Notification

Circulating Tumor Cell (CTC) Assay


Notification Issue Date: 10/01/2014

The new Medicare Advantage policy portfolio that includes this policy bulletin will become effective on 01/01/2015.



Medicare Advantage Policy

Title:Circulating Tumor Cell (CTC) Assay
Policy #:MA06.030

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

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.
Policy 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

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

ICD - 10 Procedure Code Number(s)





Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)




HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)



Coding and Billing Requirements






Policy History

01/01/2015This is a new policy.




Version Effective Date: 01/01/2015
Version Issued Date: 01/01/2015
Version Reissued Date: N/A