Obtain indication‑specific prior authorization (examples: PID up to 6 months)

Prior authorization is required and durations are indication‑specific; for example, initial authorization for primary immunodeficiency may be granted for up to 6 months when diagnostic criteria are met, and re‑authorization up to 12 months when IgG troughs are monitored and infection frequency is reduced.

• Obtain PA reflecting the indication and duration requested (e.g., up to 6 months for initial PID).
• For re‑authorization, submit yearly IgG trough monitoring or documentation of reduced infections to support up to 12 months.

Request short PA for acute MG (1 month); 6 months for refractory MG

For myasthenia gravis used for worsening weakness, acute exacerbation, or pre‑operative management, request a short (1 month) authorization. For refractory MG (failed ≥2 standard therapies) request a 6‑month authorization per criteria.

• Submit clinical documentation of worsening weakness or pre‑op indication for a 1‑month PA.
• For refractory disease, document failure of ≥2 standard therapies to support a 6‑month PA.

Request 3‑month PA for CIDP with electrodiagnostic confirmation

Initial prior authorization for CIDP should be requested for 3 months and must document disease duration ≥2 months, moderate–severe functional disability, and electrodiagnostic confirmation of diagnosis.

• Include pre‑treatment electrodiagnostic study (EMG/NCS) confirming CIDP.
• Document disease course ≥2 months and level of functional disability for a 3‑month PA.

Request 3‑month PA for dermatomyositis/polymyositis with diagnostic features

For dermatomyositis or polymyositis, request an initial 3‑month authorization and include documentation demonstrating at least 4 of the listed clinical/laboratory/pathologic features and prior trial (or contraindication) of first‑ and second‑line therapies.

• Provide records showing ≥4 diagnostic features (e.g., elevated CK, proximal weakness, EMG/myopathy changes, pathology).
• Document trials and failures of standard corticosteroid and immunosuppressive therapies or contraindications.

Follow ITP PA tiers: 1 month (new) or 6 months (chronic/refractory)

ITP authorization is time‑limited: request 1 month for newly diagnosed/initial therapy (pediatric or adult criteria) and 6 months for chronic/persistent or refractory ITP with the specified platelet thresholds and bleeding criteria.

• For newly diagnosed ITP, document age, bleeding risk or need for rapid platelet increase to support a 1‑month PA.
• For chronic/persistent ITP (≥3 months) or refractory cases, document platelet counts (<30,000/mcL or <50,000 with significant bleeding) and prior therapy failures to support a 6‑month PA.

Request 6‑month PA for CLL prophylaxis with IgG <500 mg/dL

For IVIG used as prophylaxis in CLL, submit a PA for an initial 6‑month authorization and include documentation that IG is prescribed for bacterial infection prophylaxis, history of recurrent serious infections, and a pretreatment serum IgG <500 mg/dL.

• Attach pre‑treatment serum IgG report (<500 mg/dL) and history of recurrent sinopulmonary infections requiring IV antibiotics or hospitalization.
• Request reauthorization with documentation of reduced infection frequency.

Request up to 6‑month PA for pediatric HIV prophylaxis with specified IgG thresholds

For pediatric HIV prophylaxis, request an initial authorization up to 6 months when criteria are met (e.g., pretreatment IgG <400 mg/dL, failure to form antibodies, exposure scenarios, or chronic bronchiectasis); reauthorization of 6 months requires demonstrated reduction in infections.

• Include pretreatment IgG level (for primary prophylaxis IgG <400 mg/dL) or documentation of antibody formation failure or exposure.
• Provide infection frequency data for reauthorization.

Request 6‑month PA for BMT/HSCT prophylaxis with IgG <400 mg/dL or ≤100 days post‑transplant

For BMT/HSCT recipients, request an initial 6‑month PA for prophylaxis when IG is intended to prevent post‑transplant infections and either pretreatment IgG <400 mg/dL or the request is within the first 100 days post‑transplant.

