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1 NOTE: Should you have landed here as a result of a search engine (or other) link, be advised that these files contain material that is copyrighted by the American Medical Association. You are forbidden to download the files unless you read, agree to, and abide by the provisions of the copyright statement. Read the copyright statement now and you will be linked back to here.

2 MolDX: Breast Cancer Assay: Prosigna Page 1 of 15 d MolDX: Breast Cancer Assay: Prosigna Palmetto GBA Jump to Section... Close Please Note: This is a Proposed LCD. Proposed LCDs are works in progress and not necessarily a reflection of the current policies or practices. Proposed LCDs in an approval status display on the CMS MCD for public review. Contractor Information Contractor Name Palmetto GBA Contract Number Contract Type A and B and HHH MAC (A and B and HHH MAC J - M) Palmetto GBA, (A and B and HHH MAC J - M) Palmetto GBA, (A and B and HHH MAC J - M) Palmetto GBA, (A and B and HHH MAC - Associated Contract J - M) Palmetto GBA, (A and B and HHH MAC J Numbers - M) Palmetto GBA, (A and B and HHH MAC J - M) Palmetto GBA, (A and B and HHH MAC J - M) Palmetto GBA Proposed LCD Information Source LCD ID L36125 Proposed LCD ID DL36125 Original ICD-9 LCD ID Not Applicable Proposed LCD Version 3 Proposed LCD Title MolDX: Breast Cancer Assay: Prosigna

3 MolDX: Breast Cancer Assay: Prosigna Page 2 of 15 AMA CPT ADA CDT AHA NUBC Copyright Statements CPT only copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright (c) American Dental Association. All rights reserved. CDT and CDT 2016 are trademarks of the American Dental Association. UB-04 Manual. OFFICIAL UB-04 DATA SPECIFICATIONS MANUAL, 2014, is copyrighted by American Hospital Association ("AHA"), Chicago, Illinois. No portion of OFFICIAL UB-04 MANUAL may be reproduced, sorted in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without prior express, written consent of AHA. Health Forum reserves the right to change the copyright notice from time to time upon written notice to Company. Title XVIII of the Social Security Act (SSA), 1862(a)(1)(A), states that no Medicare payment shall be made for items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Title XVIII of the Social Security Act, 1833(e), prohibits Medicare payment for any claim lacking the necessary documentation to process the claim. CMS National Coverage Policy 42 Code of Federal Regulations (CFR) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions. CMS Internet Online Manual Pub (Medicare Benefit Policy Manual), Chapter 15, Section 80, Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests CMS Internet-Only Manuals, Publication , Medicare Claims Processing Manual, Chapter 16, 50.5 Jurisdiction of Laboratory Claims, Independent Laboratory Specimen Drawing, Travel Allowance. CMS Internet Online Manual Pub (Medicare Claims Processing Manual), Chapter 23 (Section 10) Reporting ICD Diagnosis and Procedure Codes

4 MolDX: Breast Cancer Assay: Prosigna Page 3 of 15 Jurisdiction South Carolina Super MAC Jurisdiction J - M Coverage Guidance Coverage Indications, This policy provides limited coverage of the Prosigna cancer Limitations and/or Medical gene signature assay to patients that meet the following criteria Necessity consistent with the FDA indications for use: Post-menopausal female either ER+, lymph node-negative, stage I or II cancer; or ER+, lymph node-positive (1-3 positive nodes), stage II cancer. Claims for Prosigna testing will be denied when testing does not meet all of the above criteria. Background Women with early cancer and up to 3 locally positive lymph nodes whose tumor is estrogen-receptor positive will usually receive anti-hormonal therapy such as tamoxifen or aromatase inhibitors. U.S. (NCCN) and international (St. Gallen) guidelines predicate the decision for adjuvant chemotherapy on the size and grade of the cancer and other factors including genomic assays that provide additional information on risk of recurrence (Hernandez-Ava et al., 2013). According to a 2014 review, Prognostic factors provide an indication of whether a patient needs subsequent therapy. (Paoletti & Hayes, 2014). Similarly, another 2014 review article states, Efforts should be focused on reducing chemotherapy in patients unlikely to benefit. (Rampurwala et al., 2014). Accordingly, Medicare has covered cancer gene signature prognostic/predictive tests since The PAM50 cancer gene signature test was developed in the late 1990s and initial studies showed a strong correlation with cancer recurrence and with complete pathologic response to neoadjuvant chemotherapy (Parker et al., 2009). While test results are reported on a scale of as a Risk of Recurrence (ROR) score, the underlying algorithm is also able to classify cases into the luminal A and B, Her2neu, and triple-negative subtype

