MP/CG Update/Notice - July 2021 Form

P.O. Box 4330 Woodland Hills, CA

638-0621-DM-CA

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.

July 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.

To view medical policies and utilization management guidelines applicable to members enrolled in the Blue Cross and Blue Shield Service Benefit Plan, commonly referred to as the Federal Employee Program® (FEP®), please visit www.fepblue.org > Policies & Guidelines.

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, or the Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card. Please note, while the AIM criteria may be applied to HMO, the Utilization Management determination is not made by AIM for HMO business.

NEW Medical Policies effective October 1, 2021

• GENE.00057 Gene Expression Profiling for Idiopathic Pulmonary Fibrosis: This document addresses the use of gene expression profiling to assist in the diagnosis or management of idiopathic pulmonary fibrosis. o The use of gene expression profiling to assist in the diagnosis or management of idiopathic pulmonary fibrosis is considered investigational and not medically necessary in all situations.

• LAB.00041 Machine Learning Derived Probability Score for Rapid Kidney Function Decline: This document addresses the use of artificial intelligence-enabled algorithms which may combine a variety a clinical characteristics such as, biomarkers, genetics, gender or race, to generate prognostic information to enable a more personalized approach to the treatment of chronic kidney disease (e.g., KidneyIntelX).
o Use of artificial intelligence-enabled algorithms (e.g., KidneyIntelX) to predict progressive kidney function decline in chronic kidney disease is considered investigational and not medically necessary for all indications.

• MED.00137 Eye Movement Analysis Using Non-spatial Calibration for the Diagnosis of Concussion:
This document addresses the use of The EyeBOX, the first baseline-free, temporal calibration eye movement analysis device to assist physicians in objectively evaluating individuals with suspected concussion. o Eye movement analysis using non-spatial calibration is considered investigational and not medically necessary for the diagnosis of concussion.

NEW Clinical Guideline effective November 1, 2021

• CG-MED-89 Home Parenteral Nutrition: This document addresses parenteral nutrition given in the home setting. o Provides Medically Necessary criteria for initial use and continuing use in adults and children o Intradialytic parenteral nutrition is considered not medically necessary

638-0621-DM-CA

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.

UPDATED Medical Policies and Clinical Guidelines effective October 1, 2021

• MED.00004 Technologies for the Evaluation of Skin Lesions (including Dermatoscopy, Epiluminescence Microscopy, Videomicroscopy, Ultrasonography): This document addresses the use of photographic, optical, video, and other imaging technologies for the evaluation of skin lesions. o Added electrical impedance spectroscopy for the evaluation of skin lesions as Investigational and Not Medically Necessary

• TRANS.00025 Laboratory Testing as an Aid in the Diagnosis of Heart Transplant Rejection: This document addresses specific noninvasive laboratory tests for the early detection of rejection following a heart transplant. o Added noninvasive tests for detection of heart transplant rejection as Investigational and Not Medically Necessary including, but not limited to, AlloSure Heart, AlloSeq cell-free DNA, MMDx Heart, and myTAIHeart

Medical Policies converted to Clinical Guidelines

MP Number Title CG Number DME.00034 Standing Frames CG-DME-49 (effective July 1, 2021) SURG.00127 Sacroiliac Joint Fusion
(retitled to Open Sacroiliac Joint Fusion) CG-SURG-111 (effective September 12, 2021) Open Sacroiliac Joint Fusion will be reviewed by Anthem; elective, non-emergent, sacroiliac joint fusion (percutaneous/ minimally invasive techniques) is reviewed for AIM-eligible members via the AIM Musculoskeletal program.

