MP/CG Update/Notice - April 2021 Form

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, 2021

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, and rationale updates and changes that are not summarized below or on Attachment A.

Updates to AIM Specialty Health® (AIM) 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 AIM.
They do not apply to HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card.

NEW Medical Policies effective July 7, 2021

• GENE.00056 Gene Expression Profiling for Bladder Cancer: This document addresses gene expression profiling to diagnose bladder cancer, predict response to therapy in individuals with bladder cancer, and monitor individuals with a history of bladder cancer. o Gene expression profiling for diagnosing, managing and monitoring bladder cancer is considered Investigational and Not Medically Necessary

• LAB.00038 Cell-free DNA Testing to Aid in the Monitoring of Kidney Transplants for Rejection: This document addresses the use of cell-free DNA (cfDNA) as a method of detecting kidney transplant recipients at risk for transplant rejection. o Cell-free DNA testing is considered Investigational and Not Medically Necessary as a non-invasive method of determining the risk of rejection in kidney transplant recipients

• LAB.00039 Pooled Antibiotic Sensitivity Testing: This document addresses pooled antibiotic sensitivity testing (P-AST) of urine in combination with a Multiplex Polymerase Chain Reaction (M-PCR) assay for the identification of susceptible urine pathogens and antibiotic resistance genes. o Pooled antibiotic sensitivity testing is considered Investigational and Not Medically Necessary in the outpatient setting for all indications

• SURG.00159 Focal Laser Ablation for the Treatment of Prostate Cancer: This document addresses the use of focal laser ablation, also known as laser interstitial therapy or laser interstitial photocoagulation, to treat localized prostate cancer.
o Focal laser ablation is considered Investigational and Not Medically Necessary for the treatment of prostate cancer

• TRANS.00037 Uterine Transplantation: This document addresses uterine transplantation, which has been proposed as a treatment of uterine factor infertility. o Uterine transplantation is considered Investigational and Not Medically Necessary for all uses, including but not limited to the treatment of uterine factor infertility due to nonfunctioning or absent uterus o Prior authorization will be required effective July 7, 2021

UPDATED Medical Policies and Clinical Guidelines effective July 7, 2021

• ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck: This document describes the cosmetic, reconstructive, and medically necessary uses of a selection of procedures addressing the treatment of abnormalities of the head and neck.
o Removed the word “physical” from the term “physical functional impairment” in Facial Plastic Surgery, Otoplasty, Rhinophyma, Rhinoplasty or Rhinoseptoplasty and Cranial Nerve Procedures position statements o Added otoplasty using a custom-fabricated device, including but not limited to a custom fabricated alloplastic implant, as Cosmetic and Not Medically Necessary

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• CG-OR-PR-04 Cranial Remodeling Bands and Helmets (Cranial Orthotics): This document addresses the use of the adjustable band or helmet cranial orthoses as a treatment of craniosynostosis, non-synostotic plagiocephaly (asymmetrically shaped posterior head), scaphocephaly (abnormally shaped narrow head), and brachycephaly (abnormally shaped head; shortened in antero-posterior dimension without asymmetry) in infants.
o Removed condition requirement from Reconstructive criteria o Replaced current diagnostic Reconstructive criteria with criteria based on one of the following cephalometric measurements: the cephalic index, the cephalic vault asymmetry index, the oblique diameter difference index, or the cranioproportional index of plagiocephelometry o Updated formatting in the Clinical Indications section

• CG-SURG-78 Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies: This document addresses surgical excision and locoregional therapies to treat primary or metastatic cancer of the liver.
o Added transcatheter arterial chemoembolization (TACE) using immunoembolization (for example, using granulocyte-macrophage colony-stimulating factor [GM-CSF]) as Not Medically Necessary for all liver- related indications

