MP/CG Update/Notice - December 2020 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.

Q4-2020 MP/CG Updates 800-1220-DM-CA 801-1220-DM-CA 802-1220-DM-CA 846-1220-DM-CA

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December 1, 2020

[Provider Name] [Address] [City], [State] [Zip]

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.

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 and Clinical Guidelines effective March 1, 2021

• CG-MED-64 Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins as a Treatment of Atrial Fibrillation or Atrial Flutter (Radiofrequency and Cryoablation): This document addresses transcatheter radiofrequency ablation and cryoablation of arrhythmogenic foci in the pulmonary veins for the treatment of atrial fibrillation or atrial flutter. o Prior authorization required effective March 1, 2021

• CG-SURG-96 Intraocular Telescope: This document addresses an intraocular telescope used to improve certain cases of severe to profound vision impairment caused by end-stage, age-related macular degeneration (AMD). o Prior authorization required effective March 1, 2021

• GENE.00055 Gene Expression Profiling for Risk Stratification of Inflammatory Bowel Disease (IBD) Severity: This document addresses risk stratification of inflammatory bowel disease (IBD) severity using gene expression profiling from peripheral blood biomarkers. This document does not address initial irritable bowel syndrome (IBS), IBD diagnosis, ongoing IBD disease management nor the use of inflammatory markers, fecal samples or tissue biopsies for risk stratification of IBD disease severity. o Prior authorization required for AIM eligible members effective March 1, 2021

• LAB.00037 Serologic Testing for Biomarkers of Irritable Bowel Syndrome (IBS): This document addresses the use of serological testing for biomarkers to aid in the screening, diagnosis and management of irritable bowel syndrome (IBS). This document does not address any other type of testing for IBS including breath tests, fecal analysis, gene expression profiling or imaging.

• SURG.00158 Implantable Peripheral Nerve Stimulation Devices as a Treatment for Pain: This document addresses implantable peripheral nerve stimulation devices as a treatment for pain.

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.

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UPDATED Medical Policies effective March 1, 2021

• 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. These include auricular electrostimulation, H-Wave stimulation, interferential stimulation therapy, microcurrent electrical nerve stimulation, pulsed electrical stimulation, percutaneous neuromodulation therapy, supraorbital transcutaneous neurostimulation, sympathetic therapies, cranial electrical stimulation and remote electrical neuromodulation. o Revised scope to only include non-implantable devices o Reformatted Position Statement section to a single bulleted list of Investigational and Not Medically Necessary devices o Added “non-implantable” to bullet point on percutaneous neuromodulation therapy o Added percutaneous electrical nerve field stimulation (PENFS) as Investigational and Not Medically Necessary for all indications including, but not limited to, functional abdominal pain associated with irritable bowel syndrome o Moved content addressing implantable devices (temporarily or permanently implanted) to SURG.00158

• SURG.00036 Fetal Surgery for Prenatally Diagnosed Malformations: This document addresses the use of surgical techniques to correct or treat fetal malformations in utero. This document does not address surgery to correct placental or uterine abnormalities including, but not limited to, amnioreducton or laser coagulation therapy to address interfetal transfusion syndrome. o Prior authorization required effective March 1, 2021

• SURG.00062 Vein Embolization as a Treatment for Pelvic Congestion Syndrome and Varicocele: This document addresses ovarian and internal iliac vein embolization as a treatment for pelvic congestion syndrome (PCS) in women, and percutaneous testicular vein embolization for varicocele in men. o Revised title (previous title: Ovarian and Internal Iliac Vein Embolization as a Treatment of Pelvic Congestion Syndrome) o Expanded scope to include percutaneous testicular vein embolization for varicocele o Added embolization of the testicular (spermatic) veins as Investigational and Not Medically Necessary as a treatment of testicular varicocele

UPDATED Clinical Guideline effective March 1, 2021 for AIM-Eligible members

• CG-GENE-04 Molecular Marker Evaluation of Thyroid Nodules: This document addresses the use of molecular markers for the evaluation of thyroid nodules to identify genetic mutations (mutation analysis) and to identify benign thyroid nodules preoperatively. o Added the Afirma Medullary Thyroid Carcinoma (MTC) Classifier as Medically Necessary when criteria are met o Added the Afirma Xpression Atlas as Not Medically Necessary o Reformatted Medically Necessary Clinical Indications section

Medical Policy converted to Clinical Guideline effective December 16, 2020

MP Number Title CG Number GENE.00026 Cell-Free Fetal DNA-Based Prenatal Testing CG-GENE-21

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.

