Policy or Guideline Number. 1/1/2019 New DRUG Ibalizumab-uiyk (Trogarzo )

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1 Medical policy and clinical guideline updates 10/1/2018 chart Publish Date Committee Action Policy or Guideline Number Policy or Guideline Title 1/1/2019 DRUG Ibalizumab-uiyk (Trogarzo ) 1/1/2019 GENE Circulating Tumor DNA Testing for Cancer (Liquid Biopsy) CG-DME-45 Ultrasound Bone Growth Stimulation Archived DME DME-45 Ultrasound Bone Growth Stimulation CG-DRUG-103 Botulinum Toxin Archived DRUG DRUG-103 Botulinum Toxin CG-DRUG-104 Omalizumab (Xolair ) Archived DRUG DRUG-104 Omalizumab (Xolair ) CG-DRUG-105 Abatacept (Orencia ) Archived DRUG DRUG-105 Abatacept (Orencia ) CG-DRUG-106 Brentuximab Vedotin (Adcetris ) Archived DRUG DRUG-106 Brentuximab Vedotin (Adcetris ) CG-DRUG-107 Pharmacotherapy for Hereditary Angioedema

2 Archived DRUG DRUG-107 Pharmacotherapy for Hereditary Angioedema CG-DRUG-108 Enteral Carbidopa and Levodopa Intestinal Gel Suspension Archived DRUG DRUG-108 Enteral Carbidopa and Levodopa Intestinal Gel Suspension CG-DRUG-109 Asfotase Alfa (Strensiq ) Archived DRUG DRUG-109 Asfotase Alfa (Strensiq ) CG-DRUG-110 Naltrexone Implantable Pellets Archived DRUG DRUG-110 Naltrexone Implantable Pellets CG-DRUG-111 Sebelipase alfa (KANUMA ) Archived DRUG DRUG-111 Sebelipase alfa (KANUMA ) CG-DRUG-112 Abaloparatide (Tymlos ) Injection Archived DRUG DRUG-112 Abaloparatide (Tymlos ) Injection CG-MED-73 Hyperbaric Oxygen Therapy (Systemic/Topical) Archived MED MED-73 Hyperbaric Oxygen Therapy (Systemic/Topical) CG-MED-74 Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry Archived MED MED-74 Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry

3 CG-MED-75 Medical and Other Non-Behavioral Health Related Treatments for Autism Spectrum Disorders and Rett Syndrome Archived MED MED-75 Medical and Other Non-Behavioral Health Related Treatments for Autism Spectrum Disorders and Rett Syndrome CG-MED-76 Magnetic Source Imaging and Magnetoencephalography Archived RAD MED-76 Magnetic Source Imaging and Magnetoencephalography CG-MED-77 SPECT/CT Fusion Imaging Archived RAD MED-77 SPECT/CT Fusion Imaging CG-REHAB-11 Cognitive Rehabilitation Archived MED REHAB-11 Cognitive Rehabilitation CG-SURG-81 Cochlear Implants and Auditory Brainstem Implants Archived SURG SURG-81 Cochlear Implants and Auditory Brainstem Implants CG-SURG-82 Bone-Anchored and Bone Conduction Hearing Aids Archived SURG SURG-82 Bone-Anchored and Bone Conduction Hearing Aids 10/31/2018 Conversion CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity 10/31/2018 Archived SURG SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity CG-SURG-84 Mandibular/Maxillary (Orthognathic) Surgery

4 Archived SURG SURG-84 Mandibular/Maxillary (Orthognathic) Surgery 10/31/2018 Conversion CG-SURG-85 Hip Resurfacing 10/31/2018 Archived SURG SURG-85 Hip Resurfacing 10/31/2018 Conversion CG-SURG-86 Endovascular/Endoluminal Repair of Aortic Aneurysms, Aortoiliac Disease, Aortic Dissection and Aortic Transection 10/31/2018 Archived SURG SURG-86 Endovascular/Endoluminal Repair of Aortic Aneurysms, Aortoiliac Disease, Aortic Dissection and Aortic Transection CG-SURG-87 Nasal Surgery for the Treatment of Obstructive Sleep Apnea and Snoring Previous title: Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) and Snoring Archived SURG SURG-87 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) and Snoring CG-SURG-88 Mastectomy for Gynecomastia Archived SURG SURG-88 Mastectomy for Gynecomastia CG-SURG-89 Radiofrequency Neurolysis and Pulsed Radiofrequency Therapy for Trigeminal Neuralgia Archived SURG SURG-89 Radiofrequency Neurolysis and Pulsed Radiofrequency Therapy for Trigeminal Neuralgia CG-TRANS-03 Donor Lymphocyte Infusion for Hematologic Malignancies Allogeneic Hematopoietic Progenitor Cell Transplantation Archived TRANS TRANS-03 Donor Lymphocyte Infusion for Hematologic Malignancies Allogeneic Hematopoietic Progenitor Cell Transplantation