5 MolDX: Breast Cancer Assay: Prosigna Page 4 of 15 classifications. The Nanostring ncounter nucleic acid analysis system replicates the PAM50 algorithm, as an FDA cleared kit, the Prosigna Breast Cancer Gene Signature Assay (FDA, 2013). The Prosigna package insert was most recently updated in January, 2015 (FDA, 2015) reflecting additional studies (Sestak et al., 2014). Notably, the Prosigna platform and the original PAM50 platform have a correlation (Dowsett et al., 2013). For the FDA, the Prosigna test was validated in a large population of post-menopausal, estrogen-receptor positive women based on 1,017 cases of the TransATAC study (Dowsett et al., 2013). The study showed a strong correlation with long-term cancer recurrence and added substantial additional prognostic information over a clinical treatment score based on standard clinical variables. This study was replicated in an independent population, also on the Prosigna test, using 1,620 samples from the ABCSG8 trial (Gnant, 2014). A separate analysis of these trials validated prediction of distant recurrence in years 5-10 after initial diagnosis (Sestak et al., 2014) and has been incorporated in the FDA labeling (FDA, 2015). The Prosigna test is issued as separate reports, consistent with FDA review and labeling, for node-negative and node-positive (1-3 node) populations. Analytic performance, precision, reproducibility, and analysis of the clinical validations are provided in the FDA labeling (FDA, 2013; FDA, 2015). Clinical utility of this cancer gene signature has also been assessed. The study of Martin et al. (2015) showed a 20% decision impact on decisions for or against adjuvant chemotherapy in an allcomers population of 200 new cases of incident cancer, when Prosigna test information became available after all other clinical information had been considered. The net rates of selecting adjuvant chemotherapy for low, intermediate, and high risk cases was similar to that observed in a meta-analysis of Oncotype DX decision data (Carlson & Roth, 2013). Additional support for the use of these test results in treatment decisions comes from Parker et al. (2009), in which there was a strong association with neoadjuvant chemotherapy response. Low-scoring cases have a very low change of complete pathological response to neoadjuvant chemotherapy, while highscoring cases approach a 50% chance of complete pathological response. The same findings have been observed for other cancer gene signatures based on prognostic algorithms (Chang et al., 2008). Proposed Process Information

6 MolDX: Breast Cancer Assay: Prosigna Page 5 of /23/2016 Synopsis of Changes Changes Removed male cancer CPT codes : C Malignant neoplasm of nipple and areola, right male C Malignant neoplasm of nipple and areola, left male C Malignant neoplasm of nipple and areola, unspecified male C Malignant neoplasm of central portion of right male C Malignant neoplasm of central portion of left male C Malignant neoplasm of central portion of unspecified male C Malignant neoplasm of upperinner quadrant of right male C Malignant neoplasm of upperinner quadrant of left male C Malignant neoplasm of upperinner quadrant of unspecified male C Malignant neoplasm of lowerinner quadrant of right male C Malignant neoplasm of lowerinner quadrant of left male C Malignant neoplasm of lowerinner quadrant of unspecified male C Malignant neoplasm of upperouter quadrant of right male C Malignant neoplasm of upperouter quadrant of left male C Malignant neoplasm of upperouter quadrant of unspecified male C Malignant neoplasm of lowerouter quadrant of right male C Malignant neoplasm of lowerouter quadrant of left male C Malignant neoplasm of lowerouter quadrant of unspecified male C Malignant neoplasm of axillary tail of right male C Malignant neoplasm of axillary tail of left male C Malignant neoplasm of axillary tail of unspecified male Fields Changed ICD-10 Codes that Support Medical Necessity

