Immunoglobulin therapy (IVIG/SCIG) notification policy
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Defines medical necessity criteria, preferred and non-preferred products, and site-of-care / documentation requirements for intravenous and subcutaneous immunoglobulin therapies for Blue Cross Blue Shield North Carolina members.
For Guillain-Barré syndrome, added requirement that patient has severe disease requiring aid to walk and that treatment initiation is within 4 weeks of onset of neuropathic symptoms, and that IVIG not be used concurrently with plasma exchange.
Added new product Gammagard Liquid ERC (IV and SC) as a preferred IVIG product for primary humoral immunodeficiency in patients 2 years and older, with corresponding dosing and HCPCS code additions.
Reformatted and revised chronic ITP criteria to allow either platelet count ≤ 30 x 10^9/L OR platelet count < 50 x 10^9/L with symptomatic bleeding and/or increased bleeding risk; trial/failure requirements for corticosteroids and splenectomy adjusted.
Updated site-of-care bypass criteria to explicitly include history of severe adverse events or conditions that increase risk for severe adverse events (e.g., unstable renal function, cardiopulmonary conditions) for infusion location determination.
Added HCPCS code J1572 reinstatement for Flebogamma and multiple HCPCS coding additions/removals across products (e.g., J1599, J1552, J1551, J1576, C9399, J3490, J3590, 90283, 90284) in various updates.
Coverage Criteria for IVIG and SCIG
Initial criteria for approval (IVIG/SCIG)
Covered when ALL of the following are met (criteria vary by indication — summarized as grouped logic nodes below).
E.g., IgG <200 mg/dL for agammaglobulinemia; IgG <400 mg/dL for persistent hypogammaglobulinemia; selective IgG subclass deficiency on 2 occasions ≥2 SD below age‑adjusted mean; antibody response testing; CIDP electrophysiologic criteria; ITP platelet thresholds.
Medical record documentation required.
Exceptions include stability on agent ≥180 days, treated within past 180 days and at risk if changed, trial and inadequate response to preferred agents, intolerances not expected with requested agent, FDA contraindication to preferred agents, or prescriber justification with documentation.
See dosing table and Site of Care criteria in policy.
Non-preferred IVIG approval conditions
Covered when ONE of the following is met (in addition to other baseline criteria and documentation):
Medical record documentation required for the applicable exception; stability threshold = 180 days where specified.
SCIG initial coverage for primary immunodeficiency
Covered when ALL of the following are met:
Medical record documentation required for diagnostic testing, antibody responses, and infection history.
If requested SCIG is non‑preferred, applicable non‑preferred SCIG exception rules apply (see non‑preferred SCIG criteria including trials of preferred SCIG agents or other exceptions).
Continuation criteria
Covered when ALL of the following are met:
Requested quantity must not exceed maximum units allowed for the duration of approval; Site of Care criteria apply for inpatient/outpatient administration.
Site of Care Medical Necessity Criteria
Injection or infusion may be performed at a higher-acuity site (e.g., hospital/infusion center) when ONE OR MORE of the following are met:
Step Therapy / Product Trial Requirements
Use of non-preferred IVIG/SCIG products is covered only when specific trial-and-failure conditions are met (unless other criteria/exceptions apply):
Medical record documentation of trials, inadequate responses or intolerances, or applicable exceptions is required.
The policy explicitly excludes use of immunoglobulin therapy for relapsing‑remitting multiple sclerosis. Requests where the requested agent is intended to treat relapsing‑remitting MS do not meet the listed medical necessity criteria and are not eligible for approval.
Patients with selective immunoglobulin A (IgA) deficiency with known anti‑IgA antibodies are excluded from receiving IVIG/SCIG under this policy. The presence of selective IgA deficiency with documented anti‑IgA precludes coverage for the requested agent.
Summary of exclusions: the requested immunoglobulin agent will not be used to treat relapsing‑remitting multiple sclerosis, and therapy is not permitted for patients who have selective IgA deficiency with known anti‑IgA antibodies. These exclusions must be checked and documented when reviewing requests.
Requests for products that have been removed or discontinued (for example, previously listed products explicitly removed from the dosing/reference tables) are excluded. Prior authorization will not be granted for discontinued or otherwise removed IVIG products.
Use of a non‑preferred IVIG is not covered unless the request documents that one of the policy’s exception criteria is met (for example, stability on the non‑preferred agent for ≥180 days, documented trial and inadequate response to preferred agents, intolerance, or FDA‑labeled contraindication). Absent required documentation of these exceptions, requests for non‑preferred IVIG will be considered not medically necessary.
If the Site of Care criteria are not met for an outpatient hospital administration, the policy directs that the injection or infusion should be administered in a home‑based infusion or physician office setting (with or without supervision by a certified healthcare professional), unless one of the Site of Care Medical Necessity bypass conditions is documented.
