MP/CG Update/Notice - July 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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA

July 1, 2020

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

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.

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 Policy effective October 1, 2020

 DME.00042 Electronic Positional Devices for the Treatment of Obstructive Sleep Apnea: This document addresses electronic devices used in the treatment of positional obstructive sleep apnea (POSA). o Electronic positional therapy devices are considered Investigational and Not Medically Necessary in the treatment of obstructive sleep apnea

 MED.00131 Electronic Home Visual Field Monitoring: This document addresses the use of home visual field testing devices. o The use of electronic home visual field monitoring is considered Investigational and Not Medically Necessary for all indications

 MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures:
This document addresses the following soft tissue augmentation procedures: Autologous adipose-derived regenerative cell therapy (for example, Lipogems); Autologous fat grafting (autologous fat transfer); and Injectable soft tissue fillers. o Outlines the Medically Necessary, Reconstructive, Investigational and Not Medically Necessary, and Cosmetic and Not Medically Necessary indications for autologous fat grafting and injectable soft tissue fillers o Dermal fillers and regenerative therapy criteria moved from existing medical policies (ANC.00007 and MED.00110) to this new medical policy with no change to criteria o Autologous adipose-derived regenerative cell therapy (for example, Lipogems) is considered Investigational and Not Medically Necessary for all indications o Added codes 31574, C1878, L8607 for soft tissue (vocal cord) bulking agents to be reviewed for Medically Necessary criteria (previously addressed in SURG.00011) o Prior authorization required for all codes listed in this new medical policy effective October 1, 2020

 MED.00133 Ingestion Event Monitors: This document addresses ingestion event sensors for medication monitoring and adherence (ID-CAP™ System, Discover®).
o Ingestion event monitors are considered Investigational and Not Medically Necessary for medication monitoring and adherence and for all other indications

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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA  THER-RAD.00012 Electrophysiology-Guided Noninvasive Stereotactic Cardiac Radioablation: This document addresses the use of electrophysiology-guided noninvasive stereotactic cardiac radioablation as a treatment modality for cardiac arrhythmias, including drug and ablation refractory ventricular tachycardia (VT) and cardiomyopathy related to premature ventricular contractions (PVC). o The use of electrophysiology-guided noninvasive stereotactic cardiac radioablation is considered Investigational and Not Medically Necessary as a treatment modality for all indications, including drug and ablation refractory ventricular tachycardia and cardiomyopathy related to premature ventricular contractions
o Prior authorization required for AIM eligible members effective October 1, 2020

UPDATED Medical Policies and Clinical Guidelines effective October 1, 2020

 CG-DME-46 Pneumatic Compression Devices for Prevention of Deep Vein Thrombosis of the Extremities in the Home Setting: This document addresses the use of pneumatic compression devices (PCDs) for the prevention of deep vein thrombosis (DVT) of the extremities. o Revised title (previous title: Pneumatic Compression Devices for Prevention of Deep Vein Thrombosis of the Extremities) o Expanded scope of document o Revised Medically Necessary statement to include prevention of deep vein thrombosis for all indications in the home setting

 MED.00004 Technologies for the Evaluation of Skin Lesions (including Dermatoscopy, Epiluminescence Microscopy, Videomicroscopy, Ultrasonography): This document addresses the use of photographic, optical, video, and other imaging technologies for the evaluation of skin lesions. o Added reflectance confocal microscopy for the evaluation of skin lesions as Not Medically Necessary in all cases o Removed Cosmetic and Not Medically Necessary statement

UPDATED Medical Policies and Clinical Guidelines for AIM eligible members effective October 1, 2020

 CG-GENE-02 Analysis of RAS Status: This document addresses DNA testing used to determine the status of the RAS gene family (HRAS, KRAS, or NRAS), which is often used to guide therapy decisions in individuals with oncologic conditions. o Clarified scope of document to include indications for HRAS o Added HRAS as Not Medically Necessary

Clinical UM Guidelines being transitioned to AIM Rehabilitative and Habilitative Services Clinical Appropriateness Guidelines effective October 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.

