MP/CG Update/Notice - July 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-062379-24 July 2024

California | Anthem Blue Cross | Commercial

July 1, 2024

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 October 1, 2024

• MED.00148 Gene Therapy for Metachromatic Leukodystrophy: This document addresses gene therapy for metachromatic leukodystrophy (MLD), a congenital medical condition that affects the nervous system. o Outlines the Medically Necessary and Not Medically Necessary criteria for gene therapy use of atidarsagene autotemcel (Lenmeldy) for metachromatic leukodystrophy

• RAD.00069 Absolute Quantitation of Myocardial Blood Flow Measurement: This document addresses the use of the absolute quantitation of myocardial blood flow (AQMBF) which can be calculated during cardiac imaging using various modalities including positron emission tomography (PET), cardiac magnetic resonance imaging (CMR), single photon emission computed tomography (SPECT) scan imaging. o Considered Investigational and Not Medically Necessary for all indications

Updated Medical Policies effective October 1, 2024 unless otherwise stated

• MED.00055 Wearable Cardioverter Defibrillators: This document addresses the wearable cardioverter defibrillator, an external vest-like garment device that is intended to perform the same tasks as an implantable cardioverter defibrillator (ICD), without requiring any invasive procedure. o Reformatted language from “the” to “a” wearable cardioverter defibrillator and moved punctuation o Added Not Medically Necessary statement when individual has an automated external defibrillator

• MED.00135 Gene Therapy for Hemophilia: This document addresses gene therapy for hemophilia, a congenital medical condition in which the blood does not clot normally due to lack of sufficient blood-clotting proteins known as clotting factors. o Added Medically Necessary statement for fidanacogene elaparvovec-dzkt (Beqvez) - prior authorization required effective October 1, 2024 o Revised Medically Necessary statement on etranacogene dezaparvovec-drlb (Hemgenix) effective July 1, 2024

• SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting: This document addresses the use of soft tissue (e.g., skin, ligament, cartilage, etc.) substitutes in wound healing and surgical procedures. o Revised ocular indications, including the addition of SurSight to Medically Necessary and Not Medically Necessary statements section and added new Medically Necessary criterion addressing non-healing or persistent corneal epithelial defects o Removed VersaWrap and Phasix Mesh from Investigational and Not Medically Necessary statement o Added Phasix Mesh and Phasix ST Mesh to Medically Necessary and Not Medically Necessary statements

Medical Policies archived June 28, 2024

• DME.00032 Automated External Defibrillators for Home Use • MED.00125 Biofeedback and Neurofeedback • SURG.00147 Synthetic Cartilage Implant for Metatarsophalangeal Joint Disorders (NOTE: Carelon Medical Benefits Management Musculoskeletal Small Joint Surgery is used for Carelon eligible members)

American Society of Addiction Medicine (ASAM) update

While we had previously notified you of a move to The ASAM Criteria: Treatment Criteria for Addictive, Substance- Related and Co-Occurring Conditions, American Society of Addiction Medicine, 4th Edition for adults, such transition to the use of the 4th Edition for medical necessity reviews has been postponed to a future date to be determined. We will continue to use the 3rd Edition until further notice.

Carelon Medical Benefits Management, Inc. updates

Effective October 1, 2024, Carelon Medical Benefits Management, Inc. will expand multiple programs to perform medical necessity reviews for additional procedures for Anthem members. Carelon Medical Benefits Management works to improve healthcare quality and manage costs for today’s most complex and prevalent tests and treatments, helping to promote care that is appropriate, safe, and affordable.

The continued migration will expand clinical appropriateness review for procedures related to the following existing Carelon Medical Benefits Management programs: cardiovascular, musculoskeletal, radiation oncology, radiology, sleep, and surgical. In addition, some codes will migrate into a new Carelon Medical Benefits Management solution — additional outpatient utilization management (UM) that will include some transportation (including ambulance) as set forth below. Transportation may include emergency post-service reviews.

The Clinical UM Guidelines and Medical Policies adopted by Anthem for medical necessity review are listed in the table below. Carelon Medical Benefits Management will begin accepting prior authorization requests on September 23, 2024, for dates of service on or after October 1, 2024.

Members included in the new program
Updates to Carelon Medical Benefits Management programs apply to select 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. This notice does not apply to certain HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplemental, or Federal Employee Program® (FEP®). For more information, please contact the phone number on the back of the member ID card.

Pre-service review requirements
For procedures that are scheduled to begin on or after October 1, 2024, all providers must contact Carelon Medical Benefits Management to obtain pre-service review for the services including, but not limited to, the following non- emergency modalities. Please refer to the Clinical UM Guidelines and Medical Policies at anthem.com/ca/provider/policies/clinical-guidelines/updates for complete code lists.

Note: All codes will be reviewed for medical necessity for the requested service and not for site of care.

