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March 2013 Medical Policy Updates Page New: Electrical and Ultrasound Bone Growth Stimulators - Effective Apr. 1, 2013........................................ Oscillatory Positive Expiratory Pressure Devices - Effective Apr. 1, 2013............................................ Pneumatic Compression Devices - Effective Apr. 1, 2013...................................................................... Updated: Bone or Soft Tissue Healing and Fusion Enhancement Products - Effective Apr. 1, 2013..................... Revised: Abnormal Uterine Bleeding and Uterine Fibroids - Effective Apr. 1, 2013............................................ Apheresis - Effective Apr. 1, 2013........................................................................................................... Bariatric Surgery - Effective Apr. 1, 2013................................................................................................ Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes - Effective Apr. 1, 2013 Deep Brain Stimulation - Effective Apr. 1, 2013...................................................................................... Elbow Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013...................................................... Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Effective Apr. 1, 2013.... Fecal DNA Testing - Effective Apr. 1, 2013............................................................................................ Gastrointestinal Motility Disorders, Diagnosis and Treatment - Effective Apr. 1, 2013.......................... (continued on next page) 4 4 4 4 8 10 15 20 22 24 24 27 27 March 2013 Medical Policy Updates (continued) Page Revised: Gene Expression Testing - Effective Apr. 1, 2013................................................................................... Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) - Effective Apr. 1, 2013........................................................................................................................................................... Glaucoma Surgical Treatment - Effective Apr. 1, 2013........................................................................... High Frequency Chest Wall Compression Devices - Effective Apr. 1, 2013.......................................... High Ligation and Endomechanical Ablation for Varicose Veins - Effective Apr. 1, 2013.................... Hip Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013.......................................................... Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors - Effective Apr. 1, 2013 Infertility Diagnosis and Treatment - Effective Apr. 1, 2013................................................................... Intensity-Modulated Radiation Therapy - Effective Apr. 1, 2013............................................................ Knee Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013........................................................ Magnetoencephalography and Magnetic Source Imaging for Specific Neurological Applications Effective Apr. 1, 2013............................................................................................................................... Mandibular Disorders - Effective Apr. 1, 2013........................................................................................ Mechanical Stretching and CPM Devices - Effective Apr. 1, 2013......................................................... Noninvasive Prenatal Diagnosis of Fetal Aneuploidy Using Cell-Free Fetal Nucleic Acids in Maternal Blood - Effective Apr. 1, 2013.................................................................................................. Non-Surgical Treatment of Obstructive Sleep Apnea - Effective Apr. 1, 2013....................................... Outpatient Cardiovascular Telemetry - Effective Apr. 1, 2013................................................................ Plagiocephaly and Craniosynostosis - Effective Apr. 1, 2013.................................................................. Proton Beam Radiation Therapy - Effective Apr. 1, 2013........................................................................ Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders - Effective Apr. 1, 2013 Shoulder Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013.................................................. Surgical Treatment for Spine Pain - Effective Apr. 1, 2013..................................................................... Surgical Treatment of Obstructive Sleep Apnea - Effective Apr. 1, 2013................................................ Total Artificial Heart - Effective Apr. 1, 2013.......................................................................................... Transcatheter Heart Valve Procedures - Effective Apr. 1, 2013............................................................... Vagus Nerve Stimulation - Effective Apr. 1, 2013................................................................................... Wireless Capsule Endoscopy - Effective Apr. 1, 2013............................................................................. 28 30 35 36 37 38 38 39 42 46 46 47 49 49 51 52 52 54 55 56 56 59 62 62 63 65 Drug and Biologics Policy Updates New: Repository Corticotropin Injection (H.P. Acthar Gel) - Effective Apr. 1, 2013....................................... Updated: Oncology Medication Clinical Coverage - Effective Apr. 1, 2013.......................................................... Remicade (infliximab) - Effective Apr. 1, 2013....................................................................................... Revised: Actemra (tocilizumab) - Effective Apr. 1, 2013....................................................................................... Campath (alemtuzumab) - Effective Apr. 1, 2013.................................................................................... Immune Globulin (IVIG and SCIG) - Effective Apr. 1, 2013.................................................................. (continued on next page) March 2013 67 68 70 75 73 75 March 2013 Drug and Biologics Policy Updates (continued) Revised: Orencia (abatacept) - Effective Apr. 1, 2013............................................................................................ Xolair (omalizumab) - Effective Apr. 1, 2013.......................................................................................... Page 94 95 Coverage Determination Guideline (CDG) Updates New: Private Duty Nursing - Effective May 1, 2013......................................................................................... Updated: Breast Reduction Surgery - Effective Apr. 1, 2013................................................................................... Revised: Blepharoplasty, Blepharoptosis, and Brow Ptosis Repair - Effective Apr. 1, 2013.................................. Complementary and Alternative Medicine - Effective Mar. 1, 2013........................................................ Cosmetic and Reconstructive Procedures - Effective Apr. 1, 2013.......................................................... Custodial and Skilled Care Services - Effective Apr. 1, 2013.................................................................. Gender Identify Disorder Treatment (Sex Transformation) - Effective Apr. 1, 2013.............................. Nutrition (Including: Counseling, Therapy, Enteral Nutrition, Infant Formula, Breast Milk, Supplements and Food) - Effective May 1, 2013...................................................................................... Orthognathic (Jaw) Surgery - Effective Apr. 1, 2013............................................................................... Preventive Care Services - Effective Apr. 1, 2013.................................................................................... Prosthetic Devices and Wigs - Effective Apr. 1, 2013.............................................................................. Rhinoplasty, Septoplasty, and Repair of Vestibular Stenosis - Effective Apr. 1, 2013............................ Specialized, Microprocessor or Myoelectric Limbs - Effective Apr. 1, 2013.......................................... Speech Language Pathology Services - Effective Apr. 1, 2013................................................................ Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins - Effective May 1, 2013........................................................................................................................................................... 98 100 100 100 100 100 101 102 102 102 103 103 104 104 104 Utilization Review Guideline (URG) Updates New: Breast Pumps - Effective Apr. 1, 2013...................................................................................................... Revised: Chemotherapy Observation and Inpatient Hospitalization - Effective Apr. 1, 2013................................. Durable Medical Equipment and Related Supplies, Prosthetics and Orthotics - Effective Apr. 1, 2013.. March 2013 105 106 107 Medical Policy Updates NEW Title Electrical and Ultrasound Bone Growth Stimulators Effective Date Apr. 1, 2013 Coverage Rationale Two MCG™ are identified, one for electrical and electromagnetic bone growth stimulators, and one for ultrasonic bone growth Stimulators. For information regarding medical necessity review of electrical and electromagnetic bone growth stimulators, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Bone Growth Stimulators, Electrical and Electromagnetic ACG: A-0565 (AC). For information regarding medical necessity review of ultrasonic bone growth stimulators, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Bone Growth Stimulators, Ultrasonic ACG: A-0414 (AC). Oscillatory Positive Expiratory Pressure Devices Apr. 1, 2013 For information regarding medical necessity review of oscillatory positive expiratory pressure devices, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Noninvasive Positive Pressure Ventilation (CPAP, BiPAP) ACG: A-0431 (AC). Pneumatic Compression Devices Apr. 1, 2013 For information regarding medical necessity review of pneumatic compression devices, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Intermittent Pneumatic Compression with Extremity Pump ACG: ACG: A0340 (AC). Effective Date Apr. 1, 2013 Summary of Changes Clarified coverage rationale for platelet rich plasma; replaced language indicating “platelet-rich plasma (e.g., autologous platelet derived growth factor) is unproven when used to enhance bone healing” with “platelet-rich plasma (e.g., autologous platelet derived growth factor) is unproven when used to enhance bone or soft tissue healing” UPDATED Title Bone or Soft Tissue Healing and Fusion Enhancement Products Coverage Rationale Bone graft materials used in spinal fusion surgery can be categorized into the following domains: Autografts Allografts including (cadaver bone graft) Demineralized Bone Matrix (DBM) Bone Morphogenetic Proteins (BMP) Ceramic-based products Cell-based products Platelet-Rich Plasma Autografts Autografts are proven for bone fusion enhancement: Autografts harvest bone for grafting from the person undergoing surgery. The harvested bone is typically retrieved from the patient’s own tibia, fibula or iliac crest and then placed at the surgery site. Allografts Demineralized bone matrix (DBM) is a type of allograft and is proven for bone fusion enhancement. Allografts harvest bone for grafting from a 4 March 2013 Medical Policy Updates UPDATED Title Bone or Soft Tissue Healing and Fusion Enhancement Products (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale person other than the surgical candidate. Cadaver bone is one type of allograft. Allografts are proven for bone fusion enhancement. Bone Morphogenetic Proteins (BMP) Bone Morphogenetic Protein-2 (rhBMP-2) When used according to U.S. Food and Drug Administration (FDA) labeled indications, INFUSE Bone Graft is proven for the enhancement of bone healing and/or fusion of the lumbar spine in patients who meet all of the following criteria: Implanted via an anterior approach and used in conjunction with an INFUSE Bone Graft fusion device. INFUSE Bone Graft fusion devices include: o InFUSE™ bone graft/LT-Cage o InFUSE™ bone graft/Lumbar Tapered Fusion Device o InFUSE™ bone graft/InterFix™ threaded fusion device o InFUSE™ bone graft/Inter Fix™ RP threaded fusion device Skeletally mature patient (18 years of age or older or radiographic evidence of epiphyseal closure) with degenerative disc disease at one level from L4–S1 No more than Grade I spondylolisthesis at the involved level Failure of at least 6 months of nonoperative treatment INFUSE Bone Graft is unproven for all other indications including but not limited to the following: Enhancement of bone healing and/or fusion of the lumbar spine via a posterior approach. Treatment of cervical spine or any other area with or without use of other devices including the PEEK device. Known contraindications including: o hypersensitivity to recombinant human Bone Morphogenetic Protein2, bovine Type I collagen or to other components of the formulation o Pregnancy o Active infection at operative site or patient has an allergy to titanium or 5 March 2013 Medical Policy Updates UPDATED Title Bone or Soft Tissue Healing and Fusion Enhancement Products (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale titanium alloy Planned use of grafting in the vicinity of a resected or extant tumor Skeletally immature patient (younger than 18 years of age or 18 years of age or older with no radiographic evidence of epiphyseal closure) Posterolateral or posterior lumbar interbody fusion utilizing INFUSE Bone Graft has not received FDA approval. Available studies have demonstrated increased adverse events with the posterior approach. The safety and effectiveness of INFUSE Bone Graft in the cervical spine have not been demonstrated. There is insufficient clinical evidence to support the use of INFUSE Bone Graft with devices made of PEEK or other biocompatible materials. In addition, INFUSE Bone Graft has not been approved by the FDA for use with PEEK cages. When used according to U.S. Food and Drug Administration (FDA) indications, the INFUSE/MASTERGRAFTTM Posterolateral Revision Device system is proven in patients who meet all of the following criteria: Implanted via a posterolateral approach Presence of symptomatic posterolateral lumbar spine pseudoarthrosis Skeletally mature patient (older than 21 years of age or radiographic evidence of epiphyseal closure) Treatment of 2 or more levels of the lumbar spine Autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion. These patients are diabetics and smokers. The INFUSE/MASTERGRAFTTM Posterolateral Revision Device system is unproven for all other indications including the following: Known contraindications including: o hypersensitivity to recombinant human Bone Morphogenetic Protein2, bovine Type I collagen or to other components of the formulation o Known active malignancy or patients 6 March 2013 Medical Policy Updates UPDATED Title Bone or Soft Tissue Healing and Fusion Enhancement Products (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale undergoing treatment for a malignancy o Pregnancy o Active infection at operative site Planned use of grafting in the vicinity of a resected or extant tumor Skeletally immature patient (older than 21 years of age or radiographic evidence of epiphyseal closure) INFUSE/MASTERGRAFTTM Posterolateral Revision Device system has not received FDA approval for any other indications except those indicated as proven. The safety and effectiveness of INFUSE/MASTERGRAFTTM Posterolateral Revision Device system has not been demonstrated for other conditions in studies published in peerreviewed literature. Bone Morphogenetic Protein-7 (BMP-7) OP-1 Implant and OP-1 Putty are unproven for the enhancement of bone healing and/or fusion with or without use of other devices (including the PEEK device). Use of BMP7 has not demonstrated accelerated healing. In one study better results were achieved in patients receiving traditional autograft. Additionally, available studies have been limited by substantial loss of study participants at follow-up as well as by short follow-up times. Bone graft substitutes have overlapping properties and are made of a variety of materials such as polymers (degradable and nondegradable), ceramics and composites (calcium phosphate, calcium sulfate, and bioactive glass), factor-based techniques (recombinant growth factors) and cell-based techniques (mesenchymal stem cells). Ceramic-based products: Ceramic –based products such as beta tricalcium phosphate (b-TCP) when used alone or with bone marrow aspirate are unproven for the enhancement of bone healing and/or fusion. Only very weak conclusions about effectiveness of ceramic-based products may be drawn from studies because of small sample size, lack of control or comparison 7 March 2013 Medical Policy Updates UPDATED Title Bone or Soft Tissue Healing and Fusion Enhancement Products (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale groups in most studies. The absence of a formal assessment of clinical outcomes in most studies limits the conclusions that can be drawn about the place of b-TCP in bone healing and fusion. Furthermore, definitive patient selection criteria have not been established for the use of b-TCP bone void fillers. Cell-based products: Cell based products such as mesenchymal stem cells, Osteocel, or Trinity Evolution are unproven for the enhancement of bone healing. Available clinical evidence is insufficient to establish the safety and efficacy for the use of bone graft or cell-based substitutes. Platelet-Rich Plasma Platelet-rich plasma (e.g., autologous platelet derived growth factor) is unproven when used to enhance bone or soft tissue healing. Evidence in the published scientific literature is inconsistent and does not lend strong support to the clinical utility of using PRP to augment bone or soft tissue healing. OptiMesh® The OptiMesh deployable grafting system is unproven. There is insufficient evidence that the use of OptiMesh will improve structural support of the vertebrae. Further studies are needed to evaluate safety and efficacy of this grafting system. Information Pertaining to Medical Necessity Review (When Applicable) No criteria in addition to the above indications apply to medical necessity review. REVISED Title Abnormal Uterine Bleeding and Uterine Fibroids Effective Date Apr. 1, 2013 Summary of Changes Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references Coverage Rationale Endometrial Ablation Endometrial ablation, using the following techniques, is proven for treating menorrhagia or metrorrhagia in premenopausal women: Cryoablation (HerOption®) 8 March 2013 Medical Policy Updates REVISED Title Abnormal Uterine Bleeding and Uterine Fibroids (continued) Effective Date Apr. 1, 2013 Summary of Changes to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) Coverage Rationale Thermal balloon ablation (Gynecare Thermachoice®) Hydrothermal ablation (Hydro ThermAblator®) Radiofrequency ablation (NovaSure®) Microwave ablation (Microsulis® Microwave Endometrial Ablation (MEA) System) Manual endometrial ablation techniques such as resectoscopic ablation or laser ablation Levonorgestrel-Releasing Intrauterine Device The levonorgestrel-releasing intrauterine device (LNG-IUD) is proven for treating menorrhagia in premenopausal women. Uterine Fibroids Uterine artery embolization (UAE) is proven for treating symptomatic uterine fibroids for women who do NOT wish to preserve their childbearing potential. Uterine artery embolization (UAE) is unproven for treating symptomatic uterine fibroids for women who wish to preserve their childbearing potential. The effects of UAE on ovarian and uterine function and on fertility are relatively unknown. Further studies of safety and/or efficacy in published, peer-reviewed medical literature are necessary. Magnetic resonance imaging (MRI)-guided cryoablation is unproven for treating uterine fibroids. The published evidence on MRI-guided cryoablation for uterine fibroids is very limited, as the procedure has been evaluated in very few patients. The long-term outcomes and overall health benefits remain unknown. Further long-term studies on larger samples published in peer-reviewed medical literature are necessary to demonstrate the safety and efficacy of this technology. Magnetic resonance imaging (MRI)-guided focused ultrasound ablation (FUA) is unproven for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this procedure and to 9 March 2013 Medical Policy Updates REVISED Title Abnormal Uterine Bleeding and Uterine Fibroids (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale evaluate the efficacy and safety of this procedure relative to other treatments for uterine fibroids. See the Benefit Considerations section for potential coverage of unproven services. Information Pertaining to Medical Necessity Review (When Applicable) Endometrial Ablation For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Hysteroscopy, with or without Endometrial Resection, Ablation or Myomectomy, ACG: A-0286 (AC). Refer to section on endometrial ablation. Uterine Artery Embolization For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Uterine Artery Embolization, ACG: A-0287 (AC). Apheresis Apr. 1, 2013 Revised list of proven indications: o Added: Prophylaxis of cardiac transplant rejection Sickle cell disease for one of the following: - Red blood cell exchange for treating acute stroke, acute chest syndrome, or multiorgan failure - Prophylaxis with red blood cell exchange for primary or secondary stroke prevention or for prevention of transfusional iron overload o Replaced “familial Therapeutic apheresis is proven for the following diagnoses: ABO incompatible heart transplantation in children less than 40 months of age (plasma exchange) ABO incompatible hematopoietic stem cell and bone marrow transplant (plasma exchange) ABO incompatible kidney transplantation (plasma exchange) Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome) (plasma exchange) ANCA-associated rapidly progressive glomerulonephritis (Wegener’s Granulomatosis) (plasma exchange) Anti-glomerular basement membrane disease (Goodpasture’s syndrome) (plasma exchange) Babesiosis (RBC exchange) Cardiac allograft rejection or prophylaxis of cardiac transplant rejection (photopheresis) Chronic inflammatory demyelinating polyneuropathy (plasma exchange) Cryoglobulinemia (plasma exchange) Cutaneous T-cell lymphoma; mycosis fungoides; Se´zary syndrome, 10 March 2013 Medical Policy Updates REVISED Title Apheresis (continued) Effective Date Apr. 1, 2013 Summary of Changes hypercholesterolemi a (plasma exchange or selective adsorption)” with “heterozygous or homozygous familial hypercholesterolemi a (plasma exchange or selective adsorption)” Revised list of unproven indications; removed sickle cell disease Added information pertaining to medical necessity review (when applicable) Updated list of applicable (proven) ICD-9 diagnosis codes; added 282.41, 282.42, 289.52, 282.60, 282.61, 282.62, 282.63, 282.64, 282.68 and 282.69 Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14); added D57.1, D57.01, D57.02, D57.20, D57.211, D57.212, D57.811, D57.812, D57.80, D57.811, D57.812, D57.411, D57.412, D57.40, D57.02, D57.212, D57.412 and D57.812 Coverage Rationale erythrodermic (photopheresis) Heterozygous or homozygous familial hypercholesterolemia (plasma exchange or selective adsorption) Focal segmental glomerulosclerosis, recurrent (plasma exchange) Graft-versus-host disease, skin, chronic (photopheresis) Hyperleukocytosis, leukostasis (leukocytapheresis) Hyperviscosity in monoclonal gammopathies, treatment of symptoms (plasma exchange) IgG/IgA, or IgM type of paraproteinemic polyneuropathy (plasma exchange) Lung allograft rejection (photopheresis) Multiple sclerosis (relapsing form with steroid resistant exacerbations) (plasma exchange) Myasthenia gravis (plasma exchange) Neuromyelitis optica (Devic’s syndrome) (plasma exchange) Renal transplantation, antibody mediated rejection (plasma exchange) Renal transplantation, desensitization, living or deceased donor recipients, positive crossmatch due to donor specific HLA antibody (plasma exchange) Rheumatoid arthritis, refractory (immunoadsorption) Sickle cell disease for one of the following: o Red blood cell exchange for treating acute stroke, acute chest syndrome, or multiorgan failure o Prophylaxis with red blood cell exchange for primary or secondary stroke prevention or for prevention of transfusional iron overload Thrombotic thrombocytopenic purpura (plasma exchange) Therapeutic apheresis