MP/CG Update/Notice - May 2024 Form

Carelon Medical Benefits Management, Inc. is an independent company providing utilization management services on behalf of the health plan.

Commercial services provided by Anthem Blue Cross, 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. CABC-CM-058637-24 May 2024

California | Anthem Blue Cross | Commercial

May 1, 2024

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

Dear Provider:

Anthem Blue Cross is pleased to provide you with the following updates. Please refer to the specific policy for coding, language, rationale updates and changes that are not summarized below.

NEW Medical Policies with prior authorization required effective August 1, 2024

• OR-PR.00008 Osseointegrated Limb Prostheses: This document addresses the use of osseointegrated (bone-anchored) prosthetic devices for improving the mobility and function of people who have had limb loss.
o Outlines the Medically Necessary and Not Medically Necessary criteria

• SURG.00162 Implantable Shock Absorber for Treatment of Knee Osteoarthritis: This document addresses the use of an implantable shock absorber device (for example, MISHA™ Knee System) for the treatment of osteoarthritis of the knee. o Considered Investigational and Not Medically Necessary

Updated Medical Policy effective August 1, 2024

• LAB.00039 Combined Pathogen Identification and Drug Resistance Testing: This document addresses combined pathogen identification and drug resistance testing, including pooled antibiotic sensitivity testing (P- AST). o Previously titled “Pooled Antibiotic Sensitivity Testing” o Revised Position Statement to address “combined pathogen identification and drug resistance” testing

• SURG.00052 Percutaneous Vertebral Disc and Vertebral Endplate Procedures: This document addresses several minimally invasive surgical procedures designed to destroy nociceptive nerve fibers with or without structural changes to the intervertebral discs. o Revised Medically Necessary criteria for basivertebral nerve ablation (BVNA)

Medical Policy archived March 15, 2024

• MED.00024 Adoptive Immunotherapy and Cellular Therapy

Medical Policies and Clinical Guidelines archived April 1, 2024

• CG-GENE-04 Molecular Marker Evaluation of Thyroid Nodules • CG-GENE-10 Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability and Congenital Anomalies • CG-GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status • CG-GENE-13 Genetic Testing for Inherited Diseases • CG-GENE-14 Gene Mutation Testing for Cancer Susceptibility and Management

• CG-GENE-15 Genetic Testing for Lynch Syndrome, Familial Adenomatous Polyposis (FAP), Attenuated FAP and MYH-associated Polyposis • CG-GENE-16 BRCA Genetic Testing • CG-GENE-18 Genetic Testing for TP53 Mutations • CG-GENE-19 Measurable Residual Disease Assessment in Lymphoid Cancers Using Next Generation Sequencing • CG-GENE-21 Cell-Free Fetal DNA-Based Prenatal Testing • CG-GENE-22 Gene Expression Profiling for Managing Breast Cancer Treatment • CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities • CG-SURG-63 Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure • CG-SURG-97 Cardioverter Defibrillators • GENE.00009 Gene Expression Profiling and Genomic Biomarker Tests for Prostate Cancer • GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status • GENE.00016 Gene Expression Profiling for Colorectal Cancer • GENE.00018 Gene Expression Profiling for Cancers of Unknown Primary Site • GENE.00020 Gene Expression Profile Tests for Multiple Myeloma • GENE.00023 Gene Expression Profiling of Melanomas and Cutaneous Squamous Cell Carcinoma • GENE.00025 Proteogenomic Testing for the Evaluation of Malignancies • GENE.00041 Genetic Testing to Confirm the Identity of Laboratory Specimens • GENE.00050 Gene Expression Profiling for Coronary Artery Disease • GENE.00051 Bronchial Gene Expression Classification for the Diagnostic Evaluation of Lung Cancer • GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • GENE.00054 Paired DNA and Messenger RNA (mRNA) Genetic Testing to Detect, Diagnose and Manage Cancer • GENE.00055 Gene Expression Profiling for Risk Stratification of Inflammatory Bowel Disease (IBD) Severity • GENE.00056 Gene Expression Profiling for Bladder Cancer • GENE.00057 Gene Expression Profiling for Idiopathic Pulmonary Fibrosis • GENE.00058 TruGraf Blood Gene Expression Test for Transplant Monitoring • GENE.00059 Hybrid Personalized Molecular Residual Disease Testing for Cancer • LAB.00038 Cell-free DNA Testing to Aid in the Monitoring of Kidney Transplants for Rejection • SURG.00150 Leadless Pacemaker • TRANS.00025 Laboratory Testing as an Aid in the Diagnosis of Heart Transplant Rejection • TRANS.00041 Histological Analysis using Microarray Gene Expression Profiling for Kidney Allograft Injury or Rejection