7 MolDX: Breast Cancer Assay: Prosigna Page 6 of /23/2016 Changes C Malignant neoplasm of overlapping sites of right male C Malignant neoplasm of overlapping sites of left male C Malignant neoplasm of overlapping sites of unspecified male C Malignant neoplasm of unspecified site of right male C Malignant neoplasm of unspecified site of left male C Malignant neoplasm of unspecified site of unspecified male Documentation Requirements Fields Changed Associated Information The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See Coverage Indications, Limitations, and/or Medical Necessity") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available to the MAC upon request. Sources of Information and References Basis for Decision 1. Carlson JJ & Roth JA (2013). The impact of Oncotype DX cancer assay in clinical practice: a systematic review and meta-analysis. Breast Cancer Res Treat 141: Chang JC et al. (2008) Gene expression patterns in formalinfixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in cancer patients. Breast Cancer Res Treat108: Dowsett M et al. (2013) Comparison of PAM50 Risk of Recurrence Score With Oncotype DX and IHC4 for Predicting Risk of Distant Recurrence After Endocrine Therapy. J Clin Oncol 31: FDA (2013). 510(k) Summary: K Prosigna Breast Cancer Prognostic Gene Signature Assay.

8 MolDX: Breast Cancer Assay: Prosigna Page 7 of 15 Open Meetings 5. FDA (2015) Package Insert: Prosigna Breast Cancer Prognostic Gene Signature Assay. Version 04, 18 pages. At: 6. Gnant M et al. (2014) Predicting distant recurrence in receptorpositive cancer patients with limited clinicopathological risk: using the PAM50 Risk of Recurrence score in 1478 postmenopausal patients of the ABCSG-8 trial treated with adjuvant endocrine therapy alone. Ann Oncol 25: Hernandez-Aya LF, Gonzalez-Angulo AM. Adjuvant systemic therapies in cancer. Surg Clin North Am Apr; 93 (2): Martin M et al. (2015) Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor positive, human epidermal growth factor receptor negative, node negative early-stage cancer. Curr Med Res Opin 23: Paoletti C & Hayes DF (2014) Molecular testing in cancer. Ann Rev Med 65: Parker JS et al. (2009) Supervised risk predictor of cancer based on intrinsic subtypes. J Clin Oncol 27: Rampurwala MM et al. (2014) Update on adjuvant chemotherapy for early cancer. Breast Cancer 8: Sestak I et al. (2014) Prediction of late recurrence after 6 years of endocrine treatment: combined analysis of patients from the ABCCSG8 using the PAM50 Risk of Recurrence Score. J Clin Oncol doi: /JCO Meeting Date Meeting Information State 06/13/2016 Columbia South Carolina 06/16/2016 Durham North Carolina 06/21/2016 Charleston West Virginia 06/23/2016 Richmond Virginia Meeting Date Meeting Information State Part B MAC Contractor 06/13/2016 Columbia South Carolina Advisory Committee (CAC) 06/16/2016 Durham North Carolina Meetings 06/21/2016 Charleston West Virginia 06/23/2016 Richmond Virginia Comment Period Start Date 06/13/2016

9 MolDX: Breast Cancer Assay: Prosigna Page 8 of 15 Comment Period End Date 07/29/2016 Released to Final LCD Date Not yet released. Reason for Proposed LCD New/Updated Technology Part B Policy PO Box Proposed LCD Contact AG-275 Columbia, South Carolina B.Policy@PalmettoGBA.com Coding Information Bill Type Codes Revenue Codes CPT/HCPCS Codes Group 1: Paragraph Group 1: Codes ONCOLOGY (BREAST), MRNA ANALYSIS OF 58 GENES USING HYBRID CAPTURE, ON 0008M FORMALIN-FIXED PARAFFIN-EMBEDDED (FFPE) TISSUE, PROGNOSTIC ALGORITHM REPORTED AS A RISK SCORE Does the CPT 30% Coding No Rule Apply? ICD-10 Codes that Support Group 1: Paragraph Medical Necessity Group 1: Codes Note: Performance is Malignant neoplasm of nipple and areola, right female optimized by using code C ranges. Malignant neoplasm of nipple and areola, left female C Malignant neoplasm of nipple and areola, unspecified C Malignant neoplasm of central portion of right female C Malignant neoplasm of central portion of left female C Malignant neoplasm of central portion of unspecified C Malignant neoplasm of upper-inner quadrant of right C Malignant neoplasm of upper-inner quadrant of left C50.212

