MP/CG Update/Notice - April 2018 Form

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.

April 1, 2018

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.

NOTE: The expanded Specialty Pharmacy Drug and Genetic Testing programs in italics below apply to local Fully Insured and ASO Anthem members who have these services medically managed by AIM Specialty Health® (AIM), a separate company administering the program on behalf of Anthem. For more information go to http://www.aimprovider.com/specialtyrx/FAQ.html to view the FAQs.

NEW Medical Policies and Clinical Guidelines effective July 1, 2018

• CG-DME-42 Non-implantable Insulin Infusion and Blood Glucose Monitoring Devices o Content moved from CG-DME-01 External (Portable) Continuous Insulin Infusion Pumps, CG-DME-38 Continuous Interstitial Glucose Monitoring, and DME.00040 Automated Insulin Delivery Devices o Removed separate Medically Necessary statement regarding OmniPod and combined with the Medically Necessary statement addressing all external insulin pumps
o Clarified "Note" regarding Medically Necessary statement of replacement of insulin pumps in pediatric individuals o Clarified “Note” regarding Medically Necessary statement of replacement insulin pump o Removed Not Medically Necessary statement regarding equipment upgrades or accessories for the sole purpose of integrating pumps and continuous glucose monitors o Removed "Note" regarding intensive diabetic management in any form
o Added Medically Necessary and Not Medically Necessary statements related to replacement for continuous glucose monitors and automated insulin delivery systems

• CG-DRUG-77 Radium Ra 223 Dichloride (Xofigo): This document addresses the use of radium Ra 223 dichloride (Xofigo) injection, an alpha particle-emitting radioactive therapeutic agent which mimics calcium to bind with bone minerals in areas of bone metastases. Prior authorization review will be managed by AIM.

• CG-SURG-59 Vena Cava Filters: This document addresses clinical use of vena cava filters in the management of acute venous thromboembolism (pulmonary embolism [PE] and deep venous thrombosis [DVT]). Only outpatient requests will be reviewed. Prior authorization review will be managed by AIM.

• DRUG.00116 Vestronidase alfa (Mepsevii™): This document addresses vestronidase alfa (Mepsevii), an enzyme replacement therapy used to treat individuals with Mucopolysaccharidosis type VII. Prior authorization review will be managed by AIM.

UPDATED Medical Policies and Clinical Guidelines

• CG-DRUG-85 Tesamorelin (Egrifta®): This document addresses the use of tesamorelin (Egrifta®), a novel growth hormone-releasing factor used to reduce excess central fat accumulation in human immunodeficiency virus (HIV)–associated lipodystrophy.
o Converted from DRUG.00045 o Prior authorization review will be managed by AIM effective July 1, 2018

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. • CG-MED-67 Melanoma Vaccines: This document addresses the use of vaccines as a type of immunotherapy in the treatment of advanced melanoma. This document does not address the prophylactic use of vaccines in the prevention of cancer.
o Converted from MED.00083 o Prior authorization review will be managed by AIM effective July 1, 2018

• CG-THER-RAD-03 Radioimmunotherapy and Somatostatin Receptor Targeted Radiotherapy: This document addresses radioimmunotherapy, which is a systemic therapy that involves a targeting monoclonal antibody that is combined to a radiation emitting radionuclide to treat certain types of cancer.
o Converted from Medical Policy THER-RAD.00005
o Includes ibritumomab tiuxetan (Zevalin) as a radioimmunotherapy to treat certain types of CD20-positive (CD20+) non-Hodgkin’s Lymphoma (NHL) o Prior authorization review will be managed by AIM effective July 1, 2018

• DRUG.00074 Alemtuzumab (Lemtrada®): This document addresses the use of alemtuzumab (Lemtrada) which is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) and is used for the treatment of multiple sclerosis (MS). o Clarified alemtuzumab is Medically Necessary as single agent treatment of relapsing-remitting multiple sclerosis o Added combination treatment to Investigational & Not Medically Necessary criteria

• GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome: This document addresses genetic testing for individuals who are at higher than average risk for the development of breast and/or ovarian cancer.
o Revised Medically Necessary criteria to indicate BRCA1/BRCA2 testing is no longer required prior to BART o Revised age limit criteria from “prior to age 50” to “age 45 years or less” in Medically Necessary statements addressing:
− BRCA1/2 and BART testing for individuals with a personal history of breast cancer − BRCA1/2 and BART testing for individuals with a family (no personal) history of breast cancer but with a first- or second-degree relative with breast cancer
o Added additional criteria for individuals belonging to a population at risk for specific mutations due to ethnic or racial background
o Added Medically Necessary criteria for individuals with history of relapsed/refractory HER2 negative, metastatic breast cancer previously treated with chemotherapy and is a candidate for PARP inhibitor therapy o Updated formatting

• GENE.00035 Genetic Testing for TP53 Mutations: This document addresses genetic testing for TP53 mutations.
o Added the subtitles Germline testing for cancer susceptibility and Somatic tumor testing
o Added the diagnosis of rhabdomyosarcoma of embryonal anaplastic subtype to Medically Necessary statement for germline testing for cancer susceptibility o Revised age criteria from "The individual was diagnosed with early onset breast cancer at age 35 years or younger with a negative BRCA1/BRCA2 test" to "The individual was diagnosed with early onset breast cancer at age 30 years or younger"
o Removed genetic counseling requirement for somatic tumor testing

• MED.00124 Tisagenlecleucel (Kymriah™): This document addresses uses of tisagenlecleucel (Kymriah™), an autologous chimeric antigen receptor (CAR) T-cell immunotherapy that targets the CD19 surface antigen expressed in B cell malignancies. o Added "Note" in the position statement re: black box warning of administration at a designated treatment center that has received certification

• SURG.00112 Occipital Nerve and Supraorbital Nerve Stimulation: This document addresses occipital nerve and supraorbital nerve stimulation, which involves the implantation of a permanent device to delivering small electrical impulses to the occipital or supraorbital nerves.
o Revised title (previous title: Occipital Nerve Stimulation) o Added Investigational & Not Medically Necessary statement for supraorbital nerve stimulation

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

MP Number Title CG Number DME.00012 Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation CG-DME-43

DRUG.00009 Growth Hormone CG-DRUG-83 DRUG.00017 Hyaluronan Injections in Joints Other Than the Knee CG-DRUG-29 DRUG.00044 Belimumab (Benlysta®) CG-DRUG-84 DRUG.00045 Tesamorelin (Egrifta®) CG-DRUG-85 DRUG.00054 Ocriplasmin (Jetrea®) Intravitreal Injection Treatment CG-DRUG-86 DRUG.00068 Vedolizumab (Entyvio®) CG-DRUG-87 DRUG.00094 Dupilumab (Dupixent®) CG-DRUG-88 SURG.00046 Gastric Electrical Stimulation CG-SURG-70 SURG.00086 Reduction Mammaplasty CG-SURG-71 SURG.00108 Endothelial Keratoplasty CG-SURG-72 THER-RAD.00005 Radioimmunotherapy and Somatostatin Receptor Targeted Radiotherapy *effective July 1, 2018 CG-THER-RAD-03 THER-RAD.00006 Selective Internal Radiation Therapy (SIRT) of Primary or Metastatic Liver Tumors
CG-THER-RAD-04

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

MP Number Title CG Number CG-DME-01 External (Portable) Continuous Insulin Infusion Pumps CG-DME-42 CG-DME-38 Continuous Interstitial Glucose Monitoring CG-DME-42 DME.00040 Automated Insulin Delivery Devices CG-DME-42 DRUG.00004 Prostacyclin Infusion Therapy and Inhalation Therapy for Treatment of Pulmonary Arterial Hypertension CG-DRUG-82

Medical Policies and Clinical Guidelines being archived and replaced by AIM Specialty Health Radiology Imaging Guidelines effective July 1, 2018

