MP/CG Update/Notice - April 2023 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.

April 1, 2023

Dear Provider:

Anthem Blue Cross is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines.
Please refer to the specific policy for coding, language, rationale updates and changes that are not summarized below.

Updates to Carelon Medical Benefits Management, Inc.* (Carelon) programs, a separate company, 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. 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.

NEW Medical Policies

• MED.00145 Digital Therapy Devices for Treatment of Amblyopia: This document addresses digital therapy devices for the treatment of amblyopia. These devices incorporate dichoptic (viewing a separate and independent field through each eye) presentations to improve visual acuity of individuals with amblyopia. o Considered Investigational and Not Medically Necessary o Prior authorization required effective July 1, 2023

UPDATED Clinical Guidelines and Medical Policies effective July 1, 2023

• CG-SURG-18 Septoplasty: This document addresses indications for septoplasty. This document may also be used to review the septoplasty component of procedures which combine both rhinoplasty and septoplasty (that is, rhinoseptoplasty). o Re-formatted hierarchy in Clinical Indications section
o Revised Medically Necessary criteria related to conservative management
o Revised “chronic recurrent sinusitis” to “chronic or recurrent acute sinusitis”
o Revised Not Medically Necessary statement to remove bulleted list below statement

Medical Policy archivals

• RAD.00036 MRI of the Breast (effective August 1, 2023; see Carelon update below) • RAD.00052 Positional MRI (effective April 12, 2023) • SURG.00053 Unicondylar Interpositional Spacer (effective April 12, 2023) • SURG.00119 Endobronchial Valve Devices (effective September 1, 2023)

Medical Policy to Clinical Guideline conversion

Effective April 12, 2023 • SURG.00151 Balloon Dilation of the Eustachian Tubes is converted to CG-SURG-117 (same title)

Specialty Pharmacy updates

Effective March 27, 2023, CC-0091 Lartruvo has been archived.

*On March 1, 2023, AIM Specialty Health began operating as Carelon Medical Benefits Management, Inc.

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

Effective August 1, 2023, Anthem Blue Cross will transition the clinical criteria for medical necessity review of MRI of

the Breast from RAD.00036 to the following Carelon Clinical Appropriateness Guidelines.
• Oncologic Imaging
• Chest Imaging

As part of this transition of clinical criteria, the following procedures will be subject to prior authorization by Carelon:
CPT

77046 Magnetic resonance imaging, breast, without contrast material; unilateral 77047 Magnetic resonance imaging, breast, without contrast material; bilateral 77048 Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis) when performed; unilateral 77049 Magnetic resonance imaging, breast, without and with contrast material(s), including computer-aided detection (CAD real-time lesion detection, characterization and pharmacokinetic analysis) when performed; bilateral

HCPCS
C8903 Magnetic resonance imaging with contrast, breast; unilateral C8905 Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral C8906 Magnetic resonance imaging with contrast, breast; bilateral C8908 Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral

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

Effective for dates of service on and after September 10, 2023, 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.

Updates by guideline • Spine Surgery o Cervical Decompression; Cervical Disk Arthroplasty for radiculopathy – removed requirement for conservative management when objective neurologic deficits are present; specified that physical therapy is optional for scenarios that do require conservative management o Cervical Decompression for degenerative cervical kyphosis – added indications for debilitating neck pain with functional limitations and clinically significant problems with horizontal gaze, swallowing, or breathing o Cervical Decompression for pseudarthrosis – shorten time required since prior procedure to 6 months (from 9 months) o Lumbar Disc Arthroplasty – removed the exclusion for “prior spine surgery of any form at the target level,” to align with FDA approval language o Lumbar Discectomy, Foraminotomy, Laminotomy for lumbar disc herniation – removed requirement for conservative management when objective neurologic deficits are present; specified that physical therapy is optional for scenarios that do require conservative management; for recurrent disc herniation, shortened conservative management duration to 6 weeks to match that of initial herniation o Lumbar Fusion for isthmic spondylolisthesis – specified that instability must be present; the presence of a pars defect alone is not an indication for fusion o Lumbar Fusion for pseudarthrosis – shorten time required since prior procedure to 6 months (from 9 months) o Lumbar Laminectomy for lumbar synovial cyst – added indication for laminectomy without fusion for synovial cyst (if symptomatic instability is present, existing criteria for fusion would apply) o Vertebroplasty/Kyphoplasty for osteolytic metastasis, myeloma, or plasmacytoma – removed requirement for prior chemo or radiation therapy o Vertebroplasty/Kyphoplasty – new exclusion for prophylactic vertebroplasty in posterior spinal fusion
• Sacroiliac Joint Fusion o Revised posterior (dorsal) minimally invasive surgical (MIS) SI joint fusion procedure description
• Imaging of the Spine o Spinal infection – added criterion for imaging in patients at risk for infection based on American College of Radiology (ACR) appropriateness criteria o Radiculopathy – added indication for CT when being done as a myelogram, based on ACR appropriateness criteria and feedback from subject matter experts • Imaging of the Extremities o Shoulder arthroplasty – clarified that MRI should not be used for preoperative assessment of bone stock and bone version (CT only) • Vascular Imaging

