Spatial Frequency Domain Imaging (SFDI)
Covered when ALL of the following are met:
ALL of the following
Spatial Frequency Domain Imaging (SFDI) is considered investigational/unproven for clinical use including measurement of tissue oxygenation (StO2), oxyhemoglobin (ctHbO2), deoxyhemoglobin (ctHbR), and dermal hemoglobin concentrations (ctHb1, ctHb2).
Corresponds to CPT 0061U; Conclusion = Unproven
Transcatheter placement of extracranial vertebral artery stent(s)
Covered when ALL of the following are met:
ALL of the following
Transcatheter placement of extracranial vertebral artery stent(s) (CPT 0075T/0076T) is considered investigational/unproven due to insufficient evidence of clinical benefit compared with medical therapy or other revascularization strategies.
Conclusion = Unproven
Retinal prosthetic devices (e.g., Argus II)
Covered when ALL of the following are met:
ALL of the following
Retinal prosthetic devices (e.g., Argus II Retinal Prosthesis System; CPT 0100T) are considered investigational/unproven for routine coverage; evidence does not establish consistent meaningful visual function improvement for broadly generalizable populations.
Conclusion = Unproven
Biomarker panel algorithmic CRC screening (e.g., BeScreened™-CRC)
Covered when ALL of the following are met:
ALL of the following
Biomarker panel algorithmic colorectal cancer screening tests (e.g., BeScreened™-CRC; CPT 0163U) using multi-analyte ELISA with proprietary algorithmic reporting are considered investigational/unproven for CRC screening due to insufficient validation and lack of demonstrated clinical utility compared with established screening modalities.
Conclusion = Unproven
Computer-aided detection (CAD) of chest radiographs
Covered when ALL of the following are met:
ALL of the following
Computer-aided detection (CAD) for chest radiographs (CPT 0174T, 0175T) is considered investigational/unproven for routine coverage; available evidence is insufficient to demonstrate improved patient-important outcomes when CAD/AI is used as an adjunct to or substitute for physician interpretation.
Conclusion = Unproven
Computer-Aided Detection (CAD)/AI for Chest Radiographs — evidence summary
Evidence summary — used to inform the coverage conclusion above:
ALL of the following
Evidence points: Studies demonstrate that some CAD/AI algorithms can detect findings (e.g., pulmonary nodules, consolidation) with sensitivity comparable to radiologists in controlled settings but with variable false-positive rates.
Clinical impact: Randomized trials and pragmatic studies have not consistently shown improved patient outcomes (e.g., earlier diagnosis, reduced morbidity) when CAD/AI is deployed for chest radiograph interpretation.
Operational concerns: Heterogeneity of algorithms, training data, and intended use (triage vs concurrent read vs second read) limits generalizability; many systems lack sufficient prospective, clinician-blinded validation in representative clinical populations.
Eyelid Thermal Pulsation (e.g., LipiFlow) and Automated Thermal Evacuation
Covered when ALL of the following are met:
ALL of the following
Eyelid thermal pulsation/automated thermal evacuation (e.g., LipiFlow; CPT 0207T) is considered investigational/unproven due to limited high‑quality evidence demonstrating durable symptomatic or objective improvement over standard therapies for meibomian gland dysfunction and dry eye disease.
Conclusion = Unproven
Guideline/evidence bullets: Randomized trials show short-term symptomatic benefits for some patients, but long-term effectiveness, optimal patient selection, and comparative effectiveness against established therapies remain uncertain.
Automated / Self-Administered Audiometry
Covered when ALL of the following are met:
ALL of the following
Automated or self‑administered pure tone and speech audiometry (CPT 0208T–0212T, 0212T combined) is considered investigational/unproven for routine diagnostic replacement of standard audiology testing due to insufficient evidence demonstrating equivalent diagnostic accuracy and clinical outcomes across intended populations and settings.
