MP/CG Update/Notice - April 2017 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.

March 30, 2017

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

Dear Provider:

Anthem Blue Cross (Anthem) is pleased to provide you with our updated Medical Policies and Clinical UM Guidelines in Attachment A. 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 Clinical UM Guidelines effective July 1, 2017:

NOTE: Pre-service clinical review of the specialty pharmacy drugs in italics below will be managed by AIM Specialty Health® (AIM), a separate company administering the program on behalf of Anthem.

• CG-DRUG-61 Gonadotropin Releasing Hormone Analogs for the Treatment of Non-Oncologic Indications: This document addresses gonadotropin releasing hormone (GnRH) analogs for the treatment of non-oncologic indications. This document does not address the use of GnRH analogs in the diagnosis of central precocious puberty or treatment of infertility.

• LAB.00034 Serological Antibody Testing For Helicobacter Pylori: This document addresses the use of serological antibody testing for Helicobacter pylori (also known as H. pylori), a causative agent for peptic ulcers, gastritis, dyspepsia and stomach cancer.

• SURG.00146 Extracorporeal Carbon Dioxide Removal: This document addresses the use of extracorporeal carbon dioxide removal (ECCO2R), a minimally invasive, low-flow, veno-venous or venous– arterial procedure used to treat acute hypercapnic respiratory failure or as an alternative to standard extracorporeal membrane oxygenation (ECMO).

• SURG.00147 Synthetic Cartilage Implant for Metatarsophalangeal Joint Disorders: This document addresses the use of a metatarsophalangeal synthetic cartilage implant.

Revised Medical Policies and Adopted Clinical UM Guidelines:

• CG-BEH-04 Substance-Related and Addictive Disorder Treatment

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 o Clarified language addressing withdrawal symptoms for inpatient detox o Reformatted clinical indications • CG-BEH-05 Eating and Feeding Disorder Treatment

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 o Updated formatting and grammar, and removed abbreviations from clinical indications

• CG-DRUG-64 FDA-Approved Biosimilar Products: This document provides clinical criteria for review of

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. FDA-approved biosimilar products with clinically equivalent cost effective agents.

Policy Impacted Products Clinically Equivalent/Cost Effective Products CG-DRUG-64 FDA Approved Biosimilar Products Inflectra® Remicade® *CG-DRUG-29 Hyanluronan injection in the knee Euflexxa®,Gel-One®, GelSyn®,Genvisc 850®, Hyalgan®,Hymovis®,Supartz® Monovisc®, Orthovisc®, Synvisc®,Synvisc One®

*CG-DRUG-29 is for clinically equivalent agents only. • DRUG.00017 Hyaluronan Injections in Joints Other Than the Knee: This document addresses the use of hyaluronan injections for the replacement or supplementation of naturally occurring intra-articular lubricants in individuals with musculoskeletal conditions in joints other than the knee, including osteoarthritis and temporomandibular joint disease. This therapy may also be referred to as viscosupplementation. This guideline is subject to CG-DRUG-64 (FDA Approved Biosimilar Products).

• SURG.00010 Treatments for Urinary Incontinence o Added implantation of the inFlow™ intraurethral valve-pump as Investigational and not medically necessary for all indications 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 http://www.anthem.com/ca select “Tools for Providers” near the bottom of the page, the click “Enter” under Welcome to Anthem Blue Cross, then click “Services described in the Medical Policies, UM Clinical Guidelines and/or Pre-certification Requirements” under Learn More, then click “Medical Policies and Clinical UM Guidelines (for Local Plan members)”, then click “Continue” at the bottom of the page.

The expanded Specialty Pharmacy drug program applies to local Anthem members who have specialty pharmacy services medically managed by AIM Specialty Health. The expanded program does not apply to the following plans: HMO, BlueCard, HMO, Medicare Advantage, Medicaid, Medicare Supplement, and Federal Employee Program (FEP).

Ordering physicians may submit a request for services to AIM through the AIM ProviderPortalSM (available 24/7 to process orders in real-time), through the Availity Web Portal or by calling the AIM call center at 1-877-291-0360, Monday–Friday, 7:00 a.m.–5:00 p.m. Pacific Time.

