CurrentViva HealthPolicy IC-0071

IVIG (immune globulin IV) coverage and utilization policy

Policy governs prior authorization, medical necessity, dosing, duration, renewal, and maximum billable HCPCS units for intravenous immune globulin products (multiple brands) across a wide range of indications including primary and secondary immunodeficiencies, neurologic disorders, hematologic conditions, transplant-related uses, cancer-associated and immunotherapy/CAR-T toxicities. Also lists product HCPCS codes, NDCs and product specifications.

Policy Summary

PayerViva Health

PolicyIVIG (immune globulin IV) coverage and utilization policy

Policy CodePolicy IC-0071

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide required baseline labs and indication-specific documentation per the policy for IVIG requests.

POLICY UPDATE CHANGES

No material clinical or coverage changes — policy remains current with no listed updates.

30+Indications listed (approx.)

100+ICD-10 codes listed

MultipleProducts/brands listed

ManyHCPCS/NDC mappings

Coverage Summary

This policy covers intravenous immune globulin (IVIG) products (multiple brand formulations listed) for FDA‑approved and compendia‑recommended indications including primary immunodeficiencies, immune thrombocytopenia (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain‑Barré syndrome (GBS), myasthenia gravis exacerbations, dermatomyositis/polymyositis, transplant‑related uses, CAR‑T and immune checkpoint inhibitor toxicities, and other specified immune and hematologic conditions. The policy lists covered products and HCPCS/NDC mappings and a broad Appendix of covered ICD‑10 diagnosis codes.

Prior authorization (PA) is required; initial PA validity varies by indication (1, 2, 3, or 6 months or through delivery for FAIT) with indication‑specific renewal rules. Baseline safety labs (BUN and serum creatinine) must be obtained within 30 days of request, and renewal requires BUN/creatinine within the last 6 months. The policy provides indication‑specific dosing ranges and regimens (examples: PID 200–800 mg/kg q21–28d, CIDP load 2 g/kg then maintenance 1 g/kg q21d, ITP 2 g/kg or 1 g/kg x2, GBS 2 g/kg over 5 days, FAIT 1 g/kg weekly until delivery), guidance for adjusted body weight dosing when BMI ≥ 30 kg/m2 or actual weight ≥ 20% above IBW, and recommendations to reduce dose to the lowest effective amount with periodic trial of dose reduction or discontinuation except where noted (e.g., PID).

Authorization and billing guidance include per‑indication maximum billable HCPCS units and per‑day limits (examples: PID billable units = 180 per 21 days; CIDP load = 460 units over 5 days, maintenance = 230 units per 21 days; Guillain‑Barré = 460 units over 5 days for up to two courses), use of HCPCS/J‑codes and the generic 90283 where applicable, and requirement to submit one of the listed ICD‑10 covered diagnosis codes to support medical necessity.

Medical-Necessity Criteria

Initial Approval / Medical Necessity Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis is one of the covered indications listed in Medical Necessity - Covered Diagnoses (Appendix 1) or an indication supported by CMS guidance for IVIG (see Appendix 2 - CMS Guidance & Medicare Part B).
Indication-specific leaves
- Primary Immunodeficiency (PID) — see PID criteria (IgG & infection history)
- IgG subclass deficiency
- Immune Thrombocytopenia (acute or chronic ITP)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Guillain-Barré Syndrome (AIDP)
- Multifocal Motor Neuropathy
- Myasthenia Gravis (acute exacerbation/impending crisis)
- Dermatomyositis / Polymyositis
- Allogeneic bone marrow / stem cell transplant supportive therapy
- Solid organ or bone marrow transplant complications
- Autoimmune mucocutaneous blistering diseases
- Fetal Alloimmune Thrombocytopenia (FAIT)
- Neonatal Alloimmune Thrombocytopenia (NAIT)
- Kawasaki disease
- Management of CAR T-cell-related toxicities (AIDP-type and other types as specified)
- Management of immune checkpoint inhibitor-related toxicities
- Cancer-associated venous thromboembolic disease
- Toxic shock syndrome
- HIV-infected pediatric patients for bacterial control/prevention

Renewal Criteria

Renewal will be provided when ALL of the following are met:

ALL of the following

Previous authorization was granted for an approved IVIG indication covered by this policy.
Documentation of clinical benefit since prior authorization as described in the indication-specific renewal requirements below.
Safety monitoring labs obtained as specified: baseline and periodic BUN and serum creatinine values within 30 days prior to the renewal request and as clinically indicated thereafter; monitor for hemolysis and other known IVIG adverse effects.
Indication-specific evidence of continued benefit
- Primary Immunodeficiency (PID): reduction in frequency/severity of infections, decreased need for antibiotics or hospitalizations; stable trough IgG levels as documented in chart.

