MP/CG Update/Notice - October 2016 Form

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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.

October 1, 2016

[Business Name] [Address] [City], [State] [Zip]

Dear Provider:

Anthem Blue Cross is pleased to provide you with our updated and new Medical Policies and Clinical UM Guidelines. The updated polices and guidelines listed below will be effective for service dates on and after January 1, 2017.

The major new policies and changes are summarized below. Please refer to the specific policy for coding, language, and rationale updates and changes that are not summarized below.

New Medical Policies and Adopted Clinical Guidelines:

• DME.00039 Prefabricated Oral Appliances for the Treatment of Obstructive Sleep Apnea:
This document addresses the use of prefabricated oral appliances for the treatment of obstructive sleep apnea (OSA).

• DRUG.00087 Asfotase Alfa (Strensiq™): This document addresses asfotase alfa (Strensiq™), a tissue nonspecific alkaline phosphatase (TNSAP) recombinant isozyme developed to target underlying genetic causes of hypophosphatasia (HPP).

• DRUG.00088 Atezolizumab (Tecentriq™): This document addresses the use of atezolizumab (Tecentriq™), an anti-programmed death ligand 1 (PD-L1) monoclonal antibody approved by the FDA for treatment of locally advanced or metastatic urothelial carcinoma under specific circumstances.

• DRUG.00089 Daclizumab (Zinbryta™): This document addresses the uses of subcutaneous daclizumab (Zinbryta™), a humanized, monoclonal antibody used for the treatment of multiple sclerosis.

• DRUG.00091 Naltrexone Implantable Pellets: This document addresses extended-release, implantable naltrexone.

• DRUG.00092 Probuphine® (buprenorphine implant): This document addresses the use of Probuphine®, the first buprenorphine implant intended for maintenance treatment of opioid use disorder in individuals who have achieved and sustained prolonged clinical stability on low-to moderate-doses of buprenorphine.

• DRUG.00093 Sebelipase alfa (KANUMA™): This document addresses the use of sebelipase alfa (KANUMA™), a hydrolytic lysosomal cholesteryl ester and triacylglycerol-specific enzyme administered intravenously for the treatment of the rare disease lysosomal acid lipase deficiency (LAL-D), also known as Wolman disease (WD) and cholesteryl ester storage disease (CESD).

• GENE.00046 Prothrombin G20210A (Factor II) Mutation Testing: This document addresses prothrombin G20210A (factor II) mutation testing for the screening, diagnosis and management of prothrombin-related thrombophilia.

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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.00047 Methylenetetrahydrofolate Reductase Mutation Testing: This document addresses methylenetetrahydrofolate reductase (MTHFR) gene mutation testing for the screening, diagnosis, and clinical management of a variety of diseases and disorders.

• LAB.00032 Zika Virus Testing: This document addresses the current testing methods for Zika virus (ZIKV), a mosquito-borne flavivirus and member of the Flaviviridae family, which includes RNA real time reverse transcription-polymerase chain reaction (RT-PCR), immunoglobulin M (IgM) and the plaque reduction neutralization test (PRNT).

• RAD.00066 Multiparametric Magnetic Resonance Imaging Fusion Targeted Prostate Biopsy:
This document addresses the use of a “fusion biopsy system” in which a multi-parametric prostate magnetic resonance image (mpMRI) is fused with real-time high definition prostate ultrasound images through the use of specialized equipment and software to target and biopsy areas suspicious for prostate cancer.

• SURG.00144 Occipital Nerve Block Therapy for the Treatment of Headache and Occipital Neuralgia:
This document addresses occipital nerve block (or blockade), as a therapy for treatment of headache syndromes.

• CG-DRUG-43 Natalizumab (Tysabri®): This document addresses natalizumab (Tysabri®), a recombinant humanized monoclonal antibody known as an alpha-4 integrin antagonist.

• CG-DRUG-44 Pegloticase (Krystexxa®): This document addresses pegloticase (Krystexxa®), a pegylated biosynthetic (recombinant DNA) uric acid specific enzyme (urate oxidase/uricase) used in adults with chronic, treatment-refractory gout.

• CG-DRUG-49 Doxorubicin® Hydrochloride Liposome Injection: This document addresses the indications for the use of doxorubicin hydrochloride liposome injection (Doxil®), for intravenous use.

• CG-DRUG-50 Paclitaxel, protein-bound (Abraxane®): This document addresses the indications for protein- bound paclitaxel (Abraxane®) a microtubule inhibitor agent to treat relapsed or metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer, metastatic adenocarcinoma of the pancreas, and other off-label oncologic conditions.

