Medical Policies/Clinical UM Guidelines Form

P.O. Box 4330 Woodland Hills, CA 91365 Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

September 1, 2022

Dear Provider:

Anthem Blue Cross is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines.
Please refer to the specific policy for coding, language, rationale updates and changes that are not summarized below.

Update to Our Message About California Senate Bill 535

In compliance with SB 535, Anthem Blue Cross and its delegated entities were previously advised to remove all prior authorization requirements for biomarker testing for members with advanced or metastatic stage 3 or 4 cancer, and biomarker testing for cancer progression or recurrence in members with advanced or metastatic stage 3 or 4 cancer.

Upon further clarification, post service review of medical necessity for biomarker testing for advanced or metastatic stage 3 or 4 cancer members is not permitted, only confirmation of advanced or metastatic stage 3 or 4 cancer is permitted.

To view medical policies and utilization management guidelines applicable to members enrolled in the Blue Cross and Blue Shield Service Benefit Plan, commonly referred to as the Federal Employee Program® (FEP®), please visit www.fepblue.org > Policies & Guidelines.

Updates to AIM Specialty Health® (AIM) programs, a separate company, apply to local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by AIM.
They do not apply to HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, or Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card.

NEW Clinical Guideline and Medical Policies (publish date is October 5, 2022, except where noted)

• CG-MED-91 Remote Therapeutic and Physiologic Monitoring Services: This document addresses the use of remote therapeutic monitoring (RTM) treatment management services when a physician or other qualified healthcare professional uses the results of RTM to manage an individual’s chronic condition under a specific treatment plan. o Outlines Medically Necessary and Not Medically Necessary criteria o Prior authorization required effective January 5, 2023

• DME.00049 External Upper Limb Stimulation for the Treatment of Tremors: This document addresses wrist- worn external upper limb stimulation therapy. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective January 5, 2023

• DME.00050 Remote Devices for Intermittent Monitoring of Intraocular Pressure: This document addresses remote devices for the intermittent monitoring of intraocular pressure (IOP). o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective January 5, 2023

• LAB.00049 Artificial Intelligence-Based Software for Prostate Cancer Detection: This document addresses the use of artificial intelligence-based software that analyzes prostate biopsy slides to assist accurate cytopathologic diagnosis. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective January 5, 2023

• MED.00140 Gene Therapy for Beta Thalassemia: This document addresses gene therapy for beta thalassemia. o Coverage criteria are currently available on our website o Outlines Medically Necessary and Investigational and Not Medically necessary criteria o Prior authorization required effective December 1, 2022

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• MED.00141 High-volume Colonic Irrigation: This document addresses the use of high-volume colonic irrigation and does not address other types of colonic irrigation which utilize smaller quantities of water, including, but not necessarily limited to, transanal and intraoperative (antegrade and retrograde) colonic irrigation. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective January 5, 2023

• TRANS.00040 Hand Transplantation: This document addresses hand transplantation for individuals with an amputated hand. o Considered Investigational and Not Medically Necessary

UPDATED Clinical Guidelines and Medical Policies effective January 5, 2023

• CG-DME-13 Lower Limb Prosthesis: This document addresses the use of lower limb prostheses required to replace the function of a lower limb loss due to trauma, disease, or a congenital condition. o Added Not Medically Necessary statements addressing prosthetics utilized primarily for leisure or sporting activities

• CG-GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status (AIM Genetic Testing program): This document addresses genotype testing for individual polymorphisms which can identify variants of specific genes associated with abnormal and normal drug metabolism. o Added thiopurine methyltransferase (TPMT) to scope of document and Clinical Indications Medically Necessary section

• CG-GENE-13 Genetic Testing for Inherited Diseases (AIM Genetic Testing program): This document addresses testing for certain diseases with an established genetic basis. o Added genes PIK3CA and CDKL5 to scope of document and Clinical Indications Medically Necessary section

• DME.00044 Robotic Arm Assistive Devices: This document addresses the use of a wheelchair mounted robotic arm intended for use in individuals with upper extremity disability and mobility limitations due to neurologic conditions, trauma, or other problems. o Revised title (previously titled Wheelchair Mounted Robotic Arm)
o Rescoped the Position Statement to also address robotic feeding assistive device

• SURG.00079 Nasal Valve Repair: This document addresses the following procedures or products used to treat nasal obstruction. (1) Nasal valve suspension for the treatment of nasal valve collapse; (2) Implantation of an absorbable nasal implant for the treatment of nasal airway obstruction caused by nasal wall collapse; and (3) Low-dose radiofrequency intranasal tissue remodeling for the treatment of nasal airway obstruction.
o Revised title (previously titled Nasal Valve Suspension)
o Revised the Position Statement o Expanded scope of document to address an absorbable nasal implant and low-dose radiofrequency intranasal tissue remodeling for the treatment of nasal airway obstruction o Content related to the absorbable nasal implant (Latera) moved from CG-SURG-87 to this document