Conclusion = Unproven
Mobile / Automated Audiometry — evidence summary and clinical interpretation
Evidence summary and clinical interpretation:
ALL of the following
Evidence points: Mobile and automated audiometry can approximate pure-tone thresholds in adults under controlled conditions; pediatric and high‑noise settings show greater variability.
Clinical interpretation: Automated results may be useful for screening or monitoring but should not fully replace comprehensive diagnostic audiometry when clinical management depends on precise thresholds or middle ear assessment.
Transluminal peripheral atherectomy of visceral/renal/abdominal/brachiocephalic arteries
Covered when ALL of the following are met:
ALL of the following
Transluminal peripheral atherectomy of visceral, renal, abdominal, or brachiocephalic arteries (CPT 0234T–0237T) is considered investigational/unproven; current evidence does not demonstrate consistent benefit and safety compared with alternative endovascular or medical therapies.
Conclusion = Unproven
PreTRM® serum proteomic biomarker test for predicting spontaneous preterm birth
Covered when ALL of the following are met:
ALL of the following
PreTRM® proteomic biomarker test for spontaneous preterm birth (CPT 0247U) is considered investigational/unproven for routine clinical use; evidence is insufficient to demonstrate improved clinical outcomes or effective management strategies based on test results.
Conclusion = Unproven
Carotid sinus baroreflex activation device (BAT)
Covered when ALL of the following are met:
ALL of the following
Carotid sinus baroreflex activation devices (Baroreflex Activation Therapy, BAT; CPT 0266T–0273T) are considered investigational/unproven for routine coverage for heart failure or hypertension; available trials show mixed results and insufficient long‑term outcome data.
Conclusion = Unproven
Baroreflex Activation Therapy (BAT) — Evidence Summary
Baroreflex Activation Therapy (BAT) — evidence summary:
ALL of the following
Evidence points: Trials demonstrate improvements in some functional endpoints for selected patients, but meta-analyses and guideline statements note limited evidence for mortality or durable major clinical outcome benefits.
Tear Film Imaging (CPT 0330T) Coverage Position
Covered when ALL of the following are met:
ALL of the following
Tear film imaging (CPT 0330T) — measurement or imaging of tear film and related metrics — is considered investigational/unproven for routine clinical use due to limited evidence linking imaging findings to improved patient management or outcomes.
Conclusion = Unproven
Myocardial Sympathetic Innervation Imaging (CPT 0331T, 0332T) Coverage Position
Covered when ALL of the following are met:
ALL of the following
Myocardial sympathetic innervation imaging using I‑123 MIBG (CPT 0331T/0332T) including planar and SPECT assessment is considered investigational/unproven for routine coverage; prognostic associations exist but clinical management changes based on testing have not been shown to improve outcomes sufficiently to warrant routine coverage.
Conclusion = Unproven
Planar 123I-MIBG myocardial scintigraphy (ADMIRE‑HF findings)
Findings from ADMIRE-HF and similar studies have been used to define prognostic thresholds; the policy stance remains unproven for routine clinical decision-making:
ALL of the following
Planar 123I‑MIBG ADMIRE‑HF findings: Heart-to-mediastinum (H/M) ratio thresholds (lower H/M associated with worse prognosis) and delayed H/M and washout rate have prognostic associations but are not established as actionable triggers that improve patient outcomes when used to guide therapy.
CPT 0331T/0332T; Conclusion = Unproven
Automated Visual Evoked Potential (VEP) for visual acuity screening
Covered when ALL of the following are met:
ALL of the following
Automated visual evoked potential (VEP) for screening of visual acuity (CPT 0333T) is considered investigational/unproven for routine screening due to insufficient evidence of diagnostic accuracy and demonstrated impact on clinical outcomes versus standard vision screening methods.
Conclusion = Unproven
Sinus tarsi implant / Subtalar arthroereisis
Covered when ALL of the following are met:
ALL of the following
Sinus tarsi implant / subtalar arthroereisis (CPT 0335T) is considered investigational/unproven for routine coverage for correction of flexible flatfoot or related indications given limited high‑quality comparative evidence of long‑term benefit and safety.
