MP/CG Update/Notice - September 2018 Form

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association.

September 1, 2018

[Provider Name] [Contact Title] [Address] [City], State Zip]

Dear Provider:

Anthem Blue Cross (Anthem) 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, and rationale updates and changes that are not summarized below.

Please note, CG-MED-23 Home Health was mistakenly included on the archive list in our June 1, 2018 update letter. This Clinical UM Guideline is still in use and is not slated for archival at this time.

NOTE: The expanded Specialty Pharmacy drug, Imaging and Radiology Oncology program(s) in italics below apply to local and ASO Anthem members who have these services medically managed by AIM Specialty Health® (AIM), a separate company administering the program on behalf of Anthem. For more information go to http://www.aimprovider.com/specialtyrx/FAQ.html to view the FAQs.

NEW Medical Policies and Clinical Guidelines effective January 1, 2019

• DRUG.00096 Ibalizumab-uiyk (Trograzo™): This document outlines criteria for the use of ibalizumab-uiyk, a humanized monoclonal antibody (mAb) that belongs to the class of human immune deficiency virus (HIV) drugs known as entry and fusion inhibitors which prevent HIV from attaching to and entering human cells.
Prior Authorization review will be managed by AIM.

• GENE.00049 Circulating Tumor DNA Testing for Cancer (Liquid Biopsy): This document outlines the criteria for the use of a circulating tumor DNA (ctDNA) test for the diagnosis or treatment of cancer, which is considered Investigation & Not Medically Necessary for all indications Reviews will be managed by AIM.

UPDATED Medical Policies and Clinical Guidelines effective December 1, 2018

• ANC.00007 Cosmetic and Reconstructive Services: Skin Related: This document addresses the cosmetic, reconstructive, and medically necessary uses of a selection of techniques used in the treatment of skin lesions and related conditions. o Added microneedling (also known as percutaneous collagen induction therapy or skin needling) as Cosmetic & Not Medically Necessary for all indications

• DRUG.00003 Chelation Therapy: This document addresses the uses of chelation therapy. Chelation therapy uses naturally occurring or chemically designed molecules to reduce potentially dangerous levels of heavy metals within the body. Chelation therapy is routinely performed for cases of iron overload, lead poisoning, copper toxicity, and other heavy metal conditions. This document is not applicable to agents used for the treatment of drug overdose or toxicities. o Clarified that the use of chelation for treatment of heavy metals is only appropriate in the setting of a confirmed diagnosis by laboratory testing

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. • DRUG.00031 Subcutaneous Hormone Replacement Implants: This document addresses indications for the use of subcutaneous hormone implants for the treatment of hormone deficit conditions. This document does not address the use of hormone implants for treatment of other indications, for example contraception or treatment of cancer. o Clarified Medically Necessary statement for subcutaneous testosterone implants used for continuation of hormone replacement therapy when criteria are met

• SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts): This document addresses mechanical circulatory assist devices which include Ventricular assist devices (VADs), Percutaneous ventricular assist devices (pVADs), and Total artificial heart.
o Added Impella CP® Heart Pump to list of examples of pVADs considered Investigational & Not Medically Necessary

Medical Policies converted to New Clinical Guidelines effective September 20, 2018 -- except where noted

