MP/CG Update/Notice - March 2019 Form

Blue Cross Of California Commercial Clinical Policy

Effective Date

Last Reviewed

Original Document

March 1, 2019

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

Dear Provider:

Anthem Blue Cross (Anthem) is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines. Please refer to the specific policy for coding, language, and rationale updates and changes that are not summarized below.

NEW Medical Policy effective June 1, 2019

• LAB.00036 Multiplex Autoantigen Microarray Testing for Systemic Lupus Erythematosus: This document addresses multiplex autoantigen microarray testing for evaluation of systemic lupus erythematosus (SLE), a chronic autoimmune disease.
o Multiplex autoantigen microarray testing to screen for, diagnose, or manage systemic lupus erythematous is considered Investigational and Not Medically Necessary

UPDATED Medical Policies and Clinical Guidelines effective June 1, 2019

• CG-TRANS-03 Donor Lymphocyte Infusion for Hematologic Malignancies after Allogeneic Hematopoietic Progenitor Cell Transplantation: This document addresses the use of donor lymphocyte infusions (DLI) after an allogeneic hematopoietic progenitor cell transplant to treat a hematologic malignancy (e.g., cancer of the blood or bone marrow, such as leukemia or lymphoma).
o Prior authorization will be required effective June 1, 2019

• MED.00110 Growth Factors, Silver-based Products and Autologous Tissues for Wound Treatment and Soft Tissue Grafting: This document addresses the use of recombinant human platelet-derived growth factor, antimicrobial silver wound dressings, autologous blood-derived wound products, platelet rich plasma (PRP), and bone marrow aspirate concentrate.
o Added bioengineered autologous skin-derived products (for example, SkinTE) as Investigational and Not Medically Necessary for all indications

• MED.00126 Fractional Exhaled Nitric Oxide and Exhaled Breath Condensate Measurements for Respiratory Disorders: This document addresses the measurement of exhaled nitric oxide and exhaled breath condensate for the diagnosis and monitoring of asthma and other respiratory disorders. o Added nasal nitric oxide as Investigational and Not Medically Necessary in the diagnosis and monitoring of asthma and other respiratory disorders

• SURG.00037 Treatment of Varicose Veins (Lower Extremities): This document addresses various modalities (listed below) 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 Replaced "non-surgical management" with "conservative therapy" in the Medically Necessary criteria o Added sclerotherapy used in conjunction with a balloon catheter (for example, KAVS procedure) as Investigational and Not Medically Necessary

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

MP Number Title CG Number SURG.00115 Keratoprosthesis CG-SURG-94 SURG.00117 Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation for Urinary and Fecal Incontinence; Urinary Retention CG-SURG-95 SURG.00136 Intraocular Telescope CG-SURG-96

Update regarding Specialty Pharmacy Clinical Site of Care claim processing

Anthem recently discovered that some specialty pharmacy claims requiring clinical site of care prior authorization through AIM Specialty Health® (AIM), a separate company, are processing despite the outcome of the prior authorization review for site of care or absent a prior authorization review for site of care. Effective June 1, 2019, our claim systems will be updated to correct this issue. It is important that coverage is provided for services in the approved site of care. If you need to request a change to the site of care previously approved please contact AIM at 1-877-291-0360, Monday–Friday, 7:00 a.m.–5:00 p.m. PT.

AIM program updates 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.

Clinical criteria updates for specialty pharmacy

On December 1, 2018, Anthem introduced the new clinical criteria page for injectable, infused or implanted drugs. Pre-service clinical review of these specialty pharmacy drugs is managed by AIM.

Effective for dates of service on and after March 1, 2019, the following new clinical criteria will be included in our clinical criteria review process. The drugs that require prior authorization will continue to require prior authorization notification with AIM.

Existing precertification requirements have not changed for the specific Clinical Criteria below. While there are no material changes, 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.