Conclusion = Unproven
Transcatheter renal sympathetic denervation (RDN) — coverage conclusion
Covered when ALL of the following are met:
ALL of the following
Transcatheter renal sympathetic denervation (RDN; CPT 0338T/0339T) is considered investigational/unproven for treatment of hypertension in routine practice; evidence from randomized trials and regulatory context does not support broad coverage at this time.
Conclusion = Unproven
RDN clinical evidence / trial summaries and regulatory context
RDN — clinical evidence / regulatory context:
ALL of the following
Evidence points: Early trials were inconsistent; subsequent device- and technique‑specific trials report variable results. Key limitations include patient selection, sham control use, and durability of effect.
Radiostereometric analysis (RSA) coverage position
Covered when ALL of the following are met:
ALL of the following
Radiostereometric analysis (RSA) placement and imaging (CPT 0347T–0350T) is considered investigational/unproven for routine clinical use; primarily a research tool for implant migration and micromotion assessment, lacking evidence of improving standard patient outcomes.
Conclusion = Unproven
Bioelectrical impedance analysis (BIA) coverage position and accuracy
Covered when ALL of the following are met:
ALL of the following
Bioelectrical impedance analysis (BIA / CPT 0358T) and bioelectrical impedance vector analysis (BIVA) are considered investigational/unproven for clinical decision-making regarding body composition in routine practice due to concerns about accuracy, variability with hydration and technical factors, and limited evidence linking results to improved management/outcomes.
Conclusion = Unproven
Electronic Brachytherapy (High Dose Rate) Coverage Determination
Covered when ALL of the following are met:
ALL of the following
Electronic high‑dose‑rate brachytherapy (HDR) devices (CPT 0394T, 0395T) for skin or interstitial applications are considered investigational/unproven; current evidence does not establish equivalent or superior outcomes versus standard radiation techniques in routine practice.
Conclusion = Unproven
Confocal Laser Endomicroscopy / Optical Endomicroscopy (CLE / pCLE) Coverage Determination
Covered when ALL of the following are met:
ALL of the following
Confocal laser endomicroscopy / optical endomicroscopy (CLE / pCLE; CPT 0397T when used with ERCP or endoscopy) is considered investigational/unproven for routine diagnostic use; evidence is insufficient that CLE-guided management improves patient outcomes over standard endoscopic evaluation and biopsy strategies.
Conclusion = Unproven
Cardiac Contractility Modulation (CCM) - Coverage Conclusion
Covered when ALL of the following are met:
ALL of the following
Cardiac contractility modulation (CCM; CPT 0408T–0412T etc.) is considered investigational/unproven for routine coverage; although some trials show symptomatic or functional improvements, evidence for mortality or long‑term clinically meaningful outcomes is inadequate for broad coverage.
Conclusion = Unproven
Percutaneous cryoablation / cryoneurolysis (including iovera) - Coverage Conclusion
Covered when ALL of the following are met:
ALL of the following
Percutaneous cryoablation / cryoneurolysis including devices such as iovera for knee osteoarthritis or other pain conditions is considered investigational/unproven for many indications; evidence is mixed and long‑term benefit and comparative effectiveness versus established therapies remain uncertain.
Conclusion = Unproven
iovera system: Specific evidence summary indicates some short-term pain relief in limited studies for knee OA and postoperative pain, but overall evidence base is insufficient to support routine coverage across indications.
Drug‑eluting ocular inserts (CPT 0444T/0445T)
Covered when ALL of the following are met:
ALL of the following
Drug‑eluting ocular inserts (CPT 0444T, 0445T) are considered investigational/unproven for routine coverage pending robust clinical trials demonstrating safety and treatment benefit compared with standard topical/intraocular therapies.
