CurrentViva HealthPolicy IC-0059

Subcutaneous Immune Globulin (SCIG) — Coverage Criteria and Authorization

Coverage and prior authorization criteria for subcutaneous immune globulin (SCIG) products for members of Viva Health, including indications, dosing, authorization lengths, and renewal requirements; applies to clinicians prescribing Hizentra, HyQvia, Gamunex-C, Gammagard Liquid/ERC, Gammaked, Cuvitru, Cutaquig, Xembify, and related SCIG products.

Policy Summary

PayerViva Health

PolicySubcutaneous Immune Globulin (SCIG) — Coverage Criteria and Authorization

Policy CodePolicy IC-0059

Change TypeNo material changes

Effective Date

Next Review DateAug 5, 2025

Key ActionObtain prior authorization for SCIG products; initial approvals are for 6 months with renewals every 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization

12 monthsrenewal prior auth

1840/28dHizentra max units (CIDP)

336/28dGamunex/Gammagard max units

BUN/Crrenal labs required

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Coverage and Medical Necessity Criteria

Primary Immunodeficiency (PID) initial approval

Covered when ALL of the following are met for primary immunodeficiency (PID):

PID initial criteria: Patient is at least 2 years of age; baseline BUN and serum creatinine obtained within 30 days of request; AND either IgG <200 mg/dL OR both: (1) history of multiple hard-to-treat infections as evidenced by at least one of the following — four or more ear infections within 1 year; two or more serious sinus infections within 1 year; two or more months of antibiotics with little effect; two or more pneumonias within 1 year; recurrent deep skin or organ abscesses; persistent oral thrush or fungal skin infection; need for IV antibiotics to clear infections; two or more deep-seated infections including septicemia; family history of PID — AND (2) documented deficiency in producing antibodies in response to vaccination with titers drawn before vaccination and again between 4 and 8 weeks after vaccination.IgG <200 mg/dL

Examples of PID include Wiskott-Aldrich syndrome, X-linked agammaglobulinemia, common variable immunodeficiency, IgG subclass deficiency, transient hypogammaglobulinemia of infancy, and combined immunodeficiencies.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) initial approval

Covered when ALL of the following are met for CIDP (Hizentra and HyQvia only):

CIDP initial criteria: Patient is at least 18 years of age; physician has assessed baseline disease severity using an objective tool (e.g., INCAT, MRC muscle strength, 6-minute walk test, Rankin/Modified Rankin); AND therapy is used as initial maintenance after stabilization with IVIG OR used for re-initiation of maintenance after relapse requiring IVIG reinduction.age >=18 for these criteria

Refer to IVIG medical necessity criteria (Document Number: IC-0071) for IVIG-specific stabilization and induction requirements.

Acquired immune deficiency (CLL/SLL)

Covered when ALL of the following are met for immune deficiency secondary to CLL/SLL:

IgG threshold or infections: Either: (A) IgG <200 mg/dL; OR (B) IgG <500 mg/dL with recurrent sinopulmonary infections requiring IV antibiotics or hospitalization; OR (C) patient has a history of multiple hard-to-treat infections (examples: four or more ear infections/yr; two or more serious sinus infections/yr; two or more months of antibiotics with little effect; two or more pneumonias/yr; recurrent deep skin or organ abscesses; persistent thrush or fungal skin infection; need for IV antibiotics to clear infections; two or more deep-seated infections including septicemia) AND documented deficiency in producing antibodies in response to vaccination with titers drawn before vaccination and again between 4 and 8 weeks post-vaccination.

SCIG dosing and conversion criteria

Dosing and administration covered when meeting product-specific conversion and scheduling rules

SCIG dosing from prior IVIG: When switching from IVIG, initiate SCIG approximately 1 week after the last IVIG infusion and calculate the weekly SCIG dose using the product-specific multiplier formulas (e.g., weekly dose = 1.37 * previous IVIG dose (g) / number of weeks between IVIG doses for Gamunex-C/Gammaked/Gammagard and Xembify; Cuvitru and Cutaquig use a 1.30 multiplier for certain switches).weekly dose formula

Examples provided for Gamunex-C/Gammaked/Gammagard, Xembify, Cuvitru, and Cutaquig.

SCIG dosing from prior SCIG: When switching from one SCIG product to another, initiate therapy 1 week after the last SCIG dose; the weekly dose in grams should equal the prior SCIG weekly dose. Biweekly dosing equals twice the weekly dose; frequent dosing (2–7 times per week) divides the weekly dose by the desired number of administrations per week.same weekly grams

Applies across listed products.