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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA Medical Policy to be archived July 8, 2020

 TRANS.00036 Stem Cell Therapy for Peripheral Vascular Disease

Specialty Pharmacy updates  

Prior authorization updates

Effective for dates of service on and after October 1, 2020, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our prior authorization review process. Anthem’s prior authorization clinical review of non-oncology specialty pharmacy drugs is managed by Anthem’s medical specialty drug review team.

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 available at www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html.

Clinical Criteria HCPCS or CPT Code(s) Drug ING-CC-0038 J3110 Bonsity ING-CC-0162 C9061, J3490, J3590 Tepezza ING-CC-0163 C9399, J3490 Durysta Step therapy updates

Effective for dates of service on and after October 1, 2020, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our existing specialty pharmacy medical step therapy review process.

Clinical Criteria Status Drug(s) HCPCS Codes ING-CC-0072 Preferred Avastin J9035, C9257 ING-CC-0072 Preferred Mvasi Q5107 ING-CC-0072 Preferred Zirabev Q5118 ING-CC-0072 Preferred Eylea J0178 ING-CC-0072 Non-preferred Lucentis J2778 ING-CC-0072 Non-preferred Macugen J2503 ING-CC-0072 Non-preferred Beovu J0179

CORRECTION: June 2020 step therapy update on clinical criteria ING-CC-0003

Panzyga has been non-preferred for ING-CC 0003 since 2018. In Anthem’s written June 2020 notice, we stated Panzyga would be effective September 1, 2020. This was included in error.

New MCG 24th Edition Guidelines effective July 1, 2020

Effective July 1, 2020, we will begin using the new acute viral illness guidelines that have been added to the 24th edition of MCG. Based on the presenting symptoms or required interventions driving the need for treatment or hospitalization, these guidelines are not a substantive or material change to existing MCG guidelines we use now, such as systemic or infectious condition, pulmonary disease, or adult or pediatric pneumonia guidelines.

Inpatient & Surgical Care (ISC)  Viral Illness, Acute – Inpatient Adult (M-280)  Viral Illness, Acute – Inpatient Pediatric (P-280)  Viral Illness, Acute – Observation Care (OC-064)

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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA Recovery Facility Care (RFC)  Viral Illness, Acute – Recovery Facility Care (M-5280)

For questions, please contact the provider service number on the back of the member's ID card.

Update to AIM Clinical Appropriateness Guidelines

Effective for dates of service on and after October 1, 2020, the following updates by section will apply to the AIM Clinical Appropriateness Guidelines.

Changes to the AIM Musculoskeletal Program prior authorization requirements and setting determinations

AIM administers the musculoskeletal program, which includes the medical necessity review of certain surgeries of the spine and joints and interventional pain treatment. For certain surgeries, the review also includes a consideration of the level of care for AIM eligible members.

According to the clinical criteria for level of care, which is based on clinical evidence as outlined in the AIM Level of Care Guideline for Musculoskeletal Surgery and Procedures, it is generally appropriate to perform joint codes (CPT codes 27130, 29871, 29892) and 4 spine codes (CPT codes 22633, 22634, 63265 and 63267) in a hospital outpatient setting. To avoid additional clinical review for these procedures, providers requesting prior authorization should either choose “hospital observation” admission as the site of service or Hospital Outpatient Department (HOPD). If the provider determines that an inpatient stay is necessary due to post-operative care requirements, they can initiate a concurrent review request for inpatient admission with the health plan by contacting the number on the back of the member ID card.

