Updates to Medical Policies and Clinical UM Guidelines
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- Myra Palmer
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1 Updates t Medical Plicies and Clinical UM Guidelines Effective May 1, 2016 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 May 1, 2016 DRUG Bendamustine Hydrchlride (TREANDA ): This dcument addresses the indicatins fr the use f bendamustine hydrchlride (HCL), a cyttxic, bifunctinal mechlrethamine derivative with alkylatr and antimetablite activities used in the treatment f nclgic cnditins. Outlines the medically necessary, and investigatinal and nt medically necessary, criteria fr bendamustine HCL DRUG Meplizumab (Nucala ): This dcument addresses the use f meplizumab (Nucala), a humanized mnclnal antibdy against interleukin-5 used fr the treatment f individuals with severe esinphilic asthma nt well cntrlled with inhaled crticsterids and lng-acting beta-agnists. Outlines the medically necessary, and investigatinal and nt medically necessary, criteria fr meplizumab THER-RAD Image-guided Radiatin Therapy (IGRT) with External Beam Radiatin Therapy (EBRT): This dcument addresses image-guided radiatin therapy (IGRT) when used in cmbinatin with cnfrmal external beam radiatin therapy (EBRT). Outlines the medically necessary, and investigatinal and nt medically necessary, criteria fr IGRT used in cnjunctin with EBRT Revised Medical Plicies and Adpted Clinical UM Guidelines Effective May 1, 2016 LAB Advanced Lipprtein Testing: This dcument addresses the use f advanced testing f lipprteins fr cardivascular disease (CVD) risk assessment and management and all ther indicatins. Title revised (ld title was frm Advanced Lipprtein Testing in Cardiac Disease Risk Assessment and Management) Expanded scpe f plicy Revised psitin statement t state that advanced lipprtein testing is investigatinal and nt medically necessary fr CVD risk assessment and management and fr all ther indicatins Updated Descriptin, Ratinale, Cding and Reference UniCare Life & Health Insurance Cmpany Page 1 f 5
2 MED Autmated Evacuatin f Meibmian Gland: This dcument addresses the use f devices which will autmate the prcess f applying heat and intermittent pressure fr the treatment f meibmian gland dysfunctin, and assciated imaging. Revised scpe f dcument t include imaging assciated with the autmated evacuatin devices Added tear film imaging as investigatinal and nt medically necessary Updated Descriptin, Backgrund, Cding and Reference MED Therapeutic Apheresis: This dcument addresses therapeutic apheresis, a prcedure by which bld is remved frm the bdy, separated int cmpnents, manipulated and returned t the individual. Revised medically necessary indicatin fr thrmbtic micrangipathy clarifying that plasmapheresis (plasma exchange) is medically necessary fr the treatment f thrmbtic micrangipathy secndary t ticlpidine r malignancy Added HLA incmpatibility with hapl-type hematpietic stem cell transplant as a medically necessary indicatin fr plasmapheresis r plasma exchange Made a minr frmatting change in medically necessary criteria fr erythrcytapheresis r phlebtmy Clarified that the treatment f thrmbtic micrangipathy secndary t drugs ther than ticlpidine (fr example, clpidgrel, cyclsprine, gemcitabine, quinine, r tacrlimus) is investigatinal and nt medically necessary Remved hematpietic stem cell transplant ABO incmpatible as investigatinal and nt medically necessary indicatin fr cytapheresis Made minr wrding changes thrughut psitin statement Updated Descriptin, Ratinale, Definitins, Cding and References SURG Bariatric Surgery and Other Treatments fr Clinically Severe Obesity: This dcument addresses surgical and ther treatments fr clinically severe besity. Title revised (ld title was Surgery fr Clinically Severe Obesity) Expanded scpe f dcument t include nn-surgical treatments Added an investigatinal and nt medically necessary statement fr surgical prcedures when criteria are nt met Revised investigatinal and nt medically necessary statement addressing ther prcedures and treatment mdalities Added balln systems (such as the ReShape Integrated Dual Balln System) and vagus (r vagal) nerve blcking devices (such as the MAESTRO Rechargeable System) as investigatinal and nt medically necessary Updated Descriptin, Ratinale, Backgrund, Definitins, Cding, Reference and Index THER-RAD Neutrn Beam Raditherapy: This dcument addresses neutrn beam radiatin therapy. Re-categrized (previus categry and number was RAD.00047) Revised psitin statement t nw cnsider neutrn beam raditherapy investigatinal and nt medically necessary fr all indicatins Updated Ratinale, Cding and Reference 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 page, select the buttn fr Medical Plicies; then select Review all medical plicies and clinical UM guidelines. UniCare Life & Health Insurance Cmpany Page 2 f 5
