Drugs & Biologicals: Provenge
Provenge(r) (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Provenge is administered as three infusions, generally two weeks apart. Provenge should be administered via intravenous infusion over a period of approximately 60 minutes.

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.

For purposes of reimbursement, we will require the following:
  • 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)
Since the drug is administered by infusion three times, we would expect a claim filed for each administration. Only the first infusion requires the accompanying documentation. However, each claim must be accompanied with the name of the drug, an invoice, the NCD number and the dose given on that date of service. Medicare will allow a maximum of three infusions per lifetime. This article is effective for dates of service on or after April 29, 2010.