Length of Authorization

Initial and renewal prior authorization validity periods and non‑renewable indications are:

ALL of the following

Default initial prior authorization validity: 6 months unless an indication‑specific initial period is specified below.
Initial PA validity shorter periods
- 1 month initial PA: Acute ITP; Myasthenia Gravis (acute crisis); Kawasaki disease; Neonatal Alloimmune Thrombocytopenia (NAIT); Toxic Shock Syndrome; Management of Immune Checkpoint Inhibitor Related Toxicities; Cancer‑Associated Venous Thromboembolic Disease.
- 2 months initial PA: Management of CAR T‑Cell‑Related Toxicities (AIDP‑type); Guillain‑Barré Syndrome (acute).
- 3 months initial PA: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Multifocal Motor Neuropathy; Dermatomyositis; Polymyositis; Allogeneic Bone Marrow or Stem Cell Transplant support.

Dosing and Administration Criteria

Dosing and administration rules, including adjusted body weight use and rounding:

ALL of the following

Dosing must follow the indication‑specific dosing ranges in the policy and product labeling; dosing calculations should be documented in the medical record.
Adjusted body weight rule
- Use adjusted body weight for dosing when patient is obese (actual body weight appreciably greater than ideal body weight).
- Adjusted body weight (AdjBW) = IBW + 0.4 × (Actual Body Weight − IBW).
- Ideal body weight (IBW) formulas should be documented (e.g., Devine formula) and rounding conventions applied per institutional billing rules; doses may be rounded to the nearest vial or billing unit as allowed.

Maximum Units (per dose and over time) [HCPCS Unit]

Per‑indication billable unit limits and allowable frequency (HCPCS units) — billable units shown per single dose and the applicable number of days/intervals:

ALL of the following

Primary Immunodeficiency (PID) and supportive care after Rethymic transplant: Billable Units = 180; Per # days = 21.
IgG Subclass Deficiency: Billable Units = 90; Per # days = 14.
CIDP: Load: Billable Units = 460; Load Per # days = 5. Maintenance: Billable Units = 230; Maintenance Per # days = 21.
Immune thrombocytopenia (ITP): Billable Units = 460; Per # days = 28 (acute ITP courses limited; see non‑renewable list).
Fetal Alloimmune Thrombocytopenia (FAIT): Billable Units = 230; Per # days = 7 (authorization through delivery only).

Medical Necessity — Covered Diagnoses (Appendix 1)

Covered ICD-10 Diagnosis Codes (Appendix 1)ICD-10Covered

G03.9	Meningitis, unspecified
G04.81	Other encephalitis and encephalomyelitis
G04.89	Other myelitis
G04.90	Encephalitis and encephalomyelitis, unspecified
G04.91	Myelitis, unspecified
G25.82	Stiff-man syndrome
G56.80	Other specified mononeuropathies of unspecified upper limb
G56.81	Other specified mononeuropathies of right upper limb
G56.82	Other specified mononeuropathies of left upper limb
G56.83	Other specified mononeuropathies of bilateral upper limbs

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Coding

HCPCS codes listed for IVIG productsHCPCSCovered

J1554	Asceniv, 500 mg
J1552	Alyglo, 500 mg
J1556	Bivigam, 500 mg
J1572	Gamunex-C / multiple Grifols/Takeda products (500 mg) - various J-code mappings noted
J1557	Gammaplex mapping noted (500 mg)
J1566	Gammagard S/D mapping association
J1561	Gamunex-C mapping variations noted
J1568	Octagam mapping noted
J1459	Privigen mapping noted
J1576	Panzyga mapping noted