If the Site of Care Medical Necessity Criteria are not satisfied, requests for administration at a higher‑acuity site (e.g., outpatient hospital infusion center or inpatient setting) are not supported. Inpatient administration may be approved only when the medical necessity criteria are met and the admission is not solely for the purpose of administering the injection or infusion.
Product Codes and Key Clinical Thresholds
| J1552 | Alyglo HCPCS (IVIG) 90283 |
| J1554 | Asceniv HCPCS (IVIG) 90283 |
| J1556 | Bivigam HCPCS (IVIG) 90283 |
| J1551 | Cutaquig HCPCS (SCIG) 90284 |
| J1555 | Cuvitru HCPCS (SCIG) 90284 |
| J1572 | Flebogamma HCPCS (IVIG) 90283 |
| J1566 | Gammagard S/D HCPCS (IVIG) 90283 |
| J1569 | Gammagard Liquid HCPCS (IV/SC) 90283/90284 |
| C9399 | Gammagard Liquid ERC / Qivigy / Yimmugo miscellaneous HCPCS |
| J1561 | Gammaked / Gamunex-C HCPCS (IV/SC) 90283/90284 |
| C9399 | Notation in policy dosing table (IVIG related unspecified code) |
| J3490 | IVIG not otherwise specified (noted in policy updates) |
| J3590 | IVIG not otherwise specified (noted in policy updates) |
| J1599 | IVIG not otherwise specified (added/removed in updates) |
| J1572 | Flebogamma (coding reinstatement noted) |
| J1552 | Alyglo (added to dosing reference table) |
| J1551 | Cutaquig (added to dosing reference table) |
| J1576 | Panzyga (added 7/1/2023) |
| 90283 | Immune globulin administration/related code (added to multiple products) |
| 90284 | Immune globulin administration/related code (added to Gammagard Liquid ERC) |
Prior Authorization, Documentation, and Step Therapy Requirements
Obtain prior authorization for restricted IVIG/SCIG; document non-preferred exception
Prior authorization is required for the listed restricted IVIG and SCIG products. Requests for non-preferred IVIG must document that the member meets one of the listed exception conditions (e.g., currently stable on the requested agent ≥180 days, treated within past 180 days and at risk if changed, trial and inadequate response to two preferred IVIG agents, intolerance to two preferred agents, FDA contraindication to all preferred agents, or prescriber justification).
- Prior authorization required for restricted products listed in the policy.
- Non-preferred IVIG requests must include documentation meeting one of the exception criteria.
Provide indication-specific clinical documentation with prior authorization
Submit prior authorization with medical record documentation that the patient meets the clinical criteria for the requested indication (e.g., primary immunodeficiency diagnostic thresholds such as IgG <200 mg/dL or <400 mg/dL where specified), evidence of inadequate antibody response and recurrent infections, and documentation of prior treatment failures/intolerances when applicable.
- Document baseline IgG and diagnostic testing as specified for the indication.
- Provide records of recurrent, persistent, or severe infections and prior therapy responses or intolerances.
Use product-specific HCPCS codes and updated coding when requesting/claiming
Use product-specific HCPCS codes and updated coding designations when submitting prior authorization and claims; follow the policy dosing/HCPCS mappings and recent coding updates (including C9399, J3490, J3590, J1599, J1572, and administration codes 90283/90284 as applicable).
- Select the HCPCS code corresponding to the requested product per the policy dosing table.
- Apply updated codes listed in policy history when applicable to the product requested.
Document trials of two preferred IVIG agents before non-preferred IVIG
For non-preferred IVIG products, document trial and inadequate response or intolerance to TWO preferred IVIG agents prior to authorization unless an exception applies (e.g., stability on current agent ≥180 days, FDA contraindication, or prescriber justification).
- Provide medical record evidence of trials and inadequate response or intolerance to two preferred IVIG products (Octagam, Gamunex-C, Gammaked, Gammagard, Privigen) unless an exception is met.
- Exceptions include current stability on the requested agent ≥180 days, recent treatment with the agent within 180 days and risk if changed, or FDA-labeled contraindication.
Confirm and document step-therapy trial-and-failure for non-preferred IVIG/SCIG
When requesting non-preferred IVIG or SCIG, include documentation showing inadequate response or intolerance to two preferred agents (or meeting other listed exceptions such as current stable use or FDA contraindication). For non-preferred SCIG, document trials of preferred SCIG agents (Hizentra and Xembify) as required.
- For non-preferred IVIG: document two preferred IVIG failures or an applicable exception.
- For non-preferred SCIG: document trials/failures of preferred SCIG agents (Hizentra, Xembify) or an applicable exception.
- HyQvia generally requires trial of one preferred IVIG product prior to use unless criteria are met.