• CG-SURG-82 Bone-Anchored and Bone Conduction Hearing Aids: This document addresses the use of implantable bone-anchored hearing aids, transcutaneously worn, non-surgical application of a bone-anchored hearing aid using a headband or Softband, partially-implantable magnetic bone conduction hearing aids, and an intraoral bone conduction hearing aid.
o Removed Reorganized Clinical Indications section o Reorganized and clarified bilateral hearing loss Medically Necessary criteria o Clarified Medically Necessary criteria for transcutaneously-worn bone conduction hearing aids for both bilateral and unilateral hearing loss o Revised audiologic pure tone average bone conduction threshold criteria for unilateral implant for bilateral hearing loss o Moved device-specific threshold information to the Discussion section o Clarified Medically Necessary criteria for transcutaneously worn and fully- or partially-implantable bone conduction hearing aids for unilateral hearing loss o Added Not Medically Necessary statement for when Medically Necessary criteria have not been met o Clarified Not Medically Necessary statement regarding replacement parts or upgrades
o Added bone conduction hearing aids using an adhesive adapter behind the ear as Not Medically Necessary for all indications

Medical Policies converted to Clinical Guidelines effective April 7, 2021

MP Number Title CG Number GENE.00011 Gene Expression Profiling for Managing Breast Cancer Treatment CG-GENE-22 GENE.00007 Cardiac Ion Channel Genetic Testing CG-GENE-23 GENE.00017 Genetic Testing for Diagnosis and Management of Hereditary Cardiomyopathies (including arrhythmogenic right ventricular dysplasia/cardiomyopathy) CG-GENE-23

Clinical Guidelines to be archived and added to other existing Clinical Guidelines effective April 1, 2021 (except where noted)

CG Number Title Moved into CG Number CG-GENE-02 Analysis of RAS Status CG-GENE-14 CG-GENE-03 BRAF Mutation Analysis CG-GENE-14 CG-GENE-05 Genetic Testing for DMD Mutations (Duchenne or Becker Muscular Dystrophy) CG-GENE-13 CG-GENE-12 PIK3CA Mutation Testing for Malignant Conditions CG-GENE-14 CG-GENE-20 Epidermal Growth Factor Receptor (EGFR) Testing CG-GENE-14 *Effective April 7, 2021

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Medical Policies to be archived • MED.00077 In-Vivo Analysis of Gastrointestinal Lesions - effective April 7, 2021 • SURG.00022 Lung Volume Reduction Surgery - effective June 25, 2021

Prior Authorization and Quantity Limit updates

Effective for dates of service on and after July 1, 2021, the following specialty pharmacy codes from current clinical criteria document will be included in our prior authorization and quantity limit review process.

Clinical Criteria information is available at https://www.anthem.com/ca/ms/pharmacyinformation/clinicalcriteria.html.

Prior authorization clinical review is managed by the medical specialty drug review team.

Clinical Criteria HCPCS or CPT Code(s) Drug ING-CC-0027 J0897 Xgeva

Site of Care medical necessity reviews for long-acting colony-stimulating factors – beginning August 1, 2021

Our March 1, 2021, letter included an update to Site of Care medical necessity reviews for long-acting colony- stimulating factors (ING-CC-0002). The effective date has been moved from June 1, 2021, to August 1, 2021.

Effective with dates of service on or after August 1, 2021, local fully-insured Anthem members will require a medical necessity review of the site of care for the following long-acting colony-stimulating factors for oncology indications: Fulphila, Neulasta, Neulasta Onpro, Nyvepria, Udenyca, and Ziextenzo.

Starting July 19, 2021, ordering providers may submit prior authorization requests for the hospital outpatient site of care for these medications for dates of service on or after August 1, 2021, to AIM in one of the following ways:
• Access AIM ProviderPortalSM directly at providerportal.com. Online access is available 24/7 to process orders in real-time, and is the fastest and most convenient way to request authorization. • Access AIM via the Availity Web Portal at availity.com
• Call the AIM Contact Center toll-free number: 1-877-291-0360, Monday through Friday, 7:00 a.m. – 5:00 p.m. PT.

Providers should continue to verify eligibility and benefits for all members prior to rendering services.
If you have questions, please call the Provider Service phone number on the member’s ID card.

MCG Care Guidelines 25th Edition

Effective July 1, 2021, we will upgrade to the 25th Edition of MCG care guidelines for the following modules: Inpatient & Surgical Care (ISC), General Recovery Care (GRC), Chronic Care (CC), Recovery Facility Care (RFC), and Behavioral Health Care (BHC). The below tables highlight new guidelines and changes that may be considered more restrictive.

