MP/CG Update/Notice - August 2019 Form

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MP/CG Update/Notice - August 2019

Indications

(1) Does the request meet this criterion: CG-GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status: This document addresses genotype testing for polymorphisms which can identify variants of specific genes associated with abnormal and normal drug metabolism. Prior authorization will be required effective? 
(2) Does the request meet this criterion: GENE.00051 Bronchial Gene Expression Classification for the Diagnostic Evaluation of Lung Cancer: This document addresses gene expression classification for the diagnostic evaluation of lung cancer in individuals with suspected lung cancer following identification of pulmonary lesions on computed tomography? 
(3) Does the request meet this criterion: MED.00129 Gene Therapy for Spinal Muscular Atrophy: This document addresses gene therapy for spinal muscular atrophy (SMA), a rare, and often fatal genetic disease affecting muscle strength and movement. One gene therapy product, Zolgensma® (onasemnogene abeparvovec-xioi), has been approved? 
(4) Does the request meet this criterion: SURG.00153 Cardiac Contractility Modulation Therapy: This document addresses the use of cardiac contractility modulation therapy designed to treat chronic moderate-to-severe heart failure. UPDATED Clinical Guidelines and Medical Policies effective November 1, 2019? 
(5) Does the request meet this criterion: DME.00037 Cooling Devices and Combined Cooling/Heating Devices: This document addresses the devices utilized for the treatment of pain and swelling after trauma and surgery and for musculoskeletal and other conditions. Included are both passive cold therapy devices and active cold therapy devices, as well as? 

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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.

August 1, 2019

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

Dear Provider:

Anthem Blue Cross (Anthem) is pleased to provide you with our new and updated Clinical Criteria, Clinical UM Guidelines and Medical Policies. 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. It does 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 Clinical Guidelines and Medical Policies effective November 1, 2019

• CG-GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status: This document addresses genotype testing for polymorphisms which can identify variants of specific genes associated with abnormal and normal drug metabolism. Prior authorization will be required effective November 1, 2019.

• GENE.00051 Bronchial Gene Expression Classification for the Diagnostic Evaluation of Lung Cancer:
This document addresses gene expression classification for the diagnostic evaluation of lung cancer in individuals with suspected lung cancer following identification of pulmonary lesions on computed tomography (CT) scans. Prior authorization will be required effective November 1, 2019.

• MED.00129 Gene Therapy for Spinal Muscular Atrophy: This document addresses gene therapy for spinal muscular atrophy (SMA), a rare, and often fatal genetic disease affecting muscle strength and movement. One gene therapy product, Zolgensma® (onasemnogene abeparvovec-xioi), has been approved by the Food and Drug Administration (FDA). Prior authorization will be required effective November 1, 2019.

• SURG.00153 Cardiac Contractility Modulation Therapy: This document addresses the use of cardiac contractility modulation therapy designed to treat chronic moderate-to-severe heart failure.

UPDATED Clinical Guidelines and Medical Policies effective November 1, 2019

• DME.00037 Cooling Devices and Combined Cooling/Heating Devices: This document addresses the devices utilized for the treatment of pain and swelling after trauma and surgery and for musculoskeletal and other conditions. Included are both passive cold therapy devices and active cold therapy devices, as well as devices that combine compression or heat therapy in the same device. o Added devices that combine cooling and vibration to the Investigational and Not Medically Necessary statement

• LAB.00027 Selected Blood, Serum and Cellular Allergy and Toxicity Tests: This document addresses selected unproven blood, serum and cellular allergy and toxicity tests.
o Added Mediator Release Test to Investigational and Not Medically Necessary statement

• LAB.00033 Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer:
This document addresses the use of protein biomarkers, specifically the 4Kscore® test, for the screening, detection and management of prostate cancer.
o Clarified Investigational and Not Medically Necessary statement to include 4Kscore and AR-V7

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. • OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis: This document addresses the use of microprocessor controlled lower limb prostheses including, but not limited to, knee prostheses and foot-ankle prostheses. o Clarified Medically Necessary position statement criteria 2 through 4 o Added statement that use of prosthetic devices that combine both a microprocessor controlled knee and foot-ankle prosthesis is considered Investigational and Not Medically Necessary for all indications