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Product NDCsNDC

69800-0250-XX	Asceniv NDC
61476-0104-XX	Alyglo NDC
69800-6502-XX	Bivigam NDC (5 g)
69800-6503-XX	Bivigam NDC (10 g)
61953-0005-XX	Gamunex-C / related NDC patterns (multiple entries noted)
00944-2700-XX	Gammagard Liquid NDC
00944-2705-XX	Gammagard ERC NDC
00944-2656-XX	Gammagard S/D NDC
76125-0900-XX	Gammaked NDC
64208-8234-XX	Gammaplex 5% NDC

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HCPCS to NDC mappings / product examplesmixed

J1572	J1572 mapped to multiple products (e.g., Gamunex-C, Gammagard variants, Gammaked, Gammaplex) with local mapping variations
J1459	J1459 referenced as mapping for Privigen in document
J1576	J1576 referenced as mapping for Panzyga
J1599	J1599 referenced for Gammagard ERC, Qivigy, Yimmugo mappings
90283	90283 - immune globulin (IgIV), human, for intravenous use (listed with multiple line-item variants 1..5)

Provider Actions & Billing Rules

Prior Authorization

Obtain prior authorization

Prior authorization is required for IVIG products. Initial prior authorization validity varies by indication — see Section I for specific durations (examples: 1 month, 2 months, 3 months, 6 months, or through delivery for FAIT).

Documentation Required

Baseline labs required

Obtain baseline laboratory testing as part of the prior authorization request and before initiating therapy.

Blood urea nitrogen (BUN) and serum creatinine obtained within 30 days of the prior authorization request
Vaccine titers: drawn before vaccination and again between 4 and 8 weeks after vaccination when assessing antibody response

Documentation Required

Evidence of infections / diagnostic testing

Provide diagnostic evidence supporting the requested indication; include copies of relevant testing and prior records with the request.

Documented history of prior infections where required (e.g., recurrent sinopulmonary infections, deep-seated infections, IV antibiotic courses)
Electrodiagnostic testing reports for neuropathies (e.g., nerve conduction studies showing demyelination, conduction block, prolonged latencies)
Cerebrospinal fluid (CSF) analysis when required for diagnosis (e.g., Guillain-Barré syndrome)
Muscle biopsy reports when required to support diagnoses such as dermatomyositis or polymyositis

Billing Rule

Adhere to max HCPCS units per indication

Adhere to maximum HCPCS units per indication when billing. Ensure units billed per dose and per time period do not exceed the policy "Maximum Units" for the specific diagnosis.

Examples: CIDP loading 460 units (per policy) with maintenance 230 units; ITP 460 units (per dose) for specified number of days; FAIT 230 units per dose (per policy)
Other indication limits include Kawasaki's Disease 460 units (2 doses only), Multifocal Motor Neuropathy 460 units, and various transplant/supportive care limits as listed in the Maximum Units section
Reference the policy "Maximum Units" section for the full per-indication unit and days limits before submitting claims

Documentation Required

Renewal safety labs

For renewal/continuation requests, provide recent safety laboratory results and document any infusion adjustments.

BUN and serum creatinine within the last 6 months must be provided for renewal requests
If renal function has declined or other safety issues arise, document infusion rate adjustments or other management steps taken

Documentation Required

Objective response documentation for renewals

Document objective clinical response for renewal approvals. Provide measurable evidence of continued benefit compared to baseline.

Validated functional or strength scales (e.g., INCAT score, Medical Research Council [MRC] muscle strength grading, 6-minute walk test)
Relevant laboratory markers where applicable (e.g., platelet counts for ITP)
Documented physical exam findings demonstrating clinical improvement or stabilization compared with baseline

Billing Rule

Report HCPCS/90283 variants

Report the appropriate HCPCS and J-code variants when billing IVIG and related administration products; follow local payer mapping guidance where applicable.

Common codes: 90283 (immue globulin, diagnostic/administration-related), J1572, J1459, J1576, J1599
Confirm local/mapped code variants with payer billing instructions or local Medicare MAC guidance prior to claim submission

Documentation Required

Use covered ICD-10 diagnosis codes

Claims must include a covered ICD-10 diagnosis code that corresponds to an approved indication. Follow applicable Medicare NCDs, LCDs, and LCAs where they apply.

Ensure the claim includes one of the policy-listed ICD-10 diagnosis codes supporting medical necessity
When treating Medicare patients, observe relevant MAC jurisdiction coverage determinations (NCD/LCD/LCA) that may affect coverage and coding

Documentation Required

Reference Medicare coverage resources

Refer to CMS resources and the Medicare Administrative Contractor jurisdiction for additional coverage and coding guidance when applicable.

