Summary & Overview
HCPCS J8565: Gefitinib, Oral 250 mg
HCPCS Level II code J8565 denotes Gefitinib, oral, 250 mg, an oral antineoplastic agent used in targeted oncology care. Nationally, accurate coding for oral oncology medications is important for claims processing, benefit administration, and monitoring utilization of specialty therapies. This code enables standardized reporting for dispensing and coverage of gefitinib across payers and Medicare.
Key payers covered in this overview include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise briefing on the clinical role of gefitinib, common sites of service for dispensing and oversight, and what to expect in payer coverage discussions. The publication provides benchmarks and policy-relevant context for billing and coverage of oral anticancer drugs, highlights areas where payer policy updates commonly occur, and outlines billing considerations that affect reimbursement workflows.
This summary targets billing managers, pharmacy leaders, and policy analysts seeking a national-level reference for coding and payer engagement related to oral oncology agents coded with J8565. Data not available in the input will be noted where applicable in detailed sections.
Billing Code Overview
HCPCS Level II code J8565 represents Gefitinib, oral, 250 mg, an oral systemic oncology medication used for targeted treatment of certain cancers. The service type is oral antineoplastic therapy, and the typical site of service is outpatient prescription or clinic-administered oral chemotherapy where oral oncology agents are dispensed or supervised.
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Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with metastatic non–small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation is prescribed oral targeted therapy with gefitinib 250 mg daily (J8565). The medication is dispensed by the oncology infusion/specialty pharmacy or clinic pharmacy and administered at home by the patient. Typical workflow: oncologist documents EGFR mutation status and treatment plan in the medical record, writes the prescription for gefitinib, and requests receipt and dispensing through the clinic or specialty pharmacy. The pharmacy submits the HCPCS Level II code J8565 for payor billing when applicable (for example, under medical benefit arrangements or buy-and-bill scenarios). Visits include baseline assessment (history, physical, performance status), baseline labs (liver function tests, electrolytes), periodic toxicity monitoring (dermatologic, hepatic), and follow-up oncology visits for response assessment. Prior authorization may be required by payors such as Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, BUCA, or Medicare. Documentation includes diagnosis, mutation test results, dosing, dispensing date, days supplied, and any applicable modifier(s).
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unmodified claim |