June 28, Dear Provider:

Transcription

1 June 28, 2016 Dear Prvider: Anthem Blue Crss is pleased t prvide yu with ur updated and new Medical Plicies and Clinical UM Guidelines. The updated plices listed belw are effective fr service dates n and after Octber 1, 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. Attachment A summarizes ther minr changes and clarificatins. New Medical Plicies effective Octber 1, 2016: DRUG Daratumumab (Darzalex ): This dcument addresses the use f daratumumab (DARZALEX), a human anti-cd38 mnclnal antibdy (mab) used fr the treatment f multiple myelma (including plasma-cell leukemia) resistant t ther therapies. DRUG Eltuzumab (Empliciti ): This dcument addresses eltuzumab (Empliciti), a humanized IgG1 mnclnal antibdy that targets the signaling lymphcytic active mlecule (SLAM) family member F7 (SLAMF7) prtein that is expressed n myelma cells and natural killer cells. DRUG Interfern gamma-1b (Actimmune ): This dcument addresses the indicatins fr interfern gamma-1b (Actimmune), a bilgic respnse mdifier used in the management f chrnic granulmatus disease, severe malignant stepetrsis, and nclgic cnditins. DRUG Ixabepilne (Ixempra ): This dcument addresses ixabepilne (Ixempra), a nn-taxane chemtherapy agent which blcks cells in the mittic phase f the cell divisin cycle, leading t cell death. Ixabepilne is used as a secnd r subsequent line f therapy, alne r in cmbinatin with ral capecitabine, t treat breast cancer resistant r refractry t ther therapies. DRUG Mecasermin (Increlex ): This dcument addresses the use f mecasermin (Increlex), a recmbinant human insulin-like grwth factr-1 (rhigf-1) drug, prpsed fr the treatment f cnditins related t IGF-1 deficiency (IGFD) and ther frms f grwth hrmne insensitivity. GENE Detectin and Quantificatin f Tumr DNA Using Next Generatin Sequencing in Lymphid Cancers: This dcument addresses next generatin sequencing (which includes, but is nt limited t high-thrughput and deep sequencing) f tumr DNA t assist in determining the success f the treatment, frming a prgnsis, mnitring disease prgressin and chsing therapies fr individuals with lymphid cancer. SURG SpaceOAR System: This dcument addresses the use f SpaceOAR, an injectable liquid hydrgel prduct intended t create distance and serve as a spacer between the prstate and the anterir rectal wall in individuals underging raditherapy fr prstate cancer. 1