• Submit pretreatment IgG level or documentation that therapy is requested within 100 days post‑transplant.
• For reauthorization, provide evidence of reduced infection frequency.

Request 3‑month PA for MMN with electrodiagnostic confirmation

For multifocal motor neuropathy (MMN), request an initial 3‑month authorization and include electrodiagnostic confirmation and documentation of progressive, multifocal asymmetrical weakness for ≥1 month.

• Attach EMG/NCS confirming MMN and clinical documentation showing ≥1 month of the characteristic weakness.
• Document response for any reauthorization request (6 months if improved).

Request 1‑month PA for acute GBS when onset <4 weeks and disease severe

For Guillain‑Barré syndrome, request a short authorization (1 month total) when onset of neurologic symptoms is <4 weeks from therapy start and disease is severe (significant weakness or respiratory involvement).

• Provide timeline of symptom onset (<4 weeks) and documentation of severity (e.g., inability to stand/walk, respiratory weakness).
• PA should be limited to 1 month total per policy.

Request 6‑month PA for LEMS with confirmatory testing and trial of other agents

For Lambert‑Eaton myasthenic syndrome (LEMS), request an initial 6‑month authorization and include confirmatory testing (anti‑P/Q antibodies or neurophysiology) and documentation that anticholinesterases and amifampridine were tried and unsuccessful or not tolerated.

• Attach anti‑P/Q antibody test result or neurophysiology studies.
• Document trials and failures or intolerance of anticholinesterases and amifampridine to support the 6‑month PA.

Request 1‑month PA for pediatric Kawasaki syndrome

For pediatric Kawasaki syndrome, request authorization for 1 month for members under 18 years of age and include pediatric dosing/indication details with the PA request.

• Document patient age (<18) and indication of Kawasaki syndrome.
• Include dosing (e.g., single 2 g/kg IVIG dose) per product dosing tables when submitting PA.

Request 6‑month PA for F/NAIT treatment

For fetal/neonatal alloimmune thrombocytopenia (F/NAIT), request an initial authorization of 6 months for treatment and include maternal/neonatal treatment rationale and dosing details.

• Provide maternal and/or neonatal clinical documentation supporting F/NAIT treatment.
• Include dosing schedules shown (e.g., maternal 2 g/kg/week; neonatal 1 g/kg once).

Request 6‑month PA for PRCA with confirmed parvovirus B19 viremia

For parvovirus B19‑induced pure red cell aplasia (PRCA), request a 6‑month authorization and submit documentation confirming parvovirus B19 viremia and severity (severe, refractory anemia).

• Attach test result confirming parvovirus B19.
• Document severity/refractoriness of anemia and bone marrow suppression to support a 6‑month PA.

Request 6‑month PA for stiff‑person syndrome after failed first‑line therapy

For stiff‑person syndrome, request an initial 6‑month authorization and include records showing inadequate response to benzodiazepines and/or baclofen and anti‑GAD antibody test results confirming the diagnosis.

• Provide documentation of failed first‑line therapies (benzodiazepines/baclofen).
• Attach anti‑GAD antibody testing results to confirm diagnosis.

Request 1‑month PA for ICI‑related toxicities when ICI held and moderate/severe toxicity present

For immune checkpoint inhibitor (ICI)‑related toxicities, request a 1‑month authorization when the offending PD‑1/PD‑L1 agent has been held or discontinued and the member has a moderate or severe immune‑related adverse event listed in the policy.

• Document that the ICI was held/discontinued and describe the moderate/severe adverse event (e.g., myocarditis, bullous dermatitis, pneumonitis, myasthenia gravis).
• PA should be requested for 1 month total per the policy.

Request 6‑month PA for acquired red cell aplasia

Authorization of 6 months may be granted for acquired red cell aplasia; include clinical documentation supporting the diagnosis when requesting PA.

