Viva Health IVIG Coverage & Prior Auth Update

Primary Immunodeficiency (PID)

Covered when ONE of the following PID criteria is met

PID criteria: Patient has an IgG level < 200 mg/dL.IgG < 200 mg/dL

Includes diagnoses such as Wiskott-Aldrich syndrome, X-linked agammaglobulinemia, common variable immunodeficiency, transient hypogammaglobulinemia of infancy, antibody deficiency with near normal immunoglobulin levels, and combined deficiencies (list not all inclusive).

Alternative PID criteria: Patient has a history of multiple hard-to-treat infections as indicated by at least one enumerated infection criterion; AND patient has a deficiency in producing antibodies in response to vaccination with titers drawn before challenge and between 4 and 8 weeks after vaccination.titers pre- and 4–8 weeks post-vaccination

Examples of infection criteria include: ≥4 ear infections/year, ≥2 serious sinus infections/year, ≥2 pneumonias/year, recurrent deep skin/organ abscesses, need for IV antibiotics, two or more deep-seated infections including septicemia, persistent thrush or fungal skin infections, ≥2 months antibiotics with little effect, or family history of PID.

IgG Subclass Deficiency

Covered when ALL of the following are met

IgG Subclass Deficiency: Patient has an IgG level < 400 mg/dL; AND patient has a history of recurrent infections; AND patient is receiving prophylactic antibiotic therapy.IgG < 400 mg/dL

Immune Thrombocytopenia (ITP) — acute and chronic

Covered when ANY of the following acute or chronic ITP criteria are met

Acute ITP: Used to manage acute bleeding due to severe thrombocytopenia (platelet count < 30 x 10^9/L); OR to increase platelet counts prior to invasive surgical procedures (platelet count < 100 x 10^9/L); OR patient has severe thrombocytopenia (platelet count < 20 x 10^9/L).platelet count thresholds as listed

Chronic ITP: Patient is at increased risk for bleeding as indicated by a platelet count < 30 x 10^9/L; AND patient has a history of failure, contraindication, or intolerance to corticosteroids; AND duration of illness > 6 months.platelet count < 30 x 10^9/L; duration > 6 months

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Covered when ALL of the following are met

CIDP: Disease course is progressive or relapsing/remitting for >2 months; AND abnormal or absent deep tendon reflexes in upper or lower limbs; AND electrodiagnostic testing indicating demyelination meeting one of the listed electrophysiologic criteria (e.g., partial motor conduction block in ≥2 motor nerves, distal CMAP duration increase plus another demyelination criterion, abnormal temporal dispersion in ≥2 motor nerves, reduced motor conduction velocity in ≥2 motor nerves, prolonged distal motor latency in ≥2 motor nerves, absent/prolonged F waves in specified numbers of motor nerves); AND patient is refractory or intolerant to corticosteroids given in therapeutic doses for at least 3 months; AND baseline strength/weakness has been documented using an objective clinical measuring tool (e.g., INCAT, MRC, 6‑MWT, Rankin).disease >2 months; corticosteroid trial ≥3 months

Electrodiagnostic options are listed in policy and alternative combinations of criteria are acceptable per document.

Guillain-Barré Syndrome (AIDP)

Covered when ALL of the following are met

Guillain-Barré Syndrome (AIDP): Patient has severe disease requiring assistance to ambulate; AND onset of symptoms less than 1 month; AND abnormal or absent deep tendon reflexes in upper or lower limbs; AND diagnosis confirmed using cerebrospinal fluid (CSF) analysis.symptom onset < 1 month

Multifocal Motor Neuropathy

Covered when ALL of the following are met

Multifocal Motor Neuropathy: Progressive, focal, asymmetric limb weakness without sensory symptoms for >1 month; AND complete or partial conduction block or abnormal temporal dispersion in ≥2 motor nerves; AND normal sensory nerve conduction on all nerves tested; AND baseline strength/weakness documented using an objective clinical measuring tool (e.g., INCAT, MRC, 6‑MWT, Rankin).>1 month

Myasthenia Gravis

Covered when ALL of the following are met

Myasthenia Gravis: Positive serologic test for anti-acetylcholine receptor (AchR) antibodies; AND acute exacerbation resulting in impending myasthenic crisis (respiratory compromise, acute respiratory failure, and/or bulbar compromise); AND failing on conventional immunosuppressant therapy alone; AND patient will be on combination therapy with corticosteroids or other immunosuppressant.