Medical Policies and Clinical Guideline to be archived July 7, 2021 except where noted

• CG-MED-75 Medical and Other Non-Behavioral Health Related Treatments for Autism Spectrum Disorders and Rett Syndrome • DME.00009 Vacuum Assisted Wound Therapy in the Outpatient Setting
• GENE.00042 Genetic Testing for Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy Syndrome (content moved to CG-GENE-13) • GENE.00046 Prothrombin (Factor II) Genetic Testing (content moved to CG-GENE-13) • RAD.00001 Computed Tomography to Detect Coronary Artery Calcification (AIM Imaging of the Heart Clinical Appropriateness Guideline will be used)

Clinical UM Guideline to be de-adopted effective September 1, 2021

• CG-MED-79 Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing System

Clarification to Specialty Referrals for Participating HMO Medical Groups

On April 1 we notified Participating HMO Medical Groups of a new requirement to submit out-of-network referral information to Anthem effective July 1, 2021 in order to comply with the requirements of the Department of Managed Health Care and the Knox-Keene Act. Please note that this requirement applies to all specialty referrals, not just out-of-network specialty referrals.

Update on colorectal cancer screening

On May 18, 2021, the United States Preventive Services Task Force (USPSTF) issued a final recommendation regarding screening for colorectal cancer. The update now recommends screening in all average risk individuals (including African Americans) starting at age 45 years (from age 50 years previously) to age 75. The update is based on emerging evidence that colorectal cancer cases in persons younger than age 50 years have been slowly increasing (for reasons that are not entirely understood).

638-0621-DM-CA

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.

Specialty pharmacy medical step therapy drug review clarification

Our March 1, 2021 letter included an update to Site of Care medical necessity reviews for long-acting colony- stimulating factors (Fulphila, Neulasta / Neulasta Onpro, Nyvepria, Udenyca, Ziextenzo), and our April 1, 2021 letter moved the effective date from June 1, 2021 to August 1, 2021. This program has been canceled. We apologize for any inconvenience.

Prior authorization updates

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

Please note, 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.

To access the clinical criteria information please go to www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html

Clinical Criteria HCPCS or CPT Code(s) Drug *ING-CC-0195 C9399, J3490, J3590, J9999 Abecma (idecabtagene vicleucel)

  * Oncology use is managed by AIM Specialty Health® (AIM).

Step therapy updates

Effective for dates of service on and after October 1, 2021, the following specialty pharmacy code from a current clinical criteria document will be included in our existing specialty pharmacy medical step therapy review process.

Prior authorization clinical review of non-oncology specialty pharmacy drugs is managed by the medical specialty drug review team.

Clinical Criteria Status Drug HCPCS Codes ING-CC-0020 Non-preferred Tysabri (natalizumab) J2323

AIM Specialty Health Imaging of the Heart Clinical Appropriateness Guideline for Computed Tomography to Detect Coronary Artery Calcification

Effective November 1, 2021, prior authorization will be required for AIM-eligible members for Computed Tomography to Detect Coronary Artery Calcification for the following procedures:

CPT code Description 75571 Computed tomography, heart, without contrast material, with quantitative evaluation of coronary artery calcium S8092 Electron beam CT (also known as ultrafast CT, cine CT)

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: 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. The current and upcoming guidelines are available at https://aimspecialtyhealth.com/anthem185/.

638-0621-DM-CA

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.

MCG updates effective August 19, 2021

W0174 Transcranial Magnetic Stimulation BHG • Revised Clinical Indications for Procedure o “Major depressive disorder (severe)” changed to “Treatment resistant major depressive disorder” o “Relapse of symptoms after remission” changed to “Relapse of symptoms after virtual absence of depressive symptoms” • Updated footnote with timeframe for Remission, Relapse, and Recovery statements

W0118 Musculoskeletal Surgery or Procedure GRG • For open sacroiliac joint fusion, see CG-SURG-111 Open Sacroiliac Joint Fusion • For elective, non-emergent, sacroiliac joint fusion (percutaneous/minimally invasive techniques), see AIM Musculoskeletal Program Clinical Appropriateness Guidelines

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

638-0621-DM-CA

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.

