The new Medicare Advantage policy portfolio that includes this policy bulletin will become effective on 01/01/2015.
CellSearch® Circulating Tumor Cell (CTC) assay is considered medically necessary and, therefore, covered for the following established diagnoses:
The CellSearch® System was originally cleared by the FDA in January 2004 as a diagnostic tool for identifying and counting circulating tumor cells (CTCs) in a blood sample to predict progression-free survival and overall survival in patients with metastatic breast cancer. In November 2007, the CellSearch™ System was cleared as an aid in monitoring metastatic colorectal patients..
This policy is consistent with Medicare’s coverage determination. The Company’s payment methodology may differ from Medicare.
Subject to the terms and conditions of the applicable Evidence of Coverage, CellSearch® System (CTC) is covered under the medical benefits of the Company’s Medicare Advantage plans when the medical necessity criteria listed in this medical policy are met.
Subject to the terms and conditions of the applicable Evidence of Coverage, CellSearch® Circulating Tumor Cell (CTC) for use as an ancillary diagnostic component is not eligible for payment under the medical benefits of the Company’s Medicare Advantage products because the approval and reimbursement for routine costs associated with a qualifying clinical trial for Medicare Advantage members are processed through the local Medicare Administrative Contractor (MAC).
“At present, the most feasible use of CTCs is monitoring of patients with metastatic disease. Although technically “prognostic,” elevated CTC levels over time in a patient receiving therapy are essentially predictive of resistance to that therapy and suggest that a new therapy, if available, is indicated.”
There is limited coverage for the CellSearch® CTC (Veridex, LLC) assay. CTC testing is best reserved for the setting of a clinical trial where chemotherapy selection is more systematically subjected to revision.
The CTC assay is reported as a numerical result where five or more cells per 7.5 mL of whole blood predicts worse prognosis in individuals with known recurrent breast and prostate cancer, and three or more cells are predictive of shorter progression-free survival and overall survival in metastatic colorectal cancer.