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

Sipuleucel-T (Provenge) is covered for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer when used per NCD 110.22 and consistent with the FDA label. Billing requires HCPCS Q2043 (for dates of service on/after 2011-07-01) which includes collection and activation procedures but not administration (bill CPT 96365 separately), and Medicare limits coverage to a maximum of three infusions per lifetime; services lacking required documentation or not meeting NCD/FDA criteria will be denied.

"Sipuleucel-T is covered for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer when used according to NCD 110."

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