Clarified that the use of chelation for treatment of heavy metals is only appropriate in the setting of a confirmed diagnosis by laboratory testing.

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Alaina Joseph
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1 NOTICE OF MATERIAL CHANGE TO CONTRACT September 1, 2018 RE: Plicy, Clinical UM Guidelines changes ntificatin letter Dear Prvider: Anthem Blue Crss and Blue Shield and ur subsidiary cmpany, HMO Clrad (Anthem) are pleased t prvide yu with ur updated and new medical plicies. Anthem will als be implementing changes t ur Clinical Utilizatin Management (UM) Guidelines that are adpted fr Clrad/Nevada. The Clinical UM guidelines published n ur website represent the clinical UM guidelines currently available t all Plans fr adptin thrughut ur rganizatin. Because lcal practice patterns, claims systems and benefit designs vary, a lcal Plan may chse whether r nt t implement a particular clinical UM guideline. The link belw can be used t cnfirm whether r nt the lcal Plan has adpted the clinical UM guideline(s) in questin. Adptin lists are created and maintained slely by each lcal Plan. The majr new plicies and changes are summarized belw. Please refer t the specific plicy fr cding, language, and ratinale updates and changes that are nt summarized belw. New Plicies effective fr service dates n and after December 1, 2018 DRUG Ibalizumab-uiyk (Trgarz ): This dcument utlines the ly Necessary and Investigatinal & Nt ly Necessary criteria fr the use f ibalizumab-uiyk, a humanized mnclnal antibdy (mab) that belngs t the class f human immune deficiency virus (HIV) drugs knwn as entry and fusin inhibitrs which prevent HIV frm attaching t and entering human cells. GENE Circulating Tumr DNA Testing fr Cancer (Liquid Bipsy): This dcument addresses the use f a circulating tumr DNA (ctdna) test fr the diagnsis r treatment f cancer. Use f a circulating tumr DNA (ctdna) test fr the diagnsis r treatment f cancer is cnsidered Investigatinal & Nt ly Necessary fr all indicatins. Revised Plicies and Adpted Clinical UM Guidelines effective December 1, 2018: ANC Csmetic and Recnstructive Services: Skin Related: This dcument addresses the csmetic, recnstructive, and medically necessary uses f a selectin f techniques used in the treatment f skin lesins and related cnditins. Added micrneedling (als knwn as percutaneus cllagen inductin therapy r skin needling) as Csmetic & Nt ly Necessary fr all indicatins. DRUG Chelatin Therapy: This dcument addresses the uses f chelatin therapy. Chelatin therapy uses naturally ccurring r chemically designed mlecules t reduce ptentially dangerus levels f heavy metals within the bdy. Chelatin therapy is rutinely perfrmed fr cases f irn verlad, lead pisning, cpper txicity, and ther heavy metal cnditins. This dcument is nt applicable t agents used fr the treatment f drug verdse r txicities. Clarified that the use f chelatin fr treatment f heavy metals is nly apprpriate in the setting f a cnfirmed diagnsis by labratry testing. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 1 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

