HCPCS Code J9317: Injection, Sacituzumab Govitecan-hziy, 2.5 mg

HCPCS J9317 covers sacituzumab govitecan-hziy for advanced cancers with billing and coverage details.

## **What is HCPCS code J9317?** HCPCS Code J9317 represents the billing code for injection, sacituzumab govitecan-hziy, 2.5 mg, a targeted antibody-drug conjugate used primarily in oncology. This medication is most often prescribed for triple-negative breast cancer (TNBC) and metastatic urothelial cancer. Its use is guided by specific national comprehensive cancer network (NCCN) clinical practice guidelines and is indicated for patients with unresectable locally advanced, recurrent, or metastatic disease who have received prior treatment. Prior therapy requirements for sacituzumab govitecan-hziy include: - Metastatic urothelial cancer: Patients who have previously received a platinum-containing chemotherapy or a PD-1/PD-L1 inhibitor. - Triple-negative breast cancer (TNBC): Patients who have received at least two prior lines of therapy for metastatic disease. Medicare coverage and other payer reimbursement typically require clear documentation of prior therapy, unacceptable toxicity to other treatments, and alignment with recognized guidelines like the NCCN Drugs & Biologics Compendium.

## **Documentation requirements** When billing HCPCS Code J9317 for sacituzumab govitecan-hziy, the patient’s medical records must fully support the medical necessity of the treatment. Documentation should confirm the presence and clearly defined nature of the malignant neoplasm, the absence of contraindications, and evidence that the patient meets the NCCN clinical practice guidelines for the drug’s use. The record should specify the exact diagnosis, such as triple negative breast cancer, metastatic urothelial cancer, bladder cancer, or another eligible primary carcinoma, and indicate whether the disease is locally advanced, unresectable, recurrent, or in the metastatic setting. It should also detail all prior treatment and prior therapy received, including platinum-containing chemotherapy, endocrine therapy, preoperative systemic therapy, or treatment with a single agent, while noting any unacceptable toxicity or disease progression. The provider should outline the planned dose (per 2.5 mg unit) and intravenous infusion schedule, confirming that the regimen follows the protocols in the NCCN drugs & biologics compendium. Any adverse reactions, infusion-related reactions, or immune-mediated effects that occur should be recorded, along with laboratory results, imaging, and clinical evaluations used to assess response criteria. The file must also include verification that the patient meets Medicare coverage or other insurer-specific following criteria, confirming that their eligibility aligns with CMS and NCCN recommendations.

## **Billing requirements** - Bill per 2.5 mg of sacituzumab govitecan-hziy administered via intravenous infusion. - The injection procedure itself must be billed separately from the drug. Use the appropriate CPT codes for chemotherapy administration, such as 96413 (chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug). - For drugs like sacituzumab govitecan-hziy, which come in single-use vials, it is crucial to document and report any discarded amounts. Use the JW modifier to indicate the portion of the drug that was discarded, and the JZ modifier to attest that there was no discarded drug. - Confirm that the patient meets NCCN clinical practice guidelines for eligible cancers and that documentation supports the medical necessity of the treatment. - When billing Medicare, ensure the claim meets CMS coverage criteria and is consistent with the NCCN drugs & biologics compendium. - Retain evidence of clinical response, disease status, and treatment rationale in the patient’s medical records for audit purposes. - Prior authorization is often required. It is essential to verify payer-specific requirements before administration.

## **Other relevant codes** - J9316 – Injection, trastuzumab deruxtecan, 1 mg - J9306 – Injection, pertuzumab, 1 mg

Frequently asked questions

HCPCS Code J9317 is used to bill for sacituzumab govitecan-hziy, a drug given via intravenous infusion to treat certain cancers, including triple-negative breast cancer and metastatic urothelial cancer, after prior treatment.

Yes, Medicare may cover J9317 when it meets NCCN clinical practice guidelines and other CMS criteria, such as documented disease progression following at least two lines of therapy or unacceptable toxicity from prior treatment.

Medical records should indicate the cancer type, stage, prior therapies, and clinical justification for sacituzumab govitecan-hziy. Documentation must also include the dose, infusion details, and any adverse or infusion-related reactions.