Pre-approval required for IVIG

IVIG generally requires pre-approval by the health plan; requests must document the clinical and laboratory criteria relevant to the indication (e.g., IgG thresholds or other diagnostic evidence) to establish medical necessity.

Prior authorization when documentation requires severity/prior treatment

When the indication requires showing severe progressive disease or prior inadequate response to conventional agents, prior authorization must include documentation demonstrating those clinical findings.

• Show evidence of severe progressive disease where applicable
• Document trials and inadequate response to conventional therapies

Prior authorization: autoimmune blistering diseases

Prior authorization requests for autoimmune mucocutaneous blistering diseases must demonstrate the specific diagnosis, that disease is severe and progressive, and that conventional agents were tried with inadequate response.

• Specify the blistering diagnosis (e.g., bullous pemphigoid, mucous membrane pemphigoid, pemphigus subtypes)
• Document severe progressive disease and prior inadequate response to corticosteroids and immunosuppressives

Prior authorization expected for listed IVIG indications

Prior authorization is expected when IVIG is requested for the listed autoimmune mucocutaneous blistering diseases or specified infectious/toxic conditions and must include supporting documentation that policy criteria are met.

• Include diagnosis-specific documentation for infectious indications (e.g., measles PEP, parvovirus B19, TSS)
• For autoimmune indications, include severity and prior therapy details

Prior authorization required for ITP

Prior authorization is required when IVIG is requested for adult immune thrombocytopenia (ITP); the request must document the diagnosis and the clinical circumstances per policy criteria.

• Documented diagnosis of ITP in an adult
• Provide platelet counts and bleeding-risk assessment as applicable

Prior authorization: age and platelet requirements for adult ITP

When requesting IVIG for adult ITP, prior authorization must document that the patient is ≥18 years and meets platelet-count criteria as stated in the policy.

• Age ≥ 18 years
• Platelet count threshold (policy references <10,000/mm³ primary; alternative mentions of <30,000/mm³ in parts of the text)

Prior authorization must document diagnosis and criteria

Prior authorization must establish medical necessity by documenting the diagnosis and that the individual meets the stated criteria (e.g., age for ITP, failed conventional therapy for blistering diseases, or documented TSS).

• Provide diagnosis and relevant numeric or clinical thresholds
• Show prior therapy history when required

Document diagnosis and criteria (age, platelet count, prior therapies)

Medical necessity for IVIG requires documentation of the diagnosis and fulfillment of the policy criteria, including adult age where specified, recent platelet count for ITP, and prior therapies for blistering diseases.

• Age (≥18) for adult ITP
• Recent platelet count showing policy-specified threshold
• Evidence of prior trial and inadequate response to conventional agents for blistering diseases

Prior authorization: document that policy criteria are met

Prior authorization requests must show that policy criteria are met for the referenced indications (e.g., agammaglobulinemia thresholds for immunodeficiency, platelet-count thresholds for ITP, or documented severe progressive disease for blistering diseases).

• Laboratory thresholds for immunodeficiency (e.g., IgG cutoffs) when applicable
• Documentation of severe progressive disease plus failed conventional therapy for blistering diseases
• Platelet counts per ITP thresholds

Prior authorization and documentation required for listed conditions

Prior authorization and documentation are implied for IVIG when used for listed conditions; submit supporting records that demonstrate the diagnosis and that clinical criteria are satisfied.

• Attach medical records showing the documented diagnosis
• Include lab values and prior-treatment notes as appropriate

Prior authorization: adult status, platelet count, bleeding risk for ITP

Prior authorization for adult ITP must document that the patient is ≥18 years, has platelet counts below policy thresholds, and that the patient is at risk for severe or intracranial bleeding when platelet criteria are used.

• Age ≥ 18 years
• Platelet count < 10,000/mm³ (primary threshold) and assessment of bleeding risk

Prior authorization: documentation for adult ITP and severe blistering disease

Prior authorization for IVIG in the listed indications requires documentation of the adult ITP platelet count <10,000/mm³ (or alternate threshold referenced) or documentation of severe blistering disease meeting policy criteria.

• Document platelet counts and bleeding-risk assessment for ITP
• Document severe progressive disease and prior inadequate response for blistering diseases

Prior authorization: include age, platelet count, bleeding-risk or blistering severity

Prior authorization requests must include diagnosis, age, recent platelet count, and either a bleeding‑risk assessment for ITP or documentation of severe progressive disease and prior inadequate response to conventional agents for blistering diseases.

• Diagnosis and age (≥18 for ITP)
• Recent platelet count and bleeding-risk assessment
• Evidence of prior trials and inadequate response to corticosteroids/immunosuppressives for blistering diseases

Prior authorization: clinical criteria required for adult ITP

Prior authorization requires clinical documentation demonstrating the individual is an adult (≥18 years) and meets platelet-count and bleeding-risk thresholds when IVIG is requested for ITP.

• Age ≥ 18 years
• Platelet count consistent with policy thresholds (<10,000/mm³ primary or <30,000/mm³ as an alternate mention)
• Assessment of risk for severe or intracranial bleeding

Prior authorization: document numeric thresholds or severity/prior therapy failure

Prior authorization is required with documentation of diagnosis and evidence that the individual meets the numeric platelet thresholds or disease-severity/prior-therapy failure criteria per the policy.

