MP/CG Update/Notice - December 2019 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.

December 1, 2019

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

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.

New Medical Policies and Clinical Guidelines

• CG-GENE-13 Genetic Testing for Inherited Diseases: This document addresses testing for certain diseases with an established genetic basis.
Effective February 6, 2020 o Content moved from GENE.00012 (Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent) and GENE.00043 (Genetic Testing of an Individual’s Genome for Inherited Diseases)
o Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of Medical Policy to Clinical Guideline transition o Removed whole genome, whole exome, and gene panel testing from document (moved to GENE.00052) Effective March 1, 2020 o Add screening and testing of individuals with suspected Autism Spectrum Disorders (ASDs) and Rett syndrome and for genes NLGN3 and NLGN4X o Change ATM (ataxia telangiectasia mutated) to Not Medically Necessary; delete code 0136U (not applicable)

• CG-GENE-14 Gene Mutation Testing for Solid Tumor Cancer Susceptibility and Management: This document addresses gene mutation testing to: (1) determine whether an individual is at risk for the development of solid malignant tumors (including but not limited to breast, colon, lung, pancreatic and ovarian cancers) and (2) guide targeted cancer therapy in individuals with solid malignant tumors. Effective February 6, 2020 o All content except panel codes moved from GENE.00001; whole genome, whole exome, and gene panel testing moved to GENE.00052 o Title revised (previous title: Genetic Testing for Cancer Susceptibility) o Investigational and Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition o Limited scope to gene mutation testing for solid tumor cancer susceptibility and management o Add 81403 and 81408 and additional genes to other Tier 2 codes to pend for Medically Necessary criteria; add 81242 as Not Medically Necessary for this indication. Effective March 1, 2020 o Add criteria for gene mutation testing to guide targeted cancer therapy in individuals with solid tumors o Add codes 81307 and 81308

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.

• GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling-13 Genetic Testing for Inherited Diseases: This document outlines the Medically Necessary and Not Medically Necessary criteria for whole genome sequencing, whole exome sequencing, gene panels and molecular profiling. Effective February 6, 2020 o Contains content from all other documents regarding whole genome/whole exome/mitochondrial DNA testing, all panel tests (defined as 5 or more genes, or gene mutation variants, same day, same member, same rendering provider) and molecular profiling
− GENE.00001 Genetic Testing for Cancer Susceptibility − GENE.00012 Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent − GENE.00025 Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignancies − GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility − GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome − GENE.00030 Genetic Testing for Endocrine Gland Cancer Susceptibility − GENE.00035 Genetic Testing for TP53 Mutations − GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases o Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of Medical Policy to Clinical Guideline transition

Updated Medical Policies effective March 1, 2020

• DME.00025 Self-Operated Spinal Unloading Devices: This document addresses self-operated spinal unloading devices, which are designed to support the upper body’s weight and transfer that weight to the hips via a mechanical or pneumatic mechanism. o Add HomeTrac advertised as home traction device (DME) as Investigational & Not Medically Necessary

• GENE.00009 Gene-Based Tests for Screening, Detection and Management of Prostate Cancer: This document addresses gene-based tests for the screening, detection and management of prostate cancer. o Add new CPT code 81542 as Investigational & Not Medically Necessary

• GENE.00011 Gene Expression Profiling for Managing Breast Cancer Treatment: This document addresses the use of genetic profiling of breast tumors to predict breast cancer recurrence and response to therapy. o Add new CPT codes 81522 for EndoPredict with Medically Necessary criteria, and 0153U as Investigational & Not Medically Necessary

• LAB.00030 Measurement of Serum Concentrations of Monoclonal Antibody Drugs and Antibodies to Monoclonal Antibody Drugs: This document addresses the measurement of serum concentrations of monoclonal antibody (MAB) drugs, including tumor necrosis factor (TNF) antagonist drugs, and antibodies to MAB drugs in individuals with various conditions. o Add new CPT codes 80145, 80230 and 80280 for adalimumab, infliximab, vedolizumab assays, considered Investigational & Not Medically Necessary

• SURG.00028 Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH):
This document addresses various surgical and minimally invasive procedures used in the treatment of benign prostatic hyperplasia, and the use of these procedures. o Revise title (previous title: Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia [BPH] and Other Genitourinary Conditions) o Revise scope of document to only address benign prostatic hyperplasia (BPH) o Combine surgical and minimally invasive treatment into one Medically Necessary section
o Revise Medically Necessary criteria for transurethral incision of the prostate by adding "prostate volume less the 30 mL o Add transurethral convective water vapor thermal ablation in individuals with prostate volume less than 80 mL as Medically Necessary indication o Add waterjet tissue ablation as Medically Necessary indication o Transurethral radiofrequency needle ablation moved from Medically Necessary to Not Medically Necessary
section o Investigational & Not Medically Necessary indications changed to Not Medically Necessary

