Updates t Medical Plicies Effective Octber 1, 2017 and Nvember 1, 2017 The majr new plicies and changes are summarized belw, and additinal updates are in Attachment A. Please refer t the specific plicy fr cding, language, and ratinale updates and changes that are nt summarized belw. New Medical Plicies Effective Octber 1, 2017 MED.00121 Implantable Interstitial Glucse Sensrs: This dcument addresses the use f implantable interstitial glucse sensrs (fr example, the Eversense Cntinuus Glucse Mnitring System). MED.00122 Wilderness Prgrams: This dcument addresses wilderness prgrams, including services such as adventure therapy r wilderness therapy when part f wilderness prgrams prvided in an utdr envirnment and prpsed as a treatment ptin fr a variety f medical cnditins r behaviral health disrders. SURG.00148 Spectral Analysis f Prstate Tissue by Flurescence Spectrscpy: This dcument addresses the use f spectral analysis f prstate tissue by flurescence spectrscpy, which invlves using fiber ptics t differentiate between nrmal prstate tissue and suspicius prstate tissue. SURG.00150 Leadless Pacemakers: This dcument addresses a single chamber implantable transcatheter pacing system t mnitr and regulate the heart rate and rate-respnsive bradycardia. New Medical Plicies effective Nvember 1, 2017 DRUG.00099 Cerlipnase Alfa (Brineura ): This dcument addresses the use f cerlipnase alfa (Brineura), a recmbinant human tripeptidyl peptidase 1 enzyme replacement therapy in the treatment f late infantile neurnal cerid lipfuscinsis type 2. DRUG.00101 Kevzara (sarilumab): This dcument addresses the use f sarilumab (Kevzara) in adults with mderately t severely active rheumatid arthritis and fr ther cnditins. DRUG.00103 Abalparatide (Tymls ) Injectin: This dcument addresses the use f abalparatide (Tymls ) injectin, which is a nvel synthetic 34 amin acid peptide and is intended fr subcutaneus use. Abalparatide is an analg f human parathyrid hrmne related peptide, PTHrP (1-34) that selectively activates the parathyrid hrmne type 1 receptr fr the treatment f pstmenpausal steprsis in a select ppulatin f wmen cnsidered at high risk fr fractures. DRUG.00107 Avelumab (Bavenci ): This dcument addresses the use f avelumab (Bavenci), a prgrammed death ligand-1 (PD-L1) blcking antibdy apprved by the FDA fr treatment f metastatic Merkel cell carcinma. Claims are administered by UniCare Life & Health Insurance Cmpany. Page 1 f 5
DRUG.00108 Edaravne (Radicava ): This dcument addresses the use f edaravne (Radicava). Edaravne is a free radical scavenger apprved by the FDA fr treatment f amytrphic lateral sclersis (ALS). DRUG.00109 Durvalumab (IMFINZI ): This dcument addresses the use f durvalumab (IMFINZI), a human G1 k mnclnal prgrammed death ligand 1 (PD-L1) antibdy fr the treatment f lcally advanced r metastatic urthelial carcinma under certain cnditins. Revised Medical Plicies Effective Octber 1, 2017 DRUG.00062 Obinutuzumab (Gazyva ): This dcument addresses the indicatins and criteria fr the use f binutuzumab (Gazyva). Clarified that binutuzumab is Medically Necessary as a first-line treatment f CLL/SLL withut del(17p) mutatin when used in cmbinatin with chlrambucil Revised Medically Necessary criteria fr the treatment f fllicular lymphma by adding additinal chemtherapy regimens t be used in cmbinatin with binutuzumab GENE.00001 Genetic Testing fr Cancer Susceptibility: This dcument addresses genetic testing t determine whether an individual is at risk fr the develpment f cancer based n a genetic test. GENE.00002 Preimplantatin Genetic Diagnsis Testing: This dcument addresses the use f preimplantatin genetic diagnsis (PGD) and preimplantatin genetic screening (PGS) which is perfrmed as part f an assisted reprductive prcedure. Revised the first Medically Necessary statement t be screening instead f diagnsis Mved Medically Necessary criteria regarding balanced translcatin t the Medically Necessary statement addressing diagnsis Clarified Medically Necessary psitin statement regarding gender selectin t replace the term gender with sex GENE.00007 Cardiac In Channel Genetic Testing: This dcument addresses genetic testing f cardiac in channel mutatins in persns with suspected channelpathies, such as lng QT syndrme (LQTS), in rder t determine the risk fr sudden cardiac death (SCD). Made minr language changes in psitin statement GENE.00012 Precnceptin r Prenatal Genetic Testing f a Parent r Prspective Parent: This dcument addresses precnceptin r prenatal genetic testing n a parent r prspective parent t determine carrier status f an autsmal recessive disrder, an x-linked disrder, r a disrder with