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    LICENSE FOR USE OF PHYSICIANS’ CURRENT PROCEDURAL TERMINOLOGY, FOURTH EDITION ("CPT")


    End User Point and Click Amendment:

    CPT codes, descriptions and other data only are copyright 2020 American Medical Association. American Medical Association. All Rights Reserved (or such other date of publication of CPT). CPT is a trademark of the American Medical Association (AMA).

    You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.

    Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CPT for resale and/or license, transferring copies of CPT to any party not bound by this agreement, creating any modified or derivative work of CPT, or making any commercial use of CPT. License to use CPT for any use not authorized herein must be obtained through the AMA, CPT Intellectual Property Services, AMA Plaza, 330 Wabash Ave., Suite 39300, Chicago, IL 60611-5885. Applications are available at the AMA Web site, http://www.ama-assn.org/cpt.

    Applicable FARS\DFARS Restrictions Apply to Government Use. Please click here to see all U.S. Government Rights Provisions. opens in new window

    AMA Disclaimer of Warranties and Liabilities.

    CPT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon no upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.

    CMS Disclaimer

    The scope of this license is determined by the AMA, the copyright holder. Any questions pertaining to the license or use of the CPT should be addressed to the AMA. End Users do not act for or on behalf of the CMS. CMS DISCLAIMS RESPONSIBILITY FOR ANY LIABILITY ATTRIBUTABLE TO END USER USE OF THE CPT. CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

    Should the foregoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled "I Accept".

    LICENSE FOR USE OF CURRENT DENTAL TERMINOLOGY (CDTTM)


    End User License Agreement:

    These materials contain Current Dental Terminology (CDTTM), copyright © 2020 American Dental Association (ADA). All rights reserved. CDT is a trademark of the ADA.

    The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement.

    If you do not agree with all terms and conditions set forth herein, click below on the button labeled "I do not accept" and exit from this computer screen.

    If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. As used herein, "you" and "your" refer to you and any organization on behalf of which you are acting.

    1. Subject to the terms and conditions contained in this Agreement, you, your employees and agents are authorized to use CDT only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Use of CDT is limited to use in programs administered by Centers for Medicare & Medicaid Services (CMS). You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials.

    2. Any use not authorized herein is prohibited, including by way of illustration and not by way of limitation, making copies of CDT for resale and/or license, transferring copies of CDT to any party not bound by this agreement, creating any modified or derivative work of CDT, or making any commercial use of CDT. License to use CDT for any use not authorized herein must be obtained through the American Dental Association, 211 East Chicago Avenue, Chicago, IL 60611. Applications are available at the American Dental Association web site, http://www.ADA.org.

    3. Applicable Federal Acquisition Regulation Clauses (FARS)/Department of Defense Federal Acquisition Regulation supplement (DFARS) Restrictions Apply to Government Use. Please click here to see all U.S. Government Rights Provisions. opens in new window

    4. Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.

    5. ADA DISCLAIMER OF WARRANTIES AND LIABILITIES. CDT is provided "as is" without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. No fee schedules, basic unit, relative values or related listings are included in CDT. The ADA does not directly or indirectly practice medicine or dispense dental services. The sole responsibility for software, including any CDT and other content contained therein, is with CMS; and no endorsement by the ADA is intended or implied. The ADA expressly disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon notice to you if you violate the terms of this Agreement.

      The ADA is a third party beneficiary to this Agreement.

    6. CMS DISCLAIMER. The scope of this license is determined by the ADA, the copyright holder. Any questions pertaining to the license or use of the CDT should be addressed to the ADA. End Users do not act for or on behalf of the CMS. CMS disclaims responsibility for any liability attributable to end user use of the CDT. CMS will not be liable for any claims attributable to any errors, omissions, or other inaccuracies in the information or material covered by this license. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material.

      The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I Accept". If you do not agree to the terms and conditions, you may not access or use software. Instead you must click below on the button labeled "I Do Not Accept" and exit from this computer screen.

    LICENSE FOR NATIONAL UNIFORM BILLING COMMITTEE (NUBC)


    American Hospital Association Disclaimer


    The American Hospital Association ("the AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.


    The license granted herein is expressly conditioned upon your acceptance of all terms and conditions contained in this agreement. If the foregoing terms and conditions are acceptable to you, please indicate your agreement by clicking below on the button labeled "I Accept". If you do not agree to the terms and conditions, you may not access or use the software. Instead, you must click below on the button labeled "I Do Not Accept" and exit from this computer screen.

