CurrentViva HealthPolicy IC-0059

Subcutaneous Immune Globulin (SCIG) products coverage and criteria

Policy IC-0059 defines medical necessity, initial and renewal prior authorization criteria, dosing/administration guidance, authorization lengths, maximum billable units per product and HCPCS/NDC billing mappings for subcutaneous immune globulin (SCIG) products (Hizentra, Gamunex-C, Gammaked, Gammagard Liquid/ERC, HyQvia, Cuvitru, Cutaquig, Xembify and related hyaluronidase) for multiple indications including PID, CIDP (Hizentra & HyQvia only), and immune deficiency secondary to CLL/SLL.

Policy Summary

PayerViva Health

PolicySubcutaneous Immune Globulin (SCIG) products coverage and criteria

Policy CodePolicy IC-0059

Change TypeNo material change

Effective DateJul 20, 2010

Next Review Date

Key ActionObtain baseline BUN and serum creatinine within 30 days of request and include results with the prior authorization submission.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this update.

8Named SCIG Products Covered

6 monthsInitial PA Duration

12 monthsRenewal PA Interval

1840/1680/336/1600Example Max Billable Units (by product)

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Covered ICD-10 codes listed

3Cited Medicare LCA IDs

Coverage Summary

Policy IC-0059 (status: CURRENT; Date of Origin: 7/20/2010; Last Review Date: 08/05/2025) covers specified subcutaneous immune globulin (SCIG) products including Hizentra, Gamunex-C, Gammaked, Gammagard Liquid/ERC, HyQvia, Cuvitru, Cutaquig, and Xembify and related hyaluronidase components. Covered indications include FDA-approved and compendia-recommended uses for primary immunodeficiency (PID), chronic inflammatory demyelinating polyneuropathy (CIDP) limited to Hizentra and HyQvia, and immune deficiency secondary to CLL/SLL. Initial prior authorization is provided for 6 months with renewals available every 12 months. Authorization and dosing follow product- and indication-specific rules (including maximum billable units per product/timeframe) and require baseline labs and documentation per the policy.

Policy thresholds & quick facts

IgG thresholdsIgG <200 mg/dL qualifies; IgG <500 mg/dL qualifies when recurrent serious infections present

Baseline labs timingBUN and serum creatinine obtained within 30 days of request

BUN/creatinine for renewalBUN and serum creatinine obtained within the last 6 months

Age thresholdsPediatric PID: ≥2 years; Adult PID/CIDP criteria reference ≥18 years

Initial prior authorization duration6 months

Renewal intervalMay be renewed every 12 months

Example max billable units (selected)Hizentra 1840/1680 per 28 days (CIDP/other); Xembify 1680 per 21 days; Gamunex-C/Gammaked/Gammagard 336 per 28 days; Cuvitru/Cutaquig 1600 per 28 days

Number of named products covered8

Covered ICD-10 codes count35+ listed (additional 3 codes for Hizentra/HyQvia)

Cited Medicare LCAsA56786, A57778, A57554

Medical Necessity Criteria (Initial and Renewal)

General Preauthorization Requirements and Baseline Labs

Covered when ALL of the following are met:

Baseline values for BUN and serum creatinine obtained within 30 days of request

Include results with prior authorization submission

Primary Immunodeficiency (PID) - Pediatric

Covered when ALL of the following are met:

ALL of the following

Patient is at least 2 years of age>=2 years
ONE of

Coding (HCPCS, NDC, ICD-10, Billing Units)

Product-specific HCPCS codes (covered mappings)HCPCS|NDCCovered

J1559	Hizentra, Injection, immune globulin (Hizentra), 100 mg
J1561	Gammaked/Gamunex-C, Injection, immune (10%), 500 mg unit
J1575	HyQvia, Injection, immune (HyQvia), 100 mg
J1555	Cuvitru, Injection, immune globulin (Cuvitru), 100 mg
J1551	Cutaquig, Injection, immune globulin (cutaquig), 100 mg
J1558	Xembify, Injection, immune globulin (Xembify), 100 mg
J3590	Gammagard Liquid ERC / Immune Globulin, human, subcutaneous - unclassified biologics (used for some products)
C9399	Unclassified drugs or biologicals (used for Immune Globulin, Human, Subcutaneous)
90284	immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each

