CurrentColorado Rocky Mountain Health PlansPolicy 2026T0535XXX

Omnibus/Unproven CPT/HCPCS Codes (Radiology/Diagnostic Imaging and related services)

Lists numerous CPT/HCPCS codes with payer conclusions of 'Unproven' and summarizes coverage stance for multiple diagnostic and procedure codes; applies to UnitedHealthcare Commercial and Individual Exchange benefit plans (partial document).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmnibus/Unproven CPT/HCPCS Codes (Radiology/Diagnostic Imaging and related services)

Policy CodePolicy 2026T0535XXX

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionDocument services with the specific listed code and supply clinical justification when requesting prior authorization, as unproven-designated codes are at high risk for denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

manyCodes = Unproven

~100+Omnibus codes listed

1Policy identifier present

2Benefit plan populations named

1320Registry patients (BASILAR/PERSIST)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage determinations and rationale

Ocular insert coverage considerations

Placement of drug‑eluting ocular inserts under the eyelid(s) (CPT 0444T, 0445T) is considered unproven and not medically necessary. Coverage decisions are based on available randomized controlled trials, small phase II studies, and guideline statements which do not yet support routine clinical use for glaucoma or ocular hypertension. The following criteria summarize the clinical rationale and evidence limitations.

The published randomized and controlled trials are small and underpowered to establish long‑term efficacy or safety: Brandt et al. (2016) randomized 130 participants and showed intraocular pressure (IOP) reductions with a bimatoprost insert over 6 months that were similar to timolol at several time points but the study was underpowered for non‑inferiority across all time points.

A phase II randomized trial (Rubião et al., 2021) with a very small sample size (n~29) comparing a chitosan‑based bimatoprost insert to topical bimatoprost demonstrated similar short‑term IOP reductions over three weeks but was limited by sample size and short follow‑up.

Longer term outcomes important to glaucoma management (visual field preservation, progression rates, adherence benefits translating into clinical benefit) are not established in the current literature; retention rates and device tolerability beyond 6–12 months are incompletely characterized.

Guideline context: major ophthalmology practice guidelines (AAO Preferred Practice Patterns) do not currently endorse ocular inserts as standard therapy and do not include insert devices in routine treatment algorithms for primary open‑angle glaucoma or ocular hypertension.

Potential advantages (improved adherence, consistent drug delivery) remain theoretical without confirmatory evidence showing improved patient‑centered outcomes; safety signals in existing studies were consistent with known prostaglandin analogue effects but long‑term device‑related complications (insert migration, local irritation, infection) require further study.

Operational note: when billing for investigational use or clinical trials, ensure appropriate prior authorization and documentation of trial enrollment and informed consent in the medical record.

Code tables and coding details

Omnibus / Listed Codes (sample)HCPCSNot Covered

0061U

Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]), using spatial frequency domain imaging (SFDI) and multi-spectral analysis

Omnibus Codes (continued)CPTNot Covered

0174T	Computer-aided detection (CAD) with physician review, chest radiograph(s), concurrent with primary interpretation
0175T	Computer-aided detection (CAD) with physician review, chest radiograph(s), performed remote from primary interpretation

RSA and related Omnibus CodesCPTNot Covered

0348T	Radiologic examination, radiostereometric analysis (RSA); spine
0349T	Radiologic examination, radiostereometric analysis (RSA); upper extremity(ies)
0350T	Radiologic examination, radiostereometric analysis (RSA); lower extremity(ies)

Omnibus Codes (Listed)mixedNot Covered

0664T	Donor hysterectomy (including cold preservation); open, from cadaver donor
0665T	Donor hysterectomy (including cold preservation); open, from living donor
0666T	Donor hysterectomy (including cold preservation); laparoscopic or robotic, from living donor
0667T	Recipient uterus allograft transplantation from cadaver or living donor
0668T	Backbench standard preparation of cadaver or living donor uterine allograft prior to transplantation
0669T	Backbench reconstruction...venous anastomosis, each
0670T	Backbench reconstruction...arterial anastomosis, each
0672T	Endovaginal cryogen-cooled, monopolar radiofrequency remodeling for urinary incontinence
0686T	Histotripsy of malignant hepatocellular tissue, including image guidance
0692T	Therapeutic ultrafiltration

