CMS Clarifies Coverage for Prostate Cancer Immunotherapy
Effective June 30, 2011, the Centers for Medicare & Medicaid Services (CMS) will cover autologous cellular immunotherapy treatment for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer.
Sipuleucel-T (PROVENGE®) is the first immunotherapy for prostate cancer to receive approval by the U.S. Food and Drug Administration (FDA). It works by stimulating the body’s natural defenses (such as the white blood cells called dendritic cells, T-lymphocytes, and mononuclear cells) so that they attack and destroy—or at least prevent the proliferation of—cancer cells.
Sipuleucel-T supply is reported using HCPCS Level II code Q2043 Sipuleucel-T, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion. Coverage is limited to one treatment regimen in a patient’s lifetime, consisting of three doses with each dose administered approximately two weeks apart, for a total treatment period not to exceed 30 weeks from the first administration.
In a recent MLN Matters® article, MM7431, CMS clarifies that a separate payment for the cost of administration is allowed (e.g., CPT® 96413 Chemotherapy administration, intravenous infusion technique; up to one hour, single or initial substance/drug and 96415 … each additional hour (list separately in addition to code for primary procedure). Q2043 is inclusive of all other all routine costs.