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Clinical UM Guidelines De-adopted effective December 1, 2020

• CG-DME-41 Ultraviolet Light Therapy Delivery Devices for Home Use • CG-LAB-03 Tropism Testing for HIV Management
• CG-MED-24 Electromyography and Nerve Conduction Studies • CG-MED-75 Medical and Other Non-Behavioral Health Related Treatments for Autism Spectrum Disorders and Rett Syndrome • CG-SURG-85 Hip Resurfacing • CG-SURG-89 Radiofrequency Neurolysis and Pulsed Radiofrequency Therapy for Trigeminal Neuralgia • CG-SURG-94 Keratoprosthesis • CG-SURG-102 Alcohol Septal Ablation for Treatment of Hypertrophic Cardiomyopathy

Specialty pharmacy prior authorization updates

The October 1, 2020 provider update letter included several updates to the specialty pharmacy prior authorization review process. Two drugs were incorrectly identified. Please note that Tecartus (ING-CC-0168) is an oncology drug and use is managed by AIM. Zilretto (ING-CC-0177) is a non-oncology drug and use is managed by Anthem’s medical specialty drug review team.

Effective for dates of service on and after March 1, 2021, the following specialty pharmacy codes from new clinical criteria documents 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.

Anthem‘s prior authorization clinical review of non-oncology specialty pharmacy drugs is managed by Anthem’s medical specialty drug review team. Review of specialty pharmacy drugs for oncology indications is managed by AIM and are shown in italics in the tables below.

Clinical Criteria HCPCS or CPT Code(s) Drug ING-CC-0179 J9999 Blenrep ING-CC-0180 J3490, J3590, J9999 Monjuvi ING-CC-0182 J1756 Venofer ING-CC-0182 J2916 Ferrlecit ING-CC-0182 J1750 Infed ING-CC-0182 J1439 Injectafer ING-CC-0182 Q0138 Feraheme ING-CC-0182 J1437 Monoferric

• Oncology use is managed by AIM.

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

  Clinical Criteria HCPCS or CPT Code(s) Drug ING-CC-0095* J9041, J9044 Velcade ING-CC-0181 J3490 Veklury

• Oncology use is managed by AIM.

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.

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Specialty pharmacy medical step therapy updates

Effective for dates of service on and after March 1, 2021, the following specialty pharmacy codes from new clinical criteria documents will be included in our existing specialty pharmacy medical step therapy review process.

Clinical Criteria Status Drug(s) HCPCS Codes ING-CC-0182 Preferred Venofer J1756 ING-CC-0182 Preferred Ferrlecit J2916 ING-CC-0182 Preferred Infed J1750 ING-CC-0182 Non-preferred Injectafer J1439 ING-CC-0182 Non-preferred Feraheme Q0138 ING-CC-0182 Non-preferred Monoferric J1437 ING-CC-0174 Non-preferred Kesimpta J3490 (NOC) ING-CC-0174 Non-preferred Kesimpta J3590 (NOC) ING-CC-0174 Non-preferred Kesimpta C9399 (NOC)

Specialty pharmacy quantity supply limit

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

Clinical Criteria HCPCS or CPT Code(s) Drug ING-CC-0078 J0129 Orencia

Clinical criteria information is available at www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html

Update to AIM Clinical Appropriateness Guidelines

Effective for dates of service on and after March 14, 2021, the following updates by section will apply to the AIM Clinical Appropriateness Guidelines.

AIM Advanced Imaging of the Heart • Evaluation of patients with cardiac arrhythmias
o Updated repeat TTE criteria o Added restrictions for patients whose initial echocardiogram shows no evidence of structural heart disease, and follow-up echocardiography is not appropriate for ongoing management of arrhythmia. • Evaluation of signs, symptoms, or abnormal testing
o Added restrictions for TTE in evaluation of palpitation and lightheadedness based on literature.

• Diagnostic Coronary Angiography o Updated criteria to evaluate patients with suspected congenital coronary artery anomalies

AIM Advanced Imaging
• Chest Imaging and Head and Neck Imaging o Hoarseness, dysphonia, and vocal cord weakness/paralysis – primary voice complaint  Require laryngoscopy for the initial evaluation of all patients with primary voice complaint • Brain Imaging and Head and Neck Imaging o Hearing loss
 Added CT temporal bone for evaluation of sensorineural hearing loss in any pediatric patients or in adults for whom MRI is nondiagnostic or unable to be performed  Higher allowed threshold for consecutive frequencies to establish SNHL  Remove CT brain as an alternative to evaluating hearing loss based on ACR guidance

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.