• Provide diagnostic and severity documentation for acquired red cell aplasia.
• Request PA for a 6‑month initial authorization per policy.

Request 1‑month PA for ADEM when steroids insufficient or contraindicated

For acute disseminated encephalomyelitis (ADEM), request a 1‑month authorization if the member had insufficient response or a contraindication to IV corticosteroids; document prior steroid therapy or contraindication.

• Attach records showing inadequate response to IV corticosteroids or a contraindication.
• PA should be requested for 1 month per the policy.

Obtain PA per condition; typical durations are 1 or 6 months

Obtain prior authorization for each condition per the indication‑specific durations in the policy; most authorizations are time‑limited (commonly 1 month or 6 months) and must reference the specific covered indication.

• Select the PA duration that matches the listed indication (e.g., 1 month for post‑transfusion purpura, 6 months for many transplant and chronic conditions).
• Include the specific indication on the PA request to align with policy durations.

Submit PA with the indication‑specific authorization duration (examples: 1 or 6 months)

Time‑limited authorizations in this policy are specified per indication (examples include 1 month for post‑transfusion purpura and 6 months for renal transplantation with ABO incompatibility); ensure the PA request reflects the indication‑specific duration.

• Verify the exact indication‑specific duration in the policy and enter that duration on the PA.
• Attach supporting clinical documentation required by the specific indication.

Document product, indication, and dosing; observe medication quantity limits

When requesting coverage, reference product‑ and indication‑specific dosing limits listed in the policy (medication quantity limits define maximum regimens, e.g., many indications use 2 g/kg loading or 800 mg/kg maintenance).

• Document the exact product, route, dose, and schedule on the PA to match the product‑indication dosing table.
• Be aware that quantity limits and maximum dosing regimens (e.g., 2 g/kg total, 800 mg/kg q3 weeks) are specified per product/indication.

Specify product and dosing (e.g., Bivigam, Flebogamma DIF, Gammagard Liquid) on PA

Providers should reference the product‑specific dosing entries when requesting PA; examples include Bivigam, Flebogamma DIF, and Gammagard Liquid dosing regimens listed in the policy.

• List the selected product and include the product‑specific dosing regimen from the policy (e.g., Bivigam CIDP initial 2 g/kg over 2–5 days).
• If multiple formulations are available, indicate which formulation will be used and attach dosing plan.

Document trials and failures of standard therapies when required (step therapy)

For several indications the policy requires trial and failure of standard therapies before IVIG authorization (e.g., refractory myasthenia gravis requires failure of ≥2 standard therapies). Document prior treatments and outcomes when submitting PA.

• Include clinical records describing standard therapies tried and failed (e.g., corticosteroids, azathioprine, mycophenolate) where required.
• For ITP, attach records of corticosteroid or anti‑D trial (unless contraindicated).

Provide prior‑therapy documentation per condition (dermatomyositis, LEMS, SPS, refractory MG)

Step‑therapy requirements are specified for multiple conditions: document prior failure or contraindication of first‑ and second‑line therapies for dermatomyositis/polymyositis, LEMS, stiff‑person syndrome, and refractory MG to support authorization.

• Attach evidence of prior therapy trials and reasons for discontinuation or intolerance.
• For LEMS, include anti‑P/Q antibody or neurophysiology plus trial of anticholinesterases and amifampridine.

Include documentation of failure/intolerance to standard therapies to support PA

Many indications require documentation failure, contraindication, or intolerance to standard therapies (e.g., corticosteroids, immunosuppressants); include this information in the PA to avoid denial.

• Clearly state prior treatments attempted and clinical rationale for IVIG when standard therapies failed or are contraindicated.
• For PANS/PANDAS, document prior systemic corticosteroid trial and objective baseline assessments.