Dermatomyositis

Covered when ALL of the following are met

Dermatomyositis: Severe active disease; AND proximal weakness in all upper and/or lower limbs OR clinically amyopathic dermatomyositis; AND diagnosis supported by muscle biopsy or classic skin manifestations (e.g., heliotrope rash, Gottron's papules) where applicable; AND failed trial of corticosteroids; AND failed trial of an immunosuppressant; AND patient will be on combination therapy with corticosteroids or other immunosuppressants; AND documented baseline physical exam and muscular strength/function.

Polymyositis

Covered when ALL of the following are met

Polymyositis: Severe active disease; AND proximal weakness in all upper and/or lower limbs; AND diagnosis confirmed by muscle biopsy; AND failed trial of corticosteroids; AND failed trial of an immunosuppressant; AND patient will be on combination therapy with corticosteroids or other immunosuppressants; AND documented baseline physical exam and muscular strength/function.

Complications of Transplanted Solid Organ and Bone Marrow Transplant

Coverage provided for one or more of the following transplant-related indications (list not exhaustive)

Transplant complications: Suppression of panel reactive anti‑HLA antibodies prior to transplantation; treatment of antibody‑mediated rejection of solid organ transplantation; prevention or treatment of viral infections post‑transplant (e.g., CMV, Parvovirus B19, BK virus).

Applies to complications of transplanted solid organ and bone marrow transplant.

Stiff-Person Syndrome

Covered when ALL of the following are met

Stiff-Person Syndrome: Presence of anti‑glutamic acid decarboxylase (GAD) antibodies; AND patient has failed >2 treatments among benzodiazepines, anti‑spasticity agents, or anti‑epileptics; AND patient has a documented baseline physical exam.failed >2 prior treatments

Allogeneic Bone Marrow or Stem Cell Transplant

Covered when ALL of the following are met

Allogeneic Bone Marrow or Stem Cell Transplant: Use for prevention of acute graft‑versus‑host disease (aGVHD) or infection; AND transplant was allogeneic; AND patient has an IgG level < 400 mg/dL.IgG < 400 mg/dL

HIV Infected Children: Bacterial Control or Prevention

Covered when ALL of the following are met

HIV-infected children: Patient is < 13 years of age; AND patient has an IgG level < 400 mg/dL.age < 13 years; IgG < 400 mg/dL

Stiff-Person Syndrome

Stiff‑Person Syndrome — Stiff‑Person Syndrome — covered when ALL of the following are met

SPS criteria: Patient has anti‑GAD antibodies; AND patient has failed >2 of the following treatments: benzodiazepines, anti‑spasticity agents, or anti‑epileptics; AND patient has a documented baseline physical exam.>2 failed agents

Allogeneic Bone Marrow or Stem Cell Transplant

Allogeneic BMT/HSCT — covered when ALL of the following are met

Allogeneic transplant criteria: Used for prevention of acute Graft‑Versus‑Host‑Disease (aGVHD) or infection; AND patient's BMT/HSCT transplant was allogeneic; AND patient has an IgG level < 400 mg/dL.IgG < 400 mg/dL

Fetal Alloimmune Thrombocytopenia (FAIT)

Fetal Alloimmune Thrombocytopenia — covered when ANY of the listed history items present

FAIT screening/history: Patient has history of one or more of: previous FAIT pregnancy; family history of the disease; or screening reveals platelet alloantibodies.

Prior authorization validity for FAIT may be provided through delivery date only (see policy).

Autoimmune Mucocutaneous Blistering Diseases

Covered when ALL of the following are met

Blistering disease criteria: Patient diagnosed with an autoimmune mucocutaneous blistering disease (pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid, epidermolysis bullosa acquisita, pemphigus gestationis, linear IgA dermatosis); AND disease is severe, extensive and debilitating; AND diagnosis confirmed by biopsy; AND disease is progressive; AND refractory to conventional therapy with corticosteroids plus immunosuppressive agents; AND patient has a documented baseline physical exam.refractory to corticosteroids + immunosuppressive therapy

Policy notes mild/non‑severe disease is not described as covered.

Acquired Immune Deficiency Secondary to ALL or Multiple Myeloma

Covered when ANY of the following are met

ALL/MM criteria: Patient has recurrent, life‑threatening infections; OR IVIG used for prevention of infection; AND patient has an IgG level < 400 mg/dL.IgG < 400 mg/dL

In multiple myeloma, subtract the M spike from measured IgG to estimate normal IgG levels.

