intro":"","nodes":["{\"operator\":\"any\",\"children\":[{\"text\":\"Meibomian Gland Evaluation and Evacuation (CPT 0207T) — Policy decision: Not medically necessary / Unproven. Rationale: Automated meibomian gland evacuation devices using heat and intermittent pressure have limited high-quality evidence demonstrating symptomatic or objective benefit over conventional therapies; clinical trials are small, heterogeneous, and lack long-term outcomes.\"},{\"text\":\"Automated / Mobile Audiometry (CPT 0208T–0212T series) — Policy decision: Not medically necessary / Unproven. Rationale: Pure tone and speech audiometry performed using automated or mobile/tablet/smartphone platforms have insufficient evidence of comparable accuracy and reliability to standard audiology testing in typical clinical contexts; concerns include variability in testing environments, calibration, and limited validation in diverse populations.\"},{\"text\":\"Computer-Aided Detection (CAD) for Chest Radiography (CPT 0174T/0175T) — Informational evidence summary: CAD tools for chest x‑ray interpretation are classified as unproven due to inconsistent evidence of improved diagnostic outcomes; they should not be considered standard of care absent validated benefit.\"},{\"text\":\"Transluminal Peripheral Atherectomy (CPT 02341/02351/02361/0237T) — Policy decision: Unproven for renal, visceral, abdominal aorta, and brachiocephalic arteries. Rationale: Clinical evidence is limited regarding efficacy and safety compared with alternative revascularization strategies; there is insufficient data on long-term vessel patency and clinical outcomes.\"},{\"text\":\"PreTRM Proteomic Test (CPT 0247U / IBP4/SHBG) — Policy decision: Unproven. Rationale: Serum-based IBP4/SHBG proteomic biomarker testing for predicting spontaneous preterm birth lacks adequate evidence that test results improve clinical management or perinatal outcomes; prospective outcome studies are insufficient.\"},{\"text\":\"Baroreflex Activation Therapy (BAT) including Carotid Sinus Devices (CPT 0266T–0273T series) — Policy decision: Unproven. Rationale: Implantable carotid sinus baroreflex activation systems (e.g., Barostim Neo, MobiusHD) for heart failure or resistant hypertension have mixed results and limited long-term randomized data demonstrating morbidity or mortality benefit; evidence insufficient for routine coverage outside clinical trials.\"},{\"text\":\"Tear Film Imaging (CPT 03301) — Policy decision: Unproven. Rationale: Tear film imaging modalities have not demonstrated consistent correlation with clinically meaningful outcomes or that imaging-guided therapies improve symptoms versus standard assessment.\"},{\"text\":\"Myocardial Sympathetic Innervation Imaging (CPT 0331T/0332T) with 123I‑MIBG — Policy decision: Unproven. Rationale: Although imaging of myocardial sympathetic innervation shows pathophysiologic correlations, current evidence does not establish that routine use improves clinical decision-making or outcomes for broad populations; further validation required.\"},{\"text\":\"Automated Visual Evoked Potentials (CPT 0333T) — Policy decision: Unproven. Rationale: Automated VEP screening for visual acuity lacks sufficient evidence of diagnostic accuracy, reproducibility, and impact on clinical outcomes to support coverage.\"},{\"text\":\"Sinus Tarsi Implant / Subtalar Arthroereisis (CPT 0335T; HCPCS S2117; CPT 0510T/0511T) — Policy decision: Unproven / Not medically necessary. Rationale: Devices and implants for sinus tarsi/subtalar arthroereisis have inconsistent outcome data and uncertain long-term benefits; complication and revision rates raise concerns.\"},{\"text\":\"Renal Sympathetic Denervation (RDN) — Transcatheter / Percutaneous (CPT 0339T series, 03391) — Policy decision: Unproven. Rationale: Evidence for RDN in hypertension and other indications remains mixed; although some trials show BP reduction, overall evidence is insufficient to establish sustained clinical benefit across populations, and practice recommendations remain cautious.