Other secondary immunodeficiencies that result in hypogammaglobulinemia and/or B‑cell aplasia are not listed as routine indications in this policy. Such cases will be reviewed individually and evaluated on a case‑by‑case basis, with coverage determined based on documented IgG levels, infection history, antibody response to vaccination, and other clinical evidence provided by the treating clinician.

Within the portion of the policy provided here there are no explicit clinical exclusions stated. Dosing and administration statements note that regimens are variable and product‑specific; for detailed exclusionary language refer to other sections of the full policy if required.

This policy text is prepared for non‑Medicare coverage determinations. Medicare NCDs, LCDs, LCAs, and the Medicare Benefit Policy Manual may impose different or additional requirements; providers should consult applicable CMS coverage documents when the member’s benefits are governed by Medicare, as compliance with those rules could affect coverage or claims processing.

In the excerpt reviewed there are no explicit statements listing conditions or scenarios described as 'not medically necessary'. Coverage determinations should follow the criteria and clinical requirements set forth elsewhere in the policy when assessing medical necessity.

Billing Codes, Units, and Diagnosis Codes

Product-specific billable units / Max units (per dose and over time)mixed

Hizentra (20%)	Billable unit = 100 mg; Billable units/28 days = 1840 (CIDP), 1680 (all other indications)
Gamunex-C, Gammaked, & Gammagard liquid/ERC	Billable units/28 days = 336
Cuvitru & Cutaquig	Billable units/28 days = 1600
HyQvia (CIDP) - Loading Dose	Week1:0, Week2:400, Week3:400, Week4:800, Week6:1200, Week9:1600
HyQvia (CIDP) - Maintenance	Billable units/21 days = 1600
HyQvia (All other indications) - Loading	Week1:300, Week2:600, Week4:900
HyQvia (All other indications) - Maintenance	Billable units/21 days = 1200
Xembify - Loading	180 daily for 5 days
Xembify - Maintenance	Billable units/21 days = 1680

Covered HCPCS Codes for SCIG ProductsHCPCSCovered

J1559	Hizentra 20% (vials & prefilled syringes) - 100 mg per unit
J1561	Gammaked / Gamunex-C - 500 mg per unit
J1555	Cuvitru 20% - 100 mg per unit
J1551	Cutaquig 16.5% - 100 mg per unit
J1558	Xembify 20% - 100 mg per unit
J1575	HyQvia 10% - 100 mg per unit
J3590	Gammagard Liquid ERC - unclassified biologics
C9399	Unclassified drugs or biologicals (as applicable)

Product NDCs (selected list)NDC

44206-0451-01	Hizentra 20% vial, 1 g (5 mL)
44206-0452-02	Hizentra 20% vial, 2 g (10 mL)
44206-0454-04	Hizentra 20% vial, 4 g (20 mL)
44206-0455-10	Hizentra 20% vial, 10 g (50 mL)
44206-0456-21	Hizentra 20% prefilled syringe, 1 g (5 mL)
44206-0457-22	Hizentra 20% prefilled syringe, 2 g (10 mL)
44206-0458-24	Hizentra 20% prefilled syringe, 4 g (20 mL)
44206-0455-25	Hizentra 20% prefilled syringe, 10 g (50 mL)
76125-0900-01	Gammaked 10% vial, 1 g (10 mL)
76125-0900-25	Gammaked 10% vial, 2.5 g (25 mL)

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Covered HCPCS/Unclassified CodesHCPCSCovered

J3590	Unclassified biologics (e.g., Gammagard Liquid ERC)
C9399	Unclassified drugs or biologicals (as applicable)
90284	immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg
J1575	HyQvia 10% - Injection, immune globulin (HyQvia), 100 mg

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

C83.00	Small cell B-cell lymphoma, unspecified site
C83.01	Small cell B-cell lymphoma, lymph nodes of head, face, and neck
C83.02	Small cell B-cell lymphoma, intrathoracic lymph nodes
C83.03	Small cell B-cell lymphoma, intra-abdominal lymph nodes
C83.04	Small cell B-cell lymphoma, lymph nodes of axilla and upper limb
C83.05	Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limb
C83.06	Small cell B-cell lymphoma, intrapelvic lymph nodes
C83.07	Small cell B-cell lymphoma, spleen
C83.08	Small cell B-cell lymphoma, lymph nodes of multiple sites
C83.09	Small cell B-cell lymphoma, extranodal and solid organ sites

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Authorization, Documentation, and Billing Instructions

Prior Authorization

Prior Authorization Duration

Prior authorization validity will be provided initially for 6 months. Renewals may be authorized for 12 months thereafter. Providers should request appropriate renewal prior to expiration to avoid interruption of therapy.