Attachment A – Updates as of July 1, 2021 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-GENE-04 (AIM Genetic Testing) Molecular Marker Evaluation of Thyroid Nodules • Added ThyGeNEXT and ThyraMIR as Medically Necessary • Removed ThyGenX and ThyraMIR from Not Medically Necessary statement • Removed RosettaGX from position statement CG-GENE-10 (AIM Genetic Testing) Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability and Congenital Anomalies • Revised title (previous title: Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability (Intellectual Development Disorder) and Congenital Anomalies CG-GENE-11 (AIM Genetic Testing) Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status • Revised Medically Necessary statement addressing carbamazepine and allopurinol changing language from “Asian descent” to “a population who is at high risk due to ethnic heritage”
• Removed drug trade names from Medically Necessary statements • Revised Not Medically Necessary statements CG-GENE-13 (AIM Genetic Testing) Genetic Testing for Inherited Diseases • Revised language to clarify that testing of individual genes is for germline genetic diseases • Revised language for preconception or prenatal genetic screening of a parent or prospective parent to determine carrier status is for germline genetic disorders • Updated table of genes to add: AGXT, POMC, PCSK1, LEPR, RAI1, NOTCH3, F2, G20210A • Moved content of GENE.00042 (Genetic Testing for CADASIL) into CG-GENE-13 with addition of NOTCH3 gene to table of Medically Necessary genes for CADASIL syndrome • Moved content of GENE.00046 (Prothrombin (Factor II) Genetic Testing) into CG-GENE-13 with addition of F2 gene mutations to table of Medically Necessary genes for prothrombin-related thrombophilia CG-SURG-12 Penile Prosthesis Implantation • Changed “impotence” to “erectile dysfunction” • Changed criterion on duration of erectile dysfunction from greater than 1 year to greater than 6 months • Reformatted and simplified Medically Necessary statement regarding causes and duration CG-SURG-24 Functional Endoscopic Sinus Surgery (FESS) • Removed specific diagnoses from Medically Necessary and Not Medically Necessary statements • Revised Medically Necessary FESS criteria by removing specific diagnoses, examples of medical therapy for chronic polyposis, and diagnostic criteria for allergic fungal sinusitis • Revised Not Medically Necessary FESS statement CG-SURG-55 Intracardiac Electrophysiological Studies (EPS) and Catheter Ablation • Revised criterion C in Medically Necessary Clinical Indications to clarify that EPS testing for evaluation of supraventricular tachyarrhythmias (SVT) is Medically Necessary when either criteria 1 or 2 are met

638-0621-DM-CA

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.

CG-SURG-71 Reduction Mammaplasty • Added breast cancer risk reduction to Not Medically Necessary statement • Removed wording on psychological considerations from Cosmetics and Not Medically Necessary statement CG-SURG-84 Mandibular/Maxillary (Orthognathic) Surgery • Removed the word “physical” from “physical functional impairment” in Clinical Indications
ANC.00007 Cosmetic and Reconstructive Services: Skin Related • Removed the word “physical” from “physical functional impairment” in Position Statement and throughout document ANC.00009 Cosmetic and Reconstructive Services of the Trunk and Groin • Removed the word “physical” from “physical functional impairment” in Position Statement and throughout document • Added "congenital defect" to reconstructive statement for genitalia DME.00012 Intrapulmonary Percussive Ventilation Devices • Revised title (previous title: Intrapulmonary Percussive Ventilation Devices for Airway Clearance)
• Clarified Position Statement • Added CPT code E1399 for additional devices with no specific code DME.00024 Transtympanic Micropressure • Revised title (previous title: Transtympanic Micropressure for the Treatment of Ménière’s Disease) • Replaced the word 'applications' with the word 'treatment' in the Position Statement GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT code 0250U effective July 1, 2021 for the PGDx elio tissue complete test to be reviewed for Medical Necessity criteria for cancer diagnoses LAB.00011 Analysis of Proteomic Patterns • Added CPT code 0249U effective July 1, 2021 for Theralink Reverse Phase Protein Array; considered Investigational and Not Medically Necessary LAB.00027 Selected Blood, Serum and Cellular Allergy and Toxicity Tests • Added basophil activation test (BAT) as Investigational and Not Medically Necessary MED.00090 Wireless Capsule for the Evaluation of Suspected Gastric and Intestinal Motility Disorders • Reformatted Position Statement MED.00098 Hyperoxemic Reperfusion Therapy • Added CPT category III code 0659T effective July 1, 2021 for infusion of supersaturated oxygen; considered Investigational and Not Medically Necessary MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures • Removed the word “physical” from “physical functional impairment” in Position Statement and throughout document • Revised the Reconstructive position statement for autologous fat grafting to clarify autologous fat grafting may be appropriate in some individuals following breast reconstructive surgery OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis • Revised Medically Necessary criteria for microprocessor controlled lower limb prosthesis
• Added microprocessor controlled foot or ankle systems as Medically Necessary when criteria are met • Clarified Investigational and Not Medically Necessary statement addressing microprocessor controlled foot-ankle prosthesis • Added K1014 effective April 1, 2021 SURG.00007 Vagus Nerve Stimulation • Added K1020 effective April 1, 2021