5 8/29/2018 Revised ADMIN Immunizations 1/1/2019 Revised ANC Cosmetic and Reconstructive Services: Skin Related 8/29/2018 Revised CG-ADMIN-02 Clinically Equivalent Cost Effective Services Targeted Immune Modulators 8/29/2018 Revised CG-DME-07 Augmentative and Alternative Communication (AAC) Devices/Speech Generating Devices (SGD) 8/29/2018 Revised CG-DRUG-09 Immune Globulin (Ig) Therapy 8/29/2018 Revised CG-DRUG-65 Tumor Necrosis Factor Antagonists 8/29/2018 Revised CG-DRUG-68 Bevacizumab (Avastin ) for Non- Ophthalmologic Indications 8/29/2018 Revised CG-DRUG-73 Denosumab (Prolia, Xgeva ) 8/29/2018 Revised CG-DRUG-81 Tocilizumab (Actemra ) 8/29/2018 Revised CG-GENE-03 BRAF Mutation Analysis 8/29/2018 Revised CG-MED-35 Retinal Telescreening Systems 8/29/2018 Revised CG-MED-71 Wound Care in the Home Setting 8/29/2018 Revised CG-SURG-01 Colonoscopy 8/2/2018 Revised CG-SURG-24 Functional Endoscopic Sinus Surgery (FESS) 8/29/2018 Revised CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities 8/2/2018 Revised CG-SURG-73 Balloon Sinus Ostial Dilation 8/29/2018 Revised CG-THER-RAD-03 Radioimmunotherapy and Somatostatin Receptor Targeted Radiotherapy 1/1/2019 Revised DRUG Chelation Therapy 1/1/2019 Revised DRUG Subcutaneous Hormone Replacement Implants 8/29/2018 Revised DRUG Ipilimumab (Yervoy ) 8/29/2018 Revised DRUG Eculizumab (Soliris ) 8/2/2018 Revised DRUG Ramucirumab (Cyramza ) 8/2/2018 Revised DRUG Pembrolizumab (Keytruda ) 8/29/2018 Revised DRUG Nivolumab (Opdivo )

6 8/29/2018 Revised DRUG Atezolizumab (Tecentriq ) 8/29/2018 Revised DRUG Lutetium Lu 177 dotatate (Lutathera ) 8/29/2018 Revised GENE Epidermal Growth Factor Receptor (EGFR) Testing 8/2/2018 Revised GENE Gene Expression Profiling for Managing Breast Cancer Treatment 8/29/2018 Revised GENE Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignant Tumors 8/2/2018 Revised GENE Genetic Testing for Colorectal Cancer Susceptibility 8/29/2018 Revised GENE Genetic Testing for Breast and/or Ovarian Cancer Syndrome 1/1/2019 Revised MED Axicabtagene ciloleucel (Yescarta ) Previous title: Axicabtagene ciloleucel (Yescarta ) 8/2/2018 Revised MED Tisagenlecleucel (Kymriah ) Previous title: Tisagenlecleucel (Kymriah ) 8/29/2018 Revised SURG Treatments for Urinary Incontinence 8/2/2018 Revised SURG Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures 8/2/2018 Revised SURG Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention 1/1/2019 Revised SURG Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) REVIEWED 8/29/2018 ed CG-DRUG-24 Repository Corticotropin Injection (H.P. Acthar Gel) 8/29/2018 ed DME Standing Frames 8/29/2018 ed DRUG Monoclonal Antibodies to Interleukin-23 8/29/2018 ed SURG Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions

7 8/29/2018 ed SURG Internal Rib Fixation Systems No change ed SURG Synthetic Cartilage Implant for Metatarsophalangeal Joint Disorders THIRD PARTY CRITERIA Cardiology By AIM AIM Clinical Appropriateness Guidelines: Advanced Imaging-Imaging of the Heart Coronary CT Angiography (CCTA) Magnetic Resonance Imaging (MRI) Cardiac Myocardial Perfusion Imaging Positron Emission Tomography (PET) Myocardial Imaging Resting Transthoracic Echocardiography (TEE) Stress Echocardiography (SE) By AIM AIM Clinical Appropriateness Guidelines: Arterial Ultrasound Duplex Ultrasound Imaging of the Extracranial Arteries Musculoskeletal By AIM AIM Musculoskeletal Program: Level of Care Guidelines for Musculoskeletal Surgery and Procedures Inpatient Observation Surgical Level of Care Outpatient HOPD and ASC Guidelines Radiation Oncology By AIM AIM Clinical Appropriateness Guidelines: Radiation Oncology Breast Cancer Colorectal and Anal Cancers Gastrointestinal Cancers, Non-Colorectal: Cholangiocarcinoma, Esophageal, Gastric, Liver, Pancreatic Head and Neck Cancers (including Thyroid) Lung Cancer: Small Cell and Non-Small Cell Other Tumor Types: Sarcoma, Thymoma, Thymic Carcinoma, Pediatric Tumors, and

