and SCIG) – Individual Exchange Medical Benefit Drug Policyopen_in_new

Policy CodePolicy IEXD0035.18

Change TypeRevision / Addition / Quarterly code update

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Multifocal motor neuropathy (MMN) - Clarification: MMN is a proven indication recognized in evidence‑based guidelines; ensure documentation of diagnosis, electrophysiology, and response to therapy.

Multifocal motor neuropathy (MMN) - DuplicationGuard: (Consolidated criteria above — do not duplicate in requests.)

Multifocal motor neuropathy (MMN) - End

Multifocal motor neuropathy (MMN) - End2

Authorization duration: Authorization will be for no more than 12 months12 months

Diagnosis-Specific Requirements — Continuation Nodes

Continuation-specific diagnosis nodes (require documentation of positive clinical response to therapy; specialist involvement as specified).

Diagnosis-Specific Continuation Requirements

CIDP - Continuation of Therapy
- Positive response: Documentation of positive clinical response to therapy as measured by an objective scale (e.g., Rankin, Modified Rankin, MRC scale)
MMN - Continuation of Therapy
- Positive response: Documentation of positive clinical response to therapy as measured by an objective scale (e.g., Rankin, Modified Rankin, MRC scale)
LEMS - Continuation of Therapy
- Diagnosis and prior failure: Diagnosis of Lambert-Eaton myasthenic syndrome (LEMS) and history of failure, contraindication, or intolerance to immunomodulator monotherapy (e.g., azathioprine, corticosteroids)
- Concomitant therapy: Concomitant immunomodulator therapy will be used for long-term management unless contraindicated
- Specialist involvement: Prescribed by or in consultation with a neurologist
Multifocal motor neuropathy (MMN) - Continuation
- Positive response: Documentation of positive clinical response to therapy as measured by an objective scale (e.g., Rankin, Modified Rankin, MRC scale)
Other continuation nodes: Continuation of therapy for other diagnosis-specific indications requires documentation of positive clinical response and compliance with any specialist or adjunct therapy requirements specified in the initial-therapy criteria

Intolerance to all preferred products: Documentation of intolerance, contraindication, or adverse event to all of the preferred immune globulin products

Physician attestation of expected tolerance: Physician attests that the same intolerance, contraindication, or adverse event would not be expected to occur with the requested non-preferred product

Preferred products are named immune globulin formulations (examples include Bivigam, Cutaquig, Cuvitru, Flebogamma DIF, Gammagard Liquid/S-D, Gammaked, Gammaplex, Gamunex-C, Hizentra, HyQvia, Octagam, Privigen, Xembify) that are covered when the General and Diagnosis-Specific Requirements are met. The Non-preferred product criteria require clinical justification for use of a non-preferred product by documenting either a trial and inadequate response to all preferred products with a physician attestation that the requested product is expected to be superior, or documented intolerance/contraindication/adverse event to all preferred products plus physician attestation that the same issue would not be expected with the requested non-preferred product. (The brief also identifies Alyglo, Asceniv, and Panzyga as not medically necessary.)

History & physical documenting severity/frequency of symptoms or infections.
Laboratory results supporting indication (e.g., IgG level for hypogammaglobulinemia; infection documentation for B‑cell targeted therapy post‑treatment assessment).
Objective scales or measures where applicable (neurologic scales, functional assessments).

Step Therapy

Preferred product step

Non‑preferred product approvals require documentation of a trial of all preferred immune globulin products with inadequate response, or documentation of intolerance/contraindication to all preferred products, plus a physician attestation that the requested product is expected to be clinically superior or tolerated.

Document trial of all preferred products with minimal response and residual disease activity, or document intolerance/contraindication/adverse events to all preferred products.
Include prescriber attestation that the requested non‑preferred product is expected to provide superior clinical response or avoid anticipated adverse events.

Prior Authorization

Specialist involvement, member benefit plan, and applicability

Specialist prescribing expectations and plan applicability: prescriptions for complex or indication‑specific uses (e.g., neurologic indications, post B‑cell targeted therapy management) should be from an appropriate specialist. Refer to the member’s benefit plan for coverage specifics and limits. Note: This Individual Exchange policy applies to all states except Nevada; for Nevada follow the UnitedHealthcare Commercial Medical Benefit Drug Policy guidance.

Specialist involvement: neurologic indications should involve a neurology specialist and follow specialty guidance when available.
Assess IgG level and infection history for members after B‑cell targeted therapies to determine need for prophylactic IVIG.
Consult the member‑specific benefit plan for formulary, utilization management, site‑of‑care, and cost‑share details.
Nevada: this Individual Exchange policy does NOT apply — refer to UnitedHealthcare Commercial policy for Nevada.

Billing Rule

Product‑specific J‑code reporting and updated HCPCS codes

Billing and coding: report product‑specific J‑codes and use the updated HCPCS codes as listed. J1553 has been added — ensure claims indicate the correct J‑code for the specific immune globulin product administered.

Report product‑specific J‑codes on claims; include NDC/product mapping per billing guidance.
Use updated HCPCS codes (J1553 added).
See provider_actions code groups for the full list of affected J‑codes and code group mappings.

Documentation Required

Measles PEP dosing, weight requirement, and IVIG dose limits

Measles (rubeola) post‑exposure prophylaxis (PEP): document member weight to determine IVIG dosing — IVIG PEP dosing is weight‑based and must meet the policy’s threshold for administration. For posttransfusion purpura, IVIG dosing must not exceed 2 days of therapy per policy limits.

Measles PEP: include member weight to verify appropriate IVIG dose for post‑exposure prophylaxis.
Posttransfusion purpura: IVIG dosing limited to treatment not to exceed 2 days.

Specialty-specific notes: dermatology recognizes IVIG for autoimmune bullous diseases and life-threatening SJS/TEN; neurology supports IVIG as first-line or proven therapy for CIDP induction and for GBS, and as second-line or adjunct therapy for ADEM, refractory myasthenia gravis, NMOSD and other neuroimmunologic disorders per specialty guidance and electrodiagnostic criteria; hematology considers IVIG first-line for fetomaternal alloimmune thrombocytopenia and for certain thrombocytopenias and hemolytic conditions; transplantation uses IVIG in desensitization and as adjunct therapy for antibody-mediated rejection (AMR) as standard practice by expert opinion.

Previous policy version IEXD0035.17 archived.