Q2043 — Sipuleucel-t, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Medical records must document that sipuleucel-T is being used according to NCD 110.22 and consistent with the FDA label, including documentation of diagnosis, symptom status (asymptomatic or minimally symptomatic), and that the autologous cellular process (leukapheresis, activation, reinfusion) was followed.
- Use HCPCS Q2043 for dates of service on or after 2011-07-01; for dates prior to 2011-07-01 bill J3490, J3590, or C9273 (C9273 being replaced by Q2043).
- Document that Q2043 billing includes collection of patient cells, activation with PAP-CM-CSF, leukapheresis, and all preparatory procedures associated with sipuleucel-T.
- Document administration using CPT 96365 (IV infusion, initial up to 1 hour) for each infusion when seeking payment for administration separate from Q2043.
Key Coverage Criteria
- Sipuleucel-T is covered for patients with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer when used according to NCD 110.22 and consistent with the FDA label.
- Coverage applies only for the FDA-approved autologous cellular immunotherapy procedure involving leukapheresis, antigen activation, and reinfusion administered as described in the product labeling.
1 Active Policy
A55719 — Sipuleucel-T (Provenge) - Coverage Criteria for Prostate Cancer Clarification
Related Codes
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