Noncovered Investigational Services Form

Harvard Pilgrim tT TUFTS Health Care Health Plan

Medical Necessity Guidelines:
Noncovered Investigational Services
Effective December 1, 2023

Prior Authorization Required If REQUIRED, submit supporting clinical documentation pertinent to service request to the FAX numbers below. Yes ☐ No ☒

Notification Required IF REQUIRED, concurrent review may apply. Yes ☐ No ☒

Applies to:

• Commercial Products
• Harvard Pilgrim Health Care Commercial products; 800-232-0816
• Tufts Health Plan Commercial products; 617-972-9409
• CareLinkSM – Refer to CareLink Procedures, Services and Items Requiring Prior Authorization
• Public Plans Products
• Tufts Health Direct – A Massachusetts Qualified Health Plan (QHP) (a commercial product); 888-415-9055
• Tufts Health Together – MassHealth MCO Plan and Accountable Care Partnership Plans; 888-415-9055
• Tufts Health RITogether – A Rhode Island Medicaid Plan; 857-304-6404
• Tufts Health One Care – A dual-eligible product; 857-304-6304
• The MNG applies to Tufts Health One Care members unless a less restrictive LCD or NCD exists.

Senior Products

• Harvard Pilgrim Health Care Stride Medicare Advantage; 866-874-0857
• Tufts Health Plan Senior Care Options (SCO), (a dual-eligible product); 617-673-0965
• Tufts Medicare Preferred HMO, (a Medicare Advantage product); 617-673-0965
• Tufts Medicare Preferred PPO, (a Medicare Advantage product); 617-673-0965

*For the purposes of this document, this date refers to the date when the list was updated with the addition or deletion of items/services. Please see specific item to determine when that item was placed on noncovered status.

According to the The Plan Evidence of Coverage (EOC), a treatment or procedure is considered investigative or unproven if reliable evidence shows that the treatment is “under study to determine its safety, efficacy, toxicity, maximum tolerated dose, or its efficacy as compared with a standard means of treatment or diagnosis”.

Tufts Health Plan restricts coverage to those devices, treatments, or procedures for which the safety and efficacy have been proven, or where the clinical evidence is such that the treatment is at least as beneficial as any established evidence-based alternatives. Any device, medical treatment, supply or procedure for which safety and efficacy has not been established and proven is considered investigational (unproven) and therefore not medically necessary and is excluded from coverage.

To determine whether a device, medical treatment, supply or procedure is proven safe and effective the following hierarchy of reliable evidence is used:

1. Published formal technology assessments and/or high quality meta analyses
2. Well-designed randomized studies published in credible, peer-reviewed literature
3. High quality case-control or cohort studies
4. Historical control studies, or case reports and/or case series
5. Reports of expert opinion from national professional medical societies or national medical policy organizations

With respect to clinical studies, only those reports and articles containing scientifically valid data and published in the referred medical and scientific literature shall be considered reliable evidence. Specifically, not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence or personal professional opinions. Also not included is the fact that a provider or a number of providers have elected to adopt a device, medical treatment, or procedure as their personal treatment or procedure of choice or standard of practice.

Policy and Coverage Criteria:

Point32Health companies2122376Noncovered Investigational

The plan considers the following services and technology as experimental/investigational, and therefore not covered (this is not an all-inclusive list):

• Abiliti Gastric Stimulation
• ABRx Antibiotic Resistance Panel (Diatherix Laboratories)
• AccuBoost for breast cancer (Non-invasive image-guided breast brachytherapy)
• Acoustic heart sound recording, computer analysis only
• Acoustic heart sound recording, computer analysis with interpretation and report
• Acoustic heart sound recording, interpretation and report only
• Active Specific Immunotherapy with Therapeutic Melanoma Vaccines
• Agile Patency Capsule (except when used for 'patency capsule' trial before a planned video capsule when the request is suspected Crohn's disease)
• AlloSure (CareDX Inc.)
• Alpha-Stim for Treatment of Chronic Pain
• AlzoSure Predict- Alzheimer's Early Prediction Bloodtest
• Amniotic Allografts for Tendon and Ligament Injuries
• Amniotic fluid epidural injections in the management of patients with LBP
• Amniotic membrane tissue (e.g. tissue graft, injection) for treatment of orthopedic conditions (e.g. spinal, tendon/ligament injury/inflammation, osteoarthritis, cartilage restoration)
• Amplatzer Cardiac Plug (ACP) and Amplatzer Amulet devices in left atrial appendage closure to reduce risk of stroke in adult patients with NVAF
• AmpliChip™ Cytochrome P450 (CYP450) Test for pharmacogenic assay of medication sensitivity
• Ancillary Hyaluronic-Hyaluronidase testing for bladder cancer screening and detection
• Angiotensin Receptor 1 (AGTR1) c.*86A>C (1166A>C, A1166C) Polymorphism Testing for Essential Hypertension
• Anora Miscarriage Test for Miscarriage, (Natera)
• Anoscopy, with delivery of thermal energy to the muscle of the anal canal (eg, for fecal incontinence)
• Anser VDZ® Test (Prometheus Laboratories) for monitoring vedolizumab treatment of Crohn's disease
• Anterior Scoliosis Correction (ASC)
• Antiprothrombin (phospholipid cofactor) antibody, each Ig class
• Apollo Overstitch™ Endoscopic Suturing System for bariatric applications
• Apple Watch Irregular Rhythm Notification Feature (Apple Inc.) for Detection of Atrial Fibrillation
• AQUACEL Ag Advantage (ConvaTec) for Wound Care
• ARISK™ Autism Risk Assessment Test
• ArthroFLEX Decellularized Dermal Allograft
• Arthrographic Hydrodilation for Adhesive Capsulitis
• Arthroscopic Microdiscectomy (AMD)
• Aspire Assist Aspire Bariatrics
• Asynchronous texting including but not limited to depression and anxiety.

• ATI Neurostimulation System (Autonomic Technologies Inc.) for Electrical Stimulation of the Sphenopalatine Ganglion (SPG) for Headache
• Autism and Intellectual Disability NGS Panel
• Autism NGS Panel (Fulgent Diagnostics)
• AutismNext
• Autologous micro-fragmented adipose tissue (MFAT) injection for treatment of degenerative joint disease
• Autologous Serum Eye Drops
• Autologous Stem Cell Transplantation (ASCT) for Crohn’s Disease (CD)
• Autosomal Dominant Hereditary Spastic Paraplegia (AD-HSP)
• Autosomal Dominant Thrombocytopenia (Prevention Genetics)
• Axone Sequencing Genome Testing
• BBDRisk Dx (Silbiotech Inc.)
• Bilateral Frontoparietal Polymicrogyria (BFPP)
• BioCartilage for orthopedic indications
• BioDryFlex® human amniotic allograft
• BioDFence® G3 human amniotic allograft
• Bioidentical Hormone Replacement Therapy for Menopause (BHRT)
• Bioimpedance Spectroscopy
• Bioness H200 Wireless Hand Rehabilitation System (Bioness) in Patients with Traumatic Brain Injury
• BioZorb 3D Bioabsorbable Marker (Focal Therapeutics)
• Bleeding Disorders NextGen Sequencing (NGS) Panel (Prevention Genetics)
• Blood-Based Genetic Testing for Colorectal Cancer Screening
• BluePrint Molecular Subtyping Profile for Breast Cancer
• Bone Marrow Failure Region of Interest (Claritis Genomics)
• Bone substitute injection for subchondral bone cysts
• BostonSight PROSE Treatment for Dry Eye Disease
• Bovine Collagen Implants for the Treatment of Rotator Cuff Injuries (REGENETEN bioinductive implant)
• BRCAvantage Plus (BRCA1, BRCA2, TP53, STK11, PTEN, CDH1, PALB2)
• Breast Cancer Focus Panel (Fulgent Genetics)
• Breast Ovarian Cancer NGS Panel (Fulgent Diagnostics)
• Breast/GYN Cancer Panel (GeneDx)
• BreastTrue High Risk Panel for Hereditary Breast Cancer, (Pathway Genomics Corp.)
• BROCA Cancer Risk Prenatal Test
• Burst -frequency spinal cord stimulation
• CancerIntercept Detect
• CancerIntercept Monitor
• CancerNext Next-Gen Cancer Panel (Ambry Genetics Corp.)
• CancerPlex (KEW Inc.)
• Capillary Malformation-Arteriovenous Malformation Syndrome (CMAVM)
• Carbon monoxide, expired gas analysis (e.g., ETCOc/hemolysis breath test)
• CardioMag MCG System (MagnetoCardioGraphy; CardioMag Imaging Inc.)
• Cartilage transfer surgery (OATS and mosaicplasty) for joints other than knee and ankle
• Cartiva synthetic cartilage implant
• CASR DNA Sequencing Test (Athena Diagnostics)
• Catheter based thrombectomy procedure- The JETi system
• Catheter lavage of mammary duct(s) for collection of cytology specimen(s), in high risk individuals (GAIL risk scoring or priorpersonal history of breast cancer), each breast; single duct
• Catheter lavage of mammary duct(s) for collection of cytology specimen(s), in high risk individuals (GAIL risk scoring or prior personal history of breast cancer), each breast; each additional duct
• C-Brace Orthotronic Mobility System (Ottobock)
• Charcot-Marie-Tooth Neuropathy, Type 1 (CMT1, CMT2, ) CMTX
• CHEK2-related cancer test: The CHEK2-related cancer test may diagnose a personal and/or family
• Chemokine CC Motif Receptor 5 (CCR5) CCR5-Δ32 Polymorphism
• Chiropractic Biophysics (CBP) for Segmented Somatic Dysfunction of Spinal Regions
• Chromosomal Microarray Analysis Mitochondrial/Metabolic (MitoMet®) Testing
• ClariFix (Cryotherapy using ClariFix for Treatment of Chronic Rhinitis)
• ClonoSEQ (Adaptive Biotechnologies)
• CMI Magnetocardiograph Model 2409 (CardioMag Imaging Inc.) for Diagnosis of Acute Chest Pain
• Coagulation Factor Deficiency NextGen Sequencing (NGS) Panel (Prevention Genetics)
• Coated VICRYL* Plus Antibacterial (polyglactin 910) Suture
• COLMOL (OSU Wexner Medical Center Clinical Laboratories)
• ColoNext™ for Hereditary Colorectal Cancer
• ColonSentry (Innovative Diagnostic Laboratory)
• Color Hereditary Cancer Test (30 genes)
• Color Test (Color Genomics )
• Combination Heat/Ice Devices for Use After Knee Surgery
• Combined Cardiac Panel (GeneDx)
• COMPASS; COMPASS is an assessment of bone marrow and/or blood workups that uses several technologies to provide results to a team of experts
• 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)
• Comprehensive Brain Malformations Panel (GeneDX)
• Comprehensive Epilepsy Evaluation NGS Panel
• Comprehensive Non-Specific Intellectual Disability Panel
• Comprehensive Personalized Medicine Panel, (Alpha-Genomix Laboratories)
• Computer-Assisted Semen Analysis (CASA) for Infertility
• Computerized Neurocognitive Testing (CNT), e.g.

• ImPACT™, for Sports-Related Head Injury
• Conductive Keratoplasty for Treatment of Keratoconus
• Congenital Disorders of Glycosylation (CDG) Panel by Massively Parallel Sequencing (BCM-MitomeNGS) (Baylor MiracaGenetics Laboratories)
• Constant Therapy
• Coolief Cooled Radiofrequency (RF) System (Halyard Health) for Knee and Hip Pain
• Corneal incisions in the donor cornea created using a laser, in preparation for penetrating or lamellar keratoplasty (List separately in addition to code for primary procedure)
• Noncovered Investigational Services 3
• Coronary Artery Calcium Scoring to Assess the Risk of Coronary Artery Disease in Asymptomatic Adults
• Cranial electrical stimulation (CES) for the treatment of migraine/headaches
• Cranial electrical stimulation (CES) for treatment of chronic pain (e.g.

• fibromyalgia, chronic pain from SCI)
• Craniosacral Therapy
• Craniosynostosis NGS Panel and/or HDT array (Connective Tissue Gene Tests)
• Cunningham Panel (Moleculera Labs)
• CureSight for Amblyopia in Children
• Cxbladder, (Pacific Edge Ltd), (e.g., Cxbladder Triage, Cxbladder Detect, and Cxbladder Monitor)
• CYP2C19 Genotyping to Predict Response to Voriconazole
• CYP2C19 Pharmacogenomic Genotyping to Direct Clopidogrel Therapy for Secondary Prevention in Patients with a History of Stroke and/or Transient Ischemic Attack (TIA)
• CYP2C19 Pharmacogenomic Genotyping to Direct Clopidogrel Therapy in Adult Patients Undergoing Percutaneous Coronary Intervention (PCI)
• CYP2D6 Genotyping to Guide Dosing with Eliglustat Tartrate (Cerdelga) in Gaucher Disease Type 1
• CYP3A4 Genotyping for Ivacaftor Metabolism and Toxicity
• Cytochrome P450 (CYP450) Genotyping to Predict Response to Antidepressant and Antipsychotic Medications
• DCISionRT (PreludeDx)
• Decipher Prostate Biopsy (Decipher Biosciences)
• Decipher Prostate Cancer Classifier
• Decipher® Prostate Cancer Test (GenomeDx Biosciences)
• Decision Dx Melanoma
• DecisionDx-GBM (Castle Biosciences Inc.)
• DecodEX Microbial Genetic Identification; NGS) test for the identification and relative abundance of microbial pathogens in a patient sample
• DeNovo NT Natural Tissue Graft (Zimmer Inc.) for Articular Cartilage Repair
• dermaPACE system (Sanuwave Inc) extracorporeal shock-wave system for treatment of chronic full thickness diabetic foot ulcers
• 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 device