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SFDI technologyCPTNot Covered

0061U

Transcutaneous measurement of five biomarkers using SFDI and multi-spectral analysis

Retinal prosthesis procedure and supply codesmixed

0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy.
0472T	Device evaluation, interrogation, and initial programming of intraocular retinal electrode array (e.g., retinal prosthesis), in person, with iterative adjustment... including visual training, with review and report.
0473T	Device evaluation and interrogation of intraocular retinal electrode array (e.g., retinal prosthesis), in person, including reprogramming and visual training, with review and report.
L8608	Miscellaneous external component, supply or accessory for use with the Argus II Retinal Prosthesis System

Biomarker panel test codeCPTNot Covered

0163U

Oncology (colorectal) screening, biochemical enzyme-linked immunosorbent assay (ELISA) of 3 plasma or serum proteins ... reported as likelihood of CRC or advanced adenomas

Biomarker panel CRC screening (example)HCPCSNot Covered

0163U

Oncology (colorectal) screening, biochemical ELISA of 3 plasma or serum proteins with demographic data, proprietary algorithm, reported as likelihood of CRC or advanced adenomas

CAD for chest radiographCPTNot Covered

0174T	Computer-aided detection (CAD) with physician review, chest radiograph(s), concurrent with primary interpretation
0175T	Computer-aided detection (CAD) with physician review, chest radiograph(s), performed remote from primary interpretation

Eyelid thermal pulsation / wearable heat devicesCPTNot Covered

0207T	Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral
0563T	Evacuation of meibomian glands, using heat delivered through wearable, open-eye eyelid treatment devices and manual gland expression, bilateral

Automated audiometry CPT/temporary codes listed in this sectionCPT

0208T	Pure tone audiometry (threshold), automated; air only.
0209T	Pure tone audiometry (threshold), automated; air and bone.
0210T	Speech audiometry threshold, automated.
0211T	Speech audiometry threshold, automated; with speech recognition.
0212T	Comprehensive audiometry threshold evaluation and speech recognition (0209T, 0211T combined), automated

Peripheral atherectomy (Category III) — unprovenCPTNot Covered

0234T	Transluminal peripheral atherectomy... renal artery.
0235T	Transluminal peripheral atherectomy... visceral artery (except renal), each vessel.
0236T	Transluminal peripheral atherectomy... abdominal aorta.
0237T	Transluminal peripheral atherectomy... brachiocephalic trunk and branches, each vessel.

PreTRM proteomic test codesCPT | HCPCSNot Covered

0247U	Obstetrics (preterm birth), insulin-like growth factor-binding protein 4 (IBP4), sex hormone-binding globulin (SHBG), quantitative measurement by LC-MS/MS... reported as predictive-risk stratification for spontaneous preterm birth.
81599	Unlisted multianalyte assay with algorithmic analysis (when used to report PreTRM)

Tear film imagingCPTNot Covered

0330T

Tear film imaging, unilateral or bilateral, with interpretation and report

Tear film imaging CPT‑like codesHCPCS

0330T

Tear film imaging, unilateral or bilateral, with interpretation and report

123I‑MIBG imaging CPT‑like codesHCPCS

0331T	Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment
0332T	Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment; with tomographic SPECT

Not Covered / Unproven Procedures (VEP)CPTNot Covered

0333T

Visual evoked potential, screening of visual acuity, automated, with report

Not Covered / Unproven Procedures (Sinus tarsi implant / Arthroereisis)CPT|HCPCSNot Covered

0335T	Insertion of sinus tarsi implant
0510T	Removal of sinus tarsi implant
0511T	Removal and reinsertion of sinus tarsi implant
S2117	Arthroereisis, subtalar

RDN CPT Category IIICPT

0338T	Transcatheter renal sympathetic denervation...; unilateral.
0339T	Transcatheter renal sympathetic denervation...; bilateral.

Reported CPT/Category III and related codesCPT

0347T	Placement of interstitial device(s) in bone for radiostereometric analysis (RSA).
0348T	Radiologic examination, radiostereometric analysis (RSA); spine
0349T	Radiologic examination, radiostereometric analysis (RSA); upper extremity(ies)
0350T	Radiologic examination, radiostereometric analysis (RSA); lower extremity(ies)
0358T	Bioelectrical impedance analysis whole body composition assessment, with interpretation and report.

