MP/CG Update/Notice - June 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.

June 1, 2018

[Provider 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.

NOTE: The expanded Specialty Pharmacy drug, Imaging and Radiology Oncology program(s) in italics below apply to local 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 September 1, 2018

• CG-SURG-73 Balloon Sinus Ostial Dilation: This document addresses the use of balloon sinus ostial dilation for surgery of the sinuses, including for the treatment of sinusitis. o Content for balloon sinus ostial dilation moved from SURG.00089 Balloon and Self-Expanding Absorptive Sinus Ostial Dilation

• DRUG.00098 Lutetium Lu 177 dotatate (Lutathera®): This document addresses the use of lutetium Lu 177 dotatate (Lutathera), a therapeutic radiopharmaceutical agent for the treatment of gastroenteropancreatic neuroendocrine tumors and other indications.

• MED.00120 Voretigene neparvovec (Luxturna™): This document addresses the use of voretigene neparvovec-rzyl (Luxturna™), a gene replacement therapy intended to treat retinal dystrophies caused by biallelic RPE65 gene mutations.

• SURG.00151 Balloon Dilation of Eustachian Tube: This document addresses the use of balloon dilation of the Eustachian tubes, also known as balloon dilatation Eustachian tuboplasty. o Use of balloon dilation of the eustachian tubes is considered Investigational & Not Medically Necessary for all situations

UPDATED Medical Policies and Clinical Guidelines effective September 1, 2018

• CG-DME-06 Pneumatic Compression Devices for Lymphedema: This document addresses the use of pneumatic compression devices for the treatment of lymphedema. o Added "head or neck" pneumatic compression garments to the Not Medically Necessary statement

• CG-DRUG-44 Pegloticase (Krystexxa®): This document addresses pegloticase (Krystexxa), a pegylated biosynthetic (recombinant DNA) uric acid specific enzyme (urate oxidase/uricase) used in adults with chronic, treatment-refractory gout. o Prior authorization review will be managed by AIM

• CG-DRUG-89 Implantable and Extended-Release Buprenorphine-Containing Products: This document addresses the use of implantable and extended-release products containing buprenorphine, including Probuphine and Sublocade, both of which are used to treat opioid dependence and substance abuse disorder. o Content moved from DRUG.00092 Buprenorphine Implant (Probuphine®)
o Title revised o Removed brand names for Probuphine, Subutex and Suboxone from clinical indications statements o Added new HCPCS codes Q9991, Q9992 for Sublocade

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 Expanded scope to include Medically Necessary and Not Medically Necessary statements for extended- release buprenorphine-containing products o Prior authorization review will be managed by AIM

• CG-MED-23 Home Health: This document addresses home health care and the conditions under which it would be considered medically necessary.
o Added "Note" in description to indicate this document does not address home health care for mental health conditions o Removed references to licensed mental health professionals from clinical indications
o Updated formatting

• CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities: This document addresses the use of peripheral vascular angioplasty, with and without stenting, and with or without atherectomy, for the treatment of occlusive peripheral arterial disease (PAD) of the lower extremities.
o Added Medically Necessary criteria for the use of primary stent placement for stenosis or occlusion of intermediate-length lesions of the femoropopliteal artery o Added Medically Necessary statement for use of covered stent devices for claudication due to aortoiliac occlusive disease (AIOD) when criteria are met o Updated Not Medically Necessary statement

• DRUG.00003 Chelation Therapy: This document addresses the uses of chelation therapy. o Removed "or clinical findings (that is, symptoms consistent with metal toxicity)" from Medically Necessary statement for metal poisoning confirmed through lab results

• DRUG.00050 Eculizumab (Soliris®): This document addresses the use of eculizumab in the treatment of individuals with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis, and other conditions. o Revised Medically Necessary criteria for continuation of treatment in aHUS, adding criteria for use until an individual becomes a candidate for physician-directed cessation o Added Medically Necessary criteria and a Note for resumption of eculizumab when relapse occurs following discontinuation of therapy for aHUS.

