CurrentClover HealthPolicy 3950-A

Jurisdiction Specific Medicare Part B Intravenous Immune Globulin (IVIG)

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This policy governs coverage and prior authorization for brand and generic IVIG products administered under Medicare Part B in Jurisdiction 6 and Jurisdiction K states when an approved indication and applicable clinical criteria are met.

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Intravenous Immune Globulin (IVIG)

Policy CodePolicy 3950-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the diagnosis and clinical indication for IVIG, and submit Medicare-approved compendia support for unlisted indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16IVIG products referenced

50+Covered indications

6 monthsStandard authorization duration

1 monthAcute-indication authorization

<400 mg/dL

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CurrentClover HealthPolicy 3950-A

Jurisdiction Specific Medicare Part B Intravenous Immune Globulin (IVIG)

Customize your policy alerts

Sign up for clover_health Policy 3950-A alerts

Get alerted when Policy 3950-A changes without checking for updates manually.

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Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Intravenous Immune Globulin (IVIG)

Policy CodePolicy 3950-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the diagnosis and clinical indication for IVIG, and submit Medicare-approved compendia support for unlisted indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

16IVIG products referenced

50+Covered indications

6 monthsStandard authorization duration

1 monthAcute-indication authorization

<400 mg/dL

Chronic GVHD IgG threshold

100 daysPost-transplant timing

Covered Indications and Medical Necessity

Pure Red Cell Aplasia

Covered when the following condition is met:

Pure red cell aplasia: Severe, refractory anemia associated with bone marrow suppression, with parvovirus B19 viremia

Authorization may be granted for 6 months

Hematopoietic Stem Cell Transplantation

Covered when ALL of the following are met:

Hematopoietic stem cell transplantation

Age: Member is 20 years of age or older>=20 years
Timing: IVIG will be used during the first 100 days after transplantationFirst 100 days
Transplant type: IVIG will not be used for autologous transplants

Chronic Graft versus Host Disease

Covered when ALL of the following are met:

Chronic graft versus host disease

Hypogammaglobulinemia: Member has laboratory-proven hypogammaglobulinemiaIgG <400 mg/dL
Acute infection: Member has at least one acute infection requiring hospitalization and/or parenteral antibiotics
Diagnosis: Member has a confirmed diagnosis of chronic graft versus host disease
Post-transplant timing: Member is at least 100 days post-transplant

Systemic Lupus Erythematosus

Covered when the following condition is met:

Severe active systemic lupus erythematosus: Other interventions have been unsuccessful, have become intolerable, or are contraindicated

Authorization may be granted for 6 months

Autoimmune Retinopathy

Covered when the following condition is met:

Autoimmune retinopathy: Disease is sight threatening and refractory to corticosteroids and immunosuppressant therapy

Authorization may be granted for 6 months

Stiff-Man Syndrome

Covered when ALL of the following are met:

Stiff-man syndrome

Confirmed diagnosis: Diagnosis has been confirmed by anti-glutamic acid decarboxylase (GAD) antibody testing
First-line treatment response: Member had an inadequate response to first-line treatment with benzodiazepines, such as diazepam, and/or baclofen

Susac Syndrome

Covered when the following condition is met:

Susac syndrome: Disease is refractory or relapsing

Authorization may be granted for 6 months

Autoimmune Mucocutaneous Blistering Diseases

Covered when ALL of the following are met:

Autoimmune mucocutaneous blistering diseases

Biopsy confirmation: Member has biopsy-proven autoimmune mucocutaneous blistering disease
Eligible diagnosis
- Pemphigus vulgaris
- Pemphigus foliaceus
- Bullous pemphigoid
- Mucous membrane pemphigoid (cicatricial pemphigoid)

Specified Acute Indications

Covered for the specified acute indications:

Specified acute indications

Acquired thrombocytopenia
Acute disseminated encephalomyelitis
Guillain-Barre syndrome
Japanese encephalitis virus disease
Kawasaki disease
Measles (rubeola) prophylaxis

All Other Indications

Covered when the indication is approvable:

Other approvable indications: Treatment of an approvable indication listed in the covered-use section of this document

Authorization may be granted for 6 months

Clinical Thresholds and Timing Requirements

Chronic GVHD IgG Requirement

IgG thresholdLess than 400 mg/dL

Acute infectionAt least one acute infection requiring hospitalization and/or parenteral antibiotics

DiagnosisConfirmed chronic graft versus host disease

Hematopoietic Stem Cell Transplantation

TimingIVIG must be used during the first 100 days after transplantation

Minimum ageMember is 20 years of age or older

Transplant typeIVIG will not be used for an autologous transplant

Authorization, Documentation, and Denial Risks

Prior Authorization

Pure Red Cell Aplasia: 6-Month Authorization

Prior authorization may be approved for 6 months for treatment of pure red cell aplasia involving severe, refractory anemia associated with bone marrow suppression and parvovirus B19 viremia.

