Patients receiving sipuleucel-T infusions will have been to a pheresis center for leukapheresis. The individual patient lymphocytes will be used to manufacture a patient-specific medication (autologous cellular therapy), which when infused back into the patient (usually three days after leukapheresis) will stimulate a positive immunogenic response against his prostate cancer.
- A diagnosis of prostate cancer (ICD-9-CM) 185 – Malignant neoplasm, prostate. Documentation in the chart would demonstrate the patient was asymptomatic or minimally symptomatic and had metastatic castrate resistant (hormone refractory) disease.
- Documentation must be submitted with the first infusion including:
- Evidence of metastases to soft tissue or bone
- Testosterone levels < 50ug or below lowest level of normal
- Two sequential rising PSA levels obtained 2–3 weeks apart or other evidence of disease progression
- Patient cannot be getting simultaneous chemotherapy and should not be getting immunosuppressive therapy
- Intravenous infusion codes 96365 (initial hour) or 96366 (each additional hour if needed to complete the dose)
- Use code J3490 (unclassified drug) for the sipuleucel-T and supply the NDC number 30237890006 and description ‘sipuleucel-T’ in the information loop of electronic claims (box 19 of paper claims)