HCPCS Code J9145: Injection, Daratumumab, 10 mg

Learn more about HCPCS code J9145 to improve accuracy in your coding process.

## **What is HCPCS code J9145?** HCPCS code J9145 specifically identifies injection, daratumumab, 10 mg, as a billable unit for healthcare reimbursement. Daratumumab, marketed under the brand name Darzalex and as Darzalex Faspro (the subcutaneous formulation combined with hyaluronidase fihj), represents a monoclonal antibody treatment that has received Food and Drug Administration (FDA) approval for multiple indications (U.S. Food and Drug Administration, 2024). This covers several key treatment scenarios and other indications. Primary indications include treatment of multiple myeloma in newly diagnosed patients who are eligible or ineligible for autologous stem cell transplant, patients with relapsed or refractory disease, and those with double-refractory conditions following prior therapy. This also includes treatment of light chain amyloidosis in specific patient populations. Daratumumab demonstrates significant effectiveness across various treatment settings. For newly diagnosed patients with multiple myeloma, the drug serves as both induction and consolidation therapy when used in combination therapy protocols. Clinical findings show particular benefit when combined with standard agents depending on the specific treatment regimen (Abdallah & Kumar, 2019). Patients with relapsed multiple myeloma who have received prior lines of treatment represent a significant portion of those receiving daratumumab therapy. The drug has proven effectiveness in refractory multiple myeloma cases, particularly those double refractory to both proteasome inhibitor and immunomodulatory agent therapies. Clinical studies have identified improved outcomes when daratumumab is administered as combination therapy rather than monotherapy in most scenarios.

## **HCPCS code J9145 documentation requirements** The documentation for HCPCS Code J9145 must clearly establish the patient's diagnosis, treatment history, and eligibility for daratumumab (Darzalex or Darzalex Faspro). - Medical records must include an established diagnosis of multiple myeloma or light chain amyloidosis with appropriate diagnostic testing results. - Treatment plans should specify whether daratumumab is being used as monotherapy or combination therapy. - Each administration must be documented with the exact number of milligrams administered, date of administration, and method of delivery. - The medical record should note any pre-medication given, administration time, and monitoring during and after treatment. - Note the corresponding or following criteria established by the payer.

## **HCPCS code J9145 billing requirements** Billing for J9145 requires adherence to Centers for Medicare & Medicaid Services (CMS) guidelines and Medicare coverage policies. Each 10 mg unit of daratumumab constitutes one billable unit under this code, regardless of whether the drug is administered as Darzalex (intravenous) or Darzalex Faspro (subcutaneous). Medicare coverage for daratumumab follows specific criteria established by CMS for medically necessary cancer treatments. Patients must meet FDA-approved indications and demonstrate appropriate clinical circumstances as defined in Medicare policy. Medicaid services coverage varies by state, with some states providing broader coverage than others for this treatment.

## **Other relevant codes** - J9999: Not otherwise classified, antineoplastic drugs - J1100: Injection, dexamethasone sodium phosphate, 1 mg - J2650: Injection, prednisolone acetate, up to 1 ml

## **References** Abdallah, N., & Kumar, S. K. (2019). Daratumumab in untreated newly diagnosed multiple myeloma. Therapeutic Advances in Hematology, 10, 2040620719894871. https://doi.org/10.1177/2040620719894871 U.S. Food and Drug Administration. (2024, July 30). FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-multiple

Frequently asked questions

Darzalex (daratumumab) is an immunotherapy, specifically a monoclonal antibody, not traditional chemotherapy. It targets the CD38 protein on multiple myeloma cells, helping the immune system recognize and destroy these cancer cells.

Daratumumab injection treats multiple myeloma by binding to CD38 on cancerous plasma cells, leading to their destruction. It is used alone or with other drugs to control the progression of this bone marrow cancer.

The HCPCS code for platelet-rich plasma (PRP) injection is often C9276, which covers autologous PRP obtained by centrifugation and injected for therapeutic purposes. Other related codes may be used depending on the procedure and payer policies.