Total hip arthroplasty (CPT code 27130) is currently reviewed for medical necessity and level of care. Effective October 1, 2020, 4 spine codes (CPT codes 22633, 22634, 63265 and 63267) and 2 joint codes (29871 and 29892) will be incorporated into the AIM Level of Care Guideline for Musculoskeletal Surgery and Procedures. We will review requests for inpatient admission and will require the provider to substantiate the medical necessity of the inpatient setting with proper medical documentation that demonstrates one of the following:

 Current postoperative care requirements are of such an intensity and/or duration that they cannot be met in an observation or outpatient surgical setting.
 Anticipated postoperative care requirements cannot be met, even initially, in an observational surgical setting due to the complexity, duration, or extent of the planned procedure and/or substantial preoperative patient risk.

Peer to peer conversations are available to a provider at any time to discuss the applicable clinical criteria and to provide information about the circumstances of a specific member.

Providers should continue to submit pre-service review requests to AIM using one of the following ways:

 Access AIM ProviderPortalSM directly at providerportal.com. Online access is available 24/7 to process orders in real-time, and is the fastest and most convenient way to request authorization.
 Access AIM via the Availity Portal at availity.com
 Call the AIM Contact Center toll-free number: 1-877-291-0360, Monday–Friday, 7:00 a.m.–5:00 p.m. PT

For questions related to guidelines, please contact AIM via email at aim.guidelines@aimspecialtyhealth.com. Additionally, you may access and download a copy of the current and upcoming guidelines at specialtyhealth.com/marketing/guidelines/185/index.html. For inpatient admission, please contact the health plan at the number on the back of the member ID card.

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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA 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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA Attachment A – Updates as of July 1, 2020 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes ANC.00007 Cosmetic and Reconstructive Services: Skin Related • Moved information addressing dermal fillers, collagen injections and hyaluronic acid gel products to new policy MED.00132 Adipose-derived Regenerative Cell Therapy CG-GENE-12 PIK3CA Mutation Testing for Malignant Conditions • Add code 0177U effective 07/01/2020 (therascreen®) PIK3CA RGQ PCR Kit companion test CG-GENE-13 Genetic Testing for Inherited Diseases • Added ApoB, CPOX, HMBS, LDLR, LDLRAP1, MYH11, PCSK9, PPOX, TGFBR1, and TGFBR2 to table of genes in Discussion section • Moved S3841 and S3842 to CG-GENE-14 • Coding update - added 0170U CG-GENE-14 Gene Mutation Testing for Solid Tumor Cancer Susceptibility and Management • Updated Clinical Utility table in Discussion section • Updated Targeted Cancer Therapies table in Appendix A • Added S3841 and S3842 from CG-GENE-13 CG-GENE-16 BRCA Testing for Breast and/or Ovarian Cancer Syndrome • Added 0172U effective 07/01/2020 for companion test myChoice CDx as Medically Necessary for Zejula therapy CG-MED-23 Home Health • Coding update - added G2168 and G2169 CG-MED-74 Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry • Clarified scope of document • Clarified Medically Necessary statement addressing mobile cardiac telemetry • Added Medically Necessary statement to address replacement of implantable ambulatory event monitors • Added separate Not Medically Necessary statement for mobile cardiac telemetry CG-SURG-27 Gender Reassignment Surgery • Added text to Medically Necessary statement for mastectomy referring reader to see Further Considerations section for individuals under 18 years of age • Added new Further Considerations section addressing mastectomy procedures for individuals < 18 years of age DME.00009 Vacuum Assisted Wound Therapy in the Outpatient Setting • Removed Investigational and Not Medically Necessary statement addressing battery-powered devices
DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices • Added transcutaneous electrical modulation pain reprocessing as Investigational and Not Medically Necessary for all indications including, but not limited to, treatment of acute and chronic pain
• Reordered statements in alphabetical order DME.00034 Standing Frames • Added non-powered standing frame as Medically Necessary when criteria are met • Revised Investigational and Not Medically Necessary statement to be a Not Medically Necessary statement • Clarified that a powered standing frame is Not Medically Necessary GENE.00007 Cardiac Ion Channel Genetic Testing • Information and a table of major genes for LQTS was added to the Background section • Updated Coding section to clarify genes for LQTS • Code 81413 removed; moved to GENE.00052