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.

o Placement of prostatic stents moved from standalone statement to combined Not Medically Necessary
statement

• SURG.00037 Treatment of Varicose Veins (Lower Extremities): This document addresses various modalities for the treatment of valvular incompetence (reflux) of the great saphenous vein (GSV) or small saphenous vein (SSV) (also known as greater saphenous vein or lesser saphenous vein, respectively) and associated varicose tributaries as well as telangiectatic dermal veins. o Add the anterior accessory great saphenous vein (AAGSV) to the Medically Necessary criteria for ablation and made additional clarifications o Add language to the Medically Necessary criteria for ablation techniques addressing variant anatomy o Add limits to retreatment to the Medically Necessary criteria for all procedures

• SURG.00047 Transendoscopic Therapy for Gastroesophageal Reflux Disease, Dysphagia and Gastroparesis): This document addresses selected transendoscopic therapies for the treatment of gastroesophageal reflux disease (GERD) and dysphagia.
o Revise title (previous title: Transendoscopic Therapy for Gastroesophageal Reflux Disease and Dysphagia) o Expand scope to include gastroparesis o Add gastric peroral endoscopic myotomy or peroral pyloromyotomy as Investigational & Not Medically Necessary

• SURG.00097 Vertebral Body Stapling and Tethering for the Treatment of Scoliosis in Children and Adolescents): This document addresses vertebral body stapling and vertebral body tethering as surgical treatments of scoliosis.
o Revise title (previous title: Vertebral Body Stapling for the Treatment of Scoliosis in Children and Adolescents) o Expand scope of document to include vertebral body tethering o Add vertebral body tethering as Investigational & Not Medically Necessary

• SURG.00121 Transcatheter Heart Valve Procedures: This document addresses the transcatheter (percutaneous or catheter-based) approach for aortic or pulmonary heart valve replacement, transcatheter mitral valve repair using leaflet repair or percutaneous annuloplasty, and transcatheter tricuspid valve repair or replacement. o Add new CPT codes 0569T and 0570T for tricuspid valve procedures, considered Investigational & Not Medically Necessary

• SURG.00127 Sacroiliac Joint Fusion: This document addresses proposed indications for sacroiliac joint fusion, a surgical procedure which fuses the iliac bone (pelvis) to the spine (sacrum). o Clarified Medically Necessary statement for open sacroiliac joint fusion procedures (SIJF) (excluding minimally invasive or percutaneous SIJF procedures) when criteria met o Add Medically Necessary statement minimally invasive and percutaneous SIJF procedures for the treatment of chronic SI joint pain or functional impairment subsequent to pelvic girdle trauma when criteria met o Revise Investigational & Not Medically Necessary statement for SIJF procedures, including but not limited to "poorly defined low back pain"
o Revise Investigational & Not Medically Necessary statement for minimally invasive SIJF and percutaneous SIJF procedures to include conditions not listed above

• TRANS.00010 Autologous and Allogeneic Pancreatic Islet Cell Transplantation: This document addresses autologous and allogeneic pancreatic islet cell transplantation. o Add new CPT codes 0584T, 0585T and 0586T for islet cell transplantation, considered Investigational & Not Medically Necessary

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.

Medical Policies converted to Clinical Guidelines effective February 6, 2020 (Changes noted in Attachment A)

MP Number Title CG Number GENE.00006 Epidermal Growth Factor Receptor (EGFR) Testing CG-GENE-20 GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility CG-GENE-15 GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome CG-GENE-16 GENE.00030 Genetic Testing for Endocrine Gland Cancer Susceptibility CG-GENE-17 GENE.00035 Genetic Testing for TP53 Mutations CG-GENE-18 GENE.00045 Detection and Quantification of Tumor DNA Using Next Generation Sequencing in Lymphoid Cancers CG-GENE-19 MED.00109 Corneal Collagen Cross-Linking CG-SURG-105 RAD.00023 Single Photon Emission Computed Tomography Scans for Noncardiovascular Indications CG-MED-87 SURG.00122 Venous Angioplasty with or without Stent Placement or Venous Stenting Alone CG-SURG-106

Medical Policy to be archived effective December 14, 2019

RAD.00054 MRI of the Bone Marrow

Clinical Guideline to be archived effective February 5, 2020

CG-SURG-62 Radiofrequency Ablation to Treat Tumors Outside the Liver is being combined with CG-SURG-61 Cryosurgical or Radiofrequency Ablation to Treat Solid Tumors Outside the Liver (previous title: Cryosurgical Ablation of Solid Tumors Outside the Liver).

