MP/CG Update/Notice - January 2024 Form

P.O. Box 4330 Woodland Hills, CA 91365 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. CABC-CM-048648-23 December 2023

January 1, 2024

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, rationale updates and changes that are not summarized below.

NEW Medical Policies and Clinical UM Guidelines with prior authorization required effective May 1, 2024

• RAD.00068 Myocardial Strain Imaging: This document addresses the use of myocardial strain imaging to detect subclinical cardiac dysfunction. o Myocardial strain imaging in considered investigational and not medically necessary for all indications

• CG-DME-50 Automated Insulin Delivery Systems: This document addresses the use of automated insulin delivery systems for the management of diabetes mellitus.
o Outlines Medically Necessary and Not Medically Necessary criteria

• CG-DME-51 External Insulin Pumps: This document addresses the use of external insulin pumps, which provide subcutaneous insulin infusion to treat diabetes mellitus.
o Outlines Medically Necessary and Not Medically Necessary criteria

• CG-DME-52 Continuous Passive Motion Devices in the Home Setting: This document addresses the use of continuous passive motion devices in the home setting. o Use of a continuous passive motion (CPM) device in the home setting is considered not medically necessary for all indications

• CG-MED-94 Vestibular Function Testing: This document addresses the use of selected tests of vestibular function, specifically, use of electronystagmography (ENG) and videonystagmography (VNG), caloric testing, and rotational chair testing. o Outlines Medically Necessary and Not Medically Necessary criteria

UPDATED Medical Policies

• SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation: This document addresses the use of deep brain, cortical, and cerebellar stimulation. Updates below are effective April 1, 2024. o Reformatted Position Statement and added headers o Reformatted Medically Necessary statements to move target treatment areas into criteria o Revised Medically Necessary statement for primary dystonia to remove dystonia manifestation types o Reformatted Medically Necessary statements for deep brain stimulation (DBS) for Parkinson’s, primary dystonia, and obsessive-compulsive disorder o Reformatted Medically Necessary statements for epilepsy o Revised DBS for epilepsy Medically Necessary statement regarding non-epileptic seizures o Revised Position Statement to add revision/replacement with Medically Necessary and Investigational and Not Medically Necessary statements for DBS, cortical stimulation, and battery o Revised and reformatted Investigational and Not Medically Necessary statements

• SURG.00142 Genicular Procedures for Knee Pain: This document addresses genicular procedures for knee pain, including nerve genicular radiofrequency ablation (also called genicular neurotomy, genicular denervation, or cooled radiofrequency therapy), and genicular artery embolization. Updates below are effective May 1, 2024. o Revised title (previously titled: Genicular Nerve Blocks and Ablation for Chronic Knee Pain) o Added genicular artery embolization to the scope of document o Revised Position Statement to add genicular artery embolization as Investigational and Not Medically Necessary o Added CPT code 37242 for arterial embolization, considered Investigational and Not Medically Necessary when specified as genicular artery embolization for knee pain

Medical Policy conversion effective January 3, 2024

• GENE.00053 Metagenomic Sequencing for Infectious Disease in the Outpatient Setting converted to LAB.00050 Metagenomic Sequencing for Infectious Disease in the Outpatient Setting

MCG Guidelines 27th Edition Update

The following customization will be archived February 23, 2024 and we will revert to the original MCG criteria below.

Archive customization Title Adopt Non-customization W0114 Inpatient & Surgical Care (ISC) - Atrial Fibrillation
M-505 W0141 General Recovery Care (GRG) - Urologic Surgery or Procedure SG-US

American Society of Addiction Medicine (ASAM) 4th Edition Update for Adults

The American Society of Addiction Medicine (ASAM) has issued updated criteria for adults. For further information, go to the ASAM website at https://www.asam.org.

Effective April 1, 2024, medical necessity reviews will be performed using The ASAM Criteria: Treatment Criteria for Addictive, Substance-Related and Co-Occurring Conditions, American Society of Addiction Medicine, 4th Edition for adults. Adolescent cases will continue to use The ASAM Criteria: Treatment Criteria for Addictive, Substance- Related and Co-Occurring Conditions, American Society of Addiction Medicine, 3rd Edition.

Gender Affirming Care

In the October 1, 2023 provider notification, we informed you that CG-SURG-27 Gender Affirming Surgery would be archived effective December 1, 2023. Effective April 1, 2024, World Professional Association for Transgender Health (WPATH) will be used for most* California self-insured local plan members that provide coverage for gender affirming surgery/procedures. WPATH will continue to be used for all California fully insured member reviews. For questions, please contact the provider service number on the back of the member's ID card.

