A final decision memo issued on June 30 by the Centers for Medicare & Medicaid Services (CMS) provides Medicare patients with metastatic prostate cancer immediate access to a new treatment, and new hope.
Autologous cellular immunotherapy, known clinically as sipuleucel-T, stimulates “the body’s natural defenses (such as the white blood cells called dendritic cells, T-lymphocytes and mononuclear cells) in a specific manner so that they attack and destroy, or at least prevent the proliferation of, cancer cells. Specificity is attained by intentionally exposing a patient’s white blood cells to a particular protein (called an antigen) associated with the prostate cancer. This exposure ‘trains’ the white blood cells to target and attack the prostate cancer cells. Clinically this is expected to result in a decrease in the size and/or number of cancer sites, an increase in the time to cancer progression, and/or an increase in survival of the patient,” the final decision memo explains.
Sipuleucel-T was approved by the Food and Drug Administration (FDA) in 2010 and is marketed in the United States as Provenge®. Dendreon’s Provenge comes with a $93,000 price tag, however—too steep for most wallets—and prior to this national coverage determination (NCD 110.22), local contractors generally made case-by-case determinations.
According to the final decision memo, an estimated 192,280 new cases of prostate cancer were diagnosed in 2009 and an estimated 27,360 deaths were reported. Medicare Part B coverage of this drug could potentially prolong the lives of thousands of men who ordinarily wouldn’t be able to afford treatment.
According to CMS Transmittal 2254, Change Request (CR) 7431, issued July 8, coverage for Provenge is limited to one treatment regimen in a patient’s lifetime. Treatment consists of three doses with each dose administered about two weeks apart for a total treatment period not to exceed 30 weeks from inception.
Effective for Medicare Part B claims with dates of service on and after July 1, 2011, providers will be reimbursed (based on the average sales price + 6 percent) for covered treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer provided the claim contains the following:
- 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; and
- ICD-9 code 185 Malignant neoplasm of prostate; and
- At least one of the following ICD-9 codes:
- 196.1, 196.2, 196.5, 196.6, 196.8, 196.9, 197.0, 197.7, 198.0, 198.1, 198.5, 198.7, 198.82
Note: Contractors will not separately pay for routine costs associated with Provenge. Q2043 is all-inclusive and represents all routine costs associated with its administration.
Coverage for the off-label use of Provenge is up to the discretion of the Medicare administrative contractors (MACs). For a local coverage determination (LCD) by an individual MAC to cover Provenge off-label, the primary ICD-9 diagnosis code must be either 233.4 Carcinoma in situ of prostate or 185 Malignant neoplasm of prostate. ICD-9 233.4 may not be used for on-label coverage claims.
July 15th, 2011