policy update bulletin

Transcription

1 I aw Octber 2017 plicy update bulletin Medical & Administrative Plicy Updates UnitedHealthcare respects the expertise f the physicians, health care prfessinals, and their staff wh participate in ur netwrk. Our gal is t supprt yu and yur patients in making the mst infrmed decisins regarding the chice f quality and cst-effective care, and t supprt practice staff with a simple and predictable administrative experience. The Plicy Update Bulletin was develped t share imprtant infrmatin regarding Oxfrd Medical and Administrative Plicy.* *Where infrmatin in this bulletin cnflicts with applicable state and/r federal law, UnitedHealthcare fllws such applicable federal and/r state law

2 Oxfrd Medical and Administrative Plicy Updates Overview This bulletin prvides cmplete details n Oxfrd Clinical, Administrative and Reimbursement Plicy updates. The inclusin f a health service (e.g., test, drug, device r prcedure) in this bulletin indicates nly that UnitedHealthcare has recently adpted a new plicy and/r updated, revised, replaced r retired an existing plicy; it des nt imply that Oxfrd prvides cverage fr the health service. In the event f an incnsistency r cnflict between the infrmatin prvided in this bulletin and the psted plicy, the prvisins f the psted plicy will prevail. Nte that mst benefit plan dcuments exclude frm benefit cverage health services identified as investigatinal r unprven/nt medically necessary. Physicians and ther health care prfessinals may nt seek r cllect payment frm a member fr services nt cvered by the applicable benefit plan unless first btaining the member s written cnsent, acknwledging that the service is nt cvered by the benefit plan and that they will be billed directly fr the service. Tips fr using the Plicy Update Bulletin: A cmplete library f Oxfrd Medical and Administrative Plicies is available at OxfrdHealth.cm > Prviders > Tls & Resurces > Medical Infrmatin > Medical and Administrative Plicies. Frm the table f cntents, click the plicy title t be directed t the crrespnding plicy update summary. Frm the plicy updates table, click the plicy title t view a cmplete cpy f a new, updated, r revised plicy. Plicy Update Classificatins New New clinical cverage criteria and/r dcumentatin review requirements have been adpted fr a health service (e.g., test, drug, device r prcedure) Updated An existing plicy has been reviewed and changes have nt been made t the clinical cverage criteria r dcumentatin review requirements; hwever, items such as the clinical evidence, FDA infrmatin, and/r list(s) f applicable cdes may have been updated Revised An existing plicy has been reviewed and revisins have been made t the clinical cverage criteria and/r dcumentatin review requirements Replaced An existing plicy has been replaced with a new r different plicy Retired The health service(s) addressed in the plicy are n lnger being managed r are cnsidered t be prven/medically necessary and are therefre nt excluded as unprven/nt medically necessary services, unless cverage guidelines r criteria are therwise dcumented in anther plicy Nte: The absence f a plicy des nt autmatically indicate r imply cverage. As always, cverage fr a health service must be determined in accrdance with the member s benefit plan and any applicable federal r state regulatry requirements. Additinally, UnitedHealthcare reserves the right t review the clinical evidence supprting the safety and effectiveness f a medical technlgy prir t rendering a cverage determinatin. 2 Oxfrd Plicy Update Bulletin: Octber 2017

3 Oxfrd Medical and Administrative Plicy Updates In This Issue Take Nte Page Implementatin f Revised Guidelines fr Cnsultatin Services Delayed... 7 NEW Carrier Testing fr Genetic Diseases - Effective Nv. 1, Ilaris (Canakinumab) - Effective Jan. 1, Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis and Treatment Decisins - Effective Nv. 1, Pharmacgenetic Testing - Effective Nv. 1, Review at Launch fr New t Market Medicatins - Effective Jan. 1, Whle Exme and Whle Genme Sequencing - Effective Nv. 1, UPDATED Cre Decmpressin fr Avascular Necrsis - Effective Oct. 1, Entyvi (Vedlizumab) - Effective Nv. 1, Fetal Aneuplidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Bld - Effective Nv. 1, High Frequency Chest Wall Cmpressin Devices - Effective Oct. 1, Infliximab (Remicade, Inflectra, Renflexis ) - Effective Oct. 1, Lithtripsy fr Salivary Stnes - Effective Oct. 1, Nerve Graft t Restre Erectile Functin During Radical Prstatectmy - Effective Oct. 1, Plagicephaly and Cranisynstsis Treatment - Effective Oct. 1, Sliris (Eculizumab) - Effective Nv. 1, Unicndylar Spacer Devices fr Treatment f Pain r Disability - Effective Oct. 1, Abnrmal Uterine Bleeding and Uterine Fibrids - Effective Nv. 1, Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins - Effective Nv. 1, Drug Cverage Guidelines - Effective Oct. 1, Renflexis (Infliximab) Drug Cverage Guidelines - Effective Nv. 1, Alecensa (Alectinib) Cinqair (Reslizumab) Daklinza (Daclatasvir) Entyvi (Vedlizumab) Epclusa (Sfsbuvir/Velpatasfir) Oxfrd Plicy Update Bulletin: Octber 2017

4 Oxfrd Medical and Administrative Plicy Updates In This Issue Haegarda [C1 Esterase Inhibitr Subcutaneus (Human)] Harvni (Ledipasvir/Sfsbuvir) Humira (Adalimumab) Inflectra (Infliximab) Incivek (Telaprevir) Kalydec (Ivacaftr) Kymriah (Tisagenlecleucel) [CAR-T (Chimeric Antigen Receptr) Cell Therapy] Mavyret (Glecaprevir and Pibrentasvir) Mincycline Extended-Release (Generic Sldyn) Nucala (Meplizumab) Olysi (Simeprevir) Orencia (Abatacept): SQ Injectin Oxistat (Oxicnazle Nitrate) Rebetl (Ribavirin) Renflexis (Infliximab) Reprnex (Mentrpins) Sensipar (Cinacalcet) Sliris (Eculizumab) Sldyn (Mincycline HCL) Svaldi (Sfsbuvir) Stelara (Ustekinumab): Sub-Cutaneus Injectin Stelara (Ustekinumab): Intraveneus Infusin Technivie (Ombitasvir/Paritaprevir/Ritnavir) Triptdur (Triptrelin) Tymls (Abalparatide) Victrelis (Bceprevir) Viekira Pak Viekira XR (Ombitasvir, Paritaprevir (ABT-450) and Ritnavir) Vsevi (Sfsbuvir/Velpatasvir/Vxilaprevir) Xlair (Omalizumab) Xatmep (Methtrexate) Xeljanz (Tfacitinib) Xeljanz XR Xlair (malizumab) Xtandi (Enzalutamide) Zepatier (Elbasvir/Grazprevir) Zvirax Ointment Fllicle Stimulating Hrmne (FSH) Gnadtrpins - Effective Nv. 1, Gene Expressin Tests fr Cardiac Indicatins - Effective Nv. 1, Genetic Testing fr Hereditary Cancer - Effective Nv. 1, Gnadtrpin Releasing Hrmne Analgs - Effective Nv. 1, Oxfrd Plicy Update Bulletin: Octber 2017