World Professional Association for Transgender Health (WPATH) Standards of Care for the Health of Transgender and Gender Diverse People. * Most California self-insured local plans that provide coverage for gender affirming surgery/procedures will continue to use CG-SURG-27 until April 1, 2024 during their transition to WPATH. Other California self-insured local plans that provide coverage for gender affirming surgery/procedures with group specific customizations will continue until further notice. California self-insured national plans that provide coverage for gender affirming surgery/procedures will continue to use group specific customizations (where applicable) or MCG (GRG GG-FMMF: Gender-Affirming Surgery or Procedure GRG) criteria.

Air Ambulance Services – Claims Processing and Medical Necessity Review

To improve accuracy and timeliness of air ambulance transport claim processing for members with air ambulance benefits in their specific plan, please note the following:
• Include pertinent hospital records (e.g. emergency department record, inpatient discharge or transfer summary, etc.) and the air ambulance “run report” (e.g. patient's demographics, vital signs, assessments, and information on any interventions performed)
• Air ambulance services are reviewed for medical necessity determination using the Anthem Clinical Guideline, CG-ANC-04 Ambulance Services: Air and Water*
• Use of air ambulance services for non-medically necessary purposes is not covered, including but not limited to:

• In lieu of available ground transport solely to reserve local area Emergency Medical Services (EMS) availability

• Convenience of member, family, provider or hospital/hospital system (including excess miles to transport within the hospital’s health system when another closer receiving hospital has capability/capacity)
  If you have questions, please contact your local provider relationship management representative.

  *CG-ANC-04 Ambulance Services: Air and Water (https://www.anthem.com/dam/medpolicies/abc/active/guidelines/gl_pw_c120386.html).

Notification of Inpatient (IP) admissions through Availity, phone or fax; Termination of eCensus for Commercial Members

Effective Immediately we ask that providers utilize Availity (preferred option) or phone or fax to inform Anthem of IP admissions for Commercial members. Anthem Blue Cross will no longer accept notices via eCensus effective April 1, 2024, for Commercial members.

Specialty Pharmacy updates

Prior authorization clinical review of non-oncology use of specialty pharmacy drugs is managed by Anthem’s 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.

Prior authorization updates Correction: In the August 2023 provider update letter, we announced prior authorization for Zynyz (CC-0240) would be effective November 2023. In the September 2023 provider update letter, we announced prior authorization for Epkinly (CC-0242) would be effective December 2023. Please be advised that the prior authorization effective date for Epkinly and Zynyz is January 1, 2024. These are oncology drugs managed by Carelon Medical Benefits Management.

Effective September 18, 2023, CC-0030 Implantable and ER Buprenorphine Containing Agents was archived.

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

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

Clinical Criteria Drug HCPCS or CPT code(s) CC-0068 Ngenla (somatrogon-ghla) C9399, J3590

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

Site of care updates Effective for dates of service on and after April 1, 2024, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our site of care review process.

Clinical Criteria Drug HCPCS or CPT code(s) CC-0189 Amondys 45 (casimersen) J1426 CC-0241 Elfabrio (pegunigalsidase alfa-iwxj) J2508 CC-0193 Evkeeza (evinacumab) J1305 CC-0044 Exondys 51 (eteplirsen) J1428 CC-0154 Givlaari (givosiran) J0223 CC-0231 Lamzede (velmanase alfa-tycv) J0217 CC-0209 Leqvio (inclisiran) J1306 CC-0013 Mepsevii (vestronidase alfa) J3397 CC-0185 Oxlumo (lumasiran) J0224 CC-0073 Prolastin (alpha 1 proteinase inhibitor) J0256 CC-0049 Radicava (edaravone) J1301 CC-0246 Rystiggo (rozanolixizumab-noli) J9333* CC-0225 Tzield (teplizumab-mzwv) J9381 CC-0170 Uplizna (inebilizumab-cdon) J1823 CC-0172 Viltepso (viltolarsen) J1427 CC-0160 Vyepti (eptinezumab-jjmr) J3032 CC-0152 Vyondys 53 (golodirsen) J1429

CC-0207 Vyvgart Hytrulo (efgartigimod alfa 2 mg and hyaluronidase-qvfc) J9334

*Coding update effective January 1, 2024; previously listed with Not Otherwise Classified (NOC) codes

