Noncovered Investigational Services(Eff. beginning 1.1.24) Form

Procedure is not covered

Effective Date

Last Reviewed

11/16/2023

Original Document

Harvard Pilgrim tT TUFTS HealthCare Health Plan

Medical Necessity Guidelines:
Noncovered Investigational Services
Effective January 1, 2024*

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

If REQUIRED, concurrent review may apply. Yes O No X

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:

Published formal technology assessments and/or high quality meta analyses
Well-designed randomized studies published in credible, peer-reviewed literature
High quality case-control or cohort studies
Historical control studies, or case reports and/or case series
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 companies

2122376Noncovered 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 Prosthetic - C466Replacement of the Ocular Surface Ecosystem (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 prior personal 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 provideresults to a team of expertsComplement 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 Miraca Genetics 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 ofStroke 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 apatient 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 devACT 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 whenperformed
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.

for primary diagnosis of ASD, to aid in the evaluation of syndromic orFactor 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 LLCcomplex ASD, to aid in the evaluation of idiopathic ASD)

Genetic testing for:

Factor V Leiden in Women with Unexplained Recurrent Pregnancy loss
Familial Hemiplegic Migraine (FHM)
Family Members of Individuals with Brugada Syndrome
FGFR-Related Craniosynostosis
Fragile X-Associated Primary Ovarian Insufficiency
Individuals Clinically Diagnosed with Brugada Syndrome
Inflammatory Bowel Disease
Ki67 (MK167) Proliferation Marker Testing in DCIS and Breast Cancer
Narcolepsy
Alzheimer’s Disease (Athena Labs)
Friedreich Ataxia (FRDA) for Movement Disorders
Melanoma, CDKN2A (various manufacturers including Myriad)
Patients with or Suspected of Congenital and/or Prelingual Nonsyndromic Hearing Loss (e.g., OtoSCOPE®)

Noncovered Investigational Services 5

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
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:
o NESS H200; NESS L300; NESS L300 Plus
o Bionicare Knee System
o WalkAide
o Odstock Dropped Foot Stimulator (ODFS) Pace
HPA-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 Hospital 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 evaluation of 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 TherapySystem
Osseointegrated 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)
PGxOne™ Plus (Admera Health)
Pharmacogenetic testing for single-gene variants in the CYP2D6, CYP3A4, CYP3A5, ABCB1, and UGT2B7 genes for general opioid 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.,

Noncovered Investigational Services 9

Single anastomosis duodenal switch

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.

Noncovered Investigational Services 10

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)
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)

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

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.

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."

Procedure Code Description Exclusion Category Origination Date Last Review Date

0001U *“Authorization review for HPHC and THPPs | is managed by Carelon Medical Benefits Management__| Red blood cell antigen typing, DNA, human erythrocyte antigen gene analysis of 35 antigens from 11 blood groups, utilizing whole blood, common RBC alleles reported (PreciseType® HEA Test) Investigational February 1, 2017 November 16, 2023
0002U Oncology (colorectal), quantitative assessment of three urine metabolites (ascorbic acid, succinic acid and carnitine) by liquid chromatography with tandem mass spectrometry (LC- MS/MS) using multiple reaction monitoring acquisition, algorithm reported as likelihood of adenomatous polyps (PolypDX™) Investigational February 1, 2017 September 20, 2023

Noncovered Investigational Services 11

Procedure Code Description Exclusion Category Origination Date Last Review Date
0008U Helicobacter pylori detection and antibiotic resistance, DNA, 16S and 23S rRNA, gyrA, pbp1, rdxA and rpoB, next generation sequencing, formalin- fixed paraffin embedded or fresh tissue, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline and rifabutin (AmHPR Helicobacter pylori Antibiotic Resistance Next Generation Sequencing Panel, American Molecular Laboratories, Inc.) Investigational August 1, 2017 September 20, 2023

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 risk0112U Investigational October 1, 2019 September 20, 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 Molecular0120U **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 ManagementHereditary pan cancer (eg, hereditary breast and ovarian cancer, hereditary endometrial cancer, hereditary colorectal cancer), targeted mRNA sequence analysis panel (18 genes) (List separately in addition to code for primary procedure) (+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) (List separately in addition to code for primary procedure) (+RNAinsight™ for GYNPlus®, Ambry Genetics)Investigational

Procedure Code Description Exclusion Category Origination Date Last Review Date

Noncovered Investigational Services

Removal of intraocular foreign body from anterior segment, magnetic or nonmagnetic extraction, performed at the same session by the same physician as the cataract removal (List separately in addition to code for primary procedure).

Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed.

Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber, including defibrillation threshold evaluation, induction of arrhythmia, evaluation of sensing for arrhythmia termination, and programming or reprogramming of sensing or therapeutic parameters, when performed.

Removal and replacement of subcutaneous implantable cardioverter-defibrillator pulse generator only.

Electronic analysis with reprogramming of implanted subcutaneous continuous cardiac rhythm monitor system, including review and report by a physician or other qualified health care professional.

Intracranial neurostimulator pulse generator or receiver replacement.

Removal of intracranial neurostimulator pulse generator or receiver.

Interrogation device evaluation (in person) with analysis, review and report, includes connection, recording and disconnection per patient encounter; intracranial neurostimulator pulse generator or receiver system.

Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with anlysis, including review and report, intracranial neurostimulator pulse generator or receiver system.

Wound closure utilizing adhesive strips as sole repair material (including debridement when performed).

Tissue glue wound closure (List separately in addition to code for primary procedure).

Closure of postlaminectomy pseudoarthrosis, posterior spine, requiring instrumentation (eg, pedicle fixation, transfacet, translaminar screw fixation); lumbar.

Destruction by chemical injection (eg, hypertonic saline, phenol, ethanol): major peripheral nerve or branch: trigeminal nerve.

Ultraviolet B light therapy; initial consultation, diagnosis, treatment prescription and development, and phototest.

Continuous hemoperfusion for the removal of toxins, first 2 hours.

Extracorporeal selective catalytic reduction of low-density lipoprotein cholesterol via heparin-induced extracorporeal low-density lipoprotein precipitation (LDL apheresis) or equivalent selective DRG.

Subsequent hours (List separately in addition to code for primary procedure)

Application of blood product antimicrobial suspension (platelet rich plasma or similar product) using negative pressure wound therapy, per session; total wound(s) surface area less than or equal to 100 square centimeters.

Total wound(s) surface area greater than 100 square centimeters (List separately in addition to code for primary procedure).

Note:

'...' represents that text has been truncated due to extensive length. Text provided above is not exhaustive and is a selection from the available list of Noncovered Investigational Services.

Noncovered Investigational Services

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.

Noncovered Investigational Services 64

NanoKnife device Investigational
Glomerular filtration rate (GFR) measurement(s), transdermal, including sensor placement and administration of a single dose of fluorescent pyrazine agent Investigational 0603T
Glomerular filtration rate (GFR) monitoring, transdermal, including sensor placement and administration of more than one dose of fluorescent pyrazine agent, each 24 hours Investigational 0604T
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 0605T
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 0605T
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 0606T
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 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; analysis of data received and transmission of reports to the physician or other qualified health care professional Investigational 0608T
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 0609T

Noncovered Investigational Services

NanoKnife device Investigational January 1, 2017 September 20, 2023

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")

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}

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)
each additional noncoronary vessel (List separately in addition to code for primary procedure) Investigational January 1, 2016 February 15, 2023
37252InvestigationalJanuary 1, 2016February 15, 2023
37253InvestigationalJanuary 1, 2016February 15, 2023

Noncovered Investigational Services 85

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
37790	Penile venous occlusive procedure	Investigational	November 20, 2006	October 18, 2023
41512	Tongue base suspension, permanent suture technique	Investigational	October 1, 2014	February 15, 2023
41530	Submucosal ablation of the tongue base, radiofrequency, one or more sites, per session	Investigational	January 1, 2006	September 20, 2023
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
43284	Laparoscopy, surgical, esophageal sphincter augmentation procedure, placement of sphincter augmentation device (ie, magnetic band), including cruroplasty when performed, (e.g., Linx Reflux Management System)	Investigational	January 1, 2017	September 20, 2023
43285	Removal of esophageal sphincter augmentation device, (e.g., Linx Reflux Management System)	Investigational	January 1, 2017	September 20, 2023
43648	Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum	Investigational	January 1, 2007	September 20, 2023
44705 53451	Preparation of fecal microbiota for instillation, including assessment of donor specimen Periurethral transperineal adjustable	Investigational EXCEPT when billed with any of the following ICD-10 diagnosis code(s): A04.71, A04.72 Investigational	January 1, 2013 January 1, 2022	September 20, 2023 October 18, 2023
	balloon continence device; bilateral insertion, including cystourethroscopy and imaging guidance (ProAct (Uromedica))