Listed CPT/Category III codes mentionedCPT

0358T	Bioelectrical impedance analysis whole body composition assessment, with interpretation and report
0395T	High dose rate electronic brachytherapy, interstitial or intracavitary treatment, per fraction, includes basic dosimetry, when performed

Optical endomicroscopy CPT/interpretation codesCPT

0397T	Endoscopic retrograde cholangiopancreatography (ERCP), with optical endomicroscopy (List separately in addition to code for primary procedure)
43206	Esophagoscopy, flexible, transoral; with optical endomicroscopy
43252	Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy
88375	Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session

CCM and related codesCPT/HCPCS

0408T	Insertion or replacement of permanent cardiac contractility modulation system; pulse generator with transvenous electrodes
0409T	Insertion or replacement of permanent cardiac contractility modulation system; pulse generator only
0410T	Insertion or replacement of permanent cardiac contractility modulation system; atrial electrode only
0411T	Insertion or replacement of permanent cardiac contractility modulation system; ventricular electrode only
0412T	Removal of permanent cardiac contractility modulation system; pulse generator only
0413T	Removal of permanent cardiac contractility modulation system; transvenous electrode (atrial or ventricular)
0414T	Removal and replacement of permanent cardiac contractility modulation system pulse generator only
0415T	Repositioning of previously implanted cardiac contractility modulation transvenous electrode (atrial or ventricular lead)
0416T	Relocation of skin pocket for implanted cardiac contractility modulation pulse generator
0417T	Programming device evaluation (in person) with iterative adjustment; implantable cardiac contractility modulation system

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Percutaneous cryoablation/cryoneurolysis codesCPT

0440T	Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal/peripheral nerve
0441T	Ablation, percutaneous, cryoablation, includes imaging guidance; lower extremity distal/peripheral nerve
0442T	Ablation, percutaneous, cryoablation, includes imaging guidance; nerve plexus or other truncal nerve

Drug-eluting ocular insert CPT II/T codes (listed)CPTNot Covered

0444T	Initial placement of a drug-eluting ocular insert under one or more eyelids, including fitting, training, and insertion, unilateral or bilateral.
0445T	Subsequent placement of a drug-eluting ocular insert under one or more eyelids, including re-training, and removal of existing insert, unilateral or bilateral.

Middle ear OCT procedure codesCPTNot Covered

0485T	Optical coherence tomography (OCT) of middle ear, with interpretation and report; unilateral.
0486T	Optical coherence tomography (OCT) of middle ear, with interpretation and report; bilateral.

Unproven / Not Medically Necessary — HFPCPTNot Covered

0506T

Macular pigment optical density measurement by heterochromatic flicker photometry, unilateral or bilateral, with interpretation and report

Unproven / Not Medically Necessary — Meibography dual imagingCPTNot Covered

0507T

Near-infrared dual imaging (i.e., simultaneous reflective and trans-illuminated light) of meibomian glands, unilateral or bilateral, with interpretation and report

Wireless LV endocardial pacing — listed codesCPT

0515T	Insertion of wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming, and imaging supervision and interpretation, when performed; complete system (includes electrode and generator [transmitter and battery]).
0516T	Insertion of wireless cardiac stimulator for left ventricular pacing; electrode only.
0517T	Insertion of wireless cardiac stimulator for left ventricular pacing; both components of pulse generator (battery and transmitter) only.
0518T	Removal of pulse generator for wireless cardiac stimulator for left ventricular pacing; battery component only.
0519T	Removal and replacement of pulse generator for wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming; both components (battery and transmitter).
0520T	Removal and replacement of pulse generator for wireless cardiac stimulator for left ventricular pacing; battery component only.
0521T	Interrogation device evaluation (in person) with analysis, review and report ... wireless cardiac stimulator for left ventricular pacing.
0522T	Programming device evaluation (in person) with iterative adjustment ... wireless cardiac stimulator for left ventricular pacing.
0861T	Removal of pulse generator for wireless cardiac stimulator for left ventricular pacing; both components (battery and transmitter).
0862T	Relocation of pulse generator for wireless cardiac stimulator for left ventricular pacing, including device interrogation and programming; battery component only.

