HCPCS Code Q5108: Injection, pegfilgrastim-jmdb (Fulphila®), biosimilar, 0.5 mg

Learn about HCPCS Code Q5108 for Fulphila®, its billing guidelines, documentation needs, and use in reducing febrile neutropenia risk.

Use Code

## **What is pegfilgrastim-jmdb (Fulphila®)?** Pegfilgrastim-jmdb (Fulphila®) is a biosimilar medication classified under colony stimulating factors designed to stimulate the production of white blood cells. It is used primarily in patients with cancer who receive myelosuppressive chemotherapy, where the risk of neutropenia—a dangerously low level of neutrophils—increases the likelihood of infection. Fulphila® helps to decrease the incidence of febrile neutropenia by supporting the immune system through enhanced bone marrow function. This medication is administered as a timed single subcutaneous injection per chemotherapy cycle. The specific HCPCS code for billing is Q5108, which identifies the injection of this biosimilar drug. Each unit of Q5108 equals 0.5 mg, so a standard 6 mg syringe should be billed as 12 units. Pegfilgrastim-jmdb may also be used in treatment to mitigate hematopoietic subsyndrome in cases of acute radiation syndrome. It is medically indicated for use in non-myeloid malignancies and is an effective drug to support patients undergoing chemotherapy by boosting white blood cell counts and reducing infection risk. The benefits of pegfilgrastim-jmdb include lowering the incidence of infection manifested by febrile neutropenia, supporting continued chemotherapy treatment without delays, and improving patient outcomes. As a biosimilar, it provides a clinically equivalent and cost-effective alternative to the reference pegfilgrastim drug.

## **HCPCS code Q5108 documentation requirements** To bill HCPCS Code Q5108 for injection of pegfilgrastim-jmdb (Fulphila®), biosimilar 0.5 mg, documentation should include: - Medical necessity supporting the use of pegfilgrastim-jmdb to reduce the incidence of infection manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy for nonmyeloid malignancies. - Accurate patient diagnosis using appropriate ICD-10-CM codes (e.g., D70.x for neutropenia, or other cancer diagnosis codes) that justify treatment. - Details on dosage administered, noting that each unit represents 0.5 mg of pegfilgrastim-jmdb. For example, a 6 mg dose requires billing 12 units. - Documentation of administration details, including date, injection site, and provider credentials. - Use of applicable CPT code(s) such as 96372 for subcutaneous injection administration procedures. Q5108 covers only the drug itself and does not include cannula insertion or other injection administration services, which must be billed separately. - Documentation or evidence of any prior authorization/approval requirements by the payer. - Records of patient response to therapy and any adverse effects. - Use appropriate modifiers (e.g., -JG or -TB) for drugs acquired under the 340B program when applicable. - Detailed clinical recordkeeping to ensure compliance with Medicare, Medicaid, and commercial payer policies.

## **Q5108 billing requirements** Billing Requirements for HCPCS Code Q5108 (Injection, pegfilgrastim-jmdb [Fulphila®], biosimilar, 0.5 mg): - Bill Q5108 units based on the dose administered; 1 unit equals 0.5 mg of pegfilgrastim-jmdb. For example, a 6 mg syringe should be billed as 12 units. - Use appropriate ICD-10-CM diagnosis codes to support medical necessity, commonly neutropenia codes like D70.x or relevant cancer diagnoses. - Include CPT code 96372 (or similar) for administration of subcutaneous injection alongside Q5108. - Submit claims on CMS-1500 or UB-04/837I forms with complete patient and provider information. - Follow payer-specific requirements, including prior authorization or treatment authorization requests if required. - Use appropriate modifiers for drugs acquired through programs such as 340B (-JG or -TB) when applicable. - Ensure claims are submitted with accurate dose units and without combining multiple drugs on the same claim line. - Verify reimbursement policies with payers to understand payment rates and coverage for Q5108. - Maintain thorough documentation of patient diagnosis, treatment plan, dose administered, injection date, and provider credentials to support claims and audits. - Submit only clean claims with all required information to facilitate timely reimbursement. Coverage and reimbursement depend on medical necessity, payer-specific guidelines, and proper documentation, not just claim formatting.

## **Other relevant codes** - **J2506** — Injection, pegfilgrastim (Neulasta®, reference product), 0.5 mg. - **Q5110** — Injection, pegfilgrastim-bmez (Ziextenzo®), biosimilar, 0.5 mg. - **Q5111** — Injection, pegfilgrastim-cbqv (Udenyca®), biosimilar, 0.5 mg. - **96372** — Administration code for SC injection.

Frequently asked questions

Bill 12 units (Q5108 = 0.5 mg/unit).

No, Fulphila® is only available as a pre-filled syringe.

No. Fulphila® must be administered at least 24 hours after chemotherapy, which means billing for Q5108 also cannot occur on the same day as chemotherapy. Since billing is tied to the date of administration, the claim for Q5108 should reflect the day the drug is actually given—typically the day after chemotherapy.