Expansion of Carelon Medical Benefits Management programs

Effective April 1, 2024, Carelon Medical Benefits Management, Inc., a specialty health benefits company, will expand multiple programs to perform medical necessity reviews for additional procedures for Anthem Blue Cross members as further outlined below. Carelon Medical Benefits Management works with leading insurers 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 expansions will require clinical appropriateness review for additional procedures related to the Carelon Medical Benefits Management expanded cardiology, genetic testing, radiology, musculoskeletal, surgical and radiation oncology programs. The Clinical Guidelines and Medical Policies that have been adopted by Anthem to be used for medical necessity review are listed in the table below. Carelon Medical Benefits Management will begin accepting prior authorization requests on March 18, 2024, for dates of service on or after April 1, 2024.

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.

Pre-service review requirements For procedures that are scheduled to begin on or after April 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 Guidelines on the microsite resource pages listed below this table for complete code lists.

Program Services Clinical Guideline/ Medical Policy Expanded Cardiology • Treatment of varicose veins • Artery stent placement with/without angioplasty • Embolization procedures
• Dialysis circuit procedures • Electrophysiological (EPS) studies • Cardiac ablation • Cardiac monitors • Cardiac contractility modulation
• Wearable cardioverter defibrillators • Wireless cardiac resynchronization therapy (CRT) for left ventricular pacing • Venous angioplasty with/without stent placement
• Vein embolization treatment for pelvic congestion syndrome and varicocele • Patent foramen ovale closure devices
• CG-MED-64 • CG-MED-74 • CG-SURG-28 • CG-SURG-55 • CG-SURG-76 • CG-SURG-83 • CG-SURG-93 • CG-SURG-106 • MED.00055 • RAD.00059 • SURG.00032 • SURG.00037 • SURG.00062 • SURG.00152 • SURG.00153 • THER-RAD.00012 Radiology • Radiostereometric analysis • Quantitative ultrasound for tissue characterization • Myocardial sympathetic innervation and imaging with/without single-photon emission computerized tomography (SPECT) • Lumbar discography • CG-SURG-29 • RAD.00064 • RAD.00065 • RAD.00067 Radiation Oncology • Hyperthermia for cancer therapy
• CG-MED-72 Musculoskeletal • Extraosseous subtalar joint implantation and arthroereisis
• Genicular nerve blocks and ablation for chronic knee pain • Percutaneous and endoscopic spinal surgery • SURG.00052 • SURG.00071 • SURG.00092

• Implanted devices for spinal stenosis • Percutaneous vertebral disc and endplate procedures
• Cryoablation for podiatric conditions • SURG.00100 • SURG.00104 • SURG.00142

Genetic Testing • Topographic genotyping • Chromosomal microarray analysis • Gene expression profiling • Gene mutation testing • Gene sequencing • Panel and other multi-gene tests for polymorphisms • Genetic test for inherited diseases • Molecular marker evaluation of thyroid nodules • Hybrid personalized molecular residual disease tests for cancer • Breast cancer (BRCA) gene tests • Cell-free DNA tests to aid in monitoring of kidney transplant rejection • Laboratory tests to aid in diagnosis of heart transplant rejection • CG-GENE-04 • CG-GENE-10 • CG-GENE-13 • CG-GENE-14 • CG-GENE-16 • CG-GENE-18 • CG-GENE-19 • CG-GENE-21 • CG-GENE-22 • GENE.00009 • GENE.00010 • GENE.00016 • GENE.00018 • GENE.00020 • GENE.00023 • GENE.00050 • GENE.00052 • GENE.00054 • GENE.00055 • GENE.00057 • GENE.00059 • LAB.00015 • LAB.00025 • LAB.00038 • LAB.00050 • TRANS.0025 Surgical • Wireless capsule endoscopy
• Bariatric surgery
• Paraoesophageal hernia repair
• Ablation procedures — treatment of Barrett’s esophagus • Transendoscopic therapy for gastroesophageal reflux/dysphagia/gastroparesis
• Lower esophageal sphincter augmentation devices • CG-SURG-83 • CG-SURG-92 • CG-SURG-101 • MED.00090 • SURG.00047 • SURG.00131

To determine if prior authorization is needed for a member on or after April 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 the Availity portal 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. ProviderPortal is available twenty-four hours a day, seven days a week, processing requests in real-time using clinical criteria. Go to providers.carelonmedicalbenefitsmanagement.com to register.