2 DRUG Subcutaneus Hrmne Replacement Implants: This dcument addresses indicatins fr the use f subcutaneus hrmne implants fr the treatment f hrmne deficit cnditins. This dcument des nt address the use f hrmne implants fr treatment f ther indicatins fr example cntraceptin r treatment f cancer. Clarified ly Necessary statement fr subcutaneus teststerne implants used fr cntinuatin f hrmne replacement therapy when criteria are met. SURG Mechanical Circulatry Assist Devices (Ventricular Assist Devices, Percutaneus Ventricular Assist Devices and Artificial Hearts): This dcument addresses mechanical circulatry assist devices which include Ventricular assist devices (VADs), Percutaneus ventricular assist devices (pvads), and Ttal artificial heart. Added Impella CP Heart Pump t list f examples f pvads cnsidered Investigatinal &Nt ly Necessary. Anthem Plicies and Clinical UM Guidelines are develped by ur natinal Plicy and Technlgy Assessment Cmmittee. The Cmmittee, which includes Anthem medical directrs and representatives frm practicing physician grups, meets quarterly t review current scientific data and clinical develpments. All cverage written r administered by Anthem excludes frm cverage, services r supplies that are investigatinal and/r nt medically necessary. A member s claim may nt be eligible fr payment if it was determined nt t meet medical necessity criteria set in Anthem s medical plicies. Review prcedures have been refined t facilitate claim investigatin. Anthem s Plicies and Clinical UM Guidelines are available nline: The cmplete list f ur Plicies and Clinical UM Guidelines may be accessed n Anthem s Web site at anthem.cm. Select Prviders, then Prviders Overview. Select Find Resurces fr Yur State, and pick Clrad. On the Prvider Hme page, frm the Plicy, Clinical UM Guidelines, Pre-Cert Requirements tut (2 nd blue bx n the left side f page), select enter. Click n the link titled Plicies and Clinical UM Guidelines (fr Lcal Plan Members). Click Cntinue, then select the either the Plicies r the UM Guidelines tab. T view the list f specific clinical UM guidelines adpted by Clrad, navigate t the Disclaimer page by fllwing the instructins abve; scrll t the bttm f the page. Abve the Cntinue buttn, click n the link titled Specific Clinical UM Guidelines adpted by Anthem Blue Crss and Blue Shield f Clrad. Sincerely, Elizabeth Kraft, M.D. Directr Anthem Blue Crss and Blue Shield Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 2 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

3 Plicy Attachment A Revised Plicies and Clinical Guidelines Plicy Title Plicy / Clinical Guideline ADMIN Immunizatins Remved Nt ly Necessary statement addressing FluMist fr the flu seasn. ACIP nw recmmends any licensed age-apprpriate influenza vaccine fr the seasn, including FluMist. DME Ultrasund Bne Grwth Stimulatin plicy archived 09/20/2018. Cnverted t CG-DME- 45. DRUG Btulinum Txin plicy archived 09/20/2018. Cnverted t CG-DRUG Added Xemin fr chrnic sialrrhea in adults t CECEA table. DRUG Omalizumab (Xlair ) plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Abatacept (Orencia ) plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Ipilimumab (Yervy ) Added ipilimumab in cmbinatin with nivlumab as subsequent therapy fr metastatic clrectal cancer as ly Necessary when criteria are met. Added ipilimumab in cmbinatin with nivlumab as first-line treatment f stage IV r recurrent NSCLC as ly Necessary when criteria are met. Clarified ly Necessary statement fr RCC. Remved NSCLC frm Investigatinal & Nt ly Necessary statement. DRUG Brentuximab Vedtin (Adcetris ) plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Eculizumab (Sliris ) Revised ly Necessary statement fr resumptin f eculizumab when relapse ccurs in an individual wh has discntinued therapy, adding r greater than 25% frm baseline t criteria addressing atypical hemlytic uremic syndrme. Added Guillain-Barre syndrme t Investigatinal & Nt ly Necessary statement. DRUG Pharmactherapy fr Hereditary Angiedema plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Enteral Carbidpa and Levdpa Intestinal Gel Suspensin plicy archived 09/20/2018. Cnverted t CG-DRUG Cnslidated nt medically necessary indicatins int a single nt medically necessary statement in Clinical Indicatins sectin. DRUG Ramucirumab (Cyramza ) Added ly Necessary statement fr use f ramucirumab in lcally advanced, unresectable r metastatic urthelial carcinma when criteria are met. Remved geniturinary cancer frm the Investigatinal & Nt ly Necessary statement. DRUG Pembrlizumab (Keytruda ) Added the treatment f recurrent r metastatic cervical cancer as ly Necessary when criteria are met. Added adjuvant therapy fr the treatment f resected high- Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 3 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

