MP/CG Update/Notice - October 2021 Form

P.O. Box 4330 Woodland Hills, CA 91365 1 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross an d 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.

October 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, 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, Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card

NEW Medical Policies effective January 1, 2022 (publish date October 6, 2021)

• DME.00043 Neuromuscular Electrical Training for the Treatment of Obstructive Sleep Apnea or Snoring:
This document addresses the use of neuromuscular electrical training of the tongue muscles as a treatment of obstructive sleep apnea (OSA) or snoring. o Considered Investigational and Not Medically Necessary o Prior authorization required effective January 1, 2022

• GENE.00058 TruGraf Blood Gene Expression Test for Transplant Monitoring: This document addresses the TruGraf® blood gene expression test is a blood-based gene expression assay designed to identify transplant recipients who are inadequately immunosuppressed. o Considered Investigational and Not Medically Necessary o Prior authorization required effective January 1, 2022

• LAB.00040 Serum Biomarker Tests for Risk of Preeclampsia: This document addresses biomarker testing to identify individuals at increased risk of preeclampsia during pregnancy. o Considered Investigational and Not Medically Necessary o Prior authorization required effective January 1, 2022

• LAB.00042 Molecular Signature Test for Predicting Response to Tumor Necrosis Factor Inhibitor Therapy:
This document addresses molecular signature testing to predict response to Tumor Necrosis Factor inhibitor (TNFi) therapy. o Considered Investigational and Not Medically Necessary o Prior authorization required effective January 1, 2022

2 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insu rance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

• OR-PR.00007 Microprocessor Controlled Knee-Ankle-Foot Orthosis: This document addresses the use of a microprocessor controlled knee-ankle-foot orthosis that provides support for individuals with lower extremity weakness. o Provides Clinical Indications for Medically Necessary and Not Medically Necessary criteria
o Prior authorization required effective January 1, 2022

UPDATED Clinical Guideline effective January 1, 2022 (publish date October 6, 2021)

• CG-DME-44 Electric Tumor Treatment Field (TTF): This document addresses electrical fields known as “tumor treatment fields (TTF)” that are created by low-intensity, intermediate frequency (100–200 kilohertz [kHz]) electric currents delivered to the malignant tumor site by insulated electrodes placed on the skin surface. o Added Medically Necessary indications for continuation therapy

Medical Policies to be archived October 6, 2021

• GENE.00024 DNA-Based Testing for Adolescent Idiopathic Scoliosis • MED.00085 Antineoplaston Therapy • RAD.00037Whole Body Computed Tomography Scanning

Specialty Pharmacy Site of Care updates

Effective for dates of service on and after January 1, 2022, the following specialty pharmacy codes from current clinical criteria documents will be included in our Site of Care review process.

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

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

Clinical Criteria Drug HCPCS or CPT Code(s) ING-CC-0062 Avsola Q5121 ING-CC-0081 Crysvita J0584 ING-CC-0162 Tepezza J3241

Specialty Pharmacy Quantity Limit updates

Effective for dates of service on and after January 1, 2022, the following specialty pharmacy codes from current clinical criteria documents will be included in our quantity limit 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.

Clinical Criteria Drug HCPCS or CPT Code(s) ING-CC-0009 Lemtrada J0202 ING-CC-0011 Ocrevus J2350 ING-CC-0014

Avonex J1826, Q3027 Betaseron J1830 Copaxone J1595 Extavia J1830 Glatopa J1595 Plegridy C9399, J3590

3 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insu rance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

Rebif J1826, Q3028 ING-CC-0020 Tysabri J2323 ING-CC-0029 Dupixent J3490, J3590 ING-CC-0038 Bonsity J3110 Forteo J3110 Tymlos C9399, J3490 ING-CC-0042

Siliq C9399, J3490, J3590 Taltz C9399, J3490, J3590 ING-CC-0048 Spinraza J2326 ING-CC-0062

Avsola Q5121 Erelzi J3590 Eticovo J3590 ING-CC-0066 Kevzara C9399, J3490, J3590 ING-CC-0075 Riabni Q5123 ING-CC-0077 Palynziq C9399, J3590 ING-CC-0082 Onpattro J0222 ING-CC-0156 Reblozyl J0896 ING-CC-0159 Scenesse J7352 ING-CC-0160 Vyepti J3032 ING-CC-0162 Tepezza J3241 ING-CC-0163 Durysta J7351 ING-CC-0170 Uplizna J1823 ING-CC-0172 Viltepso J1427 ING-CC-0173 Enspryng J3490, J3590 ING-CC-0174 Kesimpta C9399, J3490, J3590 ING-CC-0177 Zilretta J3304 ING-CC-0181 Veklury J3490 ING-CC-0183 Sogroya J3590 ING-CC-0185 Oxlumo J0224 ING-CC-0188 Imcivree J3490, J3590 ING-CC-0193 Evkeeza C9079, J3490 ING-CC-0194 Cabenuva C9077, 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 “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

4 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insu rance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