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inv-107: mRS measurement timepoints

mRS measurement timepoints90 days and 1 year

Prior authorization, documentation, and denial risk guidance

Prior Authorization

Prior authorization, documentation, and denial risk guidance

Many codes and services addressed in this policy are considered unproven or investigational. Providers should expect prior authorization for many of the listed procedures and devices; lack of prior authorization or insufficient documentation may lead to denial.

Unproven / not medically necessary (sample): 0061U (SFDI biomarkers), 0075T/0076T (extracranial vertebral artery stenting), 0100T (subconjunctival retinal prosthesis implantation), 0163U (CRC biomarker panel), 0174T/0175T (CAD chest radiograph), 0207T/0563T (eyelid thermal pulsation procedures), 0333T (automated VEP), 0506T (heterochromatic flicker photometry), 0507T (near-infrared meibomian imaging), 0515T–0522T (wireless LV endocardial CRT codes).
title":"Prior authorization, documentation, and denial risk guidance","type":"callout","variant":"prior_auth"}],

Situations where investigational technologies may be used (research / limited contexts)

Not specified for listed imaging modalities in this excerpt

Per-code indication: Specific clinical indications are not provided in this excerpt; only code descriptions and payer conclusions are listed.

Full policy likely contains indication-specific criteria.

Assessment of superficial tissue oxygenation and microvascular disease risk in the foot (research/adjunctive)

SFDI research/adjunctive use: SFDI has been used to map tissue oxygenation and hemoglobin content and to stratify microvascular disease severity in feet at risk for ulceration; evidence is preliminary and prospective wound-outcome studies are needed before routine clinical use.

Observational studies and ECRI assessment indicate promising technical performance but insufficient outcome data

Prior authorization expectations

Note

Contrast and imaging agent notes

Note

Explicit not medically necessary findings

All services and code combinations identified in this policy excerpt that are labeled Unproven are treated as not medically necessary in the payer's determination and are not covered for routine clinical use.

The policy reiterates that procedures and technologies concluded to be Unproven may be denied when billed, and prior authorization alone will not establish coverage for these services.

Consistent with the document's coverage stance, interventions and diagnostic tests listed as Unproven are excluded from medical necessity coverage and are not routinely covered outside of specified research or trial contexts.

Use of a laboratory, algorithm‑based three‑protein colorectal cancer screening panel (example: BeScreened™, CPT 0163U) is considered Unproven and not medically necessary for CRC screening because evidence is insufficient and USPSTF recommendations do not include serum tests for population screening.

The policy lists several technologies as not covered, including computer‑aided detection (CAD) for chest radiographs (e.g., 0174T/0175T), thermal pulsation and wearable eyelid heat devices for meibomian gland dysfunction (e.g., 0207T/0563T), and blood‑based biomarker panels for colorectal cancer screening (e.g., 0163U), all classified as unproven due to inadequate evidence of benefit.

Tear film imaging to monitor or assess tear film disorders (CPT 0330T and equivalent platforms) is considered unproven and not medically necessary because studies report small sample sizes, device variability, and lack of demonstrated impact on patient outcomes.

Background, definitions and evidence context

Scope: This excerpt summarizes an omnibus set of newly created and existing CPT/HCPCS codes with the payer conclusion of Unproven. It is intended to document coverage conclusions per code and to provide supporting references and evidence summaries; it does not replace full policy text or plan‑specific benefit language. Readers should refer to the full policy and benefit plan documents for authorization, documentation, and exception rules.

inv-188: Definition — Unproven

Unproven — policy definitionServices and listed CPT/HCPCS codes in this policy section are concluded as 'Unproven' by the payer (insufficient evidence of safety/efficacy)

Coverage implicationProcedures/technologies designated 'Unproven' are considered not medically necessary and at risk for denial

ExamplesMultiple codes (e.g., 0061U, 0075T/0076T, 0163U, 0100T) are explicitly labeled Unproven in the coverage summary

inv-189: Definition — SFDI

Key terms and thresholds

inv-246: SFDI (frequency limits placeholder)

