CurrentAetnaPolicy N/A

Immunoglobulins Therapy Medication and/or Infusion Precertification Request - Coverage Criteria

Precertification request form and required clinical documentation for outpatient and infusion-site administration of immune globulin products for Aetna members; used by prescribing and dispensing providers to request start or continuation of immunoglobulin therapy.

Policy Summary

PayerAetna

PolicyImmunoglobulins Therapy Medication and/or Infusion Precertification Request - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Immunoglobulins Therapy Precertification Request form with all required clinical checklist items and documentation to support initiation or continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20+indications listed

6form pages

~20products listed

Providedcontact info

6follow-up items

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Coverage Criteria

Coverage criteria — initiation and continuation (form-driven)

Coverage is assessed based on documentation submitted on the Immunoglobulins Therapy Precertification Request form. All initiation and continuation requests (except GamaSTAN) require completion of the form fields and supporting clinical documentation as noted below.

General submission requirements: All requests (except GamaSTAN) require completion of all form fields, selection of product, dose, frequency, and ICD/CPT administration codes; documentation of prior immunoglobulin use within the last 3 months (if applicable); and documentation of prior treatment responses, adverse reactions, IgA antibody status, and venous access issues.

See product information and general questions on form.

Request type: Indicate whether this is an initiation request, a continuation of existing treatment, a continuation after a gap greater than 8 weeks, or a new therapy request (patient has not received the requested medication in the last 6 months) or a brand‑switch.

Form capture of continuation/new therapy status.

Precertification checklist completion: The clinical information checklist on the form must be completed for the specific indication requested (e.g., laboratory values, diagnostic confirmation, prior therapies tried and responses). Incomplete or illegible forms may lead to denial or delay.

See instruction that all fields must be completed and legible.

Adverse events and infusion issues: Document any prior adverse events to the requested product and whether conventional interventions were ineffective, plus whether the patient has lab‑confirmed anti‑IgA antibodies or severe venous access issues that necessitate outpatient hospital setting.

Form asks about adverse events, IgA antibodies, and venous access.

Initiation-specific requirement: For initiation requests (except GamaSTAN) the specific indication must be selected on the form and the associated required clinical items completed (examples include diagnosis confirmation, pre‑treatment IgG level where requested, prior therapy trials and responses).

Form lists many initiation indications with associated required fields.

Continuation-specific requirement: For continuation requests document clinical benefit (e.g., reduction in frequency of bacterial infections for immunodeficiency/CLL/transplant/HIV; significant improvement or maintenance of improvement for neurologic or myopathic disorders), use of lowest effective dose/frequency, and monitoring such as annual trough IgG with dose re‑evaluation when applicable.

Continuation checklist items and trough IgG monitoring questions present on form.

Exception—GamaSTAN: GamaSTAN requests have separate, indication‑specific documentation requirements related to post‑exposure prophylaxis (see GamaSTAN criteria).

GamaSTAN is listed as an exception to general documentation rules.

Indication-specific required clinical criteria

The precertification form captures indication‑specific clinical items. Coverage is supported when ALL required checklist items for the selected indication are completed and documented on the form.

Immune thrombocytopenia (ITP) — initial and chronic: For newly diagnosed or previously untreated ITP indicate timing (diagnosed within past 3 months or initial therapy), patient age group, and provide current pretreatment platelet count (choices on form: <30,000/mcL; 30,000 to <50,000/mcL; ≥50,000/mcL). For chronic/persistent (≥3 months) or unresponsive ITP document duration, whether relapsed after previous IG response, and history of inadequate response/intolerance/contraindication to corticosteroid or anti‑D therapy.pretreatment platelet count thresholds

Form includes checkboxes for platelet ranges and prior responses.

Primary immunodeficiency and related disorders: Specify the immunodeficiency (e.g., CVID, X‑linked agammaglobulinemia, SCID, Wiskott‑Aldrich), provide history of recurrent bacterial infections, indicate whether IG was initiated inpatient, provide pre‑treatment IgG level, confirm exclusion of other causes of immune deficiency, and for age ≥2 years document impaired antibody response to pneumococcal polysaccharide vaccine when applicable.pre‑treatment IgG level (including ≥2 SD below mean for age when prompted)

Except where noted below for GamaSTAN, clinical documentation is required for all immunoglobulin precertification requests. The form requires selection of the product, dose, frequency, and diagnosis codes and completion of clinical checklist items (prior IG within 3 months, infusion venue, continuation status, prior adverse events, IgA antibody status, and venous access issues). GamaSTAN is explicitly listed on the product selection and treated as an exception to the general documentation requirement in the form language.