3 Attachment A The revised medical plicies listed belw will becme effective fr services rendered n r after May 1, Medical Plicy Number DRUG Medical Plicy Title Brentuximab Vedtin (Adcetris ) Medical Plicy / Clinical Guideline Changes Clarified medically necessary criteria addressing Hdgkin lymphma Added the treatment f individuals with CD30+ psitive T-cell lymphma that is relapsed r refractry t first-line therapy as medically necessary Updated Ratinale, Backgrund, Cding and Reference DRUG Ziv-aflibercept (Zaltrap ) Added anal adencarcinma, appendiceal adencarcinma and small bwel adencarcinma as medically necessary when criteria are met Updated Ratinale, Backgrund, Definitin, Cding and Reference DRUG Carfilzmib (Kyprlis ) Title revised - replaced trademark in brand name with registered mark Clarified and refrmatted medically necessary criteria addressing the treatment f multiple myelma Added carfilzmib in cmbinatin with lenalidmide and dexamethasne as medically necessary when the individual has received ne t three prir lines f therapy Added the treatment f Waldenström's macrglbulinemia as medically necessary when criteria are met Cding, Reference and Index DRUG Antihemphilic Factrs and Cltting Factrs Clarified medically necessary criteria addressing recmbinant Factr VIIa (NvSeven RT) by adding "fr the treatment f bleeding episdes and peri-perative management" in individuals with Glanzmann s thrmbasthenia and a dcumented refractriness t platelet transfusins with r withut antibdies t platelets Added the drug Nuwiq as medically necessary when the recmbinant antihemphilic factr (Factr VIII) criteria are met Added human plasma-derived cagulatin Factr X, (Cagadex) as medically necessary when criteria are met UniCare Life & Health Insurance Cmpany Page 3 f 5
4 DRUG (cntinued) Antihemphilic Factrs and Cltting Factrs Added Cagadex as investigatinal and nt medically necessary when the criteria are nt met and fr all ther indicatins including, but nt limited t periperative management f bleeding in majr surgery in individuals with mderate and severe hereditary Factr X deficiency Clarified medically necessary criteria addressing human plasma-derived cncentrate Factr XIII (Crifact) Cding, Reference and Appendix DRUG Pembrlizumab (Keytruda ) Revised ECOG perfrmance status criterin t be 0-2 (previusly 0-1) in medically necessary criteria addressing individuals with melanma Added the treatment f metastatic nn-small cell lung cancer (NSCLC) as medically necessary when criteria are met Clarified investigatinal and nt medically necessary sectin Definitin, Cding, Reference and Index DRUG Nivlumab (Opdiv ) Revised medically necessary criteria addressing nivlumab used as secnd-line r subsequent therapy fr individuals with melanma with dcumented disease prgressin while receiving r since cmpleting mst recent therapy, t include in cmbinatin with ipilimumab, if PD-1 agent nt previusly used Revised ECOG perfrmance status criterin t be 0-2 (previusly 0-1) in medically necessary criteria addressing individuals with melanma and NSCLC Expanded the use f nivlumab fr the treatment f metastatic NSCLC t include all types (remved the wrd squamus) Added the treatment f advanced r metastatic (clear cell) renal cell carcinma (RCC) as medically necessary when criteria are met Updated investigatinal and nt medically necessary statement Cding, Reference and Index GENE Preimplantatin Genetic Diagnsis Testing Added a histry f trismy in a previus pregnancy as a medically necessary indicatin fr preimplantatin genetic testing Made minr wrding changes in medically necessary sectin Updated Descriptin and Reference Remved ICD-9 cdes frm Cding sectin UniCare Life & Health Insurance Cmpany Page 4 f 5
5 GENE Gene Expressin Prfiling fr Managing Breast Cancer Treatment Revised medically necessary criteria addressing tumr size t state: tumr greater than 1.0 cm and less than r equal t 5.0 cm (previusly the upper limit was 4.0 cm) Made minr wrding changes in psitin statement Updated Ratinale, Reference and Index Remved ICD-9 cdes frm Cding sectin GENE Analysis f KRAS Status Remved the registered and trademark symbls frm the psitin statement Definitin, Cding, Reference and Index GENE BRAF Mutatin Analysis Added BRAF V600E mutatin analysis as medically necessary fr individuals with nnsmall cell lung cancer (NSCLC) t select thse wh wuld benefit frm treatment with vemurafenib (Zelbraf ) Added BRAF V600E mutatin analysis as medically necessary fr individuals with relapsed hairy-cell leukemia t select thse wh wuld benefit frm treatment with vemurafenib (Zelbraf ) Definitins, Cding and Reference SURG SURG SURG Allgeneic, Xengraphic, Synthetic and Cmpsite Prducts fr Wund Healing and Sft Tissue Grafting Bariatric Surgery and Other Treatments fr Clinically Severe Obesity Transcatheter Heart Valve Prcedures Added Perlane and Restlyane t list f prducts cnsidered investigatinal and nt medically necessary Updated Descriptin, Ratinale, Cding and Reference Title revised (was Surgery fr Clinically Severe Obesity) Expanded scpe f dcument t include nn-surgical treatments Added an investigatinal and nt medically necessary statement fr surgical prcedures when criteria are nt met Revised investigatinal and nt medically necessary statement addressing ther prcedures and treatment mdalities Added balln systems (such as the ReShape Integrated Dual Balln System) and vagus (r vagal) nerve blcking devices (such as the MAESTRO Rechargeable System) as investigatinal and nt medically necessary Definitins, Cding, Reference and Index Added the SAPIEN 3 transcatheter heart valve t medically necessary criteria addressing transcatheter artic valve replacement (TAVR) Made minr wrding changes in psitin statement Updated Ratinale, Descriptin, Backgrund and Reference Remved ICD-9 cdes frm Cding sectin UniCare Life & Health Insurance Cmpany Page 5 f 5
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