4 Plicy Plicy Title Plicy / Clinical Guideline risk stage III melanma as ly Necessary when criteria are met. Added the treatment f primary mediastinal large B-cell lymphma as ly Necessary when criteria are met. Added cntinuatin maintenance therapy f recurrent r metastatic NSCLC (squamus cell and nnsquamus) as ly Necessary when criteria are met. Clarified ly Necessary criteria addressing urthelial carcinma. DRUG Nivlumab (Opdiv ) Added nivlumab in cmbinatin with ipilimumab as subsequent therapy fr metastatic clrectal cancer as ly Necessary when criteria are met. Added nivlumab in cmbinatin with ipilimumab as first-line treatment f stage IV r recurrent NSCLC as ly Necessary when criteria are met. DRUG Asftase Alfa (Strensiq ) plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Atezlizumab (Tecentriq ) Clarified ly Necessary criteria addressing urthelial carcinma. Added ly Necessary statements fr first-line and cntinuatin maintenance therapy fr nnsquamus NSCLC. DRUG Naltrexne Implantable Pellets plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Sebelipase alfa (KANUMA ) plicy archived 09/20/2018. Cnverted t CG-DRUG DRUG Lutetium Lu 177 dtatate (Lutathera ) Added ly Necessary statement fr use f lutetium Lu 177 dtatate in lcally advanced brnchpulmnary r thymus NETs when criteria are met. Added ly Necessary statement fr use f lutetium Lu 177 dtatate as primary treatment fr lcally unresectable r metastatic phechrmcytma r paraganglima when criteria are met. DRUG Abalparatide (Tymls ) Injectin plicy archived 09/20/2018. Cnverted t CG-DRUG GENE Epidermal Grwth Factr Receptr (EGFR) Testing Added simertinib (Tagriss ) t ly Necessary statement. Added new ly Necessary and Investigatinal & Nt ly Necessary statements addressing the use f circulating tumr DNA testing. GENE Analysis f Fecal DNA fr Clrectal plicy archived 09/01/2018. Cancer Screening GENE Gene Expressin Prfiling fr Managing Breast Cancer Treatment Remved ly Necessary criterin requiring "Histlgy is nt tubular r cllid (als referred t as mucinus)". Simplified HER2 ly Necessary criteria. GENE GENE Mlecular Prfiling and Prtegenmic Testing fr the Evaluatin f Malignant Tumrs Genetic Testing fr Clrectal Cancer Susceptibility Expanded ly Necessary criteria fr NSCLC t assess tumr mutatin burden and identify candidates fr checkpint inhibitin immuntherapy. Crrected typgraphical errr in the ly Necessary criteria fr Lynch syndrme by changing MSH1 t MLH1. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 4 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

5 Plicy GENE Plicy Title Genetic Testing fr Breast and/r Ovarian Cancer Syndrme Plicy / Clinical Guideline Added genetic testing t detect BRCA and BART as ly Necessary fr individuals wh require cnfirmatry testing fr a BRCA1/BRCA2 mutatin(s) detected by a Fd and Drug Administratin (FDA)-authrized direct-t-cnsumer (DTC) test reprt. plicy archived 09/20/2018. Cnverted t CG-MED- 73. plicy archived 09/20/2018. Cnverted t CG-MED- 74. MED Hyperbaric Oxygen Therapy (Systemic/Tpical) MED Implantable Ambulatry Event Mnitrs and Mbile Cardiac Telemetry MED and Other Nn-Behaviral plicy archived 09/20/2018. Cnverted t CG-MED- Health Related Treatments fr 75. Autism Spectrum Disrders and Rett Syndrme MED Axicabtagene cilleucel (Yescarta ) Revised Title. Previus title: Axicabtagene cilleucel (Yescarta ). Refrmatted and clarified ly Necessary criteria. Updated Investigatinal & Nt ly Necessary statement. MED Tisagenlecleucel (Kymriah ) Revised Title. Previus title: Tisagenlecleucel (Kymriah ). Added large B-cell lymphma as ly Necessary indicatin when criteria are met. Updated Investigatinal & Nt ly Necessary statement. RAD Magnetic Surce Imaging and plicy archived 09/20/2018. Cnverted t CG-MED- Magnetencephalgraphy 76. RAD Magnetic Resnance Spectrscpy plicy archived 09/20/2018. (MRS) RAD CT Clngraphy (Virtual plicy archived 09/20/2018. Clnscpy) fr Clrectal Cancer RAD SPECT/CT Fusin Imaging plicy archived 09/20/2018. Cnverted t CG-MED- 77. RAD Cmputed Tmgraphy Scans fr plicy archived 09/20/2018. Lung Cancer Screening RAD Cerebral Perfusin Imaging Using plicy archived 09/20/2018. Cmputed Tmgraphy RAD Cerebral Perfusin Studies using plicy archived 09/20/2018. Diffusin and Perfusin Magnetic Resnance Imaging RAD Lw-Field and Cnventinal plicy archived 09/20/2018. Magnetic Resnance Imaging (MRI) fr Screening, Diagnsing and Mnitring RAD Functinal Magnetic Resnance plicy archived 09/20/2018. Imaging RAD Magnetic Resnance Angigraphy plicy archived 09/20/2018. f the Spinal Canal MED Cgnitive Rehabilitatin plicy archived 09/20/2018. Cnverted t CG-REHAB- 11. Remved "Nte" in Clinical Indicatins referring t CG-REHAB- 09 Acute Inpatient Rehabilitatin. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 5 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