Clinical Guideline/ Medical Policy Clinical Criteria Clinical Criteria Title Drug(s) HCPCS or CPT Code(s) CG-DRUG-29 ING-CC-0006 Hyaluronan Injections Durolane, Euflexxa, Gel-One, Gen- Syn, GenVisc, Hyalgan, Hymovis, Monovisc, Orthovisc, Supartz/FX, Synvisc/-One, TriVisc, Visco-3 J7318, J7320 , J7321, J7322, J7323, J7324, J7325, J7326, J7327, J7328, J7329 DRUG.00015 ING-CC-0007 Synagis (palivizumab) Synagis 90378 DRUG.0031 ING-CC-0008 Testopel (testosterone subcutaneous implant) Testosterone implant S0189 DRUG.00074 ING-CC-0009 Lemtrada (alemtuzumab) Lemtrada J0202 DRUG.00078 ING-CC-0010 Proprotein Convertase Praluent, Repatha J3490, J3590

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. Subtilisin Kexin 9 (PCSK9) Inhibitors DRUG.00095 ING-CC-0011 Ocrevus (ocrelizumab) Ocrevus J2350 DRUG.00099 ING-CC-0012 Brineura (cerliponase alfa) Brineura J0567 DRUG.00116 ING-CC-0013 Mepsevii (vestronidase alfa) Mepsevii J3397 CG-DRUG-03 ING-CC-0014 Beta Interferons and Glatiramer Acetate for Treatment of Multiple Sclerosis Avonex, Plegridy, Rebif, Betaseron, Extavia, Copaxone, Glatopa J1595, J1826, J1830, J3490, Q3027, Q3028 CG-DRUG-11 ING-CC-0015 Infertility Agents Menopur, Follistim AQ, Gonal-f/RFF, Bravelle, Pregnyl, Novarel, Ovidrel, Cetrotide, Ganirelix, Lupron Depot, Crinone 8% gel, Endometrin, Prochieve 8% gel J0725, J1950, J3355, J3490, J8499, S0122, S0126, S0128, S0132 CG-DRUG-27 ING-CC-0017 Xiaflex (clostridial collagenase histolyticum) injection Xiaflex J0775 CG-DRUG-28 ING-CC-0018 Lumizyme
(alglucosidase alfa) Lumizyme J0221 CG-DRUG-43 ING-CC-0020 Tysabri (natalizumab) Tysabri J2323 CG-DRUG-54 ING-CC-0021 Fabrazyme (agalsidase beta) Fabrazyme J0180 CG-DRUG-55 ING-CC-0022 Vimizim (elosulfase alfa) Vimizim J1322 CG-DRUG-56 ING-CC-0023 Naglazyme (galsulfase) Naglazyme J1458 CG-DRUG-57 ING-CC-0024 Elaprase (idursufase) Elaprase J1743 CG-DRUG-58 ING-CC-0025 Aldurazyme (laronidase) Aldurazyme J1931 CG-DRUG-73 ING-CC-0027 Denosumab agents Prolia, Xgeva J0897 CG-DRUG-84 ING-CC-0028 Benlysta (belimumab) Benlysta J0490 CG-DRUG-88 ING-CC-0029 Dupixent (dupilumab) Dupixent J3490, J3590 CG-DRUG-89 ING-CC-0030 Implantable and ER Buprenorphine Containing Agents Probuphine, Sublocade J0570, J3490, Q9991, Q9992 CG-DRUG-103 ING-CC-0032 Botulinum Toxin Botox, Xeomin, Dysport, Myobloc J0585, J0586, J0587, J0588 CG-DRUG-104 ING-CC-0033 Xolair (omalizumab) Xolair J2357 CG-DRUG-108 ING-CC-0035 Duopa (carbidopa and levodopa enteral suspension) Duopa J7340 CG-DRUG-111 ING-CC-0037 Kanuma (sebelipase alfa) Kanuma J2840 CG-DRUG-112 ING-CC-0038 Human Parathyroid Hormone Agents Tymlos J3490 DRUG.00013 ING-CC-0039 GamaSTAN [(immune globulin (human)] GamaSTAN. GamaSTAN S/D J1460, J1560 DRUG.00027 ING-CC-0040 Prialt (ziconotide) Prialt J2278 DRUG.00050 ING-CC-0041 Soliris (eculizumab) Soliris J1300 DRUG.00077 ING-CC-0042 Monoclonal Antibodies to Interleukin-17 Cosentyx (secukinumab), Siliq (brodalumab), Taltz (ixekizumab) J3490, J3590 DRUG.00080 ING-CC-0043 Monoclonal Antibodies to Interleukin-5 Cinqair (reslizumba), Fasenra (benralizumab), Nucala (mepolizumab) J0517, J2182, J2786 DRUG.00081 ING-CC-0044 Exondys 51 (eteplirsen) Exondys 51 J1428 DRUG.00086 ING-CC-0045 Increlex (mecasermin) Increlex J2170 DRUG.00090 ING-CC-0046 Zinplava (bezlotoxumab) Zinplava J0565 DRUG.00096 ING-CC-0047 Trogarzo (ibalizumab-uiyk Trogarzo J1746 DRUG.00104 ING-CC-0048 Spinraza (nusinersen) Spinraza J2326 DRUG.00108 ING-CC-0049 Radicava (edaravone) Radicava J1301 DRUG.00111 ING-CC-0050 Monoclonal Antibodies to Interleukin-23 Ilumya, Tremfya J1628, J3245 CG-DRUG-08 ING-CC-0051 Enzyme Replacement Therapy for Gaucher Disease Cerezyme, Elelyso, Vpriv J1786 , J3060, J3385 CG-DRUG-14 ING-CC-0052 Dihydroergotamine (DHE) Injection Dihydroergotamine injection J1110 CG-DRUG-33 ING-CC-0056 Selected Injectable 5HT3 Aloxi injection J2469