MP Number Title CG Number DME.00027 Ultrasound Bone Growth Stimulation CG-DME-45 DRUG.00024 Omalizumab (Xolair®) CG-DRUG-104 DRUG.00040 Abatacept (Orencia®) CG-DRUG-105 DRUG.00047 Brentuximab Vedotin (Adcetris®) CG-DRUG-106 DRUG.00058 Pharmacotherapy for Hereditary Angioedema CG-DRUG-107 DRUG.00064 Enteral Carbidopa and Levodopa Intestinal Gel Suspension CG-DRUG-108 DRUG.00087 Asfotase Alfa (Strensiq™) CG-DRUG-109 DRUG.00091 Naltrexone Implantable Pellets CG-DRUG-110 DRUG.00093 Sebelipase alfa (KANUMA™) CG-DRUG-111 DRUG.00103 Abaloparatide (Tymlos™) Injection CG-DRUG-112 MED.00005 Hyperbaric Oxygen Therapy (Systemic/Topical) CG-MED-73 MED.00051 Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry CG-MED-74 MED.00107 Medical and Other Non-Behavioral Health Related Treatments for Autism Spectrum Disorders and Rett Syndrome CG-MED-75 RAD.00019 Magnetic Source Imaging and Magnetoencephalography CG-MED-76 RAD.00042 SPECT/CT Fusion Imaging CG-MED-77 SURG.00014 Cochlear Implants and Auditory Brainstem Implants CG-SURG-81 SURG.00020 Bone-Anchored and Bone Conduction Hearing Aids CG-SURG-82 SURG.00024 Bariatric Surgery and Other Treatments for Clinically Severe Obesity CG-SURG-83 SURG.00049 Mandibular/Maxillary (Orthognathic) Surgery CG-SURG-84 SURG.00051 Hip Resurfacing CG-SURG-85 SURG.00054 Endovascular/Endoluminal Repair of Aortic Aneurysms, Aortoiliac Disease, Aortic Dissection and Aortic Transection CG-SURG-86 SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea and Snoring CG-SURG-87 SURG.00085 Mastectomy for Gynecomastia CG-SURG-88 SURG.00090 Radiofrequency Neurolysis and Pulsed Radiofrequency Therapy for Trigeminal Neuralgia CG-SURG-89 TRANS.00018 Donor Lymphocyte Infusion for Hematologic Malignancies after Allogeneic Hematopoietic Progenitor Cell Transplantation CG-TRANS-03 effective October 31, 2018

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association.

Medical Policies converted to New Clinical Guidelines effective September 1, 2018 (updates in Attachment A)

MP Number Title CG Number DRUG.00006 Botulinum Toxin
CG-DRUG-103 MED.00081 Cognitive Rehabilitation CG-REHAB-11

Medical Policies being archived

Number Title Archive Date GENE.00008 Analysis of Fecal DNA for Colorectal Cancer Screening 9/1/18

Medical Policies being archived and transitioned to AIM Advanced Imaging Clinical Appropriateness Guidelines effective September 20, 2018 (except where noted)

Number Title CG-MED-58 Coronary Artery Imaging: Contrast-Enhanced CT Angiography, Fractional Flow Reserve derived from CT, Coronary MRA, and Cardiac MRI (effective January 1, 2019) CG-SURG-44 Coronary Angiography in the Outpatient Setting (effective January 1, 2019) RAD.00002 Positron Emission Tomography (PET) and PET/CT Fusion (effective January 1, 2019) RAD.00022 Magnetic Resonance Spectroscopy (MRS) RAD.00029 CT Colonography (Virtual Colonoscopy) for Colorectal Cancer RAD.00043 Computed Tomography Scans for Lung Cancer Screening RAD.00045 Cerebral Perfusion Imaging Using Computed Tomography RAD.00046 Cerebral Perfusion Studies using Diffusion and Perfusion Magnetic Resonance Imaging RAD.00049 Low-Field and Conventional Magnetic Resonance Imaging (MRI) for Screening, Diagnosing and Monitoring RAD.00051
Functional Magnetic Resonance Imaging RAD.00055
Magnetic Resonance Angiography of the Spinal Canal

Medical Policies being archived and transitioned to AIM Musculoskeletal Clinical Appropriateness Guidelines effective January 1. 2019

Number Title CG-SURG-32 Pain Management: Cervical, Thoracic and Lumbar Facet Injection CG-SURG-33 Lumbar Fusion and Lumbar Total Disc Arthroplasty (TDA) CG-SURG-39 Pain Management: Epidural Steroid Injections CG-SURG-42 Cervical Fusion CG-SURG-43 Knee Arthroscopy CG-SURG-45 Bone Graft Substitutes CG-SURG-47 Surgical Interventions for Scoliosis and Spinal Deformity CG-SURG-48 Elective Percutaneous Coronary Interventions (PCI) CG-SURG-53 Elective Total Hip Arthroplasty CG-SURG-54 Elective Total Knee Arthroplasty CG-SURG-60 Cervical Total Disc Arthroplasty CG-SURG-65 Recombinant Human Bone Morphogenetic Protein CG-SURG-67 Treatment of Osteochondral Defects CG-SURG-68 Surgical Treatment of Femoracetabular Impingement Syndrome CG-SURG-69 Meniscal Allograft Transplantation of the Knee