    Local Coverage Determination (LCD):
    MolDX: Circulating Tumor Cell Marker Assays (L34066)


    Alert: Codes have moved from LCDs to Articles! Learn more opens in new window

    Select the Print Complete Record, Add to Basket or Email Record Buttons to print the record, to add it to your basket or to email the record.
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    To print an entire document, use the Need a PDF Button or the Print Complete Record Button.
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    • Expand All All sections on the page are Expanded
    • Collapse All All sections on the page are Collapsed

    Expand/Collapse the Contractor Information section Contractor Information

    Contractor NameContract TypeContract NumberJurisdictionState(s)
    Noridian Healthcare Solutions, LLC A and B MAC02101 - MAC AJ - FAlaska
    Noridian Healthcare Solutions, LLC A and B MAC02102 - MAC BJ - FAlaska
    Noridian Healthcare Solutions, LLC A and B MAC02201 - MAC AJ - FIdaho
    Noridian Healthcare Solutions, LLC A and B MAC02202 - MAC BJ - FIdaho
    Noridian Healthcare Solutions, LLC A and B MAC02301 - MAC AJ - FOregon
    Noridian Healthcare Solutions, LLC A and B MAC02302 - MAC BJ - FOregon
    Noridian Healthcare Solutions, LLC A and B MAC02401 - MAC AJ - FWashington
    Noridian Healthcare Solutions, LLC A and B MAC02402 - MAC BJ - FWashington
    Noridian Healthcare Solutions, LLC A and B MAC03101 - MAC AJ - FArizona
    Noridian Healthcare Solutions, LLC A and B MAC03102 - MAC BJ - FArizona
    Noridian Healthcare Solutions, LLC A and B MAC03201 - MAC AJ - FMontana
    Noridian Healthcare Solutions, LLC A and B MAC03202 - MAC BJ - FMontana
    Noridian Healthcare Solutions, LLC A and B MAC03301 - MAC AJ - FNorth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03302 - MAC BJ - FNorth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03401 - MAC AJ - FSouth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03402 - MAC BJ - FSouth Dakota
    Noridian Healthcare Solutions, LLC A and B MAC03501 - MAC AJ - FUtah
    Noridian Healthcare Solutions, LLC A and B MAC03502 - MAC BJ - FUtah
    Noridian Healthcare Solutions, LLC A and B MAC03601 - MAC AJ - FWyoming
    Noridian Healthcare Solutions, LLC A and B MAC03602 - MAC BJ - FWyoming

    Expand/Collapse the browser section LCD Information

    Document Information

    LCD ID
    L34066

    LCD Title
    MolDX: Circulating Tumor Cell Marker Assays

    Proposed LCD in Comment Period
    N/A

    Source Proposed LCD
    N/A

    AMA CPT / ADA CDT / AHA NUBC Copyright Statement
    CPT codes, descriptions and other data only are copyright 2020 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

    Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

    Current Dental Terminology © 2020 American Dental Association. All rights reserved.

    Copyright © 2013 - 2020, the American Hospital Association, Chicago, Illinois. Reproduced by CMS with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. To license the electronic data file of UB-04 Data Specifications, contact Tim Carlson at (312) 893-6816. You may also contact us at ub04@aha.org.

    Original Effective Date
    For services performed on or after 10/01/2015

    Revision Effective Date
    For services performed on or after 12/01/2019

    Revision Ending Date
    N/A

    Retirement Date
    N/A

    Notice Period Start Date
    N/A

    Notice Period End Date
    N/A

    CMS National Coverage Policy

    Title XVIII of the Social Security Act, §1862(a)(1)(A). Allows coverage and payment for only those services that are considered to be reasonable and necessary.

    42 CFR 410.32(a). Order diagnostic tests.

    42 CFR 411.15(k)(1). Particular Services excluded from coverage.
    Coverage Guidance
    Coverage Indications, Limitations, and/or Medical Necessity

    This is a NON-coverage policy for all circulating tumor cells (CTC) assays. This policy does not address tests for circulating free or circulating tumor DNA (cfDNA; ctDNA).






    Summary of Evidence

    Although the detection of elevated CTCs during therapy is a definitive indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer, no data has been forthcoming to demonstrate improved patient outcomes, or that the assay changes physician management to demonstrate improved patient outcomes.

     



    Analysis of Evidence
    (Rationale for Determination)

    Level of Evidence

    Quality of evidence – absent

    Strength of evidence – absent

    Weight of evidence – absent

    CTC testing for all malignant diagnoses will be denied as not reasonable and necessary under Title XVIII of the Social Security Act, §1862(a)(1)(A). There are been no substantive articles demonstrating clinical utility for this assay – prospective studies that demonstrate improved patient outcomes based on testing results, or that testing changes physician management to change patient outcomes.