Medical Policies to be archived

• GENE.00034 SensiGene® Fetal RhD Genotyping Test (effective October 5, 2022) • SURG.00143 Perirectal Spacers for Use During Prostate Radiotherapy (effective November 6, 2022)

Prior Authorization will also be required for the following effective January 1, 2023

• CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities • DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices • DME.00037 Cooling Devices and Combined Cooling/Heating Devices • DME.00038 Static Progressive Stretch (SPS) and Patient-Actuated Serial Stretch (PASS) Devices • LAB.00003 In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays • LAB.00015 Detection of Circulating Tumor Cells LAB.00019 Proprietary Algorithms for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease

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• LAB.00027 Selected Blood, Serum and Cellular Allergy and Toxicity Tests • LAB.00031 Advanced Lipoprotein Testing • LAB.00033 Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer
• LAB.00035 Multi-biomarker Disease Activity Blood Tests for Rheumatoid Arthritis • MED.00004 Technologies for the Evaluation of Skin Lesions (including Dermatoscopy, Epiluminescence Microscopy, Videomicroscopy and Ultrasonography) • MED.00011 Sensory Stimulation for Brain-Injured Individuals in Coma or Vegetative State • MED.00013 Parenteral Antibiotics for the Treatment of Lyme Disease • MED.00024 Adoptive Immunotherapy and Cellular Therapy • MED.00065 Hepatic Activation Therapy • MED.00082 Quantitative Sensory Testing • MED.00092 Automated Nerve Conduction Testing • MED.00096 Low-Frequency Ultrasound Therapy for Wound Management • MED.00103 Automated Evacuation of Meibomian Gland • MED.00105 Bioimpedance Spectroscopy Devices for the Detection and Management of Lymphedema • MED.00122 Wilderness Programs • MED.00125 Biofeedback and Neurofeedback • MED.00128 Insulin Potentiation Therapy • RAD.00034 Dynamic Spinal Visualization (Including Digital Motion X-ray and Cineradiography/ Videofluoroscopy) • RAD.00065 Radiostereometric Analysis (RSA) • SURG.00010 Treatments for Urinary Incontinence (NO PA - INV, NMN and MN) • SURG.00019 Transmyocardial Revascularization • SURG.00113 Artificial Retinal Devices • SURG.00116 High Resolution Anoscopy Screening for Anal Intraepithelial Neoplasia (AIN) and Squamous Cell Cancer of the Anus • SURG.00118 Bronchial Thermoplasty • SURG.00120 Internal Rib Fixation Systems • SURG.00124 Carotid Sinus Baroreceptor Stimulation Devices • SURG.00135 Radiofrequency Ablation of the Renal Sympathetic Nerves • SURG.00139 Intraoperative Assessment of Surgical Margins During Breast-Conserving Surgery with Radiofrequency Spectroscopy or Optical Coherence Tomography • SURG.00144 Occipital Nerve Block Therapy for the Treatment of Headache and Occipital Neuralgia • SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • SURG.00148 Spectral Analysis of Prostate Tissue by Fluorescence Spectroscopy • THER-RAD.00008 Neutron Beam Radiotherapy

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem Blue Cross web site at anthem.com/ca and then selecting “For Providers”, then selecting “Policies, Guidelines & Manuals” under the Provider Resources column, scroll down to select “View Medical Policies & Clinical UM Guidelines”, then selecting ”Full List page” or by entering a keyword or code in the search box.

We thank you for your continued efforts on behalf of our members and your partnership toward improved access to quality health care for Californians.