6 Plicy SURG SURG SURG SURG SURG SURG Plicy Title Treatments fr Urinary Incntinence Cchlear Implants and Auditry Brainstem Implants Bne-Anchred and Bne Cnductin Hearing Aids Breast Prcedures; including Recnstructive Surgery, Implants and Other Breast Prcedures Bariatric Surgery and Other Treatments fr Clinically Severe Obesity Transcatheter Clsure f Patent Framen Ovale and Left Atrial Appendage fr Strke Preventin Plicy / Clinical Guideline Administrative changes made t Investigatinal & Nt ly Necessary statement. plicy archived 09/20/2018. Cnverted t CG-SURG- 81. plicy archived 09/20/2018. Cnverted t CG-SURG- 82. Added cnfirmed cases f breast implant-assciated anaplastic large cell lymphma (BIA-ALCL) as ly Necessary indicatin fr implant remval. plicy archived 10/31/2018. Cnverted t CG-SURG- 83. Expanded ly Necessary statement fr transcatheter clsure f PFO using FDA apprved device as preventive therapy fr individuals with a histry f cryptgenic strke wh are under age 60 withut trial f anticagulatin when criteria are met. plicy archived 09/20/2018. Cnverted t CG-SURG- 84. SURG Mandibular/Maxillary (Orthgnathic) Surgery SURG Hip Resurfacing plicy archived 10/31/2018. Cnverted t CG-SURG- 85. SURG Endvascular/Endluminal Repair plicy archived 10/31/2018. Cnverted t CG-SURGf Artic Aneurysms, Artiliac 86. Disease, Artic Dissectin and Artic Transectin SURG Nasal Surgery fr the Treatment f Obstructive Sleep Apnea (OSA) and plicy archived 09/20/2018. Cnverted t CG-SURG- 87. Snring Revised title t Nasal Surgery fr the Treatment f Obstructive Sleep Apnea and Snring SURG Mastectmy fr Gynecmastia plicy archived 09/20/2018. Cnverted t CG-SURG- 88. SURG Radifrequency Neurlysis and Pulsed Radifrequency Therapy fr Trigeminal Neuralgia plicy archived 09/20/2018. Cnverted t CG-SURG- 89. TRANS CG-ADMIN-02 CG-DME-07 Dnr Lymphcyte Infusin fr Hematlgic Malignancies after Allgeneic Hematpietic Prgenitr Cell Transplantatin Clinically Equivalent Cst Effective Services Targeted Immune Mdulatrs Augmentative and Alternative Cmmunicatin (AAC) Devices/Speech Generating Devices (SGD) plicy archived 09/20/2018. Cnverted t CG-TRANS- 03. Added certlizumab pegl (Cimzia ) fr use in adult plaque psriasis t CECEA-TIM table (FDA expanded apprval f certlizumab pegl [Cimzia]). Clarified that a high technlgy device is electrnic and a lw technlgy device is nn-electrnic in ly Necessary criteria. CG-DRUG-09 Immune Glbulin (Ig) Therapy Added secndary hypgammaglbulinemia r agammaglbulinemia fllwing chimeric antigen receptr (CAR) T cell treatment t ly Necessary indicatins. CG-DRUG-65 Tumr Necrsis Factr Antagnists Added the use f infliximab fr immune checkpint inhibitr Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 6 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

