MP/CG Update/Notice - October 2023 Form

California | Commercial

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-040654-23

September 2023

October 1, 2023

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

• MED.00147 Cellular Therapy Products for Allogeneic Stem Cell Transplantation: This document addresses stem cell therapy products such as omidubicel for hematologic malignancies (blood cancers) which are amenable to stem cell transplantation. o Outlines Medically Necessary and Investigational and Not Medically Necessary criteria for the use of ex-vivo expansion of cord blood stem cell product o Prior authorization required effective January 1, 2024

• TRANS.00041 Histological Analysis using Microarray Gene Expression Profiling for Kidney Allograft Injury or Rejection: This document addresses histological analysis using microarray gene expression profiling as a complement to conventional biopsy processing when assessing for allograft injury or rejection in kidney transplant recipients. o Considered Investigational and Not Medically Necessary o Prior authorization required effective January 1, 2024

UPDATED Clinical UM Guidelines and Medical Policies effective January 1, 2024

• CG-OR-PR-05 Myoelectric Upper Extremity Prosthetic Devices: This document addresses the use of myoelectric prosthetic devices for individuals with an amputation or absence of a portion of an upper extremity at any level from the hand, including partial-hand, to the shoulder. o Revised formatting of Medically Necessary section o Added Repair and Replacement criteria to Clinical Indications section o Added new Medically Necessary statement regarding enhanced dexterity prosthetic arm myoelectric upper extremity prosthetic devices o Added new Medically Necessary and Not Medically Necessary criteria for device repair and replacement

• CG-SURG-61 Cryosurgical, Radiofrequency, Microwave or Laser Ablation to Treat Solid Tumors Outside the Liver: This document focuses on the use of cryosurgical (also known as cryosurgery or cryoablation), radiofrequency or laser ablation as a treatment of primary or secondary malignancies outside the liver; and, benign tumors outside the liver. o Revised title (previous title: Cryosurgical, Radiofrequency or Laser Ablation to Treat Solid Tumors Outside the Liver) o Added microwave ablation to the Clinical Indications o Added cryoablation and microwave ablation to the Medically Necessary indications for non-small cell lung cancer and malignant tumors that have metastasized to the lung o Added Not Medically Necessary statements regarding focal cryoablation of the prostate and microwave ablation for all other indications o Revised Medically Necessary indication for cryoablation of the prostate to whole gland cryoablation of the prostate o Reordered clinical indications to be based on clinical condition rather than ablative technique

• ANC.00009 Cosmetic and Reconstructive Services of the Trunk, Groin and Extremities: This document addresses a variety of surgical procedures of the trunk, groin and extremities that may be considered medically necessary, cosmetic or reconstructive in nature. o Revised title (previous title: Cosmetic and Reconstructive Services of the Trunk and Groin) o Revised Position Statement regarding lipectomy or liposuction for lymphedema and lipedema

• DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices: This document addresses certain types of electrical stimulation devices. o Revised bullets to alphanumeric in Position Statement section o Added lines to Investigational and Not Medically Necessary statement on electrical stimulation wound treatment device, electromagnetic wound treatment devices and pulsed electromagnetic field stimulation

• LAB.00011 Selected Protein Biomarker Algorithmic Assays: This document addresses the use of selected protein biomarker algorithmic assays, which involve the qualitative and/or quantitative analysis of protein constituents in a biological sample that are reported as a predictive, diagnostic or prognostic algorithmic result. o Reformatted bullets to alphanumeric in the Position Statement o Added IMMray® PanCan-d test to the Investigational and Not Medically Necessary statement

• LAB.00028 Blood-based Biomarker Tests for Multiple Sclerosis: This document addresses serum biomarker tests for multiple sclerosis (MS). o Revised title (previous title: Serum Biomarker Tests for Multiple Sclerosis) o Expanded scope of document from serum to blood-based biomarker testing for MS o Revised Position Statement to indicate blood-based biomarker tests for multiple sclerosis are considered Investigational and Not Medically Necessary for all uses