Use the CMS Coverage Database (https://www.cms.gov/medicare-coverage-database) to locate Medicare NCDs and LCDs relevant to IVIG indications
Check the applicable MAC jurisdiction for local coverage determinations that may alter coverage, documentation, or billing requirements

CMS Guidance & Medicare Part B

Medicare Part B coverage for outpatient IVIG is governed by the Medicare Benefit Policy Manual (Pub.100‑2), Chapter 15, §50 and may be limited by National Coverage Determinations (NCDs) and Local Coverage Determinations/Articles (LCDs/LCAs). The policy references the NCD for Intravenous Immune Globulin for Autoimmune Mucocutaneous Blistering Diseases (NCD 250.3) and notes that multiple contractor‑specific LCDs/LCAs exist providing billing and coding guidance for IVIG.

The document lists examples of jurisdiction‑specific NCD/LCD/LCA references and contractors (e.g., A57187, A54660, A54641, A54643, A57194, A54662, A56786, A56718, A57778, A57160) and identifies MAC jurisdictions (Noridian, Novitas, Palmetto GBA, First Coast, WPS, NGS, CGS). Providers processing Medicare (Part B) claims should consult the CMS Coverage Database and applicable contractor LCD/LCA documents for jurisdictional rules and billing instructions.

CMS Coverage Database search link: https://www.cms.gov/medicare-coverage-database/search.aspx

Referenced Medicare NCD/LCD/LCA Documents & Jurisdictions (examples)mixed

A57187	NCD/LCA/LCD document reference (example from appendix)
A54660	NCD/LCA/LCD document reference (example)
A54641	NCD/LCA/LCD document reference (example)
A54643	NCD/LCA/LCD document reference (example)
A57194	NCD/LCA/LCD document reference (example)
A54662	NCD/LCA/LCD document reference (example)
A56786	NCD/LCA/LCD document reference (example)
A56718	NCD/LCA/LCD document reference (example)
A57778	NCD/LCA/LCD document reference (example)
250.3	NCD for Intravenous Immune Globulin for Autoimmune Mucocutaneous Blistering Diseases (example)

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Background

Scope: This policy applies to intravenous immune globulin (IVIG) products (multiple brands listed) used for FDA‑approved and compendia‑recommended indications. It enumerates specific products and formulations, maps HCPCS and NDC codes to products, and covers a wide range of immune, neurologic, hematologic, transplant, and immunotherapy‑related indications.

Intent and practical guidance: the policy defines prior authorization and medical necessity criteria by indication, specifies baseline and renewal laboratory and diagnostic documentation requirements, provides dosing regimens and rules for adjusted body weight dosing, sets limits on maximum HCPCS units per dose and per time period, and includes billing instructions (use of HCPCS/J‑codes and 90283 mapping). It also includes recommendations to taper to the lowest effective dose and to document objective clinical response for renewals.

PA = Prior authorization: utilization management requirement to obtain approval before IVIG administration per indication‑specific rules and initial validity periods.

IgG = Immunoglobulin G: the key laboratory marker used for eligibility and monitoring (e.g., thresholds such as 200 mg/dL or 400 mg/dL appear in criteria).

CIDP = Chronic Inflammatory Demyelinating Polyneuropathy: an indication requiring electrodiagnostic evidence of demyelination plus clinical criteria and prior trial/intolerance of corticosteroids.

AIDP = Acute inflammatory demyelinating polyneuropathy (Guillain‑Barré type): acute neuropathy indication with specific timing, severity, reflex, and CSF diagnostic criteria.

Revision History

2025-11-04last_reviewLatest

Last reviewed

Policy Summary

PayerViva Health

PolicyIVIG (immune globulin IV) coverage and utilization policy

Policy CodePolicy IC-0071

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide required baseline labs and indication-specific documentation per the policy for IVIG requests.

On This Page

IgG Subclass Deficiency: continued recurrent infections prior to IVIG initiation and clinical improvement on IVIG; ongoing need for prophylactic antibiotics if previously present.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): objective improvement or stability on validated strength/functional scales (INCAT, MRC, 6-MWT, Rankin) compared with pre-treatment baseline.

Multifocal Motor Neuropathy: documented improvement or stabilization in objective strength measures compared with baseline.