Program Clinical UM Guideline / Medical Policy and Services Cardiovascular • MED.00111 Intracardiac Ischemia Monitoring • MED.00115 Outpatient Cardiac Hemodynamic Monitoring w/Wireless Sensor for Heart Failure Management • MED.00134 Non-Invasive Heart Failure and Arrhythmia Monitoring System Musculoskeletal • CG-DME-45 Ultrasound Bone Growth Stimulation • CG-MED-65 Manipulation Under Anesthesia • CG-MED-78 Anesthesia for Interventional Pain Management Procedures • CG-SURG-08 Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury • CG-SURG-89 Radiofrequency Neurolysis and Pulsed Radiofrequency Therapy for Trigeminal Neuralgia • SURG.00043 Electrothermal Shrinkage of Joint Capsules, Ligaments, and Tendons • SURG.00114 Facet Joint Allograft Implants for Facet Disease Radiation Oncology • THER-RAD.00008 Neutron Beam Radiotherapy Radiology • CG-MED-51 Three-Dimensional (3-D) Rendering of Imaging Studies
• CG-MED-76 Magnetic Source Imaging & Magnetoencephalography • RAD.00034 Dynamic Spinal Visualization (Including Digital Motion X-ray & Cineradiography/ Videofluoroscopy)

• RAD.00053 Cervical and Thoracic Discography Sleep • DME.00042 Electronic Positional Devices for Treatment of Obstructive Sleep Apnea • DME.00043 Neuromuscular Electrical Training for Treatment of Obstructive Sleep Apnea Surgical Surgical GI: • SURG.00116 High Resolution Anoscopy Screening • SURG.00141 Doppler-Guided Transanal Hemorrhoidal Dearterialization

To determine if prior authorization is needed for a member on or after October 1, 2024, contact the Provider Services phone number on the back of the member’s ID card for benefit information. Providers using the Interactive Care Reviewer (ICR) tool on Availity.com to pre-certify an outpatient procedure will receive a message referring the provider to Carelon Medical Benefits Management. (Note: ICR cannot accept prior authorization requests for services administered by Carelon Medical Benefits Management.)

Providers should continue to submit pre-service review requests to Carelon Medical Benefits Management using the convenient online service via the Carelon Medical Benefits Management ProviderPortalSM. ProviderPortalSM is available 24 hours a day, seven days a week, processing requests in real-time using Clinical Criteria. Go to providerportal.com to register.

For more information For resources to help your practice get started with the cardiology, musculoskeletal, radiology, sleep, surgical procedures, and radiation oncology programs, visit:
• Cardiovascular Solution | Carelon Insights at careloninsights.com/medical-benefits- management/cardiovascular. • Musculoskeletal Solution | Carelon Insights at careloninsights.com/medical-benefits- management/musculoskeletal • Radiation Oncology Solution | Carelon Insights at careloninsights.com/medical-benefits-management/specialty- care/radiation-oncology. • Radiology Solution | Carelon Insights at careloninsights.com/medical-benefits-management/radiology. • Sleep Solution | Sleep Healthcare | Carelon Insights at careloninsights.com/medical-benefits- management/specialty-care/sleep. • Surgical Procedures Solution | Carelon Insights at careloninsights.com/medical-benefits-management/specialty- care/surgical-procedures.

Our website at anthem.com/ca helps you access information and tools such as order entry checklists, Clinical UM Guidelines and Medical Policies, and FAQ. You can also contact your local network relations representative if you have any questions.

Through genuine collaboration, we can simplify access to care and help you deliver high-quality, equitable healthcare.

Updates to Carelon Medical Benefits Management, Inc. Clinical Appropriateness Guidelines

Effective for dates of service on and after October 20, 2024, the following updates will apply to the Carelon Medical Benefits Management, Inc. Clinical Appropriateness Guidelines. As part of the Carelon Medical Benefits Management guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable healthcare services.

Radiology Imaging of the Brain: − Added indications for magnetic resosnance imaging (MRI) and amyloid beta positron emission tomography (PET) imaging in Alzheimer disease to address patients considering or receiving lecanemab (Leqembi) Imaging of the Spine: − Changed Perioperative and Periprocedural Imaging to Postoperative and Postprocedural Imaging; pre- procedure requests should be reviewed based on more specific indication Imaging of the Extremities: − Separated criteria for osteomyelitis and septic arthritis into separate indications; ultrasound or arthrocentesis as preliminary tests were placed only in the septic arthritis indication Vascular Imaging:

− Computed tomography angiography (CTA)/ magnetic resonance angiography (MRA) Head addition for chronic posterior circulation stroke/transient ischemic attack (TIA) presentations (CTA/MRA neck already allowed, intracranial evaluation needed for full extent of anatomy) − Lower Extremity peripheral artery disease: Updated physiologic testing parameters and added allowance for ischemic signs/symptoms at presentation, in alignment with American College of Radiology Appropriateness Criteria − Suboptimal imaging option downgrades/removals in Brain, Head and Neck, and Abdomen/Pelvis