• ACT Clinical Management Panel
• devSEEK Sequence Analysis for Neurodevelopmental Disorders
• DGAT1 Single Gene (Fulgent Diagnostics)
• Diabetes Sentry Nocturnal Hypoglycemia Alarm
• Digital Fluoroscopic Grid System (HipGrid) for Total Hip Arthroplasty
• Discseel
• DNA Polymerase Gamma (POLG) - Related Disorders
• Dry Needling
• Dual energy x-ray absorptiometry (DEXA), body composition study, one or more sites
• Ear Popper™
• EDX110 nitrous oxide emitting dressing
• Ehlers-Danlos Syndrome (EDS) Classic Type
• ELANE (ELA2) Gene Testing for ELANE –related Neutropenia
• Electric cell signaling treatment (EST) ( Sanexas neoGEN-Series System)
• Electrical impedance scan of the breast, bilateral (risk assessment device for breast cancer)
• Electromagnetic Hearing Aids
• Electronic analysis of implanted peripheral subcutaneous field stimulation pulse generator, with reprogramming when performed

• Embrace 2: Physiological Signal Based Seizure Monitoring System
• Embryonic Stem Cell Transplants
• EndeavorRx
• EndoBarrier Endoluminal Liner
• Endolumenal Functional Lumen Imaging Probe (EndoFLIP; Medtronic Inc.)
• Endometrial Cancer Panel (GeneDx)
• Endoscopic Laser Assisted discectomy for cervical disc herniation
• Endoscopic Sleeve Gastroplasty
• Envisia Genomic Classifier (Veracyte)
• Epilepsy and Seizure Disorders Panel (Emory Genetics Laboratory)
• Epilepsy NGS Panel (Fulgent Diagnostics)

Noncovered Investigational Services 4

• ERCC1 Expression Analysis (Genzyme Genetics)
• Erector spinae block for treatment of chronic pain
• EsophyX® (transoral incisionless fundoplication)
• Esteem Totally Implantable Hearing System for Treatment of Moderate to Severe Sensioneural Hearing Loss in Adults
• Estradiol Implantation of Estradiol Pellets for Post-menopausal Disorders
• E-tegrity® Test (Hologic Inc.; distributed by Sepal Reproductive Devices) for Evaluation of Uterine Receptivity
• Expanded Non-Invasive Prenatal Testing (NIPT) Panels
• Extracorporeal Magnetic Stimulation for Urinary Incontinence
• Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, low energy
• Extracranial vein Angioplasty for Treatment of Multiple Sclerosis
• External Beam Radiation Therapy for Treatment of Dupuytren's Contracture
• EyeBOX to aid in diagnosis of concussion
• GammaTileTM Therapy for the Treatment of Recurrent Intracranial Tumors
• Ganglion Impar Block or Radiofrequency Thermocoagulation for the Treatment of Chronic Coccydynia
• Gastric Plication Surgery
• Gastric Vest System (ReShape)
• Generalized Epilepsy with Febrile Seizures Plus (GEFS+) GeneSight® Psychotropic Gene Panel
• GeneStrat (Biodesix) for all indications
• Genetic Testing for Alpha-Mannosidosis (MAN2B1 gene)
• Genetic testing for autism spectrum disorder (ASD) (e.g.

Genetic testing for Factor V Leiden in Women with Unexplained Recurrent Pregnancy loss

• Factor V (F5) HR2 Haplotype Testing for thrombophilia
• Factor V Leiden (FVL) Testing for Oral Contraceptive Use
• Factor VII (F7) p.Arg353Gln Polymorphism Testing (Quest Diagnostics Inc.)
• Factor XI Deficiency
• Factor XIIIA1 (F13A1) p.Val34Leu Polymorphism Testing
• FerriScan® – MRI measurement of liver iron concentration
• FHNext
• FiberNet® autologous fibrin and platelet system
• Fibrinogen-Beta (FGB) c.-455G>A Polymorphism Testing (Rosalind Franklin University – Clinical Immunology Laboratory)
• Fluid status monitoring(i.e., OptiVol™, Medtronic)
• FM/a Test (EpicGenetics, Inc.) For Diagnosis of Fibromyalgia
• Focal and Segmental Glomerulosclerosis (FSGS) Evaluation (Athena Diagnostics®)
• Foresight Carrier Screen (Myriad) (previously known as Counsyl Family Prep Screen (Counsyl Inc.))
• Forkhead Box Protein G1 (FOXG1) for Congenital Variant Form of Rett FoundationOne Heme
• FoundationOne Liquid (Foundation Medicine)
• Freedom Spinal Cord Stimulator (SCS) System
• Full Sense Bariatric Device from BFKW LLC

complex ASD, to aid in the evaluation of idiopathic ASD)

• Genetic Testing for Familial Hemiplegic Migraine (FHM)
• Genetic Testing for Family Members of Individuals with Brugada Syndrome
• Genetic Testing for FGFR-Related Craniosynostosis
• Genetic Testing for Fragile X-Associated Primary Ovarian Insufficiency
• Genetic Testing for Individuals Clinically Diagnosed with Brugada Syndrome
• Genetic testing for Inflammatory Bowel Disease
• Genetic Testing for Ki67 (MK167) Proliferation Marker Testing in DCIS and Breast Cancer
• Genetic Testing for Narcolepsy
• Genetic Testing for Alzheimer’s Disease (Athena Labs)
• Genetic Testing for Friedreich Ataxia (FRDA) for Movement Disorders
• Genetic Testing for Melanoma, CDKN2A (various manufacturers including Myriad)
• Genetic Testing in Patients with or Suspected of Congenital and/or Prelingual Nonsyndromic Hearing Loss (e.g., OtoSCOPE®)
• Genicular Nerve Blocks for Knee Pain
• Genomic Microarray Testing for Hematological Oncology Indications
• GI Microbial Assay Plus (GI-MAP, Diagnostic Solutions Laboratory) for Evaluation of Gastrointestinal Microbiome

Noncovered Investigational Services 5

• Global Metabolomic Assisted Pathway Screen (Baylor Miraca Genetics Laboratories)
• Glucose Transporter Type 1 (Glut-1) Deficiency Syndrome
• Glutaric Acidemia Type I via the GCDH Gene (PreventionGenetics)
• GPS Cancer (NantHealth)
• Guardant Reveal
• H/I™ (HOXB13:IL17BR) Gene Expression Ratio (AviaraDx Inc.)
• Healthy Weight DNA Insight (Pathway Genomics)
• HeartFlow® FFRCT for Noninvasive Identification of Hemodynamically Significant Coronary Artery Stenosis
• Hematopoietic Stem Cell for autoimmune disorders
• Hematopoietic Stem Cell for ovarian cancer
• Hematopoietic Stem Cell for renal cell carcinoma
• Hereditary Hemochromatosis Panel (Invitae Corp.)
• Hereditary Thrombophilia Panel (Invitae Corp.)
• High power laser therapy for musculoskeletal disorders
• High/Moderate Risk Panel, (GeneDX Inc.)
• HipGrid with PhantomMSK for use in total hip arthroplasty
• HIRREM (High-resolution, relational, resonance-based, electroencephalic mirroring) for Post-Concussion Syndrome
• HistoSonics Image guided sonic beam therapy system
• Holmium Laser Endopyelotomy for Ureteropelvic Junction Obstruction in Adults
• Home Electrical Stimulation Devices, such as:
• NESS H200;
• NESS L300;
• NESS L300 Plus
• Bionicare Knee System
• WalkAide
• Odstock Dropped Foot Stimulator (ODFS)
• PaceHPA-1a (PLA1 Platelet Antigen) Genotyping (PLA2 Polymorphism Detection)
• Human Platelet Antigen 1 Genotype (Quest Diagnostics)
• Hydrodissection in the treatment of neuropathic pain
• Hyper-IgE Syndromes Panel
• IBD sgi Diagnostic Test, (Prometheus Inc.)
• iGene Cancer Panel, (ApolloGen Molecular Diagnostics Laboratory)
• Igenomix Endometrial Receptivity Analysis (ERA)
• Image-Guided Intranasal Sphenopalatine Ganglion (SPG) Block for Treatment of Migraine Headaches
• ImPACT™ Concussion Management Test
• Implantable Insulin Pump
• In vitro chemosensitivity testing for prediction of response to chemotherapy (i.e., ChemoFx® Assay by Precision Therapeutics)
• Inert gas rebreathing for cardiac output measurement during exercise
• Inert gas rebreathing for cardiac output measurement; during rest
• Infantile Epilepsy Panel
• Injectable Amniotic Tissue–Derived Allografts for Treatment of Chronic Plantar Fasciitis
• Insulia® Diabetes Management Companion (voluntis) for management of diabetes mellitus
• Intellectual Disability NGS Panel (Fulgent)
• Intellijoint Hip System (Intellijoint Surgical)
• Intense Pulsed Light Therapy for the Treatment of Dry Eye Disease
• Interleukin 28B (IL28B) Testing for Predict Response to Treatment of Hepatitis C with Interferons and Ribaviri
• INTRACEPT® Intraosseous Nerve Ablation System
• Intragastric Balloons for Treatment of Obesity (e.g.

• ReShape Integrated Dual Balloon System, Orbera Intragastric Balloon System
• Intravascular optical coherence tomography (coronary native vessel or graft) during diagnostic evaluation and/or therapeutic intervention, including imaging supervision, interpretation, and report; initial vessel (List separately in addition to primary procedure)
• Intravascular optical coherence tomography (coronary native vessel or graft) during diagnostic evaluation and/or therapeutic intervention, including imaging supervision, interpretation, and report; each additional vessel (List separately in addition to primary procedure)
• Intravascular Ultrasound (IVUS) for guidance of percutaneous coronary interventions
• Intravenous Vitamin C for the Treatment of Cancer
• InVisionFirst-Lung (Invita)
• Invitae Aortopathy Comprehensive Panel (Invitae Corp.)
• Invitae Breast Cancer High-Risk Panel
• Invitae Comprehensive Neuromuscular Disorders Panel
• Iontophoretic Drug Delivery for the Treatment of Axillary Hyperhidrosis

Noncovered Investigational Services 6

• Kabuki Syndrome
• Know Error System (Diagnostic ID, LLC)
• Iontophoretic Drug Delivery for the Treatment of Primary Palmoplantar Hyperhidrosis
• iovera° system for the treatment of knee pain- Ablation, percutaneous, cryoablation, includes imaging guidance
• JACO Assistive Robotic Arm device for patients with neuromuscular diseases
• JaundiceChip Resequencing Array (Cincinnati Children’s Hosptal Molecular Genetics Laboratory)
• Juvederm for Vocal Cord Paralysis
• LactoTYPE, (Prometheus)
• Laparoscopy, surgical, implantation or replacement of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)
• Laparoscopy, surgical, revision or removal of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)
• Laparotomy, implantation or replacement of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)
• Laparotomy, revision or removal of gastric stimulation electrodes, lesser curvature (i.e., morbid obesity)
• Lariat Suture Delivery Device in left atrial appendage closure to reduce the risk of stroke in adult patients with NVAF
• Laser Interstitial Thermal Therapy (LITT), (e.g. NeuroBlate System)
• LDEX® U400 BIS Extracellular Fluid Analysis
• Left ventricular filling pressure, indirect measurement by computerized calibration of the arterial waveform response to Valsalva measurement
• LipiScan Dynamic Meibomian Imager for the evaluation of meibomian gland dysfunction
• Lipoprotein Subclass Quantification Using NMR LipoProfile® Test (LipoScience Inc.) for Atherosclerosis /Coronary Heart Disease (CHD)
• Lipoprotein, direct measurement, intermediate density lipoproteins (IDL) (remnant lipoproteins)
• Lokomat driven gait orthosis (DGO)
• Luminopia ONE for Treatment of -Amblyopia in Children
• LUKE Arm (Mobius Bionics LLC)
• lysoSEEK Sequence Analysis for Lysosomal Storage Disorders
• Macula Risk PGx (ArcticDx Inc.)
• Macular Translocation Surgery
• Magnetic Resonance Elastography for Detecting and Staging Liver Fibrosis.

• Magnetically controlled growing rods (MCGRs) for the treatment of early-onset scoliosis (EOS) in children
• Mammostrat® (Clarient Inc.)
• Medicinal honey wound care dressings (i.e., Medihoney™)
• Medtronic METRx™ Microdiscectomy System for lumbar disc herniation
• MelanoSITE™ FISH Test
• Meniett Low-Pressure Pulse Generator for Treatment of Meniere’s Disease
• Mesenchymal Stem cell therapy for treatment of orthopedic indications
• MI Profile test
• MI TumorSeek (Caris Life Sciences)
• Microcephaly NGS Panel
• Microcephaly Panel (Gene DX)
• Microcephaly Sequencing Panel
• Microcurrent electrical therapy (MET) for the treatment of musculoskeletal pain and the treatment of postoperative pain
• Microsurgery (e.g., transplanting lymph node(s) for preventing lymphedema, during surgery, for breast cancer)
• Microwave thermal ablation of tumors
• Migraine Headaches - Surgical Treatment
• Mild® Minimally Invasive Lumbar Decompression for Lumbar Spinal Stenosis
• Mindstreams® Cognitive Health Assessment (e.g., NeuroTrax®)
• Minimal Residual Disease (MRD) Tests
• Minimally Invasive Deformity Correction (MID-C) system for the treatment of adolescent idiopathic scoliosis
• Minimally invasive sacroiliac joint (SIJ) fusion with cylindrical threaded implants
• miraDry® (Miramar Labs®, Inc.) for the treatment of hyperhidrosis
• MIRE Therapy (Monochromatic Infrared Energy) for Peripheral Neuropathy
• MitoSwab test
• MNG Transcriptome™
• Molecular Intelligence (Caris Life Sciences)
• Monarch external Trigeminal Nerve Stimulation (eTNS) System (NeuroSigma Inc.) for the treatment of attention-deficit/hyperactivity disorder (ADHD)
• Monogram Biosciences PhenoSense GT Plus Integrase
• MRI-Guided Laser Ablation using Visualase (Visualase Inc.) for Treatment of Seizures
• mtSEEK Whole Mitochondrial Genome Analysis (Courtagen Life Sciences Inc.)
• Multi cancer early detection test- Galleri
• Myeloma Prognostic Risk Signature (MyPRS Plus) Test for Myeloma (Signal Genetics LLC)