Goal Length of Stay (GLOS) for Inpatient & Surgical Care (ISC)
Guideline MCG Code 24th Edition GLOS
25th Edition GLOS
Aortic Coarctation, Angioplasty S-152 Ambulatory or 1 day postoperative Ambulatory
Cardiac Septal Defect: Atrial, Transcatheter Closure W0016 Ambulatory or 1 day postoperative Ambulatory
Esophageal Diverticulectomy, Endoscopic S-445 Ambulatory or 1 day postoperative Ambulatory Gastrectomy, Partial - Billroth I or II S-510 4 or 6 days postoperative 5 days postoperative Hernia Repair (Non-Hiatal) S-1305 Ambulatory or 1 day postoperative Ambulatory Pancreatectomy S-1200 5 or 7 days postoperative 6 days postoperative Pyloroplasty and Vagotomy S-990 4 or 6 days postoperative 4 days postoperative Cervical Laminectomy W0097 2 days postoperative Ambulatory or 2 days postoperative

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Guideline MCG Code 24th Edition GLOS
25th Edition GLOS
Lumbar Diskectomy, Foraminotomy, or Laminotomy W0091 Ambulatory or 1 day postoperative Ambulatory Removal of Posterior Spinal Instrumentation S-530 1 day postoperative Ambulatory or 1 day postoperative Shoulder Hemiarthroplasty W0138 1 day postoperative Ambulatory or 1 day postoperative Spine, Scoliosis, Posterior Instrumentation, Pediatric W0156 4 days postoperative 3 days postoperative Bladder Resection: Cystectomy with Urinary Diversion, Conduit or Continent S-190 5 or 6 days postoperative 5 days postoperative Prostatectomy, Transurethral Resection (TURP) S-970 Ambulatory or 1 day postoperative Ambulatory Urethroplasty S-1172 Ambulatory or 1 day postoperative Ambulatory

New Guidelines for Behavioral Health Care (BHC) and Recovery Facility Care (RFC) Body System Guideline Title MCG Code Withdrawal Management Withdrawal Management, Adult: Inpatient Care
B-031-IP Withdrawal Management Withdrawal Management, Adult: Intensive Outpatient Program B-031-IOP Withdrawal Management Withdrawal Management, Adult: Outpatient Care B-031-AOP Withdrawal Management Withdrawal Management, Adult: Partial Hospital Program B-031-PHP Withdrawal Management Withdrawal Management, Adult: Residential Care B-031-RES Cardiology Hypertension M-5197 Cardiology Peripheral Vascular Disease (PVD) M-7087 Nephrology Rhabdomyolysis M-7095 Nephrology Encephalopathy M-7100 Thoracic Surgery Rib Fracture M-5545

Anthem Customizations to MCG care guideline 25th Edition

Effective July 1, 2021, the following MCG care guideline 25th Edition customizations will be implemented.

• Transcranial Magnetic Stimulation (TMS), W0174 (previously ORG: B-801-T) - Revised Clinical Indications for Procedure and added the following: o Need for acute TMS treatment, up to 6 weeks
o Acute treatment course needed as indicated by (a) Initial course of treatment for major depressive disorder (severe), or (b) Relapse of symptoms after remission o Continuation of acute treatment, up to 6 months o TMS is considered not medically necessary for all other indications not listed above, including but not limited to, the following:
 Maintenance TMS treatment  Continuation of acute TMS treatment for longer than 6 months  TMS treatment of conditions other than major depressive disorder (severe), including but not limited to, the following: Alzheimer's disease, Anxiety disorders, Bipolar depression, Neurodevelopmental disorders, Obsessive-compulsive disorder, Peripartum depression, Post-traumatic stress disorder, Substance use disorders, Tourette's syndrome.

To view a detailed summary of customizations, go to https://www.anthem.com/ca/provider/policies/clinical-guidelines/, scroll down to other criteria section and select Customizations to MCG Care Guidelines 25th Edition. For questions, please contact the provider service number on the back of the member's ID card.

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Updates to AIM Musculoskeletal Program and Advanced Imaging Clinical Appropriateness Guidelines

Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Musculoskeletal Program (Joint Surgery and Spine Surgery) and Advanced Imaging Clinical Appropriateness Guidelines. Part of the AIM guideline annual review process, these updates are focused on advancing efforts to drive clinically appropriate, safe, and affordable health care services.

