MP/CG Update/Notice - October 2020 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. October 1, 2020

[Provider Name] [Address] [City], [State] [Zip Code]

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, and rationale updates and changes that are not summarized below.

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, Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card

NEW Medical Policies and Clinical Guidelines with prior authorization required effective January 1, 2021

• 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.

• CG-MED-65 Manipulation Under Anesthesia: This document addresses the use of manipulation under anesthesia of the spine, and the use of manipulation under anesthesia of joints other than the knee and shoulder.

• CG-OR-PR-04 Cranial Remodeling Bands and Helmets (Cranial Orthotics): This document addresses the use of the adjustable band or helmet cranial orthoses as a treatment of craniosynostosis, non-synostotic plagiocephaly (asymmetrically shaped posterior head), scaphocephaly (abnormally shaped narrow head), and brachycephaly (abnormally shaped head; shortened in antero-posterior dimension without asymmetry) in infants.

• CG-SURG-86 Endovascular/Endoluminal Repair of Aortic Aneurysms, Aortoiliac Disease, Aortic Dissection and Aortic Transection: This document addresses the use of stent grafts placed endovascularly for the treatment of emergent vascular conditions of the aorta including aneurysms, thoracic aortic dissection and traumatic thoracic aortic injury (that is, transection). This document does not address endovascular treatment when limited to the iliac artery alone.

• MED.00134 Non-invasive Heart Failure and Arrhythmia Management and Monitoring System: This document addresses the use of a non-invasive heart failure and arrhythmia management and monitoring system as an early indicator for heart failure decompensation and arrhythmia detection.

• SURG.00156 Implanted Artificial Iris Devices: This document addresses the use of artificial irises to treat individuals with congenital or traumatic aniridia or individuals with iris defects.

• SURG.00157 Minimally Invasive Treatment of the Posterior Nasal Nerve to Treat Rhinitis: This document addresses the use of minimally invasive techniques to inactivate the posterior nasal nerve (PNN) and to thereby decrease the symptoms of chronic rhinorrhea or nasal congestion.

• TRANS.00025 Lab Testing to Aid in Diagnosis of Heart Transplant Rejection: This document addresses specific noninvasive laboratory tests for the early detection of rejection following a heart transplant.

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.

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UPDATED Medical Policies and Clinical Guidelines effective January 1, 2021

• CG-DME-07 Augmentative and Alternative Communication (AAC) Devices with Digitized or Synthesized Speech Output: This document addresses augmentative and alternative communication (AAC) devices with digitized or synthesized speech output. o Clarified language and added detail related to required documentation in Medically Necessary criteria o Changed "medical" and "non-medical" to "augmentative and non-augmentative" in Not Medically Necessary section

• CG-DME-44 Electric Tumor Treatment Field (TTF): This document addresses electrical fields known as “tumor treatment fields (TTF)” that are created by low-intensity, intermediate frequency (100–200 kilohertz [kHz]) electric currents delivered to the malignant tumor site by insulated electrodes placed on the skin surface. o Removed definition of tumor progression from clinical indications section and added note to refer reader to Discussion section for MacDonald criteria

• GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling: This document addresses whole genome sequencing, whole exome sequencing, and gene panel testing. o Removed Medically Necessary criteria for non small cell lung cancer for tumor burden assessment o Added molecular profiling as Medically Necessary for unresectable or metastatic solid tumors when criteria are met o Made minor grammatical revision in Lynch Syndrome criteria o Added 81488 from GENE.00033 effective September 1, 2020 o Prior authorization required for local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by AIM.

• SURG.00077 Uterine Fibroid Ablation: Laparoscopic, Percutaneous or Transcervical Image Guided Techniques: This document addresses laparoscopic and percutaneous ablative techniques for the treatment of symptomatic uterine fibroids. o Revised title (previous title: Uterine Fibroid Ablation: Laparoscopic or Percutaneous Image Guided Techniques) o Expanded scope of document to include transcervical image guided techniques o Added radiofrequency ablation using a transcervical approach in combination with imaging guidance as a treatment of uterine fibroids as Investigational & Not Medically Necessary

• SURG.00112 Implantation of Occipital, Supraorbital or Trigeminal Nerve Stimulation Devices (and Related Procedures): This document addresses occipital nerve and supraorbital nerve stimulation which involves the implantation of a permanent device to deliver small electrical impulses to the occipital or supraorbital nerves. o Revised title (previous title: Occipital Nerve and Supraorbital Nerve Stimulation) o Revised scope of document to address implanted nerve stimulation devices and related procedures o Added implantation of a trigeminal nerve stimulation device (and related procedures) as Investigational & Not Medically Necessary for all indications

• SURG.00128 Implantable Left Atrial Hemodynamic Monitor: This document addresses occipital nerve and supraorbital nerve stimulation which involves the implantation of a permanent device to deliver small electrical impulses to the occipital or supraorbital nerves. o Clarified INV&NMN statement for left atrial hemodynamic monitoring utilizing implantable device, updating list of examples to include V-LAP™ System

Medical Policy to be archived October 7, 2020

• RAD.00062 MED.00041 Intravascular Optical Coherence Tomography (OCT)

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.