For more information, go to the following microsite for the appropriate resource based on the type of procedure:

https://providers.carelonmedicalbenefitsmanagement.com/genetictesting https://providers.carelonmedicalbenefitsmanagement.com/cardiology https://providers.carelonmedicalbenefitsmanagement.com/radiology
https://providers.carelonmedicalbenefitsmanagement.com/musculoskeletal
https://providers.carelonmedicalbenefitsmanagement.com/surgicalprocedures
https://providers.carelonmedicalbenefitsmanagement.com/radoncology

These websites include helpful information and tools such as order entry checklists, links to medical necessity criteria, and FAQs. You can also call your local network relations representative if you have any questions.

Updates to Claims Match Enhancement for Carelon Medical Benefits Management, Inc. Genetic Testing Program

As part of our ongoing quality improvement efforts, we will be implementing a new Genetic Testing (GT) claim to authorization match enhancement that will ensure GT panels billed have a corresponding authorization. This enhanced match logic will be effective by April 1, 2024.

Labs that bill panels with codes in excess of what has been authorized may receive a full claim denial. The goal of this enhanced match logic is to ensure tests performed are authorized and meet medical necessity requirements.

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

Effective for dates of service on and after April 14, 2024 (except where otherwise specified), the following updates will apply to the Carelon Clinical Appropriateness Guidelines. As part of the Carelon guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.

Radiology
Imaging of the Heart: • Cardiac CT

• Cardiomyopathy: Added specificity to establish the basis for the suspicion of ARVD. This change aligns with Cardiac MRI guidelines.
• Resting Transthoracic Echocardiography (TTE)
• Evaluation of ventricular function: New indications for evaluation of patients on mavacamten for treatment of HOCM • Coronary CT Angiography (CCTA) and CT Derived Fractional Flow Reserve (FFR-CT): Annual CPT code update - removed 0501T-0504T and added 75580. Effective January 1, 2024 Imaging of the Abdomen and Pelvis: • Biliary tract dilatation or obstruction: Added indication for annual surveillance in Caroli disease/syndrome based on a 2022 guideline recommendation.
  • Diffuse liver disease: Removed indication for LiverMultiScan in hemochromatosis as there is insufficient evidence that this provides an advantage over standard MRI for this condition • Osteomyelitis: Added requirement for initial evaluation with radiographs in adult patients based on ACR appropriateness criteria. • Septic arthritis: Added requirement for initial radiographs in adult patients based on ACR appropriateness criteria Pancreatic mass, indeterminate cystic (IPMN/IPMT): For enlarging lesions in patients aged 80 or greater, increased surveillance frequency to annually and removed endpoint of 4 years.
  • Pelvic floor disorders: Added indication for MRI (MR defecography preferred) in suspected pelvic organ prolapse based on ACR appropriateness criteria
  • Transplant-related imaging: Added indication for single CT abdomen or abdomen/pelvis prior to lung, kidney, or stem cell transplant to align with CT chest guidelines.
  Imaging of the Brain:
  • Movement disorders (Adult only): Added indication for CT head for assessment of skull density prior to MRgFUS for essential tremor • Trauma: Added a 3-6 week follow up study in patients aged 6 or younger with stable or inconclusive exam, due to difficulty in accurately assessing for changes in neurologic status • Acoustic neuroma: Added long-term follow-up intervals based on specialty society guidelines Imaging of the Chest: Perioperative or periprocedural evaluation, not otherwise specified - Added indication for CT chest to be used for planning of biopsy or placement of fiducial markers using navigational bronchoscopy Imaging of the Head and Neck: • Acoustic neuroma: Added long-term follow-up intervals based on specialty society guidelines • Localized facial pain (including trigeminal neuralgia): Added MRI orbit/face/neck for this indication based on ACR criteria; some facilities use MRI face rather than brain for this condition

Oncologic Imaging Cancer Screening: • Breast cancer screening: Addition of RAD51C or RAD51D and TK11 (Peutz-Jeghers syndrome) high-risk genetic mutations (NCCN alignment citing absolute risk of 20% or greater) • Lung cancer screening: Clarification of asbestos-related lung disease as risk factor independent of smoking, aligned with original intent.

