Updates to Medical Policies and Clinical UM Guidelines
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1 Updates to Medical Policies and Clinical UM Guidelines Effective March 1, 2018 The major new policies and changes are summarized below. Please refer to the specific policy for coding, language, and rationale updates and changes that are not summarized below. New Medical Policies Effective March 1, 2018 DRUG Gemtuzumab Ozogamicin (Mylotarg ): This document addresses gemtuzumab ozogamicin (Mylotarg), a humanized anti-cd33 monoclonal antibody for the treatment of acute myeloid leukemia (AML). DRUG Copanlisib (Aliqopa ): This document addresses the use of copanlisib, a P13K kinase inhibitor administered intravenously for the treatment of follicular lymphoma. MED Axicabtagene ciloleucel (Yescarta ): This document addresses the uses of axicabtagene ciloleucel autologous chimeric antigen receptor (CAR) T-cell, CD3/CD28-based therapy, that targets the CD19 surface antigen expressed in B cell malignancies, in particular, non-hodgkin s lymphoma (NHL). Updated Medical Policies DRUG Hyaluronan Injections in Joints Other Than the Knee: This document addresses the use of hyaluronan injections for the replacement or supplementation of naturally occurring intra-articular lubricants in individuals with musculoskeletal conditions in joints other than the knee, including osteoarthritis and temporomandibular joint disease. o Revised position from Medically Necessary to Investigational and Not Medically Necessary for hyaluronan injections for the treatment of temporomandibular joint disorders MED Tisagenlecleucel (Kymriah ): This document addresses uses of tisagenlecleucel, an autologous chimeric antigen receptor (CAR) T-cell immunotherapy that targets the CD19 surface antigen expressed in B cell malignancies. o Added code Q2040 replacing NOC J3490 and J3590 o Added indication for CAR-T cell therapy and lymphapheresis related to CAR-T cell therapy Medical Policies Converted to New Clinical Guidelines No changes to clinical indications MP Number Title CG Number DME Electrical Bone Growth Stimulation CG-DME-40 DME Ultraviolet Light Therapy Delivery Devices for Home Use CG-DME-41 DRUG Eribulin mesylate (Halaven ) CG-DRUG-70 DRUG Ziv-aflibercept (Zaltrap ) CG-DRUG-71 DRUG Pertuzumab (Perjeta ) CG-DRUG-72 DRUG Denosumab (Prolia, Xgeva ) CG-DRUG-73 DRUG Plerixafor injection (Mozobil ) CG-DRUG-76 DRUG Radium Ra 223 Dichloride (Xofigo ) CG-DRUG-77 DRUG Siltuximab (Sylvant ) CG-DRUG-79
2 DRUG Cabazitaxel (Jevtana ) CG-DRUG-80 GENE Janus Kinase 2 (JAK2) V617F Gene Mutation Assay CG-GENE-01 GENE Analysis of KRAS Status CG-GENE.02 GENE BRAF Mutation Analysis CG-GENE-03 MED Treatment of Hyperhidrosis CG-MED-63 MED Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins as a Treatment of Atrial Fibrillation or Atrial Flutter (Radiofrequency and Cryoablation) CG-MED-64 MED Manipulation Under Anesthesia of the Spine and Joints other than the Knee CG-MED-65 MED Cryopreservation of Oocytes or Ovarian Tissue CG-MED-66 MED Melanoma Vaccines CG-MED-67 SURG Cryosurgical Ablation of Solid Tumors Outside the Liver CG-SURG-61 SURG Radiofrequency Ablation of Solid Tumors Outside the Liver CG-SURG-62 SURG Recombinant Human Bone Morphogenetic Protein CG-SURG-65 SURG Implanted (Epidural and Subcutaneous) Spinal Cord Stimulators (SCS) CG-SURG-66 SURG Cardiac Resynchronization Therapy (CRT) with or without an Implantable Cardioverter Defibrillator (CRT/ICD) for the Treatment of Heart Failure CG-SURG-63 SURG Treatment of Osteochondral Defects CG-SURG-67 SURG Surgical Treatment of Femoroacetabular Impingement Syndrome CG-SURG-68 TRANS Meniscal Allograft Transplantation of the Knee CG-SURG-69 Medical Policies Converted to New Clinical Guidelines (changes noted in Attachment A) MP Number Title CG Number DRUG Tumor Necrosis Factor Antagonists CG-DRUG-65 DRUG Panitumumab (Vectibix ) CG-DRUG-66 DRUG Bevacizumab (Avastin ) for Non-Ophthalmologic Indications CG-DRUG-68 DRUG Ustekinumab (Stelara ) CG-DRUG-69 DRUG Tocilizumab (Actemra ) CG-DRUG-81 DRUG Antihemophilic Factors and Clotting Factors CG-DRUG-78 DRUG Canakinumab (Ilaris ) CG-DRUG-74 DRUG Romiplostim (Nplate ) CG-DRUG-75 DRUG Antihemophilic Factors and Clotting Factors CG-DRUG-78 GENE Molecular Marker Evaluation of Thyroid Nodules CG-GENE-04 MED Therapeutic Apheresis CG-MED-68 Page 2 of 7
