Medicare Advantage

Circulating Tumor Cell (CTC) Assay
MA06.030

Policy


MEDICALLY NECESSARY

CellSearch® Circulating Tumor Cell (CTC) assay is considered medically necessary and, therefore, covered for the following established diagnoses:
    • Metastatic breast cancer
    • Metastatic colorectal cancer
    • Metastatic prostate cancer


LIMITATIONS
    • All methods for CTC enrichment/detection, other than the CellSearch® CTC assay, including PCR (RT-PCR) assays, are considered not covered, because they are considered investigational.
    • CTC for all other malignant diagnoses will be considered not medically necessary and, therefore, not covered.
    • All assays for CTC when used for routine screening or prognosis are considered not covered.
    • Further CTC testing would not be expected after the transition to palliative/hospice care.
    • It would not be expected that chemotherapy changes are sufficiently frequent enough to warrant performance of CTC more than four times, per year, for a individual.
EXPERIMENTAL/INVESTIGATIONAL

CLINICAL TRIAL

CellSearch® CTC for use as an ancillary diagnostic component is considered experimental/investigational and, therefore, not covered, with the following exception:
    • Coverage for the routine costs of a qualifying clinical trial approved by Original Medicare.


Coverage for routine costs associated with qualifying clinical trials for Medicare Advantage members are processed through the local Medicare Administrative Contractor (MAC).
    • Providers must submit all claims for routine costs associated with qualifying clinical trials to the local MAC.
    • Claims received by the Company for routine costs associated with qualifying clinical trials, including FDA-approved prescription pharmaceuticals, biologics, or devices, are not eligible for reimbursement consideration by the Company.


REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines


On Feb. 27, 2008, Veridex, LLC announced that the U.S. Food and Drug Administration (FDA) had granted expanded clearance for the CellSearch™ System to be used as an aid in the monitoring of metastatic prostate cancer (MPC) patients. The CellSearch™ System currently is cleared for monitoring metastatic breast and metastatic colorectal cancer patients.

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.

BENEFIT APPLICATION

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).

Description


Circulating tumor cells (CTC)s represent the point in the metastatic process of solid tumors when cells from a primary tumor invade, detach, disseminate, colonize, and proliferate in a distant site. Detection of elevated CTCs during therapy may be an accurate indication of subsequent rapid disease progression and mortality in breast, colorectal, and prostate cancer, noting that FDA labeling includes each of these neoplasms. Although some comparative cohort designs have been conducted to express the clinical utility of such testing, the vast majority of studies have been uncontrolled one-arm studies. As an illustration of the most sophisticated available evidence, Cristofanilli et al. (2004) and Tol et al. (2010) have reported two-armed studies in the prognostic/predictive assessment of metastatic breast and colorectal cancers, respectively. Two-armed prostate cancer studies have been performed, but are not available for review at this time, given their abstract-only availability. Paoletti et al. (2012) help to articulate such a current clinical niche as follows:

“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.

References

Novitas, Inc. LCD L32930 - Circulating Tumor Cell (CTC) Assay. 4/4/2013. Available at: https://www.novitas-solutions.com/policy/mac-ab/l32930.html. Accessed January 23, 2014.

Veridex, LLC. [Veridex website]. Available at:
https://www.veridex.com/ShowNewsItemPopup.aspx?id=25. Accessed February 22, 2013.


Coding

CPT Procedure Code Number(s)

86152, 86153


ICD - 10 Procedure Code Number(s)


ICD - 10 Diagnosis Code Number(s)


HCPCS Level II Code Number(s)
N/A

Revenue Code Number(s)



Coding and Billing Requirements



Policy History

1/1/2015
1/1/2015
 
MA06.030
 
Medicare Advantage
No