Acquired Immune Deficiency Secondary to CLL or SLL

Covered when ANY of the following are met

CLL/SLL criteria A: Patient has an IgG level < 200 mg/dL; OR patient has an IgG level < 500 mg/dL AND recurrent sinopulmonary infections requiring IV antibiotics or hospitalization.IgG <200 mg/dL OR (IgG <500 mg/dL + serious infections)

CLL/SLL criteria B: Patient has history of multiple hard‑to‑treat infections as defined by enumerated criteria AND has deficiency in producing antibodies in response to vaccination with titers drawn before challenge and between 4 and 8 weeks after vaccination.vaccine response documented

Other secondary immunodeficiencies with hypogammaglobulinemia will be evaluated case‑by‑case.

Management of Immune Checkpoint Inhibitor-Related Toxicities

Covered when listed severe toxicities are present and criteria met

ICI toxicities: Patient receiving immune checkpoint inhibitor therapy AND patient has one of the specified severe toxicities (examples include severe/life‑threatening bullous dermatitis as adjunct to rituximab, Stevens‑Johnson syndrome, toxic epidermal necrolysis, severe myasthenia gravis, demyelinating disease, myocarditis not improving after 24–48 hours of high‑dose methylprednisolone, moderate or severe Guillain‑Barré used with high‑dose methylprednisolone, pneumonitis not improving after corticosteroids, encephalitis used with high‑dose methylprednisolone for severe symptoms, severe steroid‑refractory myositis, hemolytic anemia not responsive to corticosteroids and rituximab, severe aplastic anemia unresponsive to corticosteroids after 7 days, thrombocytopenia with bleeding).failure or insufficient response to recommended steroid timelines where specified

Use is adjunctive or when specified steroid response timelines are not met per policy.

Management of CAR T-Cell–Related Toxicities

Covered when specified conditions are met

Anti-CD19 CAR T criteria: Patient received anti‑CD19 CAR T‑cell therapy AND IVIG used for management of G4 CRS refractory to high‑dose corticosteroids and anti‑IL‑6 therapy; OR patient has hypogammaglobulinemia with serum IgG < 600 mg/dL and serious or recurrent infections; OR patient has an AIDP‑type picture.IgG <600 mg/dL for anti‑CD19 with serious/recurrent infections; G4 CRS refractory

BCMA CAR T criteria: Patient received BCMA‑targeted CAR T‑cell therapy AND IVIG used for management of G4 CRS refractory to high‑dose corticosteroids and anti‑IL‑6 therapy; OR patient has hypogammaglobulinemia with serum IgG < 400 mg/dL; OR patient has an AIDP‑type picture.IgG <400 mg/dL for BCMA with infections; G4 CRS refractory

Prophylactic CAR T criteria: Used prophylactically prior to anti‑CD19 or BCMA CAR T therapy when patient has hypogammaglobulinemia (serum IgG ≤ 400 mg/dL) and serious, persistent, or recurrent bacterial infections.

Supportive Care after Rethymic transplant

Covered when ANY of the following are met

Rethymic support: Used as immunoglobulin replacement therapy in pediatric patients with congenital athymia after surgical implantation of Rethymic; OR used as re‑initiation of treatment 2 months after stopping immunoglobulin replacement therapy in pediatric patients who have an IgG trough level lower than the normal range for age.IgG trough < age‑normal

Renewals for initial IVIG after rethymic transplant are authorized until immunologic recovery as defined in policy.

Cancer-Associated Venous Thromboembolic Disease

Referenced indication listing (compendia‑recommended)

CAT criteria: Patient diagnosed with refractory heparin‑induced thrombocytopenia (HIT) OR autoimmune HIT OR patient at high bleeding risk with HIT.

Document labels this as a compendia‑recommended indication.

Renewal and Disease Response Criteria

Renewal / Continuation criteria — continued authorization requires ALL of the following

General renewal criteria: Patient continues to meet indication‑specific relevant criteria from Section III; AND absence of unacceptable toxicity from the drug (examples listed in policy); AND duration of authorization has not been exceeded; AND BUN and serum creatinine obtained within the last 6 months with infusion concentration/rate adjusted accordingly.labs within 6 months

Examples of unacceptable toxicity include renal dysfunction, thrombosis, hemolysis, severe hypersensitivity, TRALI, hyperproteinemia, increased serum viscosity, aseptic meningitis, hypertension, volume overload.

