Medical Policy New Technology Assessment and Non-Covered Services

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1 Medical Policy New Technology Assessment and Non-Covered Services Subject: New Technology Assessment and Non-Covered Services Background: Harvard Pilgrim Health Care (HPHC) does not cover services or technology (i.e. medical devices, healthcare procedures, drugs or biologics) that are considered experimental or investigational as safety and efficacy has not been supported based on published peer-reviewed medical and scientific literature. HPHC reviews each technology or service through HPHC s Technology Assessment Committee and utilizes an evidence-based approach using the following general criteria: Technology must have final approval from appropriate governing regulatory bodies Well-designed published peer reviewed literature, or opinions and evaluations by national medical associations/consensus panels, or other accredited bodies must permit conclusions on the effect of the technology on health outcomes Technology must improve net health outcomes and the beneficial effects of the health outcomes must outweigh any harmful effects on health outcomes Technology must be equally beneficial as any established alternatives and should improve health outcomes as much as or more than any established alternatives, and must be cost-effective The technology must be attainable outside the investigational setting In addition, the following medical and scientific sources are considered throughout the process: Peer-reviewed scientific studies published in medical journals that meet nationally recognized requirements for scientific manuscripts Peer-reviewed literature, biomedical compendia and other medical literature that meet the criteria of the National Institutes of Health s (NIH) National Library of Medicine Medical journals recognized by the Secretary of Health and Human Services Findings, studies or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes, such as: o Federal Agency for Healthcare Research and Quality o National Institutes of Health o National Comprehensive Cancer Network o National Academy of Sciences o Centers for Medicare and Medicaid Services (CMS) Any national board recognized by the National Institutes of Health (NIH) Peer-reviewed abstracts Medical Directories (e.g. Hayes Inc, ECRI Institute, UpToDate) U.S. Food and Drug Administration (FDA) and associated compendia New Technology Assessment and Non-Covered Services Page 1 of 6

2 If a new service or technology is not listed or determination on coverage has not been made, the service and technology will be considered experimental/investigational until it is evaluated by HPHC. Individual consideration is available for members in the interim. Policy and Coverage Criteria: Harvard Pilgrim Health Care (HPHC) considers the following services and technology as experimental/investigational, and therefore not covered (this is not an all-inclusive list): Actigraphy, as a stand-alone method for sleep disorder diagnosis AIRvance System for Tongue Base Suspension Artificial Lumbar Disc Replacement Automated External Defibrillators for Home Use AxiaLIF Bulking Agents for Fecal Incontinence Cerebral Perfusion Analysis using Computed Tomography (CT) Coflex Interlaminar Stabilization Implant Dynamic Spine Stabilization Systems Electron Beam Computed Tomography (EBCT) for Detection of Coronary Artery Disease Endosure Wireless Implantable System Extracorporeal Magnetic Innervation (ExMI) Therapy for Urinary Incontinence Extracorporeal Shock Wave Therapy (ESWT) for Refractory Tendinopathies Fecal Calprotectin Testing In Vitro Chemosensitivity and Chemoresistance Assays Ketamine Hydrochloride for Treatment of Psychiatric Disorders and Pain Management Laser Treatment of Toenail Fungus Magnetic Resonance Guided Focused Ultrasound Ablation for Uterine Fibroids Mild Procedure Neutralizing Antibody Testing in Multiple Sclerosis Patients Home Electrical Stimulation Devices, such as: o NESS H200; NESS L300; NESS L300 Plus o Bionicare Knee System o WalkAide o Odstock Dropped Foot Stimulator (ODFS) Pace Thermal Intradiscal Procedures: o Laser discectomy o Nucleoplasty o Intradiscal electrothermal annuloplasty (IEA) o Intradiscal electrothermal therapy (IDET) o Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) o Intradiscal biacuplasty (IDB) Pillar Palatal Implant System for the Treatment of Obstructive Sleep Apnea Platelet-Rich Plasma Injections Pulsed Radiofrequency Treatment Surgical Treatment of Migraine Headaches X-STOP (Interspinous Process Decompression Devices) New Technology Assessment and Non-Covered Services Page 2 of 6

