BCBS AL Radiation Oncology Guidelines - V2

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CLINICAL GUIDELINESRadiation OncologyVersion 2.0Effective August 1, 2020Clinical guidelines for medical necessity review of radiation therapy services. 2020 eviCore healthcare. All rights reserved.

Radiation Oncology GuidelinesV2.0Please note the following:CPT Copyright 2020 American Medical Association. All rights reserved. CPT is aregistered trademark of the American Medical Association. 2020 eviCore healthcare. All Rights Reserved.Page 2 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Radiation Oncology GuidelinesV2.0Please note the following:All information provided by the NCCN is “Referenced with permission from the NCCNClinical Practice Guidelines in Oncology (NCCN Guidelines ) 2019/2020 NationalComprehensive Cancer Network. The NCCN Guidelines and illustrations herein maynot be reproduced in any form for any purpose without the express written permission ofthe NCCN. To view the most recent and complete version of the NCCN Guidelines, goonline to NCCN.org.” 2020 eviCore healthcare. All Rights Reserved.Page 3 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Radiation Oncology GuidelinesV2.0Table of ContentsRadiation Oncology Guidelines For Special TechniquesHyperthermiaImage-Guided Radiation Therapy (IGRT)Neutron Beam TherapyProton Beam Therapy5691315Radiation Oncology Guidelines For Treatment by Site58Anal Canal CancerBladder CancerBone MetastasesBrain MetastasesBreast CancerCervical CancerEndometrial CancerEsophageal CancerGastric CancerHead and Neck CancerHepatobiliary CancerHodgkin’s LymphomaKidney and Adrenal CancerMultiple Myeloma and Solitary PlasmacytomasNon-Hodgkin’s LymphomaNon-malignant DisordersNon-Small Cell Lung CancerOligometastasesOther CancersPancreatic CancerPrimary Craniospinal Tumors and Neurologic ConditionsProstate CancerRectal CancerSkin Cancer – Basal cell and Squamous cellSkin Cancer – MelanomaSmall Cell Lung CancerSoft Tissue SarcomasTesticular CancerThymoma and Thymic CancerUrethral Cancer and Upper Genitourinary Tract TumorsVulvar n Oncology Guidelines ForRadiopharmaceuticalsAzedra (iobenguane I-131)Lutathera (Lutetium; Lu 177 dotatate)Selective Internal Radiation Therapy (SIRT)Xofigo (Radium-223)Zevalin 228229232237243245 2020 eviCore healthcare. All Rights Reserved.Page 4 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Radiation Oncology GuidelinesV2.0Radiation Oncology GuidelinesForSpecial Techniques 2020 eviCore healthcare. All Rights Reserved.Page 5 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Radiation Oncology GuidelinesV2.0HyperthermiaPOLICYI. The use of hyperthermia and concurrent external beam radiation therapytreatment is medically necessary for any of the following:A. Superficially recurrent melanomaB. Chest wall recurrence of breast cancerC. Recurrent cervical lymph nodes from head and neck cancerTreatment of the above conditions will be approved in the absence of both of thefollowing:A. Metastatic disease for which chemotherapy or hormonal therapy is being givenconcurrentlyB. Evidence of tumor recurrence exceeding 4 cm in depthWhen hyperthermia is indicated, no more than 10 hyperthermia treatments deliveredtwice weekly at 72-hour intervals should be utilized.II. The use of hyperthermia in the following scenarios is considered experimental,investigational, or unproven:A. Intraluminal hyperthermiaB. Endocavitary hyperthermiaC. Interstitial hyperthermiaD. Regional deep tissue hyperthermia exceeding 4 cm in depthE. Whole body hyperthermia 