Human Hyaluronidase (HyQvia component)HCPCS|NDCCovered

(Hyqvia component)

Human Hyaluronidase 160 HCPCS mapping (used with HyQvia); NDCs listed 00944-2512-02, 00944-2513-02, 00944-2514-02

Hizentra NDCs (examples provided)NDCCovered

44206-0451-01	Hizentra 20% vial, 1 g per vial, 5 mL
44206-0452-02	Hizentra 20% vial, 2 g per vial, 10 mL
44206-0454-04	Hizentra 20% vial, 4 g per vial, 20 mL
44206-0455-10	Hizentra 20% vial, 10 g per vial, 50 mL
44206-0456-21	Hizentra prefilled syringe NDC 5 mL, 1 g
44206-0457-22	Hizentra prefilled syringe NDC 10 mL, 2 g
44206-0458-24	Hizentra prefilled syringe NDC 20 mL, 4 g
44206-0455-25	Hizentra prefilled syringe NDC 50 mL, 10 g

Selected product NDC examples (Gamunex-C, Gammaked, Gammagard, HyQvia, Cuvitru, Cutaquig, Xembify)NDCCovered

76125-0900-01	Gammaked 10% NDC example
13533-0800-12	Gamunex-C 10% NDC example
00944-2705-50	Gammagard Liquid ERC NDC example
00944-2510-02	HyQvia 10% NDC example
00944-2850-01	Cuvitru 20% NDC example
00069-1061-01	Cutaquig NDC example
13533-0810-05	Xembify 20% NDC example

Billable Unit Conversions / Unit Definitionsmixed

Hizentra J1559	1 Billable unit = 100 mg (Hizentra 20%)
Gamunex-C/Gammaked J1561	1 Billable unit = 500 mg (Gamunex-C/Gammaked 10%)
HyQvia J1575	1 Billable unit = 100 mg (HyQvia 10%)
Cuvitru J1555	1 Billable unit = 100 mg (Cuvitru 20%)
Cutaquig J1551	1 Billable unit = 100 mg (Cutaquig 16.5%)
Xembify J1558	1 Billable unit = 100 mg (Xembify 20%)

Covered Diagnosis Codes (All Products)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.

1–10 of 31

1/4

Additional covered diagnosis codes applicable to Hizentra and HyQvia ONLYICD-10Covered

G61.81	Chronic inflammatory demyelinating polyneuritis.
G61.89	Other inflammatory polyneuropathies.
G62.89	Other specified polyneuropathies.

Medicare Part B LCD/LCA / NCD references (cited documents)mixed

A56786	Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Immune Globulin. Updated 01/24/2025, effective 01/01/2025.
A57778	First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Immune Globulin. Updated 01/24/2025, effective 01/01/2025.
A57554	Wisconsin Physicians Service Insurance Corporation Local Coverage Article: Billing and Coding: Immune Globulins. Updated 06/18/2025, effective 01/01/2025.

Provider Actions and Billing Rules

Prior Authorization

Prior authorization initial duration

Initial prior authorization will be provided for 6 months; prior authorization validity may be renewed every 12 months thereafter.

Renewal interval: every 12 months

Documentation Required

Baseline labs required

Obtain baseline BUN and serum creatinine within 30 days of the prior authorization request and include/attach the laboratory results with the prior authorization submission.

Documentation Required

Vaccination titer documentation for antibody deficiency

Provide pre-vaccination titers and repeat titers drawn between 4 and 8 weeks after vaccination to document deficient antibody response.

Background and Evidence

This policy addresses SCIG therapy for named products (Hizentra, Gammagard Liquid/ERC, Gamunex-C, Gammaked, HyQvia, Cuvitru, Cutaquig, Xembify) for PID, CIDP (coverage restricted to Hizentra and HyQvia), and acquired immune deficiency due to CLL/SLL. Dosing is variable by product, indication, prior IVIG regimen, and patient-specific factors; where applicable the policy provides product-specific switching and ramp-up rules (e.g., weekly-equivalent conversions for Gamunex-C/Gammaked/Gammagard Xembify multipliers, HyQvia ramp-up and maintenance schedules, and Cuvitru/Cutaquig conversion factors). For obese patients or when BMI ≥ 30 kg/m2 or actual weight is ≥ 20% above IBW, the policy specifies using an adjusted body weight formula (IBW formulas provided and Adjusted body weight = IBW + 0.4*(actual body weight - IBW)), and adult doses should be rounded to the nearest 5 gram increment.

Definitions

SCIGSubcutaneous immune globulin (SCIG)

IVIGIntravenous immune globulin (IVIG)

BUNBlood urea nitrogen

CIDPChronic Inflammatory Demyelinating Polyneuropathy

Medicare Determinations

Event Date (effective)	Document Name	Number	Type
2025-01-01	Billing and Coding: Immune Globulin	A56786	LCA
2025-01-01	Billing and Coding: Immune Globulin	A57778	LCA
2025-01-01	Billing and Coding: Immune Globulins	A57554	LCA

Revision History

2010-07-20policy_effective

Policy date of origin / initial effective date (Document Number: IC-0059, Date of Origin: 7/20/2010).

2025-08-05policy_reviewLatest

Last review date of the policy (Last Review Date: 08/05/2025).

2025-01-01medicare_lca_effective

Policy Summary

PayerViva Health

PolicySubcutaneous Immune Globulin (SCIG) products coverage and criteria

Policy CodePolicy IC-0059

Change TypeNo material change

Effective DateJul 20, 2010

Next Review Date

Key ActionObtain baseline BUN and serum creatinine within 30 days of request and include results with the prior authorization submission.

SourceLink

On This Page

Patient has an IgG level <200 mg/dL<200 mg/dL

qualifies by IgG threshold alone

Patient meets BOTH: history of multiple hard-to-treat infections (at least ONE listed) AND deficiency in producing antibodies in response to vaccination with pre- and 4–8 week post-vaccination titers

Infection examples: 4+ ear infections/yr; 2+ serious sinus infections/yr; 2+ months antibiotics with little effect; 2+ pneumonias/yr; recurrent deep skin/organ abscesses; persistent thrush/fungal skin infection; need for IV antibiotics; 2+ deep-seated infections including septicemia; family history of PID

Renewal Criteria

Renewal is authorized when ALL of the following are met:

ALL of the following

Patient continues to meet the indication-specific relevant criteria identified in section III
Absence of unacceptable toxicity from the drug (examples: severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis syndrome, hemolytic anemia, hyperproteinemia, acute lung injury, etc.)
Document absence of unacceptable toxicity
BUN and serum creatinine obtained within the last 6 months and concentration and rate of infusion adjusted accordinglyBUN/creatinine within 6 months

Indication-specific renewal evidence

Primary Immunodeficiency (PID): Disease response evidenced by one or more of: decrease in frequency of infection OR decrease in severity of infection
CIDP (Hizentra & HyQvia): Demonstrated beneficial clinical response to maintenance therapy without relapses based on an objective clinical measuring tool OR patient is re-initiating maintenance therapy after relapse while on Hizentra or HyQvia (AND patient improved and stabilized on IVIG treatment AND patient was NOT receiving maximum dosing of Hizentra or HyQvia prior to relapse)
Document objective measures; see criteria for re-initiation path
CLL/SLL acquired immune deficiency: Disease response evidenced by decrease in frequency and/or severity of infections AND continued treatment is necessary to decrease the risk of infection

Dose Calculation and Adjusted Body Weight

Use adjusted body weight when ANY of the following are met:

ANY of the following

Patient BMI ≥ 30 kg/m2BMI >= 30 kg/m2
Patient actual body weight is 20% higher than ideal body weight (IBW)actual weight >= IBW * 1.20

ALL of the following

IBW (kg) for males = 50 + [2.3*(height in inches - 60)]
IBW (kg) for females = 45.5 + [2.3*(height in inches - 60)]
Adjusted body weight = IBW + 0.4*(actual body weight - IBW)

Product- and Indication-specific Dosing Rules (selected explicit rules)

Covered dosing regimens and sequencing rules include:

Hizentra (CIDP) dosing and escalation

Initiate 1 week after last IVIG; start 0.2 g/kg/week; escalate to 0.4 g/kg/week if symptoms worsen; consider IVIG re-initiation if worsen on 0.4 g/kg/week