7 Plicy Plicy Title Plicy / Clinical Guideline therapy-related txicities (grade 3 r grade 4 adverse events) as ly Necessary when criteria are met. Added the use f certlizumab pegl fr plaque psriasis as ly Necessary when criteria are met. Added vedlizumab t Nt ly Necessary statement fr use in cmbinatin with each TNF antagnist. CG-DRUG-68 Bevacizumab (Avastin ) fr Nn- Ophthalmlgic Indicatins Added ly Necessary statement fr use f bevacizumab in advanced r recurrent endmetrial carcinma when criteria are met. Expanded ly Necessary statement fr use f bevacizumab as first-line treatment f nn-squamus NSCLC in cmbinatin chemtherapy with platinum-based therapy, a taxane, and atezlizumab when criteria are met. Expanded ly Necessary statement fr use f bevacizumab as maintenance therapy in nn-squamus cell NSCLC as a single agent r in cmbinatin with atezlizumab when criteria are met. Expanded ly Necessary statements fr use f bevacizumab in advanced r metastatic varian cancer fllwing initial surgical resectin (bth initial and maintenance therapy) when criteria are met. Clarified ly Necessary statement fr maintenance therapy with bevacizumab fr malignant mesthelima, adding unresectable. CG-DRUG-73 Densumab (Prlia, Xgeva ) Added ly Necessary indicatin fr Prlia in the treatment f adults with gluccrticid-induced steprsis when criteria met. CG-DRUG-81 Tcilizumab (Actemra ) Added ly Necessary statement fr use f tcilizumab in chrnic antibdy-mediated renal transplant rejectin when criteria are met. CG-GENE-03 BRAF Mutatin Analysis Added BRAF V600E mutatin analysis as ly Necessary in individuals with lcally advanced, unresectable r metastatic anaplastic thyrid cancer t identify thse wh wuld benefit frm treatment with dabrafenib (Tafinlar ) in cmbinatin with trametinib (Mekinist ). CG-SURG-24 Functinal Endscpic Sinus Surgery (FESS) Remved time requirement f "at least 4 cnsecutive weeks" fr antibitic therapy frm ly Necessary criteria. CG-SURG-73 Balln Sinus Ostial Dilatin Remved time requirement f "at least 4 cnsecutive weeks" fr antibitic therapy frm ly Necessary criteria. CG-THER-RAD-03 Radiimmuntherapy and Smatstatin Receptr Targeted Raditherapy Updated criteria t clarify nn-fda apprved smatstatin analgs (including ctretide, lanretide and vapretide) are Nt ly Necessary fr use as therapeutic receptr targeted radinuclide therapy. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 7 f 7 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Service, Inc. HMO prducts underwritten by HMO Clrad, Inc. Independent licensees f the Blue Crss and Blue Shield Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss and Blue Shield names and symbls are registered marks f the Blue Crss and Blue Shield Assciatin.

Added criteria requiring referral letters to mastectomy Medically Necessary statement.

Added criteria requiring referral letters to mastectomy Medically Necessary statement. NOTICE OF MATERIAL CHANGE TO CONTRACT January 1, 2019 RE: Medical Plicy and Clinical UM Guideline changes ntificatin letter Dear Prvider: Anthem Blue Crss and Blue Shield and ur subsidiary cmpany, HMO