CLINICAL GUIDELINES Radiation Therapy Version 2.0.2019 Effective July 1, 2019 Clinical guidelines for medical necessity review of radiation therapy services. © 2019 eviCore healthcare. All rights reserved. Radiation Therapy Criteria V2.0.2019 Table of Contents Brachytherapy of the Coronary Arteries 6 Hyperthermia 15 Image-Guided Radiation Therapy (IGRT) 18 Neutron Beam Therapy 22 Proton Beam Therapy 24 Radiation Therapy for Anal Canal Cancer 66 Radiation Therapy for Bladder Cancer 69 Radiation Therapy for Bone Metastases 72 Radiation Therapy for Brain Metastases 77 Radiation Therapy for Breast Cancer 85 Radiation Therapy for Cervical Cancer 96 Radiation Therapy for Endometrial Cancer 103 Radiation Therapy for Esophageal Cancer 110 Radiation Therapy for Gastric Cancer 115 Radiation Therapy for Head and Neck Cancer 118 Radiation Therapy for Hepatobiliary Cancer 122 Radiation Therapy for Hodgkin’s Lymphoma 128 Radiation Therapy for Kidney and Adrenal Cancer 132 Radiation Therapy for Multiple Myeloma and Solitary Plasmacytomas 134 Radiation Therapy for Non-Hodgkin’s Lymphoma 138 Radiation Therapy for Non-malignant Disorders 143 Radiation Therapy for Non-Small Cell Lung Cancer 161 Radiation Therapy for Oligometastases 172 Radiation Therapy for Other Cancers 182 Radiation Therapy for Pancreatic Cancer 183 Radiation Therapy for Primary Craniospinal Tumors and Neurologic Conditions 189 Radiation Therapy for Prostate Cancer 197 Radiation Therapy for Rectal Cancer 206 Radiation Therapy for Skin Cancer 209 Radiation Therapy for Small Cell Lung Cancer 217 Radiation Therapy for Soft Tissue Sarcomas 220 Radiation Therapy for Testicular Cancer 226 Radiation Therapy for Thymoma and Thymic Cancer 229 Radiation Therapy for Urethral Cancer and Upper Genitourinary Tract Tumors 233 Radiation Treatment with Azedra 235 Radiation Treatment with Lutathera 238 Radioimmunotherapy with Zevalin 243 Selective Internal Radiation Therapy 254 ______________________________________________________________________________________________________ © 2019 eviCore healthcare. All Rights Reserved. Page 1 of 259 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Radiation Therapy Criteria V2.0.2019 Please note the following: CPT Copyright 2017 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. ______________________________________________________________________________________________________ © 2019 eviCore healthcare. All Rights Reserved. Page 2 of 259 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Radiation Therapy Criteria V2.0.2019 Please note the following: All information provided by the NCCN is “Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™)©2018/2019 National Comprehensive Cancer Network. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org.” ______________________________________________________________________________________________________ © 2019 eviCore healthcare. All Rights Reserved. Page 3 of 259 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Radiation Therapy Criteria V2.0.2019 Dear Provider, This document provides detailed descriptions of eviCore’s basic criteria (also known as clinical guidelines) for radiation therapy arranged by diagnosis. They have been carefully researched and are continually updated in order to be consistent with the most current evidence-based guidelines and recommendations for the provision of radiation therapy from national medical societies and evidence-based medicine research centers. In addition, the criteria are supplemented by information published in peer-reviewed literature. Our health plan clients review the development and application of these criteria. Every eviCore health plan client develops a unique list of CPT codes or diagnoses that are part of their radiation therapy utilization management programs. Health Plan medical policy supersedes the eviCore criteria when there is conflict with the eviCore criteria and the health plan medical policy. If you are unsure of whether or not a specific health plan has made modifications to these basic criteria in their medical policy for Radiation Therapy please contact the plan or access the plan’s website for additional information. While eviCore encourages participation in clinical trials when consistent with each health plan’s policies, we want to clarify our position on the use of such standard arms outside of the research setting. The use of a control arm or standard arm in a Phase III clinical trial does not necessarily mean that other standard treatment techniques are not equally effective. Examples of multiple “standard” arms can easily be found in the treatment of prostate cancer where Intensity-Modulated Radiation Therapy (IMRT), 3-Dimensional (3-D), low dose implant or High Dose Rate (HDR) can be equally effective or breast cancer where standard whole breast fractionation or hypo-fractionation can be used. Indeed, national criteria such as National Comprehensive Cancer Network ______________________________________________________________________________________________________ © 2019 eviCore healthcare. All Rights Reserved. Page 4 of 259 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Radiation Therapy Criteria V2.0.2019 (NCCN) and American College of Radiology (ACR) Appropriateness Criteria often suggest more than one radiation technique. It is eviCore’s process to apply evidence-based criteria to the particular clinical characteristics in evaluating a case, and to certify the most appropriate regimen/modality. This regimen/modality may match one that is used as a “standard arm” in a federally funded clinical trial, or it may be one that is considered an “alternate standard”. The alternate standard will be one supported by nationally published guidelines such as the NCCN, ACR Appropriateness Guidelines, or American Society for Radiation Oncology (ASTRO) Evidence- Based Guidelines, or supported by other acceptable peer-reviewed publications. As such, eviCore will not automatically certify a case based solely on the fact that it matches the standard (control) arm of a clinical trial. This concept applies also to regimens/modalities listed by the NCCN or ACR as “acceptable” treatments for specific disease sites. Rather, we commit to working with the providing Radiation Oncologist to certify the most appropriate regimen/modality for a particular case. eviCore healthcare works hard to make your clinical review experience a pleasant one. For that reason, we have peer reviewers available to assist you should you have specific questions about a procedure. For your convenience, eviCore’s Customer Service support is available from 7 a.m. to 7 p.m. Our toll free number is (800) 918-8924. Gregg P. Allen, M.D. FAAFP EVP and Chief Medical Officer ______________________________________________________________________________________________________ © 2019 eviCore healthcare. All Rights Reserved. Page 5 of 259 400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924 www.eviCore.com Radiation Therapy Criteria V2.0.2019 Brachytherapy of the Coronary Arteries POLICY I. Coronary artery brachytherapy A. Is medically necessary when used as an adjunct to percutaneous coronary intervention (PCI) for treatment of in-stent restenosis in a native coronary artery bare-metal stent or saphenous vein graft (SVG) B. Intravascular brachytherapy (VBT) is considered medically necessary for recurrent drug-eluting stent in-stent restenosis C. All other indications are not covered because they are considered experimental, investigational, or unproven (EIU) Key Clinical Points Revascularization of obstructed arteries due to coronary artery disease (CAD) may be accomplished by PCI with balloon angioplasty, a minimally-invasive procedure in which a catheter with an inflatable balloon at the tip is inserted into the lumen of the artery and inflated, dilating the area of blockage. Coronary stents are implanted in most patients during PCI, resulting in lower rates of restenosis compared to balloon angioplasty alone. Several drug-eluting stents (DES) have been developed to minimize the incidence of restenosis, and represent approximately 70 to 90% of stent implantations. The choice of stent (bare-metal vs. drug-eluting) depends on various factors, including lesion location and morphology, patient characteristics, and the patient’s ability to adhere to the extended period of dual antiplatelet therapy required for DES. In-stent restenosis continues to be a significant problem with bare-metal stents and is thought to be caused by neointimal hyperplasia within the stent. Several mechanical treatments of in-stent restenosis were attempted, including balloon re-dilitation, removal of in-stent hyperplasia by atherectomy, and repeated bare-metal stenting. Brachytherapy was introduced as a method to treat in- stent restenosis by the delivery of gamma or beta radiotherapy via a catheter-based system. Brachytherapy affects the proliferation of smooth muscle cells that are responsible for restenosis, and may be used to treat in-stent restenosis of native coronary arteries and SVGs. The role of brachytherapy has diminished, however, and DES have emerged as the preferred