Medical Policies and Clinical Guideline archived April 10, 2024

• CG-MED-72 Hyperthermia for Cancer Therapy • LAB.00043 Immune Biomarker Tests for Cancer • SURG.00070 Photocoagulation of Macular Drusen

Medical Policies converted to Clinical UM Guidelines effective April 10, 2024

Medical Policy Title Clinical Guideline SURG.00007 Vagus Nerve Stimulation CG-SURG-120 SURG.00036 Fetal Surgery for Prenatally Diagnosed Malformation CG-SURG-121 SURG.00037 Treatment of Varicose Veins (Lower Extremities) CG-SURG-119 SURG.00103 Intraocular Anterior Segment Aqueous Drainage Devices (without extraocular reservoir) CG-SURG-118

Medical Policy being archived effective June 1, 2024

• SURG.00105 Bicompartmental Knee Arthroplasty

Criteria for Adaptive Behavioral Treatment has a new name and location starting June 1, 2024

CG-BEH-02 Adaptive Behavioral Treatment has been renamed CAL-CB-BEH-02 Adaptive Behavioral Treatment and has been relocated to https://www.anthem.com/ca/provider/behavioral-health/.

Clinical Guidelines being archived effective September 1, 2024

• CG-MED-55 Site of Care: Advanced Radiologic Imaging • CG-REHAB-10 Site of Care: Outpatient Physical Therapy, Occupational Therapy, and Speech-Language
• CG-SURG-52 Site of Care: Hospital-based Ambulatory Surgical Procedures and Endoscopic Services

Carelon Medical Benefits Management, Inc. updates

Updates to Carelon Medical Benefits Management programs apply to local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by Carelon Medical Benefits Management. They do not apply to HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, or Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card.

In the January 1, 2024, update letter, we informed you of the expansion of Carelon Medical Benefits Management programs effective April 1, 2024. Please note that clinical appropriateness review for vascular and bariatric procedures included in the Carelon Expanded Cardiology will begin on October 1, 2024.

As a reminder, ordering and servicing providers may submit prior authorization requests to Carelon using Carelon’s 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.

Carelon Genetic Testing updates

Effective for dates of service on and after September 1, 2024, the following codes will require prior authorization through Carelon Medical Benefits Management:

CPT code Description 81457 Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, microsatellite instability 81458 Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, copy number variants and microsatellite instability 81459 Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements 81462 Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants and rearrangements 81463 Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis, copy number variants, and microsatellite instability 81464 Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (eg, plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements

0420U Oncology (urothelial), mRNA expression profiling by real-time quantitative PCR of MDK, HOXA13, CDC2, IGFBP5, and CXCR2 in combination with droplet digital PCR (ddPCR) analysis of 6 single- nucleotide polymorphisms (SNPs) genes TERT and FGFR3, urine, algorithm reported as a risk score for urothelial carcinoma 0422U Oncology (pan-solid tumor), analysis of DNA biomarker response to anti-cancer therapy using cell-free circulating DNA, biomarker comparison to a previous baseline pre-treatment cell-free circulating DNA analysis using next-generation sequencing, algorithm reported as a quantitative change from baseline, including specific alterations, if appropriate 0423U Psychiatry (eg, depression, anxiety), genomic analysis panel, including variant analysis of 26 genes, buccal swab, report including metabolizer status and risk of drug toxicity by condition 0424U Oncology (prostate), exosome-based analysis of 53 small noncoding RNAs (sncRNAs) by quantitative reverse transcription polymerase chain reaction (RT-qPCR), urine, reported as no molecular evidence, low-, moderate- or elevated-risk of prostate cancer 0425U Genome (eg, unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis, each comparator genome (eg, parents, siblings) 0426U Genome (eg, unexplained constitutional or heritable disorder or syndrome), ultra-rapid sequence analysis 0428U Oncology (breast), targeted hybrid-capture genomic sequence analysis panel, circulating tumor DNA (ctDNA) analysis of 56 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutation burden 0434U Drug metabolism (adverse drug reactions and drug response), genomic analysis panel, variant analysis of 25 genes with reported phenotypes 0438U Drug metabolism (adverse drug reactions and drug response), buccal specimen, gene-drug interactions, variant analysis of 33 genes, including deletion/duplication analysis of CYP2D6, including reported phenotypes and impacted gene-drug interactions