• Document diagnosis
• Provide platelet counts demonstrating threshold
• For blistering diseases, document severe progressive disease and failed conventional agents

Step requirement: inadequate response to conventional agents before IVIG

For certain autoimmune mucocutaneous blistering diseases, IVIG is considered medically necessary only after an inadequate response to conventional agents such as corticosteroids and immunosuppressives has been documented.

• Document trial(s) of corticosteroids and immunosuppressive agents
• Show inadequate clinical response to those agents

Step therapy: prior inadequate response required for blistering diseases

Prior authorization for autoimmune blistering diseases requires documentation that conventional therapies were tried and were inadequate before IVIG is considered.

• List specific conventional therapies attempted
• Provide clinical notes showing insufficient response

Step requirement: trials of corticosteroids and immunosuppressives

Step therapy expectations include documentation of trials and inadequate response to conventional agents (corticosteroids and immunosuppressives) prior to IVIG for autoimmune mucocutaneous blistering diseases.

• Corticosteroids trial documented
• Immunosuppressive agents (examples: azathioprine, cyclophosphamide, mycophenolate) trial documented

Step therapy: required trials of listed conventional agents

The policy requires documented trial and inadequate response to conventional agents (including corticosteroids and immunosuppressives such as azathioprine, cyclophosphamide, mycophenolate) before IVIG is considered medically necessary for blistering diseases.

• Specify agents tried (examples provided in policy)
• Document duration and outcome of those trials

Step therapy — autoimmune blistering diseases require prior inadequate response

IVIG for autoimmune mucocutaneous blistering diseases is considered medically necessary only after inadequate response to conventional agents such as corticosteroids and immunosuppressants has been documented.

• Document severe progressive disease
• Document failure of conventional therapy

Step therapy: severe progressive disease plus failed conventional therapy required

For autoimmune mucocutaneous blistering diseases, IVIG is considered only when the individual has severe progressive disease and has tried and had an inadequate response to conventional agents (corticosteroids and immunosuppressives).

• Confirm severe progressive disease in clinical notes
• Provide records of conventional-agent trials and outcomes

Step therapy: prior trial and inadequate response required

Prior inadequate response to conventional agents (corticosteroids, immunosuppressives such as azathioprine, cyclophosphamide, mycophenolate) must be documented before IVIG for blistering diseases will be considered.

• Document specific agents and treatment dates
• Supply clinician assessment of inadequate response

Step therapy requirement repeated for blistering diseases

IVIG is medically necessary for autoimmune mucocutaneous blistering diseases only after trials of conventional agents have failed; the policy repeats this requirement throughout the document.

• Ensure prior-therapy documentation is included with the authorization request

Step therapy: pemphigoid/pemphigus require prior conventional-agent failure

For pemphigoid and pemphigus variants, IVIG is considered medically necessary only after trial and inadequate response to conventional agents (examples: corticosteroids, azathioprine, cyclophosphamide, mycophenolate).

• Document conventional-agent trials and response
• List examples of immunosuppressives tried

Step therapy: prior trials required (repeated)

The policy repeatedly instructs that conventional-agent failure must be documented before IVIG is considered for autoimmune mucocutaneous blistering diseases.

• Provide timeline of treatments and evidence of inadequate response

Step therapy: examples of conventional agents to document

Examples of conventional immunosuppressive agents that should be documented as tried and inadequate include azathioprine, cyclophosphamide, and mycophenolate.

• List specific agents (azathioprine, cyclophosphamide, mycophenolate) and treatment details in the record

Step therapy: document failed conventional agents (repeated instruction)

The policy reiterates that conventional agent failure is required before IVIG for autoimmune mucocutaneous blistering diseases; include documentation of those failed trials in the prior-authorization packet.

• Attach prior-treatment notes, dosing, and assessments of response

Step therapy: repeated instruction for blistering diseases

The requirement that conventional agents be tried and found inadequate before IVIG for autoimmune mucocutaneous blistering diseases is reiterated multiple times; ensure records clearly show these trials and outcomes.

• Make prior-treatment documentation explicit and easy to review

Step therapy: repeated requirement across policy

Step-therapy instructions for autoimmune mucocutaneous blistering diseases are repeated throughout the policy; prior conventional-agent failure is a consistent requirement before IVIG will be considered.

• Include documentation of severity and prior inadequate response in authorization requests

Step therapy: repeated requirement (final excerpt)

The policy's repeated statements emphasize that IVIG for autoimmune mucocutaneous blistering diseases is considered only after inadequate response to conventional agents; include clear prior-therapy records.

• Document prior use of corticosteroids and listed immunosuppressives and outcomes

Required lab documentation: IgG levels and vaccine-response evidence

Required clinical and laboratory documentation includes laboratory evidence of immunoglobulin deficiency (IgG levels and, where applicable, repeat measurements or inability to mount vaccine response) and documentation of recurrent or severe infections when indicated.