Pancreatic cancer screening: Alignment with NCCN recommended parameters; changes are overall expansive, except for:
• Older start age (from 45 to 50) for certain genes (ATM, BRCA1, BRCA2, MLH1, MSH2, MSH6, EPCAM, PALB2, TP53)
• Family history alone (relative requirement) Breast Cancer: • CT chest, CT abdomen and pelvis: Added diagnostic workup allowance when metastatic disease is clinically suspected at presentation • MRI Breast: Addition/clarification of surveillance scenarios aligned with NCCN/ACR considerations • FDG-PET/CT: Added allowance for RT planning locoregional recurrence (e.g., confirmation of regional nodal involvement)
• 18F-fluoroestradiol (18F-FES) PET/CT: Added that it Is not indicated due to uncertain net benefit; low-level evidence, insufficient data on outcomes. Cervical Cancer: • FDG-PET/CT: Update for follow-up of disease treated with either adjuvant RT or chemoradiation (NCCN alignment). Hepatocellular and Biliary Tract Cancers: • FDG-PET/CT: Removed routine preop PET/CT for biliary tract cancers (NCCN alignment) • FDG-PET/CT: Added management allowance when standard imaging cannot be done or is nondiagnostic (NCCN "consider" for equivocal finding) Lung Cancer – Non-Small Cell: FDG-PET/CT - Added management allowance when recurrence demonstrated by surveillance imaging (NCCN alignment) Lung Cancer – Small Cell: FDG-PET/CT: Clarification of initial staging allowance (NCCN alignment Lymphoma – Non-Hodgkin and Leukemia: FDG-PET/CT: NCCN alignment for interim restaging (allowed for DLBCL stage I-IV with or without bulky disease) Melanoma: Added surveillance option with MRI abdomen for liver metastases. Prostate Cancer: • 18F Fluciclovine PET/CT or 11C Choline PET/CT, 68GaProstate-specific membrane antigen (PSMA) PET/CT or 18F-DCFPyL (piflufolastat or Pylarify) PET/CT • Addition of diagnostic workup/initial staging indication.
• Specification of androgen-receptor pathway inhibitor treatment in alignment with Carelon Radiation Oncology guidelines. Sarcomas of Bone/Soft Tissue: FDG-PET/CT - Added allowance when standard imaging nondiagnostic or contraindicated (bone/soft tissue sarcoma).

Radiation Oncology IMRT for Colon Cancer: New indication for adjuvant treatment of locally advanced adenocarcinoma of the cecum. SBRT for Hepatocellular Carcinoma: Modify eligibility criteria to match clinical trial RTOG 1112 EBRT/IMRT for Prostate Cancer: Adjust for 2 Gy fractions; the total allowed dosage is the same with each fraction is a little larger (now 2 Gy) and lower number of fractions.

Musculoskeletal - Interventional Pain Management Epidural Injection Procedures and Diagnostic Selective Nerve Root Blocks: Added osteoporotic fracture as a contraindication because of increased risk of fracture and confounding source of pain. Paravertebral Facet Injection/Medial Branch Nerve Block/Neurolysis:
• Added new IBNA procedure considered not medically necessary as primarily industry sponsored studies • Added exclusions for

• Diagnostic medial branch blocks, therapeutic intraarticular facet joint injections
• Use of endoscopic neurolysis or rhizotomy
• Platelet-rich plasma injections Spinal Cord and Dorsal Root Ganglion Stimulators: • Added indication of prosthetic disc nucleus for spinal cord stimulation with strict criteria • Added clarifications

Sacroiliac Joint Fusion • Revised exclusion to include procedures that use a transfixing device.

As a reminder, ordering and servicing providers may submit prior authorization requests to Carelon using the following:
• Access Carelon’s ProviderPortalSM directly at www.providerportal.com
o Online access is available 24/7 to process orders in real-time and is the fastest and most convenient way to request authorization.

For questions related to guidelines, please contact Carelon Medical Benefits Management via email at MedicalBenefitsManagement.guidelines@Carelon.com. Additionally, you may access and download a copy of the current and upcoming guidelines at https://guidelines.carelonmedicalbenefitsmanagement.com/.