    Expand/Collapse the General Information section General Information

    Associated Information
    N/A
    Sources of Information
    N/A
    Bibliography
    1. Budd G, Cristofanilli M, Ellis M et al. Circulating Tumor Cells Versus Imaging-Predicting Overall Survival in Metastatic Breast Cancer. Clin Cancer Res. 2006; 12(21):6403-6409.

    2. Chan F, Goodman O, Fink L, Vogelzang NJ, Pomerantz D, Khoury JD. 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.

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

    4. Cohen SJ, Punt C, Iannotti N, 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.

    5. Coumans FA, Ligthart ST, Uhr JW, Terstappen LW. Challenges in the enumeration and phenotyping of CTC. Clin Cancer Res 15, 2012 18;5711.

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

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

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

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

    10. De Giorgi U, Valero V, Rohren E, 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.

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

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

    13. Fleisher M, Danila DC, Rathkopf D, 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).

    14. Goodman, Jr. OB, Fink LM, Symanowski JT, 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.

    15. Harris L, Fritsche H, Mennelet R, 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.

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

    17. Hayes DF, Cristofanilli M, Budd GT, 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.

    18. Hiltermann T, Pore M, van den Berg A, et al. Circulating tumor cells in small-cell lung cancer: a predictive and prognostic factor. Ann Oncol 2012; 23(11):2937-42.

    19. Khan MS, Kirkwood A, Tsiganiet T, et al. Circulating tumor cells as prognostic markers in neuroendocrine tumors. JCO 10.1200/JCO.2012.44.2905.

    20. Okegawa T, Nutahara K, Higashihara E. Prognostic Significance of Circulating Tumor Cells in Patients with Hormone Refractory Prostate Cancer. J of Urology. 2009; 181:1091-1097.

    21. Olmos D, Arkenau HT, Ang JE, 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.

    22. Petrelli P, Winer E, Brahmeret J et al. Clinical Cancer Advances 2009: Major Research Advances in Cancer Treatment, Prevention, and Screening-A Report From the American Society of Clinical Oncology. Jour of Clin Oncol. 2009;27(35):6052-6069.

    23. Sabbath KD and Schwartzberg L. Circulating Tumor Cells: Ready for Prime Time. Commun Oncol. 2008;5:516-520,524.

    24. Scher H, Jia X, de Bono J, 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.

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

    26. Sieuwerts AM, Kraan J, Bolt J, 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.

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

    28. Tol J, Koopman M, Cats A, et al. Chemotherapy, Bevacizumab, and Cetuximab in Metastatic Colorectal Cancer. NEJM. 2009;360(6):563-572.

     

    Expand/Collapse the Revision History section Revision History Information

    Revision History DateRevision History NumberRevision History ExplanationReason(s) for Change
    12/01/2019 R5

    The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.

    At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
    • Other (The LCD is revised to remove CPT/HCPCS codes in the Keyword Section of the LCD.
      )
    12/01/2019 R4

    As required by CR 10901, all billing and coding information has been moved to the companion article, this article is linked to the LCD. 

     

     
    • Revisions Due To Code Removal
    09/24/2018 R3

    Indications and limitations were corrected to clarify that this policy does not address tests for circulating free or circulating tumor DNA (cfDNA; ctDNA). Completed 21st Century Cures Act required fields.
    • Creation of Uniform LCDs With Other MAC Jurisdiction
    10/01/2017 R2

    Added MolDX into the title of the LCD and revised verbiage to be consistent with the MolDX Program. There is no change in coverage.

    At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
    • Creation of Uniform LCDs With Other MAC Jurisdiction
    10/01/2015 R1 This final LCD, effective 10/1/2015, combines JFA L35096 into the JFB LCD so that both JFA and JFB contract numbers will have the same final MCD LCD.
    • Creation of Uniform LCDs Within a MAC Jurisdiction

    Expand/Collapse the Associated Documents section Associated Documents

    Attachments
    N/A
    Related Local Coverage Documents
    Article(s)
    A57816 - Billing and Coding: MolDX: Circulating Tumor Cell Marker Assays opens in new window
    A55598 - Billing and Coding: MolDX: OncoCee™  opens in new window
    Related National Coverage Documents
    N/A
    Public Version(s)
    Updated on 01/29/2020 with effective dates 12/01/2019 - N/A
    Updated on 11/24/2019 with effective dates 12/01/2019 - N/A
    Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

    Expand/Collapse the Keywords section Keywords

    • Circulating Tumor
    Read the LCD Disclaimer opens in new window
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