Anthem’s Medical Policies and Clinical UM Guidelines are developed by our Medical Policy and Technology Assessment Committee. The Committee, which includes Anthem medical directors and representatives from practicing physician groups, meets quarterly to review current scientific data and clinical developments. Medical Policies and Clinical UM Guidelines are subject to the approval of the Physician Relations Committee.

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. All coverage written or administered by Anthem excludes from coverage services or supplies that are investigational and/or not medically necessary. A member’s claim may not be eligible for payment if it was determined not to meet medical necessity criteria set forth in Anthem’s Medical Policies. Review procedures have been refined to facilitate claim investigation.

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem Web site at http://www.anthem.com/ca. Under “Partner Login” select “Providers”, scroll down and click on “See Policies and Guidelines”, then select “Medical Policies and Clinical UM Guidelines (for Local Plan members)”, then click “Continue” at the bottom of the page.

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,

Jacob Asher, MD Vice President and Chief Medical Officer

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Attachment A – 4th Meeting 2018 Updates Revised Medical Policy and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-DME-07 Augmentative and Alternative Communication (AAC) Devices/Speech Generating Devices (SGD) • Clarified that a high technology device is electronic and a low technology device is non-electronic in Medically Necessary criteria CG-DRUG-09 Immune Globulin (Ig) Therapy • Added secondary hypogammaglobulinemia or agammaglobulinemia following chimeric antigen receptor (CAR) T cell treatment to Medically Necessary indications CG-DRUG-16 White Blood Cell Growth Factors • Add new code Q5108 for Fulphila (pegfilgratim-jmdb) effective October 1, 2018 CG-DRUG-64 FDA-Approved Biosimilar Products • Added CG-DRUG-90 (Intravitreal Treatment for Retinal Vascular Conditions) CG-DRUG-65 Tumor Necrosis Factor Antagonists • Added the use of infliximab for immune checkpoint inhibitor therapy-related toxicities (grade 3 or grade 4 adverse events) as Medically Necessary when criteria are met • Added the use of certolizumab pegol for plaque psoriasis as Medically Necessary when criteria are met • Added vedolizumab to Not Medically Necessary statement for use in combination with each TNF antagonist CG-DRUG-68 Bevacizumab (Avastin®) for Non-Ophthalmologic Indications • Added Medically Necessary statement for use of bevacizumab in advanced or recurrent endometrial carcinoma when criteria are met • Expanded Medically Necessary statement for use of bevacizumab as first-line treatment of non-squamous cell NSCLC in combination chemotherapy with platinum-based therapy, a taxane, and atezolizumab when criteria are met • Expanded Medically Necessary statement for use of bevacizumab as maintenance therapy in non-squamous cell NSCLC as a single agent or in combination with atezolizumab when criteria are met • Expanded Medically Necessary statement for use of bevacizumab in advanced or metastatic ovarian cancer following initial surgical resection (both initial and maintenance therapy) when criteria are met • Clarified Medically Necessary statement for maintenance therapy with bevacizumab for malignant mesothelioma, adding “unresectable” CG-DRUG-73 Denosumab (Prolia®, Xgeva®) • Added Medically Necessary indication for Prolia in the treatment of adults with glucocorticoid-induced osteoporosis when criteria met CG-DRUG-81 Tocilizumab (Actemra®) • Added Medically Necessary statement for use of tocilizumab in chronic antibody-mediated renal transplant rejection when criteria are met CG-DRUG-103 Botulinum Toxin • Content moved from DRUG.00006 • Added Xeomin for “chronic sialorrhea in adults” to Clinically Equivalent Cost Effective Agents table
CG-GENE-03 BRAF Mutation Analysis • Added BRAF V600E mutation analysis as Medically Necessary in individuals with locally advanced, unresectable or metastatic anaplastic thyroid cancer to identify those who would benefit from treatment with dabrafenib (Tafinlar®) in combination with trametinib (Mekinist®)