Requests for GamaSTAN used as post‑exposure prophylaxis must document the exposure timing and risk status specified on the form. The allowed exposure windows are: hepatitis A — within 2 weeks; measles (rubeola) — within 6 days; varicella (chickenpox) — within 10 days; and rubella — recent exposure with pregnancy status noted. For varicella prophylaxis, the form also asks whether varicella zoster immune globulin (e.g., Varizig) is currently unavailable; availability of a specific IG product may alter appropriateness of GamaSTAN. Complete the GamaSTAN checklist fields on the form to document exposure timing, vaccination/exposure history, and high‑risk status as applicable.

Coding

Administration codes requestedCPT

administration code(s) (CPT)

Form requests administration CPT codes for infusion

Diagnosis codes requestedICD-10

Primary ICD Code	Primary diagnosis code to be provided on form
Secondary ICD Code	Secondary diagnosis code to be provided on form
Other ICD Code	Additional diagnosis code field

Pretreatment platelet count

<30,000/mcLSelection option on form for current pretreatment platelet count (listed as Less than 30,000/mcL [30 x 10^9/L]).

30,000 to <50,000/mcLSelection option on form for current pretreatment platelet count (listed as 30,000 to less than 50,000/mcL [30 x 10^9/L to <50 x 10^9/L]).

>=50,000/mcLSelection option on form for current pretreatment platelet count (listed as Greater than or equal to 50,000/mcL [50 x 10^9/L]).

Platelet count thresholds for ITP

Newly diagnosed / Previously untreated ITPForm asks for pretreatment platelet count with choices: Less than 30,000/mcL; 30,000 to less than 50,000/mcL; Greater than or equal to 50,000/mcL.

Chronic / Persistent or Unresponsive ITP

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required — Complete Form & Key Fields

Submit a precertification request using the Aetna Immunoglobulins Therapy Precertification Request form. All fields on the 6-page form must be completed and legible; incomplete or illegible forms may delay review or result in denial. Include product name, exact dose, dosing frequency, primary and secondary ICD-10 diagnosis codes, administration setting, and whether this is a start or continuation of therapy. For GamaSTAN requests include exposure timing and the specific GamaSTAN checklist items (e.g., exposure within required window for hepatitis A, measles, rubella, or varicella).

Precertification required — call Aetna Precertification Notification: 1-866-752-7021 (TTY: 711) or fax 1-888-267-3277.
Include product selection (e.g., Gamunex-C, Privigen, Hizentra, GamaSTAN, etc.) and dose/frequency exactly as administered.
Provide primary and any secondary ICD-10 diagnosis codes on the form.
Indicate start of treatment or continuation and provide relevant dates; for continuations note if a gap >8 weeks occurred.

Definitions & Background

The Immunoglobulins Therapy Medication and/or Infusion Precertification Request form is the required vehicle for prior authorization of initiation and continuation of immune globulin therapies. It documents the requested product, dosing and administration details, primary and secondary diagnosis codes and a structured clinical checklist that captures indication‑specific data such as pretreatment laboratory values (e.g., IgG, platelet counts), diagnostic confirmations (biopsy, EMG/NCS, antibody testing), prior therapies tried and responses, reasons for continuation, and infusion site or access issues. Completion of all required fields and submission of supporting clinical data allows Aetna to evaluate medical necessity for the specific indication and therapy requested.

Product list

AlygloListed as selectable product on the form.

AscenivListed as selectable product on the form.

BivigamListed as selectable product on the form.

CutaquigListed as selectable product on the form.

Cuvitru

Policy Summary

PayerAetna

PolicyImmunoglobulins Therapy Medication and/or Infusion Precertification Request - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the Immunoglobulins Therapy Precertification Request form with all required clinical checklist items and documentation to support initiation or continuation requests.

SourceLink

On This Page

Form requests specific disorder, infection history, IgG values, and vaccine response.

