MP/CG Update/Notice - May 2019 Form

1 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.

May 1, 2019

[Provider Name]
[Contact Name] [Contact Title] [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.

NEW Medical Policies effective August 1, 2019

• GENE.00050 Gene Expression Profiling for Coronary Artery Disease: This document addresses use of gene expression profiling for coronary artery disease.
o Corus CAD test (moved from GENE.00043) is considered Investigational and Not Medically Necessary

• SURG.00152 Wireless Cardiac Resynchronization Therapy for Left Ventricular Pacing: This document addresses Wireless CRT for left ventricular pacing.
o Wireless CRT for left ventricular pacing is considered Investigational and Not Medically Necessary

UPDATED Medical Policies and Clinical Guidelines effective August 1, 2019

• 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 the use of enhanced computer treatment planning software (such as NovoTal) as Not Medical Necessary in all cases

• CG-DRUG-98 Bendamustine Hydrochloride: This document addresses the indications for the use of bendamustine hydrochloride, a cytotoxic, bifunctional mechlorethamine derivative with alkylator and antimetabolite activities, administered intravenously to treat several oncologic conditions. o Added C9042 and J9999 for Belrapzo (bendamustine HCL)

• CG-MED-72 Hyperthermia for Cancer Care: This document addresses hyperthermia for cancer therapy. Hyperthermia is a type of cancer treatment in which body tissue is exposed to high temperatures using external and internal heating devices. o Clarified Medically Necessary and Not Medically Necessary statements addressing frequency of treatment

• CG-SURG-09 Temporomandibular Disorders: This document addresses temporomandibular joint (TMJ) and related musculoskeletal structure disorders commonly called temporomandibular disorders (TMD), a collective term for temporomandibular joint dysfunction (TMJD), temporomandibular joint (TMJ) syndrome, and craniomandibular disorder (CMD). o Clarified Medically Necessary and Not Medically Necessary criteria and removed requirement for FDA approval of prosthetic implants

• GENE.00012 Preconception or Prenatal Testing of a Parent or Prospective Parent: This document addresses preconception or prenatal genetic testing on a parent or prospective parent to determine carrier status of an autosomal recessive disorder, an x-linked disorder, or a disorder with variable penetrance. o Added existing CPT codes 81205, 81250, 81302, 81303, 81304, 81331, 81332, S3850 and Tier 2 codes 81400, 81401, 81402, 81407, 81408 which will now be reviewed for Medically Necessary or Investigational and Not Medically Necessary criteria o Added applicable genes to Tier 2 codes

2 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.

• GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases: This document addresses the framework for consideration of genetic testing for any disease with an established genetic basis. o Removed Investigational and Not Medically Necessary statement and all other language and coding related to Corus CAD testing o Corus CAD testing now addressed in GENE.00050 (Gene Expression Profiling for Coronary Artery Disease)

Medical Policies converted to Clinical Guidelines (No changes to clinical indications)

MP Number Title CG Number DRUG.00003 Chelation Therapy MED.00127 DRUG.00034 Insulin Potentiation Therapy MED.00128 DRUG.00110 Inotuzumab ozogamicin (Besponsa®) CG-DRUG-113 GENE.00002 Preimplantation Genetic Diagnosis Testing CG-GENE-06 GENE.00005 BCR-ABL Mutation Analysis CG-GENE-07 GENE.00031 Genetic Testing for PTEN Hamartoma Tumor Syndrome CG-GENE-08 GENE.00040 Genetic Testing for CHARGE Syndrome CG-GENE-09 MED.00119 High Intensity Focused Ultrasound (HIFU) for Oncologic Indications CG-MED-81 CG-DRUG-47 Level of Care: Specialty Pharmaceuticals CG-MED-83 RAD.00066 Multiparametric Magnetic Resonance Fusion Imaging Targeted Prostate Biopsy CG-SURG-98 SURG.00048 Panniculectomy and Abdominoplasty CG-SURG-99

Medical Policies converted to Clinical Guidelines (Changes noted in Attachment A)

MP Number Title CG Number SURG.00033 Cardioverter Defibrillators CG-SURG-97

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

This update applies to local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by AIM Specialty Health® (AIM), a separate company. 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.