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 RVP II, Sr. 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. Attachment A – Updates as of March 1, 2019 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-BEH-14 Intensive In-Home Behavioral Health Services • Removed acronyms from the Clinical Indications section CG-DRUG-43 Natalizumab (Tysabri®) • Removed acronyms from the Clinical Indications section CG-DRUG-50 Paclitaxel, protein-bound (Abraxane®) • Added the treatment of locally advanced or metastatic squamous non-small cell lung cancer as Medically Necessary when criteria are met CG-DRUG-61 Gonadotropin Releasing Hormone Analogs for the Treatment of Non-Oncologic Indications • Added J3316 for Triptodur replacing J3490 NOC CG-DRUG-68 Bevacizumab (Avastin®) for Non-Ophthalmologic Indications • Added Q5107 for Mvasi replacing J3490 and J3590 CG-DRUG-90 Intravitreal Treatment for Retinal Vascular Conditions • Added Q5107 for Mvasi when specified as ocular dose CG-DRUG-99 Elotuzumab (Empliciti™) • Added Elotuzumab used in combination with pomalidomide and dexamethasone as Medically Necessary when criteria are met CG-DRUG-106 Brentuximab Vedotin (Adcetris®) • Updated Medically Necessary indications for untreated Hodgkin lymphoma (HL) to specify regimen • Expanded Medically Necessary indications to include combination therapy with bendamustine for relapsed/refractory HL and combination therapy with cyclophosphamide, doxo- rubicin, and prednisone for previously untreated CD30+ PTCL CG-MED-73 Hyperbaric Oxygen Therapy (Systemic/Topical) • Updated Clinical Indications with additional details on treatment of wounds and jaw conditions consistent with Undersea and Hyperbaric Medicine Society recommendations • Added to Not Medically Necessary statement: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL), osteonecrosis of the jaw when the cause is not radiation necrosis (osteoradionecrosis), preoperative treatment for jaw osteomyelitis, traumatic brain injury and venous stasis ulcers, pressure ulcers and non-pressure ulcers except in the subset of individuals noted in the Medically Necessary statement CG-SURG-27 Sex Reassignment Surgery • Revised Medically Necessary criteria for bilateral mastectomy to require one referral letter • Added language addressing treatment of postoperative complications and reversal procedures CG-SURG-77 Refractive Surgery • Added Medically Necessary indications for small incision lenticule extraction (SMILE) • Added SMILE to Not Medically Necessary indications when medically necessary criteria are not met CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity • Revised Medically Necessary indications to simplify criteria regarding preoperative and postoperative documentation • Reformatted Medically Necessary section; no change in intent • Revised criteria regarding reoperations/repeat surgery to clarify the types of surgery • Added Not Medically Necessary statement when Medically Necessary indications are not met • Reformatted Not Medically Necessary section; no change in intent

