HCPCS Q5116: Injection, trastuzumab-qyyp, biosimilar, 10 mg

Learn more about how to properly use and bill for HCPCS code Q5116 from our short guide.

## **What is HCPCS code Q5116?** HCPCS code Q5116 is a Level II temporary code used for billing and tracking the drug Trazimera (trastuzumab-qyyp), a biosimilar to the innovator drug trastuzumab (Herceptin®). This code specifically represents the drug in 10 mg increments. Trastuzumab-qyyp, marketed as Trazimera™, is a monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2). It’s indicated for the adjuvant treatment of HER2-overexpressing breast cancer (including cases involving the central portion, overlapping sites, or unspecified site of the breast) and for HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. As an oncology therapy, it’s also used in patients who have received prior therapy with anthracycline-based regimens. Trazimera functions by binding to the HER2 receptor, inhibiting tumor cell proliferation, and promoting antibody-dependent cellular cytotoxicity to manage malignant neoplasms. It is administered by IV infusion and is available in 150 mg single-dose and multiple-dose vials. Treatment usually begins with an initial dose, followed by subsequent weekly doses, with the last weekly dose marking the end of a cycle. Because it’s a high-cost, provider-administered IV infusion, accurate use of HCPCS code Q5116 is essential for proper reimbursement under Medicare Part B and other medical insurance plans.

## **HCPCS code Q5116 documentation requirements** Accurate and detailed documentation in the patient's medical record is crucial to support the use of HCPCS code Q5116 and demonstrate medical necessity. Key documentation elements include: - **Medical necessity**: Clear documentation that the drug is medically reasonable and necessary for the diagnosis or treatment of the patient's illness, aligning with FDA-approved indications and accepted standards of medical practice (e.g., NCCN guidelines). - **Diagnosis codes**: Appropriate ICD-10-CM diagnosis code(s) that support the medical necessity for the administration of the drug (e.g., specific codes for HER2-positive breast cancer or gastric cancer). - **Order and administration details**: The records must include the physician's written order for Trazimera, the date of service, the route of administration (e.g., intravenous infusion), the dosage administered (in milligrams) and the corresponding number of billing units (e.g., 420 mg = 42 units), and the National Drug Code (NDC) for the specific product and package size used. - **Clinical notes**: Documentation of the patient's condition, response to treatment, and any related procedures or monitoring (e.g., Left Ventricular Ejection Fraction (LVEF) checks, monitoring for infusion-related reactions). - **Drug wastage (if applicable)**: If a portion of a single-use vial is discarded, the amount of discarded drug (in units) should be reported on a separate claim line using the JW modifier, as required by Medicare and some other payers.

## **Q5116 billing requirements** Proper billing for Q5116 involves correctly reporting the drug, its administration, and any required modifiers: ### **Drug administration code** A separate CPT code is typically required for the intravenous chemotherapy administration service. Common CPT codes for infusion include: - **96413**: Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug. - **96417**: Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug) up to 1 hour (List separately in addition to code for primary procedure). ### **Modifiers** - **JA modifier**: Some payers may require the JA modifier to be reported with the drug code to indicate an intravenous route of administration. - **JW modifier**: Use the JW modifier to report the amount of drug that was discarded (unused portion of a single-dose vial). - **UD modifier**: Providers participating in the 340B drug pricing program must often append the UD modifier to the drug code. ### **Place of Service (POS)** Report the appropriate two-digit code for the location where the service was provided (e.g., 11 for office, 22 for hospital outpatient). Do note that each vial contains 150 mg, equating to 15 billing units.

## **Other relevant codes** - **J9355**: Injection, trastuzumab, excludes biosimilar, 10 mg. - **J9356**: Injection, trastuzumab and hyaluronidase-oysk, 10 mg - **Q5112**: Injection, trastuzumab-dttb, biosimilar, (Ontruzant™), 10 mg - **Q5113**: Injection, trastuzumab-pkrb, biosimilar, (Herzuma™), 10 mg - **Q5114:** Injection, trastuzumab-dkst, biosimilar, (Ogivri™), 10 mg - **Q5117**: Injection, trastuzumab-anns, biosimilar, (Kanjinti™), 10 mg - **Q5146**: Injection, trastuzumab-stfr, biosimilar, (Hercessi), 10 mg

Frequently asked questions

A biosimilar is a biological product that is highly similar to an already FDA-approved biological product (an originator or reference product), with no clinically meaningful differences in terms of safety, purity, and potency. Q5116 (Trazimera) is a biosimilar to Herceptin (trastuzumab).

Since the billing unit is 10 mg, you divide the total dose in milligrams (mg) by 10 to get the number of units to report. A dose of 420 mg is 42 units.

Yes. Q5116 only covers the cost of the drug itself. You must bill a separate CPT code (like 96413 or 96417) for the professional service of administering the intravenous infusion.