8 Other Malignancies Prostate Cancer Radiology By AIM AIM Clinical Appropriateness Guidelines: Advanced Imaging Adult Computed Tomography (CT) Chest and Adult CT Angiography (CTA) By AIM AIM Clinical Appropriateness Guidelines: Advanced Imaging - Imaging of the Abdomen & Pelvis Computed Tomography (CT) Colonography (Virtual Colonoscopy) Sleep By AIM AIM Clinical Appropriateness Guidelines: Sleep Disorder Management Polysomnography and Home Sleep Testing Multiple Sleep Latency Testing and Maintenance of Wakefulness Testing Management of Obstructive Sleep Apnea using APAP and CPAP Devices Bi-Level Positive Airway Pressure (BPAP) Devices Management of Obstructive Sleep Apnea using Oral Appliances ARCHIVED 9/1/2018 Archived GENE Analysis of Fecal DNA for Colorectal Cancer Screening Archived RAD Magnetic Resonance Spectroscopy (MRS)

9 Archived RAD CT Colonography (Virtual Colonoscopy) for Colorectal Cancer Archived RAD Computed Tomography Scans for Lung Cancer Screening Archived RAD Cerebral Perfusion Imaging Using Computed Tomography Archived RAD Cerebral Perfusion Studies using Diffusion and Perfusion Magnetic Resonance Imaging Archived RAD Low-Field and Conventional Magnetic Resonance Imaging (MRI) for Screening, Diagnosing and Monitoring Archived RAD Functional Magnetic Resonance Imaging Archived RAD Magnetic Resonance Angiography of the Spinal Canal ADMIN ADMIN ADMIN ANC CG-ANC-06 CG-DME-03 Preventive Health Guidelines Medical Necessity Criteria Investigational Criteria Biomagnetic Therapy Ambulance Services: Ground; Non-Emergent Neuromuscular Stimulation in the Treatment of Muscle Atrophy

10 CG-DME-04 CG-DME-05 CG-DME-08 CG-DME-15 CG-DME-35 CG-DME-36 CG-DRUG-11 CG-DRUG-21 CG-DRUG-31 CG-DRUG-33 CG-DRUG-47 CG-DRUG-56 CG-DRUG-69 CG-DRUG-72 CG-GENE-02 CG-GENE-04 CG-MED-05 Electrical Nerve Stimulation, Transcutaneous, Percutaneous Cervical Traction Devices for Home Use Infant Home Apnea Monitors Hospital Beds and Accessories Electric Breast Pumps Pediatric Gait Trainers Infertility Drugs Naltrexone (Vivitrol ) Injections for the Treatment of Alcohol and Opioid Dependence Oncology Drug Treatment Regimens for Adults Palonosetron Level of Care: Specialty Pharmaceuticals Galsulfase (Naglazyme ) Ustekinumab (Stelara ) Pertuzumab (Perjeta ) Analysis of KRAS Status Molecular Marker Evaluation of Thyroid Nodules Ketogenic Diet for Treatment of Intractable Seizures

11 CG-MED-26 CG-MED-40 CG-MED-44 CG-MED-49 CG-MED-57 CG-MED-58 CG-REHAB-03 CG-REHAB-08 CG-SURG-05 CG-SURG-07 CG-SURG-08 CG-SURG-11 CG-SURG-12 CG-SURG-25 CG-SURG-32 Neonatal Levels of Care External Ambulatory Event Monitors to Detect Cardiac Arrhythmias Holter Monitors Auditory Brainstem Responses (ABRs) and Evoked Otoacoustic Emissions (OAEs) for Hearing Disorders Cardiac Stress Testing with Electrocardiogram Previous title: Cardiac Stress Testing with Electrocardiogram (ECG) Coronary Artery Imaging: Contrast-Enhanced CT Angiography, Fractional Flow Reserve derived from CT, Coronary MRA, and Cardiac MRI Pulmonary Rehabilitation Private Duty Nursing in the Home Setting Maze Procedure Vertical Expandable Prosthetic Titanium Rib Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury Surgical Treatment for Dupuytren's Contracture Penile Prosthesis Implantation Injection Treatment for Morton's Neuroma Pain Management: Cervical, Thoracic & Lumbar Facet Injections