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. CG-GENE-04 Molecular Marker Evaluation of Thyroid Nodules • Updated acronym in Clinical Indications section • Description, Discussion/General Information, and References sections updated • Added Websites for Additional Information section CG-MED-57 Cardiac Stress Testing with Electrocardiogram • Acronym ECG removed from title • References were updated CG-MED-40 External Ambulatory Event Monitors to Detect Cardiac Arrhythmias • The Rationale and References sections were updated CG-REHAB-11 Cognitive Rehabilitation • Content moved from MED.00081 • Removed "Note" in Clinical Indications referring to CG- REHAB-09 Acute Inpatient Rehabilitation CG-SURG-24 Functional Endoscopic Sinus Surgery (FESS) • Removed time requirement of "at least 4 consecutive weeks" for antibiotic therapy from Medically Necessary criteria CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities • Clarified the TASC A lesion definitions in the Medically Necessary statement regarding treatment of claudication with angioplasty • Changed “femoropopliteal” to “superficial femoral artery” in the Medically Necessary statement regarding treatment of claudication with angioplasty • Revised the Medically Necessary statement regarding primary stent placement to clarify the length of intermediate-length stenosis or occlusion to be 5-15 cm • Revised the Not Medically Necessary statement for primary stent placement to clarify the type of lesions addressed • Added new Not Medically Necessary statement for treatment of occlusive arterial disease of the deep femoral artery • Clarified the Not Medically Necessary statement for Critical Limb Ischemia CG-SURG-73 Balloon Sinus Ostial Dilation • Removed time requirement of "at least 4 consecutive weeks" for antibiotic therapy from Medically Necessary criteria • Prior authorization required effective 9/1/18 CG-THER-RAD-03 Radioimmunotherapy and Somatostatin Receptor Targeted Radiotherapy
• Updated criteria to clarify non-FDA approved somatostatin analogs (including octreotide, lanreotide and vapreotide) are Not Medically Necessary for use as therapeutic receptor targeted radionuclide therapy ADMIN.00007 Immunizations • Removed Not Medically Necessary statement addressing FluMist for the 2016-2017 flu season • ACIP now recommends any licensed age-appropriate influenza vaccine for the 2018-2019 season, including FluMist • Code 90672 (quadrivalent, live [LAIV4] intranasal vaccine) removed from policy DME.00030 Altered Auditory Feedback Devices for the Treatment of Stuttering • Removed (AAF) acronym from title DRUG.00031 Subcutaneous Hormone Replacement Implants • Clarified Medically Necessary statement for subcutaneous testosterone implants used for continuation of hormone replacement therapy

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. DRUG.00046 Ipilimumab (Yervoy®) • Added ipilimumab in combination with nivolumab as subsequent therapy for metastatic colorectal cancer as Medically Necessary when criteria are met • Added ipilimumab in combination with nivolumab as first-line treatment of stage IV or recurrent NSCLC as Medically Necessary when criteria are met • Clarified Medically Necessary statement for renal cell carcinoma • Removed NSCLC from Investigational & Not Medically Necessary statement DRUG.00050 Eculizumab (Soliris®) • Revised Medically Necessary statement for resumption of eculizumab when relapse occurs in an individual who has discontinued therapy, adding “…or greater than 25% from baseline” to criteria addressing atypical hemolytic uremic syndrome • Added Guillain-Barre syndrome to Investigational & Not Medically Necessary statement
DRUG.00067 Ramucirumab (Cyramza®) • Added Medically Necessary statement for use of ramucirumab in locally advanced, unresectable or metastatic urothelial carcinoma when criteria are met • Removed genitourinary cancer from the Investigational & Not Medically Necessary statement DRUG.00071 Pembrolizumab (Keytruda®) • Added the treatment of recurrent or metastatic cervical cancer as Medically Necessary when criteria are met • Added adjuvant therapy for the treatment of resected high-risk stage III melanoma as Medically Necessary when criteria are met • Added the treatment of primary mediastinal large B-cell lymphoma as Medically Necessary when criteria are met • Added continuation maintenance therapy of recurrent or metastatic NSCLC (squamous cell and nonsquamous) as Medically Necessary when criteria are met • Clarified Medically Necessary criteria addressing urothelial carcinoma DRUG.00075 Nivolumab (Opdivo®) • Added nivolumab in combination with ipilimumab as subsequent therapy for metastatic colorectal cancer as Medically Necessary when criteria are met • Added nivolumab in combination with ipilimumab as first-line treatment of stage IV or recurrent NSCLC as Medically Necessary when criteria are met DRUG.00088 Atezolizumab (Tecentriq®) • Clarified Medically Necessary criteria addressing urothelial carcinoma • Added Medically Necessary statements for first-line and continuation maintenance therapy for non-squamous NSCLC DRUG.00095 Ocrelizumab (Ocrevus®) • Changed ™ to ® DRUG.00098 Lutetium Lu 177 dotatate (Lutathera®) • Added Medically Necessary statement for use of lutetium Lu 177 dotatate in locally advanced bronchopulmonary or thymus
neuroendocrine tumors when criteria are met • Added Medically Necessary statement for use of lutetium Lu 177 dotatate as primary treatment for locally unresectable or metastatic pheochromocytoma or paraganglioma when criteria are met