2020 eviCore healthcare. All Rights Reserved.Page 6 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Radiation Oncology GuidelinesV2.0DISCUSSIONAfter initial enthusiasm for the use of hyperthermia in the late 1970s, interest waned withthe publication of studies showing little or no benefit in the mid-1980s. Later review of thenegative findings disclosed that the critical temperature necessary for hyperthermic celldeath, 42 to 43 degrees centigrade (C), was either poorly measured or poorly maintainedin these studies. Point measurements rather than volume mapping of thermal gradientswere relied upon in planning these hyperthermia studies.Renewed interest in the use of hyperthermia began to emerge in both Europe and theUnited States (US) in the 1990s. Research from Duke University, NorthwesternUniversity, University of Southern California, Stanford University, Washington University,as well as centers in Holland, Germany, Norway, Austria, Italy, and Switzerland havecontributed substantially to the emergence of hyperthermia as a useful treatment modalitywhen combined with radiation therapy.Currently, in the US, the Food and Drug Administration (FDA) has approved hyperthermiafor use in the treatment of cancer when combined with radiation therapy for the“ palliative management of certain solid surface and subsurface malignant tumors (i.e.melanoma, squamous or basal cell tumors, adenocarcinoma, or sarcoma) that areprogressive or recurrent despite conventional therapy.” The National Cancer CenterNetwork (NCCN) recommends “ that the use of hyperthermia be limited to treatmentcenters with appropriate training, expertise and equipment.”. The NCCN Panel on BreastCancer concluded that it was a controversial Category 3 recommendation in the treatmentof local or regional recurrent breast cancer.Following FDA approval, Medicare approved coverage for local hyperthermia when usedtogether with radiation therapy. A National Coverage Determination (NCD 110.1) wasissued by Medicare (CMS) in December 1984 and remains unchanged. It states, “Localhyperthermia is covered under Medicare when used in conjunction with radiation therapyfor the treatment of primary or metastatic cutaneous or subcutaneous superficialmalignancies. It is not covered when used alone or in connection with chemotherapy.”Coding for this treatment is recognized and published in the current 2018 ACR/ASTROguide.On May 15, 2009, the FDA granted humanitarian use device (HUD) status to the BSD2000 and on November 18, 2011, the FDA granted humanitarian device exemption (HDE)to the BSD-2000 for the treatment of cervical cancer patients ineligible for chemotherapy(treatment population less than 4,000). This is the only approval for deep heating, andonly actual costs incurred in the research may be billed. Other applications for deepheating are pending for both BSD and Medifocus devices.In the US, only the BSD-500 has FDA commercial clearance for superficial heating (lessthan a 4 cm depth). This is currently the only device approved for reimbursement. Itoperates at the microwave range of 915 MHz with different applicators and power settingranging from 20 to 250 watts. The standard recommended treatment regimen for use with 2020 eviCore healthcare. All Rights Reserved.Page 7 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.comHyperthermiaAlthough research into hyperthermic treatments at depths greater than 4 cm is ongoingin the US, it is currently recognized only as investigational as are intraluminal,endocavitary, and interstitial applications.