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 – 1st Quarter 2017 Updates Revised Medical Policies and Clinical Guidelines Policy Number Title Medical Policy / Clinical Guideline Changes CG-DME-24 Wheeled Mobility Devices: Manual Wheelchairs-Standard, Heavy Duty and Lightweight • Reformatted title • Removed "Note" addressing replacement or repairs from clinical indications • Updated formatting CG-DME-31 Wheeled Mobility Devices: Wheelchairs–Powered, Motorized, With or Without Power Seating Systems and Power Operated Vehicles (POVs) • Removed "Note" addressing replacement or repairs from clinical indications • Updated formatting CG-DME-33 Wheeled Mobility Devices: Manual Wheelchairs-Ultra Lightweight • Removed "Note" addressing replacement or repairs from clinical indications • Updated formatting CG-DME-34 Wheeled Mobility Devices: Wheelchair Accessories • Removed "Note" addressing replacement or repairs from clinical indications • Updated formatting CG-DRUG-16 White Blood Cell Growth Factors • Removed MN and NMN criteria and all other language and coding addressing the biosimilar agent, Filgrastim-sndz (Zarxio™) • Added Note to refer to CG-DRUG-64 for review of biosimilar products CG-DRUG-29 Hyaluronan Injections in the Knee • Revised "Preferred Agents" section title and language to address "Clinically Equivalent Cost Effective Agents" CG-DRUG-63 Levoleucovorin Calcium (Fusilev®) • Revised "Preferred Agents" section title and language to address "Clinically Equivalent Cost Effective Agents" CG-DRUG-64 FDA-Approved Biosimilar Products • Revised "Preferred Agents" section title and language to address "Clinically Equivalent Cost Effective Agents" CG-MED-19 Custodial Care • Added Note to clinical indications section that benefit language supersedes the criteria in this document • Updated definition and examples of custodial care CG-REHAB-04 Physical Therapy • Clarified MN and NMN habilitative physical therapy criteria • Reformatted clinical indications CG-REHAB-05 Occupational Therapy • Clarified MN and NMN habilitative physical therapy criteria • Reformatted clinical indications CG-REHAB-06 Speech-Language Pathology Services • Clarified MN and NMN habilitative physical therapy criteria • Reformatted clinical indications CG-SURG-03 Blepharoplasty, Blepharoptosis Repair, and Brow Lift • Clarified MN criteria addressing blepharoplasty CG-SURG-27 Sex Reassignment Surgery • Revised criterion addressing confirmation of female gender prior to bilateral mastectomy in female-to-male transitions to remove chromosome testing CG-SURG-43 Knee Arthroscopy • Revised MN criteria addressing intra-articular joint pathology, and repair or excision of torn meniscus • Removed abbreviations from clinical indications • Added Note defining conservative 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. DME.00012 Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation • Revised title. Previous title: Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation (IPV) • Made grammar, capitalization, abbreviation and acronym clarifications in position statement DRUG.00006 Botulinum Toxin • Revised "Preferred Agents" section title and language to address "Clinically Equivalent Cost Effective Agents" DRUG.00009 Growth Hormones • Removed abbreviation from position statement • Added Note to position statement to see Definitions section for a full list of pituitary hormones • Updated formatting DRUG.00017 Hyaluronan injections for indications in joints other than the knee • Added new section addressing Clinically Equivalent Cost Effective Agents effective July 1, 2017. • Impacted Products: Euflexxa®,Gel-One®,GelSyn®,Genvisc 850®, Hyalgan®,Hymovis®,Supartz® • Clinically Equivalent/Cost Effective agents include:
Monovisc®, Orthovisc®, Synvisc® and Synvisc One® • Removed hylan G-F 20 from position statement DRUG.00068 Vedolizumab (Entyvio®) • Removed criteria addressing tuberculosis infections and testing for latent tuberculosis from NMN section DRUG.00090 Bezlotoxumab (ZINPLAVA™) • Clarified the MN language addressing the definition of severe Clostridium difficile DRUG.00092 Buprenorphine Implant (Probuphine®) • Revised title. Previous title: Probuphine® (buprenorphine implant). • Made minor typographical changes in position statement DRUG.00104 Nusinersen (SPINRAZA™) • Added Note to position statement clarifying continuation of therapy • Reviewed previous new medical policy GENE.00008 Analysis of Fecal DNA for Colorectal Cancer Screening • Revised MN position statement to clarify that Cologuard is a screening test for individuals at average risk for colorectal cancer • Added "When previous screening has been undertaken using an alternative method, then the initial Cologuard test is considered medically necessary as a screening technique for individuals at average risk for colorectal cancer based on the preceding test’s designated next appropriate screening interval" MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications • Added essential tremors to examples of conditions considered INV/NMN OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis • Clarified criterion regarding individual's ability to ambulate faster than their baseline with a swing and stance lower extremity prosthesis SURG.00007 Vagus Nerve Stimulation • Clarified INV/NMN language • Updated formatting SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added new products to the INV&NMN list • Made minor typographical revisions in the position statement

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.

SURG.00032 Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention • Clarified MN criteria to state that the device being used for transcatheter closure of a PFO must be a device that is FDA approved for that indication (that is, AMPLATZER® PFO Occluder) SURG.00086 Reduction Mammaplasty • Clarified MN criteria to indicate that the appropriate amounts (in grams) of breast tissue must be anticipated for removal from at least one breast • Updated formatting SURG.00103 Intraocular Anterior Segment Aqueous Drainage Devices (without extraocular reservoir) • Added the CyPass System, when used in conjunction with cataract surgery as a treatment to reduce intraocular pressure for the treatment of glaucoma, as medically necessary when criteria are met • Added the CyPass System to investigational and not medically necessary statement for all other indications not listed as medically necessary • Added the XEN Glaucoma Treatment System as
investigational and not medically necessary as a method to reduce intraocular pressure for the treatment of glaucoma • Removed the CyPass System as an investigational and not medically necessary device when used as a method to reduce intraocular pressure for the treatment of glaucoma SURG.00127 Sacroiliac Joint Fusion
• Clarified MN criterion addressing pelvic injury to read "Severe traumatic injuries associated with pelvic ring disruption (that is, fracture or dislocation)