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Transition to AIM Rehabilitative and Habilitative Services Clinical Appropriateness Guidelines Delay

On July 1, 2020, we announced the transition of the Anthem Clinical UM Guidelines listed below to AIM Rehabilitative and Habilitative Services Clinical Appropriateness Guidelines effective October 1, 2020. Please be advised that this transition has been delayed. The new transition date will be December 1, 2020.

Number Title CG-REHAB-04 Rehabilitative and Habilitative Services: Physical Therapy CG-REHAB-05 Rehabilitative and Habilitative Services: Occupational Therapy CG-REHAB-06 Rehabilitative and Habilitative Services: Speech-Language Pathology CG-REHAB-11 Cognitive Rehabilitation

The AIM Rehabilitative and Habilitative Services Clinical Appropriateness Guidelines are located at https://aimspecialtyhealth.com/guidelines/185/index.html.

Prior authorization updates

Effective for dates of service on and after January 1, 2021, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our prior authorization review process.

Please note, inclusion of NDC code on your claim will help expedite claim processing of drugs billed with a Not Otherwise Classified (NOC) code.

Clinical Criteria information is located at www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html.

Anthem‘s prior authorization clinical review of non-oncology specialty pharmacy drugs is managed by Anthem’s medical specialty drug review team. Review of specialty pharmacy drugs for oncology indications is managed by AIM Specialty Health® (AIM), a separate company and are shown in italics in the tables below.

Clinical Criteria HCPCS or CPT Code(s) Drug ING-CC-0002 J3590 Nyvepria ING-CC-0015 J3490 Milprosa Vaginal System ING-CC-0038 J3110 Forteo ING-CC-0100 C9065 Istodax ING-CC-0168 J3490, J3590, J9999 Tecartus ING-CC-0169 C9399, J3490, J3590, J9999 Phesgo ING-CC-0170 C9399, J3590 Uplizna ING-CC-0171 J3490, J3590, J9999 Zepzelca ING-CC-0172 C9399, J3490, J3590 Viltepso ING-CC-0173 J3490, J3590 Enspryng ING-CC-0174 J3490, J3590, C9399 Kesimpta ING-CC-0175 J9015 Proleukin ING-CC-0176 J9032 Beleodaq ING-CC-0178 J9262 Synribo ING-CC-0177 J3304 Zilretta *Non oncology use is managed by the Anthem medical specialty drug review team. Oncology use is managed by AIM.

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.

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Step therapy updates

Effective for dates of service on and after January 1, 2021, the following specialty pharmacy codes from current clinical criteria documents will be included in our existing specialty pharmacy medical step therapy review process.

Clinical Criteria Status Drug(s) HCPCS Code(s) ING-CC-0002 Preferred Neulasta J2505 ING-CC-0002 Preferred Udenyca Q5111 ING-CC-0002 Non-preferred Fulphila Q5108 ING-CC-0002 Non-preferred Ziextenzo Q5120 ING-CC-0002 Non-preferred Nyvepria J3590 Oncology use is managed by AIM.

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 and then selecting “Providers”, then selecting “Policies, Guidelines & Manuals” under the Provider Resources column, scrolling 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

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.

