CG-DRUG-64 FDA-Approved Biosimilar Products: This document provides clinical criteria for review of

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1 March 30, 2017 [Prvider Name] [Cntact Title] [Address] [City], [State] [Zip] Dear Prvider: Anthem Blue Crss (Anthem) is pleased t prvide yu with ur updated Medical Plicies and Clinical UM Guidelines in Attachment A. 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 Medical Plicies and Clinical UM Guidelines effective July 1, 2017: NOTE: Pre-service clinical review f the specialty pharmacy drugs in italics belw will be managed by AIM Specialty Health (AIM), a separate cmpany administering the prgram n behalf f Anthem. CG-DRUG-61 Gnadtrpin Releasing Hrmne Analgs fr the Treatment f Nn-Onclgic Indicatins: This dcument addresses gnadtrpin releasing hrmne (GnRH) analgs fr the treatment f nn-nclgic indicatins. This dcument des nt address the use f GnRH analgs in the diagnsis f central preccius puberty r treatment f infertility. LAB Serlgical Antibdy Testing Fr Helicbacter Pylri: This dcument addresses the use f serlgical antibdy testing fr Helicbacter pylri (als knwn as H. pylri), a causative agent fr peptic ulcers, gastritis, dyspepsia and stmach cancer. SURG Extracrpreal Carbn Dixide Remval: This dcument addresses the use f extracrpreal carbn dixide remval (ECCO2R), a minimally invasive, lw-flw, ven-venus r venus arterial prcedure used t treat acute hypercapnic respiratry failure r as an alternative t standard extracrpreal membrane xygenatin (ECMO). SURG Synthetic Cartilage Implant fr Metatarsphalangeal Jint Disrders: This dcument addresses the use f a metatarsphalangeal synthetic cartilage implant. Revised Medical Plicies and Adpted Clinical UM Guidelines: CG-BEH-04 Substance-Related and Addictive Disrder Treatment Added criteria requiring member evaluatin by a physician r ther prvider with prescriptive authrity upn admissin and during the cntinued stay t ccur with a specified frequency relative t the level f care Clarified language addressing withdrawal symptms fr inpatient detx Refrmatted clinical indicatins CG-BEH-05 Eating and Feeding Disrder Treatment Added criteria requiring member evaluatin by a physician r ther prvider with prescriptive authrity upn admissin and during the cntinued stay t ccur with a specified frequency relative t the level f care Updated frmatting and grammar, and remved abbreviatins frm clinical indicatins CG-DRUG-64 FDA-Apprved Bisimilar Prducts: This dcument prvides clinical criteria fr review f Anthem Blue Crss is the trade name f Blue Crss f Califrnia. Anthem Blue Crss and Anthem Blue Crss Life and Health Insurance Cmpany are independent licensees f the Blue Crss Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss name and symbl are registered marks f the Blue Crss Assciatin.

2 FDA-apprved bisimilar prducts with clinically equivalent cst effective agents. Plicy Impacted Prducts Clinically Equivalent/Cst Effective Prducts CG-DRUG-64 FDA Apprved Inflectra Remicade Bisimilar Prducts *CG-DRUG-29 Hyanlurnan injectin in the knee Euflexxa,Gel-One, GelSyn,Genvisc 850, Hyalgan,Hymvis,Supartz Mnvisc, Orthvisc, Synvisc,Synvisc One *CG-DRUG-29 is fr clinically equivalent agents nly. DRUG Hyalurnan Injectins in Jints Other Than the Knee: This dcument addresses the use f hyalurnan injectins fr the replacement r supplementatin f naturally ccurring intra-articular lubricants in individuals with musculskeletal cnditins in jints ther than the knee, including stearthritis and temprmandibular jint disease. This therapy may als be referred t as viscsupplementatin. This guideline is subject t CG-DRUG-64 (FDA Apprved Bisimilar Prducts). SURG Treatments fr Urinary Incntinence Added implantatin f the inflw intraurethral valve-pump as Investigatinal and nt medically necessary fr all indicatins Anthem Blue Crss Medical Plicies and Clinical UM Guidelines are develped by ur Medical 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. Medical Plicies and Clinical UM Guidelines are subject t the apprval f the Physician Relatins Cmmittee. All cverage written r administered by Anthem Blue Crss 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 frth in Anthem Blue Crss Medical Plicies. Review prcedures have been refined t facilitate claim investigatin. The cmplete list f ur Medical Plicies and Clinical UM Guidelines may be accessed n the Anthem Blue Crss Web site at select Tls fr Prviders near the bttm f the page, the click Enter under Welcme t Anthem Blue Crss, then click Services described in the Medical Plicies, UM Clinical Guidelines and/r Pre-certificatin Requirements under Learn Mre, then click Medical Plicies and Clinical UM Guidelines (fr Lcal Plan members), then click Cntinue at the bttm f the page. The expanded Specialty Pharmacy drug prgram applies t lcal Anthem members wh have specialty pharmacy services medically managed by AIM Specialty Health. The expanded prgram des nt apply t the fllwing plans: HMO, BlueCard, HMO, Medicare Advantage, Medicaid, Medicare Supplement, and Federal Emplyee Prgram (FEP). Ordering physicians may submit a request fr services t AIM thrugh the AIM PrviderPrtal SM (available 24/7 t prcess rders in real-time), thrugh the Availity Web Prtal r by calling the AIM call center at , Mnday Friday, 7:00 a.m. 5:00 p.m. Pacific Time. We thank yu fr yur cntinued effrts n behalf f ur members and yur partnership tward imprved access t quality health care fr Califrnians. Sincerely, Jacb Asher, MD Vice President and Chief Medical Officer Anthem Blue Crss is the trade name f Blue Crss f Califrnia. Anthem Blue Crss and Anthem Blue Crss Life and Health Insurance Cmpany are independent licensees f the Blue Crss Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss name and symbl are registered marks f the Blue Crss Assciatin.