IgG subclass or specific antibody deficiency: Document low IgG subclass(es) and whether subclass level was ≥2 standard deviations below the mean for age measured on at least two occasions; document normality of other immunoglobulins as prompted.IgG subclass ≥2 SD on ≥2 occasions

Form includes subclass selection and repeat measurement requirement.

Neurologic autoimmune and neuromuscular indications: For CIDP, myasthenia gravis, multifocal motor neuropathy, LEMS, opsoclonus‑myoclonus and similar disorders document diagnostic confirmation (e.g., EMG/NCS, antibody testing), disease course and severity (CIDP progressive/relapsing ≥2 months; presence of moderate‑severe functional disability; GBS onset <4 weeks for therapy), and prior standard therapies tried and failed as applicable (e.g., anticholinesterase, amifampridine, 2+ standard therapies).diagnostic confirmations and prior therapy failures

Form asks specific EMG/NCS and antibody confirmations and prior therapy trial details.

Post‑exposure prophylaxis — GamaSTAN specific items: For GamaSTAN indicate the exposure scenario and timing: hepatitis A exposure within 2 weeks, measles exposure within 6 days, varicella exposure within 10 days, rubella recent exposure and pregnancy status, and whether specific immune globulins (e.g., VZIG) are unavailable.exposure time windows

GamaSTAN has separate checklist items for exposure timing and vaccine/immune globulin availability.

Hemato‑oncologic and transplant indications: For B‑cell CLL, bone marrow/hematopoietic stem cell transplant recipients, CAR‑T related hypogammaglobulinemia, and HIV infection indicate pre‑treatment IgG level, whether IG is prescribed for prophylaxis of bacterial infections, transplant timing (e.g., within past 100 days when prompted), and for continuation document reduction in bacterial infection frequency since starting IG.pre‑treatment IgG level and infection frequency improvement

Form requests IgG levels, transplant timing, and infection‑reduction outcomes for continuation requests.

Continuation monitoring and maintenance: For continuation requests indicate clinical benefit (reduced infection frequency or sustained improvement), confirm IG is being used at the lowest effective dose and frequency, document annual trough IgG measurement (at least once per year) and whether the most recent trough is at or above the lower range of normal for age, and whether dose re‑evaluation will occur when appropriate.trough IgG monitoring and dose re‑evaluation

Form contains specific continuation questions about trough IgG, dose adjustment and clinical improvement.

For chronic (>=3 months) or ITP unresponsive to first-line therapy, same platelet count choices apply and additional items (history of prior IG response, intolerance/contraindication to corticosteroid/anti-D) are requested.

Bleeding risk/context notesForm prompts documentation of significant bleeding symptoms and risk factors (e.g., comorbidity, planned procedure, mandated anticoagulation, high-risk profession) when platelet thresholds are used.

Pretreatment IgG thresholds

IgG ≥ 500 mg/dLForm includes specific branch: for pre-treatment IgG greater than or equal to 500 mg/dL, ask whether level is ≥2 SD below mean for age (yes/no) in certain indications.

IgG ≥ 200 mg/dL (SCID context)For SCID and related testing, the form lists pre-treatment IgG greater than or equal to 200 mg/dL with additional questions about maternal T-cells and CD3 count.

IgG < 400 mg/dL (HLH/MAS)For HLH/MAS the form asks for total IgG and specifically whether the patient's total IgG level is less than 400 mg/dL.

Documentation Required

Provider Actions — Document Prior Treatment Attempts/Failures

The precertification form captures prior treatment attempts and failures necessary to support certain indications. For initiation and continuation requests, document prior therapies tried, inadequate responses, contraindications, or intolerances (for example: corticosteroids, immunosuppressants, G‑CSF, splenectomy, anti‑D, PD‑1/PD‑L1 discontinuation, benzodiazepines/baclofen for stiff person syndrome, or at least two standard therapies for myasthenia gravis). Where requested, provide dates, doses, and clinical response.

Indicate prior corticosteroid use and whether response was inadequate or contraindicated.
Document prior immunosuppressant trials (e.g., azathioprine, mycophenolate, cyclosporine) and outcomes.
For autoimmune/neuro indications, provide prior use/failure of therapies (e.g., G‑CSF for autoimmune neutropenia, splenectomy for autoimmune hemolytic anemia).
For ITP and other hematologic indications, provide pretreatment platelet counts and prior responses to IG or other therapies.