10 MolDX: Breast Cancer Assay: Prosigna Page 9 of 15 C Malignant neoplasm of upper-inner quadrant of unspecified C Malignant neoplasm of lower-inner quadrant of right C Malignant neoplasm of lower-inner quadrant of left C Malignant neoplasm of lower-inner quadrant of unspecified C Malignant neoplasm of upper-outer quadrant of right C Malignant neoplasm of upper-outer quadrant of left C Malignant neoplasm of upper-outer quadrant of unspecified C Malignant neoplasm of lower-outer quadrant of right C Malignant neoplasm of lower-outer quadrant of left C Malignant neoplasm of lower-outer quadrant of unspecified C Malignant neoplasm of axillary tail of right female C Malignant neoplasm of axillary tail of left female C Malignant neoplasm of axillary tail of unspecified C Malignant neoplasm of overlapping sites of right C Malignant neoplasm of overlapping sites of left C Malignant neoplasm of overlapping sites of unspecified C Malignant neoplasm of unspecified site of right C Malignant neoplasm of unspecified site of left female C Malignant neoplasm of unspecified site of unspecified D05.00 Lobular carcinoma in situ of unspecified D05.01 Lobular carcinoma in situ of right D05.02 Lobular carcinoma in situ of left D05.10 Intraductal carcinoma in situ of unspecified D05.11 Intraductal carcinoma in situ of right D05.80

11 MolDX: Breast Cancer Assay: Prosigna Page 10 of /23/2016 Other specified type of carcinoma in situ of unspecified Unspecified type of carcinoma in situ of unspecified D05.90 ICD-10 Codes that DO NOT Support Medical Necessity Group 1: Paragraph Note: Performance is optimized by using code ranges. Additional ICD-10 Information Associated Documents Group 1: Codes Attachments Related Local Coverage Documents There are no attachments for this LCD. This LCD version has no Related Local Coverage Documents. Related National Coverage This LCD version has no Related National Coverage Documents. Documents Version 3 - Updated on 05/23/ :56:21, by Elaine.Jeter@palmettogba.com, with effective dates N/A - N/A (Approved). Version 2 - Updated on 05/23/ :46:00, by All Versions tina.houser@palmettogba.com, with effective dates N/A - N/A. Version 1 - Updated on 05/02/ :34:39, by tina.houser@palmettogba.com, with effective dates 01/25/ N/A. Additional Information Contractor Only Notes Keywords Saved By Elaine.Jeter@palmettogba.com Saved On 05/23/2016 Date Retirement Completed Approved? Yes Close

12 MolDX: Breast Cancer Assay: Prosigna Page 11 of 15 Close This is a U.S. Government computer system subject to Federal law. This website is an official service of the Centers for Medicare & Medicaid Services. View Site Disclaimer View AMA License View ADA License View Site Privacy Policy Nondiscrimination/Accessibility Site Disclaimer The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare, Medicaid and the State Children's Health Insurance Programs, contracts with certain organizations to assist in the administration of the Medicare program (Medicare contractors). Medicare contractors are required to develop and disseminate Local Coverage Determinations (LCDs). CMS believes that the Internet is an effective method to share LCDs developed by Medicare contractors. To facilitate such sharing of information, CMS has provided the maintainer of this web site data obtained from the Medicare contractors. While every effort has been made to provide accurate and complete information, CMS does not guarantee that there are no errors in the information displayed on this web site. THE UNITED STATES GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION, PRODUCT, OR PROCESSES DISCLOSED HEREIN. Neither the United States Government nor its employees represent that use of such information, product, or processes will not infringe on privately owned rights. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information, product, or process. Close LICENSE FOR USE OF "Physicians' CURRENT PROCEDURAL TERMINOLOGY", FOURTH EDITION ("CPT") CPT codes and descriptions only are copyright 2015 American Medical Association. All Rights Reserved (or such other date of publication of CPT). CPT is a registered 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 Centers for Medicare and Medicaid Services (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 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, 515 N. State Street, Chicago, IL Applications are available at the AMA Web site,

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