Guillain-Barré Syndrome: not routinely renewable (acute, <1 month onset); renewal only for documented continued acute course and benefit for second course when within allowed policy limits.

Myasthenia Gravis: not routinely renewable for acute crisis indications; chronic use requires documentation of continued benefit and failure/intolerance to alternatives per initial criteria.

Dermatomyositis / Polymyositis: documented clinical response (muscle strength, CK if applicable, functional status); renewals allowed every 6 months.

Allogeneic Bone Marrow or Stem Cell Transplant: renewal every 3 months requires documentation of ongoing need (e.g., continued hypogammaglobulinemia or infection risk).

Autoimmune Mucocutaneous Blistering Diseases: documented clinical response; renewals allowed every 6 months.

Fetal Alloimmune Thrombocytopenia (FAIT) and NAIT: FAIT authorization valid through delivery only; NAIT is not renewable post-neonatal period per policy.

Kawasaki disease, Toxic shock syndrome, Cancer-associated VTE, CAR T-cell and checkpoint inhibitor toxicities: generally limited-duration treatments — renewals only when clear ongoing clinical indication and within policy-specified course limits.

Certain indications are not renewable per policy (e.g., acute ITP, Guillain-Barré, myasthenia gravis crisis, Kawasaki disease, FAIT, NAIT, toxic shock syndrome, checkpoint inhibitor toxicities, cancer-associated VTE, certain CAR T indications).

FAIT: authorization valid through delivery only.

Renewal intervals

Routine renewal: every 12 months unless otherwise specified.
Allogeneic Bone Marrow or Stem Cell Transplant: renew every 3 months.
Dermatomyositis/Polymyositis: renew every 6 months.
Autoimmune Mucocutaneous Blistering Diseases: renew every 6 months.

Not renewable per policy: Acute ITP; Guillain‑Barré Syndrome (acute AIDP); Myasthenia Gravis (acute crisis); Kawasaki disease; Fetal Alloimmune Thrombocytopenia (FAIT); Neonatal Alloimmune Thrombocytopenia (NAIT); Toxic Shock Syndrome; Management of Immune Checkpoint Inhibitor Related Toxicities; Cancer‑Associated Venous Thromboembolic Disease; Management of CAR T‑Cell‑Related Toxicities (AIDP‑type limited to policy course).

Maximum dose ranges and per‑dose limits are indication specific (see Maximum Units block).

Dose reduction and discontinuation: consider dose reduction for adverse effects, significant renal dysfunction, or hemolysis. Discontinue IVIG if severe hypersensitivity or life‑threatening adverse event occurs.

When adjusted body weight is used, document calculation and rationale in the chart. Round doses according to payer billing unit rules and product vial availability.

Kawasaki disease: Billable Units = 460; Per # days = 2 doses only.

Multifocal Motor Neuropathy: Billable Units = 460; Per # days = 28.

Acute Lymphocytic Leukemia / Multiple Myeloma (ALL/MM): Billable Units = 90; Per # days = 21.

CLL/SLL: Billable Units = 90; Per # days = 21.

HIV (pediatric patients only): Billable Units = 46; Per # days = 14.

Guillain‑Barré Syndrome: Billable Units = 460; Per # days = 5 (for two courses only).

Myasthenia Gravis: Billable Units = 460; Per # days = 28 (acute crisis coverage limited; renewals rare).

Autoimmune blistering diseases: Billable Units = 460; Per # days = 28; renew every 6 months if clinical response documented.

Allogeneic Bone Marrow or Stem Cell Transplant: Load: Billable Units = 120; Load Per # days = 7 (for initial 90 days). Maintenance: Billable Units = 120; Maintenance Per # days = 21.

Dermatomyositis: Billable Units = 460; Per # days = 28.

Complications of transplanted solid organ or bone marrow transplant: Billable Units = 460; Per # days = 28 (as clinically indicated).

Cancer‑Associated Venous Thromboembolic Disease: Billable Units = 230; Per # days = 2 doses only.

Management of Immune Checkpoint Inhibitor‑Related Toxicities: Billable Units = 460; Per # days = 5 (for one cycle only).

Management of CAR T‑Cell‑Related Toxicities: AIDP type: Billable Units = 460; Per # days = 5 (for two courses only). Other CAR T toxicities: Billable Units = 120; Per # days = 28.