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association.

GENE.00006 Epidermal Growth Factor Receptor (EGFR) Testing • Added osimertinib (Tagrisso™) to Medically Necessary statement • Added new Medically Necessary and Investigational & Not Medically Necessary statements addressing the use of circulating tumor DNA testing GENE.00011 Gene Expression Profiling for Managing Breast Cancer Treatment • Removed Medically Necessary criterion requiring "Histology is not tubular or colloid (also referred to as mucinous)" • Simplified HER2 Medically Necessary criteria GENE.00025 Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignant Tumors • Expanded Medically Necessary criteria for NSCLC to assess tumor mutation burden and identify candidates for checkpoint inhibition immunotherapy
GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility • Corrected typographical error in the Medically Necessary criteria for Lynch syndrome by changing “MSH1” to “MLH1” GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome • Added genetic testing to detect BRCA and BART as Medically Necessary for individuals who require confirmatory testing for a BRCA1/BRCA2 mutation(s) detected by a Food and Drug Administration (FDA)-authorized direct-to-consumer (DTC) test report GENE.00042 Genetic Testing for Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy Syndrome • Revised Title – removed “CADASIL” acronym • Added ICD-10-CM diagnosis code I67.850 for CADASIL syndrome as Investigational & Not Medically Necessary, effective October 1, 2018 GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases • Added CPT code 81434 (hereditary retinal disorders panel) • Added Medically Necessary criteria for RPE65 related to Luxturna therapy LAB.00027 Selected Blood, Serum and Cellular Allergy and Toxicity Tests • For CPT code 86001 IgG, listed specific food allergy diagnoses that would be denied Investigational & Not Medically Necessary MED.00055 Wearable Cardioverter Defibrillators • Updated study in Rationale • Updated references MED.00123 Axicabtagene ciloleucel (Yescarta®) • Revised Title – changed ™ to ® • Reformatted and clarified Medically Necessary criteria • Updated Investigational & Not Medically Necessary statement MED.00124 Tisagenlecleucel (Kymriah®) • Revised Title – changed ™ to ®
• Added large B-cell lymphoma as Medically Necessary indication when criteria are met • Updated Investigational & Not Medically Necessary statement SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Added confirmed cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as Medically Necessary indication for implant removal SURG.00032 Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention • Expanded Medically Necessary statement for transcatheter closure of PFO using FDA approved device as preventive therapy for individuals with a history of cryptogenic stroke who are under age 60 without trial of anticoagulation when criteria are met SURG.00122 Venous Angioplasty with or without Stent Placement or Venous Stenting Alone • Added ICD-10-PCS procedure codes for drug-coated balloons effective October 2, 2018 • Updated Rationale, References and Websites SURG.00126 Irreversible Electroporation • Acronym (IRE) removed from title • New ICD-10 PCS codes for liver and pancreas IRE effective
October 1, 2018 • The Rationale and References sections were updated