3 UniCare Medical Policies and Clinical UM Guidelines are developed by our Medical Policy and Technology Assessment Committee. The Committee, which includes UniCare 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 UniCare 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 in UniCare s medical policies. Review procedures have been refined to facilitate claim investigation. You can access the complete list of Medical Policies and Clinical UM Guidelines from unicarestateplan.com. On the Providers home page, select the button for Medical Policies on the right side of the page; then choose Review all medical policies and clinical UM guidelines. Page 3 of 7
4 Attachment A 4 th Quarter 2017 Updates Revised Medical Policies and Clinical Guidelines Policy Number Title Medical Policy / Clinical Guideline Changes CG-DME-31 Wheeled Mobility Devices: Wheelchairs Powered, Motorized, With or Without Power Seating Systems and Power Operated Vehicles (POVs) Removed cross reference to CG-DME-34 Wheeled Mobility Devices: Wheelchair Accessories from clinical indications CG-DRUG-09 Immune Globulin (Ig) Therapy Added code J1555 for Cuvitru replacing NOC code CG-DRUG-65 Tumor Necrosis Factor Antagonists Content moved from DRUG Added Medically Necessary s for golimumab (Simponi Aria) use in the treatment of adults with ankylosing spondylitis and psoriatic arthritis when criteria are met CG-DRUG-65 Panitumumab (Vectibix ) Content moved from DRUG Clarified Medically Necessary from "KRAS gene mutation testing" to "Extended RAS gene mutation testing with an FDA approved test" for RAS wild type which includes KRAS, NRAS, and BRAF gene mutations Updated "Notes" following Medically Necessary criteria Added Not Medically Necessary for RAS-mutant metastatic colorectal cancer, small bowel or anal adenocarcinoma or when RAS mutation status unknown CG-DRUG-68 Bevacizumab (Avastin ) for Non-Ophthalmologic Indications Content moved from DRUG Added Medically Necessary criteria for non-clear cell renal cell carcinoma CG-DRUG-69 Ustekinumab (Stelara ) Content moved from DRUG Revised Medically Necessary for use in plaque psoriasis for individuals 18 years of age or older to "12 years of age or older" Added code J3358 replacing Q9989 for Stelara IV for Crohn's disease CG-DRUG-75 Romiplostim (Nplate ) Content moved from DRUG Added Medically Necessary indication for treatment of myelodysplastic syndrome (MDS) when criteria are met Updated Not Medically Necessary CG-DRUG-78 Antihemophilic Factors and Clotting Factors Content moved from DRUG Added criteria for recombinant coagulation factor IX, GlycoPEGylated (Rebinyn) and human fibrinogen (Fibryna) Added Not Medically Necessary for prophylactic use in prevention or reduction of frequency of bleeding episodes for recombinant coagulation factor IX, GlycoPEGylated (Rebinyn) Updated Not Medically Necessary s Added code J7210 replacing C9140 for Afstyla; new code J7211 for Kovaltry CG-DRUG-81 Tocilizumab (Actemra ) Content moved from DRUG Clarified Not Medically Necessary for latent tuberculosis testing CG-GENE-02 Analysis of KRAS Status Content moved from GENE Added NOC code for extended RAS panel (e.g. Praxis test) Page 4 of 7
5 CG-GENE-04 CG-MED-24 Molecular Marker Evaluation of Thyroid Nodules Electromyography and Nerve Conduction Studies Content moved from GENE Clarified name of gene expression classifier as "Afirma" in the Medically Necessary Updated Not Medically Necessary s Added Not Medically Necessary for needle EMG or NCS for all other conditions, including but not limited to, back pain without radiculopathy, or headaches when there is no suspicion of an underlying disorder of the cranial nerves CG-MED-68 Therapeutic Apheresis Content moved from MED Added Medically Necessary indications for N-methyl D- aspartate receptor antibody encephalitis, progressive multifocal leukoencephalopathy and apheresis as a component of CAR-T therapy Added Medically Necessary indication for lymphapheresis when used to collect autologous T-cells for CAR-T cell therapy when the criteria within the specific CAR-T therapy document are met Revised Medically Necessary indications for polyneuropathy, glomerulonephritis, neuromyelitis optica disorders and paraproteinemic demyelinating neuropathies Updated Medically Necessary and Not Medically Necessary for plasmapheresis or plasma exchange Descriptor change for includes service coded as which is deleted 12/31/17; added diagnosis codes for plasmapheresis and leukapheresis to Medically Necessary criteria CG-SURG-61 DME DME Cryosurgical Ablation of Solid Tumors Outside the Liver Electrical Stimulation as a Treatment for Pain and Related Conditions: Surface and Percutaneous Devices Automated