CurrentViva HealthPolicy IC-0059

Subcutaneous Immune Globulin (SCIG) products coverage

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

Policy Summary

PayerViva Health

PolicySubcutaneous Immune Globulin (SCIG) products coverage

Policy CodePolicy IC-0059

Change TypeNo material change

Effective Date

Next Review Date

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

SourceLink

POLICY UPDATE CHANGES

No material changes to clinical coverage or policy criteria in this update.

8SCIG products listed

3Primary covered indications

6Initial PA (months)

12Renewal interval (months)

~30

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Covered ICD-10 codes

3Medicare LCA/NCD docs

Coverage Summary

Policy IC-0059 (Subcutaneous Immune Globulin products) provides medical necessity criteria and operational dosing and billing guidance for multiple SCIG products including Hizentra, Gammagard Liquid/Gammagard Liquid ERC, Gamunex-C, Gammaked, HyQvia, Cuvitru, Cutaquig, and Xembify. The policy covers indications for Primary Immunodeficiency (PID), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (limited to Hizentra and HyQvia per the policy), and immune deficiency secondary to CLL/SLL.

The document establishes the operational remit for reviewers and providers: defining medical necessity criteria for initial authorization and renewals (including baseline labs, indication-specific thresholds and objective measures), detailed product-specific dosing/switching rules (including weight/BMI adjustment formulas), and HCPCS/NDC billing mappings and maximum billable units per time period. Initial prior authorizations are issued for 6 months with renewals available every 12 months. The policy last review date is 08/05/2025.

Quick thresholds, dosing weight rules, and PA timing

Pediatric PID minimum age>= 2 years

IgG threshold (PID / CLL/SLL)< 200 mg/dL (alternative pathway: <500 mg/dL PLUS recurrent sinopulmonary infections requiring IV antibiotics or hospitalization)

Post-vaccination titer windowTiters drawn between 4 and 8 weeks after vaccination

BMI/weight criteria for adjusted body weightUse adjusted body weight if BMI >= 30 kg/m2 or actual weight >= 20% above IBW

Adjusted body weight roundingRound dose to nearest 5 gram increment in adults

Initial prior authorization duration6 months

Renewal prior authorization intervalEvery 12 months

Count of SCIG products listed in policy stats8 products listed

Medical Necessity Criteria (Initial, Indication-specific, Renewal)

General Initial Authorization Requirements

Covered when ALL of the following are met:

ALL of the following

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

ALL of the following

Prior authorization request includes documentation of diagnosis and prescriber specialty when applicable.

Primary Immunodeficiency (PID) - Pediatric

Covered when ALL of the following are met:

ALL of the following

Dosing, Administration, and Product-specific Rules

References supporting the policy include multiple product package inserts and clinical guidance documents (see the policy reference list), key clinical trials such as the PATH trial (van Schaik et al., Lancet Neurol. 2017) for CIDP, and other peer-reviewed studies addressing efficacy, safety, and pharmacokinetics of SCIG and facilitated SCIG products. The policy also cites clinical guidelines and practice parameters from professional bodies and compendia that inform indication definitions and dosing.

Where IVIG stabilization or reinduction is relevant (for example, CIDP initiation or re-initiation scenarios), the policy cross-references the IVIG medical necessity criteria Document Number: IC-0071 for the applicable intravenous requirements and reinduction rules.

Coding

Hizentra billingHCPCS|NDCCovered

J1559	Injection, immune globulin (Hizentra), 100 mg
44206-0451-01	Hizentra 20% vial NDC (1 g per vial, 5 mL)
44206-0452-02	Hizentra 20% vial NDC (2 g per vial, 10 mL)
44206-0454-04	Hizentra 20% vial NDC (4 g per vial, 20 mL)
44206-0455-10	Hizentra 20% vial NDC (10 g per vial, 50 mL)
44206-0456-21	Hizentra 20% prefilled syringe NDC (1 g, 5 mL)
44206-0457-22	Hizentra 20% prefilled syringe NDC (2 g, 10 mL)
44206-0458-24	Hizentra 20% prefilled syringe NDC (4 g, 20 mL)
44206-0455-25	Hizentra 20% prefilled syringe NDC (10 g, 50 mL)

Gammaked / Gamunex-C / Gammagard billingHCPCS|NDCCovered

J1561	Injection, immune (Gammaked/Gamunex-C), 500 mg unit
76125-0900-01	Gammaked 10% NDC (1 g/10 mL)
76125-0900-25	Gammaked 10% NDC (2.5 g/25 mL)
76125-0900-50	Gammaked 10% NDC (5 g/50 mL)
76125-0900-10	Gammaked 10% NDC (10 g/100 mL)
13533-0800-12	Gamunex-C 10% NDC (1 g/10 mL)
13533-0800-15	Gamunex-C 10% NDC (2.5 g/25 mL)
13533-0800-20	Gamunex-C 10% NDC (5 g/50 mL)
13533-0800-71	Gamunex-C 10% NDC (10 g/100 mL)
13533-0800-24	Gamunex-C 10% NDC (20 g/200 mL)