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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status • Revised title (previous title: Panel Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status) • Revised position statement to state: "The use of panel and multi-gene tests for polymorphisms to determine drug- metabolizer status is considered Investigational and Not Medically Necessary" GENE.00017 Genetic Testing for Diagnosis and Management of Hereditary Cardiomyopathies (including arrhythmogenic right ventricular dysplasia/cardiomyopathy) • Added a table of genes associated with testing for the cardiomyopathies to Rationale section GENE.00049 Circulating Tumor DNA Testing for Cancer (Liquid Biopsy) • Add code 0179U effective 07/01/2020 (Resolution ctDx Lung™) GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Add code 81413; moved from GENE.00007 LAB.00011 Analysis of Proteomic Patterns • Add code 0174U effective 07/01/2020 (Targeted Proteomic Assay) LAB.00016 Fecal Analysis in the Diagnosis of Intestinal Disorders • Added fecal analysis panels as a diagnostic test for the evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption or small intestinal overgrowth of bacteria as Investigational and Not Medically Necessary MED.00110 Silver-based Products and Autologous Skin-, Blood- or Bone Marrow-derived Products for Wound and Soft Tissue Applications • Revised title (previous title: Growth Factors, Silver-based Products and Autologous Tissues for Wound Treatment, Soft Tissue Grafting, and Regenerative Therapy) • Moved information addressing autologous adipose-derived regenerative cell therapy to MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures MED.00129 Gene Therapy for Spinal Muscular Atrophy • Add code C9399 and J3590 effective 07/01/20 for Zolgensma SURG.00007 Vagus Nerve Stimulation • Added a requirement to the Medically Necessary revision/replacement language that current device is not functioning properly • Updated Investigational and Not Medically Necessary statement addressing replacement or revision SURG.00010 Treatments for Urinary Incontinence • Add codes 0596T and 0597T effective 07/01/20 SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Add codes Q4227-Q4242, Q4244-Q4248 effective 07/01/2020 • Revised descriptor for Q4176 effective 07/01/2020; • Removed codes C1878, L8607 now addressed in MED.00132 SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation • Reformatted Medically Necessary statement addressing primary dystonia • Added unilateral or bilateral deep brain stimulation of the anterior nucleus of the thalamus as Medically Necessary for individuals with epilepsy when criteria are met • Revised and clarified the Investigational and Not Medically Necessary statement addressing all other conditions

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.

521-0720-DM-CA, 540-0720-DM-CA, 553-0720-DM-CA

SURG.00047 Transendoscopic Therapy for Gastroesophageal Reflux Disease, Dysphagia and Gastroparesis • Added peroral endoscopic myotomy (POEM) for the treatment of primary achalasia as Medically Necessary when criteria are met • Added POEM as Not Medically Necessary when criteria are not met and for all other indications • Updated Investigational and Not Medically Necessary
statement SURG.00121 Transcatheter Heart Valve Procedures • Added valve-in-valve transcatheter mitral valve repair as Investigational and Not Medically Necessary for all indications as a separate statement SURG.00126 Irreversible Electroporation (IRE) • Add 0600T and 0601T replacing NOC codes effective 07/01/20 SURG.00132 Drug-Eluting Devices for Maintaining Sinus Ostial Patency • Add code C9122 effective 07/01/2020 (Sinuva) TRANS.00035 Other Stem Cell Therapy • Revised title (previous title: Non-Hematopoietic Adult Stem Cell Therapy)
• Revised scope • Moved content from TRANS.00036 to this policy • Revised position statement to read: Stem cell therapy, including but not limited to mesenchymal stem cell therapy is considered Investigational and Not Medically Necessary for the prevention and treatment of all conditions including but not limited to peripheral vascular disease, and orthopedic, autoimmune, inflammatory and degenerative conditions • Added Note to position statement: This document does not address stem cell therapy used for disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment, or hematopoietic stem cell transplantation