Point32 New Technology Assessment and Non-Covered Services Form

Harvard Pilgrim HealthCare 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 and procedures, behavioral healthcare procedures and devices, or pharmaceuticals) 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.

• The committee reviews devices, procedures, and drugs that are brought to the committee by providers, practitioners, device manufactures and associates:

HPHC 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:
  • Federal Agency for Healthcare Research and Quality
  • National Institutes of Health
  • National Comprehensive Cancer Network
  • National Academy of Sciences
  • 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

If a new service, including but not limited to services for behavioral health therapy, medical drug, 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.

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New Technology Assessment and Non-Covered Services

VA01DEC23PHPHC

policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g.

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):

• 3D Printed Orthopedic Implants
• 4kScore® Test
• Abiliti Gastric Stimulation
• AccuBoost for breast cancer (Non-invasive image-guided breast brachytherapy)
• Actigraphy, as a stand-alone method for sleep disorder diagnosis
• Aduhelm (Aducanumab)
• Alpha-Stim for Treatment of Chronic Pain
• Alzheimer Early Prediction Bloodtest
• AlzoSure Predict
• Annular closure for prevention of recurrent lumbar disc herniation (LDH) after lumbar discectomy (LD)
• Aquablation Therapy
• AIRvance System for Tongue Base Suspension for treatment of sleep apnea
• Anser IFX, UST, VDZ
• Anterior Scoliosis Correction (ASC)
• AposTherapy System for the treatment of pain and loss of function associated with osteoarthritis of the knee
• Artificial Lumbar Disc Replacement
• Argus II Prosthetic eye system
• AspireAssist
• ATI Neurostimulation System for Electrical Stimulation of the Sphenopalatine Ganglion (SPG) for Headaches
• Automated External Defibrillators for Home Use
• Autologous Serum Eye Drops
• AxiaLIF
• BDX-XL2 Test
• Bioidentical Hormone Replacement Therapy for Menopause (BHRT)
• Bioimpedance Spectroscopy
• Boston Heart Prediabetes Assessment
• BostonSight PROSE Treatment for Dry Eye Disease
• Bulking Agents for Fecal Incontinence (e.g. Solesta)
• CardioMEMS
• Cardio-Pulmonary Stethoscope
• Cerebral Perfusion Analysis using Computed Tomography (CT)
• ClariFix Cryotherapy
• Coflex® Interlaminar Stabilization Implant
• Complement Factor H (CFH) p.Tyr402His and Age-Related Maculopathy Susceptibility 2 (ARMS2) p.Ala69Ser Polymorphism Testing for Susceptibility to Age-Related Macular Degeneration (AMD)
• Computerized Neurocognitive Testing (e.g., ImPACT for Sports-Related Head Injury)
• Conductive keratoplasty for treatment of keratoconus
• Constant Therapy
• Coolief Cooling Devices
• Corneal incisions in the donor cornea created using a laser, in preparation for penetrating or lamellar keratoplasty
• Cranial Electrical Stimulation (CES) for treatment of migraine/headaches

COVID Testing:

• Multi-targeted Panels
• ePlex®
• ePlex® Respiratory Pathogen Panel 2
• BioFire® Respiratory Panel 2.1
• BioFire® FilmArray Pneumonia Panel

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New Technology Assessment and Non-Covered Services

VA01DEC23PHPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g. Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