• CG-DRUG-51 Romidepsin (Istodax®): This document addresses the clinical uses of romidepsin for relapsed or refractory T-cell lymphoma, leukemia following at least one prior systemic therapy, or mycosis fungoides or Sézary Syndrome. • CG-SURG-55: Intracardiac Electrophysiological Studies (EPS) and Catheter Ablation: This document addresses two intracardiac electrophysiological procedures and studies, including electrophysiological studies (EPS) and catheter ablation. The procedure codes under this Clinical Guideline will require prior-authorization.

Revised Medical Policies and Adopted Clinical UM Guidelines:

• ADMIN.00007 Immunizations: This document addresses the use of childhood and adult immunizations as recommended by the American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), and the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention (CDC). o Added "Effective with the 2016-2017 influenza season, live attenuated influenza vaccine (LAIV) is considered NMN for all age groups"

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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-BEH-03 Psychiatric Disorder Treatment: This document provides medical necessity criteria for levels of care relating to psychiatric disorder treatment and psychiatric outpatient treatment (including treatment provided by a clinician licensed at the independent practice level) and medication management. o Added criteria requiring member evaluation by a physician or other provider with prescriptive authority upon admission and during the continued stay to occur with a specified frequency relative to the level of care.

• CG-SURG-53 Total Hip Arthroplasty: This document addresses elective total hip arthroplasty (THA) for hip damage severe enough to require replacement, when performed as an elective, non-emergent procedure and not as part of the care of a congenital, acute or traumatic event such as fracture (excluding fracture of implant and periprosthetic fracture. o Clarified that rheumatoid arthritis includes juvenile rheumatoid arthritis o Revised MN criteria addressing elective revision of a previous total hip arthroplasty or prior hip resurfacing

• CG-SURG-54 Total Knee Arthroplasty: This document addresses elective total knee arthroplasty (TKA) for
knee damage severe enough to require replacement, when done as an elective, non-emergent procedure and not as part of the care of a congenital, acute or traumatic event such as fracture (excluding periprosthetic fracture).
o Clarified that rheumatoid arthritis includes juvenile rheumatoid arthritis o Revised MN clinical indications addressing elective revision of a total knee arthroplasty o Clarified "Note" addressing conservative therapy

• DRUG. 00002 Tumor Necrosis Factor Antagonists: This document addresses the indications for a class of biologic immunosuppressive agents known as tumor necrosis factor (TNF) antagonists (inhibitors).
o Etanercept-szzs (FDA approved biosimilar) has been added to the criteria addressing etanercept (Enbrel®).

• DRUG.00015 Prevention of Respiratory Syncytial Virus Infections: This document addresses prevention of respiratory syncytial virus (RSV) infection with palivizumab (Synagis®), a monoclonal antibody produced by DNA recombinant technology. o Removed bronchodilator therapy as a MN intervention in the second RSV season o Removed brand names from position statement

• DRUG.00031 Subcutaneous Hormone Replacement Implants: This document addresses indications for the use of subcutaneous hormone implants for the treatment of hormone deficit conditions.
o Revised MN position statement to address the initiation of hormone replacement therapy with subcutaneous testosterone implants and added criteria for the treatment of males with congenital or acquired endogenous androgen absence or deficiency associated with primary or secondary hypogonadism o Added MN criteria for continuation of hormone replacement therapy with subcutaneous testosterone implants o Added MN criteria for subcutaneous testosterone implants for treatment of delayed puberty o Added MN criteria for subcutaneous testosterone implants for transgender individuals o Revised INV&NMN statement

• GENE.00026 Cell-Free Fetal DNA-Based Prenatal Testing: This document addresses cell-free fetal DNA- based prenatal testing for fetal aneuploidies (including fetal sex chromosome aneuploidies), fetal sex determination and microdeletions.
o Title changed (Previous title: Cell-Free Fetal DNA-Based Prenatal Screening for Fetal Aneuploidy) o Added cell-free fetal DNA-based prenatal testing for fetal sex determination as MN for singleton pregnancies at increased risk of a sex (X)-linked condition or congenital adrenal hyperplasia o Added cell-free fetal DNA-based prenatal testing for fetal sex determination as NMN for pregnancies without an increased risk of a sex (X)-linked condition or congenital adrenal hyperplasia o Added cell-free fetal DNA-based prenatal testing for fetal sex chromosome aneuploidies as INV&NMN o Added cell-free fetal DNA-based prenatal testing for microdeletion syndromes as INV&NMN o Added cell-free fetal DNA-based prenatal testing as INV&NMN for all other uses

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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.

