## **What is injection of trastuzumab-dkst?**
The injection of trastuzumab-dkst refers to the use of Ogivri®, a trastuzumab biosimilar (also known as trastuzumab dkst biosimilar Ogivri 10 mg) to treat certain cancers, most commonly breast cancer and stomach cancer. This biosimilar works by targeting HER2 receptors found on some breast cancer cells and gastric cancer cells, helping to slow or stop tumor growth.
HCPCS code Q5114 is the specific code used for billing the injection of trastuzumab-dkst (Ogivri) reported in 10 mg increments. Physicians and other providers used this code when documenting and submitting claims for the administration of trastuzumab-dkst biosimilar Ogivri.
Trastuzumab-dkst (Ogivri) is approved for the treatment of patients with HER2-positive breast cancer as well as HER2-positive gastric and gastroesophageal junction adenocarcinomas. Treatment may be used in the adjuvant, neoadjuvant, or metastatic setting based on clinical guidelines and patient needs.
Coverage by Medicare, Medicaid, and most private payers requires documented medical necessity that aligns with FDA-approved indications or evidence-based compendia-supported off-label uses.
## **HCPCS code Q5114 documentation requirements**
All documentation for billing HCPCS code Q5114 must establish medical necessity and compliance with Medicare policy. Providers should include:
### **Diagnosis and clinical justification**
The medical record must confirm a diagnosis of malignant neoplasm, such as breast cancer (e.g. unspecified female breast, left female breast, right female breast, unspecified male breast, right male breast) with staging and tumor location detailed (e.g., central portion, upper inner quadrant, upper outer quadrant, lower inner quadrant, lower outer quadrant, axillary tail, or overlapping/ unspecified sites).
Documentation should also note prior therapies received and the rationale for transitioning to trastuzumab-dkst biosimilar (Ogivri).
### **Drug and administration**
Record the drug dosage regimen, specifically trastuzumab-dkst biosimilar Ogivri 10 mg, and method of administration (typically via intravenous infusion). The documentation should reference the HCPCS code Q5114, and include the associated procedure or infusion CPT codes, which are required.
### **Prior therapy and treatment context**
Ensure the treatment plan includes details of prior therapy in keeping with oncology treatment protocols and guidelines. Records should support that Ogivri is being used appropriately—whether following initial or later lines of therapy, and that it aligns with clinical guidance for HER2-positive tumors.
### **Complete and legible records**
Medical records must be complete, legible, and include identifying patient information, treatment dates, physician signature, and any supporting imaging or pathology reports that justify continued use of trastuzumab-dkst. This will support proper claims submission and reimbursement.
## **Q5114 billing requirements**
- Use per 10 mg units: Submit one unit of Q5114 for every 10 mg of trastuzumab-dkst (Ogivri) administered. Ensure that the quantity accurately matches the dosage given.
- Medicare payment rates: The expected Medicare reimbursement for Q5114 typically ranges from approximately $44.59 to $51.84 per 10-mg unit, varying quarterly following the average sales price (ASP) updates. Since ASP-based pricing is updated quarterly, providers should verify current rates at the time of billing to ensure accurate reimbursement estimates. Please note that actual payment rates may vary depending on geographic location and billing settings.
- Modifier guidelines: No specific modifiers are required solely for Q5114. However, if the drug is acquired through the 340B program or a similar program, use the applicable modifiers (e.g., “JG”) as outlined in the Hospital Outpatient Prospective Payment System (OPPS) billing guidelines.
- Place of service & claim form: Reimbursements vary by billing setting:
1. Aligned with Median ASP Payment: Claims follow the Average Sales Price (ASP) model under Medicare Part B.
2. OPPS or Physician Offices: Submit via CMS-1450 (UB-04) for hospital outpatient settings or CMS-1500 if administered in physician offices. Claims follow the Average Sales Price (ASP) model under Medicare Part B.
- Billing compliance: Ensure claims reflect both the correct dosage and a covered diagnosis (e.g., HER2-positive breast or gastric cancer) and align with Local Coverage Determinations (LCDs) to avoid denials or rejections.
## **Other relevant codes**
- Q5113 – Injection, trastuzumab-pkrb, biosimilar (Herzuma), 10 mg
- Q5116 - Injection, trastuzumab-qyyp, biosimilar (Trazimera), 10 mg
Frequently asked questions