12 CG-SURG-33 CG-SURG-34 CG-SURG-35 CG-SURG-38 CG-SURG-39 CG-SURG-42 CG-SURG-43 CG-SURG-44 CG-SURG-45 CG-SURG-47 CG-SURG-48 CG-SURG-50 CG-SURG-51 CG-SURG-53 CG-SURG-54 CG-SURG-56 CG-SURG-60 CG-SURG-65 Lumbar Fusion and Lumbar Total Disc Arthroplasty Diagnostic Infertility Surgery Intracytoplasmic Sperm Injection (ICSI) Lumbar Laminectomy, Hemi-Laminectomy, Laminotomy and/or Discectomy Pain Management: Epidural Steroid Injections Cervical Fusion Knee Arthroscopy Coronary Angiography in the Outpatient Setting Bone Graft Substitutes Surgical Interventions for Scoliosis and Spinal Deformity Elective Percutaneous Coronary Interventions (PCI) Assistant Surgeons Outpatient Cystourethroscopy Elective Total Hip Arthroplasty Elective Total Knee Arthroplasty Diagnostic Fiberoptic Flexible Laryngoscopy Cervical Total Disc Arthroplasty Recombinant Human Bone Morphogenetic Protein

13 CG-SURG-66 CG-SURG-67 CG-SURG-68 CG-SURG-69 DME DME DME DME DRUG DRUG GENE GENE GENE GENE Implanted (Epidural and Subcutaneous) Spinal Cord Stimulators (SCS) Treatment of Osteochondral Defects Surgical Treatment of Femoroacetabular Impingement Syndrome Meniscal Allograft Transplantation of the Knee Transtympanic Micropressure for the Treatment of Meniere's Disease Altered Auditory Feedback Devices for the Treatment of Stuttering Previous title: Altered Auditory Feedback (AAF) Devices for the Treatment of Stuttering Cooling Devices and Combined Cooling/Heating Devices Prefabricated Oral Appliances for the Treatment of Obstructive Sleep Apnea Prevention of Respiratory Syncytial Virus Infections Ocrelizumab (Ocrevus ) Previous title: Ocrelizumab (Ocrevus ) Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability (Intellectual Development Disorder) and Congenital Anomalies Genetic Testing to Confirm the Identity of Laboratory Specimens Genetic Testing for Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy Syndrome Previous title: Genetic Testing for Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL) Syndrome Genetic Testing of an Individual s Genome for Inherited Diseases

14 LAB LAB LAB LAB LAB MED MED MED MED MED MED OR-PR RAD RAD RAD Fecal Analysis in the Diagnosis of Intestinal Disorders Selected Blood, Serum and Cellular Allergy and Toxicity Tests Advanced Lipoprotein Testing Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer Multi-biomarker Disease Activity Blood Tests for Rheumatoid Arthritis Wearable Cardioverter Defibrillators Wireless Capsule for the Evaluation of Suspected Gastric and Intestinal Motility Disorders Hyperoxemic Reperfusion Therapy Sipuleucel-T (Provenge ) Corneal Collagen Cross-Linking Implantable Interstitial Glucose Sensors Upper Extremity Myoelectric Orthoses Positron Emission Tomography (PET) and PET/CT Fusion Dynamic Spinal Visualization (Including Digital Motion X-ray and Cineradiography/ Videofluoroscopy) Magnetization-Prepared Rapid Acquisition Gradient Echo Magnetic Resonance Imaging (MPRAGE MRI)

15 SURG SURG SURG SURG SURG SURG SURG SURG SURG SURG SURG SURG SURG SURG SURG TRANS Partial Left Ventriculectomy Percutaneous and Endoscopic Spinal Surgery Nerve Graft Prostatectomy Uterine Fibroid Ablation: Laparoscopic or Percutaneous Image Guided Techniques Implantable Middle Ear Hearing Aids Bicompartmental Knee Arthroplasty High-Resolution Anoscopy Screening for Anal Intraepithelial Neoplasia (AIN) and Squamous Cell Cancer of the Anus Bronchial Thermoplasty Venous Angioplasty with or without Stent Placement or Venous Stenting Alone Radiofrequency and Pulsed Radiofrequency Treatment of Trigger Point Pain Irreversible Electroporation Previous title: Irreversible Electroporation (IRE) Alcohol Septal Ablation for Treatment of Hypertrophic Cardiomyopathy Interspinous Process Fixation Devices Doppler-Guided Transanal Hemorrhoidal Dearterialization Perirectal Spacers for Use During Prostate Radiotherapy Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-hodgkin Lymphoma

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