o Vascular anatomic delineation prior to procedures – removed exclusions for coronary artery bypass graft (CABG) and open valve replacement/repair o Vascular anatomic delineation prior to transcatheter aortic valve implantation (TAVI/TAVE) – allowed CT chest as an alternative to CTA o Stenosis or occlusion of extracranial carotid arteries – limited screening for patients with incidentally detected carotid calcification to those undergoing preoperative evaluation for cardiac surgery; modified criteria for management of known stenosis to allow follow-up per American College of Cardiology guidelines o Pulmonary hypertension – clarified that criteria are applicable to all causes, not just pulmonary arterial hypertension o Unexplained hypotension – removed indication as it is more appropriate for inpatient management o Peripheral arterial disease – removed cilostazol as prerequisite therapy; added baseline evaluation and surveillance indications following endovascular revascularization o Popliteal artery aneurysm – added diagnosis and management indications; added surveillance for unrepaired aneurysms to align with Society for Vascular Surgery guidelines • Sleep Disorder Management o Home Sleep Testing – changed terminology from “home sleep test/study” to “home sleep apnea test/study” throughout the document o In-Lab Sleep Studies in Adult Patients, for follow-up laboratory studies in established sleep disorder – added indication for one-time optimization of device settings after insertion of a phrenic nerve stimulator
o Contraindications to APAP – specified that APAP is contraindicated for Chronic Obstructive Pulmonary Disease (COPD) which is moderate or severe o Bi-Level Positive Airway Pressure (BPAP) Devices – added indication for patients with obesity hypoventilation syndrome o Ongoing treatment with positive airways pressure devices APAP, BPAP, or CPAP – specified that demonstration of compliance with therapy is not required for non-adult patients or for patients with disorders other than obstructive sleep apnea or central sleep apnea o Multiple Sleep Latency Testing and Maintenance of Wakefulness Testing – previous prerequisite for polysomnography was expanded to also allow prior home sleep apnea testing; for idiopathic hypersomnia, modified prerequisite for “prolonged night sleep” to “prolonged sleep during primary sleep period”

As a reminder, ordering and servicing providers may submit prior authorization requests to Carelon in one of several ways:
• 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. • Access Carelon via the Availity Web Portal at www.availity.com