5 Oxfrd Medical and Administrative Plicy Updates In This Issue Human Menpausal Gnadtrpins (hmg) - Effective Nv. 1, Immune Glbulin Site f Care Review Guidelines fr Medical Necessity f Hspital Outpatient Facility Infusin - Effective Nv. 1, Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines - Effective Nv. 1, Maximum Dsage Plicy - Effective Nv. 1, Ocrevus TM (Ocrelizumab) - Effective Nv. 1, Orencia (Abatacept) Injectin fr Intravenus Infusin - Effective Nv. 1, Panniculectmy and Bdy Cnturing Prcedures - Effective Nv. 1, Preventive Care Services - Effective Oct. 1, Sdium Hyalurnate - Effective Nv. 1, Temprmandibular Jint Disrders - Effective Oct. 1, Transcatheter Heart Valve Prcedures - Effective Nv. 1, RETIRED/REPLACED Genetic Testing - Effective Nv. 1, Helicbacter Pylri Serlgy Testing - Effective Oct. 1, Magnetencephalgraphy and Magnetic Surce Imaging fr Specific Neurlgical Applicatins - Effective Oct. 1, Mlecular Prfiling t Guide Cancer Treatment - Effective Nv. 1, Wearable Cardiverter-Defibrillatrs - Effective Oct. 1, Administrative Plicy Updates NEW Fllw-Up Care Rendered in an Emergency Rm Site f Service - Effective Nv. 1, UPDATED Claims Recvery - Effective Nv. 1, Credentialing Guidelines: Participatin in the evicre healthcare Netwrk - Effective Oct. 1, Filing Deadlines fr Claims Submissins - Effective Nv. 1, Precertificatin Exemptins fr Outpatient Services - Effective Oct. 1, Accreditatin Requirements fr Radilgy Services - Effective Nv. 1, Reimbursement Plicy Updates NEW Multiple Prcedure Payment Reductin (MPPR) fr Diagnstic Cardivascular and Ophthalmlgy Prcedures - Effective Nv. 1, Oxfrd Plicy Update Bulletin: Octber 2017

6 Oxfrd Medical and Administrative Plicy Updates In This Issue Cnsultatin Services Glbal Days Injectin and Infusin Services Maximum Frequency Per Day Obstetrical Plicy - Effective Oct. 1, Preventive Medicine and Screening Prlnged Services - Effective Nv. 1, Replacement Cdes - Effective Nv. 1, Supply Plicy - Effective Nv. 1, Urgent Care - Effective Dec. 1, Oxfrd Plicy Update Bulletin: Octber 2017

7 Take Nte IMPLEMENTATION OF GUIDELINES FOR CONSULTATION SERVICES DELAYED UnitedHealthcare previusly annunced that certain revisins t the Cnsultatin Services Reimbursement Plicy wuld becme effective fr UnitedHealthcare Cmmercial members n Oct.1, As cmmunicated in the Octber 2017 Netwrk Bulletin, in an effrt t give care prviders mre time t adjust t ptential changes in their submissin f prcedure cdes fr cnsultatin services, UnitedHealthcare will be delaying implementatin f the revisins t the Reimbursement Plicy fr services reprted with cnsultatin cdes and The fllwing Oxfrd plicies have als been impacted by this implementatin delay. Please take nte f the amended summary f changes fr each plicy listed belw. Plicy Title Cnsultatin Services Glbal Days Injectin and Infusin Services Maximum Frequency Per Day Obstetrical Plicy Preventive Care Services Preventive Medicine and Screening Temprmandibular Jint Disrders Plicy Type Reimbursement Reimbursement Reimbursement Reimbursement Reimbursement Clinical Reimbursement Clinical 7 Oxfrd Plicy Update Bulletin: Octber 2017

8 Plicy Title Effective Date Cverage Ratinale NEW Carrier Testing fr Genetic Diseases Nv. 1, 2017 Genetic cunseling is strngly recmmended prir t these tests in rder t infrm persns being tested abut the advantages and limitatins f the test as applied t a unique persn. Fr infrmatin regarding nninvasive prenatal screening (NIPT) fr fetal aneuplidy, refer t the medical plicy titled Fetal Aneuplidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Bld. Ashkenazi Jewish Carrier Screening Ashkenazi Jewish carrier screening is prven and medically necessary fr evaluating the fllwing: Individuals wh are seeking prenatal care r planning a pregnancy wh have had nt previusly had infrmative Ashkenazi Jewish carrier screening; and At least ne f the fllwing additinal criteria is met: At least ne reprductive partner is Ashkenazi Jewish (this individual has at least ne Ashkenazi Jewish grandparent); r The reprductive partners have a previusly affected child with ne f the genetic diseases included in the Ashkenazi Jewish carrier screening test and the results f this test will infrm a current r future pregnancy; r One r bth individuals have a first- r secnd-degree relative wh is affected and the results f this test will infrm a current r future pregnancy; r One r bth individuals have a first-degree relative with an affected ffspring and the results f this test will infrm a current r future pregnancy; r One f the reprductive partners is already knwn t be a carrier fr ne f the genetic disease included in the Ashkenazi Jewish carrier screening test and the results f this test will infrm a current r future pregnancy. Carrier testing fr any additinal genetic diseases as part f Ashkenazi Jewish carrier screening is cnsidered unprven and nt medically necessary. Ashkenazi Jewish carrier screening is cnsidered unprven and nt medically necessary fr all ther indicatins. Expanded Carrier Screening Panel Testing Expanded Carrier Screening Panel Testing is cnsidered unprven and nt medically necessary fr all indicatins. Ilaris (Canakinumab) Jan. 1, 2018 Ilaris (canakinumab) is prven and medically necessary fr: The treatment f Crypyrin-Assciated Peridic Syndrmes (CAPS) in patients wh meet ALL f the fllwing criteria: Fr initial therapy, all f the fllwing: One f the fllwing, as diagnsed by, r in cnsultatin with, a rheumatlgist r immunlgist with 8 Oxfrd Plicy Update Bulletin: Octber 2017

