Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer

The Centers for Medicare & Medicaid Services (CMS) finds that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment – Sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer. It is therefore reasonable and necessary to use for this on-label indication under the Social Security Act (1862(a)(1)(A)) effective for services performed on or after June 30, 2011.

HCPCS code C9273 will be deleted on June 30, 2011 and The new HCPCS code Q2043 (w.e.f July 1, 2011) will replace C9273 (Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion)

Coverage for PROVENGE®, Q2043, for asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer is limited to one

(1) treatment regimen in a patient’s lifetime, consisting of three (3) doses with each dose administered approximately two

(2) weeks apart for a total treatment period not to exceed 30 weeks from the first administration.

Billing requirements

Q2043 is all-inclusive and represents all routine costs associated with its administration. Thus contractors will not pay separately for any claims of routine costs associated with PROVENGE®, such as Common Procedure Terminology (CPT) code 96365, “intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour”.

For a local coverage determination by an individual MAC to cover PROVENGE® “off-label” for the treatment of prostate cancer, the International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code must be either 233.4 (carcinoma in situ of prostate) or 185 (malignant neoplasm of prostate). ICD-9 diagnosis code 233.4 may not be used for “on-label” coverage claims.

Also see ‘Limitations for Provenge and ICD requirements’

Reference(s): http://www.cms.gov/MLNMattersArticles/Downloads/MM7431.pdf