Added criteria requiring referral letters to mastectomy Medically Necessary statement.

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1 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 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 Medical Plicies effective fr service dates n and after April 1, 2019: MED Fractinal Exhaled Nitric Oxide and Exhaled Breath Cndensate Measurements fr Respiratry Disrders: This dcument addresses the measurement f exhaled nitric xide and exhaled breath cndensate fr the diagnsis and mnitring f asthma and ther respiratry disrders. The measurement f exhaled nitric xide is cnsidered Investigatinal and Nt Medically Necessary in the diagnsis and mnitring f asthma and ther respiratry disrders. The measurement f exhaled breath cndensate is cnsidered Investigatinal and Nt Medically Necessary in the diagnsis and mnitring f asthma and ther respiratry disrders Revised Medical Plicies and Adpted Clinical UM Guidelines effective April 1, 2019: CG-BEH-01 Screening and Assessment fr Autism Spectrum Disrders and Rett Syndrme: This dcument addresses varius tls used in the screening and testing f individuals with suspected Autism Spectrum Disrders (ASDs) and Rett syndrme. Added tests fr metablic markers in the bld, urine, tissue, r ther bilgic materials (als knwn as metablmics), including but nt limited t Amin Acid Dysregulatin Metabtype (ADDM) testing as Nt Medically Necessary. CG-SURG-27 Sex Reassignment Surgery: This dcument addresses sex reassignment surgery (als knwn as gender reassignment surgery and gender cnfirmatin surgery), which is ne treatment ptin fr extreme cases f gender dysphria, a cnditin in which a persn feels a strng and persistent identificatin with the ppsite gender accmpanied with a severe sense f discmfrt in their wn gender. Added criteria requiring referral letters t mastectmy Medically Necessary statement. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 1 f 5 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Medical 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 Anthem Medical Plicies and Clinical UM Guidelines are develped by ur natinal 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. 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 Medical Plicies and Clinical UM Guidelines are available nline: The cmplete list f ur Medical 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 Medical 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 Medical Plicies and Clinical UM Guidelines (fr Lcal Plan Members). Click Cntinue, then select the either the Medical 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. Medical Directr Anthem Blue Crss and Blue Shield Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 2 f 5 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Medical 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 Medical Plicy ADMIN MED RAD Medical Plicy Title Medical Plicy Frmatin Diaphragmatic/Phrenic Nerve Stimulatin and Diaphragm Pacing Systems Psitrn Emissin Tmgraphy (PET) and PET/CT Fusin Attachment A Revised Medical Plicies and Clinical Guidelines Medical Plicy / Clinical Guideline Updated Descriptin/Scpe sectin cncerning MPTAC membership t include behaviral health (BH) specialists. Updated text regarding subspecialty cmmittees, including remval f BH subcmmittee. Clarified that third party criteria (TPC) subcmmittees may include BH specialists. Remved the Blue Crss Blue Shield Assciatin (BCBSA) frm acceptable independent technlgy evaluatin prgrams and materials that may be used in evaluating the medical necessity r investigatinal status f new r existing services and/r prcedures. Medical plicy archived 01/03/2019. Cnverted t CG-MED-79. Medical plicy archived 01/03/2019. Cnverted t CG-MED-80. DRUG Ipilimumab (Yervy ) Added Medically Necessary criteria fr ipilimumab as primary treatment when used in cmbinatin with nivlumab fr unresectable metachrnus clrectal cancer metastases when criteria are met. Clarified Medically Necessary criteria fr ipilimumab when used in cmbinatin with nivlumab as subsequent therapy fr unresectable advanced r metastatic clrectal cancer. DRUG Obinutuzumab Refrmatted Medically Necessary