9 Plicy Title Effective Date Cverage Ratinale NEW Ilaris (Canakinumab) Jan. 1, 2018 expertise in the diagnsis f the fllwing: Familial Cld Autinflammatry Syndrme (FCAS) Muckle-Wells syndrme (MWS) and Ilaris dsing fr FCAS/MWS is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 3mg/kg up t 150 mg every 8 weeks; and Initial authrizatin will be fr n mre than 12 mnths. Fr cntinuatin therapy, all f the fllwing: Patient is currently n Ilaris therapy fr ne f the fllwing: FCAS MWS and Ilaris dsing fr FCAS/MWS is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 3mg/kg up t 150 mg every 8 weeks; and Dcumentatin f psitive clinical respnse t Ilaris therapy; and Reauthrizatin will be fr n mre than 12 mnths. The treatment f Tumr Necrsis Factr (TNF) Receptr-Assciated Peridic Syndrme (TRAPS) in patients wh meet ALL f the fllwing criteria: Fr initial therapy, all f the fllwing: Diagnsis f TRAPS by, r in cnsultatin with, a rheumatlgist r immunlgist with expertise in the diagnsis f TRAPS. and Ilaris dsing fr TRAPS is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Initial authrizatin will be fr n mre than 12 mnths. Fr cntinuatin f therapy, all f the fllwing: Patient is currently receiving Ilaris therapy fr TRAPS; and Dcumentatin f a psitive clinical respnse t therapy, defined as a decrease in frequency r severity f attacks; and Ilaris dsing fr TRAPS is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Reauthrizatin will be fr n mre than 12 mnths. The treatment f Hyperimmunglbulin D (Hyper-IgD) Syndrme (HIDS)/Mevalnate Kinase Deficiency (MKD) in patients wh meet ALL f the fllwing criteria: Fr initial therapy, all f the fllwing: One f the fllwing, as diagnsed by, r in cnsultatin with, a rheumatlgist r immunlgist with expertise in the diagnsis f the fllwing: 9 Oxfrd Plicy Update Bulletin: Octber 2017

10 Plicy Title Effective Date Cverage Ratinale NEW Ilaris (Canakinumab) Jan. 1, 2018 HIDS MKD and Ilaris dsing fr HIDS/MKD is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Initial authrizatin will be fr n mre than 12 mnths. Fr cntinuatin f therapy, all f the fllwing: Patient is currently receiving Ilaris fr ne f the fllwing: HIDS MKD and Dcumentatin f a psitive clinical respnse t therapy, defined by a decrease in frequency r severity f attacks; and Ilaris dsing fr HIDS/MKD is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Reauthrizatin will be fr n mre than 12 mnths. The treatment f Familial Mediterranean Fever (FMF) in patients wh meet ALL f the fllwing criteria: Fr initial therapy, all f the fllwing: Diagnsis f FMF by, r in cnsultatin with, a rheumatlgist r immunlgist with expertise in the diagnsis f FMF; and Histry f failure, cntraindicatin, r intlerance t clchicine; and Ilaris dsing fr FMF is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Initial authrizatin will be fr n mre than 12 mnths. Fr cntinuatin f therapy, all f the fllwing: Patient is currently receiving Ilaris fr FMF; and Dcumentatin f a psitive clinical respnse t therapy, defined by a decrease in index disease flare r nrmalizatin f CRP; and Ilaris dsing fr FMF is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Reauthrizatin will be fr n mre than 12 mnths. The treatment f Systemic Juvenile Idipathic Arthritis (SJIA) in patients wh meet ALL f the fllwing criteria: Fr initial therapy, all f the fllwing: Diagnsis f SJIA by, r in cnsultatin with, a rheumatlgist r immunlgist with expertise in the diagnsis f SJIA; and Ilaris dsing fr SJIA is in accrdance with the United States Fd and Drug Administratin apprved 10 Oxfrd Plicy Update Bulletin: Octber 2017

11 Plicy Title Effective Date Cverage Ratinale NEW Ilaris (Canakinumab) Jan. 1, 2018 labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Patient is nt receiving Ilaris in cmbinatin with anther bilgic [e.g., Actemra]; and Initial authrizatin will be fr n mre than 12 mnths. Fr cntinuatin f therapy, all f the fllwing: Patient is currently receiving Ilaris fr SJIA; and Dcumentatin f a psitive clinical respnse t therapy; and Ilaris dsing fr SJIA is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 4 mg/kg up t 300mg every 4 weeks; and Patient is nt receiving Iliaris in cmbinatin with anther bilgic [e.g., Actemra]; and Reauthrizatin will be fr n mre than 12 mnths. Ilaris is nt prven r medically necessary fr the management r treatment f cardivascular disease. Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis and Treatment Decisins Nv. 1, 2017 Gene Expressin Tests fr Breast Cancer Treatment The use f ne f the fllwing gene expressin tests is cnsidered prven and medically necessary t make a treatment decisin regarding adjuvant chemtherapy in females r males with nn-metastatic breast cancer when all f the fllwing criteria are met. Hwever, the use f mre than ne gene expressin test fr the same tumr in an individual with breast cancer is unprven and nt medically necessary. Gene Expressin Tests fr High Risk Breast Cancer Gene expressin tests fr high risk breast cancer, including MammaPrint (als referred t as the "Amsterdam Signature" r "70-Gene Signature") are cnsidered prven and medically necessary t assess distant recurrence f disease in individuals with recently diagnsed nn-metastatic breast cancer when ALL the fllwing criteria are met: High clinical risk f recurrence based n at least ne f the fllwing criteria: Lymph nde psitive (pn1-2); r Tumr size greater than 2 cm; r Prly differentiated r undifferentiated histlgy (grade 3) AND tumr size greater than 1 cm; and Hrmne receptr-psitive (estrgen receptr psitive, prgesterne receptr psitive r bth); and HER2 receptr negative; and Adjuvant chemtherapy is nt precluded due t any ther factr (e.g., advanced age and/r significant cmrbidities); and Individual and treating physician have had a discussin prir t testing regarding the ptential results f the test and determined t use the results t guide therapy MammaPrint is cnsidered unprven and nt medically necessary fr all ther indicatins. 11 Oxfrd Plicy Update Bulletin: Octber 2017