Attach indication‑specific supporting documentation (labs, diagnostics, pathology, objective scales)

Submit required supporting documentation with the PA: laboratory reports (IgG, IgA, IgM, IgG subclasses), diagnostic testing (EMG/NCS, anti‑P/Q antibodies), pathology/biopsy reports, platelet counts, and objective scales (e.g., CY‑BOCS, CGIS, PANS Scale) as applicable to the indication.

• Attach pretreatment serum IgG and IgG troughs when required.
• Include EMG/NCS for CIDP/MMN, anti‑P/Q antibody for LEMS, platelet counts for ITP, pathology for blistering diseases, and objective scales for PANS/PANDAS.

Provide pretreatment IgG level for CLL, pediatric HIV, and BMT/HSCT indications

Pretreatment serum IgG level documentation is required for certain prophylaxis indications (CLL: <500 mg/dL; pediatric HIV and BMT/HSCT: <400 mg/dL where specified); include these lab reports in the PA.

• Attach lab report showing pretreatment IgG level that meets the threshold for the indication.
• For BMT/HSCT, alternatively document request within first 100 days post‑transplant if applicable.

Include platelet counts and bleeding‑risk documentation for ITP PAs

For ITP requests, include current and pretreatment platelet counts and documentation of bleeding risk or significant bleeding as specified (thresholds differ for pediatric vs adult members).

• Provide platelet count values and clinical context (e.g., mucosal bleeding, need for rapid platelet increase).
• For adults include documentation if platelet count <50,000/mcL and further thresholds (<30,000/mcL) when applicable.

Provide diagnosis‑specific documentation (biopsy for blistering disease; objective scales for PANS/PANDAS)

Certain diagnoses require specific clinical documentation: submit biopsy/pathology reports for autoimmune mucocutaneous blistering disease and objective baseline and response measures (e.g., CY‑BOCS, CGIS, PANS Scale) for PANS/PANDAS.

• Attach biopsy and pathology confirming blistering disease.
• For PANS/PANDAS, include objective baseline assessments and, for reauthorization, documentation of clinical response using the same scales.

Include recommended diagnostic workup for PANS/PANDAS when applicable

For suspected PANS/PANDAS evaluation, include recommended diagnostic workup results as applicable: CBC with differential, ESR/CRP, comprehensive metabolic panel, throat culture/ASO/anti‑DNase B, urinalysis, and antiphospholipid antibody workup when indicated.

• Provide lab results for CBC, ESR/CRP, metabolic panel, and throat culture/ASO/anti‑DNase B.
• If indicated, include ANA/FANA and antiphospholipid testing (anticardiolipin, beta2‑glycoprotein I, dRVVT).

Provide objective response documentation for re‑authorization (e.g., CY‑BOCS, CGIS)

Re‑authorization requests may be denied if objective clinical response is not submitted; for conditions like PANS/PANDAS provide objective measures of response (e.g., CY‑BOCS, CGIS, PANS Scale) to support continuation.

• Submit objective assessment demonstrating clinical improvement for reauthorization.
• Ensure continuation requests meet the specific reauthorization criteria in the policy to avoid denial.

Continuation requests must meet reauthorization/coverage criteria or risk denial

Continuation or reauthorization requests that do not meet the coverage or reauthorization criteria may be denied; ensure submitted documentation aligns with the policy's reauthorization requirements.

• Confirm that continuation requests meet the coverage criteria or the listed reauthorization conditions for the member's specific indication.
• Include all required supporting labs, diagnostics, and objective response measures to reduce denial risk.

Off‑label/non‑listed indications may be denied — meet Tennessee compendia/literature requirements

Requests for indications not listed in the policy (i.e., not FDA‑approved, compendial, or included in the Medical Policy Manual lists) are considered experimental/investigational and may be denied; for Tennessee members, off‑label uses must be supported by a statutorily recognized compendium or peer‑reviewed literature.

• If requesting off‑label use, attach supporting references from recognized compendia or peer‑reviewed literature per Tennessee mandate.
• Expect denials for non‑listed indications without appropriate compendial or literature support.