Circulating Tumor Cell Marker Assays (DL32218)

Contractor Information

Contractor Name
Wisconsin Physicians Service Insurance Corporation
Contractor Number
00951, 00952, 00953, 00954, 52280, 05101, 05201, 05301, 05401, 05102, 05202, 05302, 05402
Contractor Type
Carrier - FI - MAC

LCD Information

Document Information
Draft stamp
LCD ID Number
DL32218

LCD Title
Circulating Tumor Cell Marker Assays

Contractor's Determination Number
PATH-033

AMA CPT/ADA CDT Copyright Statement
CPT codes, descriptions and other data only are copyright 2010 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction


Oversight Region



Original Determination Effective Date


Original Determination Ending Date


Revision Effective Date


Revision Ending Date


CMS National Coverage Policy
Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that no Medicare payment shall be made for items or service that "are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of malformed body member."

Title XVIII of the Social Security ACT (SSA), §1862(a)(7) and 42 Code of Federal Regulations, §411,15, exclude routine physical examinations.

Title XVIII of the Social Security Act (SSA), §1833(e), prohibit Medicare payment for any claim lacking the necessary documentation to process the claim.

42 CFR §410.32(d)(3)indicates diagnostic tests are payable only when the physician who is treating the beneficiary for specific medical problem and who uses the results in such treatment.

Title XVIII of the Social Security Act (SSA) §1862(a)(1)(D), Investigational or Experimental.

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 3, §3.4.1.1.E, states that contractors may require ICD-9 diagnosis codes to be submitted by providers, with every claim for a targeted service if such a requirement appears in an LCD for that service.

CMS Manual System, Pub. 100-08, Medicare Program Integrity Manual, Chapter 3, §3.4.1.2, states that the billing provider is liable for charges, if at the request of the contractor, the ordering provider does not provide adequate documentation to support the medical necessity of the test.

CMS Manual System, Pub. 100-02, Medicare Benefit Policy, Chapter 15, Section 80.1, 80.1.1, 80.1.2, 80.1.3, laboratory services must meet applicable requirements of CLIA.
Indications and Limitations of Coverage and/or Medical Necessity
This is a coverage policy for the CellSearch (Veridex) circulating tumor cell (CTC) assay. All other methods for circulating tumor cell detection, including reverse-transcription polymerase chain reaction PCR (RTPCR) Assays, are non-covered.

CTCs 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 is an accurate indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer. Therefore, CTC will be limited to metastatic breast, colorectal and prostate cancer. CTC testing for all other malignant diagnoses will be denied as not reasonable and necessary.

The CellSearch assay, an independent predictor of progression-free survival and overall survival in patients with metastatic breast, colorectal and prostate cancer, involves the automated immunomagnetic selection of CTCs based on an anti-EpCAM antibody cell capture. To perform this assay, a 7.5 ml aliquot of blood is incubated with EpCAM antibody-covered ferroparticles (nanotechnology). Circulating epithelial cells that express EpCAM are isolated in a magnetic field without centrifugation.

The supernatant containing unbound cells is removed. The enriched cell samples are labeled with a fluorescent nuclei acid dye and two monoclonal antibodies (CD 45 and Cytokeratin 8, 18, 19), each tagged with distinct fluorescent compounds. The stained cells are then analyzed on a fluorescence microscope. Digital fluorescent images are interpreted by a technician as CTCs if the cell has a nucleus, expresses keratin (EpCAM and CK) and does not express CD45.

The assay is reported as a numerical result where more than 5 cells per 7.5 ml of whole blood predicts worse prognosis in patients with known recurrent breast and prostate cancer, and more than 3 cells are predictive of shorter progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer.


Coding Information

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Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.


Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.



CPT/HCPCS Codes

86849UNLISTED IMMUNOLOGY PROCEDURE

ICD-9 Codes that Support Medical Necessity

Note: ICD-9 codes must be coded to the highest level of specificity.
153.0 - 153.9MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE
154.0 - 154.8MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION - MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS
174.0 - 174.9MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE
175.0 - 175.9MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST
185MALIGNANT NEOPLASM OF PROSTATE

Diagnoses that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

General Information

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Documentations Requirements
Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request.

Providers must include CellSearch or Circulating Cell Tumor Assay in item 19 of the CMS-1500 or the narrative field of the electronic claim.
Appendices
Utilization Guidelines
Services performed for excessive frequency are not medically necessary. Patients should be treated on an individual basis as indicated by the response to treatment. The intent of the following guidelines is to provide the maximum amount of tests required to adequately follow disease progression or treatment response.

WPS Medicare expects physicians to limit CTC testing to only times when the CTC information may change treatment. Documentation maintained in the patient record must support medical necessity and be available upon request.

Frequency

  • Baseline €“ limited to once prior to initiation of tumor-type specific chemotherapy

  • Follow-up during chemotherapy treatment - repeat every 4-6 weeks

  • Surveillance with no chemotherapy treatments - repeat every 4-6 months



A rapid rise in the CTC value usually indicates aggressive disease and impending adverse outcome. WPS Medicare would expect to see no further CTC testing after the transition to palliative/hospice care.
Sources of Information and Basis for Decision
Other Contractors LCD

Budd GT, et al. Circulating Tumor Cells Versus Imaging-Predicting Overall Survival in Metastatic Breast Cancer. Clin Cancer Res. 2006;12(21):6403-6409.