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 hovering over “Providers”, then selecting “Policies and Guidelines” under the Provider Resources column, scrolling down to select “View Medical Policies & UM Guidelines”, then selecting “Medical Policies and Clinical UM Guidelines (for Local Plan members)”, then selecting “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,

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.

Attachment A – Updates as of December 18, 2019 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes ADMIN.00001 Medical Policy Formation • Update text in Description/Scope section regarding services addressed and subspecialty committees. ANC.00009 Cosmetic and Reconstructive Services of the Trunk and Groin • Add Medically Necessary indications for liposuction and lipectomy for the treatment of lymphedema and lipedema when there is a significant physical functional impairment and other criteria are met • Expand the reconstructive indications for liposuction and lipectomy for lymphedema and lipedema beyond breast cancer when there is a significant variation from normal • Clarified Cosmetic & Not Medically Necessary statement for lipectomy or liposuction • Made minor spelling and grammar changes throughout Position Statement BEH.00002 Transcranial Magnetic Stimulation • Simplified Medically Necessary criteria addressing the use of
psychopharmacologic agents and reduced the number of required trials of antidepressant medications from 4 to 2 CG-ANC-04 Ambulance Services: Air and Water • Add the statement “Air transportation may be appropriate if the time between identification of the need for transportation until arrival at the intended destination for ground ambulance would be 30 minutes or longer than air transport" to the Medically Necessary criteria section CG-BEH-02 Adaptive Behavioral Treatment for Autism Spectrum Disorder • Revise Clinical Indications to align with code descriptor nomenclature • Add wording on Early Start Denver Model to Discussion section CG-DME-34 Wheeled Mobility Devices: Wheelchair Accessories • Add new HCPCS E2398 effective January 1, 2020 for positioning hardware CG-GENE-12 PIK3CA Mutation Testing for Malignant Conditions • Revise title (previous title: PIK3CA Mutation Testing) • Add codes 81309 and 0115U replacing 81404 effective January 1, 2020 • Clarified that document only addresses malignant conditions • Clarified Medically Necessary criteria for use of circulating tumor DNA (ctDNA) testing • Clarified Not Medically Necessary statement CG-GENE-15 Genetic Testing for Lynch Syndrome, Familial Adenomatous Polyposis (FAP), Attenuated FAP and MYH- associated Polyposis • Content except panel codes moved from GENE.00028; whole genome, whole exome, and gene panel testing moved to GENE.00052 • Title revised (previous title: Genetic Testing for Colorectal Cancer Susceptibility) • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition

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.

CG-GENE-16 BRCA Testing for Breast and/or Ovarian Cancer Syndrome • Content except panel codes moved from GENE.00029; whole genome, whole exome, and gene panel testing moved to GENE.00052 • Title revision (previous title: Genetic Testing for Breast and/or Ovarian Cancer Syndrome) • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition • Revise Clinical Indications to include recommendations from the USPSTF • Add Note to refer to the NCCN testing criteria and BRCA1 or BRCA2 mutation assessment tools listed in the Discussion/General Information section • List additional ICD-10-CM diagnosis codes to pend for Medically Necessary criteria; removed 0138U not applicable
CG-GENE-17 RET Proto-oncogene Testing
for Endocrine Gland Cancer Susceptibility • Content except panel codes moved from GENE.00030; whole genome, whole exome, and gene panel testing moved to GENE.00052 • Title revision (previous title: Genetic Testing for Endocrine Gland Cancer Susceptibility • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition CG-GENE-18 Genetic Testing for TP53 Mutations • Content except panel codes moved from GENE.00035; whole genome, whole exome, and gene panel testing moved to GENE.00052 • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition CG-GENE-19 Detection and Quantification of Tumor DNA Using Next Generation Sequencing in Lymphoid Cancers • Content moved from GENE.00045 • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition • Clarified that “minimal residual disease” is also referred to as “measurable residual disease” in Medically Necessary criteria CG-GENE-20 Epidermal Growth Factor Receptor (EGFR) Testing • Content moved from GENE.00006 • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of transition • Remove acronym and made minor wording change in Clinical Indications section CG-MED-87 Single Photon Emission Computed Tomography Scans for Noncardiovascular Indications • Content moved from RAD.00023 • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition • Add CPT 78831, revised 78803 for tumor or inflammatory any area effective January 1, 2020; delete 78205, 78206, 78320, 78607, 78647, 78710, 78807 effective December 31, 2019 CG-MED-71 Wound Care in the Home or Outpatient Setting • Revise title (previous title: Wound Care in the Home Setting) • Revise scope of document to address only chronic wounds and expanded scope to include outpatient settings CG-REHAB-11 Cognitive Rehabilitation • Add new CPT codes 97129 and 97130 effective January 1, 2020, replacing 97127 deleted December 31, 2019

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.