Joint Surgery - updates by section
• Further defined criteria for home physical therapy • Removed cognitive behavioral therapy as a conservative care modality for extremity • Added indication for diagnostic arthroscopy • Standardized radiographic criteria to align with lateral release criteria • Adhesive capsulitis - added history of trauma or post-operative contracture as a requirement
• Tendinopathy – Removed rotator cuff tear as a criterion for tenodesis/tenotomy in patients with a clinical exam who do not meet criteria for superior labral anterior-posterior (SLAP) repair or have suggestive MRI findings • Hip arthroscopy - Removed complementary alternative medicine as not typically done for the hip • Arthroscopic treatment of femoroacetabular impingement syndrome (FAIS) - Removed age as an exclusion for FAIS but further define radiographic exclusions • Unicompartmental Knee Arthroplasty/Partial Knee Replacement - Added degenerative change of the patellofemoral joint as a contraindication • Arthroscopically assisted lysis of adhesions – added ligamentous or joint reconstruction criteria • Added criteria for plica resection

Spine Surgery - updates by section • Further defined criteria for home physical therapy • Added standard conservative management requirement for instability to align with spinal stenosis indications • Added new comprehensive indication for tethered cord syndrome

Advanced Imaging of the Spine – updates by section Congenital vertebral defects • New requirement for additional evaluation with radiographs Scoliosis • Defined criteria for which presurgical planning is indicated • Requirement for radiographs and new or progressive symptoms for postsurgical imaging
Spinal dysraphism and tethered cord • Diagnostic imaging strategy limiting the use of CT to cases where MRI cannot be performed • New requirement for ultrasound prior to advanced imaging for tethered cord in infants age 5 months or less Multiple sclerosis (MS) • New criteria for imaging in initial diagnosis of MS Spinal infection • New criteria for diagnosis and management aligned with Infectious Diseases Society of America and University of Michigan guidelines Axial spondyloarthropathy • Defined inflammatory back pain • Diagnostic testing strategy outlining radiography requirements Cervical injury • Aligned with American College of Radiology position on pediatric cervical trauma Thoracic or lumbar injury • Diagnostic testing strategy emphasizing radiography and limiting the use of MRI for known fracture • Remove indication for follow-up imaging of progressively worsening pain in the absence of fracture or neurologic deficits

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Syringomyelia • Removed indication for surveillance imaging Non-specific low back pain • Aligned pediatric guidelines with ACR pediatric low back pain guidelines

Advanced Imaging of the Extremities– updates by section Osteomyelitis or septic arthritis; myositis • Removed CT as a follow up to nondiagnostic MRI due to lower diagnostic accuracy of CT Epicondylitis and Tenosynovitis – long head of biceps • Removed due to lack of evidence supporting imaging for this diagnosis Plantar fasciitis and fibromatosis • Removed CT as a follow up to nondiagnostic MRI due to lower diagnostic accuracy of CT • Added specific conservative management requirements Brachial plexus mass • Added specific requirement for suspicious findings on clinical exam or prior imaging Morton’s neuroma • Added requirements for focused steroid injection, orthoses, plan for surgery Adhesive capsulitis • Added requirement for planned intervention (manipulation under anesthesia or lysis of adhesions) Rotator cuff tear; Labral tear – shoulder; Labral tear - hip • Defined specific exam findings and duration of conservative management • Recurrent labral tear now requires same criteria as an initial tear (shoulder only) Triangular fibrocartilage complex tear • Added requirement for radiographs and conservative management for chronic tear Ligament tear – knee; meniscal tear • Added requirement for radiographs for specific scenarios • Increased duration of conservative management for chronic meniscal tears Ligament and tendon injuries – foot and ankle • Defined required duration of conservative management Chronic anterior knee pain including chondromalacia patella and patellofemoral pain syndrome • Lengthened duration of conservative management and specified requirement for chronic anterior knee pain Intra-articular loose body • Requirement for mechanical symptoms Osteochondral lesion (including osteochondritis dissecans, transient dislocation of patella) • New requirement for radiographs Entrapment neuropathy • Exclude carpal and cubital tunnel Persistent lower extremity pain • Defined duration of conservative management (6 weeks) • Exclude hip joint (addressed in other indications) Upper extremity pain • Exclude shoulder joint (addressed in other indications) • Diagnostic testing strategy limiting use of CT to when MRI cannot be performed or is nondiagnostic Knee arthroplasty, presurgical planning • Limited to MAKO and robotic assist arthroplasty cases Perioperative imaging, not otherwise specified • Require radiographs or ultrasound prior to advanced imaging