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
(e.g., hypertonic saline, enzyme) or mechanical means (e.g., catheter) including radiologic localization (includes contrast when administered), multiple adhesiolysis sessions; 1 day
Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method utilizing needle based technique to remove disc material under fluoroscopic imaging or other form of indirect visualization, with the use of an endoscope, with discography and/or epidural injection(s) at the treated level(s), when performed, single or multiple levels, lumbarInvestigational
62287InvestigationalApril 25, 2007September 20, 2023

Noncovered Investigational Services 87

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
62290	Injection procedure for discography, each level; lumbar	Investigational	April 1, 2018	November 16, 2023
62291	Injection procedure for discography, each level; cervical or thoracic	Investigational	April 1, 2018	November 16, 2023
64405	Injection(s), anesthetic agent(s) and/or steroid, greater occipital nerve	\| Investigational when billed with the following ICD-10 diagnosis code(s): G43.701, G43.709, G43.711, G43.719	April 1, 2020	August 16, 2023
64505	Injection, anesthetic agent; sphenopalatine ganglion	Investigational	October 1, 2019	August 16, 2023

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
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

Investigational when billed with at least two of these additional codes CPT Code(s): 28035, 64708, 64712, 64722. Investigational when billed with at least two of these additional CPT Code(s): 28035, 64704, 64712, 64722. Investigational when billed with at least two of these additional CPT Code(s): 28035, 64704, 64708, 64722. Investigational when billed with at least two of these additional codes: CPT Code(s): 28035, 64704, 64708, 64712.

Keratoplasty (corneal transplant); lamellar
Implantation of intrastromal corneal ring segments
Transluminal dilation of aqueous outflow canal (eg, canaloplasty); without retention of device or stent
Transluminal dilation of aqueous outflow canal (eg, canaloplasty); with retention of device or stent
Aqueous shunt to extraocular

Investigational.
January 1, 2007
January 1, 2016
January 1, 2008
January 1, 2008
April 19, 2023
April 19, 2023
April 19, 2023
April 19, 2023

66179 - Investigational - January 1, 2015 - April 19, 2023
66184 - Investigational - January 1, 2015 - April 19, 2023

Noncovered Investigational Services 88

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
67221	Destruction of localized lesion of choroid (e.g., choroidal neovascularization); photodynamic therapy (includes intravenous therapy)	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
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 coronary 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) other imaging	Investigational	January 1, 2022	September 20, 2023

Noncovered Investigational Services 89

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
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 pollypeptide [Gpiba)) (eg, neonatal alloimmune thrombocytopenia [NAIT}, post- transfusion pupura), 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 (cytochchrome 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
81285 *Authorization review for HPHC and THPPs is managed by Carelon Medical	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.
81289 **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.

Noncovered Investigational Services 90

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
81291 *“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
81306 + 7 .

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
*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 *6)	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 (eg, 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-fluoroouracil/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 81418	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
	Drug metabolism (eg, pharmacogenomics) genomic sequence analysis panel, must include testing of at least 6 genes, including CYP2C19, CYP2D6, and CYP2D6 duplication/deletion analysis	Investigational	January 1, 2023	October 18, 2023

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
81535	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; first single drug or drug combination, (ChemoFx, Helomics)	Investigational	January 1, 2016	November 16, 2023
81536	Oncology (gynecologic), live tumor cell culture and chemotherapeutic response by DAPI stain and morphology, predictive algorithm reported as a drug response score; each additional single drug or drug combination (List separately in addition to code for primary procedure), (ChemoFx, Helomics)	Investigational	January 1, 2016	November 16, 2023
81538	Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival, (VeriStrat, Biodesix, Inc.)	Covered with prior authorization for RITogether only	January 1, 2016	May 1, 2023
81539	Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability score (e.g., OPKO 4Kscore® Blood Test)	Covered with prior authorization for RITogether only	July 23, 2015	October 18, 2023
81542	Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score	Investigational	December 18, 2019	November 16, 2023
81551	Oncology (prostate), promoter methylation profiling by real-time PCR of 3 genes (GSTP1, APC, RASSF1), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a likelihood of prostate cancer detection on repeat biopsy (ConfirmMDx® for Prostate Cancer, MDxHealth Inc.)	Investigational	January 1, 2018	October 18, 2023
81554	Pulmonary disease (idiopathic pulmonary fibrosis [IPF]), mRNA, gene expression analysis of 190 genes, utilizing transbronchial biopsies, diagnostic algorithm reported as categorical result (eg, positive or negative for high probability of usual interstitial pneumonia [UIP])	Investigational	January 1, 2021	September 20, 2023