Diagnosis and clinical circumstances must support severe, refractory anemia, bone marrow suppression, and parvovirus B19 viremia.

Prior Authorization

Hematopoietic Stem Cell Transplantation: 6-Month Authorization

Prior authorization may be approved for 6 months for hematopoietic stem cell transplantation to prevent acute graft-versus-host disease, associated interstitial pneumonia, and infections.

Member must be at least 20 years of age.
IVIG must be used during the first 100 days after transplantation.
IVIG must not be used for an autologous transplant.

Covered Uses

ImmunodeficiencyPrimary and secondary immunodeficiency conditions, including secondary hypogammaglobulinemia

Neurologic indicationsImmune-mediated neurologic disorders, including chronic inflammatory demyelinating polyneuropathy, multifocal motor neuropathy, and Guillain-Barre syndrome

Autoimmune indicationsAutoimmune disorders, including autoimmune retinopathy, systemic lupus erythematosus, autoimmune hemolytic anemia, and autoimmune neutropenia

Additional covered categoriesTransplant-related conditions, infectious disease prophylaxis or treatment, hematologic disorders, and selected dermatologic diseases

Policy Summary

PayerClover Health

PolicyJurisdiction Specific Medicare Part B Intravenous Immune Globulin (IVIG)

Policy CodePolicy 3950-A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the diagnosis and clinical indication for IVIG, and submit Medicare-approved compendia support for unlisted indications.

SourceLink

On This Page

Epidermolysis bullosa acquisita

Conventional therapy circumstance

Member has failed conventional therapy
Member has a contraindication to conventional therapy
Member has rapidly progressive disease and a clinical response could not be achieved quickly enough using conventional agents, and IVIG will be given in combination with conventional treatment

Treatment duration: IVIG will be used for short-term control of the member's condition and will not be used as maintenance therapy

Moderate and severe immune checkpoint inhibitor-related toxicities

Tetanus treatment and prophylaxis

Toxic epidermal necrolysis

Toxic shock syndrome

Toxic necrotizing fasciitis

Stevens-Johnson syndrome

Varicella prophylaxis

Chronic GVHD Timing Requirement

Post-transplant timingMember must be at least 100 days post-transplant

IgG levelLaboratory-proven hypogammaglobulinemia with IgG levels below 400 mg/dL

Acute infectionAt least one acute infection requiring hospitalization and/or parenteral antibiotics

DiagnosisConfirmed chronic graft versus host disease

Prior Authorization

Chronic GVHD: 6-Month Authorization

Prior authorization may be approved for 6 months for chronic graft-versus-host disease when all required clinical criteria are met.

Laboratory-proven hypogammaglobulinemia with IgG <400 mg/dL.
At least one acute infection requiring hospitalization and/or parenteral antibiotics.
Confirmed diagnosis of chronic graft-versus-host disease.
Member is at least 100 days post-transplant.

Prior Authorization

Systemic Lupus Erythematosus: 6-Month Authorization

Prior authorization may be approved for 6 months for treatment of severe, active systemic lupus erythematosus when other interventions have been unsuccessful, have become intolerable, or are contraindicated.

Document severe, active systemic lupus erythematosus.
Document that other interventions failed, were not tolerated, or are contraindicated.

Prior Authorization

Autoimmune Retinopathy: 6-Month Authorization

Prior authorization may be approved for 6 months for sight-threatening autoimmune retinopathy that is refractory to corticosteroid and immunosuppressant therapy.

Disease must be sight threatening.
Disease must be refractory to corticosteroids and immunosuppressant therapy.

Prior Authorization

Stiff-Man Syndrome: 6-Month Authorization

Prior authorization may be approved for 6 months for stiff-man syndrome when the diagnosis and treatment requirements are met.

Diagnosis must be confirmed by anti-glutamic acid decarboxylase (GAD) antibody testing.
Member must have an inadequate response to first-line treatment with benzodiazepines, such as diazepam, and/or baclofen.

Prior Authorization

Susac Syndrome: 6-Month Authorization

Prior authorization may be approved for 6 months for Susac syndrome when the disease is refractory or relapsing.

Document refractory or relapsing disease.

Prior Authorization

Autoimmune Mucocutaneous Blistering Diseases: 6-Month Authorization

Prior authorization may be approved for 6 months for biopsy-proven autoimmune mucocutaneous blistering disease when the diagnosis, prior-treatment, and intended-use requirements are met.

