MP/CG Update/Notice - October 2017 Form

Blue Cross Of California Commercial Clinical Policy

Effective Date

Last Reviewed

Original Document

October 1, 2017

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

Dear Provider:

Anthem Blue Cross is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines.
The major new policies and changes are summarized below, and additional updates are in Attachment A. 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 program and Genetic Testing Medical Policies in italics below apply to local Anthem members who have these services medically managed by AIM Specialty Health® (AIM), a separate company administering the program on behalf of Anthem.

NEW Medical Policies effective January 1, 2018

• DRUG.00110 Inotuzumab ozogamicin (Besponsa®): This document addresses uses of inotuzumab ozogamicin (Besponsa), which is an antibody-drug conjugate (ADC) consisting of a monoclonal antibody targeting CD22, a protein found on the surface of mature B-cells in most cases of acute lymphoblastic leukemia (ALL).

• DRUG.00111 Guselkumab (Tremfya™): This document addresses the use of guselkumab (Tremfya) which is a human IgG1 lambda monoclonal antibody for use in adults for the treatment and maintenance of moderate to severe plaque psoriasis.

• LAB.00035 Multi-biomarker Disease Activity (MBDA) Blood Tests: This document addresses the use of multi-biomarker disease activity (MBDA) blood testing that produces a score designed to assess rheumatoid arthritis (RA) disease activity.

• MED.00124 Tisagenlecleucel (Kymriah™): This document addresses uses of tisagenlecleucel (Kymriah) for the treatment of B-cell acute lymphoblastic leukemia (ALL).

NEW Clinical Guidelines effective January 1, 2018

• CG-MED-23 Home Health: This document addresses home health care and the conditions under which it would be considered medically necessary. Home health care refers to intermittent skilled health care related services provided by or through a licensed home health agency to an individual in his or her place of residence. Home health care includes skilled nursing care, as well as other skilled care services including, but not limited to, physical, occupational, and speech therapies.

NEW Clinical Guidelines replacing Medical Policies effective September 15, 2017

• CG-MED-58: Coronary Artery Imaging: Contrast-Enhanced CT Angiography, Fractional Flow Reserve derived from CT, Coronary MRA, and Cardiac MRI: Content moved from RAD.00035, archived effective September 15, 2017.
o This document addresses the use of FDA approved (Pre-Market Approval [PMA]) cervical artificial intervertebral discs in cervical total disc arthroplasty to treat symptomatic cervical disc disease (SCDD) when conservative treatment options have been unsuccessful

• CG-SURG-60 Cervical Total Disc Arthroscopy: Content moved from SURG.00055, archived effective September 15, 2017.
o Added the Prestige LP cervical disc system as Medically Necessary for implantation at two contiguous levels when criteria are met o Clarified disc height statement
o Revised the contraindications criteria in the Individual Selection Criteria section

REVISED Medical Policies and Clinical UM Guidelines

• CG-DRUG-09 Immune Globulin (Ig) Therapy: This document addresses immune globulin or immunoglobulin (Ig), which is a blood product that is given for the treatment of primary immunodeficiency diseases featuring low or dysfunctional antibody levels and for certain inflammatory, autoimmune and other diseases featuring low antibody levels.
o Added Medically Necessary criteria for antenatal alloimmune thrombocytopenia, autoimmune neutropenia, refractory dermatomyositis, Lambert-Eaton myasthenic syndrome treatment, hyperimmunoglobulinemia E syndrome (HIE), myasthenia gravis, severe hyperbilirubinemia in neonates, polymyositis o Updated formatting

• CG-DME-31 Wheeled Mobility Devices: Wheelchairs-Powered, Motorized, With or Without Power Seating Systems and Power Operated Vehicles (POVs): This document addresses criteria for wheelchairs - powered, motorized, power operated vehicles and powered seating systems. o Revised clinical indications to include criteria for groups of power/motorized wheelchairs.

• DRUG.00043 Tocilizumab (Actemra®) Pharmacotherapy for Hereditary Angioedema: This document addresses the use of tocilizumab (Actemra®),
o Added Medically Necessary criteria for the treatment of “Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.” This was in response to the concurrent approval of tisagenlecleucel (Kymriah™).