Vascular Imaging – updates by section • Alternative non-vascular modality imaging approaches, where applicable
Hemorrhage, Intracranial
• Clinical scenario specification of subarachnoid hemorrhage indication. • Addition of Pediatric intracerebral hemorrhage indication. Horner’s syndrome; Pulsatile Tinnitus; Trigeminal neuralgia
• Removal of management scenario to limit continued vascular evaluation

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Stroke/TIA; Stenosis or Occlusion (Intracranial/Extracranial) • Acute and subacute time frame specifications; removal of carotid/cardiac workup requirement for intracranial vascular evaluation; addition of management specifications • Sections separated anatomically into anterior/posterior circulation (Carotid artery and Vertebral or Basilar arteries, respectively) Pulmonary Embolism
• Addition of non-diagnostic chest radiograph requirement for all indications • Addition of pregnancy-adjusted YEARS algorithm
Peripheral Arterial Disease
• Addition of new post-revascularization scenario to both upper and lower extremity PAD evaluation

As a reminder, ordering and servicing providers may submit prior authorization requests to AIM in one of several ways:
• Access AIM’s ProviderPortalSM directly at providerportal.com. Online access is available 24/7 to process orders in real-time and is the fastest and most convenient way to request authorization. • Access AIM via the Availity Web Portal at availity.com • Call the AIM Contact Center toll-free number: 1-877-291-0360, Monday–Friday, 7:00 a.m.–5:00 p.m. PT

For questions related to guidelines, please contact AIM via email at aim.guidelines@aimspecialtyhealth.com. In addition, current and upcoming guidelines are available at https://aimspecialtyhealth.com/anthem185/.

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 “Providers”, then selecting “Policies, Guidelines & Manuals” under the Provider Resources column, 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

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Attachment A – Updates as of April 7, 2021(except where noted) Revised Medical Policies and Clinical Guidelines Document Number Title Medical Policy / Clinical Guideline Changes CG-GENE-04
Molecular Marker Evaluation for Thyroid Nodules • Added CPT PLA code 0245U effective April 1, 2021, considered Investigational and Not Medically Necessary CG-GENE-13
Genetic Testing for Inherited Diseases • Content moved from CG-GENE-05 Genetic Testing for DMD Mutations (Duchenne or Becker Muscular Dystrophy) CG-GENE-14 (effective April 1, 2021) Gene Mutation Testing for Solid Tumor Cancer Susceptibility and Management • Reorganizing genetic testing topics: Moved the content of the following topics into CG-GENE-14 Gene Mutation Testing for Solid Tumor Cancer Susceptibility and Management o CG-GENE-02 Analysis of RAS Status o CG-GENE-03 BRAF Mutation Analysis o CG-GENE-12 PIK3CA Mutation Testing for Malignant Condition
o CG-GENE-20 Epidermal Growth Factor Receptor [EGFR] Testing • Added circulating tumor DNA (ctDNA) to guide targeted cancer therapy in individuals with solid tumor(s) as Medically Necessary when criteria are met • Added Not Medically Necessary criteria on circulating tumor DNA (ctDNA) when the Medically Necessary criteria are not met, including to detect the recurrence of a solid tumor, including colorectal cancer, and to test for solid tumor cancer susceptibility o Content addressing ctDNA involving 4 or fewer genes or gene variants, moved from GENE.00049 Circulating Tumor DNA Panel Testing for Cancer (Liquid Biopsy) and added to this document o Content addressing ctDNA involving 5 or more genes or gene variants (gene panel), will continue to be addressed in GENE.00049 CG-GENE-16 BRCA Genetic Testing • Revised title (previous title: BRCA Testing for Breast and/or Ovarian Cancer Syndrome • Clarified scope CG-MED-26 Neonatal Levels of Care • Clarified that the direct antiglobulin test [DAT] is also known as the direct Coombs test, and added “Routine transitional and stabilization care provided in the first 8 hours after birth” to General Nursery or Well-Baby Nursery • Clarified initial sepsis evaluation in Level I Surveillance Special Care Nursery
• Revised nasal cannula flow from 1 to 2 liters per minute for respiratory support in Level II Neonatal Intensive Care
• Revised feeding criteria to read, “Feedings complicated by episodes of apnea, bradycardia, or desaturations requiring stimulation for recovery” in Level III Neonatal Intensive Care
• Added “Peritoneal dialysis on automated recycler” and revised nasal cannula flow from 1 to 2 liters per minute in Level III Neonatal Intensive Care • Added “Renal replacement therapy with any form of hemodialysis or filtration, or peritoneal dialysis until on automated recycler” to Level IV Neonatal Intensive Care • Made minor punctuation changes throughout Clinical Indications section