SFDI frequency limits placeholderNo specific frequency limits provided for SFDI in this excerpt; device described as non-contact optical imaging of superficial tissues

Use contextSFDI intended as adjunctive assessment in foot microvascular evaluation; frequency of testing not specified

Documentation noteManufacturer states Clarifi® is part of larger assessment battery and not diagnostic alone

inv-188: Unproven definition

Unproven (definition) Policy labels services and listed CPT/HCPCS codes as 'Unproven' when available evidence is insufficient to demonstrate safety and/or efficacy

Coverage consequenceItems concluded 'Unproven' are considered not medically necessary and subject to denial absent strong justification or trial context

Document updates

2026-06-01policy_effectiveLatest

Policy became effective (Policy Number 2026T0535XXX).

codes_listed

Multiple CPT/HCPCS codes (e.g., 0061U, 0075T, 0076T, 0100T, 0163U) were listed in the coverage summary with the payer conclusion 'Unproven'.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOmnibus/Unproven CPT/HCPCS Codes (Radiology/Diagnostic Imaging and related services)

Policy CodePolicy 2026T0535XXX

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionDocument services with the specific listed code and supply clinical justification when requesting prior authorization, as unproven-designated codes are at high risk for denial.

SourceLink

On This Page

Outcome metrics reported

Modified Rankin Scale (mRS) shifts reported at 90 days and 1 year in pooled BASILAR/PERSIST registry analysis

ContextUsed to evaluate functional outcomes after EVT with/without extracranial vertebral artery stenting for PCTL

inv-108: vertebral artery stenosis severity

Vertebral artery stenosis severity threshold50–99% extracranial vertebral artery stenosis

Guideline contextESVS 2023: routine stenting not recommended for vertebrobasilar TIA/stroke; revascularization may be considered for recurrent symptoms despite best medical therapy

Asymptomatic diseaseOpen or endovascular interventions are not recommended for asymptomatic vertebral artery atherosclerotic lesions

inv-109: H/M ratio threshold

H/M ratio prognostic thresholdLate heart/mediastinum (H/M) ratio: < 1.60 vs ≥ 1.60

Associated outcomesH/M <1.60 associated with higher all-cause and cardiac mortality in ADMIRE‑HF follow-up

Use in studiesReported in OPAR and ADMIRE‑HF cohorts as prognostic stratifier across LVEF strata

inv-110: Resistant hypertension definition

Resistant hypertension definitionBlood pressure >130/80 mm Hg despite being on three antihypertensive medications at maximally tolerated doses (classes with outcomes data)

Medication classes referencedExamples include ACE inhibitors/ARBs, calcium channel blockers, thiazide diuretics, beta blockers

Patient selection contextDefinition used in RDN trial and consensus statements to identify candidates for renal denervation

inv-111: coding note

ERCP coding note0397T (ERCP with optical endomicroscopy) is to be listed/reported in addition to the primary ERCP procedure code

Associated codesAlso references esophagoscopy/EGD with optical endomicroscopy (43206, 43252) and interpretation code 88375

Reporting instructionList 0397T separately in addition to the primary procedure per document guidance

inv-112: CCM FDA-approved LVEF range

FDA‑approved LVEF range for CCMLeft ventricular ejection fraction (LVEF) 25% to 45%

Indication contextOptimizer CCM device indicated for NYHA Class III patients on guideline-directed medical therapy (not CRT candidates)

Regulatory referenceBased on FDA premarket approval (P180036) as described in policy

inv-113: FDA-approved NYHA class

FDA‑approved NYHA class for CCMNYHA Class III

Additional device criteriaPatients must be in normal sinus rhythm and not indicated for CRT

Therapy goalsIndicated to improve 6-minute walk distance, quality of life, and functional status

Imaging to support acute EVT and potential extracranial vertebral artery stenting

Imaging to evaluate posterior circulation tandem lesions: Imaging including angiographic CT and angiography is used to evaluate posterior circulation tandem lesions (PCTL) during acute endovascular therapy (EVT); documentation should record recurrent vertebrobasilar symptoms despite best medical therapy, degree/location of extracranial stenosis (50–99%), and imaging findings that informed revascularization decisions.recurrent symptoms + 50-99% extracranial stenosis

Registry analyses suggest potential benefit when stenting is performed during EVT but randomized data are lacking

CAD-assisted chest radiograph interpretation

CAD chest x-ray indication: CAD-assisted chest radiograph interpretation is unproven for routine diagnostic enhancement or screening; if used, clinician review of CAD output and documentation of clinical indication are required, but evidence does not show improved sensitivity or reduced false-positive rates.