Initial prior authorization duration: 6 months
Renewal prior authorization duration: 12 months

Prior Authorization

Prior Authorization for SCIG Products

Prior authorization is required for subcutaneous immunoglobulin (SCIG) products when billing the listed HCPCS codes. The provider must request prior authorization and ensure charges reference the product-specific HCPCS code and corresponding NDC(s).

Request prior authorization when billing SCIG HCPCS codes (e.g., J1551, J1558, J1559) using the corresponding product NDC(s).
If an unclassified code is used (e.g., J3590 or C9399), include product NDC and clinical justification with the prior authorization request.

Key Definitions and Dosing Notes

BACKGROUND

Purpose of SCIG therapySubcutaneous immunoglobulin (SCIG) provides immunoglobulin replacement or maintenance for primary and certain secondary immunodeficiencies and for CIDP

Renal monitoring requirementBaseline BUN and serum creatinine required prior to authorization due to potential renal adverse effects

Dosing variabilityDosing and transition schedules differ by indication and product (product-specific conversion and scheduling rules apply)

Primary Immunodeficiency (PID)

Examples of conditions included under PIDWiskott-Aldrich syndrome; X-linked agammaglobulinemia; common variable immunodeficiency; transient hypogammaglobulinemia of infancy; IgG subclass deficiency; combined deficiencies (e.g., severe combined immunodeficiencies, ataxia-telangiectasia)

Minimum age for PID criteria

Policy Summary

PayerViva Health

PolicySubcutaneous Immune Globulin (SCIG) — Coverage Criteria and Authorization

Policy CodePolicy IC-0059

Change TypeNo material changes

Effective Date

Next Review DateAug 5, 2025

Key ActionObtain prior authorization for SCIG products; initial approvals are for 6 months with renewals every 12 months.

SourceLink

On This Page

Dosing frequency options:

SCIG may be administered from daily up to every two weeks (biweekly). Biweekly dose = 2 × weekly dose. Frequent dosing (2–7 times/week) = weekly dose divided by number of doses per week.

frequency 1–14 days

Product-specific allowable frequencies are noted in dosing tables.

Treatment-naive or loading doses: Certain products include loading regimens or ramp-up schedules for treatment-naive patients (e.g., Xembify loading dose: 150 mg/kg/day for 5 days with maintenance 150 mg/kg/week starting Day 8; HyQvia initial ramp-up schedules apply per product labeling).loading dose examples

See product-specific ramp-up and loading dose tables for exact fractions and schedules.

Billing Rule

Product HCPCS Coding for Authorization

Use the product-specific HCPCS codes listed in the Billing Code/Availability section when submitting authorization requests and claims. Each product's billable unit and HCPCS code must be used to calculate units billed.

Examples: Hizentra – J1559 (100 mg per billable unit); Cutaquig – J1551 (100 mg per billable unit); Xembify – J1558 (100 mg per billable unit).
For products without a specific HCPCS, document NDC and use J3590/C9399 with justification.

Denial Risk

Lab and Toxicity Triggers for Denial

Baseline laboratory values (BUN and serum creatinine) must be obtained and included with initial and renewal prior authorization requests. Missing required labs or evidence of unacceptable toxicity may lead to denial or non-renewal.

Required documentation: Baseline BUN and serum creatinine obtained within 30 days of the initial request.
For renewals: BUN and serum creatinine obtained within the last 6 months.
Unacceptable toxicity examples that may trigger denial or non-renewal: severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis syndrome, hemolytic anemia, hyperproteinemia, acute lung injury.

Note

Not Applicable — Other Denial Triggers

Where the document does not specify additional explicit denial triggers beyond missing labs or unacceptable toxicity, no other automatic denial conditions are stated here. Individual cases may still be evaluated on clinical grounds.

Not applicable: no other specific denial triggers are listed in this section beyond those related to labs and toxicity.

Note

CMS/Medicare Policy Compliance

Medicare coverage rules (NCDs/LCDs/LCAs) may apply and supersede the non‑Medicare determinations in this policy where applicable. Providers billing Medicare Part B should ensure compliance with CMS manuals and applicable local coverage policies.