12 Plicy Title Effective Date Cverage Ratinale NEW Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis and Treatment Decisins Nv. 1, 2017 Gene Expressin Tests fr Intermediate and Lw Risk Breast Cancer Onctype Dx Breast, Prsigna PAM-50 Breast Cancer Prgnstic Gene Signature Assay, EndPredict and the Breast Cancer Index gene expressin tests fr intermediate and lw risk breast cancer are cnsidered prven and medically necessary t assess use f adjuvant chemtherapy in individuals with recently diagnsed nn-metastatic breast cancer when all f the fllwing criteria are met: Lymph nde negative (pn0) r axillary lymph nde micrmetastasis less than 2mm (pn1mi); and Hrmne receptr psitive (estrgen receptr psitive, prgesterne receptr psitive r bth); and HER2 receptr negative; and Adjuvant chemtherapy is nt precluded due t any ther factr (e.g., advanced age and/r significant cmrbidities); and Individual and treating physician have had a discussin prir t testing regarding the ptential results f the test and determined t use the results t guide therapy Onctype Dx Breast, Prsigna PAM-50 Breast Cancer Prgnstic Gene Signature Assay, EndPredict and the Breast Cancer Index are cnsidered unprven and nt medically necessary fr all ther indicatins. Gene expressin prfiling assays fr breast cancer treatment ther than thse previusly described as cvered are cnsidered unprven and nt medically necessary, including but nt limited t: BluePrint (als referred t as "80-gene prfile") Breast Cancer Gene Expressin Rati (als knwn as Thers H/I) BreastNext BreastOncPX BreastPRS Insight DX Breast Cancer Prfile Mammstrat NexCurse Breast IHC4 NuvSelect erx 200-Gene Assay Onctype DX DCIS SYMPHONY Genmic Breast Cancer Prfile TargetPrint TheraPrint The 41-gene signature assay The 76-gene "Rtterdam signature" assay T date, the majrity f the available studies fail t prvide sufficient evidence that gene expressin prfiling is useful fr managing the treatment f breast cancer and leads t imprved health utcmes (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f gene expressin prfiling as a technique f managing the treatment f breast cancer cmpared with traditinal clinical factrs t guide medical management and imprve clinical utcmes. 12 Oxfrd Plicy Update Bulletin: Octber 2017

13 Plicy Title Effective Date Cverage Ratinale NEW Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis and Treatment Decisins Nv. 1, 2017 Gene Expressin Prfiling t Identify the Tissue f Origin fr Cancers f Unknwn Primary Site T identify the tissue f rigin fr cancers f unknwn primary site, gene expressin prfiling assays are cnsidered unprven and nt medically necessary fr all indicatins, including but nt limited t: RespnseDX: Tissue f Origin Test CancerTYPE ID Test Rsetta Cancer Origin Test (mirview mets and mirview mets2 tests) PrOnc TumrSurceDX Test T date, the majrity f the available studies fail t prvide sufficient evidence that gene expressin prfiling t identify the tissue f rigin fr cancers lead t imprved health utcmes (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f gene expressin prfiling t identify the tissue f rigin fr cancers f unknwn primary site cmpared with traditinal clinicpathlgic factrs t guide medical management and imprve clinical utcmes. Gene Expressin Prfiling f Melanma In cutaneus and uveal melanma, gene expressin prfiling assays are cnsidered unprven and nt medically necessary fr all indicatins, including but nt limited t: DecisinDx-Melanma test DecisinDx-UM T date, the majrity f the available studies fail t prvide sufficient evidence that gene expressin prfiling f melanma leads t imprved health utcmes (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f gene expressin prfiling f melanma cmpared with traditinal clinical factrs t guide medical management and imprve clinical utcmes. Gene Expressin Prfiling as a Technique fr Clrectal Cancer (CRC) Risk Assessment r Management In clrectal cancer (CRC) risk assessment r management, gene expressin prfiling assays are cnsidered unprven and nt medically necessary, including but nt limited t: Fecal DNA testing, i.e., ClnSentry Onctype DX Cln Cancer Assay Clrectal Cancer DSA GeneFx Cln OncDefender-CRC T date, the majrity f the available studies fail t prvide sufficient evidence that gene expressin prfiling as a technique fr clrectal cancer (CRC) risk assessment r management lead t imprved health utcmes (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f gene expressin prfiling as a technique fr clrectal cancer (CRC) risk assessment r management cmpared with traditinal clinical factrs t guide medical management and imprve clinical utcmes. 13 Oxfrd Plicy Update Bulletin: Octber 2017