1–10 of 19

1/2

HyQvia billingHCPCS|NDCCovered

J1575	Injection, immune (HyQvia), 100 mg
00944-2510-02	HyQvia 10% NDC (2.5 g/25 mL)
00944-2511-02	HyQvia 10% NDC (5 g/50 mL)
00944-2512-02	Human Hyaluronidase 160 NDC (10 g/100 mL)
00944-2513-02	Human Hyaluronidase 160 NDC (20 g/200 mL)
00944-2514-02	Human Hyaluronidase 160 NDC (30 g/300 mL)

Cuvitru billingHCPCS|NDCCovered

J1555	Injection, immune globulin (Cuvitru), 100 mg
00944-2850-01	Cuvitru 20% NDC (1 g/5 mL)
00944-2850-03	Cuvitru 20% NDC (2 g/10 mL)
00944-2850-05	Cuvitru 20% NDC (4 g/20 mL)
00944-2850-07	Cuvitru 20% NDC (8 g/40 mL)
00944-2850-09	Cuvitru 20% NDC (10 g/50 mL)

Cutaquig billingHCPCS|NDCCovered

J1551	Injection, immune globulin (Cutaquig), 100 mg
00069-1061-01	Cutaquig 16.5% NDC (1 g/6 mL)
00069-1802-01	Cutaquig 16.5% NDC (1.65 g/10 mL)
00069-1476-01	Cutaquig 16.5% NDC (2 g/12 mL)
00069-1960-01	Cutaquig 16.5% NDC (3.3 g/20 mL)
00069-1509-01	Cutaquig 16.5% NDC (4 g/24 mL)
00069-1965-01	Cutaquig 16.5% NDC (8 g/48 mL)

Xembify billingHCPCS|NDCCovered

J1558	Injection, immune globulin (Xembify), 100 mg
13533-0810-05	Xembify 20% NDC (1 g/5 mL)
13533-0810-10	Xembify 20% NDC (2 g/10 mL)
13533-0810-20	Xembify 20% NDC (4 g/20 mL)
13533-0810-50	Xembify 20% NDC (10 g/50 mL)

Unclassified / miscellaneous SCIG billingHCPCSCovered

J3590	Unclassified biologics (used for some Gammagard Liquid ERC and other unclassified SCIG)
C9399	Unclassified drugs or biologicals
90284	Immune globulin (SCIg), human, for use in subcutaneous infusions, 100 mg, each

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 Covered Diagnosis Codes - referenced LCA/NCD documentsmixed

A56786	Novitas Solutions, Inc. Local Coverage Article: Billing and Coding: Immune Globulin
A57778	First Coast Service Options, Inc. Local Coverage Article: Billing and Coding: Immune Globulin
A57554	Wisconsin Physicians Service Insurance Corporation Local Coverage Article: Billing and Coding: Immune Globulins

Provider Actions and Operational Requirements

Prior Authorization

Prior authorization validity

Initial prior authorization provided for 6 months; renewals may be authorized every 12 months thereafter.

Documentation Required

Baseline labs required for initial request

Obtain baseline BUN and serum creatinine within 30 days of the request and include these values with the prior authorization documentation.

Documentation Required

Vaccination/titer documentation for secondary and some PID cases

Provide pre-challenge (baseline) antibody titers and repeat titers drawn between 4 and 8 weeks after vaccination to document antibody response when relying on vaccine-response criteria.

Medicare Determinations and Local Coverage Articles

Date (effective)	Name	Number	Type
2025-01-01	Billing and Coding: Immune Globulin (Novitas Solutions)	A56786	LCA
2025-01-01	Billing and Coding: Immune Globulin (First Coast)	A57778	LCA
2025-01-01	Billing and Coding: Immune Globulins (WPS)	A57554	LCA

Definitions and Evidence

Weight/IBW definitions

Adjusted Body Weight (formula)Adjusted body weight = IBW + 0.4*(actual body weight - IBW)

IBW (male)IBW (kg) for males = 50 + 2.3*(height in inches - 60)

IBW (female)IBW (kg) for females = 45.5 + 2.3*(height in inches - 60)

Key referenced materials listed in the policy include recent package inserts for Xembify, Cutaquig, Hizentra, HyQvia, Cuvitru, Gammagard Liquid, Gamunex-C, Gammaked, and Gammagard Liquid ERC (references 1–9 in the policy reference list).