Disease‑specific response examples: PID/IgG subclass deficiency: disease response evidenced by decreased frequency or severity of infections; Chronic ITP: achievement and maintenance of platelet count ≥ 30 x 10^9/L and at least doubling of baseline.ITP: platelets ≥ 30 x 10^9/L

Renewals for neuropathies require objective clinical improvement measured by validated tools (see policy).

IgG Subclass Deficiency — Renewal

Covered when disease response and continued need are documented

IgG Subclass Deficiency renewal: Disease response demonstrated by decrease in frequency or severity of infections; AND continued treatment is necessary to decrease risk of infection.

Immune Thrombocytopenia (ITP) — Renewal

Covered for chronic ITP when platelet response demonstrated

Chronic ITP renewal: Achievement and maintenance of platelet count ≥ 30 x 10^9/L and at least doubling of baseline platelet count.platelets ≥ 30 x 10^9/L

Neuropathies — Renewal

Covered for CIDP and Multifocal Motor Neuropathy with objective clinical improvement

CIDP renewal: Demonstrated clinical response based on objective clinical measuring tool (e.g., INCAT, MRC muscle strength, 6‑MWT, Rankin).

Renewals authorized when objective improvement documented.

Multifocal Motor Neuropathy renewal: Demonstrated clinical response based on objective clinical measuring tool (e.g., INCAT, MRC muscle strength, 6‑MWT, Rankin).

Renewals authorized when objective improvement documented.

Immunodeficiency and Transplant-related Indications

Covered when infection risk and response criteria are met for immunodeficiency and transplant-related indications

HIV‑infected children continuation: Disease response evidenced by decreased frequency or severity of infections AND continued increased risk evidenced by IgG < 400 mg/dL.IgG < 400 mg/dL

Allogeneic BMT/HSCT continuation: Patient continues to be at increased risk of infection necessitating continued therapy as evidenced by IgG < 400 mg/dL.IgG < 400 mg/dL

Complications of transplant continuation: Disease response evidenced by decreased frequency or severity of infection AND continued treatment necessary to decrease risk of infection.

CAR T-cell–Related Toxicities

Covered for management of CAR T‑cell–related toxicities when IgG thresholds met

CAR T‑cell toxicities: Patient received anti‑CD19 CAR T‑cell therapy AND serum IgG < 600 mg/dL; OR patient received BCMA‑targeted CAR T‑cell therapy AND serum IgG < 400 mg/dL.IgG <600 or <400 mg/dL depending on CAR T type

Also covers G4 CRS refractory to steroids/anti‑IL‑6 per CAR T policy.

Supportive Care after Rethymic Transplant

Covered for supportive care after rethymic transplant until immunologic recovery

Rethymic transplant initial IVIG renewals: Patient is no longer on immunosuppression with ≥10% naive CD3+ T cells; AND patient is ≥ 9 months post‑treatment; AND patient's PHA response is within normal limits.≥10% naive CD3+ T cells; ≥9 months

Renewals for re‑initiation after low IgG are continued for 1 year before retesting.

Dosing and Administration

Dosing recommendations per indication

General dosing guidance: Dose should be reduced to the lowest necessary to maintain benefit; trial of 25–50% dose reduction every 3 months for stable patients; consider trial of discontinuation if sustained improvement except where excluded (e.g., PID).25–50% reduction every 3 months

Exceptions and special considerations for HIV‑infected children, transplant and malignancy patients are described in policy.

Dose ranges by indication: Examples: PID and rethymic support 200–800 mg/kg every 21–28 days; IgG subclass deficiency 300–400 mg/kg every 14 days; CIDP initial 2 g/kg divided then 1 g/kg q21 days; ITP 2 g/kg divided over 5 days or 1 g/kg x2 in 28‑day cycle; FAIT 1 g/kg/week until delivery; many other indication‑specific regimens listed.varies by indication

See dosing table in document for full list.

Covered diagnoses + Medicare compliance

Covered when the claim or request is supported by one of the diagnosis codes listed in Appendix 1 and when applicable Medicare coverage rules (NCD/LCD/LCA) are followed

Diagnosis and payer rules: Submission must include a listed ICD‑10 code from Appendix 1 AND comply with applicable CMS NCD/LCD/LCA when Medicare Part B is involved.