81560 Transplantation medicine (allograft rejection, pediatric liver and small bowel), measurement of donor and third-party-induced CD154+T-cytotoxic memory cells, utilizing whole peripheral blood, algorithm reported as a rejection risk score (Pleximmune test) Investigational January 1, 2022 September 20, 2023

81596 Infectious disease, chronic hepatitis C virus (HCV) infection, six biochemical assays (ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, and haptoglobin) utilizing serum, Investigational January 1, 2019 September 20, 2023

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
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 performed, urine	Investigational	October 6, 2015	November 16, 2023
86152	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)	Investigational	January 1, 2013	November 16, 2023
86153	Cell enumeration using immunologic selection and identification 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, motor threshold determination, delivery and management	Covered with PA for \| ICD-10 diagnosis code(s): F32.2, F33.2. All other diagnoses considered investigational.	January 1, 2013	August 16, 2023
90868	Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent delivery and management, per session	Covered with PA for ICD-10 diagnosis code(s): F32.2, F33.2. All other diagnoses considered investigational.	January 1, 2013	August 16, 2023

Covered with PA for ICD-10 diagnosis code(s): F32.2, F33.2. All other diagnoses considered investigational.

Investigational; Covered when billed with ICD-10 diagnosis code(s):

90869 Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management January 1, 2013 August 16, 2023
91065 Breath hydrogen or methane test (e.g., for detection of lactase deficiency, fructose intolerance, bacterial overgrowth, or oro-cecal gastrointestinal transit) April 1, 2014 September 20, 2023

Noncovered Investigational Services 95

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
K90.49, K90.89	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

Description: overgrowth, or oro-cecal gastrointestinal transit Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report Gastrointestinal tract imaging, intraluminal (eg, capsule endoscopy), colon, with interpretation and report (Pillcam 2 [medtronic]). Corneal hysteresis determination, by air impulse stimulation, unilateral or bilateral, with interpretation and report. ...

Note: '...' represents truncated text due to extensive length. Text provided above is not exhaustive and is a selection from the available list of Noncovered Investigational Services.

Neuromuscular Electrical Stimulator and Related Supplies

A4560	Neuromuscular electrical stimulator	Investigational	April 1, 2023	September 20, 2023
A4575	(NMES), disposable, replacement only Topical hyperbaric oxygen chamber,	Investigational	December 27, 2010	October 18, 2023
A4596	disposable Cranial electrotherapy stimulation (CES) system supplies and	Investigational	October 1, 2022	August 16, 2023
A6000	accessories, per month Non-contact wound warming wound	Investigational	November 20, 2006	October 18, 2023

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

C1062	Intravertebral body fracture augmentation with implant (e.g., metal, polymer)	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

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
C9751	Bronchoscopy, rigid or flexible, transbronchial ablation of lesion(s) by microwave energy, including fluoroscopic guidance, when performed, with computed tomography acquisition(s) and 3-D rendering, computer-assisted, image-guided navigation, and endobronchial ultrasound (EBUS) guided	Investigational	January 1, 2019	September 20, 2023

Description pressure sensor with delivery catheter, including all system components (e.g., CardioMEMS 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

Bronchoscopy, rigid or flexible, transbronchial ablation of lesion(s) by microwave energy, including fluoroscopic guidance, when performed, with computed tomography acquisition(s) and 3-D rendering, computer-assisted, image-guided navigation, and endobronchial ultrasound (EBUS) guided transtracheal and/or transbronchial sampling (e.g., aspiration[s]/biopsy[ies]) and all mediastinal and/or hilar lymph node stations or structures and therapeutic intervention(s)

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 C9755

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 C9757

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 C9758

Transcatheter intraoperative blood vessel microinfusion(s) (e.g., intraluminal, vascular wall and/or perivascular) therapy, any vessel, including radiological supervision and interpretation, when performed Investigational C9759

Nonrandomized, nonblinded procedure for NYHA Class II, III, 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 C9760

Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed Investigational C9764

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 Investigational C9765

Noncovered Investigational Services 103

Procedure Code
Description
Exclusion Category
Origination Date
Last Review Date

Vitrectomy, mechanical, pars plana approach, with subretinal injection of pharmacologic/biologic agent Investigational C9767

Nasal/sinus endoscopy, cryoablation nasal tissue(s) and/or nerve(s), unilateral or bilateral Investigational c9771

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 Investigational C9782

procedure 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 Gastric restrictive procedure, esophagogastroduodenoscopy and intraluminal tube insertion, if performed, including all system and tissue anchoring components Endoscopic outlet reduction, gastric pouch application, with and endoscopy intraluminal tube insertion, if performed, including all system and tissue anchoring components Echocardiography image post processing for computer aided detection of heart failure with preserved ejection fraction, including interpretation and report Gastric electrophysiology mapping with simultaneous patient symptom profiling Investigational C9784