Radiation Oncology GuidelinesV2.0radiation therapy is a “ total of 10 hyperthermia treatments delivered two times per weekat 72-hour intervals, with each heat treatment preceded or followed by a standardprescribed dose of ionizing radiation within 30 minutes of the heat treatment.” A sustainedintratumoral temperature of 42.5 degrees C for 60 minutes is recommended.The FDA granted pre-market approval for the Sonotherm 1000 Ultrasound TherapySystem on September 29, 1989. This approval was for hyperthermia to treat tumors at adepth of 8 cm. Although FDA approval was granted, the device remains in clinical studyand is designated EIU.There are three clinical sites in which randomized studies have documented the benefitof hyperthermia given in conjunction with radiotherapy.1. Melanoma – 134 metastatic or recurrent lesions of malignant melanoma in 70patients were randomly assigned to receive radiation therapy (three fractions of 8 or9 Gy over 8 days) alone or followed by hyperthermia (43 degrees C for 60 minutes).Beneficial local effect was 28% for radiation alone, and 46% for combined treatment.Toxicity was not higher with hyperthermia (Overgaard, 1995)2. Breast – Five randomized trials were combined to report the benefit of combinedtreatment for superficial localized breast cancer. The control rate for radiation therapyalone was 41%, while that for combined treatment was 59%. The greatest effect wasobserved in patients with recurrent lesions in previously irradiated lesions wherefurther irradiation was limited to low doses (Vernon, 1996)References1. American College of Radiology (ACR)/American Society of Radiation Therapy (ASTRO) Coding Guide.2. BSD-2000 Brochure.3. BSD-500 Brochure.4. HUD and HDE for BSD-2000.5. Hyperthermia for Treatment of Cancer. National Coverage Determination (NCD) 110.1.6. National Comprehensive Cancer Network (NCCN) Guidelines . Version 1.2020 – January 15, 2019. BreastCancer. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines )for Breast Cancer Version 1.2020. 2020 National Comprehensive Cancer Network, Inc. All rights reserved. TheNCCN Guidelines and illustrations herein may not be reproduced in any form for any purpose without the expresswritten permission of the NCCN . To view the most recent and complete version of the NCCN Guidelines , goonline to NCCN.org7. Overgaard J, Gonzalez D, Hulshof MC, et al. Randomised trial of hyperthermia as adjuvant to radiotherapy forrecurrent or metastatic malignant melanoma. European Society for Hyperthermic Oncology. Lancet. 1995 Mar 4;345(8949):540-543.8. PMA for BSD-500 and supplement.9. Sonotherm 1000 Ultrasound Therapy System.10. Valdagni R, Amichetti M. Report of long-term follow up in a randomized trial comparing radiation therapy andradiation therapy plus hyperthermia to metastatic lymph nodes in stage IV head and neck patients. Int. J. Radiat.Oncol. Biol. Phys. 1994 Jan 1; 28(1):163–169.11. Vernon CC, Hand JW, Field SB et al. Radiotherapy with or without hyperthermia in the treatment of superficiallocalized breast cancer: Results from five randomized controlled trials. International Collaborative HyperthermiaGroup. Int J Radiat Oncol Biol Phys. 1996 Jul 1; 35(4):731-744. 2020 eviCore healthcare. All Rights Reserved.Page 8 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.comHyperthermia3. Head and neck metastatic lymph nodes – a randomized study of 44 nodes in 41patients confirmed the improved five-year actuarial nodal control of the combinedtreatment arm. In addition, the study reports a statistically significant improvement insurvival at five years and no increased toxicity from combined modality therapy(Valdagni, 1994)