\"},{\"text\":\"Radiostereometric Analysis (RSA) (CPT 0347T, 03491) — Policy decision: Unproven. Rationale: Implantation or radiologic assessment for RSA is investigational for routine clinical use due to limited evidence that RSA-guided management improves patient outcomes.\"},{\"text\":\"Bioelectrical Impedance Analysis (BIA) (CPT 03581) — Policy decision: Unproven. Rationale: Whole body composition assessment using BIA lacks consistent evidence linking use to improved clinical outcomes or management decisions in general practice.\"},{\"text\":\"Electronic Brachytherapy (EBT) / High Dose Rate EBT (includes CPT series for skin and interstitial) — Policy decision: Unproven. Rationale: For certain skin and surface applications, the evidence is limited or mixed regarding equivalence to standard HDR brachytherapy or external beam approaches; clinical outcomes and long-term data are insufficient.\"},{\"text\":\"Confocal Laser Endomicroscopy / Optical Endomicroscopy (ERCP with optical endomicroscopy CPT 0397T) — Policy decision: Unproven. Rationale: CLE/optical endomicroscopy is investigational for routine biliary/pancreatic indications given limited prospective outcome data showing improved management or outcomes.\"},{\"text\":\"Cardiac Contractility Modulation (CCM) / Optimizer Smart System (CPT 0408T–0417T series) — Policy decision: Unproven. Rationale: Implantable CCM systems have mixed trial results; evidence insufficient to define populations with clear net clinical benefit and to support routine coverage outside defined study settings.\"},{\"text\":\"Percutaneous Cryoneurolysis / iovera System — Policy decision: Unproven for many indications (knee OA, adjunct to TKA, occipital neuralgia, phantom limb pain). Rationale: While some studies report symptom relief, overall evidence is heterogeneous and limited in size/duration; long-term effectiveness and comparative benefit remain unclear.\"},{\"text\":\"Drug-Eluting Ocular Inserts — Policy decision: Unproven. Rationale: Insertable ocular drug-eluting devices lack sufficient evidence of improved outcomes or safety compared with standard topical/systemic therapies.\"},{\"text\":\"OCT of Middle Ear — Policy decision: Unproven. Rationale: Optical coherence tomography applications in the middle ear are investigational with limited clinical validation showing impact on management.\"},{\"text\":\"Heterochromatic Flicker Photometry for MPOD (macular pigment optical density) / ARMD screening — Policy decision: Unproven. Rationale: Measurement techniques for MPOD have not demonstrated clear linkage to improved ARMD outcomes or treatment decisions.\"},{\"text\":\"Near-Infrared Meibomian Imaging (e.g., LipiScan) — Policy decision: Unproven. Rationale: Imaging of meibomian glands via near-infrared modalities has insufficient evidence that imaging-guided therapy improves symptoms or outcomes.\"},{\"text\":\"Wireless Cardiac Resynchronization Therapy (Wireless CRT) — Policy decision: Unproven. Rationale: Wireless LV endocardial pacing systems have limited long-term outcome data and safety profile evidence compared with established CRT approaches.\"},{\"text\":\"Intracardiac Ischemia Monitoring (e.g., Guardian/AngelMed) — Policy decision: Unproven. Rationale: Implantable intracardiac ischemia monitors have uncertain impact on clinical outcomes and broader applicability is not established.\"},{\"text\":\"Three-Dimensional (3D) Printed Anatomic Models and Guides — Policy decision: Unproven for routine clinical use. Rationale: While useful for planning/education, evidence that 3D printed models consistently improve surgical outcomes or change management to a degree that justifies routine coverage is limited and context-dependent.\"},{\"text\":\"Substernal (Extravascular) ICD Procedures — Policy decision: Unproven. Rationale: Novel substernal/extravascular ICD implantation techniques require more evidence to confirm safety and effectiveness versus standard transvenous or subcutaneous systems.