• MED.00140 Lentiviral Gene Therapy for Beta Thalassemia and Sickle Cell Disease: This document addresses gene therapy for beta thalassemia, a genetic disease involving mutations in the human beta-globin (HBB) gene that reduces an individual’s ability to produce hemoglobin and leads to a shortage of mature red blood cells and a lack of sufficient oxygen. o Revised title (previous title: Gene Therapy for Beta Thalassemia) o Added Investigational and Not Medically Necessary statement on lovotibeglogene autotemcel

• SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea or Snoring: This document addresses surgical treatments for obstructive sleep apnea (OSA), such as uvulopalatopharyngoplasty (UPPP), hyoid myotomy and jaw realignment surgery, laser surgery, radiofrequency ablation, palatal implants, and other procedures. o Removed the criteria examples for failed continuous positive airway pressure (CPAP) treatment o Added definition for failed CPAP treatment

• SURG.00144 Occipital and Sphenopalatine Ganglion Nerve Block Therapy for the Treatment of Headache and Neuralgia: This document addresses occipital nerve blocks (or blockade) as a therapy for treatment of headache syndromes. o Revised title (previous title: Occipital Nerve Block Therapy for the Treatment of Headache and Occipital Neuralgia) o Added Investigational and Not Medically Necessary statement for sphenopalatine ganglion nerve blocks

Medical Policy conversions to Clinical Utilization Management (UM) Guidelines effective September 27, 2023

• OR.PR.00003 Microprocessor Controlled Lower Limb Prosthesis converted to CG-OR-PR-08 • OR.PR.00007 Microprocessor Controlled Lower Knee-Ankle-Foot Orthosis converted to CG-OR-PR-09

Clinical UM Guideline and Medical Policy archivals effective December 1, 2023

• CG-SURG-27 Gender Affirming Surgery • MED.00122 Wilderness Programs

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.*
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.

Including the National Drug Code (NDC) code on your claim may help expedite claim processing of drugs billed with a Not Otherwise Classified (NOC) code.

Prior authorization updates Effective for dates of service on and after January 1, 2024, the following specialty pharmacy codes from current or new clinical criteria documents 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 updates.

Clinical Criteria Drug HCPCS or CPT code(s) CC-0247 Beyfortus (nirsevimab) C9399, J3490, J3590, J9999 CC-0244* Columvi (glofitamab-gxbm) C9399, J3490, J3590, J9999 CC-0245 Izervay (avacincaptad pegol) C9399, J3490, J3590, J9999 CC-0246 Rystiggo (rozanolixizumab-noli) C9399, J3490, J3590, J9999 CC-0207 Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) C9399, J3490

• Oncology use is managed by Carelon Medical Benefits Management.

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

  Step therapy updates Courtesy notice — Effective for dates of service on and after October 1, 2023, updated step therapy criteria for iron agents found in the clinical criteria document for CC-0182 will be implemented. The preferred product list is being expanded to include Infed. Please refer to the clinical criteria document for details.

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

  Clinical Criteria Drug HCPCS or CPT code(s) CC-0247 Beyfortus (nirsevimab) C9399, J3490, J3590, J9999 CC-0245 Izervay (avacincaptad pegol) C9399, J3490, J3590, J9999 CC-0246 Rystiggo (rozanolixizumab-noli) C9399, J3490, J3590, J9999 CC-0207 Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) C9399, J3490