• SURG.00011 Allogeneic, Xenographic, Synthetic, and Composite Products for Wound Healing and Soft Tissue Grafting: This document addresses the use of soft tissue (e.g., skin, ligament, cartilage, etc.) substitutes in wound healing and surgical procedures. o Added new Medically Necessary and Investigational and Not Medically Necessary statements addressing amniotic membrane-derived products for conjunctival and corneal indications, including KeraSys and Prokera o Added new products to Investigational and Not Medically Necessary statement

• SURG.00045 Extracorporeal Shock Wave Therapy: This document addresses the use of extracorporeal shock wave therapy (ESWT), including Extracorporeal Pulse Activation Therapy (EPAT®), for the treatment of musculoskeletal conditions, soft tissue injuries, and erectile dysfunction. o Previous Title: Extracorporeal Shock Wave Therapy for Orthopedic Conditions o Added erectile dysfunction, Peyronie’s disease and wound repair to the Investigational and Not Medically Necessary statement

• SURG.00121 Transcatheter Heart Valve Procedures: This document addresses the transcatheter (percutaneous or catheter-based) approach for aortic or pulmonary heart valve replacement, transcatheter mitral valve repair using leaflet repair or percutaneous annuloplasty, and transcatheter tricuspid valve repair or replacement. o Added Investigational and Not Medically Necessary statement to address use of transcatheter tricuspid valve repair or replacement for all indications

Medical Policies converted to Clinical Guidelines (No changes to clinical indications) effective September 4, 2019

MP Number Title CG Number GENE.00021 Chromosomal Microarray Analysis (CMA) for Developmental Delay, Autism Spectrum Disorder, Intellectual Disability (Intellectual Development Disorder) and Congenital Anomalies CG-GENE-10 SURG.00133 Alcohol Septal Ablation for Treatment of Hypertrophic Cardiomyopathy CG-SURG-102

Medical Policies converted to Clinical Guidelines (Changes noted in Attachment A) effective September 4, 2019

MP Number Title CG Number SURG.00106 Ablative Techniques as a Treatment for Barrett's Esophagus CG-SURG-101

Clinical Guideline being archived and transitioned to AIM Clinical Appropriateness Guidelines effective October 1, 2019

CG-MED-80 Positron Emission Tomography (PET) and PET/CT Fusion will be archived effective October 1, 2019.
Clinical criteria for PET and PET/CT Fusion will be transitioned to AIM Cardiology – Cardiac Imaging (Myocardial PET), AIM Advanced Imaging - of the Brain and AIM Advanced Imaging – Oncologic (Miscellaneous PET) accordingly.

Anthem REMINDER: Changes to the process for Medical Non-Oncology Specialty Drug reviews effective June 15, 2019

In the June newsletter we announced the transition of the medical non-oncology specialty drug review process from AIM to Anthem medical specialty drug review team, effective June 15, 2019. Here’s a reminder of the changes.

What has changed? • Beginning June 15, 2019, for all new specialty drug review requests and reauthorization specialty drug review requests that were previously performed by AIM, providers need to contact Anthem’s medical specialty drug review team:

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. o By phone at 1-833-293-0659 or

o By fax at 1-888-223-0550 • All inquiries about an existing request initially submitted to AIM or Anthem, peer-to-peer review, or reconsideration are being managed by Anthem’s medical specialty drug review team.

What has not changed? • AIM continues to be responsible for performing medical oncology drug reviews for existing commercial medical benefit for our employer group business. • Specialty drug review processes not previously done by AIM remain unchanged. • Clinical criteria for medical non-oncology specialty drugs resides on the clinical criteria page on anthem.com (www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html). • Post Service Clinical Coverage Reviews and Grievance and Appeals process and teams have not changed.