Noncovered Investigational Services 7

• Myoelectric orthosis — a custom orthosis that uses myoelectric signals to control brace function, providing assistive motion for joint function
• MyoPro upper extremity orthosis for all indications including muscle weakness, neurological disorders or neuro-muscular damage from conditions including, spinal cord injury, traumatic brain injury, amyotrophic lateral sclerosis, multiple sclerosis and other upper limb neuromuscular disorders
• myPath Melanoma (Myriad)
• MyRisk™ Natera Miscarriage Test (Natera)
• Near-infrared guidance for vascular access requiring real-time digital visualization of subcutaneous vasculature for evaluationof potential access sites and vessel patency
• Nebulized antibiotic therapy (Except for the treatment of cystic fibrosis)
• Nerivio/remote electrical neuromodulation (REN)
• Neuroblastoma RAS Viral Oncogene (NRAS) for prediction of Treatment Response in Colorectal Cancer
• Neurodevelopment – Expanded (Ambry Genetics)
• NexCourse CRC (Genoptix Medical Laboratory)
• Next-Generation Sequencing (NGS) for Identification of Microbial Pathogens in Infections
• Next-Generation Sequencing (NGS) for Microbial Pathogens in Infection Outbreak Surveillance or Response
• NGS Epilepsy/Seizure Panel (Greenwood Genetic Center)
• NLRP3 Exon 3 Sequencing (GeneDx)
• NOD2/CARD15 gene testing for Crohn’s Disease
• Noninvasive Cardiac Radioablation for Ventricular Tachycardia
• Noninvasive methods to assess skin cholesterol (e.g., PREVU™ Point of Care Skin Test)
• Nonsyndromic Peripheral Pulmonary Stenosis, PPS (Laboratory for Molecular Medicine)
• Norditropin for Female Infertility
• NuclearMitoDX(formerly MitoNucleomeDx) (MEDomics)
• Occipital nerve stimulation (ONS) for treatment of cluster headache
• Oculofaciocardiodental (OFCD) Syndrome (Syndromic Microphthalmia 2; MCOPS2)
• Oculopharyngeal Muscular Dystrophy (OPMD) (Athena Diagnostics Inc.)
• Office based minimally invasive joint arthroscopy (e.g.

mi-eye 2, VisionScope®)

• OmniSeq Comprehensive (OmniSeq), OmniSeq Advanced (OmniSeq)
• Oncofocus (Oncologica)
• OncoGeneDx Oncopanel (DFCI)
• Oncotype DX AR-V7 Nucleus Detect Test
• Oncotype MAP™ Pan-Cancer Tissue (formerly Paradigm Cancer Diagnostic (PCDx))
• OncoVue® (InterGenetics Inc.) for Breast Cancer Risk Assessment
• One Touch Via disposable insulin delivery system
• Optic Atrophy Evaluation (OPA1) (Athena Diagnostics)
• AposTherapy System for the treatment of pain and loss of function associated with osteoarthritis of the knee, Apos TherapySystemOsseointegrated Prostheses
• OvaNext Next-Gen Cancer Panel
• Ovarian Cancer Focus Panel (Fulgent Diagnostics)
• OvaSure™ (LabCorp)
• PancNext Next-Gen Cancer Panel (Ambry Genetics Corp.)
• PancraGEN (Interpace Diagnostics)
• Pancreatic Cancer Panel (GeneDX, Inc.)
• Panexia (Myriad Genetics Inc.)
• PAP-NAP
• Partial HPRT Deficiency (Kelley-Seegmiller Syndrome)
• Pathfinder TG®; Topographic Genotyping (RedPath)
• PAULA’s Test (Protein Assays Utilizing Lung Cancer Analytes; Genesys Biolabs) for Early Detection of Lung Cancer
• Pediatric Neurology Region of Interest Trio (Claritas Genomics Inc.)
• Percepta Genomic Sequencing Classifier (GSC)
• Percutaneous Cervical Disc Decompression for Cervical Herniation
• Percutaneous mechanical thrombectomy for acute limb ischemia with AngioJet® Rheolytic Thrombectomy system (PossisMedical, Inc)

Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar - for trial, including removal at the conclusion of trial period, or for permanent implantation, with implantation of a pulse generator.

Noncovered Investigational Services 8

• Revision or removal of related pulse generator and/or electrodes, including imaging guidance, when performed, including addition of new electrodes, when performed
• Percutaneous Transcatheter Coil Embolization for Pelvic Congestion Syndrome (PCS)
• PGxOneTM Plus (Admera Health)
• Pharmacogenetic testing for single-gene variants in the CYP2D6, CYP3A4, CYP3A5, ABCB1, and UGT2B7 genes for generalopioid prescribing
• Pharmacogenetic testing/ psychopharmacology: (e.g., Genecept Assay, GeneSight®)
• Pharmacogenic testing for Warfarin responsiveness
• Phenylalanine Hydroxylase (PAH) Deficiency (Including Phenylketonuria [PKU])
• Plasma proteins predict conversion to dementia from prodromal disease
• Plasminogen Activator Inhibitor-1 (PAI-1) 4G/5G (Quest Diagnostics)
• Platelet Rich Plasma (PRP) for bone healing and fusion
• Pontocerebellar Hypoplasia Panel (GeneDx)
• Positional adaptive spinal cord stimulation
• Powered Exoskeletal Mobility Device, (e.g.

  Rewalk

  Prenatal Genetic Testing for Autism Spectrum Disorder

  Pre-Ovar KRAS-Variant Test

  PreTRM (Sera Prognostics)

  Preventest (GeneID Advanced Molecular Diagnostics LLC)

  Previstage™ GCC Colorectal Cancer Staging Test

  Previvo uterine embryo lavage catheter

  PRI-MUS™ (Prostate Risk Identification for Micro-Ultrasound) for diagnosis of prostate cancer

  Processed nerve allografts (Avance Nerve Graft) for repair of peripheral nerve discontinuities

  Proove Opioid Risk test

  Prospera (Natera)

  Prostate Core Mitomic Test (Mitomics Inc.)

  ProstateNext

  Prostatic Artery Embolization for BPH

  Proteus® Ingestible Event Marker (IEM)

  Provent Sleep Apnea Therapy

  Proveri Prostate Cancer Assay (PPCA) (Proveri Inc.)

  PTEN Gene Expression Testing in Non-Small Cell Lung Cancer (NSCLC)

  Pulsed radiofrequency treatment of chronic shoulder pain

  Pulsed radiofrequency treatment of complex regional pain syndrome of the lumbar region

  Radiofrequency Ablation of the Sural Nerve for Ankle Pain specialty

  Radiofrequency Ablation of Cluneal Nerves for Treatment of Chronic Lower Back Pain

  Radiofrequency Nerve Ablation for Treatment of Plantar Fasciitis

  Radiofrequency Neurotomy for Headaches

  Rapid Heme Panel (Dana Farber Cancer Institute/Brigham and Women’s Hospital)

  Relieva Balloon Sinuplasty (Acclarent Inc.) for Chronic Sinusitis in children

  RenalNext Next-Generation Sequencing (NGS) Panel (Ambry Genetics Corp.)

  ResponseDX: Colon® for Colorectal Cancer Treatment

  ReStore Soft Exo-SuitTM

  Retinal Dystrophy Panel (Blueprint Genetics)

  RhinAer Procedure for Treatment of Chronic Rhinitis

  Rhinophototherapy, intranasal application of ultraviolet and visible light, bilateral

  RightMed Comprehensive Test

  Riscover Hereditary Cancer Test

  Robotic Rehabilitation of Upper Extremities in Patients with Degenerative Neurological Conditions

  RosettaGX Reveal (Rosetta Genomics Ltd.)

  Saethre-Chotzen Syndrome (TWIST) Sequencing and MLPA (Greenwood Genetic Center)

  Sclerotherapy for re-anastomosis after bariatric surgery

  ScoliScore Adolescent Idiopathic Scoliosis (AIS) Prognostic Test (Transgenomic Inc.)

  SelectMDx for Prostate Cancer (MDxHealth Inc.)

  Sensigene

  SensiGene Fetal RHD Genotyping for Rh Incompatibility (Sequenom Center for Molecular Medicine)

  SensiGene Fetal Sex Determination Testing (Sequenom Center for Molecular Medicine)

  Serological Assay for the Diagnosis and management of inflammatory bowel disease

  Serum autoantibody tests for diagnosis of autoimmune epilepsy (Athena Diagnostics)

  Signatera ctDNA test

  Single anastomosis duodenal switch

  Noncovered Investigational Services 9

  Single Nucleotide Polymorphism (SNP) Testing for Breast Cancer Risk Assessment

  Single-pulse transcranial magnetic stimulation [sTMS] device for treatment of acute migraines

  Skeletal dysplasia ciliopathy NGS panel (Connective Tissue Gene Tests)

  SLCO1B1 Pharmacogenomic Genotyping for Statin Dosing or Selection

  SNaPshot Genetic Testing Panel

  SoundBite Hearing System (Sonitus Medical, Inc.)

  Spectroscopy, expired gas analysis

  Speculoscopy

  Speculoscopy, with directed sampling

  SPiN Thoracic Navigation System®

  STA2R SureGene Test for Antipsychotic and Antidepressant Response

  StabiLink MIS Interlaminar Spinal Fixation System for Spinal Fusion

  Stereotactic placement of infusion catheter(s) in the brain for delivery of therapeutic agent(s), including computerized stereotactic planning and burr hole(s)

  Stereotaxis Niobe Magnetic Navigation System (Stereotaxis Inc.) for Percutaneous Coronary Intervention in Coronary Artery Disease

  Stickler Syndrome

  Stretta Procedure (Mederi Therapeutics) for Gastroesophageal Reflux Disease (GERD)>(Stretta Radiofrequency Endoscopic Anti-reflux Procedure) (e.g., Stretta, Esophyx)

  Subchondral calcium phosphate (SCP) injections, knee

  Subcutaneous insertion of estradiol pellets for post-menopausal disorders

  Sublingual immunotherapy for the treatment of allergies and asthma (Except the following: Oralair, Grastek, Ragwitek and Odactra)

  SYMGENE68 NGS Cancer Panel, (CellNetix Pathology & Laboratories LLC)

  Syndromic Autism Panel (NGS)

  Urinalysis infectious agent detection, semi-quantitative analysis of volatile compounds

  Urinary Microsatellite Analysis

  Urine based ancillary tests designed to detect molecular changes (Tests may include, but are not limited to surviving,

  TargetNow® Molecular Profiling Test (Caris™Life Sciences)

  Telcare Glucose Monitor

  Tempus HRD

  Tenex Health Tx Procedure for tendon pain.

  • Percutaneous ultrasonic tenotomy TenJet for treatment of plantar fasciitis
  • The Genecept Assay
  • The Morning Repositioner (SomnoMed) to Restore Proper Mandibular Alignment After Use of Overnight Sleep Apnea Appliance
  • The ProMark Proteomic Prognostic Test
  • The TransPyloric Shuttle (BAROnova Inc.)
  • The Use of Information Communication Technology (ICT) to Improve Treatment Adherence in Patients with Diabetes
  • TheraSEEK Sequence Analysis for Functional Disorders (Courtagen Life Sciences Inc.)
  • Thermal Shrinkage
  • Theta Burst Stimulation for Treatment-Resistant Unipolar Depression in Adults
  • Thyroid Hormone Receptor Beta (THRB) Gene Testing
  • Tinnitus Treatment/Rehabilitation (e.g., Neuromonics® and other programs)
  • Tissue of Origin Test (ResponseDX; Response Genetics Inc.)
  • Topaz® MicroDebrider (ArthroCare Corp.) for Treatment of Tendon Disorders of the Lower Extremities
  • Topoisomerase II Alpha (TOP2A) Testing
  • ToxProtectTM (Genotox Laboratories)
  • TP63-Related Disorders (GeneDx Inc.)
  • Transcatheter pulmonary valve implantation, percutaneous approach (Edward SAPEIN Valve)
  • Transcription Factor 4 (TCF4) Testing for Pitt-Hopkins Syndrome (PTHS)
  • Transcutaneous Electrical Nerve Stimulation for Knee Osteoarthritis
  • Transmembrane Activator and CAML Interactor (TACI) Gene, Full Gene Analysis (Mayo Medical Laboratories)
  • Transoral Gastric Volume Reduction (TVGR)
  • Transpalatal Advancement Pharyngoplasty for Sleep Apnea
  • Transvascular Autonomic Modulation (TVAM)
  • Treatment(s) for incontinence, pulsed magnetic neuromodulation, per day
  • TreatmentMAP (Molecular Health)telomerase;
  • Ancillary UroVysion™ aka FISH testing)

  Use of Anser IFX and Anser ADA to Monitor Treatment in Patients with Inflammatory Bowel Disease

  Use of Anti-Infliximab Antibody Levels to monitor treatment in patients with Inflammatory Bowel Disease (IBD)

  Noncovered Investigational Services 10

  Use of Fractional CO2 laser therapy (e.g. Monalisa Touch®), radiofrequency technology (e.g. THERMIva®), and ER YAG laser therapy for vaginal rejuvenation and vaginal tightening

  USGI Primary Obesity Surgery Endolumenal (POSE)

  Uterine Transplantation for Uterine Factor Infertility

  Vercise Directional Deep Brain Stimulation (DBS) System (Boston Scientific) for Parkinson's Disease

  Vertebral Motion Analysis for Assessment of Spinal Instability

  Vestibular Evoked Myogenic Potential (VEMP) Auditory Testing

  Video Head Impulse testing (vHIT) for evaluation of vestibular disorders

  VistaSeq Hereditary Cancer Panel

  VivAer nasal airway remodeling with Radiofrequency to treat nasal obstruction

  Vizilite Oral Screening System

  Von Willebrand Factor (VWF)

  Whole Body Vibration for Promotion of Bone Growth in Postmenopausal Women

  Whole Exome Sequencing for Cancer Indications

  Wide-Area Transepithelial Sampling (WATS 3D) Biopsy for the Detection of Barrett's Esophagus or Esophageal Dysplasia

  Wireless capsule for measuring gastric emptying (SmartPill GI Monitoring System®)

  X-linked Charcot-Marie-Tooth Neuropathy, Type 1 (CMT1, CMT2, ) CMTX

  X-Linked Intellectual Disability (XLID) Multigene Panels

  The following CPT/HCPCS procedure codes are investigational and unproven and are therefore not covered.