14 Plicy Title Effective Date Cverage Ratinale NEW Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis and Treatment Decisins Nv. 1, 2017 Gene Expressin Prfile Tests fr Evaluatin r Management f Multiple Myelma Gene expressin prfile tests fr evaluatin r management f multiple myelma are cnsidered unprven and nt medically necessary, including but nt limited t: MyPRS/MyPRS Plus T date, the majrity f the available studies fail t prvide sufficient evidence that gene expressin prfile tests fr evaluatin r management f multiple myelma lead t imprved health utcmes r t manage treatment decisins (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f gene expressin prfile tests fr evaluatin r management f multiple myelma cmpared with traditinal clinical factrs t guide medical management and imprve clinical utcmes. Gene Expressin Prfile Tests fr the Screening, Detectin and Management f Prstate Cancer Gene-based tests fr the screening, detectin and management f prstate cancer are cnsidered unprven and nt medically necessary, including but nt limited t: Onctype DX Prstate Cancer Assay TMPRSS2 fusin gene Prlaris Prstate Cancer Test Decipher Prstate Cancer Classifier T date, the majrity f the available studies fail t prvide sufficient evidence that gene-based tests fr the screening, detectin and management f prstate cancer lead t imprved health utcmes r t manage treatment decisins (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f gene-based tests fr the screening, detectin and management f prstate cancer cmpared with traditinal clinical factrs t guide medical management and imprve clinical utcmes. Tpgraphic Gentyping Tpgraphic gentyping is unprven and nt medically necessary. Examples f such tests include, but are nt limited t, the fllwing: PathFinder TG T date, the majrity f the available studies fail t prvide sufficient evidence that tpgraphic gentyping lead t imprved health utcmes (i.e., clinical utility). Well-designed randmized cntrlled trials (RCTs) are needed t determine the clinical utility f tpgraphic gentyping cmpared with traditinal clinical factrs t guide medical management and imprve clinical utcmes. Multi-Gene Cancer Panels fr Diagnsis, Prgnsis and Treatment Decisins (Mlecular Prfiling) Mlecular prfiling f tumrs using a multi-gene cancer panel f up t 50 genes is cnsidered prven and medically necessary fr patients with metastatic nn-small cell lung cancer (NSCLC). 14 Oxfrd Plicy Update Bulletin: Octber 2017

15 Plicy Title Effective Date Cverage Ratinale NEW Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis and Treatment Decisins Pharmacgenetic Testing Nv. 1, 2017 Nv. 1, 2017 Use f mre than ne gene multi-gene cancer panel fr the same individual with nn-small cell lung cancer is unprven and nt medically necessary. Multi-gene cancer panels are cnsidered unprven and nt medically necessary fr all ther indicatins. Multi-gene cancer panels f greater than 50 genes are cnsidered unprven and nt medically necessary fr all indicatins. Pharmacgenetic Testing The use f pharmacgenetic testing panels fr genetic plymrphisms is cnsidered unprven and nt medically necessary fr evaluating drug-metablizer status. Examples f these panels include, but are nt limited t the fllwing: AIBiTech CardilGene Genetic Panel AIBiTech Pain Management Panel AIBiTech PsychiaGene Genetic Panel AIBiTech Urlgene Panel AIBiTech PersnaGene Panel Genecept Assay GeneSight Analgesic GeneSight Psychtrpic GeneSight ADHD Millennium PGT SM Prve Drug Metablism test panel Prve Narctic Risk test panel SureGene Test fr Antipsychtic and Antidepressant Respnse (STA 2 R) Review at Launch fr New t Market Medicatins Jan. 1, 2018 This Clinical Plicy applies t certain newly launched medical benefit medicatins that are healthcare prvider administered, have nt yet undergne review by Oxfrd, and a utilizatin management strategy has nt yet been put in place. A medicatin will be subject t review at launch when the medicatin is listed n the Review at Launch Medicatin List. A medicatin subject t review at launch will be: Excluded frm cverage until the date the medicatin is reviewed by Oxfrd and a utilizatin management strategy has been cmmunicated as may be required by law r by December 31 f the fllwing calendar year, whichever is earliest; r Reviewed against available clinical evidence, which includes applicable Clinical Plicies. Prviders are strngly encuraged t seek precertificatin n any new t market medicatins that are subject t review at launch t ensure cverage. Please be aware if precertificatin is nt requested, Oxfrd 15 Oxfrd Plicy Update Bulletin: Octber 2017

16 Plicy Title Effective Date Cverage Ratinale NEW Review at Launch fr New t Market Medicatins Jan. 1, 2018 may later deny the service r item as nt medically necessary r nt cvered. If a prvider knws r has reasn t believe that a service r item may nt be cvered, the prvider must request precertificatin frm Oxfrd prir t prviding r referring fr the service r item. A prvider may nt cllect payment frm ur cmmercial members fr services nt cvered under the applicable benefit plan, unless the member prvided written cnsent befre the service was rendered. See Oxfrd Cmmercial Supplement t the UnitedHealthcare Prvider Administrative Guide fr mre detail. Clinical Plicies express Oxfrd s determinatin f whether a health services is prven t be effective based n published clinical evidence. They are als used t decide whether a given health service is medically necessary. Services determined t be experimental, investigatinal, unprven r nt medically necessary by the clinical evidence are typically nt cvered. Whle Exme and Whle Genme Sequencing Nv. 1, 2017 Genetic cunseling is strngly recmmended prir t these tests in rder t infrm persns being tested abut the advantages and limitatins f the test as applied t a unique persn. Whle Exme Sequencing (WES) Whle exme sequencing (WES) is prven and medically necessary fr diagnsing r evaluating a genetic disrder when ALL f the fllwing criteria are met: The patient s clinical presentatin is nnspecific and des nt fit a well-defined syndrme fr which a specific r targeted gene test is available. If the patient has a suspected specific genetic syndrme, a single gene r targeted gene panel shuld be perfrmed prir t determining if WES is necessary; and WES has been recmmended by a bard-certified medical geneticist, nenatlgist, neurlgist, r develpmental pediatrician with specific expertise in the cnditins fr which testing is being cnsidered; this specialist physician will act as the rdering prvider fr WES, and this specialist physician is prepared t interpret any pssible test results (including uncertain gene variants and secndary findings unrelated t the initial test indicatins; and WES results are expected t directly influence the patient s medical management recmmendatins and clinical utcme and ne f the fllwing: The patient s clinical presentatin r clinical and family histry strngly suggest a genetic cause fr which a specific clinical diagnsis cannt be made with any clinically available targeted genetic tests; r The patient has a cnfident clinical diagnsis f a genetic cnditin where there is significant genetic hetergeneity and WES is a mre practical apprach t identifying the underlying genetic cause than are individual tests f multiple genes; r The patient likely has a genetic disrder and has had multiple targeted gene tests that have failed t identify the underlying cause. Cmparatr (e.g., parents r siblings) WES is prven and medically necessary fr evaluating a genetic disrder when the abve criteria have been met and WES is perfrmed cncurrently r has been previusly perfrmed n the patient. 16 Oxfrd Plicy Update Bulletin: Octber 2017