638-0621-DM-CA

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.

SURG.00010 Treatments for Urinary Incontinence • Removed gender specific language from Position Statement and throughout document • Reformatted Not Medically Necessary statement SURG.00095 Viscocanalostomy and Canaloplasty • Added canaloplasty as Medically Necessary for the treatment of mild to moderate primary open-angle glaucoma (POAG) • Revised Investigational and Not Medically Necessary
statements SURG.00097 Vertebral Body Stapling and Tethering for the Treatment of Scoliosis in Children and Adolescents • Added CPT category III codes 0656T, 0657T effective July 1, 2021 for vertebral body tethering; considered Investigational and Not Medically SURG.00126 Irreversible Electroporation • Added CPT code 93799 for electroporation used for pulmonary vein isolation SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea or Snoring • Added hypoglossal nerve stimulation as Medically Necessary when criteria are met • Revised Not Medically Necessary and Investigational and Not Medically Necessary statements SURG.00140 Peripheral Nerve Blocks for Treatment of Neuropathic Pain • Added CPT code 64999 when specified as a ganglion impar peripheral block, considered Investigational and Not Medically Necessary for neuropathic pain diagnoses SURG.00143 Perirectal Spacers for Use During Prostate Radiotherapy • Added the use of perirectal spacers during prostate radiotherapy as Medically Necessary when criteria are met • Revised Investigational and Not Medically Necessary statement SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Clarified Medically Necessary statement for pediatric Ventricular Assist Device (VAD) using Berlin Heart EXCOR Pediatric Ventricular Assist Device to include biventricular failure as Medically Necessary indication • Clarified Not Medically Necessary contraindications for pediatric VADs SURG.00155 Cryoneurolysis • Revised title (previous title: Cryoneurolysis for Treatment of Peripheral Nerve Pain) • Revised wording of Investigational and Not Medically Necessary statement

638-0621-DM-CA

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.

TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors • Added a single autologous (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplantation as Medically Necessary for the treatment of relapsing-remitting multiple sclerosis when criteria are met • Added a single autologous (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplant as Investigational and Not Medically Necessary for the treatment of multiple sclerosis when the Medically Necessary criteria are not met, including for primary progressive or secondary progressive forms of multiple sclerosis • Added a repeat autologous (ablative or non-myeloablative [mini-transplant]) hematopoietic stem cell transplant as Investigational and Not Medically Necessary for the treatment of relapsing-remitting multiple sclerosis • Added an allogeneic (ablative or non-myeloablative [mini- transplant]) hematopoietic stem cell transplantation, or planned tandem as Investigational and Not Medically Necessary for the treatment of multiple sclerosis • Revised Investigational and Not Medically Necessary statement for all other autoimmune diseases