Randomized trial (Hwang 2023) showed no improvement with AI-assisted CAD

Eyelid thermal pulsation for MGD

Thermal pulsation indication: Thermal pulsation devices (e.g., LipiFlow, TearCare) may be considered after failure of conservative MGD measures (warm compresses, lid hygiene, medications); evidence shows short-term benefit in many trials but is limited by study quality and uncertainty about long-term durability.documented prior conservative therapy failure

Guideline and systematic review summaries recommend cautious use and further high-quality trials

Audiometry screening/monitoring

Appropriate uses of mobile/automated audiometry: Validated mobile/tablet audiometry may be used to increase access and for monitoring when conventional pure tone audiometry (PTA) is unavailable, but confirmatory testing with standard PTA (including bone conduction/masking as indicated) is recommended for clinical decision-making; documentation should include device used, environment, and comparison to prior PTA when available.

Studies demonstrate many apps yield thresholds within ±10 dB but limitations exist in children, noisy environments, and absence of bone conduction testing

Tear film imaging for dry eye disease evaluation (investigational)

Investigational indications: Tear film imaging technologies (interferometry, meniscometry, topography, OCT) are investigational adjuncts for characterizing dry eye disease parameters but are unproven as sole diagnostic tests; clinicians should rely on conventional slit-lamp biomicroscopy and validated clinical measures when making management decisions.

Device variability and poor inter-device agreement limit interchangeability

123I‑MIBG imaging for prognostic assessment in heart failure (investigational)

Prognostic assessment: 123I‑MIBG planar or SPECT imaging may identify myocardial sympathetic dysfunction and is prognostic for cardiac events using metrics such as late H/M ratio, but routine use to guide management is unproven because trials have not demonstrated improved outcomes from imaging-guided decisions.H/M <1.60 associated with higher risk

OPAR, ADMIRE-HF follow-up and other cohorts show associations but not management benefit

I-123 MIBG planar imaging for prognostic assessment in heart failure

I-123 MIBG indications (evidence context): Planar I-123 MIBG late heart/mediastinum (H/M) ratio correlates with long-term mortality and arrhythmic risk across LVEF strata in cohort studies, but clinical trials demonstrating that imaging alters management to improve outcomes are lacking.H/M thresholds reported (e.g., 1.60)

Documentation of H/M ratio and how results would change management required if submitted for review

Automated VEPs for objective acuity estimation in selected clinical scenarios

VEP potential indications: Automated VEPs may be useful for objective acuity estimation in preverbal children, infants with cerebral visual impairment, or individuals unable to perform behavioral testing, with age-stratified reference data and correlation to other findings; automated VEPs are unproven for routine population screening.age-stratified normative data required

Guidelines do not endorse VEPs for routine screening in typical pediatric populations

Subtalar arthroereisis / sinus tarsi implant for symptomatic flexible pes planus after conservative therapy

Subtalar arthroereisis indications: Consider subtalar arthroereisis for symptomatic flexible pes planus refractory to conservative therapy in selected pediatric or adult patients, recognizing evidence is low quality and complication/implant removal rates can be substantial; not recommended as sole corrective procedure for Stage IIB adult acquired flatfoot.failure of conservative measures documented

Shared decision-making and documentation of alternatives required

RDN performed for resistant or uncontrolled hypertension within trial or approved-device contexts

uRDN/ RDN trial context: Renal denervation may be considered within the context of randomized trials or when using FDA-approved devices in carefully selected patients with resistant or uncontrolled hypertension after optimization of medical therapy and institutional credentialing; evidence shows modest short-term BP reductions but long-term outcome data remain limited.resistant hypertension per trial definitions

Device approvals (Paradise, Symplicity) require institutional oversight and appropriate patient selection

Research use and implant surveillance

Research or specialized surveillance: Radiostereometric analysis (RSA) is principally supported for research, phased introduction of implants, and specialized implant surveillance where high-precision migration data are required; routine clinical use is not supported by current evidence.