Sincerely,

John Yao, MD, MPH, MBA, MPP, FACP Chief Medical Officer

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Attachment A – Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-DME-31 Powered Wheeled Mobility Devices • Revised title (previously titled Wheeled Mobility Devices: Wheelchairs–Powered, Motorized, With or Without Power Seating Systems and Power Operated Vehicles [POVs]) • Revised Medically Necessary and Not Medically Necessary Clinical Indications to address pushrim-activated power-assist device (an addition to a manual wheelchair to convert to a pushrim-activated power assist wheelchair (PAPAW) CG-GENE-10 (AIM Genetic Testing) Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability and Congenital Anomalies • ICD-10-CM diagnosis codes O35.10X0-O35.19X9 replacing O35.1XX0-O35.1XX9 effective October 1, 2022 CG-GENE-22 (AIM Genetic Testing) Gene Expression Profiling for Managing Breast Cancer Treatment • Added Medically Necessary statement on decisions on extending adjuvant hormone therapy beyond 5 years in individuals with 1-3 positive lymph nodes CG-MED-69 Inhaled Nitric Oxide • Added Not Medically Necessary criteria for pre-operative, operative and operative management of congenital heart disease CG-SURG-63 Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure • Clarified the Medically Necessary criteria for Cardiac Resynchronization Therapy and Guideline-directed medical therapy with reorganization of criteria but no changes made CG-SURG-111 Open Sacroiliac Joint Fusion • Added new ICD-10-PCS codes XNH6058, XNH7058, XRGE058, XRGF058 effective October 1, 2022, for iFuse Bedrock Granite implant system with Medically Necessary criteria DME.00041 Ultrasonic Diathermy Devices • Revised title (previously titled: Low Intensity Therapeutic Ultrasound • Revised the Position Statement to reflect the title change GENE.00009 Gene Expression Profiling and Genomic Biomarker Tests for Prostate Cancer • Added CPT PLA code 0339U effective October 1, 2022, for SelectMDx test (was NOC code), considered Investigational and Not Medically Necessary GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status • Added CPT PLA codes 0345U, 0347U, 0348U, 0349U, 0350U effective October 1, 2022, for GeneSight and RightMed tests (were NOC), considered Investigational and Not Medically Necessary GENE.00049 Circulating Tumor DNA Panel Testing (Liquid Biopsy) • Added CPT PLA code 0333U effective October 1, 2022, for HelioLiver test, considered Investigational and Not Medically Necessary GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT PLA code 0334U for Guardant360 molecular profiling test with Medically Necessary criteria • Added CPT PLA codes 0335U, 0336U effective October 1, 2022, for IriSight whole genome tests; considered Investigational and Not Medically Necessary
• Added CPT PLA code 0343U effective October 1, 2022, for miR Sentinel prostate panel, considered Not Medically Necessary • Removed 0012U; 0013U; 0014U; 0056U deleted September 30, 2022

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GENE.00059 Hybrid Personalized Molecular Residual Disease Testing for Cancer • Added CPT PLA code 0340U effective October 1, 2022, for Signatera test (was NOC); considered Investigational and Not Medically Necessary LAB.00011 Selected Protein Biomarker Algorithmic Assays • Revised title (previously titled: Analysis of Proteomic Patterns) • Revised the Position Statement to reflect the title change • Added specific tests addressed in document to the Position Statement LAB.00015 Detection of Circulating Tumor Cells • Added CPT PLA codes 0337U, 0338U effective October 1, 2022, for CellSearch tests (were nonspecific codes) considered Investigational and Not Medically Necessary LAB.00019 Proprietary Algorithms for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease • Added CPT PLA code 0344U effective October 1, 2022, for OWLiver test considered Investigational and Not Medically Necessary • Prior authorization required effective January 1, 2023 LAB.00046 Testing for Biochemical Markers for Alzheimer's Disease • Added CPT PLA code 0346U effective October 1, 2022, for QUEST AD-Detect test considered Investigational and Not Medically Necessary MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications • Added Medically Necessary criteria for essential tremor MED.00098 Hyperoxemic Reperfusion Therapy • Added ICD-10-PCS code 5A0222C replacing 5A0512C & 5A0522C effective October 1, 2022, considered Investigational and Not Medically Necessary MED.00129 Gene Therapy for Spinal Muscular Atrophy • Revised Medically Necessary criterion to “no more than 3 copies of SMN2" RAD.00038 Use of 3-D, 4-D or 5-D Ultrasound in Maternity Care • ICD-10-CM diagnosis codes O35.00X0-O35.9XX9 replacing O35.0XX0-O35.9XX9 effective October 1, 2022 SURG.00032 Patent Foramen Ovale and Left Atrial Appendage Closure Devices for Stroke Prevention • ICD-10-CM diagnosis code Q21.12 replacing Q21.1 effective October 1, 2022, for patent foramen ovale SURG.00119 Endobronchial Valve Devices • Added a note in the Position Statement addressing individuals unable to perform a 6-Minute Walk Distance test • Updated hierarchy formatting in Position Statement SURG.00121 Transcatheter Heart Valve Procedures • Clarified Transcatheter Aortic Valve Replacement Medically Necessary Clinical Indications. • Added Medically Necessary statement for transcatheter Mitral Edge-to-Edge Repair/transcatheter mitral valve repair using an FDA approved device when criteria met • Added Not Medically Necessary statement for transcatheter mitral edge-to-edge repair/transcatheter mitral valve repair (TMVr) for the treatment of primary or secondary (functional) mitral regurgitation when the criteria above are not met • Revised Investigational and Not Medically Necessary statement TMVr to address transcatheter mitral edge-to-edge repair for all “other” indications SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea or Snoring • Added Medically Necessary criteria for hypoglossal nerve stimulation as a treatment of obstructive sleep apnea in individuals with Down syndrome • Removed examples from the Not Medically Necessary indications TRANS.00038 Thymus Tissue Transplantation • Added ICD-10-PCS code XW020D8 effective October 1, 2022, for RETHYMIC implantation procedure with Medically Necessary criteria