\"},{\"text\":\"Cryoablation / Thermal Ablation of Breast Lesions — Policy decision: Unproven. Rationale: Percutaneous cryoablation for certain breast lesions lacks sufficient comparative evidence to establish equivalence to surgical excision for oncologic control in general practice.\"},{\"text\":\"In-office Tympanostomy with Iontophoresis (Tula System) — Policy decision: Unproven. Rationale: Office-based tympanostomy tube placement using iontophoresis systems has limited high-quality evidence demonstrating improved outcomes or safety compared with standard approaches under anesthesia.\"},{\"text\":\"ReDS / RF Lung Fluid Measurement and Wearable Systems — Policy decision: Unproven. Rationale: Remote lung fluid measurement technologies and wearable ReDS systems have emerging but inconclusive evidence for management impact and outcome improvements in heart failure care.\"},{\"text\":\"EyeBOX / Eye-movement analysis without spatial calibration — Policy decision: Unproven. Rationale: Eye-movement–based concussion or vision screening tools lack sufficient prospective validation demonstrating improved clinical outcomes.\"},{\"text\":\"Hyperspectral Imaging (HSI) and Near-Infrared Spectroscopy (NIRS) for tissue oxygenation — Policy decision: Unproven. Rationale: HSI and noncontact NIR modalities measuring oxy-/deoxyhemoglobin have limited prospective evidence that they alter management or improve outcomes across indications.\"},{\"text\":\"Nevisense (EIS) for melanoma detection — Policy decision: Unproven. Rationale: Electrical impedance spectroscopy for melanoma screening has not demonstrated adequate diagnostic accuracy and outcome benefit to support routine use.\"},{\"text\":\"SSO2 Therapy (Transcatheter intracoronary supersaturated oxygen) — Policy decision: Unproven. Rationale: The supersonic oxygen infusion approach requires more evidence of clinical outcome benefit after myocardial infarction beyond current data.\"},{\"text\":\"Uterus Transplantation (UTx) for AUFI — Policy decision: Unproven. Rationale: UTx is highly experimental with limited long-term outcomes, complex resource needs, and ethical considerations; not established as standard coverage.\"},{\"text\":\"RF and Energy-Based Vaginal Therapies for SUI and Genitourinary Indications — Policy decision: Unproven. Rationale: Evidence for radiofrequency/energy-based devices for stress urinary incontinence and related indications is limited and inconsistent.\"},{\"text\":\"Ultrafiltration (Aquapheresis) for Fluid Overload/Heart Failure — Policy decision: Unproven. Rationale: Therapeutic ultrafiltration has mixed trial results and unclear net benefit versus medical therapy; evidence insufficient for routine coverage.\"},{\"text\":\"IORT (Intraoperative Radiation Therapy) — Policy decision: Unproven in select indications. Rationale: While IORT has specific applications, evidence varies by indication and approach; some uses remain investigational in this policy context.\"},{\"text\":\"RFA for Joint Pain — Policy decision: Unproven for certain joint pain indications. Rationale: Evidence varies by joint and technique; some applications lack robust trial data supporting durable benefit.\"},{\"text\":\"Kinesio Taping — Policy decision: Not medically necessary / Unproven. Rationale: Clinical trials do not consistently show clinically meaningful benefit of kinesio taping beyond placebo or standard care.\"},{\"text\":\"MRgFUS Intracranial (MRI-guided focused ultrasound thalamotomy) — Policy decision: Unproven / clinical evidence referenced. Rationale: Although some clinical data exist, long-term comparative effectiveness and safety data are evolving; coverage stance reflects current evidence.\"},{\"text\":\"Additional technologies noted as unproven in this policy part: therapeutic drug monitoring for biologics in IBD (specific assays), MBDA testing, antiphospholipid antibody subpanels (e.g., aPS/PT), spirometry in children under 3, robotic exoskeletons for ambulation, non-invasive bimodal neuromodulation for tinnitus, wrist‑worn neuromodulation (Cala Trio), FEUCs, 3D printed cranial implants, MyoPro powered orthosis, hair analysis — all considered investigational/unproven absent specific supporting evidence.\"]}]}"