Prior authorization required for listed indications

Prior authorization is required for IVIG for the listed indications; initial authorization durations are specified per indication (commonly 6 months; some indications 1–3 months or 2 months total). Providers must request prior authorization before IVIG is approved and follow the indication-specific duration noted in the criteria (e.g., 6 months for BMT/HSCT prophylaxis, 3 months for MMN, 2 months total for GBS, 1 month for Kawasaki).

• Initial authorization durations are indication-specific (examples: 6 months for many indications; 3 months for MMN; 2 months total for GBS; 1 month for Kawasaki).
• Continuation/reauthorization requires meeting the reauthorization criteria listed for the condition or initial criteria for other conditions.

Prior authorization with indication-specific criteria and duration

Prior authorization must meet the specific clinical criteria and duration for the indication before IVIG will be approved; continuation requires meeting reauthorization criteria when listed. Providers should ensure the submitted request maps to the indication-specific criteria (typical durations: 1 or 6 months depending on diagnosis).

• Prior authorization decisions are based on indication-specific criteria and duration.
• Continuation of therapy granted only when reauthorization criteria or initial criteria are met.

Prior authorization and required HCPCS/J‑code billing

Authorization and approvals may be constrained by dosing limits and require billing of IVIG administrations using the specified HCPCS/J‑codes; include product‑specific codes (including J‑codes and unclassified codes for Qivigy) on claims.

• Report IVIG administrations using the listed HCPCS/J‑codes (product-specific J‑codes such as J1459, J1557, J1561, etc.).
• When Qivigy is specified, use J3490/J3590 or C9399 as applicable per guidance in the coding section.

Document trial and failure/intolerance of first‑line therapies

For multiple indications, providers must document a trial and failure or intolerance of first-line therapies before IVIG will be authorized (examples include anticholinesterases/amifampridine for LEMS; corticosteroids or immunosuppressives for blistering disease; corticosteroids or splenectomy for autoimmune hemolytic anemia; GCSF for autoimmune neutropenia).

• LEMS: anticholinesterases and amifampridine must have been tried and were unsuccessful or not tolerated.
• Autoimmune mucocutaneous blistering disease: failure or significant complications from corticosteroids/immunosuppressives required.
• Autoimmune hemolytic anemia: nonresponse to corticosteroids or splenectomy required.
• Autoimmune neutropenia: GCSF unsuitable required.

Reserve IVIG after standard therapies fail or are contraindicated

IVIG is reserved for use after failure, intolerance, or contraindication to first‑ and second‑line therapies for some conditions (e.g., severe, active SLE and other listed diagnoses); providers must demonstrate prior standard treatments were inadequate or not tolerated.

• SLE: authorization of 6 months may be granted only after inadequate response, intolerance, or contraindication to first‑ and second‑line therapies.
• Adult HIV-associated thrombocytopenia: IVIG considered when RhIG has failed in Rh‑positive patients and criteria for bleeding/platelet count met.

Dosing and administration note (source reference)

(See source for specific language and context.)

Required diagnostic confirmation documentation

Provide confirmatory diagnostic documentation with the prior authorization: examples include neurophysiology studies or a positive anti‑P/Q type voltage‑gated calcium channel antibody for LEMS, and biopsy with pathology report for autoimmune mucocutaneous blistering disease.

• LEMS: neurophysiology (e.g., electromyography) OR positive anti‑P/Q antibody required.
• Blistering disease: diagnosis proven by biopsy and confirmed by pathology report.

Provide supporting clinical information (severity, timing, IgG, prior response)

Include supporting clinical information to justify the request: severity and timing (e.g., GBS symptom onset < 4 weeks), response to prior therapies, pretreatment serum IgG levels (e.g., for BMT/HSCT prophylaxis), and measures of clinical benefit for reauthorization (e.g., reduction in infection frequency).

• GBS: onset of neurologic symptoms < 4 weeks from anticipated start of therapy.
• BMT/HSCT prophylaxis: provide pretreatment serum IgG if used to meet criteria.
• Reauthorization: document demonstrated reduction in frequency of bacterial infections for BMT/HSCT prophylaxis.

Provide required clinical evidence and numeric thresholds (e.g., IgG < 400 mg/dL)

Ensure documentation meets numeric thresholds when specified (for example, total IgG < 400 mg/dL or two standard deviations below the mean for age for HLH/MAS, CAR‑T related hypogammaglobulinemia, and other hypogammaglobulinemia indications).

• HLH/MAS and certain secondary immunosuppression indications require total IgG < 400 mg/dL (or < -2 SD for age).
• CAR‑T related hypogammaglobulinemia requires IgG < 400 mg/dL for authorization.

Billing: report IVIG with specified HCPCS/J‑codes (product‑specific guidance for Qivigy)

Report IVIG administrations using the listed HCPCS/J‑codes on claims; when Qivigy is specified, use the unclassified HCPCS entries (J3490/J3590) or C9399 as noted in the coding guidance.

• Use product‑specific J‑codes from the coding lists (e.g., J1459, J1557, J1561, J1577 where applicable).
• If Qivigy is specified, bill with J3490/J3590 or C9399 per the coding notes.

BMT/HSCT prophylaxis: meet timing (≤100 days) or pretreatment IgG criteria

For BMT/HSCT prophylaxis, requests must meet timing or IgG criteria: IG must be requested within the first 100 days post‑transplant OR the member must have pretreatment serum IgG < 400 mg/dL; requests outside these parameters risk denial.

• Initial authorization of 6 months granted only when IG is requested within first 100 days post‑transplant OR pretreatment serum IgG < 400 mg/dL.
• Reauthorization requires demonstration of reduced bacterial infection frequency.

Diagnostic confirmation required — missing tests risk denial

Requests lacking required confirmatory diagnostic testing may be denied; examples include absence of neurophysiology or anti‑P/Q antibody testing for LEMS, or missing biopsy/pathology for autoimmune mucocutaneous blistering disease.

• LEMS: must have neurophysiology studies or positive anti‑P/Q antibody documented.
• Blistering disease: biopsy and pathology report required.

Denial risk if policy criteria are not met

Intravenous Immune Globulin is considered not medically necessary and may be denied when the member does not meet the criteria set forth in the policy (including indication criteria, prior therapy requirements, diagnostic confirmation, or numeric thresholds).

• If initial or reauthorization criteria are not met, IVIG is not medically necessary.
• Ensure all condition‑specific requirements are documented to avoid denial.

Approvals may be subject to dosing limits per labeling/guidelines

Approvals may be subject to dosing limits consistent with FDA‑approved labeling, accepted compendia, and evidence‑based practice guidelines; providers should anticipate that dosing limits could affect authorization decisions.

• Dosing and administration approvals may be constrained by labeling, compendia, or guidelines.
• Confirm proposed dosing conforms to FDA‑approved or evidence‑based limits.