Conclusion = Unproven
OCT for middle ear (CPT 0485T/0486T)
Covered when ALL of the following are met:
ALL of the following
Optical coherence tomography (OCT) for middle ear disorders (CPT 0485T/0486T; OCT otoscope devices) is considered investigational/unproven for routine clinical use; evidence linking OCT middle ear imaging to improved management or outcomes is insufficient.
Conclusion = Unproven
Heterochromatic flicker photometry (MPOD) and Near‑infrared dual imaging of meibomian glands (CPT 0506T/0507T)
Covered when ALL of the following are met:
ALL of the following
Heterochromatic flicker photometry for macular pigment optical density (MPOD; CPT 0506T) and near‑infrared dual imaging of meibomian glands (CPT 0507T) are considered investigational/unproven for routine diagnostic or prognostic use in AMD assessment and meibomian gland evaluation, respectively, due to insufficient evidence of impact on management and outcomes.
Conclusion = Unproven
Wireless cardiac stimulator / WiSE CRT and related CPT codes (0515T-0522T)
Covered when ALL of the following are met:
ALL of the following
Wireless cardiac stimulator insertion/removal CPT Category III codes (0515T–0522T excerpt) and wireless LV endocardial CRT (WiSE CRT) remain investigational/unproven for routine coverage; although WiSE CRT has FDA PMA for select patients, overall evidence is limited and policy stance is that clinical benefit is not yet sufficiently established for broad coverage.
Conclusion = Unproven; note: FDA PMA for device does not by itself establish broad coverage
Intracardiac ischemia monitoring systems coverage position
Covered when ALL of the following are met:
ALL of the following
Intracardiac ischemia monitoring systems are considered investigational/unproven for routine coverage; available evidence does not demonstrate that their use leads to improved clinical outcomes or that device-guided management strategies are standardized and beneficial.
Conclusion = Unproven
Oncology quantitative ELISA biomarker panels (coverage position)
Covered when ALL of the following are met:
ALL of the following
Oncology quantitative ELISA protein biomarker panels (e.g., CPT 0558U/0559U-type assays) for tumor detection or management are considered investigational/unproven unless specific analytic and clinical validation demonstrating improved patient outcomes is provided.
Conclusion = Unproven
3D‑printed anatomic models (coverage position)
Covered when ALL of the following are met:
ALL of the following
3D‑printed anatomic models and related 3D printing applications are considered investigational/unproven for routine coverage unless used as an intraoperative aid meeting institutional policies and supported by evidence demonstrating additive clinical benefit; many uses remain experimental.
Conclusion = Unproven
Substernal/Extravascular ICD procedures
Covered when ALL of the following are met:
ALL of the following
Substernal/extravascular ICD procedures are considered investigational/unproven for routine coverage given limited evidence of long‑term safety and comparative effectiveness versus standard transvenous or subcutaneous ICD systems.
Conclusion = Unproven
Cryoablation for breast carcinoma and fibroadenoma
Covered when ALL of the following are met:
ALL of the following
Cryoablation for breast carcinoma and fibroadenoma is considered investigational/unproven for routine coverage; evidence is insufficient to support equivalence or superiority to standard surgical management for malignant and benign breast lesions.
Conclusion = Unproven
Procedures Considered Unproven / Not Medically Necessary (selected list)
Not Medically Necessary / Unproven — the following procedures and technologies are considered investigational or not medically necessary in this part unless otherwise specified:
ANY of the following
Irreversible electroporation (IRE) for liver/renal tumors (Edison/HistoSonics) — investigational; evidence limited.
Remote Dielectric Sensing (ReDS) / wearable radiofrequency pulmonary fluid monitoring — investigational; clinical outcome benefit unproven.
HFAMS / µCor Patch remote pulmonary fluid monitoring — investigational; insufficient evidence.
Eye‑movement analysis without spatial calibration (Eye‑Sync, EyeBOX) — investigational for concussion/structural brain injury assessment.