including plasma exchange, plasmapheresis, or photopheresis is unproven for: ABO incompatible solid organ transplantation, liver perioperative Acute disseminated encephalomyelitis Acute liver failure Age related macular degeneration Amyloidosis, systemic 11 March 2013 Medical Policy Updates REVISED Title Apheresis (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Amyotrophic lateral sclerosis Aplastic anemia; pure red cell aplasia Autoimmune hemolytic anemia: warm autoimmune hemolytic anemia; cold agglutinin disease Burn shock resuscitation Catastrophic antiphospholipid syndrome Chronic focal encephalitis (Rasmussen’s encephalitis) Coagulation factor inhibitors Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, nonerythrodermic Dermatomyositis or polymyositis Dilated cardiomyopathy Graft-versus-host disease, skin, acute Graft-versus-host disease, non-skin, acute/chronic Hereditary hemochromatosis Hemolytic uremic syndrome Hyperleukocytosis, prophylaxis Hypertriglyceridemic pancreatitis Hyperviscosity in monoclonal gammopathies, prophylaxis for rituximab IgG/IgA or IgM type of paraproteinemic polyneuropathy treated with immunoadsorption Immune thrombocytopenic purpura Immune complex rapidly progressive glomerulonephritis Inclusion body myositis Inflammatory bowel disease Lambert-Eaton myasthenic syndrome Malaria Multiple myeloma type of paraproteinemic polyneuropathy Multiple sclerosis, chronic progressive or secondary progressive Myeloma cast nephropathy Nephrogenic systemic fibrosis Overdose, venoms, and poisoning Paraneoplastic neurologic syndromes Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and Sydenham’s chorea Pemphigus vulgaris Phytanic acid storage disease (Refsum’s disease) Polycythemia vera and erythrocytosis 12 March 2013 Medical Policy Updates REVISED Title Apheresis (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes) Post transfusion purpura Psoriasis Red cell alloimmunization in pregnancy Rheumatoid arthritis, refractory, treated with plasma exchange Schizophrenia Scleroderma (progressive systemic sclerosis) Sepsis with multiorgan failure Stiff-person syndrome Systemic lupus erythematosus Thrombocytosis Thrombotic microangiopathy: drugassociated Thrombotic microangiopathy: hematopoietic stem cell transplantassociated Thyroid storm Wilson’s disease, fulminant There is insufficient evidence to conclude that apheresis, plasma exchange, plasmapheresis, immunoadsorption, or photopheresis is beneficial for health outcomes such as decreased morbidity and mortality rates in patients with disorders other than those listed as proven. Information Pertaining to Medical Necessity Review (When Applicable) Apheresis is first-line therapy for the following conditions which do not require medical necessity review: Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome) (plasma exchange) ANCA-associated rapidly progressive glomerulonephritis (Wegener’s Granulomatosis) (plasma exchange) Anti-glomerular basement membrane disease (Goodpasture’s syndrome) (plasma exchange) Babesiosis (RBC exchange) Cardiac allograft rejection prophylaxis (photopheresis) Chronic inflammatory demyelinating polyneuropathy (plasma exchange) 13 March 2013 Medical Policy Updates REVISED Title Apheresis (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Cryoglobulinemia (plasma exchange) Cutaneous T-cell lymphoma; mycosis fungoides; Se´zary syndrome, erythrodermic (photopheresis) Homozygous familial hypercholesterolemia (plasma exchange or selective adsorption) Hyperleukocytosis, leukostasis (leukocytapheresis) Hyperviscosity in monoclonal gammopathies, treatment of symptoms (plasma exchange) IgG/IgA, or IgM type of paraproteinemic polyneuropathy (plasma exchange) Myasthenia gravis (plasma exchange) Renal transplantation, antibody mediated rejection (plasma exchange) Renal transplantation, desensitization, living or deceased donor recipients, positive crossmatch due to donor specific HLA antibody (plasma exchange) Sickle cell disease for one of the following: o Red blood cell exchange for treating acute stroke or multiorgan failure o Prophylaxis with red blood cell exchange for primary or secondary stroke prevention or for prevention of transfusional iron overload Thrombotic thrombocytopenic purpura (plasma exchange) Apheresis is medically necessary for persons who are refractory to or intolerant of standard therapy for the following conditions where apheresis is second-line therapy: ABO incompatible heart transplantation in children less than 40 months of age (plasma exchange) ABO incompatible hematopoietic stem cell and bone marrow transplant (plasma exchange) ABO incompatible kidney transplantation (plasma exchange) Cardiac allograft rejection (photopheresis) Focal segmental glomerulosclerosis, recurrent (plasma exchange) Heterozygous familial hypercholesterolemia (plasma exchange or selective adsorption) 14 March 2013 Medical Policy Updates REVISED Title Apheresis (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Graft-versus-host disease, skin, chronic (photopheresis) Lung allograft rejection (photopheresis) Multiple sclerosis (relapsing form with steroid resistant exacerbations) (plasma exchange) Neuromyelitis optica (Devic’s syndrome) (plasma exchange) Rheumatoid arthritis, refractory (immunoadsorption) Sickle cell disease, acute chest syndrome (red blood cell exchange) Bariatric Surgery Apr. 1, 2013 Bariatric surgery, as a primary treatment for weight loss is proven for the following: 1. Class III obesity (BMI > 40 kg/m2) 2. Class II obesity (BMI 35-39.9 kg/m2) in the presence of one or more of the following co-morbidities: Type 2 diabetes Cardiovascular disease (e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy) History of coronary artery disease with a surgical intervention such as cardiopulmonary bypass or percutaneous transluminal coronary angioplasty Cardiopulmonary problems (e.g., documented obstructive sleep apnea (OSA) confirmed on polysomnography with an AHI or RDI of >= 30 (as defined by AASM Task Force. Sleep.1999;22:667-89) History of cardiomyopathy Reorganized policy content Updated description of services to reflect most current clinical evidence and references Reformatted and revised coverage rationale: o Updated/expanded class II obesity (BMI 35-39.9 kg/m2) comorbidity descriptions for cardiovascular disease and lifethreatening cardiopulmonary problems o Added criteria for medical necessity review (when applicable) o Removed language indicating vertical banded gastroplasty (gastric banding; gastric stapling), biliopancreatic bypass (Scopinaro procedure), and biliopancreatic diversion with duodenal switch are not first-line procedures for the general bariatric surgery patient o Replaced references The following bariatric surgical procedures are proven in adults for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI): Gastric bypass (Roux-en-Y; gastrojejunal anastomosis) Adjustable gastric banding (laparoscopic adjustable silicone gastric banding) Gastric sleeve procedure (also known as laparoscopic vertical gastrectomy or 15 March 2013 Medical Policy Updates REVISED Title Bariatric Surgery (continued) Effective Date Apr. 1, 2013 Summary of Changes to “morbid obesity” with “extreme obesity” (per updated National Heart, Lung and Blood Institute (NHLBI) classification) Coverage Rationale laparoscopic sleeve gastrectomy) Vertical banded gastroplasty (gastric banding; gastric stapling) Biliopancreatic bypass (Scopinaro procedure) Biliopancreatic diversion with duodenal switch Some bariatric surgical procedures are proven in adolescents for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI) and who have: Achieved greater than 95% of estimated adult height based on documented individual growth pattern; AND A minimum Tanner stage of 4 The following bariatric surgeries are proven in adolescents: Gastric bypass (Roux-en-Y; gastrojejunal anastomosis) Adjustable gastric banding (laparoscopic adjustable silicone gastric banding) Gastric sleeve procedure (also known as laparoscopic vertical gastrectomy or laparoscopic sleeve gastrectomy) Robotic assisted gastric bypass surgery is proven non-preferentially as equivalent but not superior to other types of minimally invasive bariatric surgery. Surgical revision or a second bariatric surgery is proven for inadequate weight loss if the original criteria for bariatric surgery (BMI, co-morbidities and patient selection criteria) continue to be met. Surgical adjustment or alteration of a prior bariatric procedure is proven for complications of the original surgery, such as stricture, obstruction, pouch dilatation, erosion, or band slippage when the complication causes abdominal pain, inability to eat or drink or causes vomiting of prescribed meals. Bariatric surgical procedures in a person who has not attained an adult level of physical development and maturation are 16 March 2013 Medical Policy Updates REVISED Title Bariatric Surgery (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale unproven. Potential safety issues must be addressed in studies with sufficient sample size and adequate follow-up times necessary to demonstrate the impact of the surgery on physical, sexual and reproductive maturation and the long term improvement of comorbidities in this age group. Transoral endoscopic surgery (such as transoral gastroplasty [TOGA®], StomaphyX, and Restorative Obesity Surgery, Endoluminal [ROSE] procedure) is unproven as a treatment for obesity. The medical device used for TOGA has not received FDA approval. A clinical trial is currently underway to evaluate the safety and effectiveness of TOGA. Further studies are needed to determine the safety and efficacy of StomaphyX and the Rose procedure for the revision of gastric bypass surgery to reduce the stomach pouch and stomach outlet (stoma) to the original gastric bypass size. The mini-gastric bypass (MGB), also known as laparoscopic mini-gastric bypass (LMGBP) is unproven. Further studies are needed to determine the safety and efficacy of mini-gastric bypass surgery. In addition, patient selection criteria must be better defined for this procedure. Gastric electrical stimulation with an implantable gastric stimulator (IGS) is unproven. Further studies are needed to determine the safety and efficacy of gastric electrical stimulation with an implantable gastric stimulator as an option for treating obesity with bariatric surgery. Vagus nerve blocking (VNB) or vagal blocking therapy is unproven for treatment of obesity. Further studies are needed to determine the safety and efficacy of Vagus nerve blocking as a treatment option for obesity. Intragastric balloon is unproven as a treatment for obesity. Further studies are needed to determine the safety and efficacy of intragastric balloon as a 17 March 2013 Medical Policy Updates REVISED Title Bariatric Surgery (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale treatment option for obesity. Gastrointestinal liners (EndoBarrier) are investigational and unproven as a treatment for obesity. Gastrointestinal liners have not received FDA approval. Laparoscopic greater curvature plication, also known as total gastric vertical plication, is unproven for the treatment of obesity. Further studies are needed to evaluate the safety and efficacy of performing lower greater curvature plication for the treatment of obesity. Bariatric surgery to treat gynecological abnormalities, osteoarthritis, gallstones, urinary stress incontinence or as a treatment for gastroesophageal reflux (including for Barrett’s esophagus or gastroparesis), and other obesity associated diseases that generally do not lead to life threatening consequences is unproven. There is insufficient published clinical evidence to support bariatric surgery for the treatment of gynecological abnormalities, osteoarthritis, gallstones, urinary stress incontinence or as a primary treatment for gastroesophageal reflux and other obesity associated diseases. Bariatric surgery will frequently ameliorate symptoms of comorbidities such as gastroesophageal reflux disease and obstructive sleep apnea. However, the primary purpose of bariatric in obese person’s surgery is to achieve weight loss. Additional information for medical necessity review, where applicable: Bariatric surgery is medically necessary when ALL of the following criteria have been met: Body mass index (BMI) = or > 40 kg/m2 or BMI 35.0-39.9 kg/m2 with one or more of the medical comorbidities described above. Documentation of a motivated attempt of weight loss through a structured diet program, prior to bariatric surgery, which includes physician or other health care provider notes and/or diet or weight loss logs from a structured weight loss 18 March 2013 Medical Policy Updates REVISED Title Bariatric Surgery (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale program for a minimum of 6 months. (NHLBI, 1998) Psychological evaluation to rule out major mental health disorders which would contraindicate surgery and determine patient compliance with postoperative follow-up care and dietary guidelines. (NHLBI, 1998) The National Heart, Lung and Blood Institute (NHLBI) classify the ranges of BMI in adults as follows (NHLBI, 1998): <18.5 - Underweight 18.5 to 24.9 kg/m2 - Normal 25-29.9 kg/m2 - Overweight 30-34.9 kg/m2 - Obesity Class I 35-39.9 kg/m2 - Obesity Class II > 40 kg/m2 –Extreme Obesity Class III Extreme obesity or Class III obesity as described in a 1998 NHLBI guideline was also addressed in previous consensus statements as morbid obesity. The term “clinically severe obesity” is preferred to the once commonly used term “morbid obesity” and is described in the NHLBI practical guide document of 2000. “Surgery is an option for well-informed and motivated patients who have clinically severe obesity (BMI ≥ 40) or a BMI ≥ 35 and serious comorbid conditions.” (NHLBI 2000) For adolescents, physical development and maturation may be determined utilizing the gender specific growth chart and BMI chart. Male Growth Chart Female Growth Chart Male BMI Chart Female BMI Chart Estimated adult height may also be calculated utilizing the Mid-Parental height calculation (FP Notebook, 2008): Boy In: (Father's Height + Mother's Height + 5) / 2 Cm: (Father's Height + Mother's Height + 19 March 2013 Medical Policy Updates REVISED Title Bariatric Surgery (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale 13) / 2 Girl In: (Father's Height - 5 + Mother's Height) / 2 Cm: (Father's Height - 13 + Mother's Height) / 2 Refer to the policy for information on Tanner Stages. Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes Apr. 1, 2013 Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ care guidelines, 17th edition, 2013” (effective 04/01/13) Insulin Delivery External insulin pumps that deliver insulin by continuous subcutaneous infusion are proven for treating patients with diabetes. Disposable external insulin pumps are considered equivalent to standard insulin pumps. Implantable insulin pumps are investigational and unproven. No implantable insulin pumps have received U.S. Food and Drug Administration (FDA) approval at this time. While some preliminary studies reported improved glycemic control and fewer episodes of hypoglycemia in carefully selected patients, complications such as catheter blockage and infection were observed. Larger, randomized controlled trials are needed to determine the long term impact of implantable insulin pumps on diabetes management. Insulin infuser ports, such as the i-port® Injection Port, are unproven for insulin delivery in patients with diabetes. There is insufficient evidence demonstrating that the use of insulin infuser ports results in improved glycemic control beyond what can be achieved by using standard insulin delivery methods. In addition, an increase in complications, such as infection at the port site, has been reported when using these devices. Further well-designed, large-scale randomized controlled trials are needed to establish the safety and efficacy of this device. Continuous Glucose Monitors with or without Combined Insulin Pumps Long-term continuous glucose monitoring (greater than 72 hours), alone or in combination with an external insulin pump, is proven as a supplement to self- 20 March 2013 Medical Policy Updates REVISED Title Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale monitoring of blood glucose (SMBG) for type 1 diabetes patients who meet EITHER of the following criteria AND have demonstrated adherence to a physician ordered diabetic treatment plan: Have been unable to achieve optimum glycemic control as defined by the most current version of the American Diabetes Association (ADA) Standards of Medical Care in Diabetes; OR Have experienced hypoglycemia unawareness ADA Standards of Medical Care in Diabetes available at: http://professional.diabetes.org/ResourcesForP rofessionals.aspx?cid=84160. Accessed March 30, 2012. Long-term continuous glucose monitoring is unproven for patients with type 2 diabetes or gestational diabetes. There is insufficient evidence that the use of long-term continuous glucose monitoring leads to improvement of glycemic control in persons with type 2 or gestational diabetes. Closed-Loop Combined Systems External insulin pumps and continuous blood glucose monitors, combined into a single closed-loop system not requiring direct patient interaction, are investigational and unproven. No closed-loop systems have received FDA approval at this time. Study results fail to provide conclusive evidence that closed-loop systems lead to improved health outcomes in persons with diabetes. This system has only been tested in closed-loop mode for short periods of time in a small number of patients who were receiving more intensive medical care than is typical for most persons with diabetes. There is insufficient evidence that improved health outcomes, if any, are durable over time. Further controlled studies with larger numbers of patients and longer periods of closed-loop insulin management are needed to assess the safety and efficacy of these systems. Remote Glucose Monitoring Remote glucose monitoring (e.g., 21 March 2013 Medical Policy Updates REVISED Title Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale mySentry™) is unproven for managing patients with diabetes. There is insufficient evidence in the clinical literature to conclude that remote glucose monitoring demonstrates improvement in clinical outcomes. Additional Information As part of the ongoing effort to improve diabetes care, the National Diabetes Education Program, the American Association of Clinical Endocrinology and others have recommended the term "A1c" be used for GHB or hemoglobin A1c (HbA1c) measurement in health care practice to avoid confusion. Information Pertaining to Medical Necessity Review (When Applicable) Insulin Delivery For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th edition, 2012, Insulin Infusion Pump ACG:A-0339 (AC). Continuous Glucose Monitoring For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th edition, 2012, Continuous Glucose Monitoring ACG:A-0126 (AC). Deep Brain Stimulation Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14); removed G24.09 and G25.1 Deep brain stimulation is proven for treating the following: Idiopathic Parkinson's disease when used according to U.S. Food and Drug Administration (FDA) indications Essential tremor when used according to U.S. Food and Drug Administration (FDA) indications Primary dystonia* (occurs apart from any other identifiable illness) including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis) when used according to the U.S. Food and Drug Administration (FDA) indications *Primary dystonia may include genetic torsion dystonia, acquired torsion dystonia (not due to drugs), spasmodic torticollis, fragments of torsion dystonia, and unspecified torticollis. Deep brain stimulation is unproven for 22 March 2013 Medical Policy Updates REVISED Title Deep Brain Stimulation (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale treating secondary Parkinsonism (result of head trauma, metabolic conditions, toxicity, drugs, or other medical disorders). Well-designed studies demonstrating the efficacy of deep brain stimulation for treating secondary Parkinsonism are not available. Clinical trials are needed to demonstrate the benefit of deep brain stimulation for this patient population. Deep brain stimulation is unproven for treating secondary dystonia (occurs with illness, after trauma or following exposure to certain medications or toxins). There is inadequate evidence of the safety and efficacy of deep brain stimulation for treating secondary dystonia. Questions remain with regard to patient selection criteria and longterm benefits and safety compared with standard treatments. Formal comparisons, with large randomized controlled or comparative trials of pallidotomy, thalamotomy, and deep brain stimulation, are required before conclusions can be drawn regarding the use of deep brain stimulation for patients with secondary dystonia. Deep brain stimulation is unproven for treating conditions other than those listed as proven. This includes but is not limited to the following diagnoses: Depression Obsessive-compulsive disorder (OCD) Epilepsy Tourette syndrome Cluster headache Impulsive or violent behavior Chronic pain Trigeminal neuralgia Movement disorders caused by multiple sclerosis (MS) Some studies have examined the use of deep brain stimulation for treating major depression, obsessive-compulsive disorder (OCD), epilepsy, Tourette syndrome, cluster headache, impulsive or violent behavior, stroke pain, chronic pain, phantom limb pain, trigeminal neuralgia and movement disorders of multiple sclerosis (MS). However, because of limited studies, small sample sizes, weak study designs and heterogenous patient 23 March 2013 Medical Policy Updates REVISED Title Deep Brain Stimulation (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale characteristics, there is insufficient data to conclude that deep brain stimulation is safe and/or effective for treating these indications. Information Pertaining to Medical Necessity Review (When Applicable) Deep brain stimulation is medically necessary for idiopathic Parkinson's disease, essential tremor, or primary dystonia if signs or symptoms persist despite standard medical therapy. Elbow Replacement Surgery (Arthroplasty) Apr. 1, 2013 Revised coverage rationale; replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Elbow Arthroplasty, S-420 (ISC). Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Updated list of applicable CPT codes; added 63650, 63655, 63661, 63662, 63663, 63664, 63685 and 63688 Functional electrical stimulation (FES), a form of neuromuscular electrical stimulation (such as Parastep I), is proven for rehabilitation in persons with paralyzed lower limbs due to spinal cord injury (SCI) with all of the following characteristics: Intact lower motor units (L1 and below) (both muscle and peripheral nerves) Muscle and joint stability for weight bearing at upper and lower extremities that can demonstrate balance and control to maintain an upright support posture independently; Demonstrate brisk muscle contraction to NMES and have sensory perception of electrical stimulation sufficient for muscle contraction; Possess high motivation, commitment and cognitive ability to use such devices for walking; Able to transfer independently and demonstrate independent standing tolerance for at least 3 minutes; Demonstrate hand and finger function to manipulate controls; Post recovery from spinal cord injury and restorative surgery of at least 6-months; No hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis 24 March 2013 Medical Policy Updates REVISED Title Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Functional electrical stimulation (such as ERGYS, RT300 or ODFS Dropped Foot Stimulator) is unproven for the treatment of disuse muscle atrophy in persons with spinal cord injury (who do not meet the requirements above) or multiple sclerosis. Further studies are needed to confirm that functional electrical stimulation promotes bone remineralization and prevents or reverses muscle atrophy. Only a few studies have looked at FES as a modality of treatment of multiple sclerosis, and the results are limited and conflicting regarding whether FES improves treatment outcomes in multiple sclerosis when offered in addition to other rehabilitative treatment modalities. Functional electrical stimulation (such as Walkaide, NESS L300 or ODFS Dropped Foot Stimulator) is unproven for the treatment of gait disorders (e.g., foot drop) of central neurologic origin including but not limited to stroke or multiple sclerosis. There is insufficient evidence in the peer reviewed literature that use of functional electrical stimulation will improve health outcomes in patients with gait disorders. Published studies have included small heterogeneous patient populations, short-term follow-ups, and various treatment protocols, outcome measures, and FES devices. Only a few studies have looked at FES as a modality of treatment of multiple sclerosis, and the results are limited and conflicting regarding whether FES improves treatment outcomes in multiple sclerosis when offered in addition to other rehabilitative treatment modalities. Neuromuscular electrical stimulation (NMES) is proven for: A. Treatment of disuse muscle atrophy if: The nerve supply to the muscle is intact; and The disuse muscle atrophy is not of neurological origin but originates from conditions such as casting, splinting or contractures. B. Treatment to improve wrist and finger function and prevent or correct shoulder subluxation in persons with 25 March 2013 Medical Policy Updates REVISED Title Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale partial paralysis following stroke Neuromuscular electrical stimulation (NMES) is unproven for the treatment of neurologic, orthopedic (e.g., scoliosis) or other abnormalities including pain not listed as proven. Additionally, there is insufficient evidence for NMES for all other indications. There is insufficient evidence in the peer reviewed literature that use of electrical stimulation will improve health outcomes for the treatment of neurologic or orthopedic conditions other than those identified above as proven. Randomized, controlled trials are necessary to assess the durability of this procedure in comparison to other types of treatment. Interferential therapy (IFT) is proven for the treatment of pain associated with musculoskeletal disorders or injuries, and stimulating healing of nonsurgical soft tissue injuries. Interferential therapy is unproven to facilitate the healing of bone fractures. There is insufficient evidence from the available studies to conclude that interferential therapy promotes healing of bone fractures. None of the double-blind, randomized, placebo-controlled studies reported a positive treatment effect of interferential therapy for bone fractures. Pulsed electrical stimulation (PES) is unproven for the treatment of osteoarthritis. There is insufficient evidence to conclude that PES provides health benefits to patients with osteoarthritis. Randomized, controlled trials are necessary to assess the durability of this procedure in comparison to other types of treatment. Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS) is unproven for the treatment of pain. Evidence for the effectiveness of PSFS or PNFS based on controlled studies is lacking. Randomized controlled trials are needed to 26 March 2013 Medical Policy Updates REVISED Title Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation (continued) Effective Date Apr. 1, 2013 Fecal DNA Testing Apr. 1, 2013 Summary of Changes Information Pertaining to Medical Necessity Review (When Applicable) The above indications apply to medical necessity review. Gastrointestinal Motility Disorders, Diagnosis and Treatment Coverage Rationale evaluate the efficacy of this treatment. Apr. 1, 2013 Updated description of services to reflect most current clinical evidence, FDA information and references Revised coverage rationale; replaced language indicating “fecal DNA testing for colorectal cancer screening and/or monitoring is investigational due to lack of U.S. Food and Drug Administration (FDA) approval” with “fecal DNA testing for colorectal cancer screening and/or monitoring is unproven and investigational due to lack of U.S. Food and Drug Administration (FDA) approval” Fecal DNA testing for colorectal cancer screening and/or monitoring is unproven and investigational due to lack of U.S. Food and Drug Administration (FDA) approval. Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Gastric electrical stimulation therapy is proven for the treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology when used according to U.S. Food and Drug Administration (FDA) labeled indications. See the U.S. Food and Drug Administration (FDA) section for information regarding FDA labeling and Humanitarian Device Exemption (HDE) for gastric electrical stimulation. There is insufficient evidence in the clinical literature supporting the diagnostic accuracy of fecal DNA tests to screen for colorectal cancer in asymptomatic, average-risk patients. The existing evidence has little or no applicability to currently available fecal DNA tests. Further studies are needed to determine the analytic and clinical validity of the test as compared to other screening methods. At this time, no tests have received FDA approval. Until the FDA completes its review of fecal DNA tests, they are investigational. The FDA has classified DNA testing as a device; therefore, it is subject to FDA review. The SmartPill® wireless gastrointestinal motility monitoring system is proven for diagnosing and evaluating gastrointestinal motility disorders including gastroparesis when used according to FDA labeled indications. See the U.S. Food and Drug Administration (FDA) section of policy for information 27 March 2013 Medical Policy Updates REVISED Title Gastrointestinal Motility Disorders, Diagnosis and Treatment (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale regarding FDA labeling and indications for SmartPill. The following tests are proven for evaluating anorectal function: Rectal sensation, tone, and compliance test Anorectal manometry Cutaneous, mucous, or serosal electrogastrography is unproven for diagnosing gastric disorders including gastroparesis. There is insufficient evidence to conclude that electrogastrography can accurately diagnose gastroparesis and other gastric disorders. There are no data to conclude that electrogastrography is beneficial for health outcomes in patients with gastric disorders. Colonic manometry is unproven for evaluating colon motility. There is insufficient clinical evidence of efficacy in the published peer-reviewed medical literature for the use of colon motility testing or colonic manometry. Patient selection criteria and the role of colonic manometry in the management of motility abnormalities such as refractory constipation must be better defined in statistically robust, well-designed clinical trials. Information Pertaining to Medical Necessity Review (When Applicable) The SmartPill® wireless gastrointestinal motility monitoring system is medically necessary when earlier diagnostic tests have failed to identify the cause of symptoms consistent with a gastrointestinal motility disorder. Gastric electrical stimulation is medically necessary for refractory diabetic gastroparesis that has failed other therapies. Gene Expression Testing Apr. 1, 2013 Revised coverage rationale for oncology related services/ treatment; added language to indicate: o Multi-panel gene expression tests Oncology Multi-panel gene expression tests (e.g., Afirma®) are proven for assessing thyroid nodules that are not clearly benign or malignant based on fine-needle aspiration biopsy results alone. 28 March 2013 Medical Policy Updates REVISED Title Gene Expression Testing (continued) Effective Date Apr. 1, 2013 Summary of Changes (e.g., Afirma®) are proven for assessing thyroid nodules that are not clearly benign or malignant based on fine-needle aspiration biopsy results alone o Gene expression tests are unproven for predicting metastatic risk of uveal melanoma (e.g., DecisionDxUM) Updated list of applicable ICD-9 diagnosis codes; added 241.0, 241.1, 241.9, 226, 242.00, 242.01, 242.10, 242.11, 242.20, 242.21, 242.30, 242.31, 242.40, 242.41, 242.80, 242.81, 242.90, 242.91, V10.87, 153.0, 153.1, 153.2, 153.3, 153.4, 153.5, 153.6, 153.7, 153.8, 153.9, 190.1, 190.6, 190.8, 190.9, 203.00, 203.01, 203.02, 203.10, 203.11, 203.12, 203.80, 203.81, 203.82, 205.00, 205.01, 205.02, 205.10, 205.11, 205.12, 205.20, 205.21, 205.22, 205.80, 205.81, 205.82, 205.90, 205.91, 205.92, 207.00, 207.01, 207.02, 207.20, 207.21, 207.22, 207.80, 207.81, 207.82, 209.10, 209.11, 209.12, 209.13, 209.14, 209.15, 209.16, 209.26, 209.27, 209.50, 209.51, 209.52, 209.53, 209.54, 209.55, 209.56, 209.66, 209.67, 238.6, 429.0, 429.1, 429.2, 429.3, 429.81, 429.82, 429.83, 429.89, 429.9, V10.05, V10.84, V17.41, V17.49, V81.2 and 795.82 Coverage Rationale Gene expression tests are unproven for the following: Predicting the likelihood of colon cancer recurrence (e.g., Oncotype DX® Colon Cancer Assay) Guiding therapy in patients with myeloma (e.g., MyPRS™) Identifying tissue of origin in difficult to diagnose cancers (e.g., Pathwork® Diagnostics Tissue of Origin or CancerTYPE ID®) Predicting metastatic risk of uveal melanoma (e.g., DecisionDx-UM) There is insufficient evidence in the clinical literature demonstrating that these tests have a role in clinical decision-making or have a beneficial effect on health outcomes. Further studies are needed to determine the analytic validity, clinical validity and/or clinical utility of these tests. Non-Oncology Gene expression tests are unproven for the following: Assessing cardiovascular risk (e.g., Corus® CAD) There is insufficient evidence in the clinical literature demonstrating that this test has a role in clinical decision-making or has a beneficial effect on health outcomes. Further studies are needed to determine the analytic validity, clinical validity and clinical utility of this test. 29 March 2013 Medical Policy Updates REVISED Title Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) Effective Date Apr. 1, 2013 Summary of Changes • Revised coverage rationale: o Removed language indicating genetic counseling is strongly recommended after genetic testing for BRCA mutations o Added information pertaining to medical necessity review (when applicable) • Reformatted list of applicable CPT codes; created new table heading for codes related to large genomic rearrangements/ BART (CPT code 81213) Coverage Rationale This policy discusses genetic testing for hereditary breast and/or ovarian cancer (HBOC) syndrome otherwise known as BRCA1 and BRCA2. Definitions: Please note, for the purpose of this policy: 1. Close blood relatives are defined as follows: a. First degree relatives include parents, siblings and offspring b. Second degree relatives include half-brothers/sisters, aunts/uncles, grandparents, grandchildren and nieces/nephews affected on the same side of the family c. Third degree relatives include first cousins, great-aunts/uncles, great-grandchildren and great grandparents affected on same side of family 2. A breast cancer diagnosis includes either invasive or non-invasive (ductal carcinoma in situ) types. 3. Ovarian cancer also includes fallopian tube cancers and primary peritoneal carcinoma. 4. Limited family history is defined as having fewer than two known first-degree or second-degree female relatives or female relatives surviving beyond 45 years of age on either or both sides of the family. (e.g., individual who is adopted) 5. Documentation of personal and family history should be in the contemporaneous medical records submitted with the testing request (i.e., request form). 6. For the statements that include age guidelines, a person is considered to be 45 years of age up until the day before their 46th birthday, and a person is considered to be 50 years of age up until the day before their 51st birthday. 7. Two breast primary cancers include 30 March 2013 Medical Policy Updates REVISED Title Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale cancers appearing at the same time (synchronous) and one is not a metastasis of the other; or primary cancers developing at intervals (metachronous or asynchronous). The tumors may be in one or two breasts. 8. HBOC-associated malignancies include prostate cancer, pancreatic cancer or melanoma. The presence of these malignancies does not necessarily justify BRCA testing. For example, a female with breast cancer over age 50 whose sister had melanoma at 40 and whose father has prostate cancer would meet criteria. In another example, a female with breast cancer over age 50 whose maternal aunt had pancreatic cancer and whose paternal uncle had prostate cancer would not meet criteria because the aunt and uncle are on different sides of the family. 9. Triple-negative breast cancer refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or HER2/neu. This subtype of breast cancer is clinically characterized as more aggressive and less responsive to standard treatment and is associated with poorer overall patient prognosis. It is diagnosed more frequently in younger women, women with BRCA1 mutations and those belonging to African-American and Hispanic ethnic groups. Genetic Counseling Genetic counseling is strongly recommended prior to and after genetic testing for BRCA mutations in order to inform persons being tested about the advantages and limitations of a specific genetic test as applied to a unique person. BRCA Testing Criteria I. BRCA1 and BRCA2 testing is proven for women with a personal history of breast cancer in the following situations: A. Breast cancer diagnosed at age 45 31 March 2013 Medical Policy Updates REVISED Title Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale or younger with or without family history; OR B. Breast cancer diagnosed at age 50 or younger with: 1. At least one close blood relative with breast cancer at age 50 or younger; OR 2. At least one close blood relative with ovarian cancer; OR 3. Limited family history (see Definitions section for further clarification) C. Breast cancer diagnosed at any age with: 1. Two breast primary cancers, when first breast cancer diagnosis occurred prior to age 50 OR 2. Two breast primary cancers in a single individual with at least one close blood relative with breast cancer diagnosed at age 50 years or younger; OR 3. Two breast primary cancers in a single individual with at least one close blood relative with ovarian cancer; OR 4. Personal history of ovarian cancer; OR 5. At least two close blood relatives on the same side of the family with breast, ovarian and/or pancreatic cancer at any age; OR 6. Close male blood relative with breast cancer; OR 7. At least one close blood relative that has a BRCA1 or BRCA2 mutation; OR 8. At least two close blood relatives on the same side of the family with other HBOC syndrome associated malignancies (prostate, pancreatic, melanoma); OR 32 March 2013 Medical Policy Updates REVISED Title Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale 9. Ashkenazi Jewish or ethnic groups associated with higher mutation frequency such as, Icelandic, Swedish, Dutch or Hungarian descent D. Triple negative breast cancer diagnosed at age 60 or younger. II. BRCA1 and BRCA2 testing is proven for women with a personal history of ovarian cancer. III. BRCA1 and BRCA2 testing is proven for women and men with a personal history of pancreatic cancer at any age and at least two close blood relatives on the same side of the family with breast, ovarian and/or pancreatic cancer at any age. IV. BRCA1 and BRCA2 testing is proven for men with a personal history of breast cancer. V. BRCA1 and BRCA2 testing is proven for men and women without a personal history of breast or ovarian cancer with: A. At least one first- or second-degree blood relative meeting any of the above criteria (I-IV) OR B. At least one third-degree blood relative with breast cancer and/or ovarian cancer who has at least 2 close blood relatives with breast cancer (at least one with breast cancer at age 50 or younger) and/or ovarian cancer OR C. A known BRCA1/BRCA2 mutation in the family (defined as first-, second- or third-degree relative) VI. BRCA1 and/or BRCA2 testing is unproven for all other indications including screening of breast or ovarian cancers or for risk assessment of other cancers. While the BRCA mutation is known to be associated with other 33 March 2013 Medical Policy Updates REVISED Title Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale cancers such as prostate, pancreas and melanoma, as part of the Hereditary Breast Ovarian Cancer Syndrome (HBOC), BRCA testing is not indicated when one of these cancers is isolated in the family. Information Pertaining to Medical Necessity Review (When Applicable) The above criteria apply to medical necessity review. Additional Information Note: If there are no living family members with breast or ovarian cancer, consider testing family members affected with cancers thought to be associated with BRCA1/BRCA2, prostate and pancreatic cancers and melanoma. Large Genomic Rearrangement Testing i. Detection of large genomic rearrangements (e.g., BRACAnalysis® Large Rearrangement Test (BART)) is proven for individuals who meet the testing criteria for BRCA1/BRCA2 and have no known familial BRCA1/BRCA2 mutations*. Information Pertaining to Medical Necessity Review (When Applicable) Detection of large genomic rearrangements (e.g., BRACAnalysis® Large Rearrangement Test (BART)) is medically necessary when the following criteria are met: A. Individual meets the testing criteria for BRCA1/BRCA2 and has no known familial BRCA1/BRCA2 mutations* B. Testing is conducted on an affected family member with the highest likelihood of a BRCA1/BRCA2 mutation (NCCN, 2012) C. Test is limited to one per 34 March 2013 Medical Policy Updates REVISED Title Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale family (defined as first degree relatives: parents, siblings and offspring) I. Glaucoma Surgical Treatment Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Reflex testing will be applied by Myriad Genetics if original BRCA test results are negative. Reflex testing is defined as follow-up testing automatically initiated when certain test results are observed in the laboratory. Detection of large genomic rearrangements (e.g., BRACAnalysis® Large Rearrangement Test (BART)) is unproven for the purpose of screening in the general population. There is inadequate clinical evidence that such screening reduces mortality from breast cancer in a normal risk population. Glaucoma drainage devices, such as the ExPRESS™ mini glaucoma shunt, Molteno implant, Baerveldt tube shunt, Krupin Eye Valve, or the Ahmed glaucoma valve implant, are proven when used according to U.S. Food and Drug Administration (FDA) labeled indications. The iStent® Trabecular Micro-Bypass Stent System is unproven for the treatment of glaucoma. There is insufficient evidence demonstrating the efficacy of iStent for treating glaucoma. There are no long-term large studies that address the efficacy of the iStent compared to other intraocular pressure-lowering devices or procedures. Well-designed studies with larger patient populations and longer follow-up are required to demonstrate the safety and benefits of this device. Glaucoma drainage devices, such as Eyepass, DeepLight SOLX® Gold Shunt and other shunts that do not have FDA approval are investigational and unproven for the treatment of glaucoma. Clinical evidence is limited to small studies; 35 March 2013 Medical Policy Updates REVISED Title Glaucoma Surgical Treatment (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale therefore, additional studies are needed to establish the safety and efficacy of these devices. Canaloplasty is proven for the treatment of primary open-angle glaucoma. Viscocanalostomy is unproven for the treatment of glaucoma. Evidence from the majority of available randomized controlled trials indicates that viscocanalostomy is not as effective as trabeculectomy in reducing intraocular pressure (IOP). Transciliary fistulization is unproven for the treatment of glaucoma. Further studies are needed to evaluate longterm safety and efficacy in comparison to established filtering procedures. The currently available published data are insufficient to draw any conclusion regarding health outcomes of transciliary fistulization for the treatment of glaucoma. Information Pertaining to Medical Necessity Review (When Applicable) The use of aqueous shunts or glaucoma drainage devices with the ExPRESS™ mini glaucoma shunt, Molteno implant, Baerveldt tube shunt, Krupin Eye Valve, or the Ahmed glaucoma valve implant is medically necessary for treatment of refractory glaucoma when there is intolerance, contraindication, or failure of topical or oral medication. High Frequency Chest Wall Compression Devices Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) High-frequency chest wall compression (HFCWC), as a form of chest physical therapy, is proven for treating or preventing pulmonary complications of the following conditions: Cystic fibrosis (CF) Bronchiectasis High-frequency chest wall compression (HFCWC), as a form of chest physical therapy, is unproven for diagnoses other than cystic fibrosis and bronchiectasis, including, but not limited to respiratory symptoms attributed to neuromuscular disorders when they compromise respiration, such as amyotrophic lateral 36 March 2013 Medical Policy Updates REVISED Title High Frequency Chest Wall Compression Devices (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale sclerosis (ALS), cerebral palsy, familial dysautonomia, muscular dystrophy or quadriplegia. The evidence regarding the efficacy of HFCWC therapy in patients with non-CF or bronchiectasis-related disorders of airway clearance is very limited and thus insufficient to support definitive conclusions regarding the use of this technology in these patient populations. It remains to be proven if the primary benefit of HFCWC therapy is reduction in labor required to administer CPT or if there are other benefits, such as improved compliance or quality of life, better airway clearance, reduced infection rate or improvements in other outcomes. Larger, long-term studies will be necessary to adequately evaluate the relative benefits of HFCWC compared with conventional CPT or other types of respiratory therapy. Information Pertaining to Medical Necessity Review (When Applicable) The above criteria apply to medical necessity review. High Ligation and Endomechanical Ablation for Varicose Veins Apr. 1, 2013 Updated description of services to reflect most current clinical evidence and references Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Ligation of the great saphenous vein at the saphenofemoral junction, as a stand-alone procedure, is unproven for treating venous reflux. Ligation performed without stripping or ablation is associated with high long-term recurrence rates due to neovascularization. Ligation of the small saphenous vein at the saphenopopliteal junction, as a stand-alone procedure, is unproven for treating venous reflux. Ligation performed without stripping or ablation is associated with high long-term recurrence rates due to neovascularization. Ligation at the saphenofemoral junction, as a stand-alone procedure, is proven, when used in patients with ascending superficial thrombophlebitis, to prevent the propagation of an active clot from the superficial system to the deep venous system. Ligation at the saphenofemoral junction, as an adjunct to radiofrequency ablation or endovenous laser ablation of the main saphenous veins, is unproven. Published 37 March 2013 Medical Policy Updates REVISED Title High Ligation and Endomechanical Ablation for Varicose Veins (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale clinical evidence has not demonstrated that the addition of saphenofemoral ligation to endovenous ablation procedures provides an additive benefit in resolving venous reflux or preventing varicose vein recurrence. Endovenous ablation is a clinically effective therapy for treating venous reflux. Adding ligation to the procedure adds clinical risk without adding clinical benefit. Endomechanical ablation of varicose veins using a percutaneous infusion catheter, such as ClariVein®, is unproven for treating venous reflux. There is insufficient evidence in the clinical literature supporting the safety and efficacy of endomechanical ablation for treating varicose veins. Further results from large, well-designed studies are needed to support the clinical utility of this approach. See the Coverage Determination Guidelines titled Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins for information on additional vein procedures. Information Pertaining to Medical Necessity Review (When Applicable) Ligation at the saphenofemoral junction, as a stand-alone procedure, is medically necessary to prevent the propagation of an active clot to the deep venous system in patients with ascending superficial thrombophlebitis who fail or are intolerant of anticoagulation therapy. Apr. 1, 2013 Hip Replacement Surgery (Arthroplasty) Implantable BetaEmitting Microspheres for Treatment of Malignant Tumors Apr. 1, 2013 Revised coverage rationale; replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Hip Arthroplasty, S-560 (ISC). Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Yttrium-90 (90Y) microsphere radioembolization (SIR-Spheres® or TheraSphere®) is proven for the following indications: Unresectable metastatic liver tumors from primary colorectal cancer (CRC) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Hip: Displaced Fracture of Femoral Neck, Hemiarthroplasty, S-600 (ISC). 38 March 2013 Medical Policy Updates REVISED Title Implantable BetaEmitting Microspheres for Treatment of Malignant Tumors (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Unresectable metastatic liver tumors from neuroendocrine tumors Unresectable primary hepatocellular carcinoma (HCC) Yttrium-90 (90Y) microsphere radioembolization (SIR-Spheres® or TheraSphere®) is unproven for all other indications. Limited evidence suggests that treatment with intrahepatic microsphere radiation (IMR) might shrink tumors and relieve symptoms in some patients, sometimes enough to render some inoperable tumors operable. However, limited available evidence has not shown improved survival. In addition, the treatment's potential impact on quality of life has not been studied. No studies have yet compared the effects of IMR therapy with alternative treatments, such as chemoembolization. Randomized controlled trials are needed to determine the clinical utility of this treatment. Information Pertaining to Medical Necessity Review (When Applicable) The above indications apply to medical necessity review. Infertility Diagnosis and Treatment Apr. 1, 2013 Updated benefit considerations; added language to indicate infertility services are always subject to mandate review. Several states mandate benefit coverage for certain infertility services, but the requirements for coverage vary from state to state; legislative mandates and the member-specific benefit document must be reviewed when determining benefit coverage for infertility services Diagnostic Procedures The following procedures are proven for use in diagnosing infertility in female patients: Chromotubation of oviduct Cultures (cervical, vaginal, uterine) Hormone assay (luteinizing hormone (LH), follicle stimulating hormone (FSH), progesterone, prolactin, estradiol, thyroid, clomiphene citrate challenge test) Hysterosalpingogram Hysteroscopy Laparoscopy Pelvic ultrasound (abdominal or vaginal) Sonohysterography or saline contrast hysterosonography The following procedures are proven for use in diagnosing infertility in male patients: Antisperm antibodies Cultures (genital) Hormone assay (LH, FSH, prolactin, 39 March 2013 Medical Policy Updates REVISED Title Infertility Diagnosis and Treatment (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale testosterone) Leukocyte count in semen Rectal ultrasound (indicated when ejaculatory duct obstruction is suspected) Scrotal ultrasound Semen analysis Testicular biopsy Vasography The following tests are unproven for diagnosing infertility: Computer-assisted sperm analysis (CASA) Hemizona assay test Hyaluronan binding assay (HBA) Sperm DNA integrity testing (e.g. Sperm Chromatin Structure Assay (SCSA), Comet assay, sperm DNA fragmentation assay, TUNEL assay, Sperm DNA Decondensation™ Test (SDD)) Sperm penetration tests such as postcoital cervical mucus penetration, sperm penetration assay (SPA), zona-free hamster egg assay or sperm acrosome reaction assay Uterine/endometrial receptivity testing (e.g., E-tegrity® and Endometrial Function Test® (EFT)) There is insufficient evidence to permit conclusions regarding the use of these tests. More studies are needed to support improved outcomes (i.e., increased successful pregnancies with delivery of liveborn children) with use of these diagnostic tests. Therapeutic Procedures The following procedures are proven for the treatment of infertility: Ovulation induction Insemination procedures (intrauterine insemination (IUI) and artificial insemination (AI) including sperm washing) Assisted reproductive technologies (gamete intrafallopian transfer (GIFT), in vitro fertilization (IVF) and zygote intrafallopian transfer (ZIFT)) Assisted embryo hatching Intracytoplasmic sperm injection (ICSI) for treatment of male factor infertility 40 March 2013 Medical Policy Updates REVISED Title Infertility Diagnosis and Treatment (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Sperm retrieval techniques (including microsurgical epididymal sperm aspiration (MESA), percutaneous epididymal sperm aspiration (PESA), and testicular sperm extraction (TESE), and electroejaculation) The following procedures to correct underlying disorders are proven for the treatment of infertility: Ablation or lysis of adhesions and/or surgical treatment of endometriosis, laparoscopic or open Drainage of ovarian cyst Fimbrioplasty Transurethral resection of ejaculatory ducts for treatment of ejaculatory duct obstruction Varicocele repair Wedge resection of ovary or ovarian drilling in women with polycystic ovary syndrome. (NOTE: Ovarian drilling is a measure of last resort due to the increased risk of the formation of pelvic adhesions.) The following procedures are unproven for treating infertility: Co-culture of embryos EmbryoGlue® Partial zonal dissection (PZD) Subzonal sperm insertion (SUZI) (also referred to as SCI) Studies describe different techniques of coculture of embryos, but no standardized method of co-culturing has been defined. The use of co-cultures may improve blastocyst development but may not result in an improved pregnancy or delivery rate. There is inadequate published scientific data to permit conclusions regarding the use of EmbryoGlue. Intracytoplasmic sperm injection (ICSI) has largely replaced partial zonal dissection (PZD) and subzonal sperm insertion (SCI, SUZI) procedures. While results of one study are promising for the use of the Wurn Technique, there were no other studies to substantiate or replicate these results. There is no research to indicate that biomechanical dysfunction is a barrier to pregnancy. 41 March 2013 Medical Policy Updates REVISED Title Infertility Diagnosis and Treatment (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Cryopreservation of sperm, semen or embryos is proven for individuals who are infertile or are planning to undergo therapies that threaten their reproductive health such as cancer chemotherapy. Cryopreservation of oocytes (eggs) is unproven. Although oocyte banking can be an option for women who have no partner at the time of cancer diagnosis, research indicates that unfertilized oocytes are more prone to damage during cryopreservation procedures than embryos, and as a result, the overall pregnancy rates may be lower than standard in vitro fertilization (IVF) procedures. New methods are developing rapidly; however, their use as a means to have a child after cancer treatment must be considered investigational and offered only with appropriate informed consent in a research setting and under the auspices of an institutional review board (IRB). Cryopreservation of ovarian or testicular tissue is unproven. Ovarian tissue banking remains a promising clinical technique because it avoids ovarian stimulation and provides the opportunity for preserving gonadal function in prepubertal, as well as adult patients. However, this procedure has produced very few live births. Testicular tissue or testis xenografting are in the early phases of experimentation and have not yet been successfully tested in humans. IntensityModulated Radiation Therapy Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Breast Cancer Intensity-modulated radiation therapy (IMRT) is proven preferentially* for treating breast cancer when homogeneity of dose is essential and the patient has at least one of the following conditions: Macromastia as defined by cup size of D or larger Separation of 25.5 cm or more in the intra-thoracic distance from the midpoint of the posterior light field border of the medial tangential field to the midpoint of the posterior light field of the lateral tangential field. IMRT is proven non-preferentially* (offers no clinical advantage over standard 42 March 2013 Medical Policy Updates REVISED Title IntensityModulated Radiation Therapy (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale therapy) for treating all other cases of breast cancer. There is no difference in the criteria used for IMRT for male and female patients with breast cancer. Primary Bone and Articular Cartilage Cancer IMRT is proven preferentially* for treating primary bone and articular cartilage cancer of the skull and face, vertebral column, sacrum and coccyx when sparing the surrounding normal tissue from radiation therapy exposure is essential. Other Cancers IMRT is proven preferentially* for treating the following: Anal cancer Esophageal cancer Pancreatic cancer Prostate cancer Trachea cancer Head and neck cancers including the following sites: lip; eye; thyroid; salivary glands; hypopharynx; oropharynx; nasopharynx; other parts of the pharynx not explicitly identified here; oral cavity; tongue; nasal cavities; middle ear; accessory sinuses; larynx; lymph nodes of the head, face and neck; pituitary gland, pineal gland, carotid body; and skin of lip, eyelid, ear and external auditory canal Malignant (primary and secondary) and benign nervous system neoplasms of the following: brain including cranial nerves and cerebral meninges, spinal cord including spinal meninges *See the Benefit Considerations section of policy for more information. The use of compensator based beam modulation treatment is proven when done in combination with an IMRT indication that is listed above as proven preferentially or non-preferentially. IMRT is proven non-preferentially* for treating cervical cancer in individuals who have had a hysterectomy. 43 March 2013 Medical Policy Updates REVISED Title IntensityModulated Radiation Therapy (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale IMRT is unproven for treating the following: Colon cancer Gastric cancer Gynecological cancer (except where noted above) Lung cancer Lymphoma Pelvic bone cancer Primary or secondary liver cancer Rectal cancer Secondary bone and articular cartilage cancer Soft tissue sarcoma and all other neoplasms not listed above as proven Some studies have examined the use of IMRT for treating other cancers such as colon, rectum, uterus, stomach, liver, lung, lymphoma, and soft tissue neoplasms. However, because of limited studies, small sample sizes and weak study designs, there is insufficient data to conclude that IMRT is safe or effective for treating these neoplasms. There is also little evidence to indicate that IMRT increases survival in patients with these neoplasms. Intensity-modulated radiation therapy (IMRT) may be covered for a diagnosis that is listed above as unproven for unusual cases when at least one of the following conditions is present: The target volume is in close proximity to critical structures that must be protected An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision Requests for these exceptions will be evaluated by an independent radiation oncologist. UnitedHealthcare will make a coverage decision based on this review. Intra-fraction localization and tracking systems such as the Calypso® 4D Localization System are unproven for use in guiding radiotherapy. Results of available studies suggest that the Calypso System can provide continuous information to guide prostate radiotherapy. 44 March 2013 Medical Policy Updates REVISED Title IntensityModulated Radiation Therapy (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale However, although this technology has the potential to reduce complications of radiotherapy and improve local tumor control, none of the available studies reported clinical information related to the safety or efficacy of radiation therapy guided by the Calypso System. Further studies are needed to determine whether guidance of radiotherapy with the Calypso System benefits patients who have localized prostate cancer. Intensity-modulated radiation therapy used in conjunction with proton beam radiation therapy is unproven. Clinical evidence is insufficient to support the combined use of these technologies in a single treatment plan. Comparative effectiveness studies including randomized controlled trials are needed to demonstrate the safety and longterm efficacy of combined therapy. Information Pertaining to Medical Necessity Review (When Applicable) IMRT is medically necessary for treating breast cancer when homogeneity of dose is essential and the patient has at least one of the following conditions: Macromastia as defined by cup size of D or larger Separation of 25.5 cm or more in the intra-thoracic distance from the midpoint of the posterior light field border of the medial tangential field to the midpoint of the posterior light field of the lateral tangential field. IMRT is medically necessary for the following preferential indications: Primary bone and articular cartilage cancer of the skull and face, vertebral column, sacrum and coccyx when sparing the surrounding normal tissue from radiation therapy exposure is essential Anal cancer Esophageal cancer Pancreatic cancer Prostate cancer Trachea cancer Head and neck cancers including the following sites: lip; eye; thyroid; salivary glands; hypopharynx; oropharynx; nasopharynx; other parts of the pharynx 45 March 2013 Medical Policy Updates REVISED Title IntensityModulated Radiation Therapy (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale not explicitly identified here; oral cavity; tongue; nasal cavities; middle ear; accessory sinuses; larynx; lymph nodes of the head, face and neck; pituitary gland, pineal gland, carotid body; and skin of lip, eyelid, ear and external auditory canal Malignant (primary and secondary) and benign nervous system neoplasms of the following: brain including cranial nerves and cerebral meninges, spinal cord including spinal meninges IMRT is medically necessary for indications other than those listed above when at least one of the following conditions is present: The target volume is in close proximity to critical structures that must be protected An immediately adjacent area has been previously irradiated and abutting portals must be established with high precision Knee Replacement Surgery (Arthroplasty) Apr. 1, 2013 Revised coverage rationale; replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Knee Arthroplasty, S-700 (ISC). Magnetoencephalography and Magnetic Source Imaging for Specific Neurological Applications Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Magnetoencephalography and magnetic source imaging (MEG/MSI) are proven for the following: Presurgical evaluation in patients with intractable focal epilepsy Presurgical evaluation of brain tumors and vascular malformations Magnetoencephalography and magnetic source imaging (MEG/MSI) are unproven for the evaluation of brain function in patients with trauma, stroke, learning disorders, or other neurologic disorders and psychiatric conditions such as schizophrenia. There is insufficient evidence to conclude that the use of MEG/MSI improves health outcomes such as improved diagnostic accuracy and treatment planning for patients with trauma, stroke, learning disorders, or 46 March 2013 Medical Policy Updates REVISED Title Magnetoencephalography and Magnetic Source Imaging for Specific Neurological Applications (continued) Effective Date Apr. 1, 2013 Mandibular Disorders Apr. 1, 2013 Summary of Changes Coverage Rationale other neurologic disorders and psychiatric conditions. Further clinical trials demonstrating the clinical usefulness of this procedure are necessary before it can be considered proven to have a benefit on health outcomes for these conditions. Information Pertaining to Medical Necessity Review (When Applicable) Magnetoencephalography and magnetic source imaging are medically necessary for pre-surgical planning for refractory epilepsy when other standard methods do not localize a seizure focus. Updated description of services to reflect most current clinical evidence and references Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) Updated list of applicable CPT codes; removed 21247 The following services are proven for treating disorders of the temporomandibular joint (TMJ): Arthrocentesis Arthroplasty Arthroscopy (with or without FDA approved bone anchor devices) Arthrotomy/open joint surgery (with or without FDA approved bone anchor devices) Injections of corticosteroids for rheumatoid arthritis-related TMJ disorders Physical therapy Stabilization and repositioning splint therapy (This does not include the Dynasplint system which is discussed below.) Not all services treat all TMJ disorders; specific treatments are based upon the specific diagnosis. The following services are unproven for treating disorders of the temporomandibular joint (TMJ): Partial or total joint replacement with artificial prosthesis Biofeedback Craniosacral manipulation Passive rehabilitation therapy Low-load prolonged-duration stretch (LLPS) devices such as the Dynasplint system Published studies have not demonstrated 47 March 2013 Medical Policy Updates REVISED Title Mandibular Disorders (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale convincingly that artificial implants for treating TMJ disorders improve long-term outcomes relative to pain, dysfunction and impairment. Although results of nonrandomized and uncontrolled studies are promising, further research from controlled studies comparing artificial implants with open TMJ reconstruction using tissue grafts is needed. There are limited studies evaluating biofeedback for the treatment of musculoskeletal pain, including TMJ pain. One small uncontrolled study reported positive effects, while a larger randomized controlled study failed to demonstrate any treatment effect. Well-designed randomized, blinded and placebo-controlled outcome studies published on craniosacral manipulation for TMJ are not available. For additional information regarding manipulation under anesthesia for TMJ disorders, see the Manipulation Under Anesthesia medical policy. While there are some data from several randomized trials and case series studies that certain types of passive rehabilitation techniques may improve jaw mobility early in recovery in patients who have undergone temporomandibular joint (TMJ) surgery, or have lost jaw mobility due to TMJ derangement or to contracture following radiation therapy, these studies all included very small numbers of patients, and did not provide blinded assessment of outcomes, long-term follow-up, or information on optimal treatment protocols. Further prospective controlled clinical trials that directly compare LLPS devices to other treatment modalities are needed. Information Pertaining to Medical Necessity Review (When Applicable) Arthroplasty For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Temporomandibular Joint Arthroplasty, ACG: A-0523 (AC). 48 March 2013 Medical Policy Updates REVISED Title Mechanical Stretching and CPM Devices Effective Date Apr. 1, 2013 Summary of Changes Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Coverage Rationale The use of low-load prolonged-duration stretch (LLPS) devices such as the Dynasplint System and continuous passive motion (CPM) devices is proven for the treatment of joint contractures of the upper and lower extremities. Information for medical necessity review, when applicable: Low-load prolonged duration stretch devices are medically necessary for patients who meet the following criteria: Used in patients in the immediate postoperative phase of joint surgery as an adjunct to (and not replacement of) physical therapy to prevent contractures of the joints of the upper and/or lower extremities. The lumbar continuous passive motion device is unproven. Clinical evidence is limited to manufacturer data. There is no scientific evidence in the published peer-reviewed medical literature that these devices for patient controlled therapy are safe or effective. Static progressive (SP) stretch splint devices and patient actuated serial stretch (PASS) devices, such as the ERMI Extensionater and Flexionater, for the treatment of joint contractures of the extremities alone or combined with standard physical therapy are unproven. Clinical evidence is not sufficient to demonstrate that use of static progressive or patient actuated devices improves long-term patient outcomes. Evidence is limited primarily to short term outcomes and lack of comparison to other treatment modalities. Noninvasive Prenatal Diagnosis of Fetal Aneuploidy Using Cell-Free Fetal Nucleic Acids in Maternal Blood Apr. 1, 2013 Updated description of services to reflect most current clinical evidence and references Revised coverage rationale to indicate: o DNA-based noninvasive prenatal tests of fetal DNA-based noninvasive prenatal tests of fetal aneuploidy (including, but not limited to, MaterniT21™ PLUS, verifi™ or Harmony Prenatal Test™) are proven as screening tools for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) or trisomy 13 (Patau syndrome) in ANY ONE of the following circumstances: 49 March 2013 Medical Policy Updates REVISED Title Noninvasive Prenatal Diagnosis of Fetal Aneuploidy Using Cell-Free Fetal Nucleic Acids in Maternal Blood (continued) Effective Date Apr. 1, 2013 Summary of Changes aneuploidy (including, but not limited to, MaterniT21™ PLUS, verifi™ or Harmony Prenatal Test™) are proven as screening tools for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) or trisomy 13 (Patau syndrome) in ANY ONE of the following circumstances: Maternal age of 35 years or older at delivery Fetal ultrasound findings indicating an increased risk of aneuploidy History of a prior pregnancy with a trisomy Positive first- or second-trimester screening test results for aneuploidy Parental balanced Robertsonian translocation with an increased risk of fetal trisomy 13 or trisomy 21 o DNA-based noninvasive prenatal tests of fetal aneuploidy (e.g., MaterniT21™ PLUS, verifi™ or Harmony Prenatal Test™) are unproven for pregnant women who do not meet the Coverage Rationale Maternal age of 35 years or older at delivery Fetal ultrasound findings indicating an increased risk of aneuploidy History of a prior pregnancy with a trisomy Positive first- or second-trimester screening test results for aneuploidy Parental balanced Robertsonian translocation with an increased risk of fetal trisomy 13 or trisomy 21. DNA-based noninvasive prenatal tests of fetal aneuploidy (e.g., MaterniT21™ PLUS, verifi™ or Harmony Prenatal Test™) are unproven for pregnant women who do not meet the above criteria or women with multiple gestations. Further studies are needed to evaluate the use of these tests in low-risk populations or women with multiple gestations. Genetic Counseling Genetic counseling is strongly recommended prior to this test in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person. Information Pertaining to Medical Necessity Review (When Applicable) The above criteria apply to medical necessity review. 50 March 2013 Medical Policy Updates REVISED Title Noninvasive Prenatal Diagnosis of Fetal Aneuploidy Using Cell-Free Fetal Nucleic Acids in Maternal Blood (continued) Effective Date Apr. 1, 2013 Summary of Changes above criteria or women with multiple gestations Updated list of applicable CPT codes; added 81479 and 81599 (new codes effective 1/1/13) Added list of applicable ICD-9 diagnosis codes: 655.10, 655.11, 655.13, 758.5, 659.50, 659.53, 659.60, 659.63, V23.81 and V23.82 Added list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14) Coverage Rationale Non-Surgical Treatment of Obstructive Sleep Apnea Apr. 1, 2013 Removable oral appliances are proven for treating obstructive sleep apnea (OSA) as documented by polysomnography. Refer to the Medical Policy titled Polysomnography and Portable Monitoring for Sleep Related Breathing Disorders for further information. Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) Removable oral appliances are unproven for treating central sleep apnea. This type of sleep apnea is caused by impaired neurological function, and these devices are designed to manage physical obstructions. Nasal dilator devices (e.g., Provent®) are unproven for treating obstructive sleep apnea (OSA). There is insufficient clinical evidence supporting the safety and efficacy of nasal dilators for treating OSA. Results from available studies indicate that therapeutic response is variable among the participants. Further research from larger, well-designed studies is needed to evaluate the effectiveness of the device compared with established treatments for OSA, to determine its longterm effectiveness and to determine which patients would benefit from this therapy. Information Pertaining to Medical Necessity Review (When Applicable) Oral appliances For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Oral 51 March 2013 Medical Policy Updates REVISED Title Non-Surgical Treatment of Obstructive Sleep Apnea (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Appliances (Mandibular Advancement Devices), ACG: A-0341 (AC). Outpatient Cardiovascular Telemetry Apr. 1, 2013 Revised coverage rationale; added language to indicate outpatient cardiovascular telemetry is proven for the following indications: o Suspected cardiac arrhythmia not detected with standard cardiac event monitoring o Cryptogenic stroke with suspected occult atrial fibrillation as the cause of the stroke o Monitoring arrhythmia status following an ablation procedure Updated list of applicable (proven) ICD-9 diagnosis codes; added 426.0, 426.10, 426.11, 426.12, 426.13, 426.2, 426.3, 426.4, 426.50, 426.51, 426.52, 426.53, 426.54, 426.6, 426.7, 426.81, 426.82, 426.89, 426.9, 427.0, 427.1, 427.2, 427.31, 427.32, 427.60, 427.61, 427.69, 427.81, 427.89, 427.9, 434.01, 434.11, 434.91, 780.2, 780.4, 785.0, 785.1, V12.54 and V15.1 Outpatient cardiovascular telemetry is proven for the following indications: Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Updated list of applicable HCPCS codes; added A8000, A8001 and Cranial orthotic devices are reconstructive for the treatment of craniofacial asymmetry in infants 3-18 months of age with severe nonsynostotic positional plagiocephaly or craniosynostosis following surgical correction. Severe plagiocephaly is defined as an asymmetry of 10 mm or more in one of the following anthropometric measures: cranial Plagiocephaly and Craniosynostosis Apr. 1, 2013 Suspected cardiac arrhythmia not detected with standard cardiac event monitoring Cryptogenic stroke with suspected occult atrial fibrillation as the cause of the stroke Monitoring arrhythmia status following an ablation procedure Information Pertaining to Medical Necessity Review (When Applicable) The above criteria apply to medical necessity review. 52 March 2013 Medical Policy Updates REVISED Title Plagiocephaly and Craniosynostosis (continued) Effective Date Apr. 1, 2013 Summary of Changes A8002 Coverage Rationale vault, skull base, or orbitotragial depth; OR a cephalic index at least two standard deviations above or below the mean for the appropriate gender/age. Clinical evidence demonstrates improved surgical outcomes with the postoperative use of the orthotic device. See Information Pertaining to Medical Necessity Review (when applicable). Cranial orthotic devices are cosmetic in infants with mild to moderate plagiocephaly. There are no definitive data demonstrating that there are adverse health effects associated with a mild to moderate degree of cranial asymmetry, and, therefore, it is unclear whether treatment of these individuals provides a future health benefit, or merely a cosmetic effect. In general, severe plagiocephaly occurs in utero and is present at birth. Limited clinical evidence suggests that it may be associated with future ocular and/or oral abnormalities. Acquired plagiocephaly occurs following the placement of the infant in a supine sleeping position to prevent sudden infant death syndrome, and is ordinarily mild to moderate. Positional plagiocephaly has not been linked to future comorbidities. Surgical treatment to repair craniosynostosis is reconstructive irrespective of the approach used. Less invasive procedures including endoscopic strip craniectomy and springmediated cranioplasty are proven nonpreferentially as a form of surgical treatment to repair craniosynostosis. Information Pertaining to Medical Necessity Review (when applicable): Cranial orthotic devices are medically necessary when ALL of the following criteria are met: Infant is 18 months of age or younger Severe asymmetry is present with or without torticollis Lack of substantial improvement following conservative therapy of at least 2 months duration with cranial repositioning and stretching therapy. 53 March 2013 Medical Policy Updates REVISED Title Plagiocephaly and Craniosynostosis (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale There is evidence that cranial orthotic devices are effective in reducing the degree of craniofacial asymmetry in most infants less than 18 months of age who have nonsynostotic positional plagiocephaly. Proton Beam Radiation Therapy Apr. 1, 2013 Proton beam radiation therapy is proven for the treatment of intracranial arteriovenous malformations (AVMs) and melanoma of the uveal tract (includes the iris, ciliary body and choroid). Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ care guidelines, 17th edition, 2013” (effective 04/01/13) Proton beam radiation therapy is proven non-preferentially as one form of external beam radiation therapy for the treatment of: Primary intracranial and skull base tumors Spinal cord tumors Prostate cancer Clinical evidence comparing proton beam radiation with other forms of external beam radiation, such as intensity modulated radiation therapy (IMRT), for treating intracranial and skull base tumors, spinal cord tumors and prostate cancer is limited. Therefore, it is not possible to draw meaningful conclusions about comparative effectiveness or adverse events among the various types of external beam radiation. Proton beam radiation therapy is unproven for the treatment of other indications, including but not limited to: Age-related macular degeneration (AMD) Bladder cancer Cancer of the uterine cervix Choroidal hemangioma Esophageal cancer Hepatocellular carcinoma Non-small-cell lung cancer Tumors of the vestibular system Intracranial and skull base tumors that have metastasized from another primary site It is not known whether the higher precision of PBT actually translates to better clinical outcomes than other types of radiation treatment of many common cancers. There is 54 March 2013 Medical Policy Updates REVISED Title Proton Beam Radiation Therapy (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale limited clinical evidence that directly compares PBT with other types of radiation therapy. Comparative effectiveness studies including randomized controlled trials are needed to document the theoretical incremental advantages of particle beam therapy over other radiotherapies (e.g., IMRT, conventional radiotherapy or stereotactic photon radiosurgery) in many cancers. Current published evidence does not allow for any definitive conclusions about the comparative effectiveness of these various forms of external beam radiation. Proton beam radiation therapy used in conjunction with intensity-modulated radiation therapy (IMRT) is unproven. Clinical evidence is insufficient to support the combined use of these technologies in a single treatment plan. Comparative effectiveness studies including randomized controlled trials are needed to demonstrate the safety and longterm efficacy of combined therapy. Information Pertaining to Medical Necessity Review (When Applicable) Proton beam radiation therapy is medically necessary for the following indications: intracranial arteriovenous malformations (AVMs) melanoma of the uveal tract (includes the iris, ciliary body and choroid) Proton beam radiation therapy is not medically necessary for non-preferential indications. Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Percutaneous tibial nerve stimulation is proven for the treatment of overactive bladder syndrome including urinary frequency, urgency, and urge incontinence. Transurethral radiofrequency energy therapy (Renessa® System) is unproven for the treatment of urinary incontinence. There is insufficient evidence to conclude that transurethral radiofrequency therapy is effective for treating urinary incontinence. Analysis and interpretation of published study results are complicated by a high placebo response rate and by the single-blind design of the trials. Further studies incorporating blinded assessment of objective outcomes and 55 March 2013 Medical Policy Updates REVISED Title Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale longer follow-up are needed, both to confirm the efficacy and safety of this procedure and to define the patients who are likely to benefit from this procedure. Transvaginal radiofrequency energy therapy is unproven for the treatment of urinary incontinence. There is insufficient evidence to conclude that transvaginal radiofrequency therapy is effective for treating urinary incontinence. Studies report low cure rates and high rates of additional corrective treatment. Information Pertaining to Medical Necessity Review (When Applicable) Percutaneous tibial nerve stimulation is medically necessary for the treatment of urinary frequency, urgency, and urge incontinence in adult patients refractory to standard first-line treatment with pharmacotherapy, when anatomical abnormalities of the lower urinary tract and active urinary tract infections are excluded. Shoulder Replacement Surgery (Arthroplasty) Surgical Treatment for Spine Pain Apr. 1, 2013 Apr. 1, 2013 Revised coverage rationale; replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Shoulder Arthroplasty, S-634 (ISC). Revised coverage rationale: o Added language to indicate spinal fusion using extreme lateral interbody fusion (XLIF) or direct lateral interbody fusion (DLIF) are proven o Added coding clarification language: The North American Spine Society (NASS) recommends Spinal fusion using extreme lateral interbody fusion (XLIF) or direct lateral interbody fusion (DLIF) is proven. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Shoulder Hemiarthroplasty, S-633 (ISC). Coding Clarification The North American Spine Society (NASS) recommends that anterior or anterolateral approach techniques performed via an open approach should be billed with CPT codes 22554 – 22585. These codes should be used to report the use of extreme lateral interbody fusion (XLIF) and direct lateral interbody fusion (DLIF) procedures (NASS, 2010). Laparoscopic approaches should be billed with an unlisted procedure code. For information regarding medical necessity 56 March 2013 Medical Policy Updates REVISED Title Surgical Treatment for Spine Pain (continued) Effective Date Apr. 1, 2013 Summary of Changes that anterior or anterolateral approach techniques performed via an open approach should be billed with CPT codes 22554 – 22585; these codes should be used to report the use of extreme lateral interbody fusion (XLIF) and direct lateral interbody fusion (DLIF) procedures (NASS, 2010) Laparoscopic approaches should be billed with an unlisted procedure code o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) Updated list of applicable CPT codes; added 22586, 63265, 63267, 63268, 63270, 63271, 63272, 63286, 63300, 63301, 63302, 63303, 63304, 63305, 63306, 63307 and 63308 Updated list of applicable (unproven) CPT codes; added 0309T Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14); removed M84.48XA and M84.68XA Coverage Rationale review, when applicable, see the following Milliman Care Guidelines®, 16th Edition, 2012: Cervical Diskectomy or Microdiskectomy, Foraminotomy, Laminotomy, S-310 (ISC) Lumbar Diskectomy, Foraminotomy, or Laminotomy S-810 (ISC) Cervical Laminectomy S-340 (ISC) Lumbar Laminectomy S-830 (ISC) Cervical Fusion, Anterior S-320 (ISC) Cervical Fusion, Posterior S-330 (ISC) Lumbar Fusion S-820 (ISC) The following spinal procedures are unproven: A. Spinal fusion, when performed via the following methods: 1. Laparoscopic anterior lumbar interbody fusion (LALIF) 2. Transforaminal lumbar interbody fusion which utilizes only endoscopy visualization (such as a percutaneous incision with video visualization) 3. Axial lumbar interbody fusion (AxiaLIF) Interlaminar lumbar instrumented fusion (for example ILIF) This includes interbody cages (for example PEEK, titanium etc), screws or devices with any of the above procedures. Clinical evidence is limited primarily to retrospective studies and case series. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy. B. Spinal Decompression 1. Interspinous process decompression (IPD) systems, such as the XSTOP for the treatment of spinal stenosis 2. Minimally invasive lumbar 57 March 2013 Medical Policy Updates REVISED Title Surgical Treatment for Spine Pain (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale decompression (MILD) Clinical evidence is limited to small, uncontrolled studies with lack of blinding and long-term follow-up. No controlled trials have been performed to compare the X-STOP IPD and MILD procedures with decompressive surgery. C. Spinal Stabilization 1. Stabilization systems, such as the Dynesys® Dynamic Stabilization System or the DSS Stabilization System for the treatment of degenerative spondylolisthesis 2. Total facet joint arthroplasty, including facetectomy, laminectomy, foraminotomy, vertebral column fixation, 3. Percutaneous sacral augmentation (sacroplasty) with or without a balloon or bone cement for the treatment of back pain Clinical evidence is limited to small, uncontrolled studies with lack of blinding and long-term follow-up. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes and long-term efficacy. The Total Facet Arthroplasty System™ (TFAS) has not been approved by the U.S. Food and Drug Administration (FDA). A single clinical trial is in progress, but no results have been published. D. Stand-alone facet fusion without an accompanying decompressive procedure. This includes procedures performed with or without bone grafting and/or the use of posterior intrafacet implants such as fixation systems, facet screw systems or antimigration dowels. Clinical evidence is limited primarily to case series and 58 March 2013 Medical Policy Updates REVISED Title Surgical Treatment for Spine Pain (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale nonrandomized studies. Randomized, controlled trials comparing facet fusion to standard procedures are needed to determine impact on health outcomes and long-term efficacy. Surgical Treatment of Obstructive Sleep Apnea Apr. 1, 2013 The following surgical procedures are proven for treating obstructive sleep apnea as documented by polysomnography. Refer to the medical policy titled Polysomnography and Portable Monitoring for Sleep Related Breathing Disorders for further information. Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) Uvulopalatopharyngoplasty (UPPP) Maxillomandibular advancement surgery (MMA) Multilevel procedures whether done in a single surgery or phased multiple surgeries. There are a variety of procedure combinations, including mandibular osteotomy and genioglossal advancement with hyoid myotomy (GAHM). Radiofrequency ablation of the soft palate and/or tongue base (e.g., Coblation® or Somnoplasty™) is proven for treating mild to moderate obstructive sleep apnea as documented by polysomnography. Refer to the medical policy titled Polysomnography and Portable Monitoring for Sleep Related Breathing Disorders for further information. According to the American Academy of Sleep Medicine (AASM) the diagnosis of OSA is confirmed if the number of obstructive events† (apneas, hypopneas + respiratory event related arousals) on polysomnography (PSG) is greater than 15 events/hour or greater than 5/hour in a patient who reports any of the following: unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up breath holding, gasping or choking; or the bed partner describing loud snoring, breathing interruptions or both during the patient’s sleep (Epstein et al., 2009). † The frequency of obstructive events is reported as an apnea + hypopnea index (AHI) or respiratory disturbance index (RDI). RDI has at times been used synonymously with 59 March 2013 Medical Policy Updates REVISED Title Surgical Treatment of Obstructive Sleep Apnea (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale AHI, but at other times has included the total of apneas, hypopneas and respiratory effort related arousals (RERAs) per hour of sleep. When a portable monitor is used that does not measure sleep, the RDI refers to the number of apneas plus hypopneas per hour of recording. OSA severity is defined as Mild for AHI or RDI ≥ 5 and < 15 Moderate for AHI or RDI ≥ 15 and ≤ 30 Severe for AHI or RDI > 30/hr The following surgical procedures are unproven for treating obstructive sleep apnea: Laser-assisted uvulopalatoplasty (LAUP) Palatal implants (e.g., Pillar®) Lingual suspension (e.g., AIRvance™ Tongue Suspension (formerly Repose®) also referred to as tongue stabilization, tongue stitch or tongue fixation Transoral robotic surgery (TORS) There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved AHI or secondary outcomes. Some studies saw a worsening of symptoms as well as increased complications. Results of studies provide preliminary but inconsistent evidence that palatal implants benefit patients with mild to moderate OSA. However, the magnitude of the benefits has been small; the largest randomized controlled trial (RCT) found that average OSA worsened in spite of treatment; and the available studies involved ≤ 1 year of patient monitoring after treatment. Additional studies are needed to determine the role of palatal implants in the management of OSA There is insufficient evidence to support the safety, efficacy and long-term outcomes of lingual suspension in the treatment of OSA. The published peer-reviewed medical literature includes a few small, uncontrolled studies with short-term follow-up. Large, controlled studies, with long-term follow-up, comparing lingual suspension to established procedures are necessary. 60 March 2013 Medical Policy Updates REVISED Title Surgical Treatment of Obstructive Sleep Apnea (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale There is insufficient evidence to support the safety, efficacy and long-term outcomes of transoral robotic surgery (TORS) in the treatment of OSA. Large, controlled studies, with long-term follow-up, comparing TORS to established procedures are necessary. Information Pertaining to Medical Necessity Review (When Applicable) Uvulopalatopharyngoplasty For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Uvulopalatopharyngoplasty (UPPP), A-0245 (ACG). Maxillomandibular Osteotomy and Advancement For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Maxillomandibular Osteotomy and Advancement, A-0248 (ACG). Mandibular Osteotomy For information regarding medical necessity review, when applicable, see Milliman Care Guidelines®, 16th Edition, 2012, Mandibular Osteotomy, A-0247 (ACG). Radiofrequency Ablation In addition to the criteria listed above, radiofrequency ablation of the soft palate and/or tongue base (e.g., Coblation® or Somnoplasty™) is medically necessary for patients who fail to improve with or cannot tolerate an adequate trial of continuous positive airway pressure (CPAP) or another device, including bi-level positive airway pressure (BiPAP), auto-titrating positive airway pressure (APAP) and/or oral appliances. Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida, 2006; Ferguson, 2006). Refer to the medical policy titled Polysomnography and Portable Monitoring for Sleep Related Breathing Disorders for further information 61 March 2013 Medical Policy Updates REVISED Title Total Artificial Heart Effective Date Apr. 1, 2013 Summary of Changes Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Coverage Rationale The SynCardia temporary Total Artificial Heart (formerly known as the CardioWest™ temporary Total Artificial Heart) is proven as a bridge to heart transplantation for patients with end-stage heart disease who have failed optimal medical therapy, who have no other reasonable medical or surgical treatment options, who are ineligible for other univentricular or biventricular assist devices (BiVADs) and who meet all of the following criteria for heart transplantation: Very limited life expectancy Presence of biventricular failure and rapid decompensation Absence of irreversible organ dysfunction Unavailability of heart donor and likelihood that condition will deteriorate before donor can be identified Body surface area greater than or equal to 1.7 meters squared and large-sized heart (>1500 cc) as measured by chest x-ray. If body surface area is <1.7 meters squared, bridging with the TAH may be possible for patients with cardiomegaly and sufficient space for device implantation (i.e., anteriorposterior dimension of 10 cm at T-10 by computed tomography scan.) The AbioCor Implantable Replacement Heart is unproven as an alternative to heart transplantation. There is limited evidence that the AbioCor TAH, as a permanent replacement for the failing heart, improves survival. Welldesigned studies are needed to establish the safety and efficacy of this device. Information Pertaining to Medical Necessity Review (When Applicable) The above criteria apply to medical necessity review. Transcatheter Heart Valve Procedures Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review Aortic Valve Transcatheter aortic heart valve replacement is proven for patients with severe, symptomatic aortic stenosis who 62 March 2013 Medical Policy Updates REVISED Title Transcatheter Heart Valve Procedures (continued) Effective Date Apr. 1, 2013 Summary of Changes (when applicable) Coverage Rationale meet the following criteria: Patient is not a candidate for conventional, open valve replacement surgery Procedure is performed using a U.S. Food and Drug Administration (FDA) approved device (e.g. Edwards SAPIEN) Procedure is performed according to FDA approved labeled indications and contraindications Pulmonary Valve Transcatheter pulmonary heart valve replacement (e.g., Melody®) is unproven. There is insufficient evidence in the clinical literature demonstrating the long-term efficacy and durability of catheter-delivered prosthetic pulmonary heart valves for treating right ventricular outflow tract dysfunction. Mitral Valve Transcatheter mitral valve leaflet repair (e.g., MitraClip®) is investigational and unproven due to lack of U.S. Food and Drug Administration (FDA) approval. There is insufficient evidence in the clinical literature demonstrating the long-term efficacy of catheter-delivered mitral valve leaflet repair devices for treating mitral regurgitation. Further results from prospective, randomized controlled trials are needed to determine device durability and the ideal candidates for the procedure. Information Pertaining to Medical Necessity Review (When Applicable) The above criteria apply to medical necessity review. Vagus Nerve Stimulation Apr. 1, 2013 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Updated list of applicable HCPCS codes; added C1767 and C1778 Vagus nerve stimulation (VNS) is proven for treating epilepsy in persons without a history of left or bilateral cervical vagotomy. The U.S. Food and Drug Administration (FDA) identifies a history of left or bilateral cervical vagotomy as a contraindication to vagus nerve stimulation. Vagus nerve stimulation is unproven for treating all other indications, including the following: Alzheimer's disease 63 March 2013 Medical Policy Updates REVISED Title Vagus Nerve Stimulation (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Anxiety disorder Autism Back and neck pain Bipolar disorder Bulimia Cerebral palsy Chronic pain syndrome Cluster headaches Depression Fibromyalgia Heart failure Migraines Morbid obesity Narcolepsy Obsessive-compulsive disorder Paralysis agitans Sleep disorders Tourette's syndrome Available studies on the use of vagus nerve stimulation for treating severe, major depression or bipolar disorder refractory to medical therapy contain methodological flaws such as lack of control group, small sample size, potential bias, lack of randomization and blinding and lack of statistical power analysis. There is a substantial placebo effect associated with depression treatments and the lack of data from prospective randomized controlled or comparative clinical studies considerably limits the conclusions that can be drawn from the available evidence. Furthermore, preliminary analysis of a randomized controlled trial did not find a statistically significant difference between sham and active VNS. Definitive patient selection criteria for vagus nerve stimulation (VNS) in patients with treatment-resistant depression have not yet been established, and significant predictors of response have also not been identified. Early research has examined the use of vagus nerve stimulation for additional indications. However, because of limited studies, small sample sizes and weak study designs, there is insufficient data to conclude that vagus nerve stimulation is safe and/or effective for treating these indications. Information Pertaining to Medical Necessity Review (When Applicable) 64 March 2013 Medical Policy Updates REVISED Title Vagus Nerve Stimulation (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Vagus nerve stimulation (VNS) is medically necessary for treating epilepsy in patients with medically refractory epileptic seizures who are not surgical candidates or have failed surgical intervention. It is an expectation that the physician have experience and expertise in the use of vagus nerve stimulation. Wireless Capsule Endoscopy Apr. 1, 2013 Revised coverage rationale; replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) Wireless capsule endoscopy (WCE) is proven for the evaluation of the small bowel for one or more of the following: Patients with gastrointestinal blood loss and/or iron-deficiency anemia when other diagnostic methods, such as upper endoscopy and colonoscopy, have failed to identify the source of bleeding Patients with known Crohn's disease (regional enteritis) or clinical symptoms suggestive of Crohn’s disease when imaging studies and/or upper or lower gastrointestinal endoscopic examination fail to reveal the location or extent of the pathology, AND when treatment decisions would be affected by the results of the test Patients with clinical symptoms suggestive of celiac disease when prior serology or gastrointestinal endoscopy are not diagnostic Patients with suspected small bowel tumor when imaging studies or gastrointestinal endoscopic findings have failed to confirm a tumor Surveillance of the small bowel in patients with Lynch syndrome or inherited polyposis syndromes such as familial adenomatous polyposis and Peutz-Jeghers syndrome Wireless capsule endoscopy (WCE) is proven for screening of esophageal varices when there is an established diagnosis of cirrhosis and patient is unable to safely undergo esophagogastroduodenoscopy. Wireless capsule endoscopy (WCE) of the esophagus is unproven for all indications except for esophageal varices screening as indicated above. There is no conclusive data showing that 65 March 2013 Medical Policy Updates REVISED Title Wireless Capsule Endoscopy (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale esophageal wireless capsule endoscopy (WCE) is as accurate as conventional endoscopy or whether the results of such testing changes physician decision-making or improves health outcomes such as increased detection of esophageal pathologies such as gastroesophageal reflux disease (GERD), Barrett’s esophagus, or esophagitis. Wireless capsule endoscopy (WCE) is unproven in patients with specific contraindications including the presence of known or suspected intestinal obstruction, fistulas, or strictures; since these abnormalities may hinder passage of the capsule. Wireless capsule endoscopy (WCE) is unproven for all other indications not listed above as proven. The diagnostic utility and safety of capsule endoscopy for other indications has not been established. The AGILE™ Patency System is unproven for verification of gastrointestinal patency prior to capsule endoscopy. The AGILE Patency System is used to confirm the safety of subsequent capsule endoscopy following prior abdominal surgery, intestinal obstruction or abdominal adhesions, and in known Crohn's disease affecting the small bowel. However, to date there are few published randomized controlled trials regarding the patency system. Larger, randomized studies are needed to validate the role of the patency capsule in preventing adverse outcomes compared to established methods of evaluation in patients being considered for WCE. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 17th edition, 2013, Capsule Endoscopy ACG: A-0134 (AC). 66 March 2013 Drug and Biologics Policy Updates NEW Title Repository Corticotropin Injection (H.P. Acthar Gel) Effective Date Apr. 1, 2013 Utilization Review Guidelines Repository corticotropin injection (H.P. Acthar Gel) is proven for the treatment of: 1. Infantile spasm (i.e., West Syndrome) Additional information to support medical necessity review where applicable: Repository corticotropin injection is medically necessary for the treatment of infantile spasms for up to 4 weeks when all of the following criteria are met: A. Diagnosis of infantile spasms (i.e., West Syndrome) AND B. Patient is less than 2 years old AND C. Repository corticotropin injection dosing for infantile spasm is as follows: a. Initial dose: 75 U/m intramuscular (IM) twice daily for 2 weeks. b. After 2 weeks, dose should be tapered according to the following schedule: 30 U/m IM in the morning for 3 days; 15 U/m IM in the morning for 3 days; 10 U/m IM in the morning for 3 days; and 10 U/m IM every other morning for 6 days (3 doses). 2. Multiple sclerosis (MS), acute exacerbation Additional information to support medical necessity review where applicable: Repository corticotropin injection is medically necessary for treatment of acute exacerbations of multiple sclerosis for up to 3 weeks when all of the following criteria are met: A. Diagnosis of multiple sclerosis with acute exacerbation AND B. **History of failure, contraindication, or intolerance to corticosteroids for treatment of acute exacerbation of multiple sclerosis AND C. Repository corticotropin injection dosing for acute exacerbation is as follows: 80-120 units intramuscular (IM) or subcutaneous (SQ) daily for 2-3 weeks on a tapering schedule. 3. Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome) For the proven indications listed below, refer to the medical necessity criteria, where applicable, at the end of the list: 4. 5. 6. 7. 8. 9. 10. 11. 12. Ankylosing spondylitis* Anterior segment inflammation* Chorioretinitis* Dermatomyositis, systemic (polymyositis)* Diffuse posterior uveitis and choroiditis* Iridocyclitis* Iritis* Juvenile idiopathic arthritis* Keratitis* 67 March 2013 Drug and Biologics Policy Updates NEW Title Repository Corticotropin Injection (H.P. Acthar Gel) (continued) Effective Date Apr. 1, 2013 Utilization Review Guidelines 13. Nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus* 14. Optic neuritis* 15. Psoriatic arthritis* 16. Rheumatoid arthritis* 17. Sarcoidosis, symptomatic* 18. Serum sickness* 19. Severe erythema multiforme* 20. Stevens-Johnson syndrome* 21. Systemic lupus erythematosus (SLE)* *Additional information to support medical necessity review where applicable: Repository corticotropin injection is medically necessary when all of the following criteria are met: A. Proven indication as listed above AND B. **History of failure, contraindication, or intolerance to corticosteroids **The State of New Jersey prohibits requiring failed prior therapy or intolerance to therapy as a requirement for coverage. Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for H.P. Acthar (repository corticotropin injection). In general, Medicare covers outpatient (Part B) drugs that are furnished "incident to" a physician's service provided that the drugs are not usually self-administered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, Section 50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf Local Coverage Determinations (LCDs) exist for Corticotropin and compliance with these policies is required where applicable. (Accessed October 17, 2012) UPDATED Title Oncology Medication Clinical Coverage Effective Date Apr. 1, 2013 Summary of Changes Routine review; no change to coverage rationale Removed reference link to policy titled Avastin (bevacizumab)(retired 11/14/12) Coverage Rationale This policy provides parameters for coverage of injectable oncology medications (J9000 J9999) covered under the medical benefit based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™. The Compendium lists the appropriate drugs and biologics for specific cancers using US Food and Drug Administration (FDA)-approved disease indications and specific NCCN panel recommendations. Each recommendation is supported by a level of evidence category. UnitedHealthcare recognizes indications and 68 March 2013 Drug and Biologics Policy Updates UPDATED Title Oncology Medication Clinical Coverage (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale uses of injectable oncology medications listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus of 1, 2A, and 2B as proven and Categories of Evidence and Consensus of 3 as unproven. UnitedHealthcare will cover all chemotherapy agents for individuals under the age of 19 years. The majority of pediatric patients receive treatments on national pediatric protocols that are quite similar in concept to the NCCN patient care guidelines. Additional Information: The NCCN Clinical Practice Guidelines in Oncology™ are a comprehensive set of guidelines documenting patient management recommendations for the malignancies that affect about 97% of all patients with cancer. They also address supportive care issues. The guidelines are developed and updated by 44 individual panels, composed of more than 800 clinicians and oncology researchers from the 21 NCCN member institutions and their affiliates. NCCN Categories of Evidence and Consensus: Category 1: The recommendation is based on high-level evidence (ie, high-powered randomized clinical trials or meta-analyses), and the panel has reached uniform consensus that the recommendation is indicated. In this context, uniform means near unanimous positive support with some possible neutral positions. Category 2A: The recommendation is based on lower level evidence, but despite the absence of higher level studies, there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly, and runs the gamut from phase II to large cohort studies to case series to individual practitioner experience. Importantly, in many instances, the retrospective studies are derived from clinical experience of treating large numbers of patients at a member institution, so panel members have first-hand knowledge of the data. Inevitably, some recommendations must address clinical situations for which limited or 69 March 2013 Drug and Biologics Policy Updates UPDATED Title Oncology Medication Clinical Coverage (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale no data exist. In these instances the congruence of experience-based opinions provides an informed if not confirmed direction for optimizing patient care. These recommendations carry the implicit recognition that they may be superseded as higher level evidence becomes available or as outcomes-based information becomes more prevalent. Category 2B: The recommendation is based on lower level evidence, and there is nonuniform consensus that the recommendation should be made. In these instances, because the evidence is not conclusive, institutions take different approaches to the management of a particular clinical scenario. This nonuniform consensus does not represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data. Category 3: The recommendation has engendered a major disagreement among the panel members. Several circumstances can cause major disagreements. For example, if substantial data exist about two interventions but they have never been directly compared in a randomized trial, adherents to one set of data may not accept the interpretation of the other side's results. Another situation resulting in a Category 3 designation is when experts disagree about how trial data can be generalized. A Category 3 designation alerts users to a major interpretation issue in the data and directs them to the manuscript for an explanation of the controversy. Remicade (infliximab) Apr. 1, 2013 Infliximab is proven for the treatment of: 1. Crohn’s disease in adults and in children 6 years of age and older 2. Ulcerative colitis in adults and in children 6 years of age and older 3. Rheumatoid arthritis 4. Plaque psoriasis 5. Psoriatic arthritis 6. Ankylosing spondylitis 7. Sarcoidosis Updated list of applicable ICD-9 diagnosis codes; removed 714.4 Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14) Infliximab is unproven for the treatment of: 70 March 2013 Drug and Biologics Policy Updates UPDATED Title Remicade (infliximab) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale 1. Adult-onset Still’s disease 2. Sjogren’s syndrome 3. Graft-vs-host disease 4. Myelodysplastic syndromes 5. Behçet’s disease 6. Noninfectious ocular disease including uveitis and scleritis 7. Undifferentiated spondyloarthropathy 8. Reiter’s syndrome 9. Hidradenitis suppurativa 10. Wegener’s granulomatosis 11. Juvenile idiopathic arthritis (juvenile rheumatoid arthritis) 12. Crohn’s disease in children younger than 6 years of age 13. Ulcerative colitis in children younger than 6 years of age Infliximab is unproven for the treatment of the above conditions because statistically robust randomized controlled trials are needed to address the issue of whether infliximab has sufficient superiority in clinical efficacy compared to other available treatments to justify the inherent clinical risk in the use of a monoclonal antibody anti-tumor necrosis factor agent. Infliximab is unproven for the treatment of Crohn’s disease and ulcerative colitis in children under the age of 6 years due to a paucity of evidence that addresses the safety and efficacy of infliximab in this population. Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for Remicade® (infliximab). In general, Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually selfadministered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals available at http://www.cms.hhs.gov/manuals/Downloads/ bp102c15.pdf. Local Coverage Determinations (LCDs) for Remicade® exist and compliance with these policies is required where applicable. See the LCDs for Drugs and Biologicals: Infliximab (Remicade) and Infliximab (Remicade) (Accessed 06/22/12) 71 March 2013 Drug and Biologics Policy Updates REVISED Title Actemra (tocilizumab) Effective Date Apr. 1, 2013 Summary of Changes Updated description of services to reflect most current clinical evidence, FDA information and references Revised coverage rationale; added information to support medical necessity review Updated list of applicable ICD-9 diagnosis codes; removed 714.4 Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14) Coverage Rationale Tocilizumab is proven for the treatment of: 1. Rheumatoid arthritis Additional information to support medical necessity review where applicable: Tocilizumab is medically necessary for the treatment of rheumatoid arthritis when both of the following criteria are met: A. Moderate to severe disease activity [e.g., swollen, tender joints with limited range of motion] AND B. **Documented treatment failure, contraindication, or intolerance to one or more disease modifying antirheumatic drugs (DMARDs) [e.g., hydroxychloroquine, leflunomide, methotrexate, sulfasalazine] 2. Systemic juvenile idiopathic arthritis (SJIA) Additional information to support medical necessity review where applicable: Tocilizumab is medically necessary for the treatment of systemic juvenile idiopathic arthritis when both of the following criteria are met: A. Moderate to severe disease activity [e.g., active fever and systemic features of disease activity (e.g., serositis)] AND B. **Documented treatment failure, contraindication, or intolerance to one or more first line medications [e.g., non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids] Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for Actemra (tocilizumab). In general, Medicare covers outpatient (Part B) drugs that are furnished "incident to" a physician's service provided that the drugs are not usually selfadministered by the patients who take them. 72 March 2013 Drug and Biologics Policy Updates REVISED Title Actemra (tocilizumab) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, section 50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/ bp102c15.pdf Local Coverage Determinations (LCDs) do not exist at this time. (Accessed December 27, 2012) Campath (alemtuzumab) Apr. 1, 2013 Updated description of services to reflect most current clinical evidence and references Revised coverage rationale: o Added information to support medical necessity review for treatment of relapsing-remitting multiple sclerosis o Added language to indicate, effective 09/04/12, Campath is no longer be available commercially but will be provided through the Campath Distribution Program free of charge; additional details about this program may be found at www.campath.com Updated list of applicable ICD-9 diagnosis codes (for non-oncology indications); removed V42.2, V42.3, V42.4, V42.5, V42.89 and V42.9 This drug policy will ONLY be updated for non-oncology indications. Please refer to the Oncology Medication Clinical Coverage Policy for updated information based on the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium for oncology indications. Alemtuzumab is proven for the treatment of: 1) ** Patients undergoing peripheral blood stem cell (PBSC) and/or bone marrow transplantation 2) ** Patients undergoing solid organ transplantation 3) Relapsing-remitting multiple sclerosis (RRMS) Additional information to support medical necessity review where applicable: Alemtuzumab is medically necessary for treatment of relapsing-remitting multiple sclerosis when all of the following criteria are met: A. Diagnosis of relapsing-remitting multiple sclerosis (RRMS); AND B. One of the following: i. Treatment-naïve to alemtuzumab: 1. Patient has not been previously treated with alemtuzumab AND 2. Patient is not receiving alemtuzumab in combination with another disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, or teriflunomide) AND 3. Initial dosing is administered: 12 mg intravenously daily for 5 consecutive days 73 March 2013 Drug and Biologics Policy Updates REVISED Title Campath (alemtuzumab) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale AND 4. Regimen is administered only once within 12 months OR ii. Treatment-experienced with alemtuzumab: 1. Patient has previously received treatment with alemtuzumab AND 2. Patient is not receiving alemtuzumab in combination with another disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, or teriflunomide) AND 3. Retreatment dosing is administered: 12 mg intravenously daily for 3 consecutive days AND 4. Regimen is administered only once within 12 months ** Effective September 4th, 2012, Campath will no longer be available commercially, but will be provided through the Campath Distribution Program free of charge. Additional details about this program may be found at www.campath.com. Alemtuzumab is unproven for the treatment of: 1) Rheumatoid arthritis 2) Autoimmune neutropenia 3) Autoimmune hemolytic anemia 4) Pure red cell aplasia 5) Immune thrombocytopenic purpura 6) Evans syndrome 7) Autoimmune pancytopenia Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for alemtuzumab. Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at 74 March 2013 Drug and Biologics Policy Updates REVISED Title Campath (alemtuzumab) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale http://www.cms.hhs.gov/manuals/Downloads/ bp102c15.pdf. Local Coverage Determinations (LCDs) exist for alemtuzumab and compliance with these policies is required where applicable. See the LCD for Alemtuzumab (Campath) (Accessed December 19, 2012) Immune Globulin (IVIG and SCIG) Apr. 1, 2013 This policy refers to the following intravenous immune globulin (IVIG) drug products: Changed policy title; previously titled Immune Globulin (IVIG) Updated list of applicable IVIG drug products: o Added Bivigam™ o Removed Vivaglobulin Updated description of services to reflect most current clinical evidence and references; added FDA Safety Communication Reformatted and revised coverage rationale: o Added Alzheimer’s disease to list of unproven uses o Added paraproteinemic neuropathy to list of proven uses (previously unproven) o Added medical necessity criteria Updated list of applicable CPT codes; added 90283 and 90284 Updated list of applicable ICD-9 codes: o Added 204.12, 242.00, 242.01, 279.11, 279.8, 279.9, 288.09, 288.1, 323.01, 323.02, 323.9, 357.9, 484.1, 646.80, 646.81, 646.82, 646.83, 646.84, 678.00, 678.03, 757.39, 776.8 and 776.9 Bivigam™ Carimune® NF Flebogamma® Flebogamma® DIF Gammagard® Liquid Gammagard® S/D Gammaplex® Gammaked™ Gamunex® Gamunex®-C Octagam® Privigen® And also to the following subcutaneous immune globulin (SCIG) drug products: Gammagard® Liquid Gammaked™ Gamunex®-C Hizentra® The list that follows summarizes the proven indications for immune globulin. By clicking on each hyperlink within this list, you will be directed to the corresponding medical necessity criteria for that proven indication, where applicable. Immune globulin is proven for: 1) Asthma (severe, persistent, high-dose steroid-dependent) 2) Autoimmune bullous diseases [pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane (cicatricial) pemphigoid, epidermolysis bullosa acquisita, pemphigoid gestationis, linear IgA bullous dermatosis] 3) Autoimmune diabetes mellitus 4) Autoimmune uveitis 5) Bone marrow transplantation (BMT), 75 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes o Removed 038.10, 041.01, 242.0, 279.02, 287.33, 337.00, 337.01, 337.09, 356.9, 358.00, 694.0, 714.4, 772.10, 772.11, 772.12, 772.13, 772.14, 776.7, 995.91 and 995.92 Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14) Coverage Rationale prevention of acute graft vs. host disease (GVHD) after BMT 6) Bone marrow transplantation (BMT), prevention of infection after BMT 7) Chronic inflammatory demyelinating polyneuropathy 8) Chronic lymphocytic leukemia 9) Cytomegalovirus (CMV) induced pneumonitis in solid organ transplants 10) Dermatomyositis or polymyositis 11) Enteroviral meningoencephalitis 12) Fetomaternal alloimmune thrombocytopenia 13) Graves’ ophthalmopathy 14) Guillain-Barré syndrome (GBS) 15) HIV-infection, prevention of bacterial infection in pediatric HIV 16) IgM antimyelin-associated glycoprotein paraprotein-associated peripheral neuropathy 17) Immune thrombocytopenic purpura (ITP) 18) Kawasaki disease 19) Lambert-Eaton myasthenic syndrome (LEMS) 20) Lennox Gastaut syndrome 21) Lymphoproliferative disease, bacterial infections 22) Monoclonal gammopathy 23) Multifocal motor neuropathy (MMN) 24) Multiple sclerosis, relapsing remitting (RRMS) 25) Myasthenia gravis (MG) 26) Paraproteinemic neuropathy 27) Posttransfusion purpura 28) Primary immunodeficiency syndromes (list not all inclusive) A. Autosomal recessive agammaglobinulinemia B. Autosomal recessive hyperimmunoglobulin M syndrome (HIM) C. Bruton’s disease D. Combined immunodeficiency disorders 1. Ataxia-telangiectasia 2. DiGeorge syndrome 3. Nijmegan breakage syndrome 4. WHIM (warts, hypogammaglobulinemia, immunodeficiency, and myelokathexis) syndrome 5. Wiscott Aldrich syndrome 76 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale E. Common variable immunodeficiency F. Congenital hypogammaglobulinemia late onset, ICOS impaired G. Congenital / X-linked agammaglobulinemia H. Good syndrome (immunodeficiency with thymoma) I. Hyperimmunoglobulinemia E syndrome J. Hypogammaglobulinemia K. ICF syndrome L. Selective IgG subclass deficiencies M. Severe combined immunodeficiency N. Specific antibody deficiency O. Transient hypogammaglobulinemia of infancy, short-term treatment of recurrent severe bacterial infections P. X-linked immunodeficiency with hyperimmunoglobulin M 28) Rasmussen syndrome 29) Renal transplantation, prevention of acute humoral rejection 30) Renal transplantation, treatment of acute humoral rejection 31) Rheumatoid arthritis, severe 32) Rotaviral enterocolitis 33) Staphylococcal toxic shock 34) Stiff-person syndrome 35) Toxic epidermal necrolysis or StevensJohnson syndrome 36) Urticaria, delayed pressure General instructions to support medical necessity review where applicable: The information below indicates general precertification requirements for those proven indications not having specific medical necessity criteria in the list of proven indications. Documentation required: 1. For initial therapy: A. Diagnosis AND B. Medical records documenting all of the following: 1. History and physical examination, documenting the severity of the condition, including frequency and severity of infections 77 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale 2. Laboratory results supporting the diagnosis for which immune globulin is requested AND C. Clinically significant functional deficiency of humoral immunity as evidenced by one of the following: 1. Documented failure to produce antibodies to specific antigens OR 2. History of significant recurrent infections 2. For continuation of therapy: A. Medical records indicating objective response to therapy, including decreasing frequency and severity of infections. AND B. Statement of expected frequency and duration of proposed IVIG treatment AND C. Titration to the minimum dose and frequency to maintain a