Eligible diagnoses are pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid (cicatricial pemphigoid), or epidermolysis bullosa acquisita.
IVIG must be used for short-term control and not as maintenance therapy.

Prior Authorization

Specified Acute Indications: 1-Month Authorization

Prior authorization may be approved for 1 month for specified acute indications.

Covered acute conditions include acquired thrombocytopenia; acute disseminated encephalomyelitis; Guillain-Barre syndrome; Japanese encephalitis virus disease; Kawasaki disease; measles (rubeola) prophylaxis; moderate and severe immune checkpoint inhibitor-related toxicities; tetanus treatment and prophylaxis; toxic epidermal necrolysis; toxic shock syndrome; toxic necrotizing fasciitis; Stevens-Johnson syndrome; and varicella prophylaxis.

Prior Authorization

Other Covered Indications: 6-Month Authorization

Prior authorization may be approved for 6 months for treatment of other approvable indications listed in the covered-use section.

The indication must be listed as an approvable covered use and satisfy all applicable approval criteria.

Unsupported block type: documentation

Documentation Required

Hematopoietic Stem Cell Transplant Documentation

For hematopoietic stem cell transplantation, document the member's age, transplant type, transplant date or timing, and planned IVIG use.

Confirm the member is at least 20 years old.
Document that IVIG is planned during the first 100 days after transplantation.
Identify whether the transplant is allogeneic; IVIG is not covered for autologous transplants.

Documentation Required

Chronic GVHD Documentation

For chronic GVHD, submit laboratory, diagnostic, infection, and treatment documentation supporting every coverage criterion.

Provide IgG laboratory results showing <400 mg/dL.
Document a confirmed chronic GVHD diagnosis.
Document at least one acute infection requiring hospitalization and/or parenteral antibiotics.
Document that the member is at least 100 days post-transplant.

Documentation Required

Systemic Lupus Erythematosus Documentation

For systemic lupus erythematosus, document severe active disease and the outcome of prior interventions.

Provide clinical documentation of severe, active systemic lupus erythematosus.
Identify interventions that were unsuccessful, intolerable, or contraindicated.

Documentation Required

Autoimmune Retinopathy Documentation

For autoimmune retinopathy, document that the disease threatens sight and has not responded to corticosteroid and immunosuppressant therapy.

Provide clinical evidence of sight-threatening disease.
Document refractory status after corticosteroid and immunosuppressant therapy.

Documentation Required

Stiff-Man Syndrome Documentation

For stiff-man syndrome, submit diagnostic confirmation and treatment-response documentation.

Provide anti-GAD antibody testing confirming the diagnosis.
Document inadequate response to benzodiazepines and/or baclofen.

Documentation Required

Susac Syndrome Documentation

For Susac syndrome, document that the disease is refractory or relapsing.

Include clinical history and treatment documentation supporting refractory or relapsing disease.

Documentation Required

Autoimmune Blistering Disease Documentation

For autoimmune mucocutaneous blistering disease, submit biopsy confirmation, the specific diagnosis, and documentation addressing prior conventional therapy.

Provide biopsy confirmation.
Document one eligible diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid (cicatricial pemphigoid), or epidermolysis bullosa acquisita.
Document failed conventional therapy, a contraindication to conventional therapy, or rapidly progressive disease requiring IVIG with conventional treatment.

Unsupported block type: billing_rule

Unsupported block type: denial_risk

Denial Risk

Chronic GVHD Criteria Not Met

Coverage for chronic GVHD requires all specified hypogammaglobulinemia, infection, diagnosis, and post-transplant timing criteria. Failure to meet any one criterion may result in denial.

IgG is not <400 mg/dL or hypogammaglobulinemia is not laboratory proven.
No acute infection requiring hospitalization and/or parenteral antibiotics is documented.
Chronic GVHD is not confirmed.
Member is fewer than 100 days post-transplant.

Denial Risk

Autoimmune Blistering Disease Criteria Not Met

Coverage may be denied for autoimmune mucocutaneous blistering disease when biopsy confirmation, an eligible diagnosis, or the required conventional-therapy criteria are absent.

No biopsy-proven autoimmune mucocutaneous blistering disease.
Diagnosis is not one of the eligible diseases.
No failure or contraindication to conventional therapy is documented, and rapidly progressive disease does not require IVIG with conventional treatment.
IVIG is requested for maintenance rather than short-term control.

Denial Risk

Unsupported Dose or Frequency

A requested dose or frequency outside FDA-approved labeling must be supported by literature for the specific schedule. Without adequate support, the request may be denied or limited to an evidence-supported schedule.

Provide literature support when dose and/or frequency differs from FDA-approved labeling.
Accepted compendia and evidence-based practice guidelines may also support applicable dosing limits.