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 “For Providers”, then selecting “Policies, Guidelines & Manuals” under the Provider Resources column, select “Change State” and choose California, 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

Attachment A – Revised Medical Policies and Clinical Guidelines effective January 1, 2024 unless otherwise indicated) Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes ANC.00009 Cosmetic and Reconstructive Services of the Trunk, Groin, and Extremities
(effective January 3, 2024) • Revised Medically Necessary criteria for lipectomy or liposuction for lymphedema and lipedema related to functional impairment or medical complications • Revised clinical indications section with minor typographical updates CG-ANC-04 Ambulance Services: Air and Water (effective January 3, 2024) • Revised Clinical Indications section regarding timeframe difference for ground and air transport CG-DME-13 Lower Limb Prosthesis

• Added HCPCS code L5926 for a lower extremity prosthesis addition considered Medically Necessary when criteria are met, replacing deleted code K1022 CG-DME-31 Powered Wheeled Mobility Devices • Revised hierarchy and formatting in Clinical Indications section • Revised Medically Necessary statement regarding Group 4 devices and mobility-related activities of daily living (MRADLs) • Revised Medically Necessary criteria regarding trial period for motorized wheelchairs for children • Revised Not Medically Necessary statement regarding repair or replacement • Revised Not Medically Necessary statement regarding options/ accessories/features for powered wheeled mobility devices • Removed statement addressing home modifications CG-DME-43 High Frequency Chest Compression Devices for Airway Clearance (effective January 3, 2024) • Added examples of neuromuscular disorders to Medically Necessary criteria in Clinical Indications section CG-DME-44 Electric Tumor Treatment Field (TTF) (effective January 3, 2024) • Removed criteria requiring treatment begin within 7 weeks of completion of temozolomide and radiotherapy • Revised criteria to add definition of tumor progression to the clinical indications • Reformatted criteria to limit criteria to one requirement per line CG-GENE-13 (Carelon Genetic Testing) Genetic Testing for Inherited Diseases • Added additional genes to the table, including those identified as medically actionable by the American College of Medical Genetics (ACMG) recommendations, drug-related genes for Leqembi (lecanemab-irmb) associated with Late Onset Alzheimer’s, and Rivfloza (Nedosiran) associated with Primary hyperoxaluria type 1 • Added code 81401 when specified as apolipoprotein E (APOE) gene testing and code S3852 considered Medically Necessary when criteria are met • Added calmodulin protein (CALM) genes (NOC code 81479) considered Medically Necessary when criteria are met • Removed code 81599
• Updated code descriptors
CG-GENE-14 (Carelon Genetic Testing) Gene Mutation Testing for Cancer Susceptibility and Management (effective January 3, 2024) • Updated the Discussion/General Information (including Tables A and B) and References sections.
• Listed diagnosis codes D46.0-D46.9 to review for Medically Necessary criteria • Added genes to Tier 2 and code 81479 CG-GENE-18 (Carelon Genetic Testing) Genetic Testing for TP53 Mutations
(effective January 3, 2024) • Added personal or family history of pediatric hypodiploid acute lymphoblastic leukemia as a Medically Necessary indication for germline testing CG-GENE-19 (Carelon Genetic Testing) Measurable Residual Disease Assessment in Lymphoid Cancers Using Next Generation Sequencing
(effective January 3, 2024) • Removed the words “following transplant” from the Medically Necessary criteria for multiple myeloma in the Clinical Indications section CG-MED-19 Custodial Care (effective January 3, 2024) • Revised Clinical Indications section by changing “severe and persistent mental illness” to “serious mental illness” • Reformatted bullets to alphanumeric