• CureSight for Amblyopia in Children
• CustomFlexTM Artificial Iris, except for aniridia
• DecisionDx Melanoma, except for uveal melanoma
• DermTech PLA
• Destruction of localized lesion of choroids (e.g., choroidal neovascularization), transpupillary thermotherapy
• Destruction of macular drusen, photocoagulation
• Destruction/reduction of malignant breast tumor including breast carcinoma cells in the margins, microwave phased array thermotherapy, disposable catheter with combined temperature monitoring probe and microwave sensor, externally applied microwave energy, including interstitial placement of sensor)
• Diabetes Sentry Nocturnal Hypoglycemia Alarm
• Dual energy x-ray absorptiometry (DEXA), body composition study, one or more sites
• Dynamic Spine Stabilization Systems
• Ear PopperTM
• EndeavorRx
• Electromagnetic Hearing Aids
• Electron Beam Computed Tomography (EBCT) for Detection of Coronary Artery Disease
• Embrace 2: Physiological Signal Based Seizure Monitoring System
• EndoBarrier Endoluminal Liner
• Endoscopic Sleeve Gastroplasty
• Endosure Wireless Implantable System
• Erector Spinae Block for Treatment of Chronic Pain
• Esteem Totally Implantable Hearing System for Treatment of Moderate to Severe Sensorineural Hearing Loss in Adults
• Esophyx
• ExAblate Neuro for Treating Tremor-Dominant Parkinson Disease
• External Beam Radiation Therapy for Treatment of Dupuytren's Contracture
• Extracorporeal Magnetic Innervation (ExMI) Therapy for Urinary Incontinence
• Extracorporeal Shock Wave Therapy (ESWT) for Refractory Tendinopathies
• Extracranial Vein Angioplasty for Treatment of Multiple Sclerosis
• EyeBOX® Concussion Diagnosis Device
• E-tegrity® Test (Hologic Inc.; distributed by Sepal Reproductive Devices) for Evaluation of Uterine Receptivity

• Fecal Microbiota Transplantation (FMT) for:
  • Treatment of Obesity
  • Crohn’s disease
  • Ulcerative Colitis
• Fecal Calprotectin Testing for the treatment of, but not limited to:
  • Inflammatory bowel disease (e.g. Ulcerative colitis and Crohn’s disease)
  • Colorectal cancer
• FerriScan® – MRI measurement of liver iron concentration
• FITBONE® Intramedullary Limb-Lengthening System

HPHC Medical Policy 6741295

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New Technology Assessment and Non-Covered Services

VA01DEC23PHPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g.

Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

• GalleriTM Multi-Cancer Early Detection Test
• GammaTileTM Therapy for the Treatment of Recurrent Intracranial Tumors
• Gastric Plication Surgery
• Gastric Vest System (ReShape)
• Gastroesophageal Reflux Disease (GERD): Endoscopic Treatments in Endoscopic Treatments
• GeneDX Genetic Testing for Narcolepsy
• Genicular Nerve Blocks
• GI Effects Test
• Guardant RevealTM
• HIRRFM (High-resolution, relational, resonance-based, electroencephalic mirroring) for Post-Concussion Syndrome
• HistoSonics Image guided sonic beam therapy system
• Hybrid Autologous Chondrocyte Implantation with Osteochondral Autograft Transfer System for Treatment of Osteochondral Defects of the Knee
• HyProCure Implant for the Treatment of Ankle Instability
• Kinova JACO Assistive Robotic Arm for Neuromuscular Disease
• Vitro Chemosensitivity and Chemoresistance Assays, including, but not limited to;
• Igenomix Endometrial Receptivity Analysis (ERA)
• IMPACT Concussion Management Test
• inFlowTM Intraurethral Valve-Pump
• Insulia Diabetes Management Companion for Type II Diabetes
• Intense Pulsed Light Therapy for the Treatment of Dry Eye Disease
• InterAtrial Shunt Device for Heart Failure
• Intracept® Intraosseous Nerve Ablation System
• JETi® Peripheral Thrombectomy System
• Juvederm for Vocal Cord Paralysis

• ChemoFX Assay
• Oncotech ERD Assay
• MiCK Assay (CorrectChemo)

Off label use of Ketamine Hydrochloride for Treatment of Psychiatric Disorders and Pain Management to treat any psychiatric disorder, or chronic pain including, but not limited to:

• Complex regional pain syndrome
• Chronic neuropathic pain
• Fibromyalgia
• Migraines
• Cluster headaches

• Macula Risk PGx (ArcticDx Inc.)
• Macular Translocation Surgery
• Magnetic Resonance Elastography for Detecting and Staging Liver Fibrosis
• Magnetic Resonance Guided Focused Ultrasound Ablation for Uterine Fibroids
• Meniett Low-Pressure Pulse Generator for Treatment of Meniere's Disease
• Micro-Ultrasound Diagnosis for Prostate Cancer
• Mild Procedure

Laser Treatment of Toenail Fungus for the treatment of onychomycosis

• Laser Interstitial Thermal Therapy (LITT) (e.g. NeuroBlate System) for all indications
• LipiScan Dynamic Meibomian Imager for the evaluation of meibomian gland dysfunction
• Low-Load, Prolonged-Duration Stretch (LLPS) Devices (e.g. Dynasplint)
• Luminopia ONE for Treatment of Amblyopia in Children