sustained clinical effect AND D. Serum Immunoglobulin levels prior to IVIG therapy Note: Additional documentation may also be required for specific diagnoses as noted within each proven indication below. Immune globulin is proven for: 1) Asthma (severe, persistent, high-dose steroid-dependent) Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of severe, persistent, high-dose steroid-dependent asthma when both of the following criteria are met: A. **Patient is receiving optimal conventional asthma therapy (e.g., high-dose inhaled glucocorticoids, short- and long-acting inhaled β 78 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale agonists) AND B. **Patient has required continuous oral glucocorticoid therapy for a minimum of 2 months prior to the decision to initiate IVIG therapy 2) Autoimmune bullous diseases [pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane (cicatricial) pemphigoid, epidermolysis bullosa acquisita, pemphigoid gestationis, linear IgA bullous dermatosis] Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of autoimmune bullous diseases when all of the following criteria are met: A. Extensive and debilitating disease AND B. **Contraindication to, failure of, or significant side effects from systemic corticosteroids with concurrent immunosuppressive treatment (e.g., azathioprine, cyclophosphamide, mycophenolate mofetil) AND C. IVIG dose is 1,000 to 2,000 mg/kg divided into 3 equal doses each given on 3 consecutive days or 400 mg/kg per day given over 5 consecutive days 3) Autoimmune diabetes mellitus Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of autoimmune diabetes mellitus when both of the following criteria are met: A. Patient is newly diagnosed with insulin dependent (type 1) diabetes mellitus AND B. **Patient is not a candidate for or is refractory to insulin therapy 79 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale 4) Autoimmune uveitis 5) Bone marrow transplantation (BMT), prevention of acute graft vs. host disease (GVHD) after BMT Additional information to support medical necessity review where applicable: IVIG is medically necessary for prevention of acute GVHD after BMT when all of the following criteria are met: A. Confirmed allogeneic bone marrow transplant within the last 100 days AND B. Documented severe hypogammaglobulinemia (IgG < 400 mg/dL) AND C. IVIG dose is 500 mg/kg once weekly for the first 90 days of therapy 6) Bone marrow transplantation (BMT), prevention of infection after BMT Additional information to support medical necessity review where applicable: IVIG is medically necessary for prevention of infection after BMT when all of the following criteria are met: A. Confirmed allogeneic bone marrow transplant within the last 100 days AND B. Documented severe hypogammaglobulinemia (IgG < 400 mg/dL) AND C. IVIG dose is 500 mg/kg once weekly for the first 90 days of therapy 7) Chronic inflammatory demyelinating polyneuropathy Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of chronic inflammatory demyelinating polyneuropathy when all of the following criteria are met: A. Initial treatment: 1. Progressive symptoms present 80 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale for at least 2 months AND 2. Physical findings – symptomatic polyradiculoneuropathy as indicated by both of the following: a. Progressive or relapsing motor or sensory impairment of more than one limb AND b. Widespread hyporeflexia or areflexia AND 3. Electrophysiologic findings when any 3 of the following 4 criteria are present: a. Partial conduction block of ≥ 1 motor nerve b. Reduced conduction velocity of ≥ 2 motor nerves c. Prolonged distal latency of ≥ 2 motor nerves d. Prolonged F-wave latencies of ≥ 2 motor nerves or the absence of F waves AND 4. All of the following findings following lumbar puncture: a. White blood cell count <10/mm3 b. Elevated CSF protein AND 5. IVIG dose is 2,000 mg/kg given over 2 to 5 days B. Continuation of treatment: 1. Significant improvement in clinical condition has been documented by an objective measurement scale (e.g., Rankin, Modified Rankin, or MRC scale) and when applicable, a reduction in the level of sensory loss should be noted AND 2. For long-term treatment, documentation that the dose has been periodically reduced or the treatment withdrawn, and the effects measured. 8) Chronic lymphocytic leukemia 81 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of chronic lymphocytic leukemia when all of the following criteria are met: A. Diagnosis of chronic lymphocytic leukemia (CLL) AND B. One of the following: 1. Documented hypogammaglobulinemia (IgG < 500 mg/dL) 2. History of bacterial infection(s) associated with B-cell CLL AND C. IVIG dose is 400 mg/kg every 3 to 4 weeks 9) Cytomegalovirus (CMV) induced pneumonitis in solid organ transplants 10) Dermatomyositis or polymyositis Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of dermatomyositis or polymyositis when all of the following criteria are met: A. Diagnosis of dermatomyositis or polymyositis AND B. **History of failure or intolerance to one of the following: 1. azathioprine 2. corticosteroid therapy 3. cyclophosphamide 4. methotrexate AND C. IVIG dose is 2,000 mg/kg given over 2 to 5 days 11) Enteroviral meningoencephalitis 12) Fetomaternal alloimmune thrombocytopenia Additional information to support medical necessity review where 82 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale applicable: IVIG is medically necessary for the treatment of fetomaternal alloimmune thrombocytopenia when all of the following criteria are met: A. For pregnant women 1. Diagnosis of fetomaternal alloimmune thrombocytopenia AND 2. One or more of the following: a. Previously affected pregnancy b. Family history of the disease c. Platelet alloantibodies found on screening AND 3. IVIG dose is 1,000 mg/kg for 2 days OR B. For newborns 1. Diagnosis of fetomaternal alloimmune thrombocytopenia AND 2. Thrombocytopenia that persists after transfusion of antigennegative compatible platelets 13) Graves’ ophthalmopathy 14) Guillain-Barré syndrome (GBS) Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of Guillain-Barré syndrome when all of the following criteria are met: A. Diagnosis of Guillain-Barré Syndrome AND B. Severe disease (i.e., requiring assistance to walk) AND C. Onset of neuropathic symptoms within the last four weeks AND D. IVIG dose is 2,000 mg/kg given over 2 to 5 days 15) HIV-infection, prevention of bacterial infection in pediatric HIV 83 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Additional information to support medical necessity review where applicable: IVIG is medically necessary for the prevention of bacterial infection in pediatric HIV when all of the following criteria are met: A. Diagnosis of HIV disease AND B. Patient age ≤ 13 years AND C. One of the following criteria: 1. Documented hypogammaglobulinemia (IgG ≤ 400 mg/dL) OR 2. Functional antibody deficiency as demonstrated by either poor specific antibody titers or recurrent bacterial infections. AND D. IVIG dose is 400 mg/kg every 28 days 16) IgM antimyelin-associated glycoprotein paraprotein-associated peripheral neuropathy 17) Immune thrombocytopenic purpura (ITP) Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of immune thrombocytopenic purpura when all of the following criteria are met: A. Diagnosis of immune thrombocytopenic purpura (ITP) AND B. Documented platelet count < 50 x 109 / L AND C. IVIG dose is within specific product-specific range in chart below Carimune NF IV: 400 mg/kg daily for 2 to 5 consecutive days. In acute ITP of childhood, if an initial 84 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale platelet count response to the first two doses is adequate, therapy may be discontinued after the second day of the 5 day course. In adults and children, if after induction therapy the platelet count falls to less than 30,000/µL and/or the patient manifests clinically significant bleeding, 400 mg/kg of body weight may be given as a single infusion. If an adequate response does not result, the dose can be increased to 800 to 1,000 mg/kg of body weight given as a single infusion. Gamimune N Induction dose: 400 mg/kg IV daily for 5 days OR 1,000 mg/kg daily for 1 to 2 days Maintenance dose: In adults and children with ITP, if after induction therapy the platelet count falls to less than 30,000/mm3 and/or the patient manifests clinically significant bleeding, 400 mg/kg may be given as a single infusion. If an adequate response does not result, the dose can be increased to 800 to 1,000 mg/kg given as a single infusion. Gammagard S/D IV: 1,000 mg/kg. Up to three separate doses may be given on alternate days if required. Gammaked IV: 2,000 mg/kg divided in two doses of 1,000 85 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale mg/kg given on two consecutive days OR into five doses of 400 mg/kg given on five consecutive days Gamunex / Gamunex-C IV: 2,000 mg/kg divided in two doses of 1,000 mg/kg given on two consecutive days OR into five doses of 400 mg/kg daily given on five consecutive days Privigen IV: 1,000 mg/kg daily for 2 consecutive days 18) Kawasaki disease Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of Kawasaki disease when both of the following criteria are met: A. Diagnosis of Kawasaki disease AND B. IVIG dose is 400 mg/kg for five consecutive days or a single dose of 2,000 mg/kg 19) Lambert-Eaton myasthenic syndrome (LEMS) Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of Lambert-Eaton myasthenic syndrome when both of the following criteria are met: A. **Documentation that patient has failed or is unable to tolerate steroids and other immunosuppressive treatments (e.g., azathioprine) AND B. IVIG dose is 2,000 mg/kg given over 2 to 5 days 20) Lennox Gastaut syndrome 86 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of Lennox Gastaut syndrome when both of the following criteria are met: A. **Documentation that patient has failed or is unable to tolerate traditional anti-epileptic pharmacotherapy (e.g., carbamazepine, lamotrigine, phenytoin, valproic acid) AND B. IVIG dose is 400 mg/kg/day for 4 to 5 consecutive days 21) Lymphoproliferative disease, bacterial infections 22) Monoclonal gammopathy 23) Multifocal motor neuropathy (MMN) Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of multifocal motor neuropathy when both of the following criteria are met: A. Diagnosis of multifocal motor neuropathy AND B. IVIG dose is 2,400 mg/kg given over 2 to 5 days 24) Multiple sclerosis, relapsing remitting (RRMS) Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of relapsing remitting multiple sclerosis when all of the following criteria are met: A. Initial treatment: 1. Diagnosis of relapsingremitting multiple sclerosis (RRMS) with at least one documented relapse within the 87 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale prior 12 months. NOTE: treatment of any other type of multiple sclerosis with IVIG is not supported by clinical evidence. AND 2. Medical records documenting a comprehensive neurological examination indicating mental status, cognitive function, motor and sensory system evaluations, reflexes, gait analysis, station and coordination; EDSS Score and/or designated form. Medical records must document a progression (worsening) of the patient’s clinical status from the visit prior to the one prompting the decision to initiate IVIG therapy. AND 3. **Documented treatment failure, contraindication, or intolerance to standard conventional therapies [i.e., two of the following agents: Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), Rebif (interferon beta-1a), Tysabri (natalizumab), Aubagio (teriflunomide), or Gilenya (fingolimod)] AND 4. Induction, when indicated, is with a dose of 400 mg/kg daily for up to five days, followed by maintenance dose of up to 1,000 mg/kg monthly. B. Continuation of treatment: 1. Medical records, including findings of interval examination including neurological deficits incurred and EDSS Score. AND 2. EDSS Score, stable or improved AND 3. Documentation of decreased number of relapses since starting IVIG therapy AND 4. Diagnosis continues to be the 88 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale relapsing-remitting form of MS (RRMS) with supporting evidence of interval examination documenting changes showing the neurological deficits incurred. 25) Myasthenia gravis (MG), acute exacerbation Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of myasthenic exacerbation when all of the following criteria are met: A. Diagnosis of myasthenia gravis AND B. Evidence of myasthenic exacerbation, defined by one of the following symptoms in the last month: 1. Difficulty swallowing 2. Acute respiratory failure 3. Major functional disability responsible for the discontinuation of physical activity AND C. IVIG dose is 2,000 mg/kg given over 2 to 5 days NOTE: Evidence does not support the use of IVIG maintenance therapy for myasthenia gravis. 26) Paraproteinemic neuropathy 27) Posttransfusion purpura Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of posttransfusion purpura when both of the following criteria are met: A. Diagnosis of posttransfusion purpura AND B. IVIG dose is 1,000 mg/kg for 2 days 28) Primary immunodeficiency syndromes 89 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale (list not all inclusive) A. Autosomal recessive agammaglobinulinemia B. Autosomal recessive hyperimmunoglobulin M syndrome (HIM) C. Bruton’s disease D. Combined immunodeficiency disorders 1. Ataxia-telangiectasia 2. DiGeorge syndrome 3. Nijmegan breakage syndrome 4. WHIM (warts, hypogammaglobulinemia, immunodeficiency, and myelokathexis) syndrome 5. Wiscott Aldrich syndrome E. Common variable immunodeficiency (CVID) F. Congenital hypogammaglobulinemia late onset, ICOS impaired G. Congenital / X-linked agammaglobulinemia H. Good syndrome (immunodeficiency with thymoma) I. Hyperimmunoglobulinemia E syndrome J. Hypogammaglobulinemia K. ICF syndrome L. Selective IgG subclass deficiencies M. Severe combined immunodeficiency N. Specific antibody deficiency O. Transient hypogammaglobulinemia of infancy, short-term treatment of recurrent severe bacterial infections P. X-linked immunodeficiency with hyperimmunoglobulin M Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of primary immunodeficiency syndromes when both of the following criteria are met: A. Diagnosis of primary immunodeficiency AND B. IVIG dose is within specific product-specific range in chart below 90 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Bivigam IV: 300 to 800 mg/kg every 3 to 4 weeks Carimune NF IV: 400 to 800 mg/kg every 3 to 4 weeks Flebogamma / Flebogamma DIF IV: 300 to 600 mg/kg every 3 to 4 weeks Gammagard Liquid IV: 300 to 600 mg/kg every 3 to 4 weeks SC: 1.37 X previous IV dose divided by number of weeks between IV doses Gammagard S/D IV: 300 to 600 mg/kg every 3 to 4 weeks Gamimune N IV: 300 to 600 mg/kg every 3 to 4 weeks Gammaked IV: 300 to 600mg/kg every 3 to 4 weeks SC: 1.37 X previous IV dose divided by number of weeks between IV doses Gammaplex IV: 300 to 800 mg/kg every 3 to 4 weeks Gamunex / Gamunex-C IV: 300 to 600 mg/kg every 3 to 4 weeks SC: 1.37 X previous IV dose divided by number of weeks between IV doses Hizentra SC: 1.53 X previous IV dose divided by number of weeks between IV doses Octagam IV: 300 to 600 mg/kg every 3 to 4 weeks Privigen IV: 200 to 800 mg/kg every 3 to 4 weeks 28) Rasmussen syndrome 91 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of Rasmussen syndrome when both of the following criteria are met: A. Documentation that short term amelioration of encephalitis is needed prior to definitive surgical therapy AND B. IVIG dose is 2,000 mg/kg given over 2 to 5 days 29) Renal transplantation, prevention of acute humoral rejection 30) Renal transplantation, treatment of acute humoral rejection 31) Rheumatoid arthritis, severe 32) Rotaviral enterocolitis 33) Staphylococcal toxic shock 34) Stiff-person syndrome Additional information to support medical necessity review where applicable: IVIG is medically necessary for the treatment of stiff-person syndrome when both of the following criteria are met: A. **Documentation that patient has failed or is unable to tolerate GABAnergic medication (e.g., baclofen, benzodiazepines) AND B. IVIG dose is 2,000 mg/kg given over 2 to 5 days 35) Toxic epidermal necrolysis or StevensJohnson syndrome 36) Urticaria, delayed pressure Immune globulin is unproven for: 1) Acquired hemophilia 2) Acute disseminated encephalomyelitis (ADEM) 92 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale 3) Adrenoleukodystrophy 4) Alzheimer’s disease 5) Amyotrophic lateral sclerosis (ALS) 6) Antiphospholipid antibody syndrome (APS) in pregnancy 7) Asthma, non-steroid dependent 8) Atopic dermatitis 9) Autism spectrum disorders 10) Autoimmune hemolytic anemia 11) Autoimmune liver disease 12) Autoimmune neutropenia 13) Bone marrow transplantation (BMT), prevention of chronic graft vs. host disease (GVHD) after BMT 14) Campylobacter species-induced enteritis 15) Cerebral infarctions with antiphospholipid antibodies 16) Chronic fatigue syndrome 17) Demyelinative brain stem encephalitis 18) Demyelinating neuropathy associated with monoclonal IgM 19) Dilated cardiomyopathy 20) HIV infection, to reduce viral load 21) HTLV-1-associated myelopathy 22) Idiopathic dysautonomia, acute 23) Inclusion body myositis 24) Isolated IgA deficiency 25) Isolated IgG4 deficiency 26) Lumbosacral or brachial plexitis 27) Myocarditis, acute 28) Neonatal isoimmune hemolytic jaundice 29) Neonatal sepsis, prevention 30) Neonatal sepsis, treatment 31) Opsoclonus myoclonus 32) Paraneoplastic cerebellar degeneration, sensory neuropathy, or encephalopathy 33) Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) 34) POEMS syndrome 35) Postinfectious cerebellar ataxia 36) Postoperative sepsis 37) Pseudomembranous colitis 38) Respiratory syncytial virus (RSV) lower respiratory tract infection 39) Rheumatic fever, acute 40) Sjogren's syndrome 41) Spontaneous recurrent abortions, prevention 42) Systemic lupus erythematosus 43) Urticaria, chronic 44) Vasculitides and antineutrophil antibody 93 March 2013 Drug and Biologics Policy Updates REVISED Title Immune Globulin (IVIG and SCIG) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale syndromes Efficacy for these conditions has not been described in adequately designed studies. The available evidence is limited to case reports or case series, anecdotal reports, and open-label trials, or the available studies have failed to demonstrate a positive treatment effect. Further well-designed studies are needed to establish the role of IVIG in these conditions. Centers for Medicare and Medicaid Services (CMS): Medicare covers intravenous immune globulin (IVIG) when criteriais met. See the Medicare Benefit Policy Manual (Pub. 100-2) Chapter 15 - Section 50.6 Coverage of Intravenous Immune Globulin for Treatment of Primary Immune Deficiency Diseases in the Home at http://www.cms.hhs.gov/manuals/Downloads/ bp102c15.pdf Medicare covers Intravenous Immune Globulin when criteria is met. Refer to the National Coverage Determination (NCD) for Intravenous Immune Globulin for the Treatment of Autoimmune Mucocutaneous Blistering Diseases (250.3) Local Coverage Determinations (LCDs) exist for Intravenous Immune Globulin Immune Globulin Intravenous (IVIG) Drugs and Biologicals Immune Globulin Intravenous and compliance with these policies is required where applicable. (Accessed September 28, 2012) Orencia (abatacept) Apr. 1, 2013 Updated description of services to reflect most current clinical evidence and references Revised coverage rationale; updated information to support medical necessity review Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14) Abatacept is proven for the treatment of: 1. 2. Rheumatoid arthritis* Polyarticular juvenile idiopathic arthritis (JIA)* *Additional information to support medical necessity review where applicable: Abatacept is medically necessary for the treatment of rheumatoid arthritis or polyarticular juvenile idiopathic arthritis when both of the following criteria are met: A. Moderate to severe disease activity [e.g., 94 March 2013 Drug and Biologics Policy Updates REVISED Title Orencia (abatacept) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale swollen, tender joints with limited range of motion] AND B. **Documented treatment failure, contraindication, or intolerance to one or more disease modifying anti-rheumatic drugs (DMARDs) [e.g., hydroxychloroquine, leflunomide, methotrexate, sulfasalazine] **The State of New Jersey prohibits requiring failed prior therapy or intolerance to therapy as a requirement for coverage. Abatacept is unproven for the treatment of: 1. 2. 3. 4. 5. Multiple sclerosis Systemic lupus erythematosus Graft versus host disease (GVHD) Psoriatic arthropathy Uveitis associated with Behçet’s disease Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for abatacept (Orencia®). In general, Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually selfadministered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/ bp102c15.pdf Local Coverage Determinations (LCDs) for abatacept exist and compliance with these policies is required where applicable. (Accessed December 27, 2012) Xolair (omalizumab) Apr. 1, 2013 Revised coverage rationale; added information to support medical necessity review Omalizumab for subcutaneous use is proven for adults and adolescents with moderate to severe persistent asthma who meet ALL of the following criteria: 1. Age 12 years or older 2. Have a positive skin test or in vitro reactivity to a perennial aeroallergen 3. Symptoms inadequately controlled with inhaled corticosteroids 4. Have a baseline plasma immunoglobulin 95 March 2013 Drug and Biologics Policy Updates REVISED Title Xolair (omalizumab) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale E (IgE) level between 30 and 700 IU/mL Additional information to support medical necessity review where applicable: Omalizumab is medically necessary for treatment of moderate to severe persistent asthma when all of the following criteria are met: A. Age 12 years or older AND B. Moderate to severe persistent uncontrolled asthma as defined by one of the following: 1) Daily asthmatic symptoms 2) Daily use of inhaled short-acting beta2-agonist 3) Exacerbations affect/limit activity 4) Exacerbations (requiring oral systemic corticosteroids) 2 times a year 5) Nighttime awakening more than once per week 6) Forced expiratory volume in one second (FEV1) or peak expiratory flow PEF) < 80% of predicted level 7) Measures of asthma control indicate uncontrolled asthma (eg, Asthma Control Test [ACT] score ≤ 19 ) AND C. Baseline (pre-omalizumab treatment) serum total IgE level ≥ 30 IU/mL and ≤ 700 IU/mL AND D. Positive skin test or in vitro reactivity to a perennial aeroallergen AND E. Documented failure (eg, emergency room visit or hospitalization for asthma exacerbation, need for oral steroid burst) of at least 3 months to regular/routine treatment with one of the following: 1) One combination inhaled corticosteroid/long-acting beta2agonist product [e.g., Advair (fluticasone propionate/salmeterol), Dulera (mometasone/formoterol), Symbicort 96 March 2013 Drug and Biologics Policy Updates REVISED Title Xolair (omalizumab) (continued) Effective Date Apr. 1, 2013 Summary of Changes Coverage Rationale (budesonide/formoterol)] OR 2) Combination therapy including both of the following: (a) One inhaled corticosteroid at the maximum dosage [e.g., Flovent (fluticasone propionate), Pulmicort (budesonide), QVAR (beclomethasone dipropionate)] AND (b) One long-acting beta2agonist [e.g., Foradil (formoterol fumarate), Serevent (salmeterol xinafoate)] Omalizumab is unproven in the following: 1. Pediatric patients less than 12 years of age 2. Seasonal allergic rhinitis 3. Perennial allergic rhinitis 4. Atopic dermatitis 5. Peanut allergy 6. Acute bronchospasm or status asthmaticus 7. When given outside FDA labeling parameters 8. Chronic urticaria Centers for Medicare and Medicaid Services (CMS): Medicare does not have a National Coverage Determination (NCD) for omalizumab (Xolair). In general, Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually selfadministered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at http://www.cms.hhs.gov/manuals/Downloads/ bp102c15.pdf Local Coverage Determinations (LCDs) exist for Omalizumab (Xolair) and compliance with these policies is required where applicable. (Accessed January 3, 2013) 97 March 2013 Coverage Determination Guideline (CDG) Updates NEW Title Private Duty Nursing Effective Date May 1, 2013 Coverage Rationale Plan Document Language Before using this guideline, please check enrollee’s specific plan document and any federal or state mandates, if