MP Number Title CG-THER-RAD-01 Fractionation and Radiation Therapy in the Treatment of Specified Cancers CG-THER-RAD-02 Special Radiation Physics Consult and Treatment Procedure THER-RAD.00001 Brachytherapy for Oncologic Indications THER-RAD.00004 External Beam Intraoperative Radiation Therapy
THER-RAD.00007 Intensity Modulated Radiation Therapy (IMRT)
THER-RAD.00010 Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiotherapy (SBRT) THER-RAD.00011 Image-guided Radiation Therapy (IGRT) with External Beam Radiation Therapy (EBRT)

Ordering and servicing providers may submit prior authorization requests to AIM in one of several ways: • Access AIM’s ProviderPortalSM directly at providerportal.com. Online access is available 24/7 to process orders in real-time, and is the fastest and most convenient way to request authorization. • Access AIM via the Availity Web Portal at availity.com • Call the AIM Contact Center toll-free number: 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 to access and download a copy of the current guidelines at http://www.aimspecialtyhealth.com/PDF/Guidelines/2018/Jan01/AIM_Guidelines_RadiationOncology.pdf.

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. AIM Update

Anthem recently discovered that some specialty pharmacy and oncology services that require prior authorization through AIM have not been configured correctly in our claims systems. This may have led to incorrect processing and claims payments. We are notifying you that as of May 1, 2018, our claims systems will be updated to correctly process claims for specialty pharmacy and oncology drugs which continue to require prior authorization through AIM. For information on the codes that require prior authorization, please go to AIM’s Provider Portal at https://www/providerportal.com.

Delay in launch of new musculoskeletal program until May 1, 2018

On December 1, 2017, Anthem mailed notices to its participating providers announcing AIM would perform prior authorization reviews of certain surgeries of the spine and joints, as well as interventional pain treatment to determine medical necessity for local fully insured Anthem members beginning with dates of service on and after March 1, 2018. Please be aware that this program has been delayed. We anticipate the new implementation date will be for requests received on and after May 1, 2018.

The new musculoskeletal program will include review of the level of care/setting, pre-operative days, and expected length of stay for medical necessity using AIM clinical guidelines which have been adopted by Anthem.
All codes and clinical guidelines included in the musculoskeletal program can be found on the AIM MSK website at http://www/aimprovider.com/msk.

If there are any additional delays to this program, we will publish notification to providers in a future Network Update.

AIM Imaging level of care program expands to include local self-funded benefit plans effective July 1, 2018

Effective with dates of service on and after July 1, 2018, Anthem will offer local self-funded benefit plans in California the opportunity to add a medical necessity review of the requested level of care for non-emergent, outpatient, computed tomography (CT) imaging, magnetic resonance imaging (MRI), and magnetic resonance angiogram (MRA). The following clinical guideline will apply: Level of Care: Advanced Radiology Imaging, CG-MED-55. The clinical review will be administered by AIM.

AIM will evaluate the clinical criteria to determine if the non-emergent imaging service requires a hospital-based outpatient setting, which offers a higher intensity of resources, or if a free standing imaging center is a clinically appropriate and available alternative. For additional information, please visit the AIM Radiology website at http://aimproviders.com/radiology/.

There may be circumstances where a member’s clinical situation requires that he or she receive an MRI or CT scan in a hospital facility. Based on the information you provide, AIM reviews both the requested advanced imaging scan for clinical appropriateness and the level of care against health plan clinical criteria. The level of care review does not apply to requests for review of imaging as part of an inpatient stay or when Anthem is the secondary payer.

Please submit prior authorization requests to AIM in one of the following ways: • Access AIM ProviderPortal℠ 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. Please note, this program already applies to local fully insured Anthem members in California with imaging services medically managed by AIM. It does not apply to HMO, BlueCard® or the Federal Employee Program® (FEP®).

For questions regarding level of care reviews, please contact the provider service number on the back of the member ID card.