• DRUG.00058 Pharmacotherapy for Hereditary Angioedema: This document addresses drugs that have been specifically developed for the treatment or prevention of hereditary angioedema (HAE) attacks. o Revised title (Previous Title: Pharmacotherapy for Hereditary Angioedema [HAE]) o Added Medically Necessary statement for Haegarda for routine prophylaxis to prevent HAE attacks for individuals 12 years of age or older when criteria are met o Revised criteria for Cinryze for individuals from 13 years to age 12 or older
o Made minor formatting update and removed abbreviations from position statement
o Updated Investigational and Not Medically Necessary statement

• DRUG.00095 Ocrelizumab (Ocrevus™): This document addresses the use of ocrelizumab (Ocrevus). Ocrelizumab is an immune-suppressing humanized monoclonal antibody designed to target CD20 B-cell surface antigens.
o Added criteria for primary progressive multiple sclerosis diagnosed in accordance with McDonald criteria and individual is able to ambulate more than 5 meters (not considered wheelchair bound) o Added criteria for relapsing multiple sclerosis diagnosed in accordance with McDonald criteria and individual is able to ambulate without aid or rest for at least 100 meters o Added hepatitis C as a contraindication to Not Medically Necessary statement
o Added systemic lupus erythematosus, rheumatoid arthritis and recurrence of multiple sclerosis attacks to Investigational and Not Medically Necessary statement o Updated formatting of Investigational and Not Medically Necessary statement

• DRUG.00103 Abaloparatide (Tymlos™) Injection: This document addresses the use of abaloparatide (Tymlos) injection, which is a novel synthetic 34 amino acid peptide and is intended for subcutaneous use for the treatment of osteoporosis.
o Revised Medically Necessary criteria C to include an individual has sustained an osteoporotic low trauma fracture (fragility fracture) while on an oral bisphosphonate or has been refractory to, or intolerant of, or has a contraindication to Prolia or Reclast o Removed raloxifene and calcitonin nasal spray from criteria C o Added new criteria D that the individual has been refractory to, or intolerant of, or has a contraindication to Forteo (teriparatide)

• SURG.00010 Treatments for Urinary Incontinence: This document addresses the following treatments for urinary incontinence: Vaginal weight training; Injection of periurethral bulking agents; Transvaginal radiofrequency bladder neck suspension; Transurethral radiofrequency energy collagen micro-remodeling; Artificial urinary sphincter devices and the inFlow intraurethral valve-pump; Adjustable balloon system implantation.
o Added ProACT™ adjustable continence therapy as Investigational and Not Medically Necessary

• SURG.00140 Peripheral Nerve Blocks for Treatment of Neuropathic Pain: This document addresses the use of peripheral nerve blocks for the treatment of peripheral neuropathy. o Added existing CPT codes 64510, 64520 for sympathetic nerve blocks

Updates for Inpatient Rehabilitation, Sub-Acute Rehabilitation, and Skilled Nursing Facility

Effective with dates of service on and after January 1, 2018, Anthem Blue Cross will transition from using the Anthem Clinical Guidelines CG-REHAB-09 (Acute Inpatient Rehabilitation), CG-MED-31 (Skilled Nursing Facility Services), and CG-MED-29 (Inpatient Sub-Acute Care) to using Milliman Care Guidelines (MCG) Recovery Facility Care guidelines for the review of prior authorization requests for inpatient rehabilitation and skilled nursing facility services. This change applies to Commercial, Federal Employee Program® (FEP®) and National accounts. This change does not apply to Medicare or Medicaid plans at this time.

ARCHIVED Medical Policies and Clinical UM Guidelines

• RAD.00035 Coronary Artery Imaging: Contrast-Enhanced Coronary Computed Tomography Angiography (CCTA), Fractional Flow Reserve derived from Computed Tomography (FFRCT), Coronary Magnetic Resonance Angiography (MRA), and Cardiac Magnetic Resonance Imaging (MRI): archived effective 9/15/17, content moved to CG-MED-58.

• RAD.00060 Digital Breast Tomosynthesis: archived effective February 20, 2017.

• SURG.00055 Cervical Total Disc Arthroplasty: archived 9/15/17, content moved to CG-SURG-60.