applicable. Refer to enrollee’s plan specific SPD, Plan Documents or State Contractual Language to determine if the plan has exclusion for Private Duty Nursing. If the plan has the exclusion for Private Duty Nursing then the services are not eligible for coverage. Indications for Coverage The services being requested must: 1. Be ordered by a primary practitioner (M.D., D.O., P.A. or N.P), after a face to face evaluation by the physician, licensed or certified physician assistant or nurse practitioner; and 2. Services should be skilled in nature (please see CDG titled Custodial and Skilled Services); and 3. Home is a safe environment for the patient based on a home health assessment and therapies needed for the patient’s medical condition; and 4. Directed by or under the supervision of primary practitioner (M.D., D.O., P.A. or N.P); and 5. Be coordinated with the family and providers by a UHC clinical service team; and 6. The treatment plan with any required form should be submitted with the request for specific services and equipment*; and 7. Treatment plan should be reviewed by the UHC clinical service team for progress toward goals periodically (at least every 60 days); and 8. The services are more cost effective (check plan specific documents for cost effective definition, if not present please do not use this criteria) in the home or patient residence (not a hospital or a facility that provides skilled care) than an alternative setting(ongoing monitoring of the cumulative costs over 6 months should be documented and reviewed); and 9. Services require one or more of the following: a. Patient’s condition makes him or her homebound (not an allinclusive list) i. Poor Prognosis for full recovery; or ii. Risk of Death; or iii. Imminent risk to health status due to fragility; or iv. Condition that may deteriorate quickly without intervention; or v. Health status or functional status that can be expected to stabilize or significantly improve with the services provided; Note: the requirements above and below may vary for state specific contracts and for Long Term Products OR b. c. Patient’s condition plus the geographic distance make it unreasonable for patient to obtain the needed services in an outpatient facility, primary practitioner (M.D., D.O., P.A. or N.P) office; or Patient is technology dependent; or 98 March 2013 Coverage Determination Guideline (CDG) Updates NEW Title Private Duty Nursing (continued) Effective Date May 1, 2013 Coverage Rationale d. Nursing intervention every 2-3 hours; or e. Services are needed on a continuous basis (this is more than “intermittent or part-time”) such as suctioning or hemodynamic monitoring to assure immediate intervention 10. Patients who are birth through age 17 or up to age 21 (varies by state specific contracts or COC/SPD) must reside with a responsible adult who is either trained to provide nursing care or is capable of initiating an identified contingency plan when the scheduled private duty nurse is unexpectedly unavailable. (The name and relationship to the patient should be part of the initial request for services); Some plans may require the caregiver to provide a certain number of hours of care for the patient check the enrollee’s plan specific documents or the state contract 11. Home health services for custodial care are provided only as mandated by the state contract. (See member’s plan specific documents for definition of custodial and skilled care) 12. Recertification by the primary practitioner (M.D., D.O., P.A. or N.P), or healthcare professional must be submitted at least every 60-120 days (or more often if requested by UHC and or state contractual language) on the appropriate form *An initial assessment form must accompany the original request for services. A reassessment for certification form must accompany a request for extension of benefits. See links to forms below. Request Form: Private Duty Nursing or Shift Care -- Initial Request for Information Recertification Form: 90-120 Day Renewal or Recertification for Private Duty Nursing Coverage Limitations and Exclusions 1. Services beyond the plan benefits (hours or days). 2. Requested services are excluded in the plan documents or state specific contracts. 3. Requested services are defined as non-skilled or custodial care in enrollee/member’s plan specific documents (refer to Custodial and Skilled CDG and plan specific documents or state contractual language). 4. Services involve payment of family members or non-professional caregivers for services performed for the member unless required by state contract. 5. Services when enrollee does not meet criteria for skilled services. 6. Enrollee is no longer eligible for benefits under the plan or state contract. For ASO plans with SPD language other than fully-insured Generic COC language Please refer to the enrollee’s plan specific SPD for coverage. When a plan or state contract covers private duty nursing in the home but does not define or describe the criteria for the services this CDG may be considered and should be applied. 99 March 2013 Coverage Determination Guideline (CDG) Updates UPDATED Title Breast Reduction Surgery Effective Date Apr. 1, 2013 Summary of Changes Routine review; no change to coverage rationale Added list of applicable ICD-9 diagnosis codes: 611.1 Added list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/14): N62 Title Blepharoplasty, Blepharoptosis, and Brow Ptosis Repair Effective Date Apr. 1, 2013 Summary of Changes Note: The following summary of changes has been revised since originally announced in the February 2013 edition of the Medical Policy Update Bulletin. Cosmetic and Reconstructive Procedures Apr. 1, 2013 Custodial and Skilled Care Services Apr. 1, 2013 REVISED Updated list of applicable CPT codes: o Brow Ptosis Repair: Added 67911 o Strabismus Repair: Added note to indicate strabismus repair is considered reconstructive Added 67311, 67312, 67314, 67316, 67318, 67320, 67331, 67332 and 67334 o Canthus Repair and Lid Repair: Added 67950, 67961 and 67966 Revised coverage rationale; added information pertaining to medical necessity review (when applicable) Updated list of applicable procedure codes: Filler Material SQ Injections o Added 11950, 11951, 11952 and 1954 o Added coding clarification language to indicate: Q2026 (Injection Radiesse 0.1ML) is covered when used for treatment of facial defects due to facial lipidatrophy in persons with human immunodeficiency virus (HIV) and treatment of vocal fold insufficiency Q2027 (Injection Sculptra 0.1ML) is covered when used for treatment of facial defects due to facial lipidatrophy in persons with human immunodeficiency virus (HIV) Other uses of these devices may be cosmetic Miscellaneous Cosmetic and Reconstructive Procedures o Added 11960, 15780, 17999, 28344, 40500 and 69320 Reorganized policy content Reformatted/updated list of applicable Products; removed references to Certificates of Coverage Added reference link to Utilization Review Guideline titled Durable Medical Equipment and Related Supplies, Prosthetics and Orthotics Revised coverage rationale/indications for coverage; added language to indicate, for care to be covered, the physician must participate in the development of the plan of care and review of data collected in the home health agency’s patient assessment in addition to signed order. In addition, documentation must indicate an ongoing knowledge of any changes in the patient’s condition, drugs, or other needs and how they are being met Added definition of mechanical ventilation 100 March 2013 Coverage Determination Guideline (CDG) Updates REVISED Title Gender Identify Disorder Treatment (Sex Transformation) Effective Date Apr. 1, 2013 Summary of Changes Revised coverage rationale for standard plans: Plan Document Language o Removed language indicating sex transformation surgery is also referred to as intersex surgery Coverage Limitations and Exclusions o Added language to clarify thyroid chondroplasty is the removal or reduction of the Adam's Apple Related Services o Updated list of examples of excluded services; added radiologic procedures Revised coverage rationale for plans that cover surgical treatment of gender identity disorder: Covered Services o Added language to indicate, in addition to the surgeon fees, the benefit applies to the services related to the surgery, including, but not limited to, anesthesia, laboratory testing, pathology, radiologic procedures, hospital and facility fees, and/or surgical center fees Genital Surgery and Surgery to Change Specified Secondary Sex Characteristics Eligibility Qualifications o Revised eligibility criteria: Removed language indicating the Covered Person must complete at least 12 months of continuous hormone therapy Added language to indicate the Covered Person may be required to complete continuous hormone therapy (for those without contraindications); in consultation with the patient’s physician, this should be determined on a case-by-case basis through the Notification process. Note the following clarifications: - A biologic female patient that is only requesting a bilateral mastectomy does not need to complete hormone therapy in order to qualify for the mastectomy. However, UnitedHealthcare recommends that the patient complete at least 3 months of psychotherapy before having the mastectomy (Note: WPATH Version 6 recommends that the patient complete 3 months of psychotherapy and/or 3 months of hormone therapy) - A biologic male patient that is able to take female hormones and is considering breast augmentation surgery should take the female hormones for at least 18 months before being considered for bilateral breast augmentation since the patient may achieve adequate breast development without surgery Revised definition of gender identity disorder Updated list of applicable CPT codes; added language to indicate 55970 & 55980 (intersex surgery) may be done for congenital defects, genital anomalies, or as a treatment for gender identity disorder 101 March 2013 Coverage Determination Guideline (CDG) Updates REVISED Title Nutrition (Including: Counseling, Therapy, Enteral Nutrition, Infant Formula, Breast Milk, Supplements and Food) Effective Date May 1, 2013 Summary of Changes Revised coverage rationale: For plans with language other than fully-insured Generic COC language o Added language to clarify guidelines apply to plans that cover enteral formula o Added coverage requirements for medical necessity plans Orthognathic (Jaw) Surgery Apr. 1, 2013 Preventive Care Services Apr. 1, 2013 Revised coverage rationale: Indications for Coverage o Added reference link to CDG titled Dental Exclusion and Accidental Dental for additional information on covered oral excisions Criteria for a Coverage Determination as Reconstructive o Added language to indicate noted criteria applies to medical necessity plans Revised definition of post-surgical sequela Added reference link to Utilization Review Guideline titled Breast Pump Revised list of applicable procedure codes (effective for dates of service on or after 4/1/13): Cervical Cancer Screening, Pap Smear o Removed January 2003 USPSTF rating for sexually active women (no age limits) o Added March 2012 USPSTF rating for all women age 21 to 65 years. o Updated claims edit criteria; added language to indicate benefit applies to females age 21 to 65 years (coverage ends on 66th birthday; no frequency limit) Colorectal Cancer Screening o Moved procedure codes 88304 and 88305 from Code Group 2 to new/separate Code Group 3 o Added claim edit criteria to indicate the procedure codes listed in Code Group 3 are paid as preventive if: Billed with one of the listed diagnosis codes; and Billed with one of the procedure codes listed in Code Group 1 or Code Group 2 Immunizations o Removed G9141 (code expires 12/31/12) Screening for Obesity in Adults o Removed 2003 USPSTF rating o Added June 2012 USPSTF rating indicating clinicians should offer or refer patients with a body mass index (BMI) of 30 kg/m2 or higher to intensive, multicomponent behavioral interventions o Added diagnosis codes for BMI of 30.0 – 39.0 (V85.30 – V85.39) Women’s Preventive Health: Breastfeeding Support, Supplies, and Counseling o Added V24.1 to list of applicable diagnosis codes o Updated claim edit criteria; added language to indicate diagnosis code V24.1 is required for E0603, E0604 and A4281 – A4286 Appendix o Added Appendix A, USPSTF Grade Definitions 102 March 2013 Coverage Determination Guideline (CDG) Updates REVISED Title Prosthetic Devices and Wigs Effective Date Apr. 1, 2013 Summary of Changes Revised coverage rationale/indications for coverage; added language to indicate the prosthetic must be approved by the Food and Drug Administration (FDA) and otherwise generally considered to be safe and effective for the purposes intended and the item must be reasonable and necessary for the individual patient Rhinoplasty, Septoplasty, and Repair of Vestibular Stenosis Apr. 1, 2013 Note: The following summary of changes has been revised since originally announced in the February 2013 edition of the Medical Policy Update Bulletin. Reorganized policy content Reformatted/updated list of applicable Products; removed references to Certificates of Coverage Revised coverage rationale: Required Documentation o Clarified requirements related to documentation of chief complaint and tests that document septal deviation Criteria for a Coverage Determination as Reconstructive o Revised guidelines/requirements for septoplasty: Updated/expanded requirements for contemporaneous office notes to include criterion related to the documentation of recurrent epistaxis secondary to the septal deformity Added language to indicate a CT evaluation to determine extent of disease is the standard of care prior to any sinus procedures if there are reasons to suspect polyps as the cause for obstruction or that chronic sinusitis is the result of obstruction Replaced criteria requiring “a formal and signed written CT report documenting the degree of the septal deviation” with “a formal and signed written CT or MRI report documenting the degree of the septal deviation” Removed language related to cases where the member or physician has declined a CT scan of the maxillofacialand nasal region to document septal deviation o Revised guidelines/requirements for rhinoplasty for a nasal deformity when a functional impairment exists; added language to clarify rhinoplasty is considered reconstructive when performed in conjunction with a covered correction of congenital craniofacial anomalies including, but not limited to, correction of cleft lip, cleft palate, or combinations of the two o Added guidelines/requirements for rhinoplasty and surgical repair of vestibular stenosis or alar collapse o Added language to indicate noted criteria applies to medical necessity plans Coverage Limitations and Exclusions o Updated list of cosmetic procedures excluded from coverage; added rhinoplasty procedures performed to improve appearance Updated definition of nasal endoscopy; added nasopharyngoscopy to list of common names Updated list of applicable CPT codes (miscellaneous); added 30120, 30540, 30545, 30560 and 30620 103 March 2013 Coverage Determination Guideline (CDG) Updates REVISED Title Specialized, Microprocessor or Myoelectric Limbs Effective Date Apr. 1, 2013 Summary of Changes Reorganized policy content Reformatted/updated list of applicable Products; removed references to Certificates of Coverage Revised coverage rationale/indications for coverage o Removed reference to “C-Leg” as example of computerized and specialized lower limb prostheses o Added reference to “i Ottobock C-Leg® Microprocessor Knee System” as example of high activity knee control frame (L5930) Updated list of applicable HCPCS codes (specialized codes); added L6611, L6646, L6648, L6920, L6930, L6940, L6950, L6960, L6970 and L7040 Speech Language Pathology Services Apr. 1, 2013 Revised coverage rationale: o Added information pertaining to medical necessity review (when applicable) o Replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) o Added language to indicate, when billed alone, swallowing therapy (92526) will count toward the speech therapy benefit limit, if applicable Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins May 1, 2013 Reorganized policy content Reformatted/updated list of applicable Products; removed references to Certificates of Coverage Revised coverage rationale: Criteria for a Coverage Determination to be Reconstructive o Added guidelines for sclerotherapy and stab phlebectomy /ambulatory phlebectomy o Added list of investigational treatments not considered to be medically necessary and therefore are not covered o Added language to indicate; The patient's medical record must document the following: - history and physical findings supporting a diagnosis of symptomatic varicose veins - failure of an adequate trial of conservative treatment as described in the "Indications" section of this LCD - exclusion of other causes of edema, ulceration and pain in the limbs - performance of appropriate tests to confirm the presence and location of incompetent perforating veins - location and number of varicosities, level of incompetence of the vein and the veins involved, and - necessity of utilizing ultrasound guidance, if used The medical record must also include pre-treatment photographs of the varicose veins for which claims for sclerotherapy are submitted Updated list of applicable CPT codes; added 36470 and 36471 (sclerosing procedures) and corresponding reference link to CDG titled Cosmetic and Reconstructive Procedures for associated review criteria Added list of applicable HCPCS codes: S2202 (echosclerotherapy) 104 March 2013 Utilization Review Guideline (URG) Updates \ NEW Title Breast Pumps Effective Date Apr. 1, 2013 Utilization Review Guidelines Some states may mandate coverage for a type of breast pump and that mandate may vary from the following. Please refer to enrollee’s specific plan documents for coverage. Breastfeeding and human milk are the normative standards for infant feeding and nutrition. The American Academy of Pediatrics recommends exclusive breastfeeding for about 6 months, followed by continued breastfeeding as complementary foods are introduced with continuation of breastfeeding for 1 year or longer as mutually desired by mother and infant. Use of a breast pump may be necessary to establish and maintain expression of milk to meet the infant’s nutritional needs. The following policy addresses plans that are currently subject to, or voluntarily follow, the Health Resources and Services Administration (HRSA) requirements for coverage of breast pumps, for plan years beginning on or after August 1, 2012 (please check benefit plan documents for details.) The health reform law does not require plans and issuers that have a network of provider to cover preventive care services, including expanded women’s preventive services, provided by out-of-network providers. If a plan covers outof-network preventive services, the plan or issuer may impose cost-sharing requirements, unless a state law otherwise requires first-dollar coverage. If a plan does not cover out-of-network preventive services, then out-of-network preventive services (including breast pumps rented or purchased out of network) will not be covered. Benefits defined under the HRSA requirement include the cost of renting one breast pump per pregnancy in conjunction with childbirth. If more than one type of breast pump can meet the enrollee’s needs, benefits are available only for the most cost effective pump. UnitedHealthcare will determine the following: Which pump is the most cost effective Whether the pump should be purchased or rented Duration of a rental Timing of an acquisition Hospital Grade Breast Pump: Rental Only Hospital Grade Breast Pumps (heavy duty designed for multiple users), and the personal use attachment kit, are covered for enrollees who are lactating mothers when the enrollee obtains the hospital grade breast pump within the first two months (60 days) following delivery and their infant has one or more of the following criteria: 1. 2. Hospitalized newborn infant Congenital malformations or genetic abnormalities impacting feeding (e.g., cleft lip and palate, Down’s Syndrome) Personal Use Double Electric Breast Pump High quality, personal use double electrical breast pumps have been shown to 105 March 2013 Utilization Review Guideline (URG) Updates NEW Title Breast Pumps (continued) Effective Date Apr. 1, 2013 Utilization Review Guidelines be as effective as Hospital grade pumps in outpatient settings for breast feeding females. This includes mothers with maternal infant separation for work or school and no other identified lactation risk factors. A personal use double electrical pump may be covered for the enrollee with the following criteria: 1. 2. The woman is a lactating mother Enrollee should obtain the breast pump within one year (365 days) of delivery Additional Information about Breastfeeding: Supporting statement from Surgeon General Call to action: “Because breastfeeding confers many important health and other benefits, including psychosocial, economic, and environmental benefits, it is not surprising that breastfeeding has been recommended by several prominent organizations of health professionals, among them the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse- Midwives, American Dietetic Association, and American Public Health Association, all of which recommend that most infants in the United States be breastfed for at least 12 months. These organizations also recommend that for about the first six months, infants be exclusively breastfed, meaning they should not be given any foods or liquids other than breast milk, not even water.” The following is a list of items that encourage breastfeeding: 1. 2. 3. Appointments for follow-up visits with mother and child Hospital practices should support discharged mothers open access to feeding infant Patient education (verbal and written) includes: a. Advantages of exclusive breastfeeding b. Provision of non-commercial materials compliant with the World Health Organization Code of Marketing Breast Milk Substitutes c. Anticipatory guidance i. Engorgement ii. Signs of adequate intake iii. Signs of jaundice iv. Sleep patterns v. Maternal medication use vi. Individual feeding patterns vii. Follow-up and contact information d. Expressing, pumping, and storage of human milk e. Information on support for working mothers f. Contact information for counseling or support groups REVISED Title Chemotherapy Observation and Inpatient Hospitalization Effective Date Apr. 1, 2013 Summary of Changes Revised utilization guidelines; replaced references to “Milliman Care Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective 04/01/13) 106 March 2013 Utilization Review Guideline (URG) Updates REVISED Title Durable Medical Equipment and Related Supplies, Prosthetics and Orthotics Effective Date Apr. 1, 2013 Summary of Changes Removed reference link to Utilization Review Guideline titled Wound Pumps (retired 04/01/13) Added reference link to Coverage Determination Guideline titled Prosthetic Devices and Wigs Revised DME, Orthotics and Prosthetics Supplemental Coding Grid (attachment file); updated list of applicable HCPCS codes: o Added equipment type categories and corresponding codes for: Automatic External Defibrillators Intrapulmonary Percussive Ventilation System Mechanical In-Exsufflation Devices Pneumatic Compression Devices Pressure Reducing Support Services Group 2 Pressure Reducing Support Services Group 3 Speech Generating Devices o Wheelchair Options and Accessories: Added sub-categories and corresponding codes for; Other Power Wheelchair Accessories Miscellaneous Accessories o Hospital Beds/Pediatric: Added E0300 o Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea/ Equipment: Added E047 o Power Mobility Devices: Added K0010, K0011, K0012 and K001 o Wheelchairs-Manual (Bases): Added E1220 and E1230 107 March 2013 Medical Policy Update Bulletin If you do not contract directly with UnitedHealthcare, and participate in our network through an arrangement in which we “Lease” a network from some other entity, some of the information provided in this communication may not apply to you and/or mayimpact you differently. If you have questions regarding any of the information or need to better understand its impact on you, please contact your local Network Management representative, Physician Advocate or Hospital & Facility Advocate. If you are not sure who your contact is, please visit UnitedHealthcareOnline.com > Contact Us > Network Contacts. MN012N108 P.O. Box 1459 Minneapolis, MN554401459 M49249 5/11 For more information, visit UnitedHealthcareOnline.com