  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 Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-DME-07 Augmentative and Alternative Communication (AAC) Devices with Digitized or Synthesized Speech Output • Removed redundant punctuation in first Medically Necessary statement CG-DME-10 Durable Medical Equipment • Revised gender-specific language in the Clinical Indications section CG-GENE-14 (Carelon Genetic Testing) Gene Mutation Testing for Cancer Susceptibility and Management • Revised section “B Gene Mutation Testing to Guide Targeted Cancer Therapy” to include cancer management in the Clinical Indications section CG-GENE-15 (Carelon Genetic Testing) Genetic Testing for Lynch Syndrome, Familial Adenomatous Polyposis (FAP), Attenuated FAP and MYH-associated Polyposis • Added ICD-10-CM diagnosis codes D13.91, D48.110-D48.119
and Z83.710-Z83.719 effective October 1, 2023 replacing Z83.71 CG-MED-83 Site of Care: Specialty Pharmaceuticals • Revised formatting in Clinical Indications section • Added new Medically Necessary statement addressing geographic accessibility CG-MED-88 Preimplantation Embryo Biopsy and Genetic Testing • Revised terminology to replace preimplantation genetic screening (PGS) with preimplantation genetic testing for aneuploidies (PGT- A), and preimplantation genetic diagnosis (PGD) with preimplantation genetic testing for monogenic disorders (PGT-M) or preimplantation genetic testing for structural chromosomal rearrangements (PGT-SR) • Reformatted Medically Necessary criteria • Created new Medically Necessary criteria for PGT-SR • Revised genetic counseling requirements • Added existing CPT code 0396U for Spectrum PGT-M and 0254U for SMART PGT-A as Medically Necessary when criteria are met
CG-OR-PR-04 Cranial Remodeling Bands and Helmets (Cranial Orthotics) • Added ICD-10-CM diagnosis codes Q75.001-Q75.08 replacing Q75.0 for craniosynostosis effective October 1, 2023 CG-OR-PR-08 Microprocessor Controlled Lower Limb Prosthesis • Moved content from OR-PR.00003 • Investigational and Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition • Added new Medically Necessary statement for simultaneous use of both a microprocessor controlled knee prosthesis and microprocessor controlled foot-ankle prosthesis • Added HCPCS codes L7510, L7520 for repair, considered Medically Necessary when criteria are met CG-SURG-63 Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure • Added new ICD-10-CM code I21.B effective October 1, 2023 to end of range CG-SURG-78 Locoregional Techniques for Treating Primary and Metastatic Liver Malignancies • Added code C9790 effective October 1, 2023 for histotripsy considered Not Medically Necessary CG-SURG-79 Implantable Infusion Pumps • Revised malignant pain criteria
• Added HCPCS code E0786 for replacement pump, considered Medically Necessary when criteria are met

CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity • Added criteria regarding body mass index (BMI) parameters, pre- operative evaluations and education and treatment plans and removed criteria regarding percentage weight loss amounts and compliance evaluation for revision/conversion indications • Removed Not Medically Necessary statement regarding stomach stretching and overeating CG-SURG-97 Cardioverter Defibrillators • Added new ICD-10-CM code I21.B effective October 1, 2023 to end of range CG-SURG-108 Stereotactic Radiofrequency Pallidotomy • Added ICD-10-CM diagnosis codes G20.A1-G20.C for Parkinson's effective October 1, 2023 replacing G20 ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck • Changed code 15829 to reconstructive when criteria are met (was Cosmetic and Not Medically Necessary) DME.00041 Ultrasonic Diathermy Devices • Added code K1036 effective October 1, 2023 for device supplies and accessories, considered Investigational and Not Medically Necessary DME.00043 Neuromuscular Electrical Training for the Treatment of Obstructive Sleep Apnea or Snoring • Added codes E0490, E0491 effective October 1, 2023 for device with hardware remote, considered Investigational and Not Medically Necessary DME.00049 External Upper Limb Stimulation for the Treatment of Tremors • Revised Position Statement to include Investigational and Not Medically Necessary for Parkinson’s disease GENE.00009 Gene Expression Profiling and Genomic Biomarker Tests for Prostate Cancer • Added code 0403U effective October 1, 2023 for MyProstateScore 2.0 considered Investigational and Not Medically GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status • Added codes 0411U and 0419U effective October 1, 2023 considered Investigational and Not Medically Necessary GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added codes 0262U and 0405U considered Not Medically Necessary • Added codes 0409U, 0414U considered Medically Necessary when criteria are met • Added codes 0410U, 0413U, 0415U and 0417U considered Investigational and Not Medically Necessary
• Removed 0397U deleted as of October 1, 2023 LAB.00016 Fecal Analysis in the Diagnosis of Intestinal Disorders • Added ICD-10-CM codes K63.8211-K63.829 effective October 1, 2023 for intestinal microbial overgrowth LAB.00029 Rupture of Membranes Testing in Pregnancy • Removed code 0066U deleted as of October 1, 2023 for PartoSure test LAB.00040 Serum Biomarker Tests for Risk of Preeclampsia • Added code 0390U effective July 1, 2023 for PEPredictDx test, considered Investigational and Not Medically Necessary LAB.00041 Machine Learning Derived Probability Score for Rapid Kidney Function Decline • Added code 0407U effective October 1, 2023 for IntelxDKD test considered Investigational and Not Medically Necessary LAB.00046 Testing for Biochemical Markers for Alzheimer's Disease • Added code 0412U effective October 1, 2023 for PrecivityAD® blood test considered Investigational and Not Medically Necessary MED.00125 Biofeedback and Neurofeedback • Added ICD-10-CM diagnosis codes G43.E01-G43.E19 effective October 1, 2023 for migraine (end of range) MED.00143 Ingestible Devices for the Treatment of Constipation • Added codes A9268 and A9269 effective October 1, 2023 for Vibrant Gastro System capsule and programmer considered Investigational and Not Medically Necessary replacing NOC code MED.00145 Digital Therapy Devices for Treatment of Amblyopia • Added code A9292 effective October 1, 2023 for amblyopia software considered Investigational and Not Medically Necessary

SURG.00007 Vagus Nerve Stimulation
• Removed Investigational and Not Medically Necessary example under implanted vagus nerve stimulation (VNS) for epilepsy and added stroke rehabilitation as an example • Removed all Investigational and Not Medically Necessary examples under non implanted VNS SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting • Added new codes A2022, A2023, A2024, A2025, Q4285, Q4286 effective October 1, 2023 for products considered Investigational and Not Medically Necessary • Added existing code C1832 for Recell, considered Investigational and Not Medically Necessary SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation • Added ICD-10-CM diagnosis codes G20.A1-G20.C for Parkinson's effective October 1, 2023 replacing G20 • Added code C1787 for programming device considered Medically Necessary when criteria are met SURG.00032 Patent Foramen Ovale and Left Atrial Appendage Closure Devices for Stroke Prevention • Revised hierarchy formatting in the Position Statement section SURG.00052 Percutaneous Vertebral Disc and Vertebral Endplate Procedures • Added Medically Necessary and Not Medically Necessary criteria for intraosseous basivertebral nerve ablation (BVNA) SURG.00071 Percutaneous and Endoscopic Spinal Surgery • Added code C2614 for probe considered Investigational and Not Medically Necessary SURG.00096 Surgical and Ablative Treatments for Chronic Headaches • Added ICD-10-CM diagnosis codes G43.E01-G43.E19 effective October 1, 2023 for migraine (end of range) SURG.00112 Implantation of Occipital, Supraorbital or Trigeminal Nerve Stimulation Devices (and Related Procedures) • Added ICD-10-CM diagnosis codes G43.E01-G43.E19 effective October 1, 2023 for migraine (end of range) SURG.00150 Leadless Pacemaker • Added ICD-10-PCS X2H63V9, X2HK3V9 effective October 1, 2023 for dual chamber leadless pacemaker, considered Investigational and Not Medically Necessary SURG.00160 Implanted Port Delivery Systems to Treat Ocular Disease • Added note to clarify associated CPT codes TRANS.00004 Cell Transplantation (Mesencephalic, Adrenal-Brain and Fetal Xenograft) • Added ICD-10-CM diagnosis codes G20.A1-G20.C for Parkinson's effective October 1, 2023 replacing G20 TRANS.00009 Lung and Lobar Transplantation • Removed CPT codes 0494T, 0495T and 0496T for lung perfusion (now addressed in TRANS.00039) TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products • Added ICD-10-CM diagnosis codes G20.A1-G20.C for Parkinson's effective October 1, 2023 replacing G20 TRANS.00039 Portable Normothermic Organ Perfusion Systems • Added Medically Necessary criteria for portable normothermic heart perfusion • Reformatted Medically Necessary criteria for lung and liver perfusion