Clinical trials and peer-reviewed studies cited include the PATH trial for CIDP (van Schaik IN et al., Lancet Neurol. 2017), randomized and long-term efficacy/safety studies of Hizentra, IgPro20, and other SCIG preparations, and pharmacokinetic and facilitated SCIG studies (references throughout the bibliography).

The policy also references professional guidance and FDA/guidance documents (e.g., AAI practice parameters, Immune Deficiency Foundation guidelines, and FDA guidance on immune globulin studies) and notes that multiple peer-reviewed studies and regulatory guidance documents support the use, dosing, and pharmacokinetic considerations for SCIG and IVIG/facilitated SCIG products.

Revision History

2025-08-05last_reviewLatest

Last review

Policy Summary

PayerViva Health

PolicySubcutaneous Immune Globulin (SCIG) products coverage

Policy CodePolicy IC-0059

Change TypeNo material change

Effective Date

Next Review Date

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

SourceLink

On This Page

Patient is at least 2 years of age.

ONE of

Patient has an IgG level <200 mg/dL.
ALL of the following
- Patient has a history of multiple hard to treat infections as indicated 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 thrush in the mouth or fungal infection on the skin; Need for intravenous antibiotics to clear infections; Two or more deep-seated infections including septicemia; Family history of PID.
- The patient has a deficiency in producing antibodies in response to vaccination.
- Titers were drawn before challenging with vaccination.
- Titers were drawn between 4 and 8 weeks of vaccination.

Primary Immunodeficiency (PID) - Adult

Covered when ALL of the following are met:

ALL of the following

Patient is at least 18 years of age.
Physician has assessed baseline disease severity utilizing an objective measure/tool (e.g., INCAT, Medical Research Council (MRC) muscle strength, 6-MWT, Rankin, Modified Rankin, etc.).
ONE of
- Used as initial maintenance therapy for prevention of disease relapses after treatment and stabilization with intravenous immunoglobulin (IVIG).
  Refer to the IVIG (immune globulin IV) medical necessity criteria (Document Number: IC-0071) for the relevant intravenous criteria requirements.
- Used for re-initiation of maintenance therapy after experiencing a relapse and requiring reinduction therapy with IVIG.
  Operational: IVIG stabilization/reinduction per IC-0071 must be documented prior to SCIG renewal or initiation as re-initiation.

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - Hizentra and HyQvia ONLY

Covered when ALL of the following are met (Hizentra and HyQvia ONLY):

ALL of the following

Patient has a diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Initiation timing: For Hizentra, initiate SCIG 1 week after the last IVIG dose. For HyQvia, patients must be on stable doses of IVIG prior to starting and the starting dose/dosing frequency of HyQvia should match the patient’s previous IVIG regimen; calculate weekly equivalent dose to plan ramp-up.
Baseline objective assessment: Physician has assessed baseline disease severity using an objective tool (e.g., INCAT, MRC muscle strength, 6-MWT, Rankin, Modified Rankin, etc.).
Dosing guidance (Hizentra): Recommended starting subcutaneous dose is 0.2 g/kg (1 mL/kg) body weight per week administered in 1 or 2 sessions over 1 or 2 consecutive days. If symptoms worsen, consider increasing to 0.4 g/kg (2 mL/kg) per week administered in 2 sessions; if symptoms worsen on 0.4 g/kg/week, consider re-initiating IVIG while discontinuing Hizentra.
Dosing guidance (HyQvia): Calculate the weekly equivalent dose from prior IVIG (previous IVIG dose (g) / number of weeks between IVIG doses) to plan ramp-up. Follow product ramp-up/loading schedule and maintain same dosing frequency as prior IVIG. For HyQvia CIDP maintenance, follow product-specific loading and maintenance unit rules.
Product-specific initiation: HyQvia initiation requires prior stabilization on IVIG; Hizentra initiation requires timing 1 week after last IVIG dose.

Acquired Immune Deficiency Secondary to CLL/SLL

Covered when ALL of the following are met:

ALL of the following

Patient has IgG level <200 mg/dL; OR IgG <500 mg/dL AND patient has recurrent sinopulmonary infections requiring IV antibiotics or hospitalization.
ALL of the following
- OR patient has a history of multiple hard to treat infections as indicated 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 thrush in the mouth or fungal infection on the skin; Need for intravenous antibiotics to clear infections; Two or more deep-seated infections including septicemia.
- AND the patient has a deficiency in producing antibodies in response to vaccination;
- Titers were drawn before challenging with vaccination;
- Titers were drawn between 4 and 8 weeks of vaccination.