3 Attachment A 1 st Quarter 2017 Updates Revised Medical Plicies and Clinical Guidelines Plicy Number Title Medical Plicy / Clinical Guideline Changes CG-DME-24 Wheeled Mbility Devices: Manual Wheelchairs-Standard, Heavy Duty and Lightweight Refrmatted title Remved "Nte" addressing replacement r repairs frm clinical indicatins CG-DME-31 CG-DME-33 CG-DME-34 CG-DRUG-16 CG-DRUG-29 CG-DRUG-63 CG-DRUG-64 Wheeled Mbility Devices: Wheelchairs Pwered, Mtrized, With r Withut Pwer Seating Systems and Pwer Operated Vehicles (POVs) Wheeled Mbility Devices: Manual Wheelchairs-Ultra Lightweight Wheeled Mbility Devices: Wheelchair Accessries White Bld Cell Grwth Factrs Hyalurnan Injectins in the Knee Levleucvrin Calcium (Fusilev ) FDA-Apprved Bisimilar Prducts Remved "Nte" addressing replacement r repairs frm clinical indicatins Remved "Nte" addressing replacement r repairs frm clinical indicatins Remved "Nte" addressing replacement r repairs frm clinical indicatins Remved MN and NMN criteria and all ther language and cding addressing the bisimilar agent, Filgrastim-sndz (Zarxi ) Added Nte t refer t CG-DRUG-64 fr review f bisimilar prducts Revised "Preferred Agents" sectin title and language t address "Clinically Equivalent Cst Effective Agents" Revised "Preferred Agents" sectin title and language t address "Clinically Equivalent Cst Effective Agents" Revised "Preferred Agents" sectin title and language t address "Clinically Equivalent Cst Effective Agents" CG-MED-19 Custdial Care Added Nte t clinical indicatins sectin that benefit language supersedes the criteria in this dcument Updated definitin and examples f custdial care CG-REHAB-04 Physical Therapy Clarified MN and NMN habilitative physical therapy criteria Refrmatted clinical indicatins CG-REHAB-05 Occupatinal Therapy Clarified MN and NMN habilitative physical therapy criteria Refrmatted clinical indicatins CG-REHAB-06 CG-SURG-03 Speech-Language Pathlgy Services Blepharplasty, Blepharptsis Repair, and Brw Lift Clarified MN and NMN habilitative physical therapy criteria Refrmatted clinical indicatins Clarified MN criteria addressing blepharplasty CG-SURG-27 Sex Reassignment Surgery Revised criterin addressing cnfirmatin f female gender prir t bilateral mastectmy in female-t-male transitins t remve chrmsme testing CG-SURG-43 Knee Arthrscpy Revised MN criteria addressing intra-articular jint pathlgy, and repair r excisin f trn meniscus Remved abbreviatins frm clinical indicatins Added Nte defining cnservative therapy Anthem Blue Crss is the trade name f Blue Crss f Califrnia. Anthem Blue Crss and Anthem Blue Crss Life and Health Insurance Cmpany are independent licensees f the Blue Crss Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss name and symbl are registered marks f the Blue Crss Assciatin.