Insulin Delivery Devices Content moved from MED New code replacing 0340T for cryoablation of pulmonary tumors for supraorbital transcutaneous neurostimulation to include "treatment of acute migraine headaches, with or without aura" Revised position from Investigational and Not Medically Necessary to Medically Necessary for a hybrid closed-loop device when criteria are met Updated Not Medically Necessary and Investigational and Not Medically Necessary s DRUG Eculizumab (Soliris ) Added Medically Necessary for use in initial therapy and for continuation of treatment in generalized myasthenia gravis when criteria are met Reformatted and made changes to abbreviations and acronyms in Medically Necessary and Investigational and Not Medically Necessary s DRUG Obinutuzumab (Gazyva ) Clarified Medically Necessary criteria for follicular lymphoma for combination chemotherapy and monotherapy DRUG Pembrolizumab (Keytruda ) Added Medically Necessary for treatment of gastric or gastroesophageal junction adenocarcinoma when criteria are met Added Medically Necessary for treatment of malignant pleural mesothelioma when criteria are met DRUG Nivolumab (Opdivo ) Added Medically Necessary for hepatocellular carcinoma when criteria are met Merkel cell carcinoma when criteria are met malignant pleural mesothelioma when criteria are met adjuvant therapy for resected advanced melanoma when criteria are met Page 5 of 7
6 DRUG Eteplirsen (Exondys 51 ) Revised position from Investigational and Not Medically Necessary to Medically Necessary for the use of eteplirsen for Duchenne muscular dystrophy when criteria met Added code J1428 replacing C9484 and NOC codes DRUG Daclizumab (Zinbryta ) Revised title; changed to Clarified Medically Necessary for daclizumab use as single-agent treatment DRUG Durvalumab (Imfinzi ) Revised title; changed to upper and lower case Added Medically Necessary for non-small cell lung cancer when criteria are met Added header for urothelial carcinoma GENE GENE RAD Gene Expression Profiling for Managing Breast Cancer Treatment Genetic Testing for Inherited Peripheral Neuropathies Positron Emission Tomography (PET) and PET/CT Fusion Revised criteria for gene expression profiling as a technique for management breast cancer treatment from "Chemotherapy is a therapeutic option being considered and will be supervised by the practitioner ordering the gene expression profile" to "chemotherapy is a therapeutic option being considered by the individual and their practitioner" Added Medically Necessary for use of gene expression profiling as a genetic index used to assist in decisions of extending adjuvant hormonal therapy beyond 5 years of treatment when criteria are met Reformatted and made changes to abbreviations and acronyms throughout position Added code replacing 0008M for Prosigna Breast Cancer Assay; for MammaPrint Added code for panel test as Investigational and Not Medically Necessary Added code 0482T for PET quantitation of blood flow, deleted HCPCS code A9599 RAD MRI of the Breast Added additional genetic variants to Medically Necessary SURG SURG SURG SURG Surgical and Minimally Invasive Treatments for Benign Prostatic Hyperplasia (BPH) and Other Genitourinary Conditions Balloon and Self-Expanding Absorptive Sinus Ostial Dilation Implantable Left Atrial Hemodynamic Monitor Perirectal Spacers for Use During Prostate Radiotherapy Removed abbreviations from and added definitions to Medically Necessary, Not Medically Necessary, and Investigational and Not Medically Necessary s Added C9748 for convective water vapor thermal ablation (Investigational and Not Medically Necessary) Revised position from Investigational and Not Medically Necessary to Medically Necessary for the use of balloon sinus ostial dilation when criteria are met s Added code for balloon dilation of frontal and sphenoid sinus ostia Deleted codes 0293T, 0294T effective 12/31/17; replaced by code Added code replacing 0438T Page 6 of 7
7 SURG Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) Clarified Medically Necessary for VADs when used in accordance with FDA approval when criteria are met Added "Note" to position to refer to Background section for a list of FDA approved VADs to include Impella RP as an example of a pvad Added codes 33927, 33928, replacing 0051T, 0052T, 0053T for artificial heart systems THER-RAD Neutron Beam Radiotherapy Removed deleted 12/31/17 Claims are administered by UniCare Life & Health Insurance Company. Page 7 of 7
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