• Provide IgG values and repeat testing if referenced
• Include vaccine-response testing or explanation of inability to mount response when applicable

Required documentation: diagnosis for infectious/toxic indications

Documented diagnosis is required for indications such as measles post-exposure prophylaxis, severe anemia due to parvovirus B19, and toxic shock syndrome; include the diagnostic evidence in the prior-authorization submission.

• Attach diagnostic test results or clinician diagnosis notes for measles PEP, parvovirus B19 anemia, or TSS

Required clinical documentation: diagnosis, severity, prior inadequate response

Clinical documentation must show the diagnosis, disease severity, and prior inadequate response to conventional agents when applicable; include specific clinical notes supporting those elements.

• For blistering diseases: diagnosis, severity, and prior-treatment failure
• For ITP: diagnosis, age, platelet counts, and bleeding-risk assessment

Required documentation: list specific blistering diagnoses

Documentation should include the specific covered diagnosis (e.g., bullous pemphigoid, mucous membrane pemphigoid, pemphigus variants) and supporting evidence of severe progressive disease and prior inadequate response to conventional therapies.

• List the specific pemphigoid/pemphigus subtype
• Attach clinician assessments documenting progression and treatment failure

Diagnosis-specific documentation required

Documentation must identify the referenced condition (parvovirus B19 anemia, TSS, ITP, or autoimmune blistering disease) and include the evidence required by policy to support IVIG use.

• Include diagnosis and the specific evidence that meets policy criteria

Document diagnosis for referenced infectious conditions

Documented diagnosis is required for the listed conditions (for example, human parvovirus B19) and must be included with the authorization request.

• Provide laboratory or clinical documentation confirming the diagnosis

Required documentation: diagnosis, age, platelet count, prior therapy evidence

Medical record documentation should include diagnosis, age, recent platelet count, and evidence of prior therapies (and inadequate response) where required by the indication.

• Include age and platelet-count values for ITP
• Attach prior-treatment notes for blistering diseases

Required documentation: age, platelet count, bleeding-risk for ITP

Documentation must include age (≥18 for adult ITP), recent platelet counts demonstrating the policy threshold (primary <10,000/mm³; alternate mentions <30,000/mm³), and an assessment of bleeding risk when applicable.

• Age documentation
• Recent platelet count values
• Bleeding-risk assessment or clinician rationale

Required clinical documentation: diagnosis, severity, prior trials, platelet counts

Clinical documentation must include the diagnosis, disease severity (severe progressive disease for blistering diseases), prior trials and inadequate response to conventional agents, and platelet counts/bleeding risk for ITP.

• Diagnosis and severity notes for blistering diseases
• Records of conventional-agent trials and outcomes
• Platelet counts and bleeding-risk assessment for ITP

Required documentation: evidence conventional agents were tried and inadequate

Documentation must show that conventional agents (e.g., corticosteroids and immunosuppressive agents such as azathioprine, cyclophosphamide, mycophenolate) were tried and had inadequate response for blistering diseases prior to IVIG.

• List specific agents tried and clinical response
• Provide durations and clinician assessment of inadequate response

Denial risk if policy criteria not documented

Requests lacking documentation of meeting the policy criteria (age for ITP, platelet-count threshold, severe progressive blistering disease, or prior inadequate response to conventional agents) may be denied.

• Include all required clinical and laboratory evidence to avoid denial

Denial risk for site-of-service mismatch

Site-of-service mismatch can lead to denial: use of outpatient hospital IV infusion when the policy's site-of-service criteria are not met may be considered not medically necessary.

• Follow site-of-service guidance (preferred outpatient sites for initial 90 days, exceptions when medically necessary)

Denial risk: missing severity or prior-treatment documentation for blistering diseases

Lack of documentation that disease is severe and progressive or that conventional agents were tried and inadequate for autoimmune mucocutaneous blistering diseases may result in denial of IVIG requests.

• Provide clear clinical evidence of progression and treatment failure

Denial risk: missing age or platelet evidence for adult ITP

Requests for IVIG for adult ITP may be denied if the request does not document that the patient is ≥18 years or that the platelet-count threshold (<10,000/mm³, or alternate <30,000/mm³ where referenced) and bleeding-risk criteria are met.

• Confirm age and include recent platelet counts and bleeding-risk rationale

Denial risk: missing diagnostic indication

Requests lacking documentation of the diagnostic indication (e.g., ITP, TSS, autoimmune mucocutaneous blistering disease) risk denial; always include the documented diagnosis in the submission.

• Attach diagnostic notes or test results confirming the indication

Denial risk: missing prior-treatment documentation for blistering diseases

Failure to document prior treatment trials (corticosteroids and immunosuppressives) and inadequate response for blistering diseases may result in denial of IVIG requests.

• Provide records of prior therapies and clinician assessment of inadequate response

Denial risk: ITP platelet threshold not met

If ITP threshold criteria are not met (no documentation of age ≥18 and platelet count <10,000/mm³ or applicable alternate threshold), IVIG requests for adult ITP may be denied or considered not medically necessary.

• Include explicit platelet-count values and age in the record to meet threshold