Cardiovascular Imaging of the Heart: − Resting Transthoracic Echocardiography (TTE) o Expanded frequency of echocardiographic evaluation in patients on mavacamten (Camzyos) for treatment of hypertrophic obstructive cardiomyopathy o Expanded criteria for echocardiographic evaluation to allow a single screening for cardiac disease in patients undergoing evaluation for solid organ or hematopoietic cell transplant Cardiac Resynchronization Therapy (CRT): Added exclusion for wireless CRT
Diagnostic Coronary Angiography: Criteria reaffirmed — no changes Endovascular Revascularization − Added indication for endovascular venous arterialization of the tibial or peroneal veins
− Added exclusions for endovenous femoral-popliteal arterial revascularization with transcatheter placement of intravascular stent and intravascular lithotripsy − Also added exclusion for atherectomy (clarification) Implantable Cardioverter Defibrillators (ICD) − Transvenous ICD placement o Expanded criteria for transvenous ICD to include phospholamban, filamin-C and lamin A/C cardiomyopathies Percutaneous Coronary Intervention: Added exclusion for percutaneous transluminal coronary lithotripsy Permanent Implantable Pacemakers − Added criteria for permanent implantable pacemaker device replacement − Clarified that criteria for single chamber leadless pacemaker apply to the right ventricle − Added exclusion for right atrial single chamber leadless pacemakers − Added exclusion for dual chamber leadless pacemakers

Genetic Testing Chromosomal Microarray Analysis − Clarified recommendations for Genetic Counseling
− Clarified requirements for postnatal evaluation of individuals with:
− Congenital or early onset epilepsy (before age 3 years) without suspected environmental causes
− Autism spectrum disorder, developmental delay, or intellectual disability with no identifiable cause (idiopathic) − Clarified prenatal evaluation of a fetus with a structural fetal anomaly noted on ultrasound Pharmacogenomic Testing: Added apolipoproteinE testing Predictive and Prognostic Polygenic Testing:
− Renamed from Polygenic Risk Scores to address change in scope − Broadened guideline scope to include polygenic expression prognostic testing and multivariable prognostic genetic testing (essentially clarifications), and moved these tests to exclusions as they are considered not medically necessary Somatic Tumor Testing − Breast Cancer - Clarified gene expression profiling is to guide adjuvant therapy for localized Breast Cancer Whole Exome and Whole Genome Sequencing
− Expanded whole exome sequencing (WES) criteria to include congenital or early onset epilepsy (before age 3) without suspected environmental etiology and added other clarifications. − Clarified well-delineated genetic syndrome in criterion for multiple anomalies − Clarified Genetic Counseling details for WES

Musculoskeletal Sacroiliac Joint Fusion − New medical necessity criteria for open sacroiliac (SI) joint fusion: − As an adjunct to sacrectomy or partial sacrectomy related to tumors involving the sacrum

− As an adjunct to the medical treatment of sacroiliac joint infection/sepsis (for example, osteomyelitis, pyogenic sacroiliitis) − For severe traumatic injuries associated with pelvic ring disruption (for example, pelvic ring fractures, acetabular fracture, spinopelvic dissociation) − During multi-segment spinal constructs (for example, correction of deformity in scoliosis or kyphosis surgery) extending to the ilium as part of medically necessary lumbar spine fusion procedures − Open SI joint fusion is not medically necessary for poorly defined low back pain and sacral insufficiency fractures.

Spine Surgery − Lumbar Discectomy, Foraminotomy, and Laminotomy: Added exclusion for annular closure device − Lumbar Laminectomy: Expanded timeframe for imaging lumbar disc herniation (9 months) and lumbar spinal stenosis (12 months)

Radiation Oncology − Removed criteria for hyperthermia
− Clarified inclusion criteria of the RTOG 1112 protocol

Sleep Disorder Management − Expanded definitions and terminology − Expanded documentation of hypoventilation
− Expanded criteria for home and in-lab sleep studies − Added contraindication to automatic positive airway pressure titration for use of supplemental oxygen − Removed home sleep apnea testing (HSAT) as an option in medical necessity of multiple sleep latency test (MSLT)/ maintenance of wakefulness test (MWT) for suspected narcolepsy − Management of obstructive sleep apnea (OSA) using Implanted Hypoglossal Nerve Stimulators — Narrowed age range (raised lower limit to 13) for hypoglossal nerve stimulators (HNS) in individuals with Down syndrome and OSA to align with age range suggested by Food and Drug Administration − Miscellaneous Devices section added: electronic positional therapy and neuromuscular electrical training of the tongue musculature are considered not medically necessary due to lack of high-quality evidence

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 October 1, 2024, the following specialty pharmacy codes from current or new Clinical Criteria will be included in our prior authorization review process.