• MED.00051 Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry: This document addresses the use of implantable ambulatory event monitors and external mobile cardiac telemetry that is equipped with cellular telecommunications (also referred to as real-time remote heart monitors [loop recorders] or mobile cardiac telemetry).
o Title changed (Previous title: Real-Time Remote Heart Monitors) o Revised scope of document to include implantable ambulatory event monitors - criteria previously on CG- MED-40 o Added the use of implantable ambulatory event monitors as MN for individuals who have a history of cryptogenic stroke and have had a previous non-diagnostic trial of external ambulatory event monitoring
o Added the use of mobile cardiac telemetry as MN for individuals who have a history of cryptogenic stroke and have had a previous non-diagnostic trial of external ambulatory event monitoring o Revised INV&NMN language

• SURG.00028 Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions: This document addresses various surgical and minimally invasive procedures used in the treatment of benign prostatic hyperplasia (BPH), and the use of these procedures for other genitourinary conditions. o Added transurethral convective water vapor thermal ablation as INV&NMN o Added acronyms to procedure names in INV&NMN section

Anthem Blue Cross 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.

All coverage written or administered by Anthem Blue Cross 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 Blue Cross’ 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 Blue Cross Web site at www.anthem.com/ca, select “Provider”, and then select “Medical Policies and Clinical UM Guidelines” listed under “Learn More”. Recent changes to Medical Policies can be found under “Recent Updates". 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

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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 – 3rd Quarter 2016 Updates Revised Medical Policies and Clinical Guidelines Policy Number Title Medical Policy / Clinical Guideline Changes BEH.00002 Transcranial Magnetic Stimulation

• Revised MN criteria addressing the trials of psychopharmacologic agents required prior to TMS for major depressive disorder (MDD) by adding criteria for "a single previous depressive episode" • Made minor formatting changes in position statement CG-BEH-02 Adaptive Behavioral Treatment for Autism Spectrum Disorder • Created new section titled “When Above Criteria Are Not Met” and listed indications when adaptive behavioral treatment (ABT) will not be covered • Clarified wording in MN clinical indications section CG-MED-40 External Ambulatory Event Monitors to Detect Cardiac Arrhythmias • Title revised from Ambulatory Event Monitors to Detect Cardiac Arrhythmias
• Revised scope of document to only address external ambulatory event monitors • Moved criteria, all other language and coding addressing implantable monitors to MED.00051 CG-DRUG-21 Naltrexone (Vivitrol®) Injections for the Treatment of Alcohol and Opioid Dependence • Removed trial of oral naltrexone as required to meet MN criteria • Clarified alcohol dependence is also referred to as alcohol use disorder AND opioid dependence is also referred to as opioid use disorder throughout document • Clarified criteria for the use of injectable naltrexone for alcohol use disorder that the individual is not currently on opioid analgesics for pain management • Added criteria for the use of injectable naltrexone for alcohol use disorder to include requirement that the individual is not currently on an opioid agonist for the treatment of opioid use disorder (for example, buprenorphine and methadone) CG-SURG-27 Sex Reassignment Surgery • Added bilateral mastectomy for individuals undergoing female-to-male sex reassignment surgery as MN when criteria are met • Updated formatting in clinical indications section DRUG.00066 Antihemophilic Factors and Clotting Factors • Updated with new HCPCS code C9139 effective 10/01/16 for Idelvion DRUG.00080 Monoclonal Antibodies for the Treatment of Eosinophilic A th • Updated with new HCPCS code C9481 effective 10/01/16 for Cinqair DRUG.00088 Atezolizumab (Tecentriq™) • Updated with new HCPCS code C9483 effective 10/01/16 for Tecentriq LAB.00027 Selected Blood, Serum and Cellular Allergy and Toxicity T t • Added NOC 86849 used for Complement Antigen Test for food allergies MED.00081 Cognitive Rehabilitation • Defined abbreviation in position statement

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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.

MED.00107 Medical and Other Non- Behavioral Health Related Treatments for Autism Spectrum Disorders
and Rett Syndrome • Revised MN position statement addressing medical therapy to read: "Medication for the treatment of irritability or other conditions associated with ASD is MN when indicated" • Removed INV&NMN indications that are addressed on other documents RAD.00034 Dynamic Spinal Visualization (Including Digital Motion X-ray and Cineradiography/ Videofluoroscopy) • Added 76496 NOC when specified as videofluoroscopy RAD.00043 Computed Tomography Scans with or without Computer Assisted Detection (CAD) for Lung Cancer Screening • Updated to remove HCPCS S8032 deleted 09/30/16