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• Tinnitus
o Remove sudden onset symmetric tinnitus as an indication for advanced imaging • Head and Neck Imaging o Sinusitis/rhinosinusitis:
 Add more flexibility for the method of conservative treatment in chronic sinusitis.
 Require conservative management prior to repeat imaging for patients with prior sinus CT. • Temporomandibular joint dysfunction o Removed requirement for radiographs/ultrasound
• Cerebrospinal fluid (CSF) leak of the skull base o Added scenario for management of known leak with change in clinical condition. • Brain Imaging o Ataxia, congenital or hereditary
 Combine with congenital cerebral anomalies to create one section • Acoustic neuroma
o More frequent imaging for a watch and wait or incomplete resection
o New indication for Neurofibromatosis type 2 (NF 2) o More frequent imaging when MRI shows findings suspicious for recurrence
o Single post-operative MRI following gross total resection o Include pediatrics with known acoustics (rare but NF 2)

• Tumor – not otherwise specified o Repurpose for surveillance imaging of low-grade neoplasms • Seizure disorder and epilepsy
o Limit imaging for the management of established generalized epilepsy
o Require optimal medical management (aligning adult and pediatric language) prior to imaging for management in epilepsy • Headache o Remove response to treatment as a primary headache red flag
• Mental status change and encephalopathy o Added requirement for initial clinical and lab evaluation to assess for a more specific cause

Oncologic Imaging
• General enhancements: Updates to Scope/Definitions, general language standardization • General Content enhancements: Overall alignment with current NCCN recommendations, resulting in: o Removal of indications/parameters not addressed by NCCN
o Average risk inclusion criteria for CT Colonography
o New allowances for MRI Abdomen and/or MRI Pelvis by tumor type, liver metastatic disease o New indications for Acute Leukemia (CT, PET/CT), Multiple Myeloma (MRI, PET/CT), Ovarian Cancer surveillance (CT), Bone Sarcoma (PET/CT) o Updated standard imaging pre-requisites prior to PET/CT for Bladder/Renal Pelvis/Ureter, Colorectal, Esophageal/GE Junction, Gastric and Non-Small Cell Lung Cancers
o Additional PET/CT management scenarios for Cervical Cancer, Hodgkin Lymphoma • Other content enhancements by section: o Cancer screening: New indication for Pancreatic Cancer screening o Breast Cancer: New PET/CT indication for restaging/treatment response for bone-only metastatic disease and limitation of post-treatment Breast MRI after breast conserving therapy or unilateral mastectomy
o Prostate Cancer: MRI pelvis: removal of TRUS biopsy requirement, allowance if persistent/unexplained elevation in PSA or suspicious DRE o Axumin PET/CT: Updated inclusion criteria (removal of general MRI pelvis requirement, additional allowance for rising PSA with non-diagnostic mpMRI)

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.

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AIM Radiation Therapy
• Radiation Oncology o Special Treatment Procedure
 Removed IV requirement for chemotherapy
• CNS cancer:
o IMRT for Glioblastomas, other gliomas and metastases: Eliminated the 3D plan comparison requirement. Same change for high-grade and low-grade gliomas. o IMRT for Metastatic Brain Lesions: Added hippocampal sparing whole brain radiotherapy indication • Lung cancer:
o Eliminated the plan comparison requirement for IMRT to treat stage III non-small cell lung cancer.
o SBRT: Removed “due to a medical contraindication” language o SBRT: Added “as an alternative to surgical resection” to Stereotactic Body Radiation Therapy
o Adjusted fractionation maximum for curative treatment of non-small cell lung cancer up to 35 treatments of thoracic radiotherapy.
• Proton Beam therapy
o Added new indication for hepatocellular carcinoma and intrahepatic cholangiocarcinoma

As a reminder, ordering and servicing providers may submit prior authorization requests to AIM in one of several ways:
• Access AIM’s ProviderPortallSM 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. Additionally, you may access and download a copy of the current and upcoming guidelines at specialtyhealth.com/marketing/guidelines/185/index.html.

MCG Care Guidelines 24th Edition Customization

Effective April 1, 2021, the following new customizations will be implemented: • Gastrointestinal Bleeding, Upper (W0170, previously ORG M-180) – Customized the Clinical Indications for admission to inpatient care by revising the hemoglobin; systolic blood pressure; pulse; melena; orthostatic hypotension; and BUN criteria.
• Gastrointestinal Bleeding, Upper Observation Care (W0171, previously OCG OC-021) – Customized the Clinical Indications for observation care by revising the systolic blood pressure and hemoglobin criteria and adding melena or hematochezia and suspected history of bleeding.

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.

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To view a detailed summary of customizations go to https://www.anthem.com/ca/provider/policies/clinical-guidelines/ and scroll down to other criteria section, then select Customizations to MCG Care Guidelines 24th Edition.