Radiation Oncology GuidelinesV2.0Image-Guided Radiation Therapy (IGRT)POLICYI. IGRT during IMRTIGRT is considered medically necessary when IMRT has been approved and is beingutilized.II. IGRT during 3DCRTIGRT in conjunction with 3DCRT is medically necessary in the followingcircumstances:A. When the planning target volume (PTV) is in close proximity to a previouslyirradiated areaB. Treatment of the hepatobiliary tractC. Treatment of head and neck cancerD. Treatment of Hodgkin’s and Non-Hodgkin’s LymphomaE. Treatment of lung cancerF. Treatment of prostate cancerG. Treatment of esophageal cancerH. Treatment of gastric cancerI. Treatment of pancreatic cancerJ. Treatment of pelvic cancers (i.e. rectal cancer) when the individual is in the proneposition on a belly boardK. During breast boost when using photonsL. During external beam-based accelerated partial breast irradiation (APBI)M. During treatment of left breast cancer when a DIBH technique is being usedN. Treatment of breast cancer when the individual is in the prone positionO. During the boost to the bladderP. Preoperative or postoperative treatment of sarcomasIII. IGRT during SRS/SBRTFor Stereotactic Body Radiation Therapy (SBRT), the IGRT codes may not be billedseparately because by American Medical Association (AMA) definition they arebundled and included in the daily treatment codes. In addition, the IGRT codes maynot be billed separately with Stereotactic Radiosurgery (SRS) as stated in the ASTROcoding guide. 2020 eviCore healthcare. All Rights Reserved.Page 9 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.com

Radiation Oncology GuidelinesV2.0IV. IGRT and brachytherapyIn brachytherapy cases, imaging is medically necessary to verify source position in allbut the simplest of cases. The images may also be used to perform dosimetrycalculations. Use of applicable simulation and/or field verification codes is appropriate,such as CPT Code 77280.V. IGRT and superficial radiation therapy or electron beam therapyThe use of IGRT with either superficial radiation therapy or electron beam therapy isconsidered not medically necessary.VI. The use of IGRT is based on medical necessity for the specific diagnoses. Arequirement from the vendor does not support the medical necessity of IGRTIGRT is a method by which image guidance is applied to place the isocenter for theupcoming treatment appropriately. This technology typically is applied for an individualundergoing Intensity-Modulated Radiation Therapy (IMRT). However, in some cases inwhich the isocenter is the main concern, IGRT occasionally can be used with threedimensional (3D) conformal radiation therapy (3DCRT). The American Society forRadiation Oncology (ASTRO) together with the American College of Radiology (ACR)have published practice parameters (Loo et al, 2014) and technical standards (Cheng etal, 2014) regarding IGRT. In addition, in their 2018 Radiation Oncology Coding Resource,ASTRO has addressed IGRT in detail.Historical methodology of using port films to confirm patient set-up and block placementhas not been replaced by IGRT. For example, the Coding Resource states “ guidanceand tracking are not indicated " when " replacing ’port check’ imaging when targetlocalization is not medically necessary." Outside of treatment procedures requiring onlyisocenter placement, port films and/or verification simulations are still the appropriatemodalities. If the isocenter placement is the primary concern, i.e. for IMRT, then IGRT istypically the method utilized. This does, however, imply the target can be localized withthe specific IGRT modality requested, i.e., stereoscopic imaging for target localization,computed tomography (CT) guidance for field placement or ultrasound (US) guidance forfield placement (Weiss et al., 2011). In the event no target is localized, blocking andpatient set-up is accomplished through typical alignment of bony structures using portalimaging; appropriate coding for port films would apply.Effective 1/1/2015, IGRT techniques are covered under two different coding systems.CPT code 77387 is for billing in the Hospital Outpatient Prospective Payment System(HOPPS) and for those non-Medicare health plans that accept this definition. It may benecessary to check with the individual health plan directly before billing this code for thispurpose. Also, the new IMRT treatment delivery CPT codes (77385 and 77386) includeIGRT guidance and tracking, when performed. The technical component of IGRT(77387-TC) is packaged into the IMRT service with which it is performed and is not 2020 eviCore healthcare. All Rights Reserved.Page 10 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.comImage-Guided Radiation Therapy (IGRT)DISCUSSION