CG-OR-PR-08 Microprocessor Controlled Lower Limb Prosthesis • Added HCPCS code L5615 for a lower extremity prosthesis addition considered Medically Necessary when criteria are met, replacing deleted code K1014 CG-SURG-03 Blepharoplasty, Blepharoptosis Repair, and Brow Lift • Revised formatting of Clinical Indications section CG-SURG-81 Cochlear Implants and Auditory Brainstem Implants • Added ICD-10-CM diagnosis codes for hearing loss with unrestricted hearing in the contralateral ear considered Medically Necessary for cochlear implants when criteria are met CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity
(effective January 3, 2024) • Added code 0813T for adjustment of intragastric balloon, considered Not Medically Necessary, and code 44238 for laparoscopic procedures on the intestine, excluding the rectum, which do not have a specific code considered Medically Necessary when criteria are met CG-SURG-95 Sacral Nerve Stimulation and Percutaneous or Implantable Tibial Nerve Stimulation for Urinary and Fecal Incontinence, Urinary Retention • Revised formatting of Clinical Indications section • Revised Medically Necessary criteria for trial sacral nerve stimulators for urinary incontinence/urgency/frequency and retention to add new examples of conservative treatments • Revised permanent sacral nerve stimulators Medically Necessary criteria for urinary urgency/frequency • Revised sacral nerve stimulation Not Medically Necessary statement • Added new Medically Necessary criteria for percutaneous and implantable tibial nerve stimulation • Added new Medically Necessary and Not Medically Necessary criteria for replacement or revision of percutaneous and Implantable tibial nerve stimulators • Revised percutaneous and implantable tibial nerve stimulation Not Medically Necessary statement • Revised codes 0587T, 0588T, 64566 for tibial nerve stim considered Medically Necessary when criteria are met; removed codes 0589T, 0590T for subsequent services; added codes 0816T, 0817T, 0818T, 0819T for integrated tibial nerve stimulator (TNS) systems considered Medically Necessary when criteria are met DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices • Added new HCPCS codes A4540, E0732 for cranial electrotherapy considered Investigational and Not Medically Necessary, replacing deleted codes K1002, K1023 • Removed CPT codes 0768T, 0769T
• Updated descriptors for 0766T, 0767T DME.00042 Electronic Positional Devices for the Treatment of Obstructive Sleep Apnea • Added code E0530 considered Investigational and Not Medically Necessary, replacing deleted code K1001 DME.00043 Neuromuscular Electrical Training for the Treatment of Obstructive Sleep Apnea or Snoring • Added codes E0492, E0493 for the Snoozeal device using phone application considered Investigational and Not Medically Necessary, replacing deleted codes K1028, K1029 DME.00046 Intermittent Abdominal Pressure Ventilation Devices • Added code A4468 for exsufflation belt considered Investigational and Not Medically Necessary, replacing deleted code K1021 DME.00049 External Upper Limb Stimulation for the Treatment of Tremors • Added codes A4542, E0734 for the Cala Trio and Cala kIQ devices considered Investigational and Not Medically Necessary, replacing deleted codes K1018, K1019 GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status
• Added CPT codes 0423U, 0434U, 0438U for Genomind, RightMed and EffectiveRx tests considered Investigational and Not Medically Necessary GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT codes 81457, 81458, 81459, 81462, 81463, 81464, 0428U considered Medically Necessary when criteria are met; codes 0422U, 0424U, 0436U considered Not Medically Necessary’; and 0425U, 0426U considered Investigational and Not Medically Necessary
• Revised descriptors for codes 81445, 81449, 81450, 81451, 81455, 81456, 0356U

GENE.00056 Gene Expression Profiling for Bladder Cancer • Added CPT code 0420U for Cxbladder Detect+ test considered Investigational and Not Medically Necessary LAB.00003 In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays • Added CPT code 0435U for ChemoID test considered not Medically Necessary LAB.00016 Fecal Analysis in the Diagnosis of Intestinal Disorders • Added CPT code 0430U for a malabsorption panel considered Investigational and Not Medically Necessary LAB.00019 Proprietary Algorithms for Liver Fibrosis
(effective January 3, 2024) • Revised title (previously titled Proprietary Algorithms for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease) • Revised Investigational and Not Medically Necessary Position Statement • Added CPT code 81517 for the enhanced liver fibrosis (ELF) test considered Investigational and Not Medically Necessary, replacing deleted code 0014M LAB.00026 Systems Pathology and Multimodal Artificial Intelligence Testing for Prostate Cancer (effective January 3, 2024) • Revised title (previously titled Systems Pathology Testing for Prostate Cancer) • Added “Multimodal Artificial Intelligence” to Position Statement LAB.00046 Testing for Biochemical Markers for Alzheimer’s Disease (effective January 3, 2024) • Added Medically Necessary criteria for measurement of amyloid beta • Revised Not Medically Necessary statement • Codes 83520 and 0358U will be considered Medically Necessary for dementia diagnoses when criteria are met MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications (effective January 3, 2024) • Added Medically Necessary criteria for Parkinson's Disease • Code 0398T will be considered Medically Necessary for Parkinson's diagnosis codes when criteria are met MED.00101 Physiologic Recording of Tremor using Accelerometer(s) and Gyroscope(s) • Removed CPT codes 0533T, 0534T, 0535T and 0536T MED.00120 Gene Therapy for Ocular Conditions • Added CPT code 0810T for subretinal injection considered Medically Necessary when criteria are met; removed HCPCS code C9770 for subretinal injection MED.00125 Biofeedback and Neurofeedback • Reformatted Medically Necessary, Not Medically Necessary and Investigational and Not Medically Necessary criteria MED.00130 Surface Electromyography and Electrodermal Activity Sensor Devices for Seizure Monitoring • Added code E0746 when specified as home biofeedback SPEAC device considered Investigational and Not Medically Necessary MED.00135 Gene Therapy for Hemophilia • Added HCPCS code J1412 for Roctavian considered Medically Necessary when criteria are met, replacing C9399, J3490, J3590 MED.00144 Gene Therapy for Duchenne Muscular Dystrophy • Added HCPCS code J1413 for ELEVIDYS considered Medically Necessary when criteria are met, replacing C9399, J3490, J3590 SURG.00007 Vagus Nerve Stimulation • Added HCPCS code E0735 for non-invasive vagus nerve stimulation device considered Investigational and Not Medically Necessary, replacing deleted code K1020 SURG.00010 Treatments for Urinary Incontinence (effective January 3, 2024) • Revised Medically Necessary statements, changed to alphanumeric • Revised Note • Added Not Medically Necessary statement on periurethral bulking agents and revised existing Not Medically Necessary statement • Removed line on periurethral bulking agents from Investigational and Not Medically Necessary statement, changed to alphanumeric SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting

• Added HCPCS codes Q4279, Q4287, Q4288, Q4289, Q4291, Q4292, Q4293, Q4294, Q4295, Q4296, Q4297, Q4298, Q4299, Q4300, Q4301, Q4302, Q4303, Q4304 for products considered Investigational and Not Medically Necessary, added Q4290 considered Medically Necessary for ocular indications, revised descriptor for Q4225

SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures (effective January 3, 2024) • Revised formatting of Position Statement • Revised reconstructive statement related to procedures done in advance of mastectomy or lumpectomy • Moved reconstructive text related to procedure timing to Background section • Revised Position Statement section with text updates SURG.00037 Treatment of Varicose Veins (Lower Extremities) • Added wording to clarify when codes 36465 and 36466 may be Medically Necessary based on criteria SURG.00045 Extracorporeal Shock Wave Therapy • Added CPT code 0864T for extracorporeal shock wave therapy to corpus cavernosum considered Investigational and Not Medically Necessary, replacing 55899 SURG.00077 Uterine Fibroid Ablation: Laparoscopic, Percutaneous or Transcervical Image Guided Techniques • Added CPT code 58580 for transcervical radiofrequency ablation considered Medically Necessary when criteria are met, replacing deleted code 0404T SURG.00097 Scoliosis Surgery • Revision to Position Statement formatting • Added Medically Necessary and Investigational and Not Medically Necessary criteria for revision, replacement, or removal of vertebral body tethering to Position Statement • Added codes 22836, 22837, 22838 for thoracic tethering, and 0790T for thoracolumbar of lumbar tethering revision considered Medically Necessary when criteria are met • Revised descriptors for 0656T, 0657T SURG.00150 Leadless Pacemaker • Added CPT codes 0823T, 0824T, 0825T and 0826T for leadless atrial pacemakers considered Investigational and Not Medically Necessary SURG.00152 Wireless Cardiac Resynchronization Therapy for Left Ventricular Pacing • Added CPT codes 0861T, 0862T and 0863T considered Investigational and Not Medically Necessary; revised descriptors for 0517T, 0518T, 0519T, 0520T SURG.00157 Minimally Invasive Treatment of the Posterior Nasal Nerve to Treat Rhinitis • Added CPT codes 31242 and 31243 for radiofrequency and cryoablation of posterior nasal nerve considered Investigational and Not Medically Necessary, replacing deleted HCPCS code C9771 SURG.00158 Implantable Peripheral Nerve Stimulation Devices as a Treatment for Pain • Added new CPT codes 64596 and 64597 for integrated systems • Updated descriptor for code 64590 TRANS.00013 Small Bowel, Small Bowel/Liver, and Multivisceral Transplantation • Added diagnosis code examples K90.821-K90.829, K90.83 to document TRANS.00023 Hematopoietic Stem Cell Transplantation for Multiple Myeloma and Other Plasma Cell Dyscrasias • Removed duplicate asterisk notes within the Position Statements TRANS.00026 Heart/Lung Transplantation • Revised reference in Position Statement section TRANS.00027 Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors (effective January 3, 2024) • Added definition of tandem to Position Statement • Revised Medically Necessary criteria for autologous hematopoietic stem cell transplantation for stage IVa and stage IVb retinoblastoma
• Revised Investigational and Not Medically Necessary statement for allogeneic (ablative or non-myeloablative [mini transplant]) for retinoblastoma