17 Plicy Title Effective Date Cverage Ratinale NEW Whle Exme and Whle Genme Sequencing Nv. 1, 2017 WES is unprven and nt medically necessary fr screening and evaluating disrders in individuals when the abve criteria are nt met. Further studies are needed t evaluate the clinical utility f whle exme sequencing fr ther indicatins. Whle Genme Sequencing (WGS) Whle genme sequencing (WGS) is unprven and nt medically necessary fr screening and evaluating any disrder. Althugh WGS has the ptential t identify causal variants fr a wide variety f cnditins that may be missed with ther technlgies, as well as t identify predictive bimarkers, the infrmatin derived frm WGS has nt yet been translated int imprved patient utcmes and changed patient management. Further studies are needed t establish the clinical utility f WGS. UPDATED Cre Decmpressin fr Avascular Necrsis Oct. 1, 2017 Updated supprting infrmatin t reflect the mst current clinical evidence and references; n change t cverage ratinale r lists f applicable cdes Cre decmpressin is prven and medically necessary fr treating early (pre-cllapse stage I and II) avascular necrsis f the femral head. Cre decmpressin is unprven and nt medically necessary fr treating late avascular necrsis f the femral head r fr avascular necrsis elsewhere, including the humeral head, the distal femur, the talus r the mandibular cndyle. The available evidence fr cre decmpressin fr these cnditins is limited and lw quality. Mst clinical studies invlve a small number f patients and lack prper cntrls. Therefre, there is insufficient data t allw cnclusins regarding the safety and efficacy f cre decmpressin fr these indicatins. Entyvi (Vedlizumab) Nv. 1, 2017 Updated list f related plicies; added reference link t plicy titled Maximum Dsage Plicy Entyvi (vedlizumab) is prven and medically necessary fr the treatment f: Crhn's disease when all f the fllwing criteria are met: Fr initial therapy, all f the fllwing: Diagnsis f mderately t severely active Crhn s disease (CD); and One f the fllwing: Histry f failure, cntraindicatin, r intlerance t at least ne f the fllwing cnventinal therapies: - Tumr necrsis factr (TNF) blcker [e.g., Humira 17 Oxfrd Plicy Update Bulletin: Octber 2017

18 UPDATED Entyvi (Vedlizumab) Nv. 1, 2017 (adalimumab), Cimzia (certlizumab)] - Immunmdulatr (e.g., azathiprine, 6-mercaptpurine) - Crticsterid Crticsterid dependent (e.g., unable t successfully taper crticsterids withut a return f the symptms f CD) and Entyvi is initiated and titrated accrding t US Fd and Drug Administratin (FDA) labeled dsing fr Crhn s disease up t a maximum f 300mg every 8 weeks (r equivalent dse and interval schedule); and Patient is nt receiving Entyvi in cmbinatin with either f the fllwing: Tumr necrsis factr (TNF) blcker [e.g., Humira (adalimumab), Cimzia (certlizumab)] Tysabri (natalizumab); and Initial authrizatin will be fr n mre than 14 weeks Fr cntinuatin therapy, all f the fllwing: Dcumentatin f psitive clinical respnse t Entyvi; and Entyvi dsing fr Crhn s disease is in accrdance with the FDA labeled dsing up t a maximum f 300mg every 8 weeks (r equivalent dse and interval schedule); and Reauthrizatin will be fr n mre than 12 mnths Ulcerative clitis when all f the fllwing criteria are met: Fr initial therapy, all f the fllwing: Diagnsis f mderately t severely active ulcerative clitis (UC); and One f the fllwing: Histry f failure, cntraindicatin, r intlerance t at least ne f the fllwing cnventinal therapies: - Tumr necrsis factr (TNF) blcker [e.g., Humira (adalimumab), Simpni (glimumab)] - Immunmdulatr (e.g., azathiprine, 6-mercaptpurine) - Crticsterid Crticsterid dependent (e.g., unable t successfully taper crticsterids withut a return f the symptms f UC) and Entyvi is initiated and titrated accrding t US Fd and Drug Administratin labeled dsing fr ulcerative clitis up t a maximum 18 Oxfrd Plicy Update Bulletin: Octber 2017

19 UPDATED Entyvi (Vedlizumab) Nv. 1, 2017 f 300mg every 8 weeks (r equivalent dse and interval schedule); and Patient is nt receiving Entyvi in cmbinatin with either f the fllwing: Tumr necrsis factr (TNF) blcker [e.g., Humira (adalimumab), Simpni (glimumab)] Tysabri (natalizumab); and Initial authrizatin will be fr n mre than 14 weeks Fr cntinuatin therapy, all f the fllwing: Dcumentatin f psitive clinical respnse t Entyvi; and Entyvi dsing fr ulcerative clitis is in accrdance with the FDA labeled dsing up t a maximum f 300mg every 8 weeks (r equivalent dse and interval schedule); and Reauthrizatin will be fr n mre than 12 mnths Fetal Aneuplidy Testing Using Cell- Free Fetal Nucleic Acids in Maternal Bld Nv. 1, 2017 Updated list f applicable ICD-10 diagnsis cdes: Added O28.3, O28.9, O35.0XX0, and O35.2XX0 Remved O35.0XX9 DNA-based nninvasive prenatal tests f fetal aneuplidy are prven and medically necessary as screening tls fr trismy 21 (Dwn syndrme), trismy 18 (Edwards syndrme) r trismy 13 (Patau syndrme) in ANY ONE f the fllwing circumstances: Maternal age f 35 years r lder at delivery Fetal ultrasund findings indicating an increased risk f aneuplidy Histry f a prir pregnancy with a trismy Psitive first- r secnd-trimester screening test results fr aneuplidy Parental balanced Rbertsnian translcatin with an increased risk f fetal trismy 13 r trismy 21 DNA-based nninvasive prenatal tests f fetal aneuplidy are unprven and nt medically necessary fr all ther indicatins including, but nt limited t, the fllwing: Multiple gestatin pregnancies Screening fr micrdeletins Screening fr sex chrmsme aneuplidies Further studies are needed t evaluate the use f these tests in ther ppulatins. Genetic Cunseling Genetic cunseling is strngly recmmended prir t this test in rder t infrm persns being tested abut the advantages and limitatins f the test as applied t a unique persn. 19 Oxfrd Plicy Update Bulletin: Octber 2017