  **NOTE: Genetic and molecular diagnostic testing for Tufts Health Public Plan and Harvard Pilgrim Commercial Members is managed by AIM Specialty Health® (AIM).

  For Tufts Health Public Plan and Harvard Pilgrim Commercial Members

  Refer to Medical Necessity Guidelines:
  Genetic and Molecular Diagnostic Testing for Harvard Pilgrim Commercial, Tufts Health Direct, Tufts Health Together, Tufts Health RITogether, and Tufts Health One Care
  Note: ’No specific code available’ indicates an “unlisted code” or “miscellaneous code.”

  *“Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management.

  **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management ”

  Noncovered Investigational Services 11-20

  Description PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis), genomic sequence analysis panel utilizing a combination of NGS, Sanger, MLPA, and array CGH, with MRNA analytics to resolve variants of unknown significance when indicated (15 genes [sequencing and deletion/duplication], EPCAM and GREM1 [deletion/duplication only]), extracorporeal shock wave, high energy...

  Aspergillus flavus, blood, lavage fluid, or tissue, qualitative reporting of presence or absence of each species (MYCODART Dual Amplification Real Time PCR Panel for 4 Aspergillus species, RealTime Laboratories, Inc/MycoDART, Inc)

  Quantitative sensory testing (QST), testing and interpretation per extremity; using other stimuli to assess sensation

  Prescription drug monitoring, one or more oral oncology drug(s) and substances, definitive tandem mass spectrometry with chromatography, serum or plasma from capillary blood or venous blood, quantitative report with steady-state range for the prescribed drug(s) when detected (Oral OncolyticAssuranceRX, Firstox Laboratories, LLC, Firstox Laboratories, LLC)

  Infectious agent detection and identification, targeted sequence analysis (16S and 18S rRNA genes) with drug-resistance gene (MicroGenDX qPCR & NGS For Infection, MicroGenDX, MicroGenDX)

  Oncology (prostate), measurement of PCA3 and TMPRSS2-ERG in urine and PSA in serum following prostatic massage, by RNA amplification and fluorescence-based detection, algorithm reported as risk score (MiPS (Mi-Prostate Score), MLabs, MLabs)

  0112U Investigational October 1, 2019 September 20, 2023

  0113U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Investigational October 1, 2019 October 18, 2023

  Noncovered Investigational Services 21

  Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
  0114U *Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management	Gastroenterology (Barrett's esophagus), VIM and CCNA1 methylation analysis, esophageal cells, algorithm reported as likelihood for Barrett's esophagus (EsoGuard™, Lucid Diagnostics, Lucid Diagnostics)	Investigational	October 1, 2019	September 20, 2023
  0115U	Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and subtypes and 2 bacterial targets, amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected (ePlex Respiratory Pathogen (RP) Panel, GenMark Diagnostics, Inc, GenMark Diagnostics, Inc)	Investigational	October 1, 2019	September 20, 2023
  0116U	Prescription drug monitoring, enzyme immunoassay of 35 or more drugs confirmed with LC-MS/MS, oral fluid, algorithm results reported as a patient-compliance measurement with risk of drug to drug interactions for prescribed medications (Snapshot Oral Fluid Compliance, Ethos Laboratories)	Investigational	October 1, 2019	September 20, 2023
  0117U	Pain management, analysis of 11 endogenous analytes (methylmalonic acid, xanthurenic acid, homocysteine, pyroglutamic acid, vanilmandelate, 5-Hydroxyindoleacetic acid, hydroxymethylglutarate, ethylmalonate, 3-hydroxypropyl mercapturic acid (3-HPMA), quinolinic acid, kynurenic acid), LC-MS/MS, urine, algorithm reported as a pain-index score with likelihood of atypical biochemical function associated with pain (Foundation PISM, Ethos Laboratories)	Investigational	October 1, 2019	September 20, 2023
  0118U *Authorization review for HPHC and THPPs_ is managed by Carelon Medical Benefits Management	Transplantation medicine, quantification of donor-derived cell-free DNA using whole genome next-generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA in the total cell-free DNA (Viracor TRAC™ dd-cfDNA, Viracor Eurofins, Viracor Eurofins)	Investigational	October 1, 2019	September 20, 2023
  0119U	Cardiology, ceramides by liquid chromatography-tandem mass spectrometry, plasma, quantitative report with risk score for major cardiovascular events (MI-HEART Ceramides, Plasma, Mayo Clinic, Laboratory Developed Test)	Investigational	October 1, 2019	November 16, 2023

  Description score (MiPS (Mi-Prostate Score), MLabs, MLabs) Gastroenterology (Barrett's esophagus), VIM and CCNA1 methylation analysis, esophageal cells, algorithm reported as likelihood for Barrett's esophagus (EsoGuard™, Lucid Diagnostics, Lucid Diagnostics) Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and subtypes and 2 bacterial targets, amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected (ePlex Respiratory Pathogen (RP) Panel, GenMark Diagnostics, Inc, GenMark Diagnostics, Inc) Prescription drug monitoring, enzyme immunoassay of 35 or more drugs confirmed with LC-MS/MS, oral fluid, algorithm results reported as a patient-compliance measurement with risk of drug to drug interactions for prescribed medications (Snapshot Oral Fluid Compliance, Ethos Laboratories) Pain management, analysis of 11 endogenous analytes (methylmalonic acid, xanthurenic acid, homocysteine, pyroglutamic acid, vanilmandelate, 5-Hydroxyindoleacetic acid, hydroxymethylglutarate, ethylmalonate, 3-hydroxypropyl mercapturic acid (3-HPMA), quinolinic acid, kynurenic acid), LC-MS/MS, urine, algorithm reported as a pain-index score with likelihood of atypical biochemical function associated with pain (Foundation PIS, Ethos Laboratories) Transplantation medicine, quantification of donor-derived cell-free DNA using whole genome next-generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA in the total cell-free DNA (Viracor TRACTM dd-cfDNA, Viracor Eurofins, Viracor Eurofins) Cardiology, ceramides by liquid chromatography-tandem mass spectrometry, plasma, quantitative report with risk score for major cardiovascular events (MI-HEART Ceramides, Plasma, Mayo Clinic, Laboratory Developed Test) Oncology (B-cell lymphoma classification), mRNA, gene expression profiling by fluorescent probe hybridization of 58 genes (45 content and 13 housekeeping genes), formalin-fixed paraffin-embedded tissue, algorithm reported as likelihood for primary mediastinal B-cell lymphoma (PMBCL) and diffuse large B-cell lymphoma (DLBCL) with cell of origin subtyping in the latter (Lymph3Cx Lymphoma Molecular Subtyping Assay, Mayo Clinic, Laboratory Developed Test)

  0120U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Investigational October 1, 2019 November 16, 2023

  Noncovered Investigational Services 22

  Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
  0121U	Sickle cell disease, microfluidic flow adhesion (VCAM-1), whole blood (Flow Adhesion of Whole Blood on VCAM-1 (FAB-V), Functional Fluidics, Functional Fluidics)	Investigational	October 1, 2019	November 16, 2023
  0122U	Sickle cell disease, microfluidic flow adhesion (P-Selectin), whole blood (Flow Adhesion of Whole Blood to P-SELECTIN (WB-PSEL), Functional Fluidics, Functional Fluidics)	Investigational	October 1, 2019	November 16, 2023
  0123U	Mechanical fragility, RBC, shear stress and spectral analysis profiling (Mechanical Fragility, RBC by shear stress profiling and spectral analysis, Functional Fluidics, Functional Fluidics)	Investigational	October 1, 2019	November 16,2023
  0130U **Authorization review for HPHC and THPPs is_managed_by_Carelon_Medical_Benefits_Management	Hereditary colon cancer disorders (eg, Lynch syndrome, PTEN hamartoma_syndrome, Cowden_syndrome, familial adenomatosis polyposis), targeted mRNA sequence_analysis_panel (APC, CDH1, CHEK2, MLH1, MSH2, MSH6, MUTYH, PMS2, PTEN, and TP53) (+RNAinsight™ for ColoNext®, Ambry Genetics)	Investigational	October 1, 2019	September 20, 2023
  0131U **Authorization_review_for_HPHC_and_THPPs_is_managed_by_Carelon Medical_Benefits_Management	Hereditary breast cancer-related_disorders (eg, hereditary breast_cancer, hereditary_ovarian_cancer, hereditary_endometrial_cancer), targeted_mRNA_sequence_analysis_panel (13 genes) (+RNAinsight™ for BreastNext®, Ambry Genetics)	Investigational	October 1, 2019	November 16, 2023
  0132U **Authorization_review_for HPHC_and_THPPs_is_managed_by_Carelon Medical_Benefits Management	BreastNext(HER), Ambry Genetics Hereditary ovarian cancer-related disorders (eg, hereditary breast cancer, hereditary_ovarian_cancer, hereditary_endometrial_cancer), targeted_mRNA_sequence_analysis_panel (17_genes) (+RNAinsight™ for OvaNext®, Ambry Genetics)	Investigational	October 1, 2019	November 16, 2023
  0133U **Authorization_review_for_HPHC_and_THPPs_is_managed_by_Carelon Medical_Benefits Management	Hereditary prostate_cancer-related disorders, targeted mRNA_sequence_analysis_panel (11_genes) (+RNAinsight™ for ProstateNext®, Ambry Genetics)	Investigational	October 1, 2019	October 18, 2023
  0134U	Hereditary pan_cancer (eg, hereditary_breast_and ovarian_cancer, hereditary_endometrial_cancer, hereditary_colorectal_cancer), targeted_mRNA_sequence_analysis panel (18_genes) (+RNAinsight™ for CancerNext®, Ambry Genetics)	Investigational	October 1, 2019	November 16, 2023

  0133U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management 0134U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Hereditary pan cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), targeted mRNA sequence analysis panel (18 genes) (+RNAinsight™ for CancerNext®, Ambry Genetics) Hereditary gynecological cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), targeted mRNA sequence analysis panel (12 genes) (+RNAinsight™ for GYNPlus®, Ambry Genetics) Investigational

  0135U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Investigational October 1, 2019 November 16, 2023 Noncovered Investigational Services 23

  Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
  0136U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management |	ATM (ataxia telangiectasia mutated) (eg, ataxia_telangiectasia) MRNA sequence_analysis (+RNAinsight™ for ATM, Ambry Genetics)	Investigational	April 1, 2020	August 16, 2023
  0137U **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefit Harvard Pilgrim tT TUFTS Health Care Health Plan Medical Necessity Guidelines: Noncovered Investigational Services Effective December 1, 2023 Policy and Coverage Criteria: Necessary to determine whether a device, medical treatment, supply or procedure is proven safe and effective. The following services and technology are considered experimental/investigational, and therefore not covered (this list is not all-inclusive): Transcatheter mitral valve annulus reconstruction, with implantation of adjustable annulus reconstruction device, percutaneous approach including transseptal puncture. Tactile breast imaging by computer-aided tactile sensors, unilateral or bilateral. Percutaneous transcatheter placement of iliac arteriovenous anastomosis implant, inclusive of all radiological supervision and interpretation. Bioelectrical impedance analysis whole body composition assessment, supine position, with interpretation and report. Note: Specific codes for these procedures exist but are not provided in this overview. These services may be covered under different circumstances, can vary by patient or provider, and may depend on individual health plans. For more information regarding coverage, refer to detailed Medical Necessity Guidelines available through Harvard Pilgrim and TUFTS Health Plan or contact the plan directly. NanoKnife device) Investigational July 1, 2020 June 21, 2023 Description neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 1-3 parameters Electronic analysis with complex programming of implanted integrated neurostimulation system (eg, electrode array and receiver), including contact group(s), amplitude, pulse width, frequency (Hz), on/off cycling, burst, dose lockout, patient-selectable parameters, responsive neurostimulation, detection algorithms, closed-loop parameters, and passive parameters, when performed by physician or other qualified health care professional, posterior tibial nerve, 4 or more parameters Osteotomy, humerus, with insertion of an externally controlled intramedullary lengthening device, including intraoperative imaging, initial and subsequent alignment assessments, computations of adjustment schedules, and management of the intramedullary lengthening device Temporary female intraurethral valve- pump (ie, voiding prosthesis), initial insertion, including urethral measurement Temporary female intraurethral valve- pump (ie, voiding prosthesis), replacement Noncontact real-time fluorescence wound imaging, for bacterial presence, location, and load, per session; first anatomic site (eg, lower extremity) Noncontact real-time fluorescence wound imaging, for bacterial presence, location, and load, per session, each additional anatomic site (eg, upper extremity) (List separately in addition to code for primary procedure) Ablation, irreversible electroporation, 1 or more tumors per organ, including imaging guidance, when performed, percutaneous Ablation, irreversible electroporation, 1 or more tumors, including fluoroscopic and ultrasound guidance, when performed, open, (e.g. NanoKnife device) Glomerular filtration rate (GFR) measurement(s), transdermal, including sensor placement and administration of a single dose of fluorescent pyrazine agent Glomerular filtration rate (GFR) monitoring, transdermal, including sensor placement and administration of more than one dose of fluorescent pyrazine agent, each 24 hours Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center unilateral or bilateral; initial device provision, set-up and patient education on use of equipment Investigational 0603T Investigational July 1, 2020 October 18, 2023 0604T Investigational Investigational July 1, 2020 April 19, 2023 Noncovered Investigational Services 64 Procedure Code Description Exclusion Category Origination Date Last Review Date O605T Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center unilateral or bilateral; remote surveillance center technical support, data analyses and reports, with a minimum of 8 daily recordings, each 30 days Investigational July 1, 2020 April 19, 2023 O606T Optical coherence tomography (OCT) of retina, remote, patient-initiated image capture and transmission to a remote surveillance center unilateral or bilateral; review, interpretation and report by the prescribing physician or other qualified health care professional of remote surveillance center data analyses, each 30 days Investigational July 1, 2020 April 19, 2023 0607T Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (eg, ECG data), transmitted to a remote 24-hour attended surveillance center; set-up and patient education on use of equipment Investigational July 1, 2020 November 16, 2023 0608T Remote monitoring of an external continuous pulmonary fluid monitoring system, including measurement of radiofrequency-derived pulmonary fluid levels, heart rate, respiration rate, activity, posture, and cardiovascular rhythm (eg, ECG data), transmitted to a remote 24-hour attended surveillance center; analysis of data received and transmission of reports to the physician or other qualified health care professional Investigational July 1, 2020 November 16, 2023 0609T Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar), acquisition of single voxel data, per disc, on biomarkers (ie, lactic acid, carbohydrate, alanine, laal, propionic acid, proteoglycan, and collagen) in at least 3 discs Investigational July 1, 2020 February 15, 2023 0610T Magnetic resonance spectroscopy, determination and localization of discogenic pain (cervical, thoracic, or lumbar), transmission of biomarker data for software analysis Investigational July 1, 2020 February 15, 2023 Clarivein Investigational January 1, 2017 September 20, 2023 36474 Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites (List separately in addition to code for primary procedure) (e.g. "Clarivein") Investigational January 1, 2017 September 20, 2023 37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles){e.g.,Percutaneous Transcatheter Coil Embolization for Pelvic Congestion Syndrome} Investigational when billed with the following ICD-10 diagnosis code(s): N83.9, N83.8, N94.19, N94.10, N94.9, N94.89, 186.2, R10.2 April 1, 2018 July 19, 2023 37252 Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; initial noncoronary vessel (List separately in addition to code for primary procedure) Investigational January 1, 2016 February 15, 2023 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (e.g., congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles){e.g., Percutaneous Transcatheter Coil Embolization for Pelvic Congestion Syndrome} Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; initial noncoronary vessel (List separately in addition to code for primary procedure) Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation; each additional noncoronary vessel (List separately in addition to code for primary procedure) Penile venous occlusive procedure Tongue base suspension, permanent suture technique Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session Investigational January 1, 2016 - February 15, 2023 37253 37790 41512 Investigational November 20, 2006 - October 18, 2023February 15, 2023 41530 Investigational January 1, 2006 - September 20, 2023 Noncovered Investigational Services 85 Procedure Code Description Exclusion Category Origination Date Last Review Date 43206 Esophagoscopy, rigid or flexible, with optical endomicroscopy Investigational January 1, 2013 September 20, 2023 43210 Esophagogastroduodenoscopy, flexible, transoral; with esophagogastric fundoplasty, partial or complete, includes duodenoscopy when performed Investigational January 1, 2016 September 20, 2023 43252 Upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate, with optical endomicroscopy Investigational January 1, 2013 September 20, 2023 43257 Upper Gastrointestinal Endoscopy with delivery of thermal energy to the muscle of lower esophageal sphincter and/or gastric cardia, for treatment of gastroesophageal reflux disease, (e.g., Stretta procedure, the Bard® EndoCinch™ Suturing System, Plicator™ and Enteryx™ ) Investigational November 20, 2006 September 20, 2023 43285 Linx Reflux Management System) Removal of esophageal sphincter augmentation device, (e.g., Linx Investigational January 1, 2017 September 20, 2023 43648 Reflux Management System) Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum Investigational January 1, 2007 September 20, 2023 44705 Preparation of fecal microbiota for instillation, including assessment of donor specimen Investigational EXCEPT when billed with any of the following ICD-10 diagnosis code(s): A04.71, January 1, 2013 September 20, 2023 53451 Periurethral transperineal adjustable balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance (ProAct A04.72 Investigational January 1, 2022 October 18, 2023 53452 (Uromedica)) Periurethral transperineal adjustable balloon continence device; unilateral insertion, including cystourethroscopy and imaging guidance (ProAct Investigational January 1, 2022 October 18, 2023 53453 (Uromedica)) Periurethral transperineal adjustable balloon continence device; removal, each balloon (ProAct (Uromedica)) Investigational January 1, 2022 October 18, 2023 53454 Periurethral transperineal adjustable Investigational January 1, 2022 October 18, 2023 Percutaneous lysis of epidural adhesions using solution injection (e.g., hypertonic saline, enzyme) or mechanical means (e.g., catheter) including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 2 or more days Percutaneous lysis of epidural adhesions using solution injection (e.g., hypertonic saline, enzyme) or mechanical... SPRINT PNS System (SPR Therapeutics) for Chronic Pain Investigational October 1, 2019 September 20, 2023 64624 Destruction by neurolytic agent, genicular nerve branches including imaging guidance, when performed Investigational December 18, 2019 November 16, 2023 64625 Radiofrequency ablation, nerves innervating the sacroiliac joint, with image guidance (ie, fluoroscopy or computed tomography) Investigational December 18, 2019 November 16, 2023 64628 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; first 2 vertebral bodies, lumbar or sacral (Intacept) Investigational January 1, 2022 October 18, 2023 64629 Thermal destruction of intraosseous basivertebral nerve, including all imaging guidance; each additional vertebral body, lumbar or sacral (List separately in addition to code for primary procedure) (Intacept) Investigational January 1, 2022 October 18, 2023 64704 Neuroplasty, nerve of hand or foot Investigational when billed with at least two of these additional codes CPT Code(s): 28035, 64708, 64712, 64722 October 1, 2009 November 16, 2023 64708 Neuroplasty, major peripheral nerve, arm or leg; other than specified Investigational when billed with at least two of these additional CPT Code(s): 28035, 64704, 64712, 64722 October 1, 2009 November 16, 2023 64712 Neuroplasty, sciatic nerve Investigational when billed with at least two of these additional CPT Code(s): 28035, 64704, 64708, 64722 October 1, 2009 November 16, 2023 64722 Decompression; unspecified nerve(s) (specify) Investigational when billed with at least two of these additional codes: CPT Code(s): 28035, 64704, 64708, 64712 October 1, 2009 November 16, 2023 65710 Keratoplasty (corneal transplant); lamellar Investigational January, 1,2007 April 19, 2023 65785 Implantation of intrastromal corneal ring segments Investigational January 1, 2016 April 19, 2023 66174 Transluminal dilation of aqueous outflow canal (eg, canaloplasty); without retention of device or stent Investigational January 1, 2008 April 19, 2023 Noncovered Investigational Services 88 Procedure Code Description Exclusion Category Origination Date Last Review Date 67225 Destruction of localized lesion of choroid (e.g., choroidal neovascularization); photodynamic therapy, second eye, at single session (List separately in addition to code for primary eye treatment) Covered when billed with any of the following ICD-10 diagnosis code(s): H35.051- H35.059; H35.711-H35.719 April 1, 2010 April 19, 2023 68841 Insertion of drug-eluting implant, including punctal dilation when performed, into lacrimal canaliculus, each Investigational January 1, 2022 April 19, 2023 72285 Discography, cervical or thoracic, radiological supervision and interpretation Investigational April 1, 2018 November 16, 2023 72295 Discography, lumbar, radiological supervision and interpretation Investigational April 1, 2018 November 16, 2023 75571 Computed tomography, heart, without contrast material, with quantitative evaluation of calcium Investigational January 1, 2007 November 16, 2023 75958 Placement of proximal extension prosthesis for endovascular repair of descending thoracic aorta (e.g., aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma, or traumatic disruption), radiological supervision and interpretation Investigational November 20,2006 September 20, 2023 76391 Magnetic resonance (eg, vibration) elastography Investigational February 12, 2019 February 15, 2023 76977 Ultrasound bone density measurement and interpretation, peripheral site(s), any method Investigational July 1, 2016 February 15, 2023 76981 Ultrasound, elastography, parenchyma (eg, organ) Investigational February 12, 2019 February 15, 2023 76982 Ultrasound, elastography, first target lesion Investigational February 12, 2019 February 15, 2023 76983 Ultrasound, elastography, each additional target lesion (List separately in addition to code for primary procedure) Investigational February 12, 2019 February 15, 2023 77089 Trabecular bone score (TBS), structural condition of the bone microarchitecture; using dual X-ray absorptiometry (DXA) or other imaging data on gray-scale variogram, calculation, with interpretation and report on fracture-risk Investigational January 1, 2022 September 20, 2023 77401 Radiation treatment delivery, superficial and/or ortho voltage, per day Investigational when billed with any of the following ICD-10 diagnosis code(s): C44.01, C44.02, 044.111, C44.1121, C44.1122, C44.1191, C44.1192, C44.121, C44.1221- C44.1292, C44.211- C44.229, C44.310- C44.329, C44.41, C44.42, C44.510- C44.529, C44.611- C44.629, C44.711- C44.729, C44.81, C44.82, C44.91, C44.92 October 1, 2018 September 20, 2023 78434 Absolute quantitation of myocardial blood flow (AQMBF), positron emission tomography (PET), rest and pharmacologic stress (List separately in addition to code for primary procedure) Investigational December 18, 2019 November 16, 2023 Noncovered Investigational Services 89 Procedure Code Description Exclusion Category Origination Date Last Review Date 78800 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); limited area Investigational-for Breast Imaging only July 1, 2011 February 15, 2023 78801 Radiopharmaceutical localization of tumor or distribution of radiopharmaceutical agent(s); multiple areas Investigational-For Breast Imaging only July 1, 2011 February 15, 2023 81105 Human Platelet Antigen 1 genotyping (HPA-1), ITGB3 (integrin, beta 3 [platelet glycoprotein Illa], antigen CD61 (GPIila)) (eg, neonatal alloimmune thrombocytopenia [NAIT], post-transfusion purpura), gene analysis, common variant, HPA-1a/b (L33P) Investigational January 1, 2018 October 18, 2023 81106 Human Platelet Antigen 2 genotyping (HPA-2), GP1BA (glycoprotein 1b [platelet}, alpha polypeptide [Gpiba)) (eg, neonatal alloimmune thrombocytopenia [NAIT}, post-transfusion purpura), gene analysis, common variant, HPA-2a/b (T145M) Investigational January 1, 2018 October 18, 2023 81230 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management CYP3AS (cytochrome P450 family 3 subfamily A member 4) (eg, drug metabolism) gene analysis, common variant(s) (eg, *2, *22) Investigational January 1, 2018 October 18, 2023 81231 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management CYP3AS (cytochrome P450 family 3 subfamily A member 5) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3, *4, *5, *6, *7) Investigational January 1, 2018 October 18, 2023 81232 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management DPYD (dihydropyrimidine dehydrogenase) (eg, 5 fluorouracil/5-FU and capecitabine drug metabolism), gene analysis, common variant(s) (eg, *2A, *4, *5, *6) Investigational January 1, 2018 October 18, 2023 81277 *“Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Cytogenomic neoplasia (genome-wide) microarray analysis, interrogation of genomic regions for copy number and loss-of-heterozygosity variants for chromosomal abnormalities Investigational December 18, 2019 October 