• RAD.00038 Use of 3-D, 4-D or 5-D Ultrasound in Maternity Care: This document addresses the use of three-dimensional (3-D), four-dimensional (4-D) and five-dimensional (5-D) fetal ultrasound in maternity care and does not apply to ultrasound performed for non-pregnancy related conditions. o Revised title (old title: Use of 3-D and 4-D Ultrasound in Maternity Care) o Added 5-D ultrasound to the Investigational & Not Medically Necessary statement

• SURG.00037 Treatment of Varicose Veins (Lower Extremities): This document addresses various modalities for the treatment of valvular incompetence (reflux) of the great saphenous vein (GSV) or small saphenous vein (SSV) (also known as greater saphenous vein or lesser saphenous vein, respectively) and associated varicose tributaries as well as telangiectatic dermal veins.
o Added Investigational & Not Medically Necessary statement for cyanoacrylate adhesion as treatment of venous reflux o Updated formatting

• SURG.00132 Drug-Eluting Devices for Maintaining Sinus Ostial Patency: This document addresses drug-eluting devices placed within the sinuses for the purpose of maintaining sinus ostial patency following functional endoscopic sinus surgery (FESS) or the treatment of nasal polyps (for example, Propel®-brand Mometasone Furoate Implants and SINUVA™). o Revised title (previous title: Devices for Maintaining Sinus Ostial Patency Following Sinus Surgery) o Rescoped to address “drug-eluting” devices only
o Removed scope limitation of post-sinus surgery treatment only o Added to Investigational & Not Medically Necessary statement use for the treatment of nasal polyps

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 New Clinical Guidelines (No changes to clinical indications) effective June 28, 2018

MP Number Title CG Number BEH.00004 Activity Therapy for Autism Spectrum Disorders and Rett Syndrome CG-BEH-15 DME.00035 Electric Tumor Treatment Field (TTF) CG-DME-44 DRUG.00028 Intravitreal Treatment for Retinal Vascular Conditions CG-DRUG-90 DRUG.00032 Intravitreal Corticosteroid Implants CG-DRUG-91 DRUG.00036 Cetuximab (Erbitux®) CG-DRUG-67 DRUG.00041 Rituximab (Rituxan®) for Non-Oncologic Indications CG-DRUG-94 DRUG.00049 Belatacept (Nulojix®) CG-DRUG-95 DRUG.00056 Ado-trastuzumab emtansine (Kadcyla®) CG-DRUG-96 DRUG.00072 Alpha-1 Proteinase Inhibitor Therapy CG-DRUG-92 DRUG.00073 Rilonacept (Arcalyst®) CG-DRUG-97 DRUG.00079 Bendamustine Hydrochloride CG-DRUG-98 DRUG.00083 Elotuzumab (Empliciti™) CG-DRUG-99 DRUG.00084 Interferon gamma-1b (Actimmune®) CG-DRUG-100 DRUG.00085 Ixabepilone (Ixempra®) CG-DRUG-101 DRUG.00097 Olaratumab (Lartruvo™) CG-DRUG-102 DRUG.00101 Sarilumab (Kevzara®) CG-DRUG-93 LAB.00020 Skin Nerve Fiber Density Testing CG-LAB-13 MED.00026 Hyperthermia for Cancer Therapy CG-MED-72 MED.00076 Inhaled Nitric Oxide CG-MED-69 RAD.00011 Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Embolization (TAE) for Treating Primary or Metastatic Liver Tumors CG-SURG-80 RAD.00030 Wireless Capsule Endoscopy for Gastrointestinal Imaging and the Patency Capsule CG-MED-70 SURG.00001 Carotid, Vertebral and Intracranial Artery Stent Placement with or without Angioplasty CG-SURG-76