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. Clinical Guidelines archived February 28, 2018:

• GENE.00022 In Vitro Companion Diagnostic Devices • GENE.00027 Combined PALB2 and BRCA2 Mutation Testing for Oncologic Indications

Anthem’s 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 approximately every other month (6 times a year) 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’s Web site at http://www.anthem.com/ca. Go to > Menu > Support > Providers. Scroll down and click on the box Read Policies. Select “Medical Policies and Clinical UM Guidelines (for Local Plan members)”, then click “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,

Jacob Asher, MD Vice President and 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. The Blue Cross name and symbol are registered marks of the Blue Cross Association. Attachme nt A – 1st Medical Policy and Technology Assessme nt Committee 2018 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes ADMIN.00001 Medical Policy Formation • Updated statements concerning MPTAC and subspecialty committee voting membership • Clarified non-voting members may include internal medical directors • Added information regarding third party criteria subcommittee • Revised text related to topics brought to interim meetings CG-DME-31 Wheeled Mobility Devices: Wheelchairs–Powered, Motorized, With or Without Power Seating Systems and Power Operated Vehicles (POVs) • Clarified the medically necessary criteria for Group 1 or Group 2 standard powered/motorized wheelchair without power options, changing the conjunction from “and” to “or” after criteria CG-DRUG-29 Hyaluronan Injections • Revised title (previous title: Hyaluronan Injections in the Knee) • Rescoped; moved content from DRUG.00017 Hyaluronan Injections in Joints Other Than the Knee to Not Medically Necessary statement to include all joints • Added "thumb" as an example of joint considered Not Medically Necessary CG-DRUG-50 Paclitaxel, protein bound (Abraxane®) • Added Medically Necessary criteria for single agent use of protein-bound paclitaxel in uterine/endometrial cancer when criteria are met • Clarified Medically Necessary statements for use of protein- bound paclitaxel in the treatment of breast cancer, non-small cell lung cancer, ovarian cancer and uterine/ endometrial cancer in individuals with confirmed taxane hypersensitivity CG-DRUG-64 FDA-Approved Biosimilar Products • Added trastuzumab-dkst (Ogivri), biosimilar Herceptin CG- DRUG-73 Denosumab (Prolia®, Xgeva®) • Added multiple myeloma to the Medically Necessary statement for use of denosumab (Xgeva) when used for the prevention of skeletal-related events when criteria are met • Revised Prolia Medically Necessary statement to include use in postmenopausal women receiving adjuvant aromatase inhibitor therapy for the treatment of breast cancer • Updated Not Medically Necessary statement CG-DRUG-78 Antihemophilic Factors and Clotting Factors • Added Medically Necessary statement for use of emicizuma b-kxwh (Hemlibra) for treatment of hemophilia A when criteria are met • Added Not Medically Necessary statement for emicizumab • Added Appendix CG-DRUG-82 Prostacyclin Infusion Therapy and Inhalation Therapy for Treatment of Pulmonary Arterial Hypertension • Content moved from DRUG.00004 Prostacyclin Infusion Therapy and Inhalation Therapy for Treatment of Pulmonary Arterial Hypertension • Revised the diagnostic criteria for adult and pediatric PAH consistent with updated specialty society guideline recommendations