variable penetrance. Revised title (changed Precnceptinal t Precnceptin ) Added "familial dysautnmia" as a Medically Necessary indicatin when criteria met fr precnceptin r prenatal genetic screening f a parent r prspective parent t determine carrier status f inherited disrders Revised Medically Necessary psitin statement fr cystic fibrsis carrier screening t address using a standard panel usually cnsisting f 23 r mre f the cmmn gene mutatins Added Nt Medically Necessary psitin statements fr use f: a) cmplete DNA sequencing f the cystic fibrsis transmembrane cnductance regulatr (CFTR) gene; b) gene analysis f knwn CFTR familial variants; and c) gene analysis f CFTR duplicatin/deletin variants t determine cystic fibrsis carrier status Added Medically Necessary psitin statement t address genetic screening t determine carrier status f spinal muscular atrphy Added Medically Necessary criteria regarding genetic cunseling Made minr language and frmatting changes in psitin statement Claims are administered by UniCare Life & Health Insurance Cmpany. Page 2 f 5
GENE.00017 Genetic Testing fr Diagnsis and Management f Hereditary Cardimypathies (including ARVD/C): This dcument addresses genetic testing fr the hereditary cardimypathies which includes hypertrphic (HCM), dilated (DCM), restrictive (RCM), arrhythmgenic right ventricular dysplasia/cardimypathy (ARVD/C) and left ventricular nncmpactin (LVNC). GENE.00026 Cell-Free Fetal DNA-Based Prenatal Testing: This dcument addresses cell-free fetal DNA-based prenatal testing fr fetal aneuplidies (including fetal sex chrmsme aneuplidies), fetal sex determinatin and micrdeletins. GENE.00028 Genetic Testing fr Clrectal Cancer Susceptibility: This dcument addresses genetic testing fr individuals wh are at higher than average risk fr the develpment f clrectal cancer. Refrmatted Medically Necessary criteria GENE.00029 Genetic Testing fr Breast and/r Ovarian Cancer Syndrme: This dcument addresses genetic testing fr individuals wh are at higher than average risk fr the develpment f breast and/r varian cancer. Updated frmatting GENE.00030 Genetic Testing fr Endcrine Gland Cancer Susceptibility: This dcument addresses genetic testing fr individuals wh are at higher than average risk fr the develpment f endcrine gland cancer, including medullary thyrid cancer. Updated frmatting GENE.00031 Genetic Testing fr PTEN Hamartma Tumr Syndrme: This dcument addresses mutatin testing f the phsphatase and tensin hmlg (PTEN) gene. Updated frmatting GENE.00035 Genetic Testing fr TP53 Mutatins: This dcument addresses genetic testing fr TP53 mutatins. Added Medically Necessary statement fr use f TP53 gene mutatin testing fr individuals diagnsed with hypdiplid acute lymphcytic leukemia when criteria met GENE.00040 Genetic Testing fr CHARGE Syndrme: This dcument addresses genetic testing fr CHARGE syndrme, a rare genetic cnditin assciated with multiple cngenital anmalies. GENE.00043 Genetic Testing f an Individual s Genme fr Inherited Diseases: This dcument addresses the indicatins and criteria fr the use f binutuzumab (Gazyva). UniCare Medical Plicies and Clinical UM Guidelines are develped by ur Medical Plicy and Technlgy Assessment Cmmittee. The Cmmittee, which includes UniCare 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 UniCare 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 UniCare s medical plicies. Review prcedures have been refined t facilitate claim investigatin. Yu can access the cmplete list f Medical Plicies and Clinical UM Guidelines frm unicarestateplan.cm. On the Prviders hme page, select the buttn fr Medical Plicies n the right side f the page; then chse Review all medical plicies and clinical UM guidelines. Claims are administered by UniCare Life & Health Insurance Cmpany. Page 3 f 5
Attachment A 2 nd Quarter 2017 Updates Revised Medical Plicies Plicy Number Title Medical Plicy / Clinical Guideline Changes DRUG.00003 Chelatin Therapy Revised Investigatinal and Nt Medically Necessary criteria t DSM-5 language fr Autism Spectrum Disrders (ASD) DRUG.00071 Pembrlizumab (Keytruda ) Added Medically Necessary statement fr the use f pembrlizumab fr the treatment f individuals with clrectal cancer when criteria met Revised Medically Necessary statement fr head and neck squamus cell carcinma (HNSCC), n lnger requiring criteria requirement fr PD-L1 gene expressin Refrmatted Medically Necessary criteria DRUG.00079 Bendamustine Hydrchlride Added treatment f ndal marginal zne lymphma and peripheral T-cell lymphma t the list f examples f NHL cnsidered Medically Necessary DRUG.00083 Eltuzumab (Empliciti ) Added Medically Necessary