2 New Clinical UM Guidelines fr Individual Members Only Effective Octber 1, 2016, utpatient hip replacement, knee replacement and cervical spine fusin will be added t the precertificatin list fr ur Cmmercial Individual members. Califrnia individual members can currently be identified by prefixes JQL, JQM, JQN, JQO, JQP, JQR, VXB and VXD n the member s identificatin card. CG-SURG-42 Cervical Fusin: This dcument addresses the clinical indicatins fr anterir and psterir cervical fusin. CG-SURG-53 Elective Ttal Hip Arthrplasty: This dcument addresses elective ttal hip arthrplasty (THA) fr hip damage severe enugh t require replacement, when perfrmed as an elective, nn-emergent prcedure and nt as part f the care f a cngenital, acute r traumatic event such as fracture (excluding fracture f implant and periprsthetic fracture). CG-SURG-54 Elective Ttal Knee Arthrplasty: This dcument addresses elective ttal knee arthrplasty (TKA) fr knee damage severe enugh t require replacement, when dne as an elective, nn-emergent prcedure and nt as part f the care f a cngenital, acute r traumatic event such as fracture (excluding periprsthetic fracture). Revised Adpted Clinical UM Guidelines and Medical Plicies: CG-DRUG-16 White Bld Cell Grwth Factrs: This dcument addresses white bld cell grwth factrs, als knwn as clny stimulating factrs (CSF), which are administered t enhance recvery f bld related functins in neutrpenia (lw white bld cunt) including febrile neutrpenia (FN). Revised medically necessary criteria addressing primary prphylaxis f develping FN when greater than r equal t 10% and less than 20% fr all prducts Added pegfilgrastim (Neulasta) as medically necessary after accidental r intentinal ttal bdy radiatin f myelsuppressive dses (greater than 2 Grays [Gy]) (such as Hematpietic Syndrme f Acute Radiatin Syndrme) Added tb-filgrastim (Granix) as medically necessary: After a hematpietic prgenitr stem cell transplant (HPCT/HSCT) when criteria are met T mbilize prgenitr cells int peripheral bld fr cllectin by leukapheresis, as an adjunct t peripheral bld/hematpietic stem cell transplantatin (PBSCT/PHSCT) Refrmatted medically necessary clinical indicatins Defined abbreviatins in clinical indicatins DRUG Intravitreal Treatment fr Retinal Vascular Cnditins: This dcument addresses the fllwing medicatins used t treat retinal vascular cnditins f the eye: pegaptanib (Macugen ); bevacizumab (Avastin ); ranibizumab (Lucentis ); and aflibercept (Eylea ). Title revised Added chridal nevascularizatin assciated with mypic degeneratin as medically necessary indicatin fr ranibizumab Added diabetic retinpathy, with r withut diabetic macular edema, as medically necessary indicatin fr bevacizumab Revised the medically necessary indicatin f diabetic retinpathy t include the wrds r withut befre diabetic macular edema fr bth ranibizumab and aflibercept Added radiatin retinpathy as medically necessary indicatin fr bevacizumab, ranibizumab and aflibercept Clarified the medically necessary criteria t state that the treatment f prliferative diabetic retinpathy with r withut diabetic macular edema is a medically necessary indicatin fr bevacizumab, ranibizumab, and aflibercept 2

3 MED High Intensity Fcused Ultrasund (HIFU) fr Onclgic Indicatins: This dcument addresses the use f high intensity fcused ultrasund (HIFU) r magnetic resnance-guided fcused ultrasund (MRgFUS) fr the treatment f nclgic cnditins. Title, categry and number revised (Previus categry & number: SURG.00094; Previus title: High Intensity Fcused Ultrasund (HIFU) fr the Treatment f Prstate Cancer). Expanded scpe f dcument t include all nclgic cnditins Added the use f HIFU fr pain palliatin in individuals with lcalized metastatic bne pain as medically necessary when criteria are met Revised investigatinal and nt medically necessary statement t include when criteria are nt met and fr all ther indicatins, including but nt limited t, prstate cancer Added the bisimilar infliximab-dyyb (Inflectra ) as medically necessary fr the same indicatins fr use as infliximab (Remicade ) SURG Treatment f Varicse Veins (Lwer Extremities): This dcument addresses varius mdalities fr the treatment f valvular incmpetence (reflux) f the great saphenus vein (GSV) r small saphenus vein (SSV) (als knwn as greater saphenus vein r lesser saphenus vein, respectively) and assciated varicse tributaries as well as telangiectatic dermal veins. Added cil emblizatin as a treatment f lwer extremity veins as investigatinal and nt medically necessary SURG Mechanical Emblectmy fr Treatment f Acute Strke: This dcument addresses the use f intra-arterial mechanical emblectmy devices, als knwn as endvascular thrmbectmy, fr the treatment f acute thrmbtic r emblic strke. Remved requirement fr the treated individual t be 18 years f age r lder Added criteria that the prcedure is dne with a stent retriever device 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 Prvider, then select Medical Plicies and Clinical UM Guidelines listed under Learn Mre. Recent changes t Medical Plicies can be fund under Recent Updates". 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 3