SURG.00009 Refractive Surgery CG-SURG-77 SURG.00065 Locally Ablative Techniques for Treating Primary and Metastatic Liver Malignancies CG-SRUG-78 SURG.00068 Implantable Infusion Pumps CG-SURG-79 SURG.00081 Total Ankle Replacement CG-SURG-74 SURG.00110 Transanal Endoscopic Microsurgical (TEM) Excision of Rectal Lesions CG-SURG-75 THER-RAD.00003 Intravascular Brachytherapy (Coronary and Non-Coronary) CG-THER-RAD-07

Effective for dates of service on and after September 1, 2018, the following specialty pharmacy codes from current Medical Policies and Clinical Guidelines will be included in our existing Specialty Pharmacy Clinical Site of Care Review process (CG-DRUG-47 Level of Care: Specialty Pharmaceuticals). Prior authorization review of these specialty pharmacy drugs will be managed by AIM.

View the Clinical Site of Care drug list at http://www.aimproviders.com/specialtyrx/pdf/ClinicalSiteofCareDrugList.pdf and Clinical Site of Care pre-service clinical review FAQs at http://www.aimproviders.com/specialtyrx/FAQ.html for more information.

Medical Policy or Clinical Guideline Drug Code CG-DRUG-05 Mircera (non-ESRD) (epoetin beta) J0888 CG-DRUG-09 Cuvitru (immune globulin) J1555 CG-DRUG-16 Zarxio (filgrastim-sndz) Q5101 CG-DRUG-44 Krystexxa (Pegloticase) J2507 CG-DRUG-61 Supprelin LA (histrelin acetate) J9226 CG-DRUG-69 Stelara IV (ustekinumab) J3358

CG-DRUG-78 Fibryna (fibrinogen, human) Rebinyn (recombinant glycopegylated factor IX) J7178 J7195

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.00027 Prialt (ziconotide) J2278 DRUG.00081 Exondys 51 (eteplirsen) J1428 DRUG.00093 Kanuma (sebelipase alfa) J2840 DRUG.00095 Ocrevus (ocrelizumab) J2350

Medical Policies and Clinical Guidelines being archived

Number Title Archive Date BEH.00001
Opioid Antagonists Under Heavy Sedation or General Anesthesia as a Technique of Opioid Detoxification 10/31/2018 CG-BEH-03 Psychiatric Disorder Treatment 10/31/2018 CG-BEH-04
Substance-Related and Addictive Disorder Treatment
10/31/2018 CG-BEH-05 Eating and Feeding Disorder Treatment
10/31/2018 CG-BEH-07 Psychological Testing
10/31/2018 CG-BEH-09 Assertive Community Treatment
10/31/2018 CG-BEH-10 Basic Skills Training/Social Skills Training
10/31/2018 CG-BEH-11 Mental Health Support Services
10/31/2018 CG-BEH-12 Psychosocial Rehabilitation Services
10/31/2018 CG-BEH-13 Targeted Case Management
10/31/2018 CG-MED-22 Neuropsychological Testing 10/31/2018 CG-MED-23 Home Health 10/31/2018

Effective with dates of service on and after October 31, 2018, Anthem will begin using MCG Care Guidelines 22nd edition Behavioral Health guidelines for the review of behavioral health services. This represents a change from the behavioral health medical policies and clinical guidelines currently used.

Please note that the following behavioral health (BEH) medical policies and clinical guidelines will be retained at this time: • BEH.00002 Transcranial Magnetic Stimulation • BEH.00004 Activity Therapy for Autism Spectrum Disorders and Rett Syndrome • CG-BEH-01 Screening and Assessment for Autism Spectrum Disorders and Rett Syndrome • CG-BEH-02 Adaptive Behavioral Treatment for Autism Spectrum Disorder • CG-BEH-14 Intensive In-Home Behavioral Health Services

Anthem may continue to use additional medical policies and clinical guidelines to supplement MCG Care Guidelines.

Anthem’s medical policies and clinical guidelines:
(https://www.anthem.com/wps/portal/ca/provider?content_path=provider/f1/s1/t1/pw_b147993.htm&label= Medical%20Policy,%20Clinical%20UM%20Guidelines,%20and%20Pre-Certification%20Requirements)

Customizations to MCG Care Guidelines 22nd edition: (https://www11.anthem.com/ca/provider/f1/s0/t0/pw_g333816.pdf?refer=culdesac&name=onlinepolicies) .
This change impacts Anthem’s Commercial health plans. Providers should continue to call the phone number indicated on the back of the member ID card to request prior authorization review or for additional questions regarding behavioral health benefits.