Noncovered Investigational Services 104

Water circulating cold pad with pump Infrared heating pad system Non-contact wound warming device (temperature control unit, AC adapter and power cord) for use with warming card and wound cover Warming card for use with the non- contact wound warming device and non-contact wound warming wound cover Pump for water circulating pad Topical oxygen delivery system, not otherwise specified, includes all supplies Home ventilator, any type, used with noninvasive interface, (e.g., mask, chest shell) Investigational E0218 E0221 E0231

Noncovered Investigational Services 105

Percussor, electric or pneumatic, home model, (The Frequencer™) Investigational E0480
Intrapulmonary percussive ventilation system and related accessories Investigational E0481
Power source and control electronics unit for oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, controlled by hardware remote Investigational £0490
Oral device/appliance for neuromuscular electrical stimulation of the tongue muscle, used in conjunction with the power source and control electronics unit, controlled by hardware remote, 90-day supply Investigational E0491
Nonpneumatic sequential compression garment, trunk Investigational E0677
Upper extremity medical tubing/lines enclosure or covering device, restricts elbow range of motion Investigational E0711
Non-implanted pelvic floor electrical stimulator, complete system Investigational £0740

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
E0744	Neuromuscular stimulator for scoliosis	Together products only Investigational. applicable to Tufts Health Plan Together and Rhode Island	January 1, 2019	September 20, 2023
E0745	Neuromuscular stimulator, electronic shock unit	Together products only Investigational. applicable to Tufts Health Plan Together and Rhode Island Together products only	January 1, 2019	September 20, 2023
E0746	Electromyography (EMG), biofeedback device	Investigational. applicable to Tufts Health Plan Together and Rhode Island Together products only	January 1, 2019	September 20, 2023
E0749	Osteogenesis stimulator, electrical, surgically implanted	Investigational. applicable to Tufts Health Plan Together and Rhode Island Together products only	January 1, 2019	November 16, 2023
E0755	Electronic salivary reflex stimulator (intraoral/noninvasive)	Investigational. applicable to Tufts Health Plan Together and Rhode Island Together products only	January 1, 2019	September 20, 2023
E0761	Nonthermal pulsed high frequency radiowaves, high peak power electromagnetic energy treatment device	Investigational.	January 1, 2019	October 18, 2023
E0762	Transcutaneous electrical joint stimulation device system, includes all accessories	Investigational.	January 1, 2019	September 20, 2023
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. 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
E0770	Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified	Investigational.	January 1, 2019	October 18, 2023

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,	January 1, 2017	September 20, 2023
E1701	Replacement cushions for jaw motion rehabilitation system	ICD-10 code: R25.2 Investigational EXCEPT when billed with trismus diagnosis,	January 1, 2017	September 20, 2023
E1702	Replacement measuring scales for jaw motion rehabilitation system	ICD-10 code: R25.2 Investigational EXCEPT when billed with trismus diagnosis,	January 1, 2017	September 20, 2023
E1800	Dynamic adjustable elbow extension/flexion device, includes soft interface material	ICD-10 code: R25.2 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
E1810	Dynamic adjustable knee extension/flexion device, includes soft interface material	Investigational	February 1, 2022	September 20, 2023
E1812	Dynamic knee, extension/flexion device with active resistance control	Investigational	February 1, 2022	September 20, 2023
E1815	Dynamic adjustable ankle 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 Dynamic adjustable shoulder flexion/abduction/rotation device, includes soft interface material Virtual reality cognitive behavioral therapy device (CBT), including preprogrammed therapy software Investigational E1820 September 20, 2023 February 1, 2022 Investigational Investigational September 20, 2023 February 1, 2022 E1830 Investigational Investigational Investigational E1840 February 1, 2022 September 20, 2023 E1905 Investigational Investigational April 1, 2023 September 20, 2023

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
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
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
G0465	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)	Investigational	January 1, 2022	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 Injection, Aducanumab-AVWA, 2 MG Riboflavin 5'-phosphate, ophthalmic solution, up to 3 mL G2000 Investigational January 1, 2019 August 16, 2023 J0172 J2787 Investigational Investigational EXCEPT when billed with any of the following ICD-10 diagnosis codes: January 1, 2022 January 1, 2019 January 1, 2022 April 19, 2023

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
J7313	Injection, fluocinolone acetonide, intravitreal implant, 0.01 mg	Investigational EXCEPT when submitted with diabetic macular edema diagnosis.