4 Attachment A - 2nd Quarter 2016 Updates Revised Medical Plicies and Clinical Guidelines Plicy Number Title Medical Plicy / Clinical Guideline Changes CG-DME-01 CG-DRUG-08 CG-DRUG-15 CG-DRUG-27 CG-SURG-44 External (Prtable) Cntinuus Insulin Infusin Pumps Enzyme Replacement Therapy fr Gaucher Disease Gnadtrpin Releasing Hrmne Analgs (Previus title: Gnadtrpin Releasing Hrmne (GnRH) Analgs) Clstridial Cllagenase Histlyticum Injectin Crnary Angigraphy in the Outpatient Setting (Previus title: Crnary Angigraphy and Cardiac Catheterizatin in the Outpatient Setting) Added micrvascular r macrvascular cmplicatins (fr example, diabetic retinpathy r cardivascular disease) as medical necessary criteria fr individuals with diabetes mellitus Refrmatted and clarified medically necessary clinical indicatins fr adults with type 1, and adults and children with type 3 Gaucher disease Revised medically necessary clinical indicatins fr type 3 Gaucher disease Title revised Clarified medically necessary statement addressing varian cancer and leuprlide acetate as hrmnal therapy when used as a single agent fr persistent r recurrent epithelial varian cancer, fallpian tube cancer and primary peritneal cancer Added the treatment f Peyrnie's disease as medically necessary when criteria are met Updated nt medically necessary statement Title revised Narrwed scpe f dcument t nly address crnary angigraphy Remved criteria addressing heart catheterizatin and criteria fr angigraphy with heart catheterizatin Revised criteria addressing angigraphy fr individuals with suspected CAD based n results f prir nninvasive stress testing t include treadmill stress test as acceptable testing methd Added the evaluatin f suspected anmalus crnary arteries and preperative assessment befre pen valvular surgery as medically necessary indicatins Updated nt medically necessary statement DRUG Tumr Necrsis Factr Antagnists Added the bisimilar infliximab-dyyb (Inflectra ) as medically necessary fr the same indicatins fr use as infliximab (Remicade ) Updated the nt medically necessary and investigatinal and nt medically necessary statements t include infliximab-dyyb (Inflectra) when criteria are nt met 4

5 Plicy Number Title Medical Plicy / Clinical Guideline Changes DRUG Rituximab (Rituxan ) Remved wrding "Systemic Autimmune Disrders" frm medically necessary criteria addressing cryglbulinemia, primary Sjögren Syndrme (SS), r Systemic Lupus Erythematsus (SLE) refractry t standard therapy (that is, lack f respnse t crticsterids and at least 2 immunsuppressive agents) Added immunglbulin G4-related disease (IgG4-RD) as medically necessary when criteria are met Added pediatric nephrtic syndrme as medically necessary when criteria are met Added thrmbtic thrmbcytpenic purpura (TTP), refractry r relapsing disease (i.e., lack f respnse t plasma exchange therapy and gluccrticids) wh meet diagnstic criteria fr TTP as medically necessary Refrmatted and made changes t abbreviatins and acrnyms thrughut psitin statement Updated investigatinal and nt medically necessary statement DRUG Brentuximab Vedtin (Adcetris ) Clarified medically necessary statement addressing the treatment f individuals with CD30+ T-cell lymphma (excluding cutaneus ALCL) that is relapsed r refractry t first-line therapy Added the treatment f individuals with cutaneus CD30+ T-cell lymphma, including mycsis fungides/sezary syndrme which is relapsed, refractry r fr advanced disease presentatin (fr example, fllicultrpic, large-cell transfrmatin r extracutaneus disease) as medically necessary Added the treatment f individuals with refractry CD30+ lymphmatid papulsis that is symptmatic r characterized by extensive cutaneus lesins as medically necessary Updated investigatinal and nt medically necessary statement Made minr abbreviatin changes in psitin statement DRUG Obinutuzumab (Gazyva ) Added binutuzumab used as a single agent fr the treatment f relapsed/refractry CLL/SLL withut del (17p) mutatin as medically necessary Added binutuzumab, in cmbinatin with bendamustine fllwed by binutuzumab mntherapy fr the treatment f individuals with fllicular lymphma (FL) wh relapsed after, r are refractry t, a rituximab-cntaining regimen as medically necessary Revised investigatinal and nt medically necessary statement 5