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CG-MED-37 Intensive Programs for Pediatric Feeding Disorders • Added CPT code 99199 (no specific codes for pediatric feeding disorder services) CG-MED-87 (effective February 18, 2021) Single Photon Emission Computed Tomography Scans for Noncardiovascular Indications • Added single photon emission computed tomography (SPECT)/Subtraction Ictal SPECT Co-Registered to MRI (SISCOM for the preoperative evaluation of individuals with intractable focal epilepsy as Medically Necessary to identify and localize area(s) of epileptiform activity when other techniques designed to localize a focus are indeterminate • Revised Not Medically Necessary statement CG-MED-88 Preimplantation Genetic Diagnosis Testing • Clarified language in the Clinical Indications section regarding preimplantation genetic testing/screening for fetal aneuploidy (PGT-A) CG-SURG-18 Septoplasty • Clarified wording in Medically Necessary and Not Medically Necessary sections of Clinical Indications CG-SURG-30 Tonsillectomy for Children with or without Adenoidectomy • Updated coding to add specific diagnosis codes to review for Medically Necessary criteria CG-SURG-55 (effective February 18, 2021) Intracardiac Electrophysiological Studies (EPS) and Catheter Ablation • Reformatted criteria addressing EPS for symptomatic paroxysmal supraventricular tachyarrhythmias (SVT) with no change to criteria • Added cavotricuspid isthmus (CVI) dependent atrial flutter, symptomatic or refractory to pharmacological rate control as Medically Necessary indication to criteria addressing EPS for the evaluation of first line rhythm control treatment CG-SURG-71 Reduction Mammaplasty • Removed 1 year requirement from Medically Necessary criteria I. A and II. A CG-SURG-88
Mastectomy for Gynecomastia • Clarified length of time that a trial of analgesics or anti- inflammatory agents is required by replacing "a reasonable time period adequate to assess therapeutic effects" with "3 months" in the Medically Necessary criteria CG-SURG-95 Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation for Urinary and Fecal Incontinence, Urinary Retention • Reformatted Clinical Indications section • Removed statements about temporary sacral nerve stimulation (SNS) and trial periods from Medically Necessary criteria CG-SURG-97 Cardioverter Defibrillators • Revised Medically Necessary criteria addressing major risk factors in hypertrophic cardiomyopathy (HCM) to require 1 or more risk factors (changed from 2 or more) and added left ventricular apical aneurysm, independent of size, and left ventricular systolic dysfunction (LVEF less than 50%) to the list of risk factors • Removed “Abnormal BP response during exercise” from Medically Necessary risk factor list for HCM • Clarified Medically Necessary criteria for subcutaneous cardioverter-defibrillator (S-ICD) devices by adding “When the individual does not require cardiac pacing”  Clarified the pediatric age criteria CG-SURG-107 Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) • Revised Medically Necessary criteria for transurethral incision, prostatic urethral lift, and transurethral convective water thermal therapy to recognize cubic centimeters (cc), milliliters (ml), and grams (gm) as essentially equivalent measures of prostate size DME.00022 Functional Electrical Stimulation (FES); Threshold Electrical Stimulation (TES) • Reformatted Position Statement section with no change to stance

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DME.00041 Low Intensity Therapeutic Ultrasound • Revised title (previous title: Low Intensity Therapeutic Ultrasound for the Treatment of Pain) GENE.00009 Gene Expression Profiling and Genomic Biomarker Tests for Prostate Cancer