Technique requires implanted markers, calibration cages, and specialized imaging/software; marker-free methods are under investigation

Radiostereometric analysis for fracture healing assessment

RSA use: RSA can detect micromotion and early implant migration and may aid research on fracture healing or implant fixation, but broader clinical utility to change patient management is unproven.serial RSA at defined intervals (e.g., baseline, 6 months, 1 year)

Resource- and expertise-intensive; current role mainly research-focused

Electronic brachytherapy for nonmelanoma skin cancer (select superficial lesions)

EBT for select superficial lesions: Electronic brachytherapy may achieve short-term local control in small nonmelanoma skin cancers in limited pilot studies, but long-term comparative and randomized data versus surgical excision (e.g., Mohs) are lacking; routine use outside trials or special circumstances is not supported.

ECRI and AAD recommend caution and further trials; consider in specific patients not eligible for surgery

Indeterminate biliary strictures

pCLE adjunctive use: pCLE may be considered to improve diagnostic sensitivity for indeterminate biliary strictures when conventional ERCP tissue sampling is nondiagnostic and cholangioscopic access is feasible; operator experience and center expertise influence performance.

Meta-analyses report pooled sensitivity ~88-90% for pCLE plus ERCP

Barrett's esophagus surveillance (adjunctive)

Barrett's esophagus surveillance: CLE may be used as an adjunct to high-definition white light endoscopy and Seattle biopsy protocol in expert, high-volume centers to target biopsies, but is not recommended to replace standard surveillance in routine practice.

Guidelines (ASGE/AGA) advise adjunctive use in selected settings; pCLE did not improve detection in a randomized trial when added to HDWL

Gastric lesion evaluation

Gastric cancer evaluation: CLE shows high pooled sensitivity and specificity for gastric lesions in studies from high-volume centers and may increase targeted biopsy yield, but generalizability is limited and further prospective validation is needed before routine adoption.

Most studies originate from Asia; operator learning curve matters

Evaluation of indeterminate biliary strictures

Biliary stricture evaluation: CLE combined with ERCP demonstrates high sensitivity for differentiating benign from malignant indeterminate biliary strictures and may be a useful adjunct in specialized centers when standard sampling is inconclusive.

Meta-analysis reports sensitivity ~88-90%

Surveillance for Barrett's esophagus

BE surveillance guidance: Chromoendoscopy and CLE have shown efficacy in expert centers for BE surveillance, but randomized data do not support routine replacement of the Seattle protocol; advanced imaging may be adjunctive in high-prevalence/expert settings.

ASGE and AGA statements reflect adjunctive but not routine replacement use

Characterization of colorectal neoplasms/polypoid lesions

Colorectal lesion characterization: CLE demonstrates high pooled sensitivity and specificity for discriminating colorectal neoplasms in meta-analyses and may aid real-time characterization during endoscopy, but heterogeneity and operator dependence limit broad adoption without further prospective trials.

Endoscopy-based, real-time CLE outperforms probe-based/blinded reads

Diagnosis and characterization of middle ear effusion, biofilm detection, and assessment of TM pathology

Detecting middle ear effusion/biofilm: OCT can detect middle ear effusion characteristics and TM-adherent biofilms with high accuracy in small studies and may inform diagnosis in selected cases, but evidence is insufficient to show improved patient outcomes; OCT use is investigational and typically limited to research or specialized centers.

Preciado et al. reported reader accuracy ~90%; larger outcome trials ongoing

Research/diagnostic imaging for suspected middle ear biofilm/effusion and postoperative monitoring — evidence insufficient to establish clinical utility.

OCT middle ear indications in studies: Handheld/portable OCT has been used intraoperatively and in outpatient settings to visualize biofilms, assess TM margins and retraction, and monitor postoperative healing; while technically feasible, studies are small and do not yet establish improved clinical outcomes or management changes.

Further large comparative trials needed to define impact on management

MPOD measurement — investigational/unproven; alternative techniques may be more accurate.

HFP use case: Heterochromatic flicