Medical necessity and site-of-service review

IVIG and injectable immune globulin therapies require health plan medical necessity review; for individuals aged 13 years and older the site of service will also be reviewed.

Prior authorization requirement

Prior authorization is required and should demonstrate a documented diagnosis and supporting clinical data that the request meets the policy's medical necessity criteria.

Prior authorization: diagnosis + failed conventional therapy

When IVIG is requested for autoimmune mucocutaneous blistering diseases, prior authorization must document the diagnosis and that the patient has severe progressive disease with inadequate response to conventional agents.

Prior authorization: medical necessity summary

Prior authorization must demonstrate that the individual has severe progressive disease and has tried and had an inadequate response to conventional therapies in order to meet medical necessity.

Prior authorization for ITP (Adults)

Prior authorization is required when IVIG is requested for adult ITP; the request must document the patient's age (≥18 years) and the recent platelet count when platelet count is <10,000/mm³.

Prior authorization for autoimmune blistering diseases

Prior authorization is required for IVIG for autoimmune mucocutaneous blistering diseases and must document severe progressive disease and failure/inadequate response to corticosteroids and immunosuppressive agents.

Prior authorization — IVIG approvals require diagnosis and prior therapy

Approvals for IVIG for blistering diseases or adult ITP require prior authorization with documentation of diagnosis subtype and prior treatment failures or, for ITP, age and platelet-count evidence.

Document diagnosis subtype and prior therapy

Prior authorization submissions should identify the specific diagnosis subtype (e.g., bullous pemphigoid, mucous membrane pemphigoid, pemphigus vulgaris/foliaceus, IgA pemphigus, paraneoplastic pemphigus) and prior treatment failures for blistering diseases.

Prior authorization required for IVIG in adults

When requesting IVIG in adults, prior authorization must document the patient’s age and applicable platelet-count thresholds and prior therapy where applicable.

Document age, platelet count, and qualifying situation

Prior authorization requests must include patient age, platelet count, and, when platelet is between thresholds, the qualifying bleeding risk or medically necessary situation and documentation of prior trials when relevant.

Prior authorization — age, platelet counts, and clinical justification

Prior authorization is required for IVIG in adults with ITP or pemphigoid/pemphigus and should document age, platelet counts, bleeding risk or qualifying situations, and prior inadequate response to corticosteroids and immunosuppressive agents for blistering diseases.

Prior authorization implied when criteria met

Prior authorization is implied for IVIG use in adult ITP and listed pemphigoid/pemphigus diseases when the specified criteria (age, platelet thresholds, bleeding risk or other medically necessary situations, and prior inadequate trials) are met.

Prior authorization — adult ITP and pemphigoid/pemphigus

Prior authorization for IVIG in adult ITP should confirm age ≥18 years and platelet-count criteria with supporting clinical context (e.g., risk for severe or intracranial bleeding or need to rapidly increase platelets).

Prior authorization for IVIG in adult ITP — confirm qualifying situation

Prior authorization is expected when IVIG is requested for adult ITP to confirm age and platelet-count criteria and the presence of a qualifying medically necessary situation for rapid platelet increase.

Prior authorization for IVIG — adult ITP: document age, platelets, and situation

Prior authorization for IVIG in adult ITP must document the patient’s age (≥18 years), the platelet count, and the medical situation requiring rapid platelet increase (e.g., bleeding, planned major surgery, or intracranial bleeding risk).

Prior failure of conventional therapy required

For autoimmune mucocutaneous blistering diseases, IVIG is considered medically necessary only after failure of conventional agents; prior authorization must show prior inadequate response.

Required prior therapies before IVIG

The policy requires documentation of prior trial and inadequate response to conventional agents (corticosteroids and immunosuppressives such as azathioprine, cyclophosphamide, mycophenolate) before IVIG is considered medically necessary.

• Corticosteroids
• Azathioprine
• Cyclophosphamide
• Mycophenolate

Step therapy requirement — prior immunosuppression needed

Evidence of prior use and inadequate response to conventional agents (corticosteroids and immunosuppressives) is required prior to IVIG for listed dermatologic indications.

Step therapy: document prior trials and inadequate response

Step therapy requires prior use and inadequate response to conventional agents such as corticosteroids and immunosuppressive agents (examples: azathioprine, cyclophosphamide, mycophenolate) before IVIG is considered medically necessary for listed autoimmune blistering diseases.

• Document trial of corticosteroids
• Document trial of immunosuppressive agents (e.g., azathioprine, cyclophosphamide, mycophenolate)

Step therapy — pemphigoid/pemphigus

For pemphigoid and pemphigus indications, IVIG is considered only after trial and inadequate response to conventional agents (corticosteroids and immunosuppressive agents).

Required trial of conventional agents (examples listed)

Providers must document trials and inadequate response to conventional agents (corticosteroids and immunosuppressives such as azathioprine, cyclophosphamide, mycophenolate) before IVIG for listed dermatologic indications.

Document prior conventional therapy for blistering diseases

For mucocutaneous blistering diseases, the policy requires prior use and inadequate response to conventional agents (corticosteroids and immunosuppressive agents such as azathioprine, cyclophosphamide, mycophenolate) before IVIG is considered medically necessary.

Step therapy — document inadequate response to listed agents

Documentation must show prior trials of corticosteroids and immunosuppressives and inadequate response before IVIG for the listed autoimmune blistering diseases.

Step therapy for autoimmune blistering diseases

For pemphigoid and pemphigus, IVIG is indicated only after the individual has tried and had an inadequate response to conventional agents (e.g., corticosteroids, azathioprine, cyclophosphamide, mycophenolate).

Prior therapy requirement — examples

Providers must include prior therapy documentation (corticosteroids and immunosuppressives such as azathioprine, cyclophosphamide, mycophenolate) showing inadequate response before IVIG for pemphigoid/pemphigus.

Step therapy — pemphigoid/pemphigus: prior inadequate response required

For pemphigoid and pemphigus, IVIG is considered when the individual has tried and had an inadequate response to conventional agents such as corticosteroids and immunosuppressive agents (e.g., azathioprine, cyclophosphamide, mycophenolate).

Provider actions — summary checklist

Additional provider actions: ensure prior authorization is obtained, include specific diagnosis subtype, provide recent platelet counts and bleeding-risk assessment for ITP, and document prior trials and inadequate responses to conventional agents for blistering diseases.

• Obtain prior authorization before initiating IVIG.
• Include specific diagnosis subtype for blistering diseases.
• Provide recent platelet counts and clinician assessment of bleeding risk for ITP.
• Document prior trials and inadequate response to corticosteroids and listed immunosuppressives.

Pre-approval (prior authorization) required

Pre-approval (prior authorization) of IVIG treatment is generally required by the health plan.

Documented diagnosis required

A documented diagnosis is required for IVIG to be considered medically necessary for the listed conditions (autoimmune mucocutaneous blistering diseases, TSS, parvovirus B19 anemia, paraneoplastic).

Required clinical documentation: diagnosis, severity, prior therapies

Clinical documentation must include the diagnosis and evidence that the individual has severe progressive disease and prior inadequate response to conventional agents (corticosteroids and listed immunosuppressive agents).

Documentation should support age and prior trials

Documentation should support age (adult: ≥18 years for ITP) and prior trials of conventional agents and evidence of severe progressive disease where applicable.

Include diagnosis subtype, severity, prior trials, and platelet counts

Clinical documentation should include the specific diagnosis (type of pemphigoid/pemphigus or ITP), evidence of severe progressive disease for blistering disorders, prior trials and inadequate response to corticosteroids and immunosuppressives, and recent platelet count for ITP.

Autoimmune blistering diseases — required documentation

Clinical documentation must show severe progressive mucocutaneous blistering disease and prior inadequate response to conventional agents (steroids and immunosuppressives such as azathioprine, cyclophosphamide, mycophenolate).

ITP documentation — age, platelet count, and bleeding-risk assessment

For adult ITP, documentation must include age (≥18 years), recent platelet count (<10,000/mm³ when applicable), and clinician assessment that the individual is at risk for severe or intracranial bleeding when relevant.

Document age, platelet counts, bleeding risk, and prior trials

Documentation should demonstrate patient age (≥18 years), recent platelet counts when treating ITP, clinical assessment of bleeding risk or severe/progressive disease for blistering disorders, and prior trials with inadequate response to conventional agents.

Document platelet thresholds and qualifying indications

Document patient age, platelet count, and risk for severe or intracranial bleeding if platelet <10,000/mm³; if platelet <30,000/mm³ document one of the specified additional indications and prior therapies with inadequate response.

Documentation — adult ITP and blistering disease criteria

Documentation should support patient age (≥18 years), recent platelet count, presence or risk of severe/intracranial bleeding, or the specific medically necessary situation when platelet count is <30,000/mm³; include prior trial and inadequate response for pemphigoid/pemphigus.