Update to AIM Clinical Appropriateness Guidelines

Beginning with dates of service on and after July 1, 2018, the following updates will apply to AIM Musculoskeletal Program Clinical Appropriateness Guidelines:

Spine Surgery guideline:
• Cervical decompression with or without fusion: o Added osteotomy and corpectomy definitions
o Clarified implant/instrumentation failure
• Lumbar fusion and treatment of spinal deformity (including scoliosis and kyphosis)

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 Added osteotomy and corpectomy definitions
• Spinal Stenosis
o Removed bilateral or wide decompression

Interventional Pain Management guideline:
• Epidural injection procedures and diagnostic selective nerve root blocks
o Added preauthorization exemption for CPT codes 62320 and 62322 when used for post-procedural pain with certain ICD-10-CM diagnoses • Repeat therapeutic epidural steroid injections, clarified initial injection as therapeutic
o Clarified injection sessions for procedural requirements • Paravertebral facet injection/nerve block/neurolysis
o Increased procedural limitation for diagnostic medial branch blocks
o Increased procedural limitation for therapeutic intraarticular facet joint injections and clarified requirement for conservative treatment between injections • Sacroiliac joint injections:
o Added HCPCS code G0260

Ordering and servicing providers may submit prior authorization requests to AIM in one of the following ways: • Access AIM 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 access and download a copy of the current guidelines at http://www.aimspecialtyhealth.com/marketing/guidelines/185/index.html.

This update applies to local fully-insured Anthem, with services medically managed by AIM. It does not apply to BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, Federal Employee Program® (FEP®), members who are covered under a self-insured (ASO) benefit plan. For more information, please contact the phone number of the back of the member 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 select “Menu” in the upper left corner, select “Providers” under Partners in Health, scroll down to select “Read Policies”, then click “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 – 2nd and 3rd Meeting 2018 Updates Revised Medical Policy and Clinical Guidelines

Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-ANC-05 Ambulance Services: Ground, Emergent • Clarifications to Medically Necessary and Not Medically Necessary statements regarding mileage CG-DRUG-05 Recombinant Erythropoietin Products • Added new section addressing Clinically Equivalent Cost Effective Agents (CECEA) CG-DRUG-09 Immune Globulin (Ig) Therapy • Clarified Not Medically Necessary statement to specifically address pediatric autoimmune neuropsychiatric disorder associated with group A streptococci (PANDAS) • Updated CECEA section CG-DRUG-16 White Blood Cell Growth Factors • Added new section addressing Clinically Equivalent Cost Effective Agents (CECEA) • Descriptor revision for HCPCS code Q5101 CG-DRUG-29 Hyaluronan Injections • Added new HCPCS outpatient facility code C9465 for Durolane CG-DRUG-50 Paclitaxel, protein bound (Abraxane®) • Revised Medically Necessary criteria for recurrent, metastatic or high-risk uterine/endometrial cancer • Added the treatment of solid tumors as Medically Necessary
when criteria are met • Clarified Medically Necessary criteria for Breast Cancer, non- small cell lung cancer (NSCLC) and Ovarian Cancer CG-DRUG-62 Fulvestrant (FASLODEX®) • Added combination use with abemaciclib as Medically Necessary for breast cancer when criteria are met CG-DRUG-64 FDA Approved Biosimilar Products • Updated HCPCS codes from Q5102 to Q5103 for Inflectra and Q5104 for Renflexis • Added biosimilar to descriptor for Q5101 CG-DRUG-65 Tumor Necrosis Factor Antagonists • Updated HCPCS codes from Q5102 to Q5103 for Inflectra and Q5104 for Renflexis CG-DRUG-73 Denosumab (Prolia®, Xgeva®) • Clarified Medically Necessary statement for Xgeva when used for the prevention of skeletal-related events • Reformatted MN criteria CG-DRUG-78 Antihemophilic Factor and Clotting Factors • Added new HCPCS outpatient facility code C9468 effective 04/01/18 for Rebinyn • Expanded use of Vonvendi in von Willebrand disease to include peri-procedural management for surgical, invasive or interventional radiology procedures • Added new section addressing Clinically Equivalent Cost Effective Agents (CECEA) CG-LAB-11 Screening for Vitamin D Deficiency in Average Risk Individuals • Added new CPT PLA code 0038U for Sensieva™ Vitamin D Assay CG-SURG-27 Sex Reassignment Surgery • Clarified mastectomy criteria to indicate that the individual is a female desiring gender transition
• Clarified COS indications
• Updated formatting DME.00009 Vacuum Assisted Wound Therapy in the Outpatient Setting • Removed from Medically Necessary statement age criteria of 12 years of age or older