CG-SURG-27 Gender Reassignment Surgery • Revise title (previous title: Sex Reassignment Surgery) • Update document contents to replace “sex reassignment” with “gender reassignment” and “his or her” with “their”
• Clarified Medically Necessary statement regarding hair removal procedures • Made minor language revisions to Clinical Indications section • Add text to the Background section regarding WPATH recommendations for the content of referral letters • CPT code 19304 deleted effective January 1, 2020 CG-SURG-61 Cryosurgical or Radiofrequency Ablation to Treat Solid Tumors Outside the Liver • Merged content of CG-SURG-62 (Radiofrequency Ablation to Treat Tumors Outside the Liver) with no change in criteria effective February 1, 2020 • Revise title (previous title: Cryosurgical Ablation of Solid Tumors Outside the Liver) • Add 0581T for cryotherapy of malignant breast tumor effective January 1, 2020 CG-SURG-105 Corneal Collagen Cross-Linking • Content moved from MED.00109 • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of transition • Clarified Medically Necessary criteria addressing the time of diagnosis of progressive keratoconus ("over 24 consecutive months" changed to "within 24 months") CG-SURG-106 Venous Angioplasty with or without Stent Placement or Venous Stenting Alone • Content moved from SURG.00122 • Investigational & Not Medically Necessary changed to Not Medically Necessary as a result of transition • • No other change to clinical indications GENE.00018 Gene Expression Profiling for Cancers of Unknown Primary Site • Remove 81406, microarray deleted from Tier 2 code effective December 31, 2019 GENE.00023 Gene Expression Profiling of Melanomas • Add new CPT 81552 effective January 1, 2020, replacing 0081U deleted December 31, 2019 GENE.00025 Proteogenomic Testing for the Evaluation of Malignancies • Revise title (previous title: Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignancies) • Remove molecular profiling from document; moved to GENE.00052 MED.00074 Computer Analysis and Probability Assessment of Electrocardiographic-Derived Data • Delete CPT code 0206T effective December 31, 2019 replaced by 93799 MED.00109 Corneal Collagen Cross-Linking • Clarified Medically Necessary criteria addressing the time of diagnosis of progressive keratoconus ("over 24 consecutive months" changed to "within 24 months") MED.00110 Growth Factors, Silver-based Products and Autologous Tissues for Wound Treatment and Soft Tissue Grafting • Remove Medically Necessary and Investigational & Not Medically Necessary statements addressing recombinant human platelet-derived growth factor (becaplermin [Regranex]) MED.00117 Autologous Cell Therapy for the Treatment of Damaged Myocardium • Remove all language addressing infusion of growth factors (i.e. granulocyte colony stimulating factor) from document including Position Statement • Transitioning granulocyte colony stimulating factor criteria (filgrastim [G-CSF]) to ING-CC-0002

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.

MED.00124 Tisagenlecleucel (Kymriah™) • Clarified Investigational & Not Medically Necessary criteria
addressing history of allogeneic stem cell transplant by adding "for individuals with large B-cell lymphoma only" MED.00125 Biofeedback and Neurofeedback • Add new CPT codes 90912 and 90913 effective January 1, 2020, replacing 90911 deleted December 31, 2019 SURG.00007 Vagus Nerve Stimulation • Add CPT code C1778 for implantable lead SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Add AmbioDisk and Artacent Ocular as Medically Necessary allogeneic amniotic membrane-derived grafts or wound coverings for ocular indications • Add AmbioDisk and Artacent Ocular as Investigational & Not
Medically Necessary when the Medically Necessary criteria are not met and for all other indications • Add new products to the Investigational & Not Medically Necessary section SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Add elective removal of an implant for individuals with an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) due to the use of Allergan BIOCELL textured breast implants and tissue expanders as Medically Necessary SURG.00032 Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention • Clarified age and size of interatrial shunting in Medically Necessary criteria addressing PFO closure SURG.00141 Doppler-Guided Transanal Hemorrhoidal Dearterialization • Add CPT 46948 effective January 1, 2020 replacing 0249T deleted December 31, 2019 SURG.00142 Genicular Nerve Blocks and Ablation for Chronic Knee Pain • Add new CPT codes 64454 and 64624 replacing 64450 and 64640 effective January 1, 2020 for nerve block and destruction of genicular nerve branches SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Add FDA-approved percutaneous ventricular assist devices (pVADs) for the treatment of individuals with cardiogenic shock as Medically Necessary when criteria are met
• Revise Investigational & Not Medically Necessary statement for pVAD TRANS.00033 Heart Transplantation • Add the use a mechanical circulatory support device as a Medically Necessary indication