Radiation Oncology GuidelinesV2.0reported separately. In the Medicare Physician Fee Schedule (MPFS) setting, as well asthe Healthcare Common Procedure Coding System (HCPCS) setting, the G-Code systemhas replaced CPT codes. G6001 replaces CPT code 76950, G6002 replaces CPT code 77421, and G6017 replaces CPT code 0197T. In contrast to the HOPPS reporting,IGRT is not bundled into IMRT for MPFS and HCPCS and is reported separately.Respiratory motion management may be clinically appropriate for treating some cancers,including lung cancer and some cases of breast cancer (deep inspiration breath hold[DIBH]). Respiratory tracking by continuous localization systems or four-dimensional CT(4D-CT) are now included in CPT code 77387. This code is for billing in the HOPPS andfor those non-Medicare health plans that accept this definition. It may be necessary tocheck with the individual health plan directly before billing this code for this purpose. Inthe MPFS setting as well as the HCPCS setting, the G-Code G6017 has replaced CPT code 0197T. In the hospital-outpatient setting, G6017 is considered image guidance andis packaged into the primary service payment. For all other purposes, this code isconsidered carrier-priced and may be accepted or refused by different health plans andMedicare contractors.In IGRT-approved cases, only one method or technique of IGRT is allowed daily.References1. ASTRO coding FAQS and tips.2. ASTRO Radiation Oncology Coding Resource. Available on-line for purchase.3. Chadha M, Young A, Geraghty C, et al. Image guidance using 3D-ultrasound (3D-US) for daily positioning oflumpectomy cavity for boost irradiation. Radiat Oncol. 2011 May 9; 6:45.4. Chen Y-J, Suh S, Nelson RA, et al. Setup variations in radiotherapy of anal cancer: Advantages of target volumereduction using image-guided radiation treatment (IGRT). Int J Radiat Oncol Biol Phys. 2012 Sep 1; 84(1):289295.5. Eldredge HB, Studenski M, Keith S, et al. IGRT after prostatectomy: Evaluation of corrective shifts and toxicityusing online conebeam CT vs. weekly port films for target localization. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3 Suppl):S380.6. Graff P, Hu W, Yom SS, et al. Does IGRT ensure target dose coverage of head and neck IMRT patients?Radiother Oncol. 2012 Jul; 104(1):83-90.7. Hyer DE, Serago CF, Kim S, et al. An organ and effective dose study of XVI and OBI cone-beam CT systems. JAppl Clin Med Phys. 2010 Apr 17; 11(2):3183.8. Jaffray D, Langen KM, Mageras G, et al. Safety considerations for IGRT: Executive summary. PracticalRadiation Oncology. 2013 Jul-Sep; 3(3):167-170.9. Kan MW, Leung LHT, Wong W, et al. Radiation dose from cone beam computed tomography for image-guidedradiation therapy. Int J Radiat Oncol Biol Phys. 2008 Jan 1; 70(1):272-279.10. Leonard CE, Tallhamer M, Johnson T, et al. Clinical experience with image-guided radiotherapy in anaccelerated partial breast intensity-modulated radiotherapy protocol. Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):528-534.11. Lisbona A, Averbeck D, Supiot S, et al. IMRT combined to IGRT: increase of the irradiated volumeconsequences? Cancer Radiother. 2010 Oct; 14(6-7):563-570.12. Loo Jr. BW, Bajaj GK, Galvin JM, et al. ACR-ASTRO practice parameter for image-guided radiation therapy(IGRT). Revised 2014 (CSC/BOC), Effective June 25, 2014.13. Mohammed N, Kestin L, Grills I, et al. Comparison of IGRT registration strategies for optimal coverage of primarylung tumors and involved nodes based on multiple four-dimensional CT scans obtained throughout theradiotherapy course. Int J Radiat Oncol Biol Phys. 2012 Mar 15; 82(4):1541-1548.14. Ottosson W, Baker M, Hedman M, et al. Evaluation of setup accuracy for NSCLC patients; studying the impact ofdifferent types of cone-beam CT matches based on whole thorax, columna vertebralis, and GTV. Acta Oncol.2010 Oct; 49(7):1184-1191. 2020 eviCore healthcare. All Rights Reserved.Page 11 of 256400 Buckwalter Place Boulevard, Bluffton, SC 29910 (800) 918-8924www.eviCore.comImage-Guided Radiation Therapy (IGRT)CPT codes 77370 and 77470 should not be bill

treatment arm. In addition, the study reports a statistically significant improvement i n survival at five years and no increased toxicity from combined modality therapy (Valdagni, 1994) References 1. American College of Radiology (ACR)/American Society of Radiation Therapy (ASTRO) Coding Guide. 2. BSD-2000 Brochure. 3. BSD-500 Brochure. 4.

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