Here is a summary of the medical specialty drug changes:

Action Contact

Beginning
June 15, 2019 Submit a new prior authorization request for a medical specialty drug review

Submit a reauthorization request for a medical specialty drug review previously performed by AIM Call Anthem at 1-833-293-0659

or

Fax us at 1-888-223-0550

Inquire about an existing request (initially submitted to AIM or Anthem), peer-to-peer review, or reconsideration

Call Anthem at 1-833-293-0659

Clinical Criteria updates for specialty pharmacy

Existing precertification requirements have been revised to expand medical necessity indications or criteria for the Clinical Criteria below, and the document number and online location has changed. To access the clinical criteria information please go to www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html. The table below will assist you in identifying the new document number for the clinical criteria that corresponds with the previous Clinical Guideline/Medical Policy.

Effective June 10, 2019

MP/CG # Clinical Criteria # Title Drug(s) HCPCS/CPT codes CG-DRUG-88 ING-CC-0029 Dupixent (dupilumab) Dupixent J3490, J3590 CG-DRUG-38 ING-CC-0094 Alimta (pemetrexed disodium) Alimta J9305 CG-DRUG-42 ING-CC-0096 Asparagine Specific Enzymes (Asparaginase) Erw inaze, Asparaginase, Oncaspar J9019, J9020, J9266 CG-DRUG-63 ING-CC-0104 Levoleucovorin and Levoleucovorin Agents Fusilev, Khapzory C9043, J0641, J3490 CG-DRUG-65 ING-CC-0062 Tumor Necrosis Factor Antagonists Amjevita, Cimzia, Cyltezo, Enbrel, Erelzi, Humira, Hyrimoz, Inflectra, Ixifi, Remicade, Renflexis, Simponi/Aria J0135, J0717, J1438, J1602, J1745, J3590, Q5103, Q5104, Q5109, S9359 CG-DRUG-66 ING-CC-0105 Vectibix (panitumumab) Vectibix J9303 CG-DRUG-72 ING-CC-0110 Perjeta (pertuzumab) Perjeta J9306 CG-DRUG-76 ING-CC-0089 Mozobil (plerixafor Injection)
Mozobil J2562 CG-DRUG-96 ING-CC-0115 Kadcyla (ado-trastuzumab emtansine) Kadcyla J9354 CG-DRUG-98 ING-CC-0116 Bendamustine Hydrochloride Belrapzo, Bendeka, Treanda J9033, J9034, J9036 (prior authorization effective 9/1/19) CG-DRUG-103 ING-CC-0032 Botulinum Toxin Botox, Xeomin, Dysport, Myobloc J0585, J0586, J0587, J0588 CG-DRUG-106 ING-CC-0092 Adcetris (brentuximab) Adcetris J9042

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. DRUG.00046 ING-CC-0119 Yervoy (ipilimumab) Yervoy J9228 DRUG.00053 ING-CC-0120 Kyprolis (carfilzomib) Kyprolis J9047 DRUG.00063 ING-CC-0122 Arzerra (ofatumumab) Arzerra J9302 DRUG.00067 ING-CC-0123 Cyramza (ramucirumab) Cyramza J9308 DRUG.00071 ING-CC-0124 Keytruda (pembrolizumab) Keytruda J9271 DRUG.00075 ING-CC-0125 Opdivo (nivolumab) Opdivo J9299 DRUG.00107 ING-CC-0129 Bavencio (avelumab) Bavencio J9023

Existing precertification requirements were reviewed with no significant change to medical necessity indications or criteria for the Clinical Criteria below, and the document number and online location has changed.