18, 2023 81284 *Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management FXN (frataxin) (eg, Friedreich ataxia) gene analysis; evaluation to detect abnormal (expanded) alleles Investigational January 1, 2019 October 18, 2023 Noncovered Investigational Services 90 Procedure Code Description Exclusion Category Origination Date Last Review Date 81285 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management FXN (frataxin) (eg, Friedreich ataxia) gene analysis, characterization of alleles (eg, expanded size) Investigational January 1, 2019 October 18, 2023 81286 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management FXN (frataxin) (eg, Friedreich ataxia) gene analysis; full gene sequence Investigational January 1, 2019 October 18, 2023 Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management FXN (frataxin) (eg, Friedreich ataxia) gene analysis, known familial variant(s) Investigational January 1, 2019 October 18, 2023 Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management MTHFR (5,10-methylenetetrahydrofolate reductase) (e.g., hereditary hypercoagulability) gene analysis, common variants (e.g., 677T, 1298C) Investigational January 1, 2012 October 18, 2023 Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management NUDT15 (nudix hydrolase 15) (eg, drug metabolism) gene analysis, common variant(s) (eg, *2, *3, *4, *5, i) Investigational January 1, 2019 October 18, 2023 81313 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (e.g., prostate cancer) Investigational January 1, 2015 October 18, 2023 81327 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management SEPT9 (Septin9) (eg, colorectal cancer) promoter methylation analysis (Epi proColon [Epigenomics Inc.]) Investigational November 28, 2012 September 20, 2023 81328 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management SLCO1B1 (solute carrier organic anion transporter family, member 1B1) (eg, adverse drug reaction), gene analysis, common variant(s) (eg, *5) Investigational January 1, 2018 October 18, 2023 81335 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management TPMT (thiopurine S-methyltransferase) (eg, drug metabolism), gene analysis, common variants (eg, *2, *3) Investigational January 1, 2018 October 18, 2023 81346 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management TYMS (thymidylate synthetase) (eg, 5-fluorouracil/5-FU drug metabolism), gene analysis, common variant(s) (eg, tandem repeat variant) Investigational January 1, 2018 October 18, 2023 81355 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management VKORC1 (vitamin K epoxide reductase complex, subunit 1) (e.g., warfarin metabolism), gene analysis, common variants (e.g., -1639/3673) Investigational January 1, 2012 November 16, 2023 81419 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Drug metabolism (eg, pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis. Epilepsy genomic sequence analysis panel, must include analyses for ALDH7A1, CACNA1A, CDKL5, CHD2, GABRG2, GRIN2A, KCNQ2, MECP2, PCDH19, POLG, PRRT2, SCN1A, SCN1B, SCN2A, SCN8A, SLC2A1, SLC9A6, STXBP1, SYNGAP1, TCF4, TPP1, TSC1, TSC2, and ZEB2. Investigational January 1, 2021 August 16, 2023 81422 Fetal chromosomal microdeletion(s) Investigational January 1, 2017 October 18, 2023 Noncovered Investigational Services 91 Procedure Code Description Exclusion Category Origination Date Last Review Date *Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management genomic sequence analysis (e.g., DiGeorge syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood Investigational January 1, 2015 October 18, 2023 81440 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Nuclear encoded mitochondrial genes (e.g., neurologic or myopathic phenotypes), genomic sequence panel, must include analysis of at least 100 genes, including BCS1L, C10orf2, COQ2, COX10, DGUOK, MPV17, OPA1, PDSS2, POLG, POLG2, RRMZ2B, SCO1, SCO2, SLC25A4, SUCLA2, SUCLG1, TAZ, TK2, and TYMP. Investigational January 1, 2015 October 18, 2023 81442 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Noonan spectrum disorders (e.g., Noonan syndrome, cardio-facio-cutaneous syndrome, Costello syndrome, LEOPARD syndrome, Noonan-like syndrome), genomic sequence analysis panel, must include sequencing of at least 12 genes, including BRAF, CBL, HRAS, KRAS, MAP2K1, MAP2K2, NRAS, PTPN11, RAF1, RIT1, SHOC2, and SOS1. Investigational January 1, 2016 October 18, 2023 81448 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Hereditary peripheral neuropathies (eg, Charcot-Marie-Tooth, spastic paraplegia), genomic sequence analysis panel, must include sequencing of at least 5 peripheral neuropathy-related genes (eg, BSCL2, GJB1, MFN2, MPZ, REEP1, SPAST, SPG11, SPTLC1). Investigational January 1, 2018 October 18, 2023 81455 *"Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm or disorder, 51 or greater genes (e.g., <i>ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MET, MLL, NOTCH1, NPM1, NRAS, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET</i>), interrogation for sequence variants and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; DNA analysis or combined DNA and RNA analysis Investigational January 1, 2015 November 16, 2023 PDGFRA. PDGFRB. PGR. Investigational January 1, 2023 January 1, 2023 Hereditary peripheral neuropathies (eg, Charcot-Marie-Tooth, spastic paraplegia), genomic sequence analysis panel, must include sequencing of at least 5 peripheral neuropathy-related genes (eg, BSCL2, GJB1, MFN2, MPZ, REEP1, SPAST, SPG11, SPTLC1) Targeted genomic sequence analysis panel, solid organ or hematolymphoid neoplasm or disorder, 51 or greater genes (eg, ALK, BRAF, CDKN2A, CEBPA, DNMT3A, EGFR, ERBB2, EZH2, FLT3, IDH1, IDH2, JAK2, KIT, KRAS, MET, MLL, NOTCH1, NPM1, NRAS, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed; DNA analysis or combined DNA and RNA analysis. Whole mitochondrial genome genomic sequence, must include sequencing of entire mitochondrial genome with heteroplasmy detection (e.g., Leigh syndrome, mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes [MELAS], myoclonic epilepsy with ragged-red fibers [MERFF], neuropathy, ataxia, and retinitis pigmentosa [NARP], Leber hereditary optic neuropathy [LHON]) Noncovered Investigational Services 92 Procedure Code Description Exclusion Category Origination Date Last Review Date include sequence analysis of entire mitochondrial genome with heteroplasmy detection 81465 *Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management Whole mitochondrial genome large deletion analysis panel (e.g., Kearns- Sayre syndrome, chronic progressive external ophthalmoplegia), including heteroplasmy detection, if performed Investigational January 1, 2015 October 18, 2023 81470 *“Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID); genomic sequence analysis panel, must include sequencing of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, SLC16A2 Investigational January 1, 2015 October 18, 2023 81471 **Authorization review for HPHC and THPPs is managed by Carelon Medical Benefits Management X-linked intellectual disability (XLID) (e.g., syndromic and non-syndromic XLID); duplication/deletion gene analysis, must include analysis of at least 60 genes, including ARX, ATRX, CDKL5, FGD1, FMR1, HUWE1, IL1RAPL, KDM5C, L1CAM, MECP2, MED12, MID1, OCRL, RPS6KA3, and SLC16A2 Investigational January 1, 2015 October 18, 2023 scores for fibrosis and necroinflammatory activity in liver Investigational January 1, 2019 September 20, 2023 82777 Galectin-3 Investigational January 1, 2013 November 16, 2023 83006 Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1) Investigational January 1, 2015 October 18, 2023 83037 Glycosylated (A1C) by device cleared by FDA for home use (e.g., A1CNow+ °) Investigational April 1, 2009 October 18, 2023 83631 Lactoferrin, fecal, quantitative Investigational November 20, 2006 September 20, 2023 83987 pH; exhaled breath condensate Investigational January 1, 2006 September 20, 2023 83993 Calprotectin, fecal Investigational April 1, 2018 September 20, 2023 84145 Procalcitonin (PCT) Investigational January 1, 2009 September 20, 2023 84431 Thromboxane metabolite(s), including thromboxane if urine Investigational October 6, 2015 November 16, 2023 86152 performed, Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulating tumor cells in blood); (e.g., CellSearch Circulating Tumor Cell (CTC) Kit for monitoring Investigational January 1, 2013 November 16, 2023 Metastatic Breast Cancer) 86153 Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulating tumor cells in blood); physician interpretation and report, when required, (e.g., CellSearch Circulating Tumor Cell (CTC) Kit for monitoring Metastatic Breast Cancer) Investigational January 1, 2013 November 16, 2023 86343 Leukocyte histamine release test (LHR) Investigational January 1, 2007 October 18, 2023 86677 Antibody; Helicobacter pylori Investigational February 12, 2016 September 20, 2023 86711 Antibody; JC (John Cunningham) virus Investigational January 1, 2013 October 18, 2023 88375 Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session Investigational January 1, 2013 September 20, 2023 89329 Sperm evaluation; hamster penetration test Investigational November 20, 2006 October 18, 2023 89335 Cryopreservation, reproductive tissue, testicular Investigational January 12, 2016 May 17, 2023 89344 Storage, (per year); reproductive tissue, testicular/ovarian Investigational January 12, 2016 May 17, 2023 89354 Thawing of cryopreserved; reproductive tissue, testicular/ovarian Investigational January 12, 2016 May 17, 2023 90867 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, Covered with PA for ICD-10 diagnosis code(s): F32.2, F33.2. January 1, 2013 August 16, 2023 Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, prognostic algorithm reported as scores for fibrosis and necroinflammatory activity in liver Galectin-3 Growth stimulation expressed gene 2 (ST2, Interleukin 1 receptor like-1) Glycosylated (A1C) by device cleared by FDA for home use (e.g., A1CNow+ ®) Lactoferrin, fecal, quantitative pH; exhaled breath condensate Calprotectin, fecal Procalcitonin (PCT) Thromboxane metabolite(s), including thromboxane if performed, urine Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulating tumor cells in blood); (e.g., CellSearch Circulating Tumor Cell (CTC) Kit for monitoring Metastatic Breast Cancer) Cell enumeration using immunologic selection and identification in fluid specimen (e.g., circulating tumor cells in blood); physician interpretation and report, when required, (e.g., CellSearch Circulating Tumor Cell (CTC) Kit for monitoring Metastatic Breast Cancer) Leukocyte histamine release test (LHR) Antibody; Helicobacter pylori Antibody; JC (John Cunningham) virus Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session Sperm evaluation; hamster penetration test Cryopreservation, reproductive tissue, testicular Storage, (per year); reproductive tissue, testicular/ovarian Thawing of cryopreserved; reproductive tissue, testicular/ovarian Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management 90868 90869 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent delivery and management, per session Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-|Covered with PA for ICD-10 diagnosis code(s): F32.2, F33.2. All other diagnoses considered investigational. Covered with PA for ICD-10 diagnosis code(s): F32.2, F33.2. All other diagnoses considered investigational. Covered with PA for ICD-10 diagnosis code(s): F32.2, F33.2 January 1, 2013 - August 16, 2023 Noncovered Investigational Services 95 Procedure Code Description Exclusion Category Origination Date Last Review Date determination with delivery and management All other diagnoses considered investigational. 91065 Breath hydrogen or methane test (e.g., for detection of lactase deficiency, fructose intolerance, bacterial overgrowth, or oro-cecal gastrointestinal transit) Investigational; Covered when billed with ICD-10 diagnosis code(s): K90.49, K90.89 April 1, 2014 September 20, 2023 91112 Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report Investigational January 1, 2013 September 20, 2023 91113 Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report (Pillcam 2 (medtronic) Investigational January 1, 2022 September 20, 2023 92145 Corneal hysteresis determination, by air impulse stimulation, unilateral or bilateral, with interpretation and report Investigational January 1, 2015 April 19, 2023 92229 Imaging of retina for detection or monitoring of disease; point-of-care autonomous analysis and report, unilateral or bilateral Investigational January 1, 2021 April 19, 2023 92512 Nasal function studies Investigational October 1, 2009 October 18, 2023 92517 Vestibular evoked myogenic potential (VEMP) testing, with interpretation and report; cervical (CVEMP) Investigational January 1, 2021 February 15, 2023 92518 Vestibular evoked myogenic potential (VEMP) testing, with interpretation and report; ocular (OVEMP) Investigational January 1, 2021 February 15, 2023 92519 Vestibular evoked myogenic potential (VEMP) testing, with interpretation and report; cervical (CVEMP) and ocular (oVEMP) Investigational January 1, 2021 February 15, 2023 92548 Computerized dynamic posturography Investigational October 1, 2010 September 20, 2023 92549 Computerized dynamic posturography sensory organization test (CDP-SOT), 6 conditions (ie, eyes open, eyes closed, visual sway, platform sway, eyes closed platform sway, platform and visual sway), including interpretation and report; with motor control test (MCT) and adaptation test (ADT) Investigational December 18, 2019 September 20, 2023 93050 Arterial pressure waveform analysis for assessment of central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial pressures and augmentation index, with interpretation and report, upper extremity artery, non-invasive, Investigational January 1, 2016 November 16, 2023 cm Investigational April 1, 2023 October 18, 2023 A2022 InnovaBurn or InnovaMatrix XL, per sq | cm Investigational October 1, 2023 October 1, 2023 A2023 InnovaMatrix PD, 1 mg Investigational October 1, 2023 October 1, 2023 A2024 Resolve Matrix, per sq. Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day Remote therapeutic monitoring (eg, therapy adherence, therapy response); device(s) supply with scheduled (eg, daily) recording(s) and/or programmed alert(s) transmission to monitor cognitive behavioral therapy, each 30 days InnovaMatrix AC, per sq cm Mirragen Advanced Wound Matrix, per sq cm XCelliStem, per sq cm Microlyte Matrix, per sq cm NovoSorb SynPath dermal matrix, per sq cm Restrata, per sq cm TheraGenesis, per sq cm Symphony, per sq cm Apis, per sq cm Supra SDRM, per sq cm SUPRATHEL, per sq cm Omeza Collagen Matrix, per 100 mg Phoenix wound matrix, per sq cm PermeaDerm B, per sq cm PermeaDerm glove, each PermeaDerm C, per sq cm Kerecis Omega3 MariGen Shield, per sq cm AC5 Advanced Wound System (AC5) NeoMatriX, per sq cm InnovaBurn or InnovaMatrix XL, per sq cm InnovaMatrix PD, 1 mg Resolve Matrix, per sq cm Neuromuscular electrical stimulator (NMES), disposable, replacement only Topical hyperbaric oxygen chamber, disposable Cranial electrotherapy stimulation (CES) system supplies and accessories, per month Non-contact wound warming wound cover for use with the non-contact wound warming device and warming card Synthetic resorbable wound dressing, sterile, pad size 16 sq in or less, without adhesive border, each dressing A4575 October 18, 2023 December 27, 2010 Investigational A4596 Investigational A6000 November 20, 2006 October 18, 2023 Investigational A6460 January 1, 2019 October 18, 2023 Investigational Noncovered Investigational Services 100 Procedure Code Description Exclusion Category Origination Date Last Review Date A6461 Synthetic resorbable wound dressing, sterile, pad size more than 16 sq in but less than or equal to 48 sq in, without adhesive border, each dressing Investigational January 1, 2019 October 18, 2023 A7049 Expiratory positive airway pressure intranasal resistance valve Investigational April 1, 2023 May 17, 2023 A9268 Programmer for transient, orally ingested capsule Investigational October 1, 2023 October 1, 2023 A9269 Programmable, transient, orally ingested capsule Investigational October 1, 2023 October 1, 2023 A9272 Wound suction, disposable, includes dressing, all accessories and components, any type, each, (e.g., PICO™ Single Use Negative Pressure Wound Therapy System) Investigational March 12, 2014 October 18, 2023 Ag9291 Prescription digital cognitive and/or behavioral therapy Investigational April 1, 2022 August 16, 2023 Ag292 Prescription digital visual therapy, software-only Investigational October 1, 2023 October 1, 2023 A9628 Programmer for transient, orally ingested capsule Investigational October 1, 2023 October 1, 2023 A9629 Programmable, transient, orally