AIM Expansion

Effective with dates of service on and after January 1, 2018, Anthem Blue Cross will expand the medical necessity review as a prior authorization of all genetic testing services to self-funded health plans with services medically managed by AIM Specialty Health® (AIM), a separate company. As a reminder, this program was effective for Anthem Blue Cross fully-insured members on July 1, 2017.

Ordering physicians may submit a request for services to AIM through the AIM ProviderPortalSM (available 24/7 to process orders in real-time), through the Availity Web Portal or by calling the AIM call center at 1-877-291-0360, Monday–Friday, 7:00 a.m.–5:00 p.m. Pacific Time.

These programs already apply to local fully-insured Anthem Blue Cross members who have advanced imaging services medically managed by AIM under a full Utilization Management program. Local self-insured plans may elect to offer the review to their members. Currently, it does not apply to HMO, BlueCard, Medicare Advantage, Medicaid, Medicare Supplement, and 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 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.

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem Blue Cross Web site at http://www.anthem.com/ca select “Tools for Providers” near the bottom of the page, the click “Enter” under Welcome to Anthem Blue Cross, then click “Services described in the Medical Policies, UM Clinical Guidelines and/or Pre-certification Requirements” under Learn More, 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 – 3rd Quarter 2017 Updates Revised Medical Policies and Clinical Guidelines Policy Number Title Medical Policy / Clinical Guideline Changes ANC.00007 Cosmetic and Reconstructive Services: Skin Related • Added J3490 NOC for hyaluronic acid fillers Juvederm, Restylane considered cosmetic BEH.00002 Transcranial Magnetic Stimulation • Clarified the Investigational and Not Medically Necessary statement for use of TMS in major depressive disorder when criteria are not met
• Removed abbreviations from the position statement • Removed mood disorders from Investigational and Not Medically Necessary statement CG-ANC-06 Ambulance Services: Ground; Non-Emergent • Added Medically Necessary statement to clinical indications regarding non-emergency transport response to a call but transport not completed • Made minor formatting changes in clinical indications CG-BEH-03 Psychiatric Disorder Treatment • Added "Note" for Intensive Structured Outpatient Program to clinical indications CG-BEH-07 Psychological Testing • Clarified Medically Necessary statement for psychological testing
CG-DME-04 Electrical Nerve Stimulation, Transcutaneous, Percutaneous • Added Not Medically Necessary statement when criteria not met and for all other indications • Minor grammar update in position statement CG-DME-07 Augmentative and Alternative Communication (AAC) Devices/Speech Generating D i (SGD) • Made minor typographical and grammar edits to clinical indications CG-DRUG-56 Galsulfase (Naglazyme®) • Clarified language in Medically Necessary statement from 4- sulphatase to N-acetylgalactosamine-4-sulfatase (arylsulfatase B) CG-MED-26 Neonatal Levels of Care • Updated examples of levels of care in clinical indications
• Revised Level IV to include for the first 24 hours of monitoring of infants with major congenital anomalies or extreme prematurity who are at risk for hemodynamic instability • Made grammar, capitalization, and acronym clarifications in clinical indications CG-REHAB-08 Private Duty Nursing in the Home Setting • Revised MN criteria for initial and continuation of private duty nursing services • Updated general criteria
• Reformatted and made changes to abbreviations and acronyms in clinical indications CG-SURG-08 Sacral Nerve Stimulation as a Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury • Deleted American Spinal Injury Association from clinical indication criteria and added *As defined by the American Spinal Injury Association (ASIA) Impairment Scale” to the bottom of the clinical indications CG-SURG-24 Functional Endoscopic Sinus Surgery (FESS) • Clarified Medically Necessary statement for chronic polyposis with symptoms unresponsive to medical therapy • Clarified Medically Necessary statement for prior sinus surgery • Clarified Not Medically Necessary Statement addressing post-surgical debridement CG-SURG-27 Sex Reassignment Surgery • Added "Note" to the Medically Necessary criteria regarding timing of “top” and “bottom” surgical procedures
• Added new statement regarding nipple reconstructions following mastectomy