• Revised title (previous title: Gene-Based Tests for Screening, Detection and Management of Prostate Cancer)  Revised Position Statement to state: Gene expression profiling and genomic biomarker tests as a technique for prostate cancer screening, detection and management are considered Investigational and Not Medically Necessary for all indications  Clarified that germline testing is addressed in CG-GENE-14 Gene Mutation Testing for Solid Tumor Cancer Susceptibility and Management GENE.00049

Circulating Tumor DNA Panel Testing for Cancer (Liquid Biopsy) • Revised title (previous title: Circulating Tumor DNA Testing for Cancer [Liquid Biopsy]) • Clarified that policy only addresses 'panel' testing in Investigational and Not Medically Necessary statement and title • Moved non-panel tests to CG-GENE-14 Gene Mutation Testing for Solid Tumor Cancer Susceptibility and Management GENE.00050 Gene Expression Profiling for Coronary Artery Disease • Added CPT code 81599, no specific codes for other Gene Expression Profiling tests GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT code 0244U effective April 1, 2021 for Oncotype MAP pan cancer test to be reviewed for Medically Necessary criteria LAB.00003 In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays • Replaced "in all cases" with "for all indications" in the Investigational and Not Medically Necessary statements • Added PLA code 0228U effective January 1, 2021 for PanGIA Prostate test, considered Investigational and Not Medically Necessary LAB.00011

Analysis of Proteomic Patterns • Removed CPT codes 0012M, 0013M, now addressed in GENE.00056 • Added PLA code 0247U effective April 1, 2021, considered Investigational and Not Medically Necessary LAB.00015 Detection of Circulating Tumor Cells • Revised title (previous title: Detection of Circulating Tumor Cells in the Blood as a Prognostic Factor for Cancer) LAB.00033
Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer • Removed specific types of protein biomarker tests from Investigational and Not Medically Necessary statement • Added PLA code 0228U effective January 1, 2021, considered Investigational and Not Medically Necessary MED.00011
Sensory Stimulation for Brain- Injured Individuals in Coma or Vegetative State • Added CPT codes 97139 and 97799, considered Investigational and Not Medically Necessary MED.00057 MRI Guided High Intensity Focused Ultrasound Ablation for Non-Oncologic Indications • Added CPT code 60699, considered Investigational and Not Medically Necessary MED.00059 Idiopathic Environmental Illness (IEI) • Added CPT code 99199, considered Investigational and Not Medically Necessary MED.00087 Optical Detection for Screening and Identification of Cervical Cancer

• Revised title (previous title: Imaging Techniques for Screening and Identification of Cervical Cancer) • Removed cervicography and speculoscopy from scope of document and Position Statement • Revised Position Statement to state: The use of optical detection for the detection or identification of cervical cancer is considered Investigational and Not Medically Necessary

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MED.00125 Biofeedback and Neurofeedback • Made minor punctuation change in Investigational and Not Medically Necessary criteria for neurofeedback MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures • Replaced CPT code J3490 with more appropriate L8699 for dermal fillers with no specific code OR-PR.00005
Upper Extremity Myoelectric Orthoses • Updated descriptors for codes L8701, L8702; corrections published by CMS effective April 1, 2021 SURG.00121 (effective February 18, 2021) Transcatheter Heart Valve Procedures • Added transcatheter aortic valve replacement (TAVR) for individuals at low open surgical risk and who are 80 years of age or older as Medically Necessary when criteria are met • Added CPT category III code 0646T (effective July 1, 2021) for tricuspid implant transcatheter tricuspid valve implantation/replacement (TTVI), considered Investigational and Not Medically Necessary SURG.00145 (effective February 18, 2021) Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Revised Medically Necessary left ventricular device (LVAD) destination therapy criteria in adults
• Added the use of the HeartMate 3 LVAD in the pediatric population as Medically Necessary when used as a permanent alternative (destination therapy) in children who have been evaluated and determined not to be eligible for a heart transplant • Clarified pediatric body surface area criteria for HeartMate 3 LVAD TRANS.00011 Pancreas Transplantation and Pancreas Kidney Transplantation • Updated diagnosis codes to include additional diagnoses to pend for review of Medically Necessary criteria TRANS.00016 Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation • Made minor punctuation change in Medically Necessary criteria • Corrected and updated ICD-10-PCS codes TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors • Updated diagnosis codes to include additional code related to autoimmune disease