Attachment A – Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-DME-13 Lower Limb Prosthesis • Added HCPCS code K1022 CG-GENE-22 (AIM Genetic Testing) Gene Expression Profiling for Managing Breast Cancer Treatment • Added Medically Necessary statement on gene expression profiling with the Oncotype DX Breast Recurrence for individuals with 1-3 positive lymph nodes (pN1a, pN1b or pN1c) when criteria are met CG-MED-55 (AIM Radiology) Site of Care: Advanced Radiologic Imaging • Revised Medically Necessary statement from “the individual is less than 10 years old” to “the individual is less than 19 years old.” CG-MED-59 (AIM GI) Upper Gastrointestinal Endoscopy in Adults • Added CPT codes 0652T, 0653T, 0654T for transnasal esophagogastroduodenoscopy effective December 1, 2021 CG-MED-64 (publish date October 6, 2021) Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins
• Revised title (previous title: Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins as a Treatment of Atrial Fibrillation or Atrial Flutter (Radiofrequency and Cryoablation) • Clarified Medically Necessary statement to address transcatheter “ablation” of arrhythmogenic foci in the pulmonary veins as a treatment of symptomatic individuals when criteria are met • Combined Not Medically Necessary statements to address transcatheter ablation of arrhythmogenic foci in the pulmonary veins when the Medically Necessary criteria are not met and for all other indications CG-SURG-55 (publish date October 6, 2021) Cardiac Electrophysiological Studies (EPS) and Catheter Ablation • Revised title (previous title: Intracardiac Electrophysiological Studies [EPS] and Catheter Ablation) • Replaced the words “intracardiac” and “transcatheter” with the word “cardiac” in the Clinical Indications
• Added a note to the Description stating that this document does not address transcatheter radiofrequency ablation and cryoablation of arrhythmogenic foci in the pulmonary veins for the treatment of atrial fibrillation or atrial flutter
CG-SURG-63 (publish date October 6, 2021) Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure • Clarified associated CPT codes to most common Cardiac Resynchronization Therapy code combinations (added 33228, 33229, 33263, 33264; removed 00530, 00534, 33202, 33203, 33207, 33211, 33213, 33217, 33240, 93640, 93641, 93642) CG-SURG-76 Carotid, Vertebral and Intracranial Artery Stent Placement with or without Angioplasty • Added open transcarotid (TCAR) procedures to scope of document with no change to Clinical Indications section CG-SURG-82 Bone-Anchored and Bone Conduction Hearing Aids • Changed the stance on the ADHEAR device (adhesive adapter systems) to Medically Necessary when criteria are met

5 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insu rance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

CG-SURG-95 Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation for Urinary and Fecal Incontinence; Urinary Retention • Added ICD-10-CM diagnosis codes R35.81, R35.89 CG-SURG-111 Open Sacroiliac Joint Fusion • Added ICD-10-CM diagnosis codes M54.50-M54.59 DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices • Added CPT code K1023 GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT codes 0260U, 0264U, 0265U, 0266U, 0267U, 0268U, 0269U, 0270U, 0271U, 0272U, 0273U, 0274U, 0276U, 0277U, 0278U LAB.00003 (publish date October 6, 2021) In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays • Added CPT PLA code 0248U effective July 1, 2021; considered Not Medically Necessary LAB.00019 (publish date October 6, 2021) Proprietary Algorithms for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease • Revised title (Previously titled: Serum Markers for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease) • Changed “Serum Markers” to “Proprietary Algorithms” in the Position Statement MED.00055 (publish date October 6, 2021) Wearable Cardioverter Defibrillators • Revised and clarified the Investigational and Not Medically Necessary statement to say the wearable cardioverter defibrillator is considered Investigational and Not Medically Necessary when the criteria are not met MED.00117 Autologous Cell Therapy for the Treatment of Damaged Myocardium • Added ICD-10-CM diagnosis code I5A SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added CPT codes Q4251, Q4252, Q4253, deleted Q4228 and Q4236 SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Added ICD-10-CM diagnosis code C84.7A SURG.00032 Patent Foramen Ovale and Left Atrial Appendage Closure Devices for Stroke Prevention • Added Medically Necessary statement for transcatheter closure of left atrial appendage (LAA) for individuals with non-valvular atrial fibrillation for the prevention of stroke when criteria are met • Revised Investigational and Not Medically Necessary statement for transcatheter closure of left atrial appendage when the criteria are not met

6 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insu rance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

SURG.00077 Uterine Fibroid Ablation: Laparoscopic, Percutaneous or Transcervical Image Guided Techniques • Added Medically Necessary statement on use of laparoscopic or transcervical radiofrequency ablation • Added Not Medically Necessary statement on use of laparoscopic or transcervical radiofrequency ablation when criteria in Medically Necessary statement are not met • Removed laparoscopic radiofrequency ablation from Investigational and Not Medically Necessary statement • Removed Investigational and Not Medically Necessary statement on radiofrequency ablation using a transcervical approach SURG.00119 Endobronchial Valve Devices • Added Medically Necessary indications • Revised Investigational and Not Medically Necessary statement to Not Medically Necessary SURG.00121 Transcatheter Heart Valve Procedures • Clarified transcatheter aortic valve replacement (TAVR) Medically Necessary criteria acronym for AVA (aortic valve area) • Revised Medically Necessary criteria for TAVR in low open surgical risk to include individuals 65 years of age or older SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Clarified pediatric percutaneous ventricular assist device criteria SURG.00157 Minimally Invasive Treatment of the Posterior Nasal Nerve to Treat Rhinitis • Removed the word “area” from “posterior nasal nerve area” in the Position Statement TRANS.00016 Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00023 Hematopoietic Stem Cell Transplantation for Multiple Myeloma and Other Plasma Cell Dyscrasias • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00027 Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00028 Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias • Removed ICD-10-PCS codes deleted September 30, 2021

7 | P a g e

849-0921-DM-CA

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insu rance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

TRANS.00030 Hematopoietic Stem Cell Transplantation for Germ Cell Tumors • Removed ICD-10-PCS codes deleted September 30, 2021 • Added ICD-10-CM diagnosis code C79.63 TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00034 Hematopoietic Stem Cell Transplantation for Diabetes Mellitus • Removed ICD-10-PCS codes deleted September 30, 2021 TRANS.00035 Other Stem Cell Therapy • Removed ICD-10-PCS codes deleted September 30, 2021