HCPCS Code J0517: Injection, Benralizumab, 1 mg

Learn how to bill and document HCPCS code J0517 for benralizumab injection. Includes coverage, prior authorization, and billing requirements.

Use Code

## **What is a benralizumab injection?** A benralizumab injection is a monoclonal antibody treatment used to manage severe eosinophilic asthma and related eosinophilic conditions. Classified under HCPCS code J0517, it represents injection benralizumab, 1 mg, typically administered as a subcutaneous injection in a single-dose prefilled syringe. This biologic agent works by targeting and reducing blood eosinophils, which play a central role in eosinophil-rich granulomatous inflammation, perivascular eosinophilic infiltration, and other respiratory complications. By lowering eosinophil levels, benralizumab helps decrease asthma symptoms, asthma exacerbations, improve forced expiratory volume (FEV1), and reduce reliance on oral corticosteroids. Because it is an FDA-approved drug that requires direct physician supervision and safety oversight, benralizumab is generally prescribed for patients with uncontrolled asthma who remain symptomatic despite high-dosage inhaled corticosteroids, therapeutic drug agents, or immunosuppressive therapy. It serves as an add-on maintenance treatment, not a rescue medication for acute bronchospasm or status asthmaticus, and for better asthma management. Note: J0517 represents the drug only, and administration codes (like CPT 96372) cover the injection procedure itself. Coverage criteria, prior authorization requirements, and documentation standards for benralizumab can vary by payer. Providers should verify specific payer policies to ensure compliance and successful reimbursement.

## **HCPCS code J0517 documentation requirements** Accurate documentation for HCPCS Code J0517 is essential to demonstrate medical necessity, ensure compliance with payer policies, and support proper reimbursement for benralizumab administration. ### **Patient eligibility and diagnosis** Documentation must confirm that through thorough patient assessment, it is found that they have severe eosinophilic asthma, evidenced by a blood eosinophil count ≥150 cells/µL within six weeks of dosing, and persistent severe asthma uncontrolled despite treatment with high-dosage inhaled corticosteroids plus a second controller. The record should reflect frequent asthma exacerbations, including two or more exacerbations in the previous year requiring systemic oral corticosteroids, fulfilling criteria aligned with Global Initiative for Asthma and National Asthma Education & Prevention Program guidelines (Moda Health Plan, Inc. Medical Necessity criteria, 2023). ### **Treatment plan and prior therapy** The documentation must outline that benralizumab is being used as an add-on maintenance treatment, not for acute bronchospasm or status asthmaticus. It should include details of previous treatment cycles, such as prior use of oral corticosteroids, and provide evidence of inadequate response or refractory disease. ### **Dosing schedule and administration** Record the intended dosing schedule: a 30 mg subcutaneous injection (equivalent to 30 billing units of J0517) every 4 weeks for the first three doses, then every 8 weeks thereafter. Make note if the medication is provided via a single-dose prefilled syringe or autoinjector, and whether the administration is conducted by a healthcare provider or appropriately trained patient (Moda Health Plan, Inc. Medical Necessity criteria, 2023). Some payers may have specific billing rules depending on whether the injection is administered by the provider or self-administered by the patient, which can influence claims and reimbursement. ### **Response and renewal criteria** Include data showing clinical response, such as improved forced expiratory volume (FEV1), reduced reliance on systemic corticosteroids, fewer hospital or emergency visits, and improved quality-of-life metrics. Document absence of unacceptable toxicities (e.g., hypersensitivity reactions, active infections) and include rationale for subsequent treatment cycles or renewal (Moda Health Plan, Inc. Medical Necessity criteria, 2023).

## **J0517 billing requirements** When billing for benralizumab injection (J0517), providers should follow these key requirements: - **Code assignment**: Use J0517 for injection, benralizumab, 1 mg. - **Dosage reporting**: Bill units based on the total milligrams administered during the encounter. - **Drug acquisition**: Ensure the drug is obtained through an approved DME supplier or pharmacy network if required by the payer. - **Administration code**: Report the appropriate CPT/HCPCS administration code in addition to J0517. For subcutaneous injections like benralizumab, CPT code 96372 (therapeutic, prophylactic, or diagnostic injection) is commonly used. Verify payer preferences for administration coding. - **Diagnosis linkage**: Confirm the claim includes an approved diagnosis code (e.g., severe eosinophilic asthma) to demonstrate medical necessity. - **Supporting documentation**: Attach or maintain documentation such as prior authorization details, infusion records, and dose verification. - **Billing cycle**: Check payer-specific rules for frequency limits, prior authorization, and step therapy requirements. - **Claim accuracy**: Verify units, NDC numbers, and lot numbers are correctly listed on the claim to avoid denials. - **Coding updates**: HCPCS and CPT codes are updated annually. Always verify that J0517 and associated administration codes are current using CMS or AMA updates before claim submission to avoid denials.

## **Other relevant codes** - **J2357** - Injection, omalizumab, 5 mg

## **Reference** Moda Health Plan, Inc. Medical Necessity criteria. (2023). In Magellan Health, Inc., Magellan Health, Inc. (pp. 1–5) [Report]. https://www.modahealth.com/pdfs/med_criteria/Fasenra.pdf

Frequently asked questions

Bill J0517 per milligram administered, ensuring that the correct number of units is reported on the claim.

Yes. You must also report the appropriate CPT/HCPCS code for the drug’s administration, since J0517 only covers the medication itself.

Most payers, including Medicare Advantage and commercial insurers, require prior authorization. Approval usually depends on a documented severe eosinophilic asthma diagnosis and prior therapy history.