20 UPDATED High Frequency Chest Wall Cmpressin Devices Oct. 1, 2017 Updated supprting infrmatin t reflect the mst current clinical evidence, FDA infrmatin, and references; n change t cverage ratinale r lists f applicable cdes High-frequency chest wall cmpressin (HFCWC), as a frm f chest physical therapy, is prven and medically necessary when used fr treating r preventing pulmnary cmplicatins f the fllwing cnditins: Cystic fibrsis (CF) Brnchiectasis High-frequency chest wall cmpressin (HFCWC), as a frm f chest physical therapy, is unprven and nt medically necessary fr diagnses ther than cystic fibrsis and brnchiectasis, including, but nt limited t respiratry symptms attributed t neurmuscular disrders when they cmprmise respiratin, such as amytrphic lateral sclersis (ALS), cerebral palsy, familial dysautnmia, muscular dystrphy r quadriplegia. The clinical evidence is insufficient t supprt cnclusins regarding the use f HFCWC therapy in these patient ppulatins. Additinal research invlving larger study ppulatins and lnger treatment and fllw-up perids is needed t establish the safety and efficacy f HFCWC fr patients with impaired airway clearance disrders in these patient ppulatins. Nte: There are multiple airway clearance techniques currently used in the management f CF and brnchiectasis. These can include percussin and pstural drainage, huffing, active cycle breathing and intrapulmnary percussive ventilatin (IPV). Infliximab (Remicade, Inflectra, Renflexis ) Oct. 1, 2017 Updated list f applicable HCPCS cdes t reflect quarterly cde edits; added mdifier ZC (Merck) t Q5102 This plicy refers t the fllwing infliximab prducts: Inflectra (infliximab-dyyb) Remicade (infliximab) Renflexis (infliximab-abda) A. Preferred Prduct Remicade (infliximab) is the preferred infliximab prduct. Cverage will be prvided fr Remicade cntingent n the cverage criteria in sectin B. Cverage fr Inflectra (infliximab-dyyb) r Renflexis (infliximababda) will be prvided cntingent n the criteria in this sectin and the cverage criteria in sectin B. In rder t cntinue cverage, members already n Inflectra r Renflexis will be required t change therapy t 20 Oxfrd Plicy Update Bulletin: Octber 2017

21 UPDATED Infliximab (Remicade, Inflectra, Renflexis ) Oct. 1, 2017 Remicade unless they meet the criteria in this sectin. Preferred Prduct Criteria Treatment with Inflectra (infliximab-dyyb), Renflexis (infliximababda) r ther infliximab bisimilar is medically necessary fr the indicatins specified in this plicy when the fllwing criteria are met: Bth f the fllwing: One f the fllwing: Bth f the fllwing: - Histry f a trial f at least 14 weeks f Remicade resulting in minimal clinical respnse t therapy and residual disease activity. - Physician attests that in their clinical pinin the clinical respnse wuld be expected t be superir with Inflectra r ther infliximab bisimilar prduct, than experienced with Remicade. r Bth f the fllwing: - Histry f intlerance r adverse event t Remicade. - Physician attests that in their clinical pinin the same intlerance r adverse event wuld nt be expected t ccur with Inflectra r ther infliximab bisimilar prduct. and Bth f the fllwing: Patient has NOT had a lss f a favrable respnse after established maintenance therapy with Remicade r ther infliximab prduct. Patient has NOT develped neutralizing antibdies t any infliximab prduct that has led t an attenuatin f efficacy f therapy. B. Diagnsis-Specific Criteria Infliximab will be used t refer t all infliximab prducts. Infliximab is prven and medically necessary fr the treatment f: Ankylsing spndylitis when the fllwing criterin is met: Diagnsis f ankylsing spndylitis (AS). 21 Oxfrd Plicy Update Bulletin: Octber 2017

22 UPDATED Infliximab (Remicade, Inflectra, Renflexis ) Oct. 1, 2017 Crhn s disease when the fllwing criterin is met: One f the fllwing: Diagnsis f fistulizing Crhn s disease (Crhn s Disease Activity Index (CDAI) 220 and 400); r Bth f the fllwing: - Diagnsis f mderately t severely active Crhn s disease; and - Histry f failure, cntraindicatin, r intlerance t at least ne cnventinal therapy (e.g., crticsterids, 6- mercaptpurine, azathiprine, methtrexate, etc.). Nninfectius uveitis when BOTH f the fllwing criteria are met: Diagnsis f refractry nninfectius uveitis that is causing r threatening visin lss (e.g., nninfectius uveitis assciated with Behçet s r Reiter s syndrmes); and Histry f failure, cntraindicatin, r intlerance t ALL f the fllwing: Tpical crticsterids; Systemic crticsterids; Immunsuppressive drugs (e.g., azathiprine, cyclsprine, r methtrexate). Plaque psriasis when BOTH f the fllwing criteria are met: Diagnsis f chrnic severe plaque psriasis i.e., extensive and/r disabling); and Patient is a candidate fr systemic therapy. Psriatic arthritis when the fllwing criterin is met: Diagnsis f psriatic arthritis (PsA). Rheumatid arthritis when BOTH f the fllwing criteria are met: Diagnsis f mderately t severely active rheumatid arthritis (RA); and One f the fllwing: Member is receiving cncurrent therapy with methtrexate; Histry f cntraindicatin r intlerance t methtrexate. Sarcidsis when ALL f the fllwing criteria are met: Diagnsis f sarcidsis; and Histry f failure, cntraindicatin, r intlerance t crticsterids (e.g., prednisne, methylprednislne); and Histry f failure, cntraindicatin, r intlerance t ne 22 Oxfrd Plicy Update Bulletin: Octber 2017