3 See below for additional related policies: Non-Covered Payment Policy Link to Policy to be included at publishing Radiology- NIA Link to policy included at publishing Molecular Diagnostics- AIM Link to Policy included at publishing Billing Guidelines: Per member s benefit, any product or services, including but not limited to drugs, devices, treatments, procedures and diagnostic tests that are experimental/investigational or unproven are considered as not medically necessary, and therefore not covered. Coding: Codes listed below are non-covered and therefore not reimbursable per this policy. The list may not be all-inclusive. This is not an all-inclusive list. New Technology Assessment and Non-Covered Services Page 3 of 6

4 HCPCS Codes Description B4105 In-line cartridge containing digestive enzyme(s) for enteral feeding, each C9727 Insertion of implants into the soft palate; minimum of three implants E0617 External defibrillator with integrated electrocardiogram analysis E0740 Non-implanted pelvic floor electrical stimulator, complete system E0770 Functional electrical stimulatory, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified E1399 Durable medical equipment, miscellaneous J3490 Unclassified drugs L8605 Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies L8701 Powered upper extremity range of motion assist device, elbow, wrist, hand with single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated L8702 Powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), includes microprocessor, sensors, all components and accessories, custom fabricated S8092 Electron beam computed tomography (also known as ultrafast CT, cine CT) Unlisted procedure, skin, mucous membrane and subcutaneous tissue Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral, including fluoroscopic guidance; 1 or more additional levels (list separately in addition to code for primary procedure) Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft when performed, L5-S1 interspace Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar Revision including replacement of total disc arthroplasty (artificial disc), anterior approach Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; Cervical single interspace; lumbar Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar Unlisted procedure, spine Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia New Technology Assessment and Non-Covered Services Page 4 of 6

5 34806 Transcatheter placement of wireless physiologic sensor in aneurysmal sac during endovascular repair, including radiological supervision and interpretation, instrument calibration, and collection of pressure data (List separately in addition to code for primary procedure.) Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous Tongue base suspension, permanent suture technique Unlisted procedure, palate, uvula Unlisted procedure anus Unlisted procedure, urinary system Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (e.g. manual or automated percutaneous discectomy, percutaneous laser discectomy Unlisted ultrasound procedure Calprotectin, fecal Neutralization test, viral Nitroblue tetrazolium dye test Unlisted immunology procedure Unlisted transfusion medicine procedure Tissue culture, additional studies or definitive identification Unlisted microbiology procedure Unlisted cytogenetic study Unlisted miscellaneous pathology test Non-invasive physiologic study of implanted wireless pressure sensor in aneurysmal sac following endovascular repair, complete study including recording, analysis of pressure and waveform tracings, interpretation and report Actigraphy testing, recording, analysis, interpretation, and report (minimum of 72 hours to 14 consecutive days of recording Unlisted therapeutic, prophylactic, or diagnostic intravenous or intra-arterial injection or infusion 0019T Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, low energy 0042T Cerebral perfusion analysis using computed tomography with contrast administration, including post-processing of parametric maps with determination of cerebral blood flow, cerebral blood volume, and mean transit time 0071T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume less than 200 cc of tissue 0072T Focused ultrasound ablation of uterine leiomyomata, including MR guidance; total leiomyomata volume greater or equal to 200 cc of tissue 0092T Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), each additional interspace, cervical (List separately in addition to code for primary procedure) New Technology Assessment and Non-Covered Services Page 5 of 6

6 0095T 0098T 0101T 0102T 0163T 0164T 0165T 0195T 0196T Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in additional to code for primary procedure) Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (List separately in addition to code for primary procedure) Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), each additional interspace, lumbar (List separately in addition to code for primary procedure) Removal of total disc arthroplasty, (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure) Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, lumbar (List separately in addition to code for primary procedure) Arthrodesis, pre-sacral interbody technique, including instrumentation, imaging (when performed), and discectomy to prepare interspace, lumbar; single interspace Arthrodesis, pre-sacral interbody technique, including instrumentation, imaging (when performed), and discectomy to prepare interspace, lumbar; each additional interspace Summary of Changes: Date Change 1/19 Policy Created Approved by Clinical Medical Advisory Committee: 11/5/18 Approved by Clinical Policy Operational Committee: 1/19 Policy Effective Date: 2/1/2019 Initiated: 1/19 New Technology Assessment and Non-Covered Services Page 6 of 6

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