Renewal Criteria (General)

Coverage may be renewed when ALL of the following are met:

ALL of the following

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

Renewal Criteria - PID

Renewal covered when ALL of the following are met:

ALL of the following

Disease response as evidenced by one or more of the following: Decrease in the frequency of infection; Decrease in the severity of infection.
Continued treatment is necessary to decrease the risk of infection.

Renewal Criteria - CIDP (Hizentra/HyQvia)

Renewal covered when either of the following are met:

ANY of the following

Patient has demonstrated a beneficial clinical response to maintenance therapy without relapses, based on an objective clinical measuring tool (e.g., INCAT, MRC, 6-MWT, Rankin, Modified Rankin, etc.).
ALL of the following
- Patient is re-initiating maintenance therapy after experiencing a relapse while on Hizentra or HyQvia.
- Patient improved and stabilized on IVIG treatment prior to re-initiation (documented).
  Operational: IVIG stabilization/reinduction per IC-0071 must be documented.
- Patient was NOT receiving maximum dosing of Hizentra or HyQvia prior to relapse.

Renewal Criteria - CLL/SLL

Renewal covered when ALL of the following are met:

ALL of the following

Disease response as evidenced by one or more of the following: Decrease in the frequency of infection; Decrease in the severity of infection.
Continued treatment is necessary to decrease the risk of infection.

Dosage/Administration - Weight and BMI Adjustment; Product-specific Dosing Rules

Use the following rules for dosing calculations and product-specific dosing adjustments:

ALL of the following

Dosing should be calculated using adjusted body weight when BMI >= 30 kg/m2 OR actual body weight is >=20% higher than ideal body weight (IBW).
Use formulas: IBW (kg) for males = 50 + [2.3 x (height in inches - 60)]; IBW (kg) for females = 45.5 + [2.3 x (height in inches - 60)]; Adjusted body weight = IBW + 0.4 x (actual body weight - IBW). Round dose to nearest 5 gram increment in adult patients.
Product-specific dosing maxima and unit limits must be observed (e.g., Hizentra billable units/28 days = 1840 for CIDP, 1680 for other indications; Gamunex-C/Gammaked/Gammagard liquid/ERC = 336 units/28 days; Cuvitru/Cutaquig = 1600 units/28 days).
HyQvia product-specific loading and maintenance unit schedules must be followed (CIDP loading/maintenance and non-CIDP loading/maintenance units as per formulary limits).
For CIDP with Hizentra: start at 0.2 g/kg/week (1 mL/kg/week), may increase to 0.4 g/kg/week if symptoms worsen; if worsening on 0.4 g/kg/week, consider IVIG re-initiation and discontinuation of Hizentra.
For HyQvia: calculate weekly equivalent from prior IVIG (previous IVIG dose (g) / number of weeks between IVIG doses) to plan ramp-up; maintain same starting dose and frequency as previous IVIG.

Documentation Required

Objective measurement for CIDP

Record baseline and follow-up objective disease severity measures to support initiation and renewal for CIDP (Hizentra and HyQvia). Examples of acceptable tools include INCAT, Medical Research Council (MRC) muscle strength, 6-minute walk test (6-MWT), Rankin or Modified Rankin scales.

Billing Rule

Max billable units per product/time period

Adhere to product-specific maximum billable units per dosing interval (examples provided below). These are illustrative, not necessarily exhaustive: - Hizentra: 1840 units/28 days for CIDP and 1680 units/28 days for other indications - Gamunex-C, Gammaked, Gammagard Liquid/ERC: 336 units/28 days - Cuvitru and Cutaquig: 1600 units/28 days - HyQvia: specified loading and maintenance schedules (e.g., HyQvia CIDP maintenance 1600 units/21 days; other indications maintenance 1200 units/21 days) - Xembify: loading 180 units daily for 5 days; maintenance 1680 units/21 days Use these examples when calculating billing limits for the corresponding product and time period.

Documentation Required

Monitor for unacceptable toxicity

For renewals, document the absence of unacceptable toxicity related to therapy. Examples of unacceptable toxicities to document absence of include severe hypersensitivity/anaphylaxis, thrombosis, aseptic meningitis syndrome, hemolytic anemia, hyperproteinemia, and acute lung injury.

Documentation Required

Comply with applicable CMS NCD/LCD/LCA

Providers must comply with applicable Medicare coverage and payment guidance (NCDs, LCDs, LCAs) where relevant to Part B immune globulin coverage and billing. Follow the referenced documents A56786, A57778, and A57554 as applicable.

Billing Rule

Use MAC-specific guidance for claims

Follow billing and coding guidance from the Medicare Administrative Contractor (MAC) for your jurisdiction when submitting Medicare Part B claims for immune globulin products.