6 Plicy Number Title Medical Plicy / Clinical Guideline Changes DRUG Antihemphilic Factr and Cltting Factrs Clarified medically necessary criteria addressing measurement f factr levels thrughut psitin statement Added the fllwing factrs as medically necessary when criteria are met Antihemphilic Factr (Factr VIII) Recmbinant (Kvaltry) Antihemphilic Factr (Factr VIII) Recmbinant, pegylated (Adynvate) vn Willebrand Factr (Recmbinant) (Vnvendi) Cagulatin Factr IX, Recmbinant, Albumin Fusin Prtein (Idelvin) Added Antihemphilic Factr VIII Recmbinant (Advate, Helixate FS, Kgenate FS, Kvaltry, Nveight, Nuwiq, Recmbinate, Xyntha) fr the treatment f bleeding episdes in an individual with vn Willebrand disease (VWD) as medically necessary when criteria are met Added investigatinal and nt medically necessary statements fr antihemphilic factr (factr VIII) Recmbinant, pegylated and vn Willebrand factr (Recmbinant) DRUG Pembrlizumab (Keytruda ) Clarified medically necessary criteria addressing treatment f melanma and nn-small cell lung cancer t indicate that the individual was nt receiving therapy fr an autimmune disease r chrnic cnditin requiring treatment with a systemic immunsuppressant Added the treatment f individuals with relapsed r refractry Hdgkin lymphma, except fr thse with lymphcytepredminant Hdgkin lymphma, as medically necessary indicatin Updated investigatinal and nt medically necessary statement DRUG Nivlumab (Opdiv ) Clarified medically necessary criteria addressing treatment f melanma, nn-small cell lung cancer, and renal cell carcinma t indicate that the individual was nt receiving therapy fr an autimmune disease r chrnic cnditin requiring treatment with a systemic immunsuppressant Added the treatment f individuals with relapsed r refractry Hdgkin lymphma, except fr thse with lymphcytepredminant Hdgkin lymphma, as medically necessary indicatin Updated investigatinal and nt medically necessary statement 6

7 Plicy Number Title Medical Plicy / Clinical Guideline Changes DRUG Mnclnal Antibdies t Interleukin-17A (Previus title: Secukinumab [Csentyx ]) Title revised Expanded scpe f dcument t address bth FDA apprved IL- 17A receptr antagnists ixekizumab (Taltz ) and secukinumab (Csentyx ) Added ixekizumab fr the treatment f plaque psriasis as medically necessary when criteria are met Made minr abbreviatin changes in psitin statement Updated nt medically necessary and investigatinal and nt medically necessary statements MED Inhaled Nitric Oxide Added INO as a methd f assessing pulmnary vasreactivity in individuals with pulmnary hypertensin as medically necessary Updated investigatinal and nt medically necessary statement Made minr abbreviatin changes in psitin statement SURG THER-RAD Allgeneic, Xengraphic, Synthetic, and Cmpsite Prducts fr Wund Healing and Sft Tissue Grafting Intensity Mdulated Radiatin Therapy (IMRT) Added AllDerm RTU (als knwn as AllDerm Ready t Use) as medically necessary fr the same indicatins as AllDerm Regenerative Tissue Matrix (als knwn as AllDerm RTM) Added FlexHD as medically necessary fr breast recnstructin surgery Clarified "Nte" in medically necessary criteria Added AllDerm RTU, FlexHD, and fresh frzen unprcessed allgraft skin prducts (fr example, AllSkin, TheraSkin) as investigatinal and nt medically necessary when criteria are nt met and fr any use nt listed as medically necessary Added new prducts t the investigatinal and nt medically necessary list Added esphageal cancer as medically necessary indicatin Added the treatment f mediastinal tumrs fr which radiatin is indicated as medically necessary indicatin Revised medically necessary criteria fr the treatment f lung cancer 7