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. DME.00012 Intrapulmonary Percussive Ventilation Devices for Airway Clearance • April 1, 2018 update letter clarification: Content for high frequency chest compression devices only moved to CG-DME- 43 effective May 1, 2018 • Title updated from Oscillatory Devices for Airway Clearance including High Frequency Chest Compression and Intrapulmonary Percussive Ventilation DRUG.00046 Ipilimumab (Yervoy®) • Added the treatment of intermediate- or poor-risk, advanced renal cell carcinoma (RCC) in combination with nivolumab as Medically Necessary when criteria are met • Clarified Medically Necessary criteria addressing treatment of melanoma to include both cutaneous and uveal • Removed RCC from Investigational & Not Medically Necessary list DRUG.00047 Brentuximab Vedotin (Adcetris®) • Revised Medically Necessary criteria addressing Hodgkin lymphoma • Added previously untreated stage III or IV classical Hodgkin lymphoma, in combination with chemotherapy as Medically Necessary
• Expanded Medically Necessary criteria to include therapy as a single agent for relapsed or refractory Hodgkin lymphoma in a single line of therapy DRUG.00053 Carfilzomib (Kyprolis®) • Added primary treatment of multiple myeloma as Medically Necessary when criteria are met • Reformatted Medically Necessary criteria DRUG.00071 Pembrolizumab (Keytruda®) • Clarified Medically Necessary criteria addressing treatment of melanoma to include both cutaneous and uveal • Revised Medically Necessary criteria for nonsquamous NSCLC to include combination therapy with a platinum agent DRUG.00075 Nivolumab (Opdivo®) • Clarified Medically Necessary criteria addressing treatment of melanoma to include both cutaneous and uveal • Added the treatment of intermediate- or poor-risk, advanced renal cell carcinoma (RCC) in combination with ipilimumab as Medically Necessary when criteria are met DRUG.00076 Blinatumomab (Blincyto®) • Added minimal residual disease greater than or equal to 0.1%, following a first or second complete response to induction therapy to Medically Necessary criteria DRUG.00078 Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors • Added coronary artery disease to the Medically Necessary criteria list for clinical Atherosclerotic Cardiovascular Disease • Removed "presumed to be of atherosclerotic origin" from Medically Necessary criteria for peripheral arterial disease DRUG.00080 Monoclonal Antibodies for the Treatment of Eosinophilic Conditions • Added new HCPCS outpatient facility code C9466 for benralizumab (Fasenra) DRUG.00104 Nusinersen (SPINRAZA®) • Revised title (changed ™ to ®) • Revised Note addressing Dosing DRUG.00108 Edaravone (Radicava ®) • Changed ™ to ® DRUG.00111 Monoclonal Antibodies to Interleukin-23 • Revised title (previous title: Guselkumab [Tremfya™]) • Expanded scope of policy to include both FDA-approved anti- interleukin-23 monoclonal antibodies developed for use in adults for the treatment and maintenance of moderate to severe plaque psoriasis • Added tildrakizumab-asmn (Ilumya™) to Medically Necessary, Not Medically Necessary and 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. GENE.00006 Epidermal Growth Factor Receptor (EGFR) Testing • Added codes 88271, 88275 (FISH techniques) to be reviewed based on diagnosis codes to determine procedure used GENE.00012 Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent • Removed the genetic counseling requirement for cystic fibrosis and spinal muscle atrophy • Added a note stating “Genetic counseling should be a component of a decision to perform genetic testing” in position statement GENE.00025 Molecular Profiling and Proteogenomic Testing for the Evaluation of Malignant