Sipuleucel-T (Provenge®) - Coverage Criteria for Prostate Cancer – Clarification

Sipuleucel-T (Provenge®) is an autologous cellular immunotherapy, FDA-approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The production of Sipuleucel-T involves collection of the patient’s own cells (leukapheresis), culture with a proprietary antigen complex, and re-infusion of the “antigen-activated” patient cells back to the donor. Provenge® is administered as three intravenous infusions, generally two weeks apart. When infused back into the patient, usually three days after leukapheresis, the patient-specific medication (autologous cellular therapy) stimulates a positive immunogenic response against the prostate cancer. For coverage, patient records must document that the product is being used according to the NCD 110.22. If the documentation does not describe the criteria above, does not meet all the requirements of the NCD on sipuleucel-T,is inconsistent with the FDA label and/or is not received, the services will be denied. Off-label use of this treatment is not covered unless it meets the requirements for off-label use of chemotherapeutic drugs in the Internet Only Manual 100-02 (Benefit Policy), Chapter 15 (Covered Services), Section 50.4.5. Noridian may cover sipuleucel-T for the above condition when all requirements are met including the following coding instructions. (NOTE: Noridian will not allow payment for any off-label use of this treatment): For dates of service on/after July 1, 2011, use the following HCPCS code: Q2043 Sipuleucel-T auto CD54+. For dates of service prior to July 1, 2011, use one of the following HCPCS code: J3490, J3590 or C9273 (being replaced by Q2043). The payment of HCPCS Q2043 includes collection of patients’ cells, activation with PAP-CM-CSF, including leukapheresis and all other preparatory procedures associated with sipuleucel-T. The code Q2043 does not include the administration of the treatments. CPT® code 96365, intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to one (1) hour will be allowed for the administration of Q2043. Medicare will allow a maximum of three (3) infusions per lifetime. Sources: Internet Only Manual (IOM) Medicare National Coverage Determinations (NCD) Manual, Publication 100-03, Chapter 1, Section 110.22, IOM Medicare Claims Processing Manual, Publication 100-04, Chapter 32, Section 280; Transmittal 133, Change Request (CR)7431 dated July 8, 2011; Transmittal 2254, CR 7431 dated July 8, 2011.