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Attachment A – Updates as of October 1, 2020 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-DME-07 Augmentative and Alternative Communication (AAC) Devices with Digitized or Synthesized Speech Output • Clarified language and added detail related to required documentation in Medically Necessary criteria • Changed "medical" and "non-medical" to "augmentative and non-augmentative" in Not Medically Necessary section CG-DME-41 Ultraviolet Light Therapy Delivery Devices for Home Use • Added ICD-10-CM diagnosis code N03.A CG-DME-44 Electronic Tumor Treatment Field (TFF) • Removed definition of tumor progression from clinical indications section and added note to refer reader to Discussion section for MacDonald criteria CG-MED-55 Site of Care: Advanced Radiologic Imaging • Revised title (previous title: Level of Care: Advanced Radiologic Imaging) • Changed wording to "site of care" from "level of care" CG-MED-63 Treatment of Hyperhidrosis • Revised formatting in clinical indications section CG-MED-69 Inhaled Nitric Oxide • Clarified Medically Necessary criteria CG-MED-76 Magnetic Source Imaging and Magnetoencephalography • Added ICD-10-CM codes G40.833, G40.834 CG-MED-83 Site of Care: Specialty Pharmaceuticals • Revised title (previous title: Level of Care: Specialty Pharmaceuticals) • Changed wording to "site of care" from "level of care" CG-MED-87 Single Photon Emission Computed Tomography Scans for Noncardiovascular Indications • Added ICD-10-CM code range R51.0-R51.9 replacing R51 CG-REHAB-08 Private Duty Nursing in the Home Setting • Clarified wording in Medically Necessary statement by removing the word “licensed” CG-SURG-09 Temporomandibular Disorders • Added ICD-10-CM code M19.09 CG-SURG-27 Gender Reassignment Surgery • Added penile prostheses to Medically Necessary criteria addressing phalloplasty procedures CG-SURG-28 Transcatheter Uterine Artery Embolization • Clarified coding to list additional diagnosis codes to pend for Medically Necessary criteria, and specific code considered Not Medically Necessary CG-SURG-52 Site of Care: Hospital-Based Ambulatory Surgical Procedures and Endoscopic Services • Revised title (previous title: Level of Care: Hospital-Based Ambulatory Surgical Procedures and Endoscopic Services) • Changed wording to "site of care" from "level of care" CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity • Revised Medically Necessary criteria addressing weight loss by removing the 6 month requirement and instead including past participation in a weight loss program with inadequate weight loss despite a committed attempt at conservative medical therapy
• Removed the ReShape Integrated Dual Balloon System and the MAESTRO Rechargeable System from Not Medically Necessary section as they are no longer available CG-SURG-95 Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation for Urinary and Fecal Incontinence; Urinary Retention • Added ICD-10-CM code range K59.81-K59.89 replacing K59.8

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.

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ADMIN.00006 Review of Services for Benefit Determinations in the Absence of a Company Applicable Medical Policy or Clinical Utilization Management (UM) Guideline • Replaced single quotation marks with double quotation marks, hyphenated the words decision-making and placed an asterisk after the comma in the Description/Scope section
• Added Neurocritical Care, Micrographic Dermatologic Surgery Under Physician Specialty Societies’ table • Added Complex to Pediatric Otolaryngology in the Subspecialty Certificate section of the table
• Reformatted general and vascular surgery under the General Certificate section of the table GENE.00033 Genetic Testing for Inherited Peripheral Neuropathies • Removed CPT panel code 81448; moved to GENE.00052 which addresses genetic panel tests LAB.00011 Analysis of Proteomic Patterns • Expanded scope of Investigational & Not Medically Necessary statement to address all indications MED.00103 Automated Evacuation of Meibomian Gland • Added existing CPT Category III code 0563T for evacuation using a wearable device, considered Investigational & Not Medically Necessary OR-PR.00005 Upper Extremity Myoelectric Orthoses • Descriptor revisions for L8701, L8702 OR-PR.00006 Powered Robotic Lower Body Exoskeleton Devices • Added HCPCS code K1007 effective 10/01/2020 for ReWalk system, considered INV&NMN SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added HCPCS codes Q4249, Q4250, Q4254, Q4255 for amniotic products (considered Investigational & Not Medically Necessary) and ICD-10-CM code H18.599 replacing H18.59 SURG.00047 Transendoscopic Therapy for Gastroesophageal Reflux Disease, Dysphagia and Gastroparesis • Added ICD-10-CM code K21.00 replacing K21.0 SURG.00096 Surgical and Ablative Treatments for Chronic Headaches • Added ICD-10-CM code range R51.0-R51.9 replacing R51 SURG.00127 Sacroiliac Joint Fusion • Added ICD-10-CM codes M80.0AXA-M80.0AXS, M80.8AXA- M80.8AXS SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea or Snoring • Added device codes C1767, C1778, C1787, L8680, L8681, L8688 associated with hypoglossal nerve stimulation SURG.00131 Lower Esophageal Sphincter Augmentation Devices for the Treatment of Gastroesophageal Reflux Disease (GERD) • Added ICD-10-CM K21.00 replacing K21.0
SURG.00135 Radiofrequency Ablation of the Renal Sympathetic Nerves • Removed ICD-10-PCS codes 015L3ZZ, 015N3ZZ that are not applicable SURG.00142 Genicular Nerve Blocks and Ablation for Chronic Knee Pain • Added ICD-10-CM codes M92.501-M92.529 replacing M92.50- M92.52 SURG.00144 Occipital Nerve Block Therapy for the Treatment of Headache and Occipital Neuralgia • Added ICD-10-CM R51.0-R51.9 replacing R51 TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors • Added ICD-10-CM codes M06.0A, M08.0A, M08.2A