Chan F, et al. Dramatically Elevated Circulating Tumor Cell Numbers in a Patient With Small Cell Neuroendocrine Carcinoma of the Prostate. Arch Pathol Lab Med. 2010;134:120-123.

Cohen SJ, et al. Prognostic significance of circulating tumor cells in patients with metastatic colorectal cancer. Annals of Oncol. 2009;20(7):1223-1229.

Cohen SJ, et al. Relationship of Circulating Tumor Cells to Tumor Response, Progression-Free Survival, and Overall Survival in Patients with Metastatic Colorectal Cancer. J Clin Oncol. 2008;26(19):3213-3221.

Cristofanilli M, et al. Circulating Tumor Cells, Disease Progression, and Survival in Metastatic Breast Cancer. NEJM. 2004;351:781-91.

Danila DC, et al. Circulating tumor cells (CTC) in patients with metastatic castration resistant prostate cancer (CRPC) receiving abiraterone acetate (AA) after failure of docetaxel-based chemotherapy. J Clin Oncol. 2009;27:15s (suppl; abstr 5049).

Danila DC, et al. Circulating Tumor Cell Number and Prognosis in Progressive Castration-Resistant Prostate Cancer. ,em>Clin Cancer Res. 2007;13(23):7053-7058.

Dawood S, et al. Circulating Tumor Cells in Metastatic Breast Cancer From Prognostic Stratification to Modification of the Staging System? Cancer. 2008;113(9):2422-2430.

de Bono JS, et al. Circulating Tumor Cells Predict Survival Benefit from Treatment in Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2008;14(19):6302-6309.

de Giorgi U, et al. Circulating Tumor Cells and [18F]Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography for Outcome Prediction in Metastatic Breast Cancer. J Clin Oncol. 2009;27(20):3303-3311.

Denlinger CS, Cohen SJ. Progress in the Development of Prognostic and Predictive Markers for Gastrointestinal Malignancies. Curr Treat Options Oncol. 2007;8(5):339-351.

Fischer AH. Circulating Tumor Cells: Seeing is Believing. Arch Pathol Lab Med. 2009;133(9):1367-1369.

Goodman OB, et al. Circulating Tumor Cells in Patients with Castration-Resistant Prostate Cancer Baseline Values and Correlation with Prognostic Factors. Cancer Epidemiol Biomarkers Prev. 2009;18(6):1904-1913.

Harris L, et al. American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer. J Clin Oncol. 2007;25(33):5287-5312.

Hayes DF, Smerage J. Is there a Role for Circulating Tumor Cells in the Management of Breast Cancer? Clinical Cancer Res. 2008;14(12):3646-3650.

Hayes DF, et al. Circulating Tumor Cells at Each Follow-up Time Point During Therapy of Metastatic Breast Cancer Patients Predict Progression-Free and Overall Survival. Clin Cancer Res. 2006;12(14):4218-4224.

Okegawa T, et al. Prognostic Significance of Circulating Tumor Cells in Patients with Hormone Refractory Prostate Cancer. J of Urology. 2009;181:1091-1097.

Olmos D, et al. Circulating tumour cell (CTC) counts as intermediate end points in castration-resistant prostate cancer (CRPC): a single-centre experience. Annals of Oncol. 2009;20(1):27-33.

Petrelli NJ, et al. Clinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention, and Screening-A Report From the American Society of Clinical Oncoloy. J Clin Oncol. 2009;27(35):6052-6069.

Sabbath KD, et al. Circulating Tumor Cells: Ready for Prime Time. Commun Oncol. 2008;5:516-520,524.

Scher HI, et al. Circulating tumour cells as prognostic markers in progressive, castration-resistant prostate cancer: a reanalysis of IMMC38 trial data. Lancet Oncol. 2009;10:233-239.

Shaffer DR, et al. Circulating Tumor Cell Analysis in Patients with Progressive Castration-Resistant Prostate Cancer. Clin Cancer Res. 2007;13(7):2023-2029.

Sieuwerts AM, et al. Anti-Epithelial Cell Adhesion Molecule Antibodies and the Detection of Circulating Normal-Like Breast Tumor Cells. J Natl Cancer Inst. 2009;101(1):61-66.

Smerage JB, Hayes DF. The Measurement and Therapeutic Implications of Circulating Tumour Cells in Breast Cancer. British Journal of Cancer. 2006;94(1):8-12.

Tol J, et al. Chemotherapy, Bevacizumab, and Cetuximab in Metastatic Colorectal Cancer. NEJM. 2009;360(6):563-572.
Advisory Committee Meeting Notes
Wisconsin: 09/23/2011
Illinois: 09/21/2011
Michigan: 09/14/2011
Minnesota: 09/15/2011
J5: 10/06/2011

Open LCD Meeting Date: 09/01/2011

*- An asterisk indicates a revision to that section of the policy.

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the MAC contractor this policy was developed in cooperation with advisory groups which include representatives from various specialties, and adapted for the purpose of converting to MAC jurisdiction.
Start Date of Comment Period
10/06/2011
End Date of Comment Period
11/20/2011
Start Date of Notice Period
Revision History Number
Revision History Explanation
Reason for Change
Last Reviewed On Date
07/26/2011
Related Documents
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LCD Attachments
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Draft Contact
Kenneth Bussan - policycomments@wpsic.com
WPS Medicare
1717 W. Broadway
Madison, WI 53701-1787

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Page Last Updated: Thursday, 18-Aug-2011 12:16:36 CDT