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.00071 Pembrolizumab (Keytruda®) • Added Child-Pugh Class A advanced hepatocellular carcinoma as Medically Necessary when criteria are met • Clarified Medically Necessary criteria for Merkel cell carcinoma DRUG.00080 Monoclonal Antibodies for the Treatment of Eosinophilic Conditions • Clarified Medically Necessary criteria addressing asthma control questionnaires for benralizumab, and for reslizumab DRUG.00088 Atezolizumab (Tecentriq®) • Added small cell lung cancer as Medically Necessary when criteria are met • Clarified Medically Necessary criteria for non-small cell lung cancer DRUG.00109 Durvalumab (Imfinzi®) • Added J9173, removed C9492, J3590 and J9999. GENE.00006 Epidermal Growth Factor Receptor (EGFR) Testing • Corrected typos in the position statement: • Removed the word “the” from Medically Necessary statement A • Removed the words “either” and “or B” from Medically Necessary statement B • Added the word “not” to the third Investigational and Not Medically Necessary statement GENE.00011 Gene Expression Profiling for Managing Breast Cancer Treatment • Added 81518 for Breast Cancer Index to replace NOC codes GENE.00012 Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent • Added 81329 for SMN1 carrier testing, and 81443 for panethnic carrier panel GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome • Added 81163-81167 for BRCA testing, replacing 81211, 81213-81214 GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases • Added Tier 1 codes 81336, 81337 for SMN1 testing (were Tier 2 81400, 81403, 81405) LAB.00019 Serum Markers for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver Disease • Coding updates: added 81596 for FibroSURE/FibroTest replacing 0001M LAB.00024 Immune Cell Function Assay • Removed iSpot Lyme test from the Position Statement MED.00111 Intracardiac Ischemia Monitoring • Added 0525T-0532T replacing C9750 and 93799 MED.00115 Outpatient Cardiac Hemodynamic Monitoring Using a Wireless Sensor for Heart • Added 33289, 93264 for insertion and programming of sensor replacing C9741 and 93799 MED.00117 Autologous Cell Therapy for the Treatment of Damaged Myocardium • Removed acronym from the Clinical Indications section MED.00120 Voretigene neparvovec-rzyl (Luxturna™) • Added J3398 replacing C9032, J3490 and J3590 MED.00123 Axicabtagene ciloleucel (Yescarta®) • Added 0537T, 0538T, 0539T, 0540T; revised descriptor for Q2041 Yescarta MED.00124 Tisagenlecleucel (Kymriah®) • Added 0537T, 0538T, 0539T, 0540T; added Q2042 replacing Q2040 OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis • Revised Medically Necessary criteria related to mobility and stability benefit, ambulation, distance and on uneven terrain or stairs • Clarified the Not Medically Necessary statement OR-PR.00005 Upper Extremity Myoelectric Orthoses • Added L8701 and L8702 for MyoPro orthoses SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added EpiCord, Grafix PRIME, and the sheet or membrane form of AmnioBand as Medically Necessary when criteria are met • Revised Investigational and Not Medically Necessary statements regarding AmnioBand, EpiCord, and Grafix PRIME

SURG.00028 Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions • Added 53854 replacing NOC codes SURG.00113 Artificial Retinal Devices • Added L8608 for miscellaneous retinal device supply SURG.00122 Venous Angioplasty with or without Stent Placement or Venous Stenting Alone • Removed arterio venous dialysis access grafts Medically Necessary statement SURG.00150 Leadless Pacemaker • Added 33274, 33275 for implantation of leadless pacemaker replacing codes 0387T-0388T THER-RAD.00009 Intraocular Epiretinal Brachytherapy • Removed 0190T deleted 12/31/2018

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MP/CG Update/Notice - March 2019 Form

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