23 UPDATED Infliximab (Remicade, Inflectra, Renflexis ) Oct. 1, 2017 immunsuppressant (e.g., methtrexate, cyclphsphamide, azathiprine). Ulcerative clitis when BOTH f the fllwing criteria are met: Diagnsis f mderately t severely active ulcerative clitis (UC); and Histry f failure, cntraindicatin, r intlerance t at least ne cnventinal therapy e.g., 6-mercaptpurine, aminsalicylate, azathiprine, crticsterids. There may be ther cnditins that qualify as serius, rare diseases fr which the use f infliximab may be apprpriate. Please refer t the Benefit Cnsideratins sectin f the plicy fr additinal infrmatin. Infliximab is unprven and nt medically necessary in the treatment f: Still s disease Sjgren s syndrme Graft-vs-hst disease Myeldysplastic syndrmes Undifferentiated spndylarthrpathy Reiter s syndrme Hidradenitis suppurativa Wegener s granulmatsis Juvenile idipathic arthritis (juvenile rheumatid arthritis) Infliximab is unprven and nt medically necessary fr the treatment f the abve cnditins because statistically rbust randmized cntrlled trials are needed t address the issue f whether Infliximab has sufficient superirity in clinical efficacy cmpared t ther available treatments t justify the inherent clinical risk in the use f a mnclnal antibdy antitumr necrsis factr agent. Lithtripsy fr Salivary Stnes Oct. 1, 2017 Updated supprting infrmatin t reflect the mst current descriptin f services, clinical evidence, FDA infrmatin and references; n change t nncverage ratinale r list f applicable cdes Extracrpreal shck wave lithtripsy (ESWL) is unprven and nt medically necessary fr treating salivary stnes. There is insufficient evidence t supprt the use f ESWL fr managing salivary stnes. Further research with randmized cntrlled studies is required t demnstrate the effectiveness f ESWL. Endscpic intracrpreal laser lithtripsy is unprven and nt medically necessary fr treating salivary stnes. 23 Oxfrd Plicy Update Bulletin: Octber 2017

24 UPDATED Lithtripsy fr Salivary Stnes Oct. 1, 2017 The evidence regarding intracrpreal laser lithtripsy is limited and includes studies invlving a small number f patients. Further research with randmized cntrlled studies and larger patient sample sizes is required t demnstrate the effectiveness f endscpic intracrpreal laser lithtripsy. Nerve Graft t Restre Erectile Functin During Radical Prstatectmy Plagicephaly and Cranisynstsis Treatment Oct. 1, 2017 Updated nn-cverage ratinale; remved language indicating services are cnsidered unprven and nt medically necessary (n change t cverage guidelines) Updated supprting infrmatin t reflect the mst current clinical evidence and references Oct. 1, 2017 Updated cverage ratinale; replaced language indicating cranial rthtic devices are csmetic and nt medically necessary in infants with mild t mderate plagicephaly with cranial rthtic devices are csmetic and nt medically necessary fr treating infants with mild t mderate plagicephaly Updated supprting infrmatin t reflect the mst current descriptin f services, clinical evidence, and references Sural r ther nerve grafts t restre erectile functin during radical prstatectmy are unprven and nt medically necessary. N cmparative studies between nerve grafts and standard medical therapy (e.g., intracrpral injectin r vacuum erectin devices) have been cmpleted. The evidence fr nerve grafts fr restratin f erectile functin is derived mainly frm nn-randmized studies limited by small sample sizes. A randmized cntrlled trial was discntinued when it was determined that unilateral nerve-sparing radical prstatectmy was nt effective. Cranial rthtic devices are recnstructive and medically necessary fr: Cranisynstsis (i.e., synsttic plagicephaly) fllwing surgical crrectin. Treatment f cranifacial asymmetry in infants 3-18 mnths f age with severe nnsynsttic psitinal plagicephaly when all the fllwing criteria are present (1, 2 and 3): 1. Infant is 18 mnths f age r yunger. 2. Severe asymmetry is present with r withut trticllis. 3. There is dcumentatin f a trial f cnservative therapy f at least 2 mnths duratin with cranial repsitining, with r withut stretching therapy. Severe plagicephaly is defined as an asymmetry f 10 mm r mre in ne f the fllwing anthrpmetric measures: cranial vault, skull base, r rbittragial depth; OR a cephalic index at least tw standard deviatins abve r belw the mean fr the apprpriate gender/age. Clinical evidence demnstrates imprved surgical utcmes with the pst-perative use f the rthtic device. Nte: Please see the Descriptin f Services sectin f the plicy fr additinal infrmatin pertaining t Anthrpmetric measurements and the Cephalic Index graph. Please see the list f Related Plicies sectin f the plicy fr infrmatin 24 Oxfrd Plicy Update Bulletin: Octber 2017

25 UPDATED Plagicephaly and Cranisynstsis Treatment Oct. 1, 2017 pertaining t the repair and replacement f cranial rthtic devices. Cranial rthtic devices are csmetic and nt medically necessary fr treating infants with mild t mderate plagicephaly. There are n definitive data demnstrating adverse health effects assciated with a mild t mderate degree f cranial asymmetry, and, therefre, it is unclear whether treatment f these individuals prvides a future health benefit, r merely a csmetic effect. In general, severe plagicephaly ccurs in uter and is present at birth. Limited clinical evidence suggests that it may be assciated with future cular and/r ral abnrmalities. Acquired plagicephaly ccurs fllwing the placement f the infant in a supine sleeping psitin t prevent sudden infant death syndrme, and is rdinarily mild t mderate. Psitinal plagicephaly has nt been linked t future cmrbidities. Surgical treatment t repair cranisynstsis is recnstructive and medically necessary irrespective f the apprach used. Less invasive prcedures including endscpic strip craniectmy and spring-mediated craniplasty are prven and medically necessary as a frm f surgical treatment t repair cranisynstsis. Sliris (Eculizumab) Nv. 1, 2017 Updated list f related plicies; added reference link t plicy titled Maximum Dsage Plicy The guidelines belw prvide indicatins fr the drug Sliris (eculizumab). Precertificatin is nt required fr the drug Sliris (eculizumab); hwever the site f service fr the administratin f Sliris may require precertificatin. Sliris (eculizumab) is prven and medically necessary fr the treatment f: 1. Atypical hemlytic uremic syndrme (ahus) 2. Parxysmal ncturnal hemglbinuria (PNH) Sliris is unprven and nt medically necessary fr treatment f Shiga txin E. cli-related hemlytic uremic syndrme (STEC-HUS). Site f Care Administratin Prvider s Office r Freestanding Ambulatry Infusin Suite (nt assciated with a hspital) Administratin f Sliris in a prvider s ffice r freestanding ambulatry infusin suite nt assciated with a hspital des nt require precertificatin. 25 Oxfrd Plicy Update Bulletin: Octber 2017