ModifiedAmeriHealth Caritas VIP CarePolicy MA08.057d

Belimumab (Benlysta®) for Intravenous Use

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This policy governs Medicare Advantage Part B coverage and medical necessity for intravenous belimumab (Benlysta) in members with systemic lupus erythematosus or lupus nephritis. Coverage is subject to the applicable Evidence of Coverage, medical necessity criteria, and exclusions for experimental or investigational use.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyBelimumab (Benlysta®) for Intravenous Use

Policy CodePolicy MA08.057d

Change TypeModified

Effective DateOctober 24, 2022

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionAppend modifier JA to report intravenous administration of belimumab.

SourceLink

POLICY UPDATE CHANGES

Coverage criteria were added for individuals five years of age or older with active systemic lupus erythematosus and biopsy-proven lupus nephritis Class III, IV, and/or V who have active renal disease at screening and receive concurrent standard treatment.

Pediatric coverage for belimumab was added for individuals five years of age or older.

The policy statement identifying intravenous cyclophosphamide in combination with belimumab as experimental or investigational was removed.

A billing requirement was added to use the JA modifier for intravenous administration.

The policy was reviewed and reissued on 09/18/2026 to communicate the Company's continuing position on intravenous belimumab.

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ModifiedAmeriHealth Caritas VIP CarePolicy MA08.057d

Belimumab (Benlysta®) for Intravenous Use

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Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyBelimumab (Benlysta®) for Intravenous Use

Policy CodePolicy MA08.057d

Change TypeModified

Effective DateOctober 24, 2022

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionAppend modifier JA to report intravenous administration of belimumab.

SourceLink

POLICY UPDATE CHANGES

Pediatric coverage for belimumab was added for individuals five years of age or older.

The policy statement identifying intravenous cyclophosphamide in combination with belimumab as experimental or investigational was removed.

A billing requirement was added to use the JA modifier for intravenous administration.

The policy was reviewed and reissued on 09/18/2026 to communicate the Company's continuing position on intravenous belimumab.

Age 5+Minimum age for covered intravenous belimumab indications

2Covered disease indications

At least 1Required concurrent standard-treatment categories for systemic lupus erythematosus

JARequired modifier for intravenous administration

Not coveredSevere active central nervous system lupus or combination with other biologics/B-cell-targeted therapies

J0490HCPCS code for belimumab 10 mg injection

Covered and Unsupported Uses

Initial Therapy — Systemic Lupus Erythematosus

Covered when ALL of the following are met:

ALL of the following

Individual is 5 years of age or older.
Individual has active systemic lupus erythematosus (SLE).
Positive autoantibody test, such as antinuclear antibody (ANA), antibodies to DNA (Anti-dsDNA), or Anti-Smith (Anti-Sm).
Concurrent treatment with at least one of the following: steroids, antimalarials, immunosuppressives, or nonsteroidal anti-inflammatory drugs (NSAIDs).

Initial Therapy — Lupus Nephritis

Covered when ALL of the following are met:

ALL of the following

Individual is 5 years of age or older.
Individual has active systemic lupus erythematosus (SLE).
Biopsy-proven lupus nephritis (LN) Class III, IV, and/or V, with active renal disease at screening.
Concurrent standard treatment for lupus nephritis, such as corticosteroids along with one of the following regimens: mycophenolate for induction followed by mycophenolate for maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance.

Systemic Lupus Erythematosus With Lupus Nephritis

Coverage for belimumab in individuals with systemic lupus erythematosus and lupus nephritis requires ALL of the following:

ALL of the following

Individual is 5 years of age or older.
Individual has active systemic lupus erythematosus with biopsy-proven lupus nephritis Class III, IV, and/or V.
Active renal disease is present at screening.
Individual is receiving concurrent standard treatment for lupus nephritis in accordance with FDA labeling, including corticosteroids with an appropriate induction and maintenance regimen.

Belimumab (Benlysta) for intravenous use is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature in the following clinical circumstances:

• In individuals with severe, active central nervous system lupus.

• In combination with other biologics or B-cell-targeted therapies.

Any use of belimumab (Benlysta) for intravenous use that is not supported in either this medical policy or the off-label coverage policy is considered experimental/investigational and, therefore, not covered.

Initial Therapy Requirements

Systemic Lupus Erythematosus

Covered when all of the following are met.

Systemic lupus erythematosus initial therapy

Disease and laboratory criteria: The individual is at least five years of age, has active systemic lupus erythematosus, and has a positive autoantibody test.Age >= 5; positive ANA, anti-dsDNA, anti-Smith, or comparable autoantibody test
Concurrent treatment: The individual is receiving at least one of the following: steroids, antimalarials, immunosuppressives, or nonsteroidal anti-inflammatory drugs (NSAIDs).At least 1 treatment category

Lupus Nephritis

Covered when all of the following are met.