Adhere to trial-and-failure step therapy rules per product
Follow the policy step-therapy specifics: trial and failure of preferred IVIG products (two preferred for many non-preferred IVIG requests) prior to non-preferred IVIG; for SCIG, trial of preferred SCIG agents is required prior to non-preferred SCIG unless exceptions apply. HyQvia requires trial of one preferred IVIG product prior to use unless criteria are met.
- Document specific previous agents tried and nature of inadequate response or intolerance.
- Reference the policy for product-specific prior trial requirements (IVIG vs SCIG vs HyQvia).
Document diagnosis, baseline IgG, antibody responses, infection history, and prior therapy outcomes
Include in the medical record the diagnosis, baseline IgG levels (e.g., IgG <200 mg/dL for agammaglobulinemia or <400 mg/dL for hypogammaglobulinemia), antibody response testing results, history of recurrent infections, and documentation of prior therapy failures or intolerances to support the request.
- Baseline laboratory values (total IgG and subclass testing where applicable).
- Antigen-specific antibody response testing (e.g., diphtheria/tetanus, pneumococcal responses).
- Clinical history of infections and prior treatment outcomes.
Include antigen response testing and detailed prior treatment response/intolerance documentation
Provide antigen response documentation (e.g., inability to mount IgG response to diphtheria/tetanus or pneumococcal vaccines), records of prior treatments and their outcomes, and specifics about inadequate response or intolerance to prior agents when requesting non-preferred products.
- Include dates, doses, and clinical response to prior IVIG/SCIG or other relevant therapies.
- Document the nature of intolerances/hypersensitivities and why they are not expected with the requested agent.
Document Site of Care criteria to request non-standard infusion location
To justify administration at a site other than home or physician office, submit documentation that one or more Site of Care Medical Necessity Criteria are met (e.g., history of severe adverse event, conditions increasing risk for severe adverse events, inability to adhere, new-to-therapy or re-initiation definitions, or requirement to change product formulation).
- Specify which Site of Care criterion applies and provide supporting clinical evidence (e.g., prior anaphylaxis event, unstable renal function).
- For inpatient administration, confirm the admission is not solely for infusion unless site-of-care criteria are satisfied.
Provide exceptions or trials for non-preferred IVIG (stability 180 days or two preferred agent failures)
Non-preferred IVIG approval requires either stability on the agent for at least 180 days, recent treatment within 180 days with risk if changed, or documentation of trials/failures or intolerances to two preferred agents (or FDA contraindication); failure to meet these exception criteria risks denial.
- If claiming stability, include treatment duration and clinical stability evidence (≥180 days).
- If claiming prior trials, include dates and objective evidence of inadequate response or intolerance to two preferred IVIG agents.
Incomplete documentation (diagnosis, baseline labs, prior therapy failures) risks denial
Requests lacking medical record documentation of the diagnosis, baseline laboratory values (e.g., IgG levels), inadequate response to prior therapies, or infection history may be denied; ensure all required supporting records are included with the authorization request.
- Include diagnostic criteria and lab thresholds used to support the indication.
- Attach prior therapy notes showing inadequate response or documented intolerance.
Avoid inpatient admission solely for infusion — admissions for infusion-only may be denied
Requests for inpatient admission solely for infusion may be denied; the policy requires that infusion-only visits be administered in outpatient hospital, home-based infusion, or physician office settings unless inpatient admission meets medical necessity criteria beyond administration.
- Confirm the inpatient admission is for clinical reasons beyond administration; otherwise plan for home or office-based infusion.
- For outpatient hospital administration, ensure Site of Care criteria are met.
Requests for higher-acuity infusion site require Site of Care criteria or risk denial
Requests for infusion or injection at a site other than home or physician office (e.g., outpatient hospital) may be denied unless one or more Site of Care Medical Necessity Criteria are documented and met.
- Document applicable Site of Care criteria (history of severe adverse event, increased-risk conditions, inability to adhere, new-to-therapy, re-initiation, change in formulation).
- If criteria are not met, arrange administration in home-based infusion or physician office setting.
Background and Context
Immunoglobulin products (intravenous immune globulin, IVIG, and subcutaneous immune globulin, SCIG) are used across a broad set of indications including primary humoral immunodeficiencies, certain hematologic conditions (e.g., immune thrombocytopenia, hemolytic disease of the fetus/newborn), neurologic autoimmune disorders (e.g., CIDP, Guillain‑Barré syndrome, multifocal motor neuropathy), transplant‑related uses, and other FDA‑approved or compendia‑supported indications. The policy sets indication‑specific medical necessity criteria that include laboratory thresholds (for example, IgG <200 mg/dL for agammaglobulinemia and IgG <400 mg/dL for persistent hypogammaglobulinemia), documentation of inadequate antibody responses when required, prior treatment trials/failures or intolerances, and infection history to support replacement therapy or immunomodulatory use.
Definitions and Diagnostic Thresholds
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