criteria fr use f eltuzumab in cmbinatin with brtezmib and dexamethasne Made minr wrding change in Investigatinal and Nt Medically Necessary statement DRUG.00088 Atezlizumab (Tecentriq ) Added Medically Necessary statement fr use f atezlizumab fr first-line treatment f lcally advanced r metastatic urthelial carcinma when criteria met Clarified criteria addressing secnd-line treatment f urthelial carcinma and NSCLC t state that individual has nt received treatment with anther PD-1 r PD-L1 agent Remved abbreviatins frm the psitin statement DRUG.00097 Olaratumab (Lartruv ) Added curative befre treatment ptin in the Medically Necessary criteria addressing raditherapy r surgery Remved Medically Necessary criteria fr "laratumab use in cmbinatin with dxrubicin" and replaced it with laratumab is used in cmbinatin with dxrubicin and, after at least 8 cycles with dxrubicin r earlier discntinuatin f dxrubicin due t txicity, and then if s chsen, cntinuing laratumab as mntherapy in the absence f unacceptable txicities until disease prgressin Remved Medically Necessary statement addressing laratumab s use as mntherapy after disease prgressin with dxrubicin Cnslidated tw separate Medically Necessary statements int a single statement DRUG.00104 Nusinersen (SPINRAZA ) Revised Medically Necessary criteria fr age f nset f SMAassciated signs and symptms frm "befre 6 mnths f age" t "befre 21 mnths f age" GENE.00006 GENE.00009 Epidermal Grwth Factr Receptr (EGFR) Testing Gene-Based Tests fr Screening, Detectin and Management f Prstate Cancer Clarified Medically Necessary statement regarding EGFR testing fr individuals underging TKI inhibitr therapy Added CPT cde 0005U as Investigatinal and Nt Medically Necessary. Claims are administered by UniCare Life & Health Insurance Cmpany. Page 4 f 5
GENE.00032 Mlecular Marker Evaluatin f Thyrid Ndules Added Medically Necessary statement fr the use f a gene expressin classifier fr mlecular marker evaluatin f a thyrid ndule fr use with fine needle aspirates, after initial cytpathlgy is indeterminate (that is, atypia f undetermined significance [AUS], fllicular lesin f undetermined significance [FLUS], suspicius fr fllicular neplasm [SFN], fllicular neplasm [FN], and suspicius fr malignancy) Added Investigatinal and Nt Medically Necessary statement fr repeat testing f the same ndule and when the Medically Necessary criteria are nt met CPT cde 81545 fr Afirma gene expressin classifier test will nw pend fr Medically Necessary criteria MED.00032 Treatment f Hyperhidrsis Revised scpe f dcument Mved psitin statement and all ther language addressing treatment f hyperhidrsis with btulinum txin t DRUG.00006 MED.00076 Inhaled Nitric Oxide Remved abbreviatins frm the psitin statement RAD.00059 SURG.00001 Transcatheter Arterial Chememblizatin (TACE) and Transcatheter Arterial Emblizatin (TAE) fr Malignant Lesins Outside the Liver except Central Nervus System (CNS) and Spinal Crd Cartid, Vertebral and Intracranial Artery Stent Placement with r withut Angiplasty Remved abbreviatins frm the psitin statement Clarified symptmatic r asymptmatic stensis is necessary t meet criteria including in thse wh cannt mve the neck and thse with a trachestmy fr the Medically Necessary criteria fr extracranial cartid artery stent placement with r withut angiplasty SURG.00016 Steretactic Radifrequency Pallidtmy Revised punctuatin SURG.00049 Mandibular/Maxillary (Orthgnathic) Surgery Made minr grammar and punctuatins revisins SURG.00065 Lcally Ablative Techniques fr Remved abbreviatins frm the psitin statement Treating Primary and Metastatic Liver Malignancies SURG.00081 Ttal Ankle Replacement Remved abbreviatins frm the psitin statement SURG.00121 Transcatheter Heart Valve Prcedures Revised Medically Necessary statement fr TAVR with CreValve System t include the CreValve Evlut R System and CreValve Evlut PRO System THER-RAD.00004 External Beam Intraperative Radiatin Therapy Clarified Medically Necessary statement fr external beam intraperative radiatin therapy as the sle surce f additinal raditherapy at the time f surgical excisin when criteria are met Added a Medically Necessary statement fr use f partial breast irradiatin (PBI) with external beam intraperative PBI as an alternative t whle breast irradiatin in the treatment f early stage breast cancer when criteria are met Added an Investigatinal and Nt Medically Necessary statement fr external beam intraperative PBI fr the treatment f breast cancer when the Medically Necessary criteria are nt met Updated frmatting in the psitin statement Claims are administered by UniCare Life & Health Insurance Cmpany. Page 5 f 5