HPHC Medical Policy 6741295

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New Technology Assessment and Non-Covered Services

VA01DEC23PHPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members' unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g. Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

• Mind.Px
• Mindstreams Cognitive Health Assessment (e.g., NeuroTrax)
• MIRE Therapy (Monochromatic Infrared Energy) for Peripheral Neuropathy
• MolecuLight i:X
• MRI-Guided Laser Ablation using Visualase (Visualase Inc.) for Treatment of Seizures
• MyoPro Orthosis for Upper Extremity
• NanoKnife System
• NeoGEN Series System
• Neutralizing Antibody Testing in Multiple Sclerosis Patients
• NOCISCANTM Suite
• Norditropin for Female Infertility
• NutrEval Test
• Occipital Nerve Surgery for Neck Pain/Cervicalgia
• OncoSignal 7 Pathway Signal
• Oncotype DX AR-V7 Nucleus Detect Test
• Optic Atrophy Evaluation (OPA1) (Athena Diagnostics)
• Optical Genome Mapping
• Optimal Nutritional Evaluation (ONE) (FMV)
• OtoSCOPE® Genetic Testing for Hereditary Hearing Loss
• PAP-NAP Percutaneous Nerve Stimulation Systems (e.g.

• NSS-2 Bridge, ST Genesis/Drug Relief
• Peripheral Nerve Stimulation for Management of Back Pain, except for sacral nerve for urinary/fecal incontinence
• Plasma proteins predict conversion to dementia from prodromal disease
• Praxis Combined Whole Genome Sequencing and Optical Genome Mapping
• Praxis Optical Genome Mapping
• Praxis Transcriptome
• Praxis Whole Genome Sequencing
• PRECICE Intramedullary Limb-Lengthening System
• Processed nerve allografts (Avance Nerve Graft) for repair of peripheral nerve discontinuities
• Provent Sleep Apnea Therapy
• Pudendal Nerve Decompression for the treatment of, but not limited to:
  • Chronic pelvic pain
  • Interstitial cystitis
  • Persistent genital arousal disorder
  • Pudendal neuralgia
  • Vulvodynia/vulvar vestibulitis
• Home Electrical Stimulation Devices, such as:
  • NESS H200; NESS L300; NESS L300 Plus
  • Bionicare Knee System
  • WalkAide
  • Odstock Dropped Foot Stimulator (ODFS)
• Intradiscal Procedures:
  • Laser discectomy
  • Nucleoplasty
  • Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)
  • Intradiscal electrothermal annuloplasty (IEA)
  • Intradiscal electrothermal therapy (IDET)
• Pillar Palatal Implant System for the Treatment of Obstructive Sleep Apnea

HPHC Medical Policy 6741295

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New Technology Assessment and Non-Covered Services

VA01DEC23PHPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members’ unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