CMS guidance: Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50; search NCD/LCD/LCA at https://www.cms.gov/medicare-coverage-database/search.aspx
Where an NCD or LCD exists for a service/drug, compliance with that policy is required for Medicare claims.

Documentation Required

Required Documentation

Providers must include specific documentation with prior authorization requests to support medical necessity and accurate billing. Ensure baseline labs and clinical evidence per indication are included.

Include baseline BUN and serum creatinine (within 30 days for initial requests; within 6 months for renewals).
Include indication-specific documentation (e.g., IgG levels, infection history, vaccination titers, objective disease severity measures for CIDP such as INCAT or MRC where applicable).
When switching therapies, include dates and doses of prior IVIG/SCIG and documentation of stabilization if required (see IVIG stabilization note).

Billing Rule

Billing Documentation

When submitting charges, bill using the listed HCPCS codes and the corresponding NDC(s) and billable units for the specific product. Documentation must support the units billed (dose in mg/grams).

Billing documentation should reference the HCPCS code, NDC, number of billable units, and supporting clinical notes/dosage calculations.
Calculate units using product-specific mg per billable unit (commonly 100 mg = 1 unit) and document how the billed units were derived from the administered dose.

Billing Rule

Use Specified HCPCS Codes and Billable Units

Use the specified HCPCS codes and billable units for each product when billing. Verify the product's listed billable unit (e.g., 100 mg) and convert the prescribed dose into the correct number of units for claims.

Examples of HCPCS and billable units: Hizentra (J1559) – 1 billable unit = 100 mg; Cutaquig (J1551) – 1 billable unit = 100 mg; Xembify (J1558) – 1 billable unit = 100 mg.
For each billed unit, include corresponding NDC on the claim where required by payer rules.

Prior Authorization

IVIG Stabilization Prior to SCIG

For certain indications (e.g., CIDP with Hizentra/HyQvia), patients are expected to be stabilized on IVIG prior to initiating SCIG, or initiation timing is specified relative to the last IVIG dose. Document prior IVIG therapy and stability as part of the authorization request when applicable.

CIDP (Hizentra, HyQvia): Initiate SCIG approximately 1 week after the last IVIG dose; HyQvia patients must be on stable IVIG doses prior to starting.
For PID switches from IVIG to SCIG: initiate therapy 1–2 weeks after the last IVIG dose and document stability or rationale for transition.

Patient is at least 2 years of age for PID coverage criteria

Diagnostic evidence requiredEither IgG <200 mg/dL OR documented recurrent/hard-to-treat infections plus deficient antibody response to vaccination with pre- and 4–8 week post-vaccination titers

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

CIDP definition and product relationChronic Inflammatory Demyelinating Polyneuropathy is a demyelinating neuropathy for which Hizentra and HyQvia are indicated (Hizentra and HyQvia only per policy)

Age and assessment requirementsPatient must be at least 18 years of age and have baseline disease severity assessed with an objective tool (e.g., INCAT, MRC, 6‑MWT, Rankin)

Treatment contextSCIG (Hizentra/HyQvia) used as initial maintenance after stabilization with IVIG or for re‑initiation after relapse requiring IVIG reinduction

Weekly dose conversion

Weekly dose conversion formula from prior IVIGWeekly dose = 1.37 × (previous IVIG dose in grams / number of weeks between IVIG doses)

Alternate product multipliersCuvitru and Cutaquig use a 1.30 multiplier when switching from IVIG or HyQvia

Frequency adjustmentsBiweekly dose = twice the weekly dose; frequent dosing (2–7 times/week) = divide weekly dose by desired number of doses per week

HyQvia ramp-up

HyQvia multi-infusion ramp-up descriptionHyQvia initial treatment uses a multi-infusion ramp-up over weeks delivering fractions of the total dose across infusions before reaching full maintenance given every 3–4 weeks

Typical schedule patternInitial infusions progressively increase (examples: 1st infusion ~25–33% of dose; 2nd infusion ~50–67%; later infusions reach 75–100% and then total maintenance dose by Week 7)

Treatment intervalsRamp-up may be organized on 3‑week or 4‑week treatment intervals per the schedule

Billable unit

Billable unit definition (reiteration)1 billable unit = 100 mg for listed HCPCS product codes (e.g., J1551, J1558)

Example HCPCS codes tied to unitJ1551 (Cutaquig) and J1558 (Xembify) are specified as 100 mg per billable unit in billing information

Billing section usageThe 100 mg/unit definition is applied across the billing code/availability information for multiple SCIG products