Documentation Required

Clinical Checklist — Provide Complete Clinical Data & Attachments

Complete the Aetna Immunoglobulins Therapy Precertification Request clinical checklist in full. For non‑GamaSTAN requests include pre‑treatment laboratory values when requested (e.g., pre‑treatment IgG level, platelet counts, antibody testing, genetic confirmation where indicated) and attach supporting lab reports, pathology reports, or consultation notes. Failure to supply requested clinical data (including diagnostic testing and electrodiagnostic studies when required) may delay or result in denial.

Attach laboratory reports showing pre‑treatment IgG level when requested (e.g., CVID, HLH, stem cell or CAR‑T related hypogammaglobulinemia).
Include pathology reports for diagnoses requiring biopsy confirmation (e.g., autoimmune mucocutaneous blistering diseases).
Attach EMG/NCS reports when electrodiagnostic confirmation is required (e.g., CIDP, GBS, other neuropathies).
Provide documentation of adverse infusion events and interventions tried for infusion reactions, except for GamaSTAN where a specific exposure timeline is required.

Note

Form Captures Prior IG Use, Brand Changes, and Continuation Details

The form explicitly requests whether the patient has previously received immune globulin for the requested indication within the past 3–6 months and whether the request is for a different brand. Indicate prior IG exposure, prior responses, adverse events, and reasons for brand change. For continuation requests specify if treatment was initiated in the hospital and whether the request is to continue established therapy.

Check the box indicating prior immunoglobulin therapy within the last 3 months (or as specified) and provide dates.
If switching products, state prior product, reason for change (e.g., adverse reaction, lack of efficacy), and any relevant documentation.
For continuation after hospital initiation, state date of last treatment and whether gap >8 weeks occurred.

Documentation Required

GamaSTAN — Specific Documentation Requirements

For GamaSTAN requests only, document the specific exposure timing windows and risk factors per the GamaSTAN checklist (e.g., hepatitis A exposure within past 2 weeks, measles exposure within past 6 days, varicella exposure within past 10 days), pregnancy status for rubella, vaccine history, and unavailability of alternatives (e.g., TIG or VZIG).

State the date and nature of exposure and confirm it falls within the product‑specific prophylaxis window.
Document pregnancy status when requesting rubella prophylaxis.
If an alternative immune globulin product (e.g., Varizig, TIG) is unavailable, state this on the form and provide supporting notes.

Denial Risk

Fraud Warning & Attestation

Be aware that submitting materially false or misleading information on the precertification form may constitute insurance fraud and can result in denial and legal penalties. The request must be completed and signed (signature required) by the person submitting it.

Signer must include printed name and signature and date the form.
False statements or concealment of material information may lead to criminal and civil penalties.

Listed as selectable product on the form.

Flebogamma DIFListed as selectable product on the form.

HizentraListed as selectable product on the form.

Pre-treatment IgG level (form request)

Pre-treatment IgG (general)Form requests the patient's pre-treatment IgG level for multiple indications (e.g., CLL, bone marrow transplant, CAR-T related hypogammaglobulinemia, HIV prophylaxis).

Provide lab reportFor some indications (e.g., HLH/MAS) the form explicitly requests a copy of the laboratory report with the pre-treatment IgG level.

Context-specific useThe pre-treatment IgG value is used to determine prophylaxis vs treatment intent and to apply indication-specific thresholds (see form branches).

Pretreatment IgG level (measured serum IgG)

Numeric IgG value to reportForm requires entry of the measured serum total IgG concentration (numeric value) and, when applicable, a laboratory report copy.

Interpretive contextThe numeric pre-treatment IgG is evaluated relative to age-based norms (e.g., ≥2 SD below mean for age) and indication-specific cutoffs (e.g., <400 mg/dL for HLH; ≥200 mg/dL for SCID considerations).

Follow-up/monitoring useFor continuation requests the form also asks about trough IgG monitoring (annual trough measurement and whether most recent trough is at/above lower range of normal for age) to guide ongoing dosing decisions.