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.
November 14th, 2011
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
The Centers for Medicare & Medicaid Services (CMS) announced March 30 that it would pay for Dendreon’s prostate cancer drug, Provenge, when used to treat Medicare beneficiaries with late-stage prostate cancer. The Food and Drug Administration (FDA) approved Provenge for patients with castration-resistant, metastatic prostate cancer in April 2010. In the absence of a national coverage determination (NCD) for autologous cellular immunotherapy treatment, local Medicare contractors have had discretion to determine coverage for the $93,000 drug.
In a proposed decision memo posted on the Medicare Coverage Database website, however, CMS now says Provenge is reasonable and necessary. “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,” CMS concludes in the decision memo.
During the initial 30-day comment period of the national coverage analysis (NCA), CMS received 657 comments, most of them favorable for coverage.
The proposed decision is open for public comment through April 30, and CMS will make a final determination sometime in June.
April 1st, 2011