Refer to MNG: ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) for Treatment of Diabetic Macular Edema.

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
J7313	Injection, fluocinolone acetonide, intravitreal implant, 0.01 mg	Investigational EXCEPT when submitted with diabetic macular edema diagnosis.	June 19, 2019	April 19, 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
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

K1028
K1029

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
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** “Will deny investigational when submitted for IDEO and ExoSym Energy Storing AFO and other exoskeletal devices	IDEO and ExoSym Energy Storing AFO	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** *Will deny investigational when submitted for IDEO and ExoSym Energy Storing AFO and other exoskeletal devices	IDEO and ExoSym Energy Storing AFO	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
L8605	Injectable bulking agent, dextranomer/hyaluronic acid copolymer implant, anal canal, 1 ml, includes shipping and necessary supplies, e.g., SOLESTA® (hyaluronicacid/dextranomer)	Investigational	November 28, 2012	September 20, 2023

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 I20.8-I20.9:

L8687 - Implantable neurostimulator pulse generator, rechargeable, dual array, includes extension
L8688 - Implantable neurostimulator pulse generator, non-rechargeable, dual array, includes extension
L8698 - Miscellaneous component, supply or accessory for use with total artificial heart system
L8701 - Powered upper extremity range of motion assist device, includes microprocessor, sensors, all components and accessories, custom fabricated
L8702 - Powered extremity range of motion assist device, elbow, wrist, hand with single or double upright(s), includes microprocessor, sensors, all components and accessories

cm	Investigational	January 1, 2019	October 18, 2023
Q4195	PuraPly, per sq cm	Investigational	January 1, 2019	October 18, 2023
Q4196	PuraPly AM, per sq cm	Investigational	January 1, 2019	October 18, 2023
Q4197	PuraPly XT, per sq cm	Investigational	January 1, 2019	October 18, 2023
Q4198	Genesis Amniotic Membrane, per sq cm	Investigational	January 1, 2019	October 18, 2023
Q4199	Cygnus matrix, per sq cm	Investigational	January 1, 2022	October 18, 2023
Q4200	SkinTE, per sq cm	Investigational	January 1, 2019	October 18, 2023
Q4201	Matrion, per sq

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
Q4208	Novafix, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4209	SurGraft, per sq cm	Investigational	October 1, 2019	October 18, 2023

Description AmnioPro, BioSkin, BioRenew, WoundEx, Amniogen-45, Amniogen-200, per sq cm Helicoll, per sq cm Keramatrix, per sq cm Cytal, per square centimeter Truskin, per square centimeter Artacent wound, per square centimeter Cygnus, per square centimeter Interfyl, 1 mg Palingen or palingen xplus, per square centimeter Palingen or promatrx, 0.36 mg per 0.25 cc Miroderm, per square centimeter NeoPatch, per sq cm FlowerAmnioFlo, 0.1 cc FlowerAmnioPatch, per sq cm FlowerDerm, per sq cm Revita, per sq cm Amnio Wound, per sq cm Surgigraft, per sq cm Cellesta, per sq cm Cellesta Flowable Amnion (25 mg per cc); per 0.5 cc AmnioArmor, per sq cm Artacent AC, 1 mg Artacent AC, per sq cm Restorigin, per sq cm Restorigin, 1 cc Coll-e-Derm, per sq cm Novachor, per sq cm PuraPly, per sq cm PuraPly AM, per sq cm PuraPly XT, per sq cm Genesis Amniotic Membrane, per sq cm Cygnus matrix, per sq cm SkinTE, per sq cm Matrion, per sq cm Keroxx (2.5 g/cc), 1 cc Derma-Gide, per sq cm XWRAP, per sq cm Membrane Graft or Membrane Wrap, per sq cm Fluid Flow or Fluid GF, 1 cc Novafix, per sq cm SurGraft, per sq cm Axolotl Graft or Axolotl DualGraft, per sq cm Amnion Bio or AxoBioMembrane, per sq cm AlloGen, per cc Ascent, 0.5 mg Cellesta Cord, per sq cm Axolotl Ambient or Axolotl Cryo, 0.1 mg Artacent Cord, per sq cmQ4206 Q4208 Q4209 Q4210Investigational Investigational Investigational InvestigationalOctober 1, 2019 October 1, 2019 October 1, 2019 October 1, 2019October 18, 2023 October 18, 2023 October 18, 2023 October 18, 2023InvestigationalQ4211InvestigationalOctober 1, 2019October 18, 2023Q4212 Q4213 Q4214 Q4215Investigational Investigational Investigational InvestigationalOctober 1, 2019 October 1, 2019 October 1, 2019 October 1, 2019October 18, 2023 October 18, 2023 October 18, 2023 October 18, 2023Q4216InvestigationalInvestigationalOctober 1, 2019October 18, 2023