• Platelet-Rich Plasma Injections
• Previvo uterine embryo lavage catheter
• Prospera
• Pulsed Radiofrequency Treatment
• Pulsed Radiofrequency Treatment of Chronic Shoulder Pain
• Radiofrequency Ablation of Cluneal Nerves for Treatment of Chronic Lower Back Pain
• Radiofrequency Ablation of the Sural Nerve for Ankle Pain specialty
• Radiofrequency Neurotomy for Headaches
• Radiofrequency of the nasal valve (e.g., VivAer)
• Reflectance Confocal Microscopy (RCM)
• Relieva Balloon Sinuplasty for Chronic Sinusitis in Children
• Remote Temperature Monitoring Telemetry Devices
• ReStoreTM Soft Exo-suit
• Retinal Dystrophy Panel (Blueprint Genetics)
• ReWalkTM Personal System
• Rezum Water Vapor Therapy
• RhinAer Procedure for Treatment of Chronic Rhinitis
• RosettaGX Reveal (Rosetta Genomics Ltd.)
• Scrambler Therapy
• Serology antibody testing for the diagnosis of H. pylori
• Serum autoantibody tests for diagnosis of autoimmune epilepsy (Athena Diagnostics)
• Shockwave Peripheral Intravascular Lithotripsy (IVL) System
• Signatera ctDNA test
• Single-pulse transcranial magnetic stimulation [sTMS] device for treatment of acute migraines
• Stereotactic placement of infusion catheter(s) in the brain for delivery of therapeutic agent(s), including computerized stereotactic planning and burr hole(s)
• Sinuva Sinus Implant
• Spiration Valve System
• SmartGut
• SmartJane
• SoundBite Hearing System
• Sphenopalatine Ganglion (SPG) Block
• SPiN Thoracic Navigation System
• StabiLink MIS Interlaminar Spinal Fixation System for Spinal Fusion
• Subtalar Arthroerisis
• Surgical Treatment of Migraine Headaches
• Telcare Glucose Monitor
• Tempus HRD
• TenJet System
• The Morning Repositioner (SomnoMed) to Restore Proper Mandibular Alignment After Use of Overnight Sleep Apnea Appliance
• Theta Burst Stimulation for Treatment-Resistant Unipolar Depression in Adults
• Thyroid Hormone Receptor Beta (THRB) Gene Testing
• Tinnitus Treatment/Rehabilitation
• Transcervical Fibroid Ablation (e.g.
  • Sonata® System
  • Transoral Gastric Volume Reduction (TVGR)
  • Transpalatal Advancement Pharyngoplasty for Sleep Apnea
  • Transvascular Autonomic Modulation (TVAM)
  • TruGraf® Blood Gene Expression Test

  HPHC Medical Policy 6741295

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  New Technology Assessment and Non-Covered Services

  VA01DEC23PHPHC policies are based on medical science, and written to apply to the majority of people with a given condition. Individual members' unique clinical circumstances, and capabilities of the local delivery system are considered when making individual UM determinations.

  Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

  The Use of Information Communication Technology (ICT) to Improve Treatment Adherence in Patients with Diabetes

  • USGI Primary Obesity Surgery Endolumenal (POSE)
  • Uterine Transplantation for Uterine Factor Infertility
  • VenaSeal Closure System
  • Vercise Directional Deep Brain Stimulation (DBS) System (Boston Scientific) for Parkinson's Disease
  • Versiti™ Panel Tests:
    • aHUS Genetic Evaluation
    • Autosomal Dominant Thrombocytopenia Panel
    • Coagulation Disorder Panel
    • Congenital Neutropenia Panel
    • Comprehensive Bleeding Disorder Panel
    • Fibrinolytic Disorder Panel
    • Comprehensive Platelet Disorder Panel
    • Inherited Thrombocytopenia Panel
    • Platelet Function Disorder Panel
    • Thrombosis Panel
  • Vertebral Motion Analysis for Assessment of Spinal Instability
  • Vestibular Evoked Myogenic Potential (VEMP) Testing
  • Vibrant System (Vibrant Gastro Inc.) for Chronic Idiopathic Constipation
  • Video Head Impulse Testing (vHIT) for evaluation of vestibular disorders
  • Vivistim Paired Vagus Nerve Stimulation (VNS) system
  • Whole Body Vibration for Promotion of Bone Growth in Postmenopausal Women
  • Wide Area Transepithelial Sampling with 3D Tissue Analysis Device (WATS3D)
  • X-STOP (Interspinous Process Decompression Devices)
  • Zephyr Endobronchial Valve System
  • µ-Cor™ Heart Failure and Arrhythmia Management System

  Products only available under other benefits (e.g., dental, pharmacy, behavioral) are not covered under the medical benefit.

  As an example, Prothelial and Omnipod Dash are not available through the medical benefit.

  Coverage described in this policy is standard under most HPHC plans. Specific benefits may vary by product and/or employer group. Please reference appropriate member materials (e.g., Benefit Handbook, Certificate of Coverage) for member-specific benefit information.

  See below for additional related policies:

  • Non-Covered Payment Policy – Non-Covered Payment Policy
  • Radiology- NIA – NIA Radiology
  • Molecular Diagnostics- AIM – Molecular Diagnostics Management

  Individual consideration may be given if:

  1. The member has a benefit for the general service.
  2. The technology has an approval by a governing body (e.g., FDA)
  3. Requested treatment is a treatment of last resort; and all other covered services have been tried and failed or inappropriate for the member.
  4. The member must have the exact characteristics of the population that was studied in the governing body approval studies