Appendix 1 enumerates covered ICD‑10 codes; Appendix 2 directs compliance with CMS guidance.

Prior authorization (PA) validity varies by indication and is defined in the policy. Initial PA is generally provided for 6 months unless otherwise specified, with several indications having shorter initial coverage windows or indication‑specific renewal frequencies. The policy explicitly lists indications for which prior authorization validity may NOT be renewed, including acute ITP, Guillain‑Barré syndrome, myasthenia gravis, Kawasaki disease, FAIT, NAIT, toxic shock, management of immune checkpoint inhibitor–related toxicities, cancer‑associated VTE, and CAR T‑cell–related AIDP‑type. For planning and authorization workflows, refer to the indication‑specific PA durations in the policy when submitting requests or scheduling reauthorizations.

Use of IVIG for mucocutaneous blistering diseases is limited to severe, extensive, debilitating, progressive, biopsy‑confirmed, and treatment‑refractory presentations. The policy requires biopsy confirmation and failure of conventional therapy with corticosteroids plus immunosuppressive agents before IVIG is considered; mild or non‑severe blistering disease is not described as an indication for IVIG in this policy excerpt.

Patients with primary immunodeficiency (PID) are explicitly excluded from trials of IVIG treatment discontinuation. The policy directs that PID patients should not be considered for dose‑reduction/discontinuation trials and therefore require ongoing replacement therapy unless other clinical criteria specify otherwise.

Within the provided excerpt there are no additional explicit coverage exclusions listed beyond the indication‑level rules already stated; the cited section focuses on HCPCS/90283 code mappings and product NDC references rather than stating further clinical exclusions.

For Medicare beneficiaries, coverage determinations and billing must comply with applicable NCDs, LCDs, and LCAs and the Medicare Benefit Policy Manual. The policy notes that where Medicare Part B applies, providers must follow CMS guidance and that additional plan‑level indications or limits may be applied at the health plan’s discretion.

For patients with acquired immune deficiency secondary to CLL or SLL, IVIG is not supported solely by moderate reductions in IgG without evidence of clinical need. The policy requires either IgG < 200 mg/dL OR IgG < 500 mg/dL with documented recurrent serious/sinopulmonary infections requiring IV antibiotics or hospitalization, or documented poor vaccine response; moderate IgG reductions alone are insufficient to justify IVIG.

Patients who remain at ongoing increased risk of infection (for example following solid organ transplant or with hematologic malignancies such as CLL, SLL, ALL, or MM) are not candidates for discontinuation trials. The policy requires that transplant, HIV pediatric, and cancer‑related patients meet disease‑control or risk‑reduction criteria before considering dose reduction or stopping IVIG.

This excerpt does not contain explicit ‘not medically necessary’ determinations; the document segment emphasizes coding mappings (HCPCS/90283), product NDCs, and references rather than listing standalone not‑medically‑necessary statements.

Refer to the main policy sections and appendices for complete criteria, coding, and documentation requirements when preparing prior authorization requests; Medicare‑specific guidance is summarized in Appendix 2.

J1552	Immune globulin, intravenous — product-specific (500 mg unit)
J1554	Immune globulin, intravenous — Asceniv (500 mg unit)
J1556	Immune globulin, intravenous — Bivigam (500 mg unit)
J1572	Injection, immune globulin, intravenous, non-specified (500 mg unit)

J1561	Immune globulin, intravenous — alternate mapping
J1566	Immune globulin, intravenous — product mapping
J1568	Immune globulin, intravenous — Octagam mapping
J1459	Immune globulin, intravenous — Privigen mapping

J1552	Alyglo — 500 mg unit
J1554	Asceniv — 500 mg unit
J1556	Bivigam — 500 mg unit
J1572	Multiple IVIG products mapped to this code; verify specific product mapping
J1561	Alternate mapping used by some manufacturers
J1566	Alternate mapping for Gammagard S/D
J1568	Octagam mapping
J1459	Privigen mapping
90283	Immune globulin (IgIV), human, for intravenous use — legacy/alternate code

OpenPayer

Intravenous Immune Globulin (IVIG) — Coverage Criteria

Medical Necessity and Coverage Criteria

Billing Codes, HCPCS, and Diagnosis Codes

Prior Authorization, Documentation, and Billing Instructions

Background and Context

Definitions and Clinical Terms