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
Q4217	WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound Xplus, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4218	SurgiCORD, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4219	SurgiGRAFT-DUAL, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4220	BellaCell HD or Surederm, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4221	Amnio Wrap2, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4222	ProgenaMatrix, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4224	Human Health Factor 10 Amniotic Patch (HHF10-P), per sq cm	Investigational	April 1, 2022	October 18, 2023
Q4225	AmnioBind, per sq cm	Investigational	April 1, 2022	October 18, 2023
Q4226	MyOwn Skin, includes harvesting and preparation procedures, per sq cm	Investigational	October 1, 2019	October 18, 2023
Q4227	AmnioCoreTM, per sq cm	Investigational	July 1, 2020	October 18, 2023
Q4229	Cogenex Amniotic Membrane, per sq cm	Investigational	July 1, 2020	October 18, 2023
Q4230	Flowable 0.5 cc		2020	October 2023
	Cogenex Amnion, per	Investigational	July 1,	18,
Q4231	Corplex P, per cc	Investigational	July 1, 2020	October 18, 2023
Q4232	Corplex, per sq.

Q4233 SurFactor or NuDyn, per 0.5 cc Investigational
Q4234 XCellerate, per sq cm Investigational
Q4235 AMNIOREPAIR or AltiPly, per sq cm Investigational
Q4237 Cryo-Cord, per sq cm Investigational
Q4238 Derm-Maxx, per sq cm Investigational
Q4239 Amnio-Maxx or Amnio-Maxx Lite, per sq cm Investigational
Q4240 CoreCyte, for topical use only, per 0.5 cc Investigational
Q4241 PolyCyte, for topical use only, per 0.5 cc Investigational
Q4242 AmnioCyte Plus, per 0.5 cc Investigational
Q4244 Procenta, per 200 mg Investigational
Q4245 AmnioText, per cc Investigational
Q4246 CoreText or ProText, per cc Investigational
Q4247 Amniotext patch, per sq cm Investigational
Q4248 Dermacyte Amniotic Membrane Allograft, per sq cm Investigational
Q4249 AMNIPLY, for topical use only, per sq cm Investigational
Q4250 AmnioAmp-MP, per sq cm Investigational
Q4251 Vim, per sq cm Investigational
Q4252 Vendaje, per sq cm Investigational
Q4253 Zenith Amniotic Membrane, per sq cm Investigational
Q4254 Novafix DL, per sq cm Investigational
Q4255 REGUaRD, for topical use only, per sq cm Investigational
Q4256 MLG-Complete, per sq cm Investigational
Q4257 Relese, per sq. cm Investigational

Description:

WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound Xplus, per sq cm
SurgiCORD, per sq cm
SurgiGRAFT-DUAL, per sq cm
BellaCell HD or Surederm, per sq cm
Amnio Wrap2, per sq cm
ProgenaMatrix, per sq cm
Human Health Factor 10 Amniotic Patch (HHF10-P), per sq cm
AmnioBind, per sq cm
MyOwn Skin, includes harvesting and preparation procedures, per sq cm
AmnioCoreTM, per sq cm
Cogenex Amniotic Membrane, per sq cm
Cogenex Flowable Amnion, per 0.5 cc
Corplex P, per cc
Corplex, per sq cm
SurFactor or NuDyn, per 0.5 cc
XCellerate, per sq cm
AMNIOREPAIR or AltiPly, per sq cm
Cryo-Cord, per sq cm
Derm-Maxx, per sq cm
Amnio-Maxx or Amnio-Maxx Lite, per sq cm
CoreCyte, for topical use only, per 0.5 cc
PolyCyte, for topical use only, per 0.5 cc
AmnioCyte Plus, per 0.5 cc
Procenta, per 200 mg
AmnioText, per cc
CoreText or ProText, per cc
Amniotext patch, per sq cm
Dermacyte Amniotic Membrane Allograft, per sq cm
AMNIPLY, for topical use only, per sq cm
AmnioAmp-MP, per sq cm
Vim, per sq cm
Vendaje, per sq cm
Zenith Amniotic Membrane, per sq cm
Novafix DL, per sq cm
REGUaRD, for topical use only, per sq cm
MLG-Complete, per sq cm
Relese, per sq cm
Enverse, per sq cm
TAG, per sq cm
Dual Layer Impax Membrane, per sq cm
SurGraft TL, per sq cm
Cocoon Membrane, per sq cm
NeoStim TL, per sq cm
NeoStim Membrane, per sq cm
NeoStim DL, per sq cm
SurGraft FT, per sq cm
SurGraft XT, per sq cm