ingested capsule, for use with external programmer, per month Investigational October 1, 2023 October 1, 2023 C1062 Intravertebral body fracture augmentation with implant Investigational January 1, 2021 November 16, 2023 C1749 Endoscope, retrograde imaging illumination colonoscope device Investigational October 1, 2010 September 20, 2023 C1761 (implantable) Catheter, transluminal intravascular lithotripsy, coronary Investigational July 1, 2021 October 19, 2022 C1818 Integrated keratoprosthesis Investigational January 1, 2007 April 19, 2023 C1821 Interspinous process distraction device (implantable) Investigational January 1, 2007 November 16, 2022 C1823 Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads Investigational January 1, 2019 August 16, 2023 C1824 Generator, cardiac contractility modulation (implantable) Investigational December 18, 2019 October 19, 2022 C1825 Generator, neurostimulator (implantable), non-rechargeable with carotid sinus baroreceptor stimulation lead(s) Investigational January 1, 2021 October 19, 2022 C1826 Generator, neurostimulator Investigational January 1, 2023 August 16, 2023 SPY Portable Handheld Imaging System (SPY-PHI) (Stryker) Investigational April 1, 2012 - September 20, 2023 C9734 Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with or without magnetic resonance (MR) guidance Investigational April 1, 2013 September 20, 2023 Probe, image guided, robotic, waterjet ablation Probe, percutaneous lumbar discectomy Implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components (e.g., CardioMEMSTM HF System) Insertion of new or replacement of permanent pacemaker with atrial transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system) Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system) Insertion of new or replacement of permanent pacemaker with atrial and ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system) Dermal substitute, native, non-denatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 square centimeters Insertion of implants into the soft palate; minimum of three implants (Pillar Procedure) Nonophthalmic fluorescent vascular angiography, (e.g. SPY Portable Handheld Imaging System (SPY-PHI) (Stryker) Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with or without magnetic resonance (MR) guidance Noncovered Investigational Services 103 Creation of arteriovenous fistula, percutaneous using magnetic-guided arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, when performed) and fistulogram(s), angiography, venography, and/or ultrasound, with radiologic supervision and interpretation, when performed Investigational January 1, 2019 - September 20, 2023 C9755 - Investigation January 1, 2019 - September 20, 2023 Description C9755: arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, when performed) and fistulogram(s), angiography, venography, and/or ultrasound, with radiologic supervision and interpretation, when performed Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and excision of herniated intervertebral disc, and repair of annular defect with implantation of bone anchored annular closure device, including annular defect measurement, alignment and sizing assessment, and image guidance; 1 interspace, lumbar Investigational April 1, 2022 - November 16, 2023 C9757 - Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and excision of herniated intervertebral disc, and repair of annular defect with implantation of bone anchored annular closure device, including annular defect measurement, alignment and sizing assessment, and image guidance; 1 interspace, lumbar C9758 - Blinded procedure for NYHA Class III/IV heart failure; transcatheter implantation of interatrial shunt or placebo control, including right heart catheterization, transesophageal echocardiography (TEE)/intracardiac echocardiography (ICE), and all imaging with or without guidance (e.g., ultrasound, fluoroscopy), performed in an approved investigational device exemption (IDE) study Investigational July 1, 2020 - November 16, 2023 C9760 - Nonrandomized, nonblinded procedure for NYHA Class Il, Ill, IV heart failure, transcatheter implantation of interatrial shunt or placebo control, including right and left heart catheterization, transeptal puncture, transesophageal echocardiography (TEE)/intracardiac echocardiography (ICE), and all imaging with or without guidance (e.g., ultrasound, fluoroscopy), performed in an approved investigational device exemption (IDE) study Investigational July 1, 2020 - November 16, 2023 C9764 - Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed C9766 - Revascularization, endovascular, open or percutaneous, any vessel(s), with intravascular lithotripsy and transluminal stent placement(s), includes angioplasty within the same vessel(s), when performed C9767 - Revascularization, endovascular, open or percutaneous, any vessel(s), with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed C9770 - Vitrectomy, mechanical, pars plana approach, with subretinal injection of pharmacologic/biologic agent c9771 - Nasal/sinus endoscopy, cryoablation nasal tissue(s) and/or nerve(s), unilateral or bilateral C9782 - Blinded procedure for New York Heart Association (NYHA) Class II or III heart failure, or Canadian Cardiovascular Society (CCS) Class III or IV chronic refractory angina; transcatheter intramyocardial transplantation of autologous bone marrow cells (e.g., mononuclear) or placebo control, autologous bone marrow harvesting and preparation for transplantation, left heart catheterization including ventriculography, all laboratory services, and all imaging with or without guidance (e.g., transthoracic echocardiography, ultrasound, fluoroscopy), performed in an approved investigational device exemption (IDE) study C9783 - Blinded procedure for transcatheter implantation of coronary sinus reduction device or placebo control, including vascular access and closure, right heart catherization, venous and coronary sinus angiography, imaging guidance and supervision and interpretation when performed in an approved investigational device exemption (IDE) study C9784 - Gastric restrictive procedure, endoscopic sleeve gastroplasty, with esophagogastroduodenoscopy and intraluminal tube insertion, if performed, including all system and tissue anchoring components C9785 - Endoscopic outlet reduction, gastric pouch application, with endoscopy and intraluminal tube insertion, if performed, including all system and tissue anchoring components C9786 - Echocardiography image post processing for computer aided detection of heart failure with preserved ejection fraction, including interpretation and report Neuromuscular stimulator for scoliosis (E0744) - Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only. Origination Date: January 1, 2019; Last Review Date: October 18, 2023 Neuromuscular stimulator, electronic shock unit (£0745) - Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only. Origination Date: January 1, 2019; Last Review Date: September 20, 2023 Electromyography (EMG), biofeedback device (E0746) - Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only. Origination Date: January 1, 2019; Last Review Date: September 20, 2023 Osteogenesis stimulator, electrical, surgically implanted (£0749) - Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only. Origination Date: January 1, 2019; Last Review Date: November 16, 2023 Electronic salivary reflex stimulator (intraoral/noninvasive) (E0761) - Nonthermal pulsed high frequency radiowaves, high peak power electromagnetic energy treatment device. Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only. Origination Date: January 1, 2019; Last Review Date: October 18, 2023 Transcutaneous electrical joint stimulation device system, includes all accessories (E0762) - Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only. Origination Date: January 1, 2019; Last Review Date: September 20, 2023 Noncovered Investigational Services 106 Procedure Code Description Exclusion Category Origination Date Last Review Date E0764 Functional neuromuscular stimulation, transcutaneous stimulation of sequential muscle groups of ambulation with computer control, used for walking by spinal cord injured, entire system, after completion of training program Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only January 1, 2019 September 20, 2023 E0765 FDA approved nerve stimulator, with replaceable batteries, for treatment of nausea and vomiting Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only January 1, 2019 September 20, 2023 E0769 Electrical stimulation or electromagnetic wound treatment device, not otherwise classified Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only January 1, 2019 October 18, 2023 £0770 Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified Investigational. Applicable to Tufts Health Plan Together and Rhode Island Together products only January 1, 2019 Review Date Not Provided Procedure Code Description Exclusion Category Origination Date Last Review Date E0782 Terbutaline therapy via subcutaneous infusion pump for pre-term labor Investigational July 1, 2009 September 20, 2023 E0783 Terbutaline therapy via subcutaneous infusion pump for pre-term labor Investigational July 1, 2009 September 20, 2023 E1629 Tablo hemodialysis system for the billable dialysis service Investigational January 1, 2022 September 20, 2023 E1700 Jaw motion rehabilitation system Investigational EXCEPT when billed with: trismus diagnosis, ICD-10 code: R25.2 January 1, 2017 September 20, 2023 E1701 Replacement cushions for jaw motion rehabilitation system Investigational EXCEPT when billed with: trismus diagnosis, ICD-10 code: R25.2 January 1, 2017 September 20, 2023 E1702 Replacement measuring scales for jaw motion rehabilitation system Investigational EXCEPT when billed with: trismus diagnosis, ICD-10 code: R25.2 January 1, 2017 September 20, 2023 E1800 Dynamic adjustable elbow extension/flexion device, includes soft interface material Investigational February 1, 2022 September 20, 2023 E1802 Dynamic adjustable forearm pronation/supination device, includes soft interface material Investigational February 1, 2022 September 20, 2023 E1805 Dynamic adjustable wrist extension/flexion device, includes soft interface material Investigational February 1, 2022 September 20, 2023 Dynamic adjustable elbow extension/flexion device, includes soft interface material Dynamic adjustable forearm pronation/supination device, includes soft interface material Dynamic adjustable wrist extension/flexion device, includes soft interface material Dynamic adjustable knee extension/flexion device, includes soft interface material Dynamic knee, extension/flexion device with active resistance control Dynamic adjustable ankle extension/flexion device, includes soft interface material Replacement soft interface material, dynamic adjustable extension/flexion device Dynamic adjustable toe extension/flexion device, includes soft interface material Investigational E1812 September 20, 2023 February 1, 2022 Investigational Investigational September 20, 2023 E1815 February 1, 2022 Investigational Investigational September 20, 2023 Investigational February 1, 2022 E1820 Investigational Investigational February 1, 2022 E1830 September 20, 2023 Noncovered Investigational Services 107 Procedure Code Description Exclusion Category Origination Date Last Review Date E1840 Dynamic adjustable shoulder flexion/abduction/rotation device, includes soft interface material Investigational February 1, 2022 September 20, 2023 E1905 Virtual reality cognitive behavioral therapy device (CBT), including preprogrammed therapy software Investigational April 1, 2023 September 20, 2023 E2120 Pulse generator system for tympanic treatment of inner ear endolymphatic fluid Investigational July 1, 2008 February 15, 2023 G0176 Activity therapy, such as music, dance, art or play therapies not for recreation, related to the care and treatment of patient's disabling mental health problems, per session (45 minutes or more) Investigational November 1, 2011 August 16, 2023 G0186 Destruction of localized lesion of choroid (for example, choroidal neovascularization); photocoagulation, feeder vessel technique (one or more sessions) Investigational June 8, 2016 April 19, 2023 G0255 Current perception threshold/sensory nerve conduction test, (SNCT) per limb, any nerve Investigational January 1, 2007 August 16, 2023 G0282 Electrical stimulation, (unattended), to one or more areas, for wound care Investigational November 20,2006 October 18, 2023 G0295 Electromagnetic therapy, to one or more areas, for wound care other than described in G0329 or for other uses Investigational November 20, 2006 October 18, 2023 G0327 Colorectal cancer screening, blood- based biomarker Investigational July 1, 2021 September 20, 2023 G0329 Electromagnetic therapy, to one or more areas for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic ulcers and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care as part of a therapy plan of care Investigational November 20, 2006 October 18, 2023 G0428 Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex) Investigational January 1, 2011 November 16, 2023 G0455 Preparation with Instillation of fecal microbiota by any method, including assessment of donor specimen Investigational EXCEPT when billed with any of the following ICD-10 diagnosis code(s): A04.71, A04.72 January 1, 2013 September 20, 2023 G0460 Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment Investigational July 1, 2013 October 18, 2023 Autologous platelet rich plasma for chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment Autologous platelet rich plasma (PRP) for diabetic chronic wounds/ulcers, using an FDA-cleared device (includes administration, dressings, phlebotomy, centrifugation, and all other preparatory procedures, per treatment) Blinded administration of convulsive therapy procedure, either electroconvulsive therapy (ECT, current covered gold standard) or magnetic seizure therapy (MST, non- covered experimental therapy), performed in an approved IDE-based clinical trial, per treatment session G2000 Investigational January 1, 2019 August 16, 2023 Noncovered Investigational Services 108 Procedure Code Description Exclusion Category Origination Date Last Review Date J0172 Injection, Aducanumab-AVWA, 2 MG Investigational January 1, 2022 January 1, 2022 J2787 Riboflavin 5'-phosphate, ophthalmic solution, up to 3 mL Investigational EXCEPT when billed with any of the following ICD-10 diagnosis codes: H18.621- H18.623 for ages 14 through age 64 January 1, 2019 April 19, 2023 J7313 Injection, fluocinolone acetonide, intravitreal implant, 0.01 mg Investigational EXCEPT when submitted with diabetic macular edema diagnosis. Procedure Code Description Exclusion Category Origination Date Last Review Date J0172 Injection, Aducanumab-AVWA, 2 MG Investigational January 1, 2022 January 1, 2022 J2787 Riboflavin 5'-phosphate, ophthalmic solution, up to 3 mL Investigational EXCEPT when billed with any of the following ICD-10 diagnosis codes: H18.621- H18.623 for ages 14 through age 64 January 1, 2019 April 19, 2023 J7313 Injection, fluocinolone acetonide, intravitreal implant, 0.01 mg Investigational EXCEPT when submitted with diabetic macular edema diagnosis. June 19, 2019 April 19, 2023 J7402 Mometasone furoate sinus implant, (Sinuva), 10 mcg Investigational April 1, 2021 February 15, 2023 K1006 Suction pump, home model, portable or stationary, electric, any type, for use with external urine management system Investigational October 1, 2020 October 18, 2023 K1007 Bilateral hip, knee, ankle, foot (HKAFO) device, powered, includes pelvic component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors Investigational October 1, 2020 September 20, 2023 K1009 Speech volume modulation system, any type, including all components and accessories Investigational October 1, 2020 September 20, 2023 K1016 Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve Investigational April 1, 2021 August 16, 2023 K1017 Monthly supplies for use of device coded at K1016 Investigational April 1, 2021 August 16, 2023 K1018 External upper limb tremor stimulator of the peripheral nerves of the wrist Investigational April 1, 2021 August 16, 2023 K1019 Supplies and accessories for external upper limb tremor stimulator of the peripheral nerves of the wrist Investigational April 1, 2021 September 20, 2023 K1020 Noninvasive vagus nerve stimulator Investigational April 1, 2021 August 16, 2023 K1021 Exsufflation belt, includes all supplies and accessories Investigational October 1, 2021 September 20, 2023 K1023 Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm Investigational October 1, 2021 August 16, 2023 K1024 Nonpneumatic compression controller with sequential calibrated gradient pressure Investigational October 1, 2021 September 20, 2023 Mometasone furoate sinus implant, (Sinuva), 