4 DME Oscillatry Devices fr Airway Clearance including High Frequency Chest Cmpressin and Intrapulmnary Percussive Ventilatin Revised title. Previus title: Oscillatry Devices fr Airway Clearance including High Frequency Chest Cmpressin and Intrapulmnary Percussive Ventilatin (IPV) Made grammar, capitalizatin, abbreviatin and acrnym clarificatins in psitin statement DRUG Btulinum Txin Revised "Preferred Agents" sectin title and language t address "Clinically Equivalent Cst Effective Agents" DRUG Grwth Hrmnes Remved abbreviatin frm psitin statement Added Nte t psitin statement t see Definitins sectin fr a full list f pituitary hrmnes DRUG Hyalurnan injectins fr indicatins in jints ther than the knee Added new sectin addressing Clinically Equivalent Cst Effective Agents effective July 1, Impacted Prducts: Euflexxa,Gel-One,GelSyn,Genvisc 850, Hyalgan,Hymvis,Supartz Clinically Equivalent/Cst Effective agents include: Mnvisc, Orthvisc, Synvisc and Synvisc One Remved hylan G-F 20 frm psitin statement DRUG Vedlizumab (Entyvi ) Remved criteria addressing tuberculsis infectins and testing fr latent tuberculsis frm NMN sectin DRUG Bezltxumab (ZINPLAVA ) Clarified the MN language addressing the definitin f severe Clstridium difficile DRUG Buprenrphine Implant (Prbuphine ) Revised title. Previus title: Prbuphine (buprenrphine implant). Made minr typgraphical changes in psitin statement DRUG Nusinersen (SPINRAZA ) Added Nte t psitin statement clarifying cntinuatin f therapy Reviewed previus new medical plicy GENE MED OR-PR Analysis f Fecal DNA fr Clrectal Cancer Screening MRI Guided High Intensity Fcused Ultrasund Ablatin fr Nn-Onclgic Indicatins Micrprcessr Cntrlled Lwer Limb Prsthesis Revised MN psitin statement t clarify that Clguard is a screening test fr individuals at average risk fr clrectal cancer Added "When previus screening has been undertaken using an alternative methd, then the initial Clguard test is cnsidered medically necessary as a screening technique fr individuals at average risk fr clrectal cancer based n the preceding test s designated next apprpriate screening interval" Added essential tremrs t examples f cnditins cnsidered INV/NMN Clarified criterin regarding individual's ability t ambulate faster than their baseline with a swing and stance lwer extremity prsthesis SURG Vagus Nerve Stimulatin Clarified INV/NMN language SURG Allgeneic, Xengraphic, Synthetic and Cmpsite Prducts fr Wund Healing and Sft Tissue Grafting Added new prducts t the INV&NMN list Made minr typgraphical revisins in the psitin statement Anthem Blue Crss is the trade name f Blue Crss f Califrnia. Anthem Blue Crss and Anthem Blue Crss Life and Health Insurance Cmpany are independent licensees f the Blue Crss Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss name and symbl are registered marks f the Blue Crss Assciatin.

5 SURG Transcatheter Clsure f Patent Framen Ovale and Left Atrial Appendage fr Strke Preventin Clarified MN criteria t state that the device being used fr transcatheter clsure f a PFO must be a device that is FDA apprved fr that indicatin (that is, AMPLATZER PFO Occluder) SURG Reductin Mammaplasty Clarified MN criteria t indicate that the apprpriate amunts (in grams) f breast tissue must be anticipated fr remval frm at least ne breast SURG Intracular Anterir Segment Aqueus Drainage Devices (withut extracular reservir) Added the CyPass System, when used in cnjunctin with cataract surgery as a treatment t reduce intracular pressure fr the treatment f glaucma, as medically necessary when criteria are met Added the CyPass System t investigatinal and nt medically necessary statement fr all ther indicatins nt listed as medically necessary Added the XEN Glaucma Treatment System as investigatinal and nt medically necessary as a methd t reduce intracular pressure fr the treatment f glaucma Remved the CyPass System as an investigatinal and nt medically necessary device when used as a methd t reduce intracular pressure fr the treatment f glaucma SURG Sacriliac Jint Fusin Clarified MN criterin addressing pelvic injury t read "Severe traumatic injuries assciated with pelvic ring disruptin (that is, fracture r dislcatin) Anthem Blue Crss is the trade name f Blue Crss f Califrnia. Anthem Blue Crss and Anthem Blue Crss Life and Health Insurance Cmpany are independent licensees f the Blue Crss Assciatin. ANTHEM is a registered trademark f Anthem Insurance Cmpanies, Inc. The Blue Crss name and symbl are registered marks f the Blue Crss Assciatin.