Procedure Code	Description	Exclusion Category	Origination Date
Q4256	Investigational	April 1, 2022	October 18, 2023
Q4257	Investigational	April 1, 2022	October 18, 2023
Q4258	Investigational	April 1, 2022	October 18, 2023
Q4261	Investigational	July 1, 2022	October 18, 2023
Q4262	Investigational	January 1, 2023	October 18, 2023
Q4263	Investigational	January 1, 2023	October 18, 2023
Q4264	Investigational	April 1, 2023	October 18, 2023
Q4265	Investigational	April 1, 2023	October 18, 2023
Q4266	Investigational	April 1, 2023	October 18, 2023
Q4267	Investigational	April 1, 2023	October 18, 2023
Q4268	Investigational	April 1, 2023	October 18, 2023
Q4269	Investigational	April 1, 2023	October 18, 2023

Noncovered Investigational Services 115

Procedure Code	Description	Exclusion Category	Origination Date	Last Review Date
Q4270	Complete SL, per sq cm	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 AC, per sqcm	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 sqcm	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	Investigational	July 1, 2023	October 18, 2023
Q4281	Barrera SL or Barrera DL, per sq cm	Investigational	July 1, 2023	October 18, 2023
Q4282	Cygnus Dual, per sq cm	Investigational	July 1, 2023	October 18, 2023
Q4283	Biovance Tri-Layer or Biovance 3L, per sq cm	Investigational	July 1, 2023	October 18, 2023
Q4284	DermaBind SL, per sq cm	Investigational	July 1, 2023	October 18, 2023
Q4285	NuDYN DL or NuDYN DL MESH, per sq cm	Investigational	October 1, 2023	October 1, 2023
Q4286	NuDYN SL or NuDYN SLW, per sq cm	Investigational	October 1, 2023	October 1, 2023

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.

Update History

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
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
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
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
May 17, 2023: Reviewed by MPAC, investigational items update/removed
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, investigational items updated, effective November 1, 2023
September 20, 2023: Reviewed by MPAC, investigational items updated,
October 18, 2023: Reviewed by MPAC, investigational items updated/added or removed. Point32Health integrated policy, effective January 1, 2024
November 16, 2023: Reviewed by MPAC, investigational items updated/removed/added, effective December 1, 2023
December 13, 2023: Investigational items updated

Noncovered Investigational Services 118

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

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.

GenHealth is the best way to run RCM including eligibility, prior auth, billing, and denials with AI that works like a teammate in your EMR and billing systems.

Noncovered Investigational Services(Eff. beginning 1.1.24) Form

Procedure is not covered

Harvard Pilgrim tT TUFTS HealthCare Health Plan

Applies to:

Public Plans Products

Senior Products

According to the The Plan Evidence of Coverage (EOC),

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

Policy and Coverage Criteria:

Point32Health companies

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

Genetic testing for:

Noncovered Investigational Services 5

Noncovered Investigational Services 6

Noncovered Investigational Services 9

Noncovered Investigational Services 10

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

For Tufts Health Public Plan and Harvard Pilgrim Commercial Members

Noncovered Investigational Services

Note:

Noncovered Investigational Services

Noncovered Investigational Services 64

Noncovered Investigational Services

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

Intravascular ultrasound (noncoronary vessel) during diagnostic evaluation and/or therapeutic intervention, including radiological supervision and interpretation;

Noncovered Investigational Services 85

Percutaneous lysis of epidural adhesions using solution injection

Noncovered Investigational Services 87

Investigational; Covered when billed with ICD-10 diagnosis code(s):

Noncovered Investigational Services 95

Neuromuscular Electrical Stimulator and Related Supplies

Noncovered Investigational Services 103

Noncovered Investigational Services 104

Noncovered Investigational Services 105

Refer to MNG: ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) for Treatment of Diabetic Macular Edema.

Background, Product and Disclaimer Information

Update History

Noncovered Investigational Services 118

Noncovered Investigational Services 119

Choose how you'd like to learn more.

Try GenHealth free.

Automate intake, eligibility, and PA with AI agents that work in your EMR and billing systems.