For questions, please contact the provider service number on the back of the member's ID card.

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem web site at www.anthem.com/ca. Select “Providers”, under the Provider Resources column choose “Policies, Guidelines & Manuals”, then scroll down to “View Medical Policies & Clinical UM Guidelines”, then select ”Full List page” or enter 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

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.

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Attachment A – Updates as of December 1, 2020 Revised Medical Policies and Clinical Guidelines

Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-BEH-02 Adaptive Behavioral Treatment • Revised title (previous title: Adaptive Behavioral Treatment for Autism Spectrum Disorder) • Expanded scope of document to include all diagnoses • Added adaptive behavioral treatment as Not Medically Necessary for all indications other than ASD CG-GENE-12 PIK3CA Mutation Testing for Malignant Conditions • Reworded Not Medically Necessary statement CG-GENE-18 Genetic Testing for TP53 Mutations • Added germline testing as Medically Necessary when a TP53 mutation is identified during somatic tumor testing and criteria are met CG-GENE-20 Epidermal Growth Factor Receptor (EGFR) Testing • Removed gene amplification from scope of document • Removed all language addressing gene amplification including the Not Medically Necessary statement CG-MED-23 Home Health • Updated number hierarchy and formatting in Medically Necessary Clinical Indications section CG-MED-26 Neonatal Levels of Care • Removed the words “high-flow” from nasal cannula O2 criteria in examples of respiratory support services in levels II and III Medically Necessary Clinical Indications CG-MED-87 Single Photon Emission Computed Tomography Scans for Noncardiovascular Indications • Added liver malignancies - to determine arterial hepatic perfusion as a component of selective internal radiation therapy (SIRT) or radioembolization treatment as Medically Necessary indication CG-SURG-95 Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation for Urinary and Fecal Incontinence; Urinary Retention • Added existing codes C1820, C1883, L8685 for Interstim rechargeable ADMIN.00001 Medical Policy Formation • Added text in Scope section addressing the evidence review process ANC.00009 Cosmetic and Reconstructive Services of the Trunk and Groin • Added correction of lymphedema (for example, related to surgical mastectomy) or lipedema using lipectomy or liposuction as Reconstructive when done to address a significant variation from normal • Made minor formatting changes in Position Statement • Added codes 55899, 58999 for phalloplasty, vaginal tightening GENE.00003 Genetic Testing and Biochemical Markers for the Diagnosis of Alzheimer's Disease • Added CPT PLA codes 0206U, 0207U effective 10/01/20; considered Investigational and Not Medically Necessary GENE.00023 Gene Expression Profiling of Melanomas • Added CPT MAAA code 81529 effective January 1, 2021; considered Investigational and Not Medically Necessary GENE.00049 Circulating Tumor DNA Testing for Cancer (Liquid Biopsy) • Added PLA codes 0229U, 0239U effective January 1, 2021 as Investigational and Not Medically Necessary

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.

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GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added Medically Necessary criteria for prostate cancer using gene panels when the panel evaluates HRR repair gene alterations and an individual is a candidate for treatment with Lynparza (olaparib) GENE.00053 Metagenomic Sequencing for Infectious Disease in the Outpatient Setting • Revised descriptor 0152U effective January 1, 2021 MED.00116 Near-Infrared Spectroscopy Brain Screening for Hematoma Detection • Removed the specific model number of the InfraScanner device from the Investigational and Not Medically Necessary statement MED.00128 Insulin Potentiation Therapy • Insulin codes J1815, J1817 will pend for related diagnoses; clarified only Investigational and Not Medically Necessary if specified as IPT MED.00129 Gene Therapy for Spinal Muscular Atrophy • Changed “6 months of age or younger” to “2 years of age or younger” in Medically Necessary statement • Removed criterion on use of nusinersen (Spinraza) from Medically Necessary statement • Removed second Medically Necessary statement relating to age at time of FDA approval of onasemnogene abeparvovec- xioi SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added TheraSkin as Medically Necessary for the treatment of lower extremity dermal wounds when criteria are met • Revised Note addressing fresh frozen unprocessed allograft skin products • Revised several Medically Necessary statements to begin with the name of the product • Added new products to the Investigational and Not Medically Necessary statement SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Updated descriptors with January 1, 2021 CPT changes; codes 19324, 19366 to be deleted December 31, 2020 SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation • CPT code 61870 to be deleted December 31, 2020 SURG.00037 Treatment of Varicose Veins (Lower Extremities) • Updated punctuation in Position Statement SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Moved examples of optimal medical therapy from LVAD destination therapy Medically Necessary statement to Rationale section TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias • Added diagnosis codes specifically mentioned as Investigational and Not Medically Necessary