Tumors • Added CPT PLA codes 0036U, 0037U (EXaCT-1 Whole Exome and FoundationOne CDx™ tests; considered Investigational & Not Medically Necessary GENE.00026 Cell-Free Fetal DNA-Based Prenatal Testing • Removed the genetic counseling requirement for fetal aneuploidy and fetal sex determination • Added a note stating “Genetic counseling should be a component of a decision to perform genetic testing” in position statement GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility • Added additional Medically Necessary criteria to selected statements for genetic testing for Lynch syndrome to include individuals with a personal or family history of endometrial cancer when criteria are met
• Added Medically Necessary statement for genetic testing for Lynch syndrome when the individual for whom the test is requested, has a first-degree relative with colorectal cancer or endometrial cancer diagnosed prior to age 50 • Added Medically Necessary criteria for genetic testing for Lynch syndrome in individuals with a "history of" or "first- degree relative with" synchronous or metachronous tumors • Added Amsterdam II and revised Bethesda criteria to Medically Necessary statement • Deleted Appendix with Amsterdam II and revised Bethesda criteria GENE.00041 Genetic Testing to Confirm the Identity of Laboratory Specimens • Descriptor revision for CPT PLA code 0020U LAB.00011 Analysis of Proteomic Patterns • Added CPT MAAA codes 0012M, 0013M (CxBladder tests; considered Investigational & Not Medically Necessary) MED.00005 Hyperbaric Oxygen Therapy (Systemic/Topical) • Procedure codes for HBOT will pend for additional ICD-10-CM diagnosis code L59.8
OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis • Added the individual has functional K-Level 3 or above to Medically Necessary criteria for use of a microprocessor controlled lower limb prosthesis RAD.00029 CT Colonography (Virtual Colonoscopy) for Colorectal Cancer • Added Medically Necessary statement for CT colonography surveillance beginning at an age appropriate for the specific high risk condition, at frequency every 3 years as an alternative to colonoscopy when criteria are met • Updated formatting SURG.00026 Deep Brain, Cortical, and Cerebellar Stimulation • Removed Medically Necessary criteria requiring failure of prior vagal nerve stimulation (VNS) treatment before cortical stimulation with the RNS System SURG.00032 Transcatheter Closure of Patent Foramen Ovale and Left Atrial Appendage for Stroke Prevention • Removed brand name from Medically Necessary criteria for transcatheter closure of patent foramen ovale SURG.00033 Cardioverter Defibrillators • Added Medically Necessary criteria for ICD therapy for cardiac sarcoidosis when criteria are met

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.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) and Snoring • Added new HCPCS outpatient facility code C9749 for repair of lateral nasal wall with implants SURG.00089 Self-Expanding Absorptive Sinus Ostial Dilation • Revised title (previous title: Balloon and Self-Expanding Absorptive Sinus Ostial Dilation • Rescoped to address self-expanding absorptive sinus ostial dilation only; content addressing balloon sinus ostial dilation moved to CG-SURG-73 Balloon Sinus Ostial Dilation • No change to Investigational & Not Medically Necessary statement for self-expanding absorptive sinus ostial dilation SURG.00098 Mechanical Embolectomy for Treatment of Acute Stroke • Added criteria set for individuals last known to be well 6 to 16 hours earlier when criteria are met SURG.00121 Transcatheter Heart Valve Procedures • Removed criteria from Medically Necessary statement for TAVR devices re “individual was offered surgery but refused”