Cost of Administering Sipuleucel-T (PROVENGE®) is Now Reimbursable by Medicare

On November 2, 2011, the Centers for Medicare and Medicaid Services (“CMS”) issued a Medicare Learning Network Matters article entitled Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (“CR 7431”) wherein it “instructs that, effective for services performed on or after June 30, 2011, CMS concludes that the evidence is adequate to support the use of autologous cellular immunotherapy treatment – Sipuleucel-T; PROVENGE® for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.” Reimbursement for PROVENGE® (with a new HCPCS code of Q2043, replacing C9273), for the above-noted indication, is limited to one treatment regimen for the patient’s lifetime, which consists of three doses that are administered roughly two weeks apart. The treatment period may not exceed 30 weeks from the first administration. Administration of the treatments is not included in Q2043.

On November 7, 2011, CMS revised CR 7431, in which it specifically affirmed that that the cost of administering PROVENGE® is not included in Q2043, but separate payment for the cost of administration is permissible.

Q2043 is all-inclusive and represents routine costs, except for the cost of administration. Please note that the cost of administration can now be billed separately.

For more information, please contact Abby Pendleton, Esq. or Jessica L. Gustafson, Esq. at (248) 996-8510 or (212) 734-0128 or visit the HLP website.