HyQvia (CIDP) initiation and ramp-up

Patients must be on stable IVIG prior to starting; calculate weekly equivalent dose and use same starting dose/frequency as previous IVIG after ramp-up schedule

Switching multipliers and timing when converting from IVIG to SCIG

General rules: initiate 1 week after last IVIG (some products 1–2 weeks); weekly dose often = product-specific multiplier * (previous IVIG dose (g)/number of weeks between IVIG doses). Examples: Gamunex-C/Gammaked/Gammagard Liquid: 1.37*; Cuvitru/Cutaquig: 1.30*; Xembify: 1.37*; Hizentra switching: initiate 1–2 weeks after last IVIG

Xembify loading and maintenance: Xembify treatment-naïve loading dose: 150 mg/kg/day for 5 consecutive days; maintenance: 150 mg/kg/week starting Day 8Loading 150 mg/kg/day x5; maintenance 150 mg/kg/week

Administration frequency may range daily up to biweekly depending on product

Administration frequency rules: SCIG administration frequency: may be administered daily up to biweekly depending on product; biweekly dose = twice weekly dose; frequent dosing (2–7 times/week) = divide weekly dose by desired number of administrations

Biweekly and frequent dosing rules apply across products

Documentation Required

Objective disease severity assessment for CIDP

Document baseline and follow-up objective clinical measures (examples: INCAT, MRC muscle strength, 6-minute walk test [6-MWT], Rankin/Modified Rankin) for initiation and for renewal when treating CIDP with Hizentra or HyQvia.

Billing Rule

Maximum billable units per product/timeframe

Adhere to product-specific maximum billable units and loading/maintenance schedules. Examples: Hizentra 1840 units/28 days for CIDP; Gamunex-C / Gammaked / Gammagard Liquid/ERC 336 units/28 days; Cuvitru / Cutaquig 1600 units/28 days. Follow each product's specified maximums and any listed loading schedules (e.g., HyQvia ramp-up and maintenance schedules).

Hizentra: 1840 units per 28 days (CIDP)
Gamunex-C / Gammaked / Gammagard Liquid/ERC: 336 units per 28 days
Cuvitru / Cutaquig: 1600 units per 28 days

Documentation Required

Toxicity monitoring for renewals

For renewals, document absence of unacceptable toxicity (examples include severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis syndrome, hemolytic anemia, hyperproteinemia, acute lung injury, etc.) and obtain BUN and serum creatinine within the last 6 months with infusion concentration and rate adjusted accordingly.

Documentation Required

Use of listed ICD-10 codes for coverage

Submit claims and prior authorization requests with one of the covered ICD-10 diagnosis codes listed in Appendix 1. Note that additional diagnosis codes (G61.81, G61.89, G62.89) apply for Hizentra and HyQvia (CIDP) as specified in the appendix.

Documentation Required

Comply with CMS NCD/LCD/LCA where applicable

For Medicare Part B claims, follow applicable Medicare National/Local Coverage Determinations, Local Coverage Articles, and the Medicare Benefit Policy Manual Chapter 15 §50. Refer to the cited Medicare documents A56786, A57778, and A57554 where applicable.

Medicare document IDs: A56786, A57778, A57554

PIDPrimary Immunodeficiency

IBWIdeal body weight (IBW) — male: 50 + 2.3*(height in inches - 60); female: 45.5 + 2.3*(height in inches - 60)

Evidence / References

PATH trial (CIDP)van Schaik et al., PATH Study. Lancet Neurol. 2017 (multicenter randomized double-blind placebo-controlled trial)

Package inserts referencedXembify (July 2024); Cutaquig (March 2025); Hizentra (April 2023); HyQvia (July 2025); Cuvitru (Feb 2025); Gammagard (Sept 2024); Gamunex-C (Jan 2020); Gammaked (Jan 2020); Gammagard Liquid ERC (June 2025)

Selected references noteMultiple peer-reviewed studies and guideline documents (refs 18-36) and FDA/compendium citations through 2025 provide clinical support

Medicare Local Coverage Articles (A56786, A57778, A57554) effective date for Billing and Coding: Immune Globulin / Immune Globulins (effective 01/01/2025).

2010-07-20policy_origin

Document date of origin listed in policy header (Date of Origin: 7/20/2010).