Specialty Pharmacy updates

Prior authorization clinical review of non-oncology use of specialty pharmacy drugs is managed by the Medical Specialty Drug Review team. Review of specialty pharmacy drugs for oncology use is managed by Carelon Medical Benefits Management, Inc., a separate company.

Important to note: Currently, your patients may be receiving these medications without prior authorization. As of the effective date below, you may be required to request prior authorization review for your patients’ continued use of these medications.

Inclusion of national drug code (NDC) code on your claim will help expedite claim processing of drugs billed with a not otherwise classified (NOC) code.

Access our Clinical Criteria at anthem.com/ca/ms/pharmacyinformation/clinicalcriteria.html to view the complete information for these prior authorization updates.

Prior authorization updates

Effective for dates of service on and after August 1, 2024, the following specialty pharmacy codes from new Clinical Criteria will be included in our prior authorization review process.

Clinical Criteria Drug HCPCS or CPT code(s) CC-0259 Amtagvi (lifleucel)
(contact the Transplant unit at 888-574-7215) J3490, J3590 CC-0258 iDoseTR (travoprost Implant) J3490, J3590 CC-0260 Nexobrid (anacaulase-bcdb) J7353

Note: Prior authorization requests for certain medications may require additional documentation to determine medical necessity.

Quality limit updates Effective for dates of service on and after August 1, 2024, the following specialty pharmacy codes from current Clinical Criteria will be included in our quantity limit review process.

Clinical Criteria Drug HCPCS or CPT code(s) CC-0064 Arcalyst (rilonacept) J2793 CC-0139 Evenity (romosozumab-aqqg) J3111 CC-0258 iDoseTR (travoprost Implant) J3490, J3590 CC-0064 Interleukin-1 inhibitors (Ilaris [canakinumab]) J0638 CC-0057 Krystexxa (pegloticase) J2507 CC-0260 Nexobrid (anacaulase-bcdb) J7353 CC-0068 Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive (somatropin drugs) J2941 CC-0047 Trogarzo (ibalizumab-uiyk) J1746 CC-0067 Tyvaso (treprostinil) J7686 CC-0067 Ventavis (Iloprost) Q4074

Site of Care updates Effective for dates of service on and after August 1, 2024, the following specialty pharmacy codes from current Clinical Criteria will be included in our site of care review process.