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-38 Lumbar Laminectomy, Hemi- Laminectomy, Laminotomy and/or Discectomy • Updated ICD-10-CM diagnosis codes M48.061, M48.062 effective 10/01/2017 DME.00009 Vacuum Assisted Wound Therapy in the Outpatient Setting • Made minor typographical revisions to the Medically Necessary statement DME.00036 Ultraviolet Light Therapy Delivery Devices for Home Use • Clarified Medically Necessary statement that the treatment criteria apply to all conditions
• Updated formatting of position statement DRUG.00002 Tumor Necrosis Factor Antagonists
• Removed Clinically Equivalent Cost Effective Agents section • Separated Simponi and Simponi Aria Medically Necessary criteria into separate sections
• Removed abbreviations from position statement • Coding updated to add modifier -ZC effective 10/01/2017; used with HCPCS code Q5102 to indicate Renflexis DRUG.00004 Prostacyclin Infusion Therapy and Inhalation Therapy for Treatment of Pulmonary Arterial Hypertension • ICD-10-CM update I27.20-I27.29 replacing I27.2 and added I27.83 effective 10/01/17 DRUG.00006 Botulinum Toxin • Updated Clinically Equivalent Cost Effective Agents section with new indication of lower limb spasticity in adults for Dysport DRUG.00015 Prevention of Respiratory Syncytial Virus Infections • Added "Note" to the position statement section requesting clinical documentation supporting the presence of hemodynamically significant congenital heart disease or chronic lung disease when required • Removed abbreviations from position statement DRUG.00031 Subcutaneous Hormone Replacement Implants • Updated Medically Necessary section with headers to separate the Medically Necessary indications • Clarified diagnosis coding for testosterone pellets S0189, considered Investigational and Not Medically Necessary if used as part of estrogen/testosterone regimen DRUG.00040 Abatacept (Orencia®) • Added Medically Necessary statement for psoriatic arthritis • Added criteria for individual age 2 or years older for administration of subcutaneous injection for polyarticular juvenile idiopathic arthritis
• Updated Investigational and Not Medically Necessary
statement • Added ICD-10-CM diagnosis codes L40.50-L40.59 to pend for medical necessity criteria DRUG.00042 Ustekinumab (Stelara®) • Removed abbreviations from position statement DRUG.00043 Tocilizumab (Actemra®) • Updated Medically Necessary indication for CAR T-cell induced cytokine release syndrome DRUG.00052 Pertuzumab (Perjeta®) • Revised Medically Necessary criteria for neoadjuvant/adjuvant use in early stage, locally advanced, or inflammatory breast cancer
• Added criteria that pertuzumab is used for a maximum of 18 cycles (12 month course)

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.00055 Denosumab (Prolia®, Xgeva®) • Clarified Medically Necessary criteria for Prolia for treatment of postmenopausal adult with a medical contraindication to other available osteoporosis therapies
• Clarified Medically Necessary criteria for Xgeva when used for the prevention of skeletal-related events in adults with solid tumor bone metastases
• Updated formatting in position statement DRUG.00058 Pharmacotherapy for Hereditary Angioedema • Revised title (Previous Title: Pharmacotherapy for Hereditary Angioedema [HAE]) • Added J3490 (new drug – Haegarda/C1-esterase-inhibitor [Human] subcutaneous) with Medically Necessary statement for routine prophylaxis to prevent HAE attacks for individuals 12 years of age or older when criteria are met • Revised criteria for Cinryze for individuals from 13 years to age 12 or older
• Made minor formatting update and removed abbreviations from position statement
• Updated Investigational and Not Medically Necessary
statement DRUG.00071 Pembrolizumab (Keytruda®) • Revised Medically Necessary criteria for use in treatment of colorectal cancer when criteria are met
• Added Medically Necessary statement for use as treatment of unresectable or metastatic solid tumors when criteria are met • Clarified criteria for use as a single agent in first-line treatment of advanced metastatic Non-Small Cell Lung Cancer when no sensitizing EGFR mutations or ALK translocations in nonsquamous carcinoma • Updated formatting
• Reviewed document that was previously revised and effective 06/16/2017
• Revised ICD-10-CM diagnosis codes to pend for all solid tumor diagnoses for medical necessity criteria DRUG.00078 Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitors • ICD-10-CM update descriptor changes effective 10/01/17 DRUG.00080 Monoclonal Antibodies for the Treatment of Eosinophilic Asthma • Reformatted and made changes to abbreviations and acronyms in position statement DRUG.00082 Daratumumab (DARZALEX™) • Added Medically Necessary criteria for use of daratumumab in combination with pomalidomide and dexamethasone when criteria are met DRUG.00090 Bezlotoxumab (ZINPLAVA™) • ICD-10-CM update A04.71, A04.72 replacing A04.7 effective 10/01/17 DRUG.00091 Naltrexone Implants for the Treatment of Alcohol and Opioid Use Disorders • Added NOC 17999, 22999 if used for implantation of biodegradable pellets DRUG.00099