Effective September 1, 2019

MP/CG # Clinical Criteria # Title Drug(s) HCPCS/CPT codes CG-DRUG-01 ING-CC-0141 Off-Label Drug and Approved Orphan Drug Use N/A N/A CG-DRUG-44 ING-CC-0057 Krystexxa (pegloticase) Krystexxa J2507 CG-DRUG-45 ING-CC-0058 Octreotide Agents Sandostatin, Sandostatin LAR Depot J2353 , J2354 CG-DRUG-49 ING-CC-0098 Doxorubicin Hydrochloride Liposome Doxil, Lipodox Q2049, Q2050 CG-DRUG-50 ING-CC-0099 Abraxane (paclitaxel protein-bound) Abraxane J9264 CG-DRUG-51 ING-CC-0100 Istodax (romidepsin) Istodax J9315 CG-DRUG-53 ING-CC-0136 Drug Dosage, Frequency, and Route of Administration N/A N/A CG-DRUG-62 ING-CC-0103 Faslodex (fulvestrant) Faslodex J9395 CG-DRUG-67 ING-CC-0106 Erbitux (cetuximab)
Erbitux J9055 CG-DRUG-68 ING-CC-0107 Bevacizumab for Non- Ophthalmologic Indications Avastin, Mvasi J9035, Q5107 CG-DRUG-70 ING-CC-0108 Halaven (eribulin mesylate) Halaven J9179 CG-DRUG-71 ING-CC-0109 Zaltrap (ziv-aflibercept) Zaltrap J9400 CG-DRUG-75 ING-CC-0111 Nplate (romiplostim) Nplate J2796 CG-DRUG-77 ING-CC-0112 Xofigo (radium Ra 223 dichloride) Xofigo A9606, 79101 CG-DRUG-80 ING-CC-0114 Jevtana (cabazitaxel) Jevtana J9043

CG-DRUG-83 ING-CC-0068

Grow th Hormone Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, somatrem, sernoreline acetate, Serostim, Zomacton, Zorbtive J2940, J2941 CG-DRUG-85 ING-CC-0069 Egrifta (tesamorelin) Egrifta J3490 CG-DRUG-86 ING-CC-0070 Jetrea (ocriplasmin) Jetrea J7316 CG-DRUG-99 ING-CC-0117 Empliciti (elotuzumab) Empliciti J9176 CG-DRUG-100 ING-CC-0085 Actimmune (interferon gamma-1b)
Actimmune J9216 CG-DRUG-101 ING-CC-0090 Ixempra (ixabepilone) Ixempra J9207 CG-DRUG-102 ING-CC-0091 Lartruvo (olaratumab) Lartruvo J9285 CG-DRUG-111 ING-CC-0037 Kanuma (sebelipase alfa) Kanuma J2840 CG-DRUG-113 ING-CC-0131 Besponsa (inotuzumab ozogamicin) Besponsa J9229 CG-MED-67 ING-CC-0135 Melanoma Vaccines
Imlygic J9325, J3590

CG-THER-RA D-03 ING-CC-0118 Radioimmunotherapy and Somatostatin Receptor Targeted Radiotherapy Zevalin, Azedra, Lutathera 79403, A9543, 79101, A9699, C9408, A9513 DRUG.00062 ING-CC-0121 Gazyva (obinutuzumab)
Gazyva J9301 DRUG.00076 ING-CC-0126 Blincyto (blinatumomab)
Blincyto J9039 DRUG.00082 ING-CC-0127 Darzalex (daratumumab) Darzalex J9145 DRUG.00086 ING-CC-0045 Increlex (mecasermin) Increlex J2170 DRUG.00088 ING-CC-0128 Tecentriq (atezolizumab) Tecentriq J9022 DRUG.00095 ING-CC-0011 Ocrevus (ocrelizumab) Ocrevus J2350 DRUG.00109 ING-CC-0130 Imfinzi (durvalumab)
Imfinzi J9173 DRUG.00112 ING-CC-0132 Mylotarg (gemtuzumab ozogamicin) Mylotarg J9203

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. DRUG.00118 ING-CC-0133 Aliqopa (copanlisib) Aliqopa J9057 MED.00106 ING-CC-0134 Provenge (sipuleucel-T) Provenge Q2043

The following Clinical Criteria were revised and might result in services that were previously covered but may now be found to be not medically necessary.

Effective November 1, 2019

MP/CG # Clinical Criteria # Title Drug(s) HCPCS/CPT codes

CG-DRUG-16 ING-CC-0002 Colony Stimulating Factor Agents Fulphila, Granix, Leukine, Neulasta/OnPro injector, Neupogen, Nivestym,
Prokine, Udenyca, Zarxio 96377, J1442, J1447, J2505, J2820, Q5101, Q5108, Q5110, Q5111, S9537 CG-DRUG-79 ING-CC-0113 Sylvant (siltuximab) Sylvant J2860 DRUG.00104 ING-CC-0048 Spinraza (nusinersen) Spinraza 96450, J2326 DRUG.00111 ING-CC-0050 Monoclonal Antibodies to Interleukin-23 Ilumya, Skyrizi, Tremfya J1628, J3245, J3490, J3590

Update to AIM Clinical Appropriateness Guidelines

AIM Radiation Oncology: Proton Beam Therapy Clinical Appropriateness Guideline

Effective for dates of service on and after November 10, 2019, the following updates will apply to the AIM Radiation Oncology: Proton Beam Therapy Clinical Appropriateness Guideline.

• Sinonasal cancer: Added criteria and diagnosis codes for locally advanced sinonasal cancer when tumor involves base of skull and proton beam therapy is needed to spare orbit, optic nerve, optic chiasm, or brainstem
• Ocular Melanoma: Removed tumor size restrictions for treating melanoma of the uveal tract
• Pediatric tumors: Clarified proton beam therapy appropriate for all pediatric tumors requiring radiation therapy

AIM Advanced Imaging Clinical Appropriateness Guidelines

Effective for dates of service on and after November 10, 2019, the following updates will apply to the AIM Advanced Imaging Clinical Appropriateness Guidelines.

Oncologic Imaging Guideline contains updates to the following:
• Colorectal cancer, germ cell tumors, kidney cancer, multiple myeloma, prostate cancer and cancers of unknown primary / cancers not otherwise specified,
• Added new sections on hepatobiliary cancer and suspected metastases • Added allowance for MRI and/or MRCP for diagnostic workup of hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma • Added allowance for PET “When standard imaging prior to planned curative surgery for cholangiocarcinoma has been performed and has not demonstrated metastatic disease”

Vascular Imaging Guideline contains updates to the following:
• Brain, Head and Neck: Aneurysm - intracranial, Aneurysm - extracranial, Arteriovenous malformation (AVM) and fistula (AVF), Fibromuscular dysplasia, Hemorrhage - intracranial, Stenosis or occlusion - extracranial, Stenosis or occlusion - intracranial, stroke and Venous thrombosis or compression - intracranial • Chest: Acute aortic syndrome, Aortic aneurysm, Pulmonary artery hypertension • Abdomen and Pelvis: Acute aortic syndrome, Aneurysm of the abdominal aorta or iliac arteries, Hematoma/hemorrhage within the abdomen or unexplained hypotension, Renal artery stenosis (RAS)/Renovascular hypertension, Venous thrombosis or compression – intracranial, Stenosis or occlusion of the abdominal aorta or branch vessels, not otherwise specified
• Upper Extremity: Peripheral arterial disease, Venous thrombosis or occlusion • Lower Extremity: Added physiologic testing for peripheral arterial disease and further defined indications for classic presenting symptoms of lower extremity peripheral arterial disease • Added arterial ultrasound guideline content • Aligned peripheral arterial ultrasound with advanced vascular imaging criteria

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Imaging of the Heart Guideline contains updates to the following:
• Blood Pool Imaging: Changes address appropriate evaluation and surveillance of LV function in patients following cardiac transplantation. Additional language is more restrictive based on the literature and aligns with the resting transthoracic echocardiography guideline.
• Cardiac CT: Quantitative evaluation of coronary artery calcification has been revised with new more expansive language based on review of the literature.

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 guidelines at http://www.aimspecialtyhealth.com/marketing/guidelines/185/index.html.

Anthem customization to MCG Care Guidelines 23rd edition

Effective November 1, 2019, the following MCG Care Guideline 23rd edition customization will be implemented for Chemotherapy, Inpatient & Surgical Care (W0162) for adult patients. This customization provides specific criteria and guidance on the following: • Revised Clinical Indications for admission and added examples for: o Aggressive hydration needs that cannot be managed in an infusion center o Prolonged marrow suppression • Added Regimens that cannot be managed as an outpatient with examples

To view the summary of MCG 23rd edition customizations, click on the following link: https://www.anthem.com/wps/portal/ca/culdesac?name=onlinepolicies&content_path=provider/f1/s0/t0/pw_a1117 22.htm&label=Overview

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

Anthem Medical Policies and Clinical UM Guidelines are developed by our Medical Policy and Technology Assessment Committee. The Committee, which includes Anthem medical directors and representatives from practicing physician groups, meets quarterly to review current scientific data and clinical developments. Medical Policies and Clinical UM Guidelines are subject to the approval of the Physician Relations Committee.

All coverage written or administered by Anthem excludes from coverage services or supplies that are investigational and/or not medically necessary. A member’s claim may not be eligible for payment if it was determined not to meet medical necessity criteria set forth in Anthem’s Medical Policies. Review procedures have been refined to facilitate claim investigation.

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem Web site at http://www.anthem.com/ca and then hovering over “Providers”, then selecting “Policies and Guidelines” under the Provider Resources column, scrolling down to select “View Medical Policies & UM Guidelines”, then selecting “Medical Policies and Clinical UM Guidelines (for Local Plan members)”, then selecting “Continue” at the bottom of the page.

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 Senior Clinical 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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Attachme nt A – Updates as of August 2019 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-ANC-06 Ambulance Services: Ground; Non-Emergent • Clarified Medically Necessary statement with examples of bed- confined • Clarified Not Medically Necessary statement CG-DME-07 Augmentative and Alternative Communication (AAC) Devices with Digitized or Synthesized Speech Output • Previous title: Augmentative and Alternative Communication (AAC) Devices/Speech Generating Devices (SGD) • Revised Clinical Indications to specify scope of the document as limited to digitized and synthesized speech generating devices CG-DME-42 Non-implantable Insulin Infusion and Blood Glucose Monitoring Devices • Added notes to Description section addressing device types • Clarified and updated formatting in the Clinical Indications section CG-DME-45 Ultrasound Bone Growth Stimulation • In the Medically Necessary statement, clarified what is meant by “location and poor vascular supply” in Bullet 3a CG-MED-59 Upper Gastrointestinal Endoscopy in Adults • In Sequential or Periodic Diagnostic EGD in Adults section of Clinical Indications, changed “and” to “or” in criterion A.1 CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities • Changed “exercise” to “activity” in the Medically Necessary statement regarding the absence of other conditions in the treatment of claudication • Changed “TASC type A of the common iliac, external iliac, or superficial femoral arteries, defined as follows” to “has one of the following anatomic characteristics” in the Medically Necessary statement regarding targeted lesions • Revised formatting of the Clinical Indications section CG-SURG-81 Cochlear Implants and Auditory Brainstem Implants • Removed text related to FDA approval status from the Medically Necessary statements CG-SURG-101 Ablative Techniques as a Treatment for Barrett's Esophagus • Converted from SURG.00106 • Revised Medically Necessary indications to include intramucosal cancer (IMC) • Added cryoablation to Medically Necessary criteria DME.00038 Static Progressive Stretch (SPS) and Patient-Actuated Serial Stretch (PASS) Devices • Added information related to the Elite Seat device to the Description/Scope, Rationale and Index sections (moved from CG-DME-39 Dynamic Low-Load Prolonged-Duration Stretch Devices) • Removed HCPCS code E1399 - not applicable for PASS devices GENE.00010 Genotype Panel Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status • Previous title: Genotype Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status • Removed genotype testing for single polymorphisms of metabolizing enzymes for specific drugs and moved into CG- GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status effective September 4, 2019 GENE.00001 Genetic Testing for Cancer Susceptibility • Added CPT 0104U for CancerNext as Investigational and Not Medically Necessary effective July 1, 2019 GENE.00011 Gene Expression Profiling for Managing Breast Cancer Treatment • Made administrative update to Position Statement GENE.00025 Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignancies • Previous title: Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignant Tumors • Removed CPT code 0057U - deleted 06/30/19

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility • Added CPT coded 0101U effective 07/01/19 for ColoNext as Investigational and Not Medically Necessary GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome • Expanded Medically Necessary indications for BRCA1/2 and BART testing: − Added Medically Necessary criteria for individuals with a personal or family history of breast cancer diagnosed between the ages of 46 and 50 years − Revised criteria for individuals with a personal history of breast cancer and relatives on the same side of the family with pancreatic cancer so that the phrase “at least 2 or more first-, second- or third-degree relatives” was changed to “at least 1 or more first-, second- or third-degree relatives − Expanded Medically Necessary criteria addressing an individual with a history of pancreatic cancer
− Revised criterion for individuals with a family (no personal) history of cancer to include “when they have a relative who would meet any one of the criteria for individuals with a personal history of cancer, but that relative is not available for testing” • Added CPT codes 0102U and 0103U for BreastNext and OvaNext as Investigational and Not Medically Necessary effective July 1, 2019 GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases • Added CPT 0094U for Rapid Whole Genome Sequencing as Investigational and Not Medically Necessary effective July 1, 2019 GENE.00044 Analysis of PIK3CA Status in Tumor Cells • Added Medically Necessary indication for PIK3CA mutation testing using tumor tissue when treatment with a phosphatidylinositol-3-kinase (PI3K) inhibitor (for example, alpelisib) is indicated • Modified the Investigational and Not Medically Necessary statement: changed “for all indications” to “for all other indications not listed above” ING-CC-0029 Dupixent (dupilumab) • Updated Medically Necessary criteria for atopic dermatitis to allow for age 12 and older ING-CC-0032 Botulinum Toxin • Updated indication table to indicate Xeomin is FDA approved for blepharospasm ING-CC-0057 Krystexxa (pegloticase) • Wording and formatting changes ING-CC-0062 Tumor Necrosis Factor Antagonists • Added treatment of nonradiographic axial spondyloarthritis as Medically Necessary for Cimzia ING-CC-0065 Agents for Hemophilia and von Willebrand Disease • Added J7208 and delete C9141 and J7192 for Jivi LAB.00011 Analysis of Proteomic Patterns • Added CPT 0092U for REVEAL Lung Nodule Characterization
as Investigational and Not Medically Necessary effective July 1, 2019 LAB.00015 Detection of Circulating Tumor Cells in the Blood as a Prognostic Factor for Cancer • Added CPT 0091U for FirstSightCRC as Investigational and Not Medically Necessary effective July 1, 2019 LAB.00016 Fecal Analysis in the Diagnosis of Intestinal Disorders • Added CPT 81599 if described as test for intestinal disorders MED.00119 Corneal Collagen Cross-Linking • Modified Medically Necessary statement on progressive keratoconus • Modified Medically Necessary criteria on corneal ectasia SURG.00005 Partial Left Ventriculectomy • Removed the acronym for partial left ventriculectomy (PLV) from the Position Statement SURG.00010 Treatments for Urinary Incontinence • Added CPT Category III codes 0548T-0551T replacing C9746 for ProACT as Investigational and Not Medically Necessary effective July 1, 2019

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. The Blue Cross name and symbol are registered marks of the Blue Cross Association.

SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Added reduction mammaplasty done in advance of mastectomy or lumpectomy for breast cancer to the covered Reconstructive procedures SURG.00028 Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions • Added Prostatic urethral lift to Medically Necessary statement with criteria for treatment of benign prostatic hyperplasia • Changed to "Prostatic urethral lift when criteria are not met" in Investigational and Not Medically Necessary statement • Added Prostatic urethral lift to Investigational and Not Medically Necessary statement for treatment of genitourinary conditions other than benign prostatic hyperplasia SURG.00032 Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention • Removed ICD-10 code 02L73CK; not applicable for transcatheter procedure SURG.00120 Internal Rib Fixation Systems • Clarified Medically Necessary statement regarding open approach and dependency of mechanical ventilation

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