Clinical Criteria Drug HCPCS code(s) CC-0003 Alyglo (immune globulin intravenous, human-stwk) J1599 CC-0062 Simlandi (adalimumab-ryvk) J3590 CC-0261 Winrevair (sotatercept-csrk) C9399, J3590

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

Step therapy updates Effective for dates of service on and after October 1, 2024, the following specialty pharmacy codes from current Clinical Criteria will be included in our specialty pharmacy medical step therapy review process.

Clinical Criteria Status Drug HCPCS code(s) CC-0003 Non-preferred Alyglo (immune globulin intravenous, human-stwk) J1599 CC-0062 Non-preferred Cimzia (certolizumab pegol) J0717 CC-0042 Non-preferred Cosentyx intravenous (secukinumab) C9399, J3490, J3590, C9166 CC-0050 Non-preferred Ilumya (tildrakizumab) J3245 CC-0050 Non-preferred Omvoh (mirkizumab-mrkz) C9168, J3590

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

Clinical Criteria Drug HCPCS code(s) CC-0062 Simlandi (adalimumab-ryvk) J3590 CC-0261 Winrevair (sotatercept-csrk) C9399, J3590

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 July 1, 2024 Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes ANC.00006 Biomagnetic Therapy • Revised Investigational and Not Medically Necessary statement ANC.00009 Cosmetic and Reconstructive Services of the Trunk, Groin, and Extremities • Added “met for each anatomical region being considered for treatment” to lipectomy or liposuction Not Medically Necessary statement CG-MED-59 (Carelon Surgical GI) Upper Gastrointestinal Endoscopy in Adults • Revised clinical indications in Medically Necessary statement on screening esophagogastroduodenoscopy (EGD) in adults at risk for Barrett’s esophagus and removed male sex • Added proton pump inhibitors as an example of appropriate trial of therapy to Medically Necessary CG-MED-74 Implantable Ambulatory Event Monitors and Mobile Cardiac Telemetry • Revised Medically Necessary statements regarding 14 day requirement for trial of external ambulatory cardiac event monitoring • Revised formatting to criteria for implantable ambulatory event monitor for cryptogenic stroke LAB.00016 Fecal Analysis Panels in the Diagnosis of Intestinal Disorders • Revised Title (previously titled: Pain Management Biomarker Analysis) • Revised first Investigational and Not Medically Necessary statement to add "for all indications”
• Deleted second Investigational and Not Medically Necessary statement LAB.00019 Proprietary Algorithms for Liver Fibrosis • Added code 0468U for the NASHnext test, considered Investigational and Not Medically Necessary LAB.00042 Molecular Signature Test for Predicting Response to Tumor Necrosis Factor Inhibitor • Added code 0456U for PrismRA test considered Investigational and Not Medically Necessary, replacing 81479 and 81599 LAB.00046 Testing for Biochemical Markers for Alzheimer's Disease • Added code 0459U for Elecsys® Total Tau CSF (tTau) and β- Amyloid (1-42) CSF II (Abeta 42) Ratio, considered Investigational and Not Medically Necessary LAB.00048 Analysis of Urine Biomarkers for Chronic Pain Management • Revised Title (previously titled: Pain Management Biomarker Analysis) • Revised Investigational and Not Medically Necessary
statement MED.00013

Parenteral Antibiotics for the Treatment of Lyme Disease • Revised Medically Necessary criteria related to heart blocks • Revised formatting in Clinical Indications section • Added codes J0687, J0688, J0689, J0744, J2183, J2184, J2281 for brand non-equivalent products considered Investigational and Not Medically Necessary for Lyme MED.00140 Gene Therapy for Beta Thalassemia • Added code J3393 replacing C9399, J3490 and J3590 for Zynteglo MED.00146 Gene Therapy for Sickle Cell Disease • Added code J3394 replacing C9399, J3490 and J3590 for Lyfgenia

SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting • Added new codes Q4311-Q4333
• Removed deleted codes Q4210, Q4277 SURG.00019 Transmyocardial Revascularization • Revised formatting in Clinical Indications from bullets to alphabetical list SURG.00121 Transcatheter Heart Valve Procedures • Revised Medically Necessary statement for transcatheter aortic valve replacement SURG.00155 Cryoneurolysis • Revised Investigational and Not Medically Necessary
statement, removing example TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias • Updated diagnosis coding for autologous stem cell harvesting and transplant related to gene therapy TRANS.00039 Portable Normothermic Organ Perfusion Systems • Added codes 0894T, 0895T, 0896T replacing 32999 and 47399 for liver perfusion systems as Medically Necessary when criteria are met