Cerliponase Alfa (Brineura™) • Removed criteria that the individual is 3 years of age or older from position statement DRUG.00107 Avelumab (Bavencio®) • Added Medically Necessary criteria for locally advanced or metastatic urothelial carcinoma when criteria are met • Updated formatting GENE.00001 Genetic Testing for Cancer Susceptibility • Added 0013U and 0014U as Investigational and Non Medically Necessary

Vagus Nerve Stimulation • Added Medically Necessary statement for replacement or revision of an implanted neurostimulator pulse generator system (with or without lead changes) for medically and surgically refractory seizures when criteria are met • Updated the Investigational and Not Medically Necessary statement
• Clarified the Investigational and Not Medically Necessary statement for use of non-implantable VNS as acute or preventive treatment for specific types of headaches SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added new products to Investigational and Not Medically Necessary list
• Removed Perlane and Restylane from Investigational and Not Medically Necessary list
• Removed abbreviation from position statement • CPT code 31574 for injection laryngoplasty will now pend, when billed with Cymetra Q4112 is considered
Investigational and Not Medically Necessary (when billed with other agents such as Perlane or Restylane this policy will not apply)

SURG.00014 Cochlear Implants and Auditory Brainstem Implants • Added a "Note" to the Medically Necessary criteria that for a young child, a parent or guardian may act as the surrogate for participation • Reformatted and made changes to abbreviations and acronyms in position statement • Updated Investigational and Not Medically Necessary statement SURG.00020 Bone-Anchored and Bone Conduction Hearing Aids • Removed abbreviations in the position statement SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Added ICD-10-PCS codes for nipple reconstruction SURG.00024 Bariatric Surgery and Other Treatments for Clinically Severe Obesity • Updated the Investigational and Not Medically Necessary statements • Existing CPT code 43633 will pend for obesity diagnoses as the code may be billed for an obesity procedure (Billroth) SURG.00054 Endovascular/Endoluminal Repair of Aortic Aneurysms, Aortoiliac Disease, Aortic Dissection and Aortic Transection • Removed ICD-10-PCS procedure codes 04VC3FZ , 04VD3FZ deleted 09/30/2017 SURG.00066 Percutaneous Neurolysis for Chronic Neck and Back Pain • Correction to coding section to remove invalid ICD-10-CM diagnosis codes SURG.00074 Nasal Surgery for the Treatment of Obstructive Sleep Apnea (OSA) and Snoring • Added CPT 30999 NOC code for unlisted procedures such as Latera nasal implant SURG.00085 Mastectomy for Gynecomastia • Updated ICD-10-CM diagnosis codes N63.0-N63.42 effective 10/01/2017 SURG.00121 Transcatheter Heart Valve Procedures • Revised Medically Necessary statement for TAVR with the CoreValve System, CoreValve Evolut R System and CoreValve Evolut PRO System to include coverage for individuals at intermediate or greater risk when criteria met SURG.00122

Venous Angioplasty with or without Stent Placement or Venous Stenting Alone • Revised title
• Clarified Medically Necessary statement to include venous stenting alone • Updated Investigational and Not Medically Necessary statement
SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Updated ICD-10-PCS procedure codes effective 10/01/2017

Book a walkthrough

Walk through this policy with us

Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.

GenHealth is the best way to run RCM including eligibility, prior auth, billing, and denials with AI that works like a teammate in your EMR and billing systems.

MP/CG Update/Notice - October 2017 Form

Previewing the first 5 questions