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. CG-SURG-33 Lumbar Fusion and Lumbar Total Disc Arthroplasty • Revised title (previous title: Lumbar Fusion and Lumbar Total Disc Arthroplasty [TDA]) • Revised osteopenia or osteoporosis contraindication criteria for lumbar TDA to delete reference to DEXA T scores and to indicate, “Bone density that does not meet the minimum level specified for the implanted device”
• Added information for when DEXA scanning is indicated • Added an Appendix which provides device specific definitions of inadequate bone density DEXA T scores for each FDA DME.00012 Intrapulmonary Percussive Ventilation Devices for Airway Clearance • Revised title (previous title: Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation) • Moved criteria for high frequency chest compression devices to new clinical UM guideline CG-DME-43 High Frequency Chest Compression Devices for Airway Clearance DRUG.00031 Subcutaneous Hormone Replacement Implants • Revised Medically Necessary criteria for symptomatic hypogonadism (primary or secondary) to include examples of primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired)
• Added the term “Gender Incongruence” to the Clinical Indications section for treatment in gender reassignment • Updated formatting DRUG.00046 Ipilimumab (Yervoy®) • Added Medically Necessary statement for use in combination with nivolumab therapy for small cell lung cancer when criteria are met
• Added non-small cell lung cancer to Investigational & Not Medically Necessary statement DRUG.00075 Nivolumab (Opdivo®) • Clarified Medically Necessary use of nivolumab as a single agent for resected advanced melanoma for adjuvant therapy
• Added Medically Necessary statement for use as a single agent or in combination with ipilimumab for small cell lung cancer when criteria are met DRUG.00077 Monoclonal Antibodies to Interleukin-17A • Added Medically Necessary statement for use of ixekizumab in active psoriatic arthritis in adults when criteria are met • Updated Investigational & Not Medically Necessary statement DRUG.00080 Monoclonal Antibodies for the Treatment of Eosinophilic Conditions • Revised title and scope (previous title: Monoclonal Antibodies for the Treatment of Eosinophilic Asthma) • Added benralizumab (Fasenra) to Medically Necessary statements for initial use and continuation therapy in eosinophilic asthma when criteria are met • Added Medically Necessary statements for initial use and continuation therapy with mepolizumab in eosinophilic granulomatosis with polyangiitis when criteria are met • Reformatted the Medically Necessary criteria statement for continuation therapy for reslizumab and mepolizumab in eosinophilic asthma
• Reformatted position statements • Updated Investigational & Not Medically Necessary statements DRUG.00082 Daratumumab (DARZALEX™) • Added Medically Necessary criteria for use in combination with melphalan, prednisone and a proteasome inhibitor (PI) (for example, bortezomib) for newly diagnosed multiple myeloma when criteria are met • Updated Investigational & Not Medically Necessary statements

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.00099 Cerliponase Alfa (Brineura™) • Clarified Medically Necessary statement requiring the diagnosis to be confirmed
• Added criteria that there is no documentation of device-related complications GENE.00009 Gene-Based Tests for Screening, Detection and Management of Prostate Cancer • Added new CPT 0011M effective 01/01/2018 as considered Investigational & Not Medically Necessary GENE.00010 Genotype Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status • Added ICD-10-CM diagnosis codes for bipolar disorders, neuralgia, peripheral neuropathy, neuropathic pain to pend for review for code 81381 HLA single allele GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility • Revised Medically Necessary criteria for genetic testing for Lynch syndrome to separately address when information that may guide targeted testing is (1) available and (2) unavailable
• Deleted separate criteria that requires negative MSH2 testing prior to EPCAM testing • Added Appendix MED.00100 Diaphragmatic/Phrenic Nerve Stimulation and Diaphragm Pacing Systems • Added central sleep apnea to Investigational & Not Medically Necessary statement MED.00123 Axicabtagene ciloleucel (Yescarta™) • Added "Note" in the position statement regarding black box warning of administration at a designated treatment center that has received certification SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Revised Medically Necessary criteria for the sheet or membrane form of EpiFix
• Revised Medically Necessary criteria for Integra Bilayer Matrix Wound Dressing • Added Medically Necessary statements for Biobrane, DermACELL, DermaMatrix, EZ Derm, Oasis, PriMatrix, Strattice, and the sheet or membrane form of GraftJacket • Deleted TransCyte from policy • Updated Investigational & Not Medically Necessary statements SURG.00098 Mechanical Embolectomy for Treatment of Acute Stroke • Added Medically Necessary criteria for individuals who were last known to be well 6 to 24 hours earlier • Updated formatting SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Added clarification note to Medically Necessary statement that FDA approved VADs are appropriate for pediatrics, specifically Heartmate 3 Left Ventricular Assist System