Clinical criteria Drug HCPCS or CPT code(s) CC-0252 Adzynma (ADAMTS13, recombinant-krhn) C9167 CC-0001 Aranesp (darbepoetin alfa) J0881 CC-0034 Berinert (c1 esterase inhibitor [human]) J0597
CC-0042 Bimzelx (bimekizumab-bkzx) C9399, J3590 CC-0042 Cosentyx (secukinumab) C9399, J3490, J3590 CC-0061 Eligard, Lupron Depot (leuprolide acetate) J9217 CC-0001 Epogen, Procrit (epoetin alfa) J0885 CC-0034 Kalbitor (ecallantide) J1290
CC-0228 Leqembi (lecanemab) J0174 CC-0061 Leuprolide Acetate Depot (Cipla) (leuprolide acetate) J1954 CC-0061 Lupron Depot (leuprolide acetate) J1950 CC-0111 Nplate (romiplostim) J2796
CC-0050 Omvoh (mirikizumab-mrkz) C9168 CC-0018 Pombiliti (cipaglucosidase alfa-atga) J1203 CC-0001 Retacrit (epoetin alfa-epbx) Q5106 CC-0235 Revcovi (elapegademase-lvlr) C9399, J3590 CC-0256 Rivfloza (nedosiran) J3490 CC-0034 Ruconest (recombinant c1 esterase inhibitor) J0596
CC-0203 Ryplazim (plasminogen, human-tvmh) J2998 CC-0058 Sandostatin (octreotide) J2354 CC-0058 Sandostatin LAR Depot (octreotide) J2353 CC-0236 Signifor LAR (pasireotide) J2502 CC-0066* Tofidence (tocilizumab-bavi) Q5133 CC-0020 Tyruko (natalizumab-sztn) Q5134 CC-0250 Veopoz (pozelimab-bbfg) J9376 CC-0257 Wainua (eplontersen) C9399, J3490 CC-0254 Zilbrysq (zilucoplan) J3490 CC-0062 Zymfentra (infliximab-dyyb) J3590

• Oncology use is managed by Carelon Medical Benefits Management.

MCG Care Guidelines 28th Edition

Effective September 1, 2024, we will upgrade to the 28th edition of MCG Care Guidelines for the following modules. Below is high level summary of the updates and is not intended to be all inclusive. • Behavioral Health Care (BHG)

• The goal length of stay (GLOS) has been changed in 2 guidelines in the 28th edition of Behavioral Health Care. • Inpatient & Surgical Care (ISC)
• Goal length of stay (GLOS) has changed in a total of 72 Optimal Recovery Guidelines in the 28th edition of Inpatient & Surgical Care. In medical Optimal Recovery Guidelines, the GLOS has changed in 37 guidelines and the GLOS has changed in a total of 35 surgical Optimal Recovery Guidelines in the 28th edition of Inpatient & Surgical Care. • General Recovery Care (GRG)
• Benchmark length of stay (BLOS) has been refined in the 28th edition of General Recovery Care. • Recovery Facility Care (RFC)
• A total of 1 guideline has been removed from the 28th edition of Recovery Facility Care. • Chronic Care (CCG)

• A total of 10 guidelines have been moved in the 28th edition of Chronic Care.

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

  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,

  Jo Ann Nishimoto, MD Medical Director

Attachment A – Revised Medical Policies and Clinical Guidelines effective April 10, 2024, unless otherwise indicated) Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-DME-31 Powered Wheeled Mobility Devices (effective April 1, 2024) • Added code E2298 replacing deleted code E2300 for power seating system, also added code K0108 CG-DME-50 Automated Insulin Delivery Systems • Removed criteria related to HbA1c range • Revised criteria related to blood glucose concentrations and self-monitoring CG-MED-88 Preimplantation Embryo Biopsy (effective April 1, 2024) • Revised title (previously titled “Preimplantation Embryo Biopsy and Genetic Testing”) • Revised Clinical Indications to address preimplantation embryo biopsy only CG-SURG-18 Septoplasty • Revised formatting in Clinical Indications section CG-SURG-78 Locoregional Techniques for Treating Primary and Metastatic Liver Malignancies (effective April 1, 2024) • Added Medically Necessary indication for arterially directed therapies to treat unresectable intrahepatic cholangiocarcinoma • Revised Medically Necessary criteria term microwave ablation to MWA in the bridge to liver transplantation section • Removed code C9790, not applicable • Added code C9797 for embolization, considered Medically Necessary when criteria are met ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck • Added existing codes 21086, L8045 related to auricular prostheses considered Medically Necessary or Reconstructive when criteria are met LAB.00015 Detection of Circulating Tumor Cells (effective April 1, 2024) • Removed code 0317U, criteria have been transitioned to Carelon Medical Benefits Management guidelines LAB.00025 Topographic Genotyping • Added code 89240 which may be used for this service LAB.00041 Machine Learning Derived Probability Score for Rapid Kidney Function Decline (effective April 1, 2024) • Updated descriptor for code 0407U LAB.00046
Testing for Biochemical Markers for Alzheimer's Disease (effective April 1, 2024) • Added code 0445U for βAmyloid (Abeta 42) and phosphor tau (pTau181) , electrochemiluminescent immunoassay (ECLIA) considered Investigational and Not Medically Necessary MED.00055 Wearable Cardioverter Defibrillators (effective April 1, 2024) • Removed references to related documents in the Description section; removed reference to CG-SURG-97 Cardioverter Defibrillators in Medically Necessary criteria and replaced with applicable implantable cardioverter defibrillator guidelines used by the plan MED.00125 Biofeedback and Neurofeedback (effective April 1, 2024) • Added code S9002 for home biofeedback device, considered Investigational and Not Medically Necessary