criteria. (Gazyva ) Added binutuzumab as Medically Necessary fr the treatment f CLL/SLL in the first-line f therapy in cmbinatin with bendamustine and as a single agent when criteria are met. DRUG Pembrlizumab (Keytruda ) Added the use f pembrlizumab fr the first-line treatment f metastatic squamus NSCLC as Medically Necessary when criteria are met. Added the use f pembrlizumab fr the treatment f small cell lung cancer (SCLC) as subsequent therapy as Medically Necessary when criteria are met. Remved "Presence f human immundeficiency virus (HIV) infectin, hepatitis B infectin and hepatitis C infectin" frm Investigatinal and Nt Medically Necessary statement. Added "Treatment used as first-line therapy, except as described in Medically Necessary criteria" t Investigatinal and Nt Medically Necessary statement. DRUG Nivlumab (Opdiv ) Revised Medically Necessary criteria fr nivlumab as primary treatment t include in cmbinatin with ipilimumab fr unresectable metachrnus clrectal cancer metastases when criteria are met. Clarified Medically Necessary criteria fr nivlumab when used in cmbinatin with ipilimumab as subsequent therapy fr unresectable advanced r metastatic clrectal cancer. Remved "Presence f human immundeficiency virus (HIV) infectin, hepatitis B infectin and hepatitis C infectin" frm Investigatinal and Nt Medically Necessary statement. DRUG Bezltxumab (ZINPLAVA ) Clarified Medically Necessary criteria fr individuals at high risk f Clstridium difficile infectin recurrence. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 3 f 5 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Medical 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 Medical Plicy GENE LAB MED SURG SURG SURG SURG TRANS CG-DME-40 CG-DRUG-45 CG-DRUG-62 Medical Plicy Title Epidermal Grwth Factr Receptr (EGFR) Testing Rupture f Membranes Testing in Pregnancy Crneal Cllagen Crss- Linking Mechanical Emblectmy fr Treatment f Acute Strke Intracular Anterir Segment Aqueus Drainage Devices (withut extracular reservir) Internal Rib Fixatin Systems Transcatheter Heart Valve Prcedures Hematpietic Stem Cell Transplantatin fr Select Leukemias and Myeldysplastic Syndrme Nninvasive Electrical Bne Grwth Stimulatin f the Appendicular Skeletn Octretide acetate (Sandstatin ; Sandstatin LAR Dept) Fulvestrant (FASLODEX ) Medical Plicy / Clinical Guideline Simplified Medically Necessary and Investigatinal and Nt Medically Necessary statements. Revised title. Previus title: Rupture f Membranes (ROM) Testing in Pregnancy. Remved acrnym frm psitin statement. Added Medically Necessary statements with clinical criteria. Investigatinal and Nt Medically Necessary statement changed t all ther indicatins. Made minr wrding clarificatin t Medically Necessary statement. Added the implantatin f Hydrus Micrstent as Medically Necessary when criteria are met. Added Hydrus Micrstent t Investigatinal and Nt Medically Necessary statement fr all ther indicatins nt listed as Medically Necessary. Added Hydrus Micrstent t Investigatinal and Nt Medically Necessary statement fr anterir segment aqueus drainage devices inserted internally r externally withut an extracular reservir. Add the use f an internal rib fixatin system as Medically Necessary fr the treatment f flail chest resulting in the inability t discntinue mechanical ventilatin in the absence f ther causes f ventilatr dependency such as severe brain injury. Revised Medically Necessary statements fr TAVR, remving end stage renal disease requiring chrnic dialysis r creatinine clearance frm list f cmrbid cnditins r cntraindicatins that wuld preclude the expected benefit frm artic stensis crrectin. Added minimal residual disease (MRD) psitivity fllwing inductin as a "high risk" factr t acute lymphblastic leukemia (ALL) Medically Necessary criteria. Revised Medically Necessary statement addressing allgeneic stem cell transplantatin fr chrnic lymphcytic leukemia (CLL)/small lymphcytic lymphma (SLL) t state: "Allgeneic (ablative r nn-myelablative stem cell transplantatin is cnsidered Medically Necessary fr individuals with CLL r SLL wh are refractry t small mlecule inhibitr therapy" (remved all ther current criteria). Revised title. Previus title: Electrical Bne Grwth Stimulatin. Revised scpe f dcument t nly address nninvasive electrical bne grwth stimulatin f the appendicular skeletn. Remved infrmatin related t invasive and semi-invasive electrical bne grwth stimulatin fr all cnditins and nninvasive bne grwth stimulatin fr spinal cnditins. Remved abbreviatins frm Clinical Indicatin statements. Replaced specific brand name drugs (palbciclib and abemaciclib) with the general term f CDK4/6 inhibitr in Medically Necessary criteria. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 4 f 5 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Medical 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 Medical Plicy Medical Plicy Title Medical Plicy / Clinical Guideline CG-DRUG-63 Levleucvrin Revised title. Previusly titled: Levleucvrin Calcium (Fusilev ). Prducts Revised scpe t include all available FDA-apprved levleucvrin agents (Fusilev & Khapzry). Added NCCN 2A indicatins t the Medically Necessary clinical indicatins statements. CG-DRUG-65 Tumr Necrsis Factr Antagnists Revised Medically Necessary statement fr use f adalimumab (Humira) fr individuals with hidradenitis suppurativa lwering the age frm 18 t 12 years f age r lder. CG-DRUG-77 Radium Ra 223 Dichlride (Xfig ) Added the use f Radium Ra 223 in cmbinatin with abiraterne acetate plus prednisne/prednislne as Nt Medically Necessary. CG-DRUG-78 Antihemphilic Factrs and Cltting Factrs Added Medically Necessary and Nt Medically Necessary criteria fr antihemphilic factr (factr VIII) damctcg alfa pegl (Jivi). Expanded Medically Necessary criteria fr emicizumab (Hemlibra). Expanded Medically Necessary criteria fr cagulatin Factr X, Human plasma-derived (Cagadex). CG-DRUG-88 Dupilumab (Dupixent ) Added the treatment f mderate t severe asthma as Medically Necessary when criteria are met. Added Medically Necessary criteria fr cntinuatin f therapy. CG-DRUG-107 Pharmactherapy fr Added Takhzyr as Medically Necessary when criteria are met. Hereditary Angiedema Updated Nt Medically Necessary criteria t include Takhzyr. CG-GENE-01 Janus Kinase 2 (JAK2)V617F and JAK2 Revised title. Previus title: Janus Kinase 2 (JAK2) V617F Gene Mutatin Assay. exn 12 Gene Mutatin Assays Added Medically Necessary and Nt Medically Necessary criteria fr Janus Kinase 2 exn 12 gene mutatin testing. Remved select abbreviatins frm the Clinical Indicatins sectin. CG-GENE-03 BRAF Mutatin Analysis Changed vemurafenib (Zelbraf ) t an FDA-apprved BRAF inhibitr in the Medically Necessary statement addressing individuals with NSCLC. Added new indicatin which reads: BRAF V600E mutatin analysis is cnsidered Medically Necessary in individuals with Erdheim-Chester Disease t identify thse wh wuld benefit frm treatment with vemurafenib (Zelbraf ). CG-MED-26 Nenatal Levels f Care Clarified Medically Necessary criteria fr: 1) General Nursery r Well-Baby Nursery; 2) Level I Surveillance Special Care Nursery; 3) Level II Nenatal Intensive Care; and 4) Level III Nenatal Intensive Care. CG-MED-65 Manipulatin Under Anesthesia Revised title. Previus title: Manipulatin Under Anesthesia f the Spine and Jints ther than the Knee. Remved manipulatin f shulder frm scpe f dcument. Updated Clinical Indicatins. CG-REHAB-07 Skilled Nursing and Skilled Rehabilitatin Clarified descriptin f prvider f utpatient skilled rehabilitatin services in Clinical Indicatins sectin. Services (Outpatient) CG-SURG-60 Cervical Ttal Disc Arthrplasty Revised clinical indicatins t nte that Secure-C cervical artificial disc is cnsidered Medically Necessary at a single level when criteria are met. CG-THER-RAD- 03 Radiimmuntherapy and Smatstatin Receptr Targeted Raditherapy Mved cntent f DRUG Lutetium Lu 177 dtatate (Lutathera ) t this Clinical UM Guideline. Added Medically Necessary and Nt Medically Necessary criteria fr ibenguane I 131 (Azedra), a newly FDA apprved radilabeled nrepinephrine analg targeted therapy. Anthem Blue Crss and Blue Shield 700 Bradway Denver, Clrad Page 5 f 5 Anthem Blue Crss and Blue Shield is the trade name f Rcky Muntain Hspital and Medical 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.

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