10 mcg Suction pump, home model, portable or stationary, electric, any type, for use with external urine management system Bilateral hip, knee, ankle, foot (HKAFO) device, powered, includes pelvic component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors Speech volume modulation system, any type, including all components and accessories Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve Monthly supplies for use of device coded at K1016 External upper limb tremor stimulator of the peripheral nerves of the wrist Supplies and accessories for external upper limb tremor stimulator of the peripheral nerves of the wrist Noninvasive vagus nerve stimulator Exsufflation belt, includes all supplies and accessories Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm Nonpneumatic compression controller with sequential calibrated gradient pressure Nonpneumatic sequential compression garment, full arm Oral device/appliance used to reduce upper airway collapsibility, without fixed mechanical hinge, custom fabricated, includes fitting and adjustment Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle for the reduction of snoring and obstructive sleep apnea, controlled by phone application Investigational K1027 October 1, 2021 September 20, 2023 Investigational K1028 April 1, 2022 May 17, 2023 Noncovered Investigational Services 109 Procedure Code Description Exclusion Category Origination Date Last Review Date K1029 Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by phone application, 90-day supply Investigational April 1, 2022 May 17, 2023 K1030 External recharging system for battery (internal) for use with implanted cardiac contractility modulation generator, replacement only Investigational April 1, 2022 November 16, 2023 K1035 Molecular diagnostic test reader, nonprescription self-administered and self-collected use, FDA approved, authorized or cleared Investigational April 1, 2023 October 18, 2023 L1945** IDEO and ExoSym Energy Storing AFO and other exoskeletal devices Will deny investigational when submitted for IDEO and ExoSym Energy Storing AFO and other exoskeletal devices Investigational June 8, 2016 September 20, 2023 L2006 Knee-ankle-foot (KAF) device, any material, single or double upright, swing and/or stance phase microprocessor control with adjustability, includes all components (e.g., sensors, batteries, charger), any type activation, with or without ankle joint(s), custom fabricated Investigational December 18, 2019 September 20, 2023 L2755** IDEO and ExoSym Energy Storing AFO and other exoskeletal devices Will deny investigational when submitted for IDEO and ExoSym Energy Storing AFO and other exoskeletal devices Investigational June 8, 2016 September 20, 2023 L3904 Wrist hand finger orthosis, external powered, electric, custom fabricated Investigational December 10, 2014 September 20, 2023 L5859 Addition to lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable flexion/extension assist control, includes any type motor(s) Investigational October 1, 2019 September 20, 2023 L5969 Addition, endoskeletal ankle-foot or ankle system, power assist, includes any type motor(s) Investigational October 1, 2019 September 20, 2023 L5991 Addition to lower extremity prostheses, osseointegrated external prosthetic connector Investigational October 1, 2023 October 1, 2023 L6715 Terminal device, multiple articulating digit, includes motor(s), initial issue or replacement Investigational January 1, 2012 September 20, 2023 Wrist hand finger orthosis, external powered, electric, custom fabricated Addition to lower extremity prosthesis, endoskeletal knee-shin system, powered and programmable flexion/extension assist control, includes any type motor(s) Addition, endoskeletal ankle-foot or ankle system, power assist, includes any type motor(s) Addition to lower extremity prostheses, osseointegrated external prosthetic connector Terminal device, multiple articulating digit, includes motor(s), initial issue or replacement Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies, e.g., SOLESTA® (hyaluronicacid/dextranomer) Injectable bulking agent for vocal cord medialization, 0.1 ml, includes shipping and necessary supplies Miscellaneous external component, supply or accessory for use with the Argus II Retinal Prosthesis System Interphalangeal joint spacer, silicone or equal, each Electrical stimulator supplies (external) L8607 January 1, 2016 February 15, 2023 Investigational L8608 January 1, 2019 April 19, 2023 Investigational L8678 April 1, 2023 September 20, 2023 Investigational Noncovered Investigational Services 110 Procedure Code Description Exclusion Category Origination Date Last Review Date L8679 Implantable neurostimulator pulse generator, any type Investigational EXCEPT when billed with any of the following ICD-10 diagnosis code(s): G89.28-G89.29 G90.511-G90.519 G90.521-G90.529 G90.59 G57.70-G57.73 G56.40-G56.43 January 1, 2014 August 16, 2023 L8680 Implantable neurostimulator electrode, each Investigational EXCEPT when billed with any of the following ICD-10 diagnosis code(s): G21.4, G24.1, G25.0-G25.2, G40.011- G40.019; G40.111- G40.119; G40.211- G40.219, G40.311- G40.319, G40.813, G40.814, G40.A11, G40.A19, G89.28- G89.29 G90.511-G90.519 G90.521-G90.529 G90.59 G57.70-G57.73 G56.40-G56.43 November 20, 2006 August 16, 2023 L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator Investigational EXCEPT when billed with any of the following ICD-10 diagnosis code(s): G21.4, G24.1, G25.0-G25.2, G40.011- G40.019; G40.111- G40.119; G40.211- G40.219, G40.311- G40.319, G40.813, G40.814, G40.A11, G40.A19, G89.28- G89.29 G90.511-G90.519 G90.521-G90.529 G90.59 G57.70-G57.73 G56.40-G56.43 November 20, 2006 August 16, 2023 cm Investigational January 1, 2018 - October 18, 2023 Q4177 FlowerAmnioFlo, 0.1 cc Investigational January 1, 2018 - October 18, 2023 Q4178 FlowerAmnioPatch, per sq cm Investigational January 1, 2018 - October 18, 2023 Q4179 FlowerDerm, per sq cm Investigational January 1, 2018 - October 18, 2023 Q4180 Revita, per sq cm Investigational January 1, 2018 - October 18, 2023 Q4181 Amnio Wound, per sq cm Investigational January 1, 2018 - October 18, 2023 Q4183 Surgigraft, per sq cm Investigational January 1, 2019 - October 18, 2023 Q4184 Cellesta, per sq cm Investigational January 1, 2019 - October 18, 2023 Q4185 Cellesta Flowable Amnion (25 mg per cc); per 0.5 cc Investigational January 1, 2019 - October 18, 2023 Q4188 AmnioArmor, per sq cm Investigational January 1, 2019 - October 18, 2023 Q4189 Artacent AC, 1 mg Investigational January 1, 2019 - October 18, 2023 Q4190 Artacent AC, per sq cm Investigational January 1, 2019 - October 18, 2023 Q4191 Restorigin, per sq cm Investigational January 1, 2019 - October 18, 2023 Q4192 Restorigin, 1 cc Investigational January 1, 2019 - October 18, 2023 Noncovered Investigational Services 114 Q4202 Keroxx (2.5 g/cc), 1 cc Investigational January 1, 2019 October 18, 2023 Q4203 Derma-Gide, per sq cm Investigational January 1, 2019 October 18, 2023 Q4204 XWRAP, per sq cm Investigational January 1, 2019 October 18, 2023 Q4205 Membrane Graft or Membrane Wrap, per sq cm Investigational October 1, 2019 October 18, 2023 Q4206 Fluid Flow or Fluid GF, 1 cc Investigational October 1, 2019 October 18, 2023 DualGraft, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4211 - Amnion Bio or AxoBioMembrane, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4212 - AlloGen, per cc - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4213 - Ascent, 0.5 mg - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4214 - Cellesta Cord, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4215 - Axolotl Ambient or Axolotl Cryo, 0.1 mg - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4216 - Artacent Cord, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4217 - WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound Xplus, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4218 - SurgiCORD, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4219 - SurgiGRAFT-DUAL, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4220 - BellaCell HD or Surederm, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4221 - Amnio Wrap2, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4222 - ProgenaMatrix, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4224 - Human Health Factor 10 Amniotic Patch (HHF10-P), per sq cm - Investigational (Effective Dates: April 1, 2022 - October 18, 2023) Q4225 - AmnioBind, per sq cm - Investigational (Effective Dates: April 1, 2022 - October 18, 2023) Q4226 - MyOwn Skin, includes harvesting and preparation procedures, per sq cm - Investigational (Effective Dates: October 1, 2019 - October 18, 2023) Q4227 - AmnioCoreTM, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4229 - Cogenex Amniotic Membrane, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4230 - Cogenex Flowable Amnion, per 0.5 cc - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4231 - Corplex P, per cc - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4232 - Corplex, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4233 - SurFactor or NuDyn, per 0.5 cc - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4234 - XCellerate, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4235 - AMNIOREPAIR or AltiPly, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4237 - Cryo-Cord, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4238 - Derm-Maxx, per sq cm; Amnio-Maxx or Amnio-Maxx Lite, per sq cm - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) Q4241 - CoreCyte, topical use only, per 0.5 cc - Investigational (Effective Dates: July 2020 - October 2023) Q4242 - AmnioCyte Plus, per 0.5 cc - Investigational (Effective Dates: July 1, 2020 - October 18, 2023) cm Investigational April 1, 2022 - October 18, 2023 Q4258 Enverse, per sq cm Investigational April 1, 2022 - October 18, 2023 Q4261 TAG, per sq cm Investigational July 1, 2022 - October 18, 2023 Q4262 Dual Layer Impax Membrane, per sq cm Investigational January 1, 2023 - October 18, 2023 Q4263 SurGraft TL, per sq cm Investigational January 1, 2023 - October 18, 2023 Q4264 Cocoon Membrane, per sq cm Investigational January 1, 2023 - October 18, 2023 Q4265 NeoStim TL, per sq cm Investigational April 1, 2023 - October 18, 2023 Q4266 NeoStim Membrane, per sq cm Investigational April 1, 2023 - October 18, 2023 NeoStim cm 2023 - October 2023 Q4267 DL, per sq Investigational April 1, 18, Q4268 SurGraft FT, per sq. Q4269 SurGraft XT, per sq cm Investigational April 1, 2023 October 18, 2023 Q4270 Complete SL, per sqcm Investigational April 1, 2023 October 18, 2023 Q4271 Complete FT, per sq cm Investigational April 1, 2023 October 18, 2023 Q4272 Esano A, per sq cm Investigational July 1, 2023 October 18, 2023 Q4273 Esano AAA, per sq cm Investigational July 1, 2023 October 18, 2023 Q4274 Esano AC, per sqcm Investigational July 1, 2023 October 18, 2023 Q4275 Esano ACA, per sq cm Investigational July 1, 2023 October 18, 2023 Q4276 ORION, per sq cm Investigational July 1, 2023 October 18, 2023 Q4277 WoundPlus membrane or E-Graft, per sq cm Investigational July 1, 2023 October 18, 2023 Q4278 EPIEFFECT, per sq cm Investigational July 1, 2023 October 18, 2023 Q4280 Xcell Amnio Matrix, per sq cm Barrera SL Barrera DL, per sq cm Investigational July 1, 2023 October 18, 2023 Q4281 Cygnus Dual, per sq cm Biovance Tri-Layer or Biovance 3L, per sq cm Investigational July 1, 2023 October 18, 2023 Q4284 Q4285 DermaBind SL, per sq cm NuDYN DL or NuDYN DL MESH, per sq cm Investigational July 1, 2023 October 18, 2023 Q4286 NuDYN SL or NuUDYN SLW, per sq cm Investigational October 1, 2023 October 1, 2023 $0596 Phakic intraocular lens for correction of refractive error Investigational April 1, 2012 April 19, 2023 $1030 Continuous noninvasive glucose monitoring device, purchase Investigational October 1, 2017 October 18, 2023 $1031 Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor Investigational October 1, 2017 October 18, 2023 $1090 Mometasone furoate sinus implant, 370 micrograms Investigational September 22, 2015 February 15, 2023 January 19, 2022: Reviewed by MPAC, investigational items updated, added and removed. February 9, 2022: Investigational items added/removed February 10, 2022: Investigational items added/removed February 11, 2022: Investigational item added March 2, 2022: Investigational items removed/added March 16, 2022: Reviewed by MPAC, investigational items, added/updated May 18, 2022: Reviewed by MPAC, investigational items, added/updated May 23, 2022: Coding updated May 26, 2022: Coding updated October 1, 2022: Effective October 1, 2022, AIM Specialty Health® (AIM) will oversee medical necessity review for Tufts Health Public Plans October 7, 2022: Coding updated October 19, 2022: Reviewed by MPAC, investigational items updated November 16, 2022: Reviewed by MPAC, investigational item removed/upated December 1, 2022: Reviewed by MPAC, investigational items updated December 21, 2022: Reviewed by MPAC, investigational items removed/updated January 18, 2023: Reviewed by MPAC, investigational items updated, added and removed January 30, 2020: Investigational item removed February 13, 2020: Investigational items removed February 17, 2020: Investigational item removed February 19, 2020: Reviewed by IMPAC, Investigational items updated/removed/added February 28, 2020: Investigational items updated/removed/added June 17, 2020: Reviewed by IMPAC, investigational items updated/added July 15, 2020: Reviewed by IMPAC, investigational items updated/added August 5, 2020: Coding updated September 16, 2020: Reviewed by IMPAC, investigational items updated/added/removed April 13, 2021: Coding updated April 21, 2021: Reviewed by IMPAC, investigational items updated/added June 15, 2022: Reviewed by MPAC, investigational items, added/updated July 20, 2022: Reviewed by MPAC, investigational items removed/updated September 21, 2022: Reviewed by MPAC, investigational items updated, added, removed May 17, 2023: Reviewed by MPAC, investigational items update/removed October 18, 2023: Reviewed by MPAC, investigational items updated/added or removed. Point32Health integrated policy, effective January 1, 2024 February 15, 2023: Reviewed by MPAC investigational items updated April 3, 2023: Investigational items added/removed April 19, 2023: Reviewed by MPAC, investigational items updated June 6, 2023:Investigational items updated/removed June 21, 2023: Reviewed by MPAC, investigational items updated July 1, 2023: Coding updated August 16, 2023: Reviewed by MPAC, investigationa items updated, effective November 1, 2023 September 20, 2023: Reviewed by MPAC, investigational items updated, November 16, 2023: Reviewed by MPAC, investigational items updated/removed/added, effective December 1, 2023 December 13, 2023: Investigational items updated BACKGROUND, PRODUCT AND DISCLAIMER INFORMATION Medical Necessity Guidelines are developed to determine coverage for benefits and are published to provide a better understanding of the basis upon which coverage decisions are made. We make coverage decisions using these guidelines, along with the Member’s benefit document, and in coordination with the Member’s physician(s) on a case-by-case basis considering the individual Member's health care needs. Medical Necessity Guidelines are developed for selected therapeutic or diagnostic services found to be safe and proven effective in a limited, defined population of patients or clinical circumstances. They include concise clinical coverage criteria based on current literature review, consultation with practicing physicians in our service area who are medical experts in the particular field, FDA and other government agency policies, and standards adopted by national accreditation organizations. We revise and update Medical Necessity Guidelines annually, or more frequently if new evidence becomes available that suggests needed revisions. For self-insured plans, coverage may vary depending on the terms of the benefit document. If a discrepancy exists between a Medical Necessity Guideline and a self-insured Member’s benefit document, the provisions of the benefit document will govern. For Tufts Health Together (Medicaid), coverage may be available beyond these guidelines for pediatric members under age 21 under the Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefits of the plan in accordance with 130 CMR 450.140 and 130 CMR 447.000, and with prior authorization. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this guideline is not a guarantee of payment or a final prediction of how specific claim(s) will be adjudicated. Claims payment is subject to eligibility and benefits on the date of service, coordination of benefits, referral/authorization, utilization management guidelines when applicable, and adherence to plan policies, plan procedures, and claims editing logic. 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