For questions related to guidelines, please contact Carelon 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 Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-GENE-13 (Carelon Genetic Testing) Genetic Testing for Inherited Diseases • Added CPT code 0378U effective April 1, 2023 for UCGSL RFC1 Repeat Expansion Test, and gene RFC1 to table, considered Not Medically Necessary CG-GENE-19 (Carelon Genetic Testing) Measurable Residual Disease Assessment in Lymphoid Cancers Using Next Generation Sequencing • Added CPT code 0364U effective April 1, 2023, for clonoSEQ (was NOC code) CG-SURG-106 Venous Angioplasty with or without Stent Placement or Venous Stenting Alone • Added new Medically Necessary criterion for idiopathic intracranial hypertension (IIH) CG-SURG-108 Stereotactic Radiofrequency Pallidotomy • Revised Medically Necessary statement to address secondary and other causes of parkinsonism • Added new Medically Necessary criteria related to contraindications previously in the Not Medically Necessary statement CG-SURG-97 Cardioverter Defibrillators • Removed code 00534 for associated anesthesia, not addressed CG-SURG-117 Balloon Dilation of Eustachian Tube • Moved content from SURG.00151 (same title) • Revised Investigational & Not Medically Necessary statement to Medically Necessary and Not Medically Necessary criteria for use of balloon dilation of the eustachian tubes (BDET) • CPT codes 69705, 69706 considered Medically Necessary when criteria are met (were Investigational & Not Medically Necessary) DME.00048 Virtual Reality-Assisted Therapy Systems • Added new code E1905 effective April 1, 2023, for VR cognitive behavioral therapy device such as RelieVRx; considered Investigational & Not Medically Necessary DME.00049 External Upper Limb Stimulation for the Treatment of Tremors • Revised descriptor for code K1019 effective April 1, 2023 GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status • Added CPT code 0380U effective April 1, 2023, for PersonalisedRX; considered Investigational & Not Medically Necessary GENE.00049 Circulating Tumor DNA Panel Testing (Liquid Biopsy) • Added new Medically Necessary statement for panels that assess tumor mutation burden (TMB) and revised Investigational & Not Medically Necessary statement • CPT codes 0239U (FoundationOne Liquid CDx) and 0326U (Guardant360) considered Medically Necessary when criteria are met (previously Investigational & Not Medically Necessary) • Added CPT code 0368U effective April 1, 2023, for ColoScape Colorectal Cancer Detection, considered Investigational & Not Medically Necessary GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT code 0379U effective April 1, 2023, for a molecular profiling panel, Medically Necessary when criteria are met • Removed codes 0130U, 0131U, 0132U, 0134U, 0135U that will be addressed in GENE.00054 GENE.00054 Paired DNA and Messenger RNA (mRNA) Genetic Testing to Detect, Diagnose and Manage Cancer • Added CPT codes 0130U, 0131U, 0132U, 0134U, 0135U previously addressed in GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling, considered Investigational & Not Medically Necessary LAB.00003 In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays • Removed CPT codes 0324U, 0325U deleted April 1, 2023

LAB.00026 Systems Pathology Testing for Prostate Cancer • Added CPT code 0376U effective April 1, 2023, for ArteraAI Prostate Test; considered Investigational & Not Medically Necessary LAB.00031 Advanced Lipoprotein Testing • Added CPT code 0377U effective April 1, 2023, for Liposcale®; considered Investigational & Not Medically Necessary LAB.00039 Pooled Antibiotic Sensitivity Testing • Added CPT codes 0372U, 0374U effective April 1, 2023, for genitourinary antibiotic resistance tests, considered Investigational & Not Medically Necessary MED.00101 Physiologic Recording of Tremor using Accelerometer(s) and Gyroscope(s) • Added CPT code 0778T, considered Investigational & Not Medically Necessary MED.00120 Gene Therapy for Ocular Conditions • Revised note in Position Statement to replace "pregnant women" with "individuals who are pregnant" and revised formatting MED.00135 Gene Therapy for Hemophilia • Added new HCPCS code J1411 (replacing NOC codes) effective April 1, 2023, for Hemgenix SURG.00010 Treatments for Urinary Incontinence • Added new codes A4341, A4342 effective April 1, 2023, for inFlow device and supplies, considered Investigational & Not Medically Necessary (NOC code A4335 no longer applicable) SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting • Revised Medically Necessary statement to include SimpliDerm for breast reconstruction; Kerecis and TheraSkin for diabetic foot ulcers; AmnioBand for venous stasis ulcers; OviTex for complex abdominal wall wounds • Revised formatting in several Medically Necessary statements • Revised Not Medically Necessary statement to align with revisions to Medically Necessary statements • Added new products/codes (A2019, A2020, A2021, Q4265, Q4266, Q4267, Q4268, Q4269, Q4270, Q4271) to the Investigational & Not Medically Necessary statement SURG.00158 Implantable Peripheral Nerve Stimulation Devices as a Treatment for Pain • Added new code L8678 effective April 1, 2023, for stimulator supplies (patch), considered Investigational & Not Medically Necessary when used with peripheral nerve stimulation (PNS) pain device; also added existing code L8681 for programming device used with PNS