Billing and Coding

Intravenous Administration ModifierModifier

JA	Administered Intravenously

CPT Procedure Code Number(s)CPT

N/A

ICD-10 Procedure Code Number(s)ICD-10

N/A

ICD-10 Diagnosis Code Number(s)ICD-10Covered

M32.0	Drug-induced systemic lupus erythematosus
M32.10	Systemic lupus erythematosus, organ or system involvement unspecified
M32.11	Endocarditis in systemic lupus erythematosus
M32.12	Pericarditis in systemic lupus erythematosus
M32.13	Lung involvement in systemic lupus erythematosus
M32.14	Glomerular disease in systemic lupus erythematosus
M32.15	Tubulo-interstitial nephropathy in systemic lupus erythematosus
M32.19	Other organ or system involvement in systemic lupus erythematosus
M32.8	Other forms of systemic lupus erythematosus
M32.9	Systemic lupus erythematosus, unspecified

HCPCS Level II Code Number(s)HCPCSCovered

J0490

Injection, Belimumab 10 mg

Revenue Code Number(s)Revenue

N/A

ModifiersModifierCovered

JA	Administered intravenously

Intravenous Administration ModifierModifier

JA	Administered Intravenously

Documentation, Billing, and Coverage Requirements

Note

Other Coverage Requirements Apply

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, utilization management or precertification/referral requirements, provider contracts, and Company policies apply.

Documentation Required

Medical Necessity Records Required

The individual's medical record must reflect the medical necessity for the care provided. Records may include documentation from professional providers, hospitals, nursing homes, home health agencies, therapy providers, and test reports.

Clinical Background

Systemic lupus erythematosus is an autoimmune disease in which the immune system produces autoantibodies against the body's own cells. This autoimmune activity can cause widespread inflammation and tissue damage affecting multiple organs, with periods of illness and remission. Lupus nephritis is an organ-threatening manifestation involving the kidneys. Belimumab is a B-lymphocyte stimulator pathway inhibitor used with standard therapy.

Condition Definitions

Systemic lupus erythematosus (SLE)

DefinitionAn autoimmune disease with periods of illness and remission in which the immune system produces antibodies to cells within the body, leading to widespread inflammation and tissue damage.

Key immunologic featureImmunologic abnormalities, especially the production of antinuclear antibodies (ANA), are a prominent feature.

Clinical manifestationsSLE can affect the joints, skin, brain, lungs, kidneys, and blood vessels; individuals may experience fatigue, joint pain or swelling, skin rashes, and fevers.

Lupus nephritis (LN)

DefinitionThe most common organ-threatening manifestation of systemic lupus erythematosus.

Renal diseaseLupus nephritis involves renal disease that can be demonstrated through serum and urine laboratory tests, and nephritis can be identified with a kidney biopsy.

Administration Setting

Billing Rule

Use the appropriate infusion setting

When intravenous belimumab can be administered in multiple settings, reimbursement may be limited to the most appropriate and cost-effective setting consistent with the member's medical needs and condition, monitoring requirements, and associated services.

Policy Summary

PayerAmeriHealth Caritas VIP Care

PolicyBelimumab (Benlysta®) for Intravenous Use

Policy CodePolicy MA08.057d

Change TypeModified

Effective DateOctober 24, 2022

Last ReviewSep 18, 2026

Next Review DateN/A

Key ActionAppend modifier JA to report intravenous administration of belimumab.

SourceLink

On This Page

Lupus nephritis initial therapy

Disease criteria: The individual is at least five years of age, has active systemic lupus erythematosus, and has biopsy-proven lupus nephritis Class III, IV, and/or V with active renal disease at screening.Age >= 5; Class III, IV, and/or V; active renal disease at screening
Concurrent standard treatment: The individual receives corticosteroids with either mycophenolate for induction followed by mycophenolate for maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance.One qualifying regimen

Initial Therapy

Coverage criteria for belimumab in individuals five years of age or older with active systemic lupus erythematosus and lupus nephritis include all of the following.

Initial coverage criteria

Age and systemic disease: The individual is five years of age or older and has active systemic lupus erythematosus.Age >= 5 years
Lupus nephritis class: The individual has biopsy-proven lupus nephritis Class III, Class IV, and/or Class V.Class III, IV, and/or V
Active renal disease and treatment: The individual has active renal disease at screening and receives concurrent standard treatment for lupus nephritis.Active renal disease at screening
Standard treatment includes corticosteroids with mycophenolate for induction followed by mycophenolate for maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance.

Report Intravenous Administration

For drugs with more than one method of administration, append modifier JA to indicate the route of administration.

JA — Administered intravenously

Denial Risk

Unsupported Uses Are Not Covered

Belimumab for intravenous use is experimental/investigational and not covered when used in unsupported circumstances, including severe active central nervous system lupus, combination therapy with other biologics or B-cell-targeted therapies, or any use not supported by this medical policy or the applicable off-label coverage policy.

Denial Risk

Missing Documentation May Result in Denial

The Company may review or audit services regardless of the provider's participation status. All requested documentation must be made available upon request; failure to provide medical records or supporting information may result in denial for the drug.

Denial Risk

Benefit and Coverage Limitations

Subject to the applicable Evidence of Coverage, covered belimumab administration is eligible under the medical benefit when the medical necessity criteria in this policy are met. Uses identified as experimental or investigational are not eligible for coverage or reimbursement, and this policy addresses only coverage under the medical benefit (Part B), not the pharmacy benefit (Part D).

Clinical impactLupus nephritis can result in significant morbidity and mortality and adversely affect renal survival, quality of life, and work disability.

Standard therapyStandard therapy includes corticosteroids along with induction and maintenance medications.