Required clinical documentation — age, platelets, bleeding/therapies

Documentation must include age, current platelet count, presence of bleeding or other medically necessary situations for ITP, and prior trials with inadequate response to conventional agents for pemphigoid/pemphigus diagnoses.

Documentation — urgent situations and prior therapy

Documentation should include patient age, platelet count, documentation of bleeding risk or specific urgent situation (e.g., major bleeding, planned major surgery, intracranial bleeding risk), and prior trial and inadequate response to conventional agents for pemphigoid/pemphigus.

Documentation — qualifying clinical situations for platelet <30,000/mm³

Documentation must support patient age (≥18 years), recent platelet count, and presence of qualifying clinical situations (risk of severe or intracranial bleeding; need to rapidly increase platelets for major bleeding or planned major surgery) or inadequate response to conventional agents for pemphigoid/pemphigus.

Documentation — describe bleeding or intracranial risk when applicable

Documentation should include age, recent platelet count, and description of bleeding or risk for intracranial bleeding and, if applicable, documentation of the medically necessary situation requiring rapid platelet increase.

Documentation — justify IVIG for platelet <30,000/mm³ or <10,000/mm³

Documentation should include the patient's age, current platelet count, and clinical justification when platelet count is <30,000/mm³ (e.g., active bleeding, planned major surgery, or risk of intracranial bleeding) or when platelet count is <10,000/mm³ with risk for severe bleeding.

Site-of-service noncompliance triggers denial

Use of non-preferred sites of service for infusion/injection therapies when the policy's site-of-service criteria are not satisfied is considered not medically necessary and may trigger denial.

Documentation-based denial risk — severity and prior therapy

IVIG may be denied if there is no documentation that the individual has severe progressive disease and has tried and had an inadequate response to conventional agents as required by the policy.

Denial risk — missing diagnosis or prior therapy evidence

Requests lacking a documented diagnosis or evidence that the disease is severe progressive and that conventional agents were tried and inadequate may be denied.

Denial risk — ITP platelet/age criteria not met

Requests for IVIG for adult ITP may be denied if the patient is not aged ≥18 years or the platelet count does not meet the <10,000/mm³ threshold (or the <30,000/mm³ plus qualifying situation where applicable).

Denial risk — inadequate prior therapy for blistering diseases

IVIG requests for autoimmune mucocutaneous blistering diseases may be denied if there is no documentation of severe progressive disease or inadequate response to conventional agents.

Denial risk — missing prior therapy or disease severity

Requests that do not document severe progressive disease or prior inadequate response to conventional agents (corticosteroids, azathioprine, cyclophosphamide, mycophenolate) for blistering diseases may not meet medical necessity and risk denial.

Denial risk — missing adult ITP eligibility documentation

For adult ITP, absence of documentation that the patient is ≥18 years and has platelet count <10,000/mm³ with risk for severe or intracranial bleeding may lead to denial.

Denial risk — failure to meet documented medical necessity criteria

Requests for IVIG that do not meet documented medical necessity criteria (age requirement, platelet thresholds, or documented severe progressive blistering disease with prior inadequate response) may be denied.

Denial triggers — missing age, platelet, or prior therapy documentation

Requests for IVIG in adults that do not document age ≥18, platelet counts meeting thresholds, or lack documentation of risk for severe/intracranial bleeding or inadequate response to conventional agents may be denied.

Denial risk — not meeting platelet thresholds

Requests for IVIG for adults with ITP that do not meet the stated platelet thresholds (<10,000/mm³ with bleeding risk or <30,000/mm³ with an additional qualifying situation) may be denied.

Denial risk — criteria unmet

Requests for IVIG when criteria for adult ITP (age, platelet thresholds, or documented medically necessary situations) or the listed dermatologic disease criteria are not met may be at risk for denial.

Denial risk — unsupported ITP indications

Requests for IVIG that do not document age ≥18 for adult ITP or do not document platelet counts meeting the stated thresholds (e.g., <10,000/mm³ or <30,000/mm³ with an appropriate urgent situation) may be denied.

Denial risk — missing age or platelet criteria

Requests lacking documentation that the patient is age 18+ or platelet counts below specified thresholds (e.g., <10,000/mm³ or <30,000/mm³ with qualifying situation) may be at risk for denial.

Denial risk — not meeting platelet/age criteria

Requests for IVIG for adult ITP that do not meet age and platelet-count criteria (age ≥18 and platelet count <10,000/mm³ with risk for severe bleeding, or platelet count <30,000/mm³ with a documented medically necessary situation) may be denied.