RAD.00059 Catheter-based Embolization Procedures for Malignant Lesions Outside the Liver (effective April 1, 2024) • Added code C9797 for embolization, considered Investigational and Not Medically Necessary for specific diagnoses SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting (effective April 1, 2024) • Revised Medically Necessary statement to include Cortiva and Surgimend for breast reconstruction • Revised Medically Necessary statement to include EPICEL, Integra Omnigraft Dermal Regeneration Template, and ReCell for the treatment of partial and deep thickness burns • Revised Medically Necessary statement to include Biovance and Oasis for the treatment of diabetic foot ulcers • Revised Not Medically Necessary statement to align with revisions to Medically Necessary statements • Added new products to the Investigational and Not Medically Necessary statement SURG.00126 Irreversible Electroporation (effective April 1, 2024) • Added ICD-10-PCS code 02583ZF for irreversible electroporation of cardiac conduction mechanism, considered Investigational and Not Medically Necessary SURG.00135 Renal Sympathetic Nerve Ablation • Revised title (previously titled “Radiofrequency Ablation of the Renal Sympathetic Nerves”) • Revised Investigational and Not Medically Necessary statement to include any method of ablation SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Revised Percutaneous Ventricular Assist Devices (pVAD) criteria to include extracorporeal membrane oxygenation (ECMO) as concomitant therapy • Revised Total Artificial Heart criteria for simplification • Removed code 33929, now addressed in TRANS.00033 SURG.00152 Wireless Left Ventricular Pacing for Cardiac Resynchronization Therapy • Revised title (previously titled “Wireless Cardiac Resynchronization Therapy for Left Ventricular Pacing”) • Revised language in the Clinical Indications section SURG.00154 Microsurgical Procedures for the Prevention or Treatment of Lymphedema (effective April 1, 2024)

• Added ICD-10-PCS codes 0DXU0ZV, 0DXU0ZW, 0DXU0ZX, 0DXU0ZY, 0DXU4ZV, 0DXU4ZW, 0DXU4ZX, 0DXU4ZY for omentum transfer, considered Investigational and Not Medically Necessary for lymphedema diagnoses SURG.00157 Minimally Invasive Treatment of the Posterior Nasal Nerve to Treat Rhinitis (effective April 1, 2024) • Added note regarding code 30117 when used for posterior nasal nerve ablaton SURG.00158 Implantable Peripheral Nerve Stimulation Devices as a Treatment for Pain (effective April 1, 2024) • Added code A4438 for a component of the NALU device, considered Investigational and Not Medically Necessary when specified for peripheral nerve

TRANS.00028 Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma • Updated formatting in Position Statement section • In the Medically Necessary Position Statement section for non- Hodgkin Lymphoma (NHL), created criterion B3 • In the Investigational and Not Medically Necessary section for NHL, updated bullet “A” by adding “when criteria above are not met, including” • Added ICD-10-CM diagnosis codes C91.50-C91.52 for lymphoma (Medically Necessary when criteria are met) TRANS.00033 Heart Transplantation • Added code 33929 previously addressed in SURG.00145, considered Medically Necessary when criteria are met TRANS.00038 Thymus Tissue Transplantation • Added endocrine procedure code 60999