Number Title CG-SURG-86 Implanted (Epidural and Subcutaneous) Spinal Cord Stimulators (SCS)

Clinical Criteria updates for Specialty Pharmacy

On February 1, 2019 Anthem notified providers of new Clinical Criteria that will require Prior Authorization review effective May 1, 2019. The letter misidentified codes for Akynzeo and Onpattro. The correct codes are J1454 for Akynzeo (ING-CC-0074), and, C9036 and J3490 for Onpattro (ING-CC-0082). There is also a secondary code of C9043 for Khapzory (CG-DRUG-63).

3 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 table below summarizes Clinical Guidelines that are being converted to Clinical Criteria effective May 1, 2019.
While there are no material changes, the document number and online location has changed. To access the current clinical criteria information please go to www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html.

Clinical Guideline Clinical Criteria Clinical Criteria Title ( new title) Drugs CG-DRUG-05 ING-CC-0001 Erythropoiesis Stimulating Agents Aranesp, Epogen, Mircera, Procrit, Retacrit CG-DRUG-16 ING-CC-0002 Colony Stimulating Factor Agents Fulphila, Granix, Leukine, Neulasta/OnPro injector, Neupogen, Nivestym, Prokine, Udenyca, Zarxio CG-DRUG-09 ING-CC-0003 Immunoglobulins Bivigam, Carimune NF, Cuvitru, Flebogabba/DIF, Gammagard, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Hizentra, Hyqvia, Octagam, Panzyga, Privigen CG-DRUG-24 ING-CC-0004 H.C Acthar Gel (repository corticotropin injection) H.P. Acthar CG-DRUG-91 ING-CC-0031 Intravitreal Corticosteroid Implants Iluvien, Ozurdex, Retisert CG-DRUG- 107 ING-CC-0034 Hereditary Angioedema Agents Berinert, Cinryze, Firazyr, Haegarda, Kalbitor, Ruconest, Takhyzro CG-DRUG- 110 ING-CC-0036 Naltrexone Implantable Pellets Naltrexone pellets CG-DRUG-65 ING-CC-0062 Tumor Necrosis Factor Agents Amjevita, Cimzia, Cyltezo, Enbrel, Erelzi, Humira, Hyrimoz, Inflectra, Ixifi, Remicade, Renflexis, Simponi/Aria CG-DRUG-78 ING-CC-0065 Agents for Hemophilia and von Willebrand Disease Advate, Adynovate, Afstyla, Alphanate, Alphanine SD, Alprolix, Bebulin, Benefix, Coagadex, Corifact, Electate, FEIBA, Fibryna, Helixate FS, Hemlibra, Hemofil M, Humate P, Idelvion, Ixinity, Jivi, Koate- DVI, Kogenate FS, Monoclate-P, Mononine, Novoeight, NovoSeven RT, Nuwiq, Obizur, Profilnine SD, Rebinyn, Recombinate, RiaSTAP, Rixubis, Tretten, Vonvendi, Wilate, Xyntha/Solofues CG-DRUG-90 ING-CC-0072 Selective Vascular Endothelial Growth Factor (VEGF) Antagonists Avastin, Eylea, Lucentis, Macugen, Mvasi Specialty Pharmacy medical step therapy drug list updates Anthem specialty pharmacy medical step therapy drug list- clarification In the February provider letter, we stated that Colony Stimulating Factor Agents ING-CC-0002 would be included in our specialty pharmacy medical step therapy review process effective May 1, 2019. This applies to non- oncology uses of these drugs at this time. We will notify you when we begin the medical step therapy review process for oncology indications.

ING-CC-0034 Hereditary Angioedema Agents

Effective for dates of service on and after August 1, 2019, the following specialty pharmacy codes from new clinical criteria will be included in our existing specialty pharmacy medical step therapy review process. Haegarda® and Takhzyro™ will be the preferred prophylactic agents over Cinryze®.

Please note, inclusion of NDC code on your claim will shorten the claim processing time of drugs billed with a Not Otherwise Classified (NOC) code.

4 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.

Clinical Criteria is located at https://www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html

Clinical Criteria Status Drug HCPCS /CPT Code NDC Code ING-CC-0034 Preferred Agent Haegarda® J0599 63833-0828-02 63833-0829-02 ING-CC-0034 Preferred Agent Takhzyro™ J3490, J3590, C9399 47783-0644-01 ING-CC-0034 Non-Preferred Agent Cinryze® J0598 42227-0081-05

MCG Updates

Effective August 1, 2019, Anthem will upgrade to the 23rd edition of MCG care guidelines for the following modules: Inpatient & Surgical Care (ISC), General Recovery Care (GRC), Chronic Care (CC), Recovery Facility Care (RFC), Behavioral Health Care (BHC).

Goal Length of Stay (GLOS) changes for Inpatient & Surgical Care (ISC)

Guideline MCG Number 23rd Edition GLOS
22nd Edition GLOS Neurology- Traumatic Brain Injury, Nonsurgical Treatment M-78 Ambulatory or 2 days 2 days Orthopedics-Lumbar Fusion S-820 2 days postoperative 3 days postoperative

New Optimal Recovery Guidelines (ORGs), Common Complications and Conditions (CCC) and Level of Care (LOC) Guidelines Module Guideline Title MCG No. ISC ORG Anorexia Nervosa, Child or Adolescent P-585 ISC ORG Substance-Related Disorders, Child or Adolescent P-596 ISC ORG Left Atrial Appendage Closure, Percutaneous M-333 ISC ORG Abdominal Pain, Undiagnosed, Pediatric P-05 ISC ORG Craniotomy for Traumatic Brain Injury or Intracerebral Hemorrhage, Pediatric P-414 ISC ORG Craniotomy, Supratentorial, Pediatric
P-411 ISC ORG Headaches, Pediatric P-185 ISC ORG Hernia Repair (Non-Hiatal), Pediatric P-1305 ISC ORG Inflammatory Bowel Disease, Pediatric P-565 ISC ORG Pelvic Inflammatory Disease (PID), Acute, Pediatric P-260 ISC ORG Spine, Scoliosis, Posterior Instrumentation, Pediatric P-1056 ISC ORG Supraventricular Arrhythmias, Pediatric P-510 ISC CCC Pain: Common Complications and Conditions
CCC-050 RFC ORG Degenerative Joint Disease (DJD) M-7030 BHC LOC Obsessive-Compulsive and Related Disorders, Adult: Inpatient Care
B-030-IP BHC LOC Obsessive-Compulsive and Related Disorders, Child or Adolescent: Inpatient Care B-029-IP BHC LOC Obsessive-Compulsive and Related Disorders: Residential Care B-030-RES BHC LOC Obsessive-Compulsive and Related Disorders: Partial Hospital Program B-030-PHP BHC LOC Obsessive-Compulsive and Related Disorders: Intensive Outpatient Program B-030-IOP BHC LOC Obsessive-Compulsive and Related Disorders: Acute Outpatient Care B-030-AOP

Anthem Customizations to MCG care guideline 23rd Edition

Effective August 1, 2019, the following MCG care guideline 23rd edition customizations will be implemented.
• Left Atrial Appendage Closure, Percutaneous (W0157) - customized to refer to SURG.00032 Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention • Spine, Scoliosis, Posterior Instrumentation, Pediatric (W0156) - customized to refer to Musculoskeletal Program Clinical Appropriateness Guidelines, Level of Care Guidelines and Preoperative Admission Guidelines

5 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.

A more detailed summary of customizations can be found at https://www11.anthem.com/ca/provider/f1/s0/t0/pw_g356592.pdf?refer=culdesac&name=onlinepolicies

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

6 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 May 1, 2019 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-GENE-01 Janus Kinase 2, CALR, and MPL Gene Mutation Assays • Revised title (Previous title: Janus Kinase 2 [JAK2]V617F and JAK2 exon 12 Gene Mutation Assays) • Reformatted Medically Necessary clinical indications • Added CALR and MPL gene mutation testing as Medically Necessary when criteria are met • Added CALR and MPL gene mutation testing as Not Medically Necessary when Medically Necessary criteria are not met CG-DRUG-63 Levoleucovin Products • Added HCPCS code C9043 for Khapzory (prior authorization effective May 1, 2019) CG-GENE-04 Molecular Marker Evaluation of Thyroid Nodules • Added ThyroSeq as Medically Necessary when criteria met • Revised Not Medically Necessary statements addressing ThyroSeq CG-SURG-97 Cardioverter Defibrillators • Converted from SURG.00033 • Investigational and Not Medically Necessary changed to Not Medically Necessary as a result of MP to CUMG transition • Removed acronym from clinical indications • Moved Note addressing use of ICD therapy in children to the Discussion section DME.00032 Automated External Defibrillators for Home Use • Removed acronym from position statement DRUG.00053 Carfilzomib (Kyprolis®) • Expanded Medically Necessary criteria addressing carfilzomib in combination with panobinostat for relapsed or refractory multiple myeloma to include all proteasome inhibitors not only bortezomib • Expanded criteria for relapsed or refractory multiple myeloma to include combination therapy with daratumumab and dexamethasone as Medically Necessary DRUG.00076 Blinatumomab (Blincyto®) • Removed acronyms from position statement DRUG.00082 Daratumumab (DARZALEX®) • Clarified Medically Necessary statement for combination therapy for relapsed or refractory multiple myeloma to require one prior line of therapy including a proteasome inhibitor (PI) or immunomodulatory agent instead of at least two prior lines of therapy including a PI and lenalidomide DRUG.00088 Atezolizumab (Tecentriq®) • Added the treatment of breast cancer as Medically Necessary when criteria are met • Removed breast cancer from Investigational and Not Medically Necessary statement GENE.00007 Cardiac Ion Channel Genetic Testing • Removed acronyms from position statement GENE.0010 Genotype Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status • Added genotype testing to determine the presence of the HLA- B*58:01 allele as Medically Necessary in individuals of Asian descent for whom the use of allopurinol is being considered for treatment GENE.00017 Genetic Testing for Diagnosis and Management of Hereditary Cardiomyopathies (including arrhythmogenic right ventricular dysplasia/cardiomyopathy) • Revised title (Previous title: Genetic Testing for Diagnosis and Management of Hereditary Cardiomyopathies (including ARVD/C)
• Removed acronyms from title and position statement

7 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.

GENE.00045 Detection and Quantification of Tumor DNA Using Next Generation Sequencing in Lymphoid Cancers • Added next generation sequencing of tumor DNA to detect or quantify minimal residual disease in individuals with multiple myeloma following transplant as Medically Necessary MED.00053 Non-Invasive Measurement of Left Ventricular End Diastolic Pressure in the Outpatient Setting • Revised title (Previous title: Non-Invasive Measurement of Left Ventricular End Diastolic Pressure (LVEDP) in the Outpatient Setting) • Removed acronym from position statement MED.00101 Physiologic Recording of Tremor using Accelerometer(s) and Gyroscope(s) • Removed the words "FDA-approved" from the position statement MED.00120 Voretigene neparvovec-rzyl (Luxturna®) • Revised title (registration mark) MED.00125 Biofeedback and Neurofeedback • Made formatting change to Medically Necessary criteria SURG.00022 Lung Volume Reduction Surgery • Removed acronym from position statement SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation • Clarified Medically Necessary statement SURG.00121 Transcatheter Heart Valve Procedures • Reformatted Medically Necessary section, removing device names from position statements and removing list of comorbid conditions and contraindications • Added “Note” to refer to background section of document for list of FDA approved THV devices used for TAVR and TPVs • Revised transcatheter (aortic, pulmonic, valve-in-valve) Investigational and Not Medically Necessary statements to Not Medically Necessary NMN statements • Removed Investigational and Not Medically Necessary statement for TAVR with any device other than those listed above • Removed Investigational and Not Medically Necessary
statement for transcatheter valve implantation in other valve locations SURG.00139 Intraoperative Assessment of Surgical Margins During Breast- Conserving Surgery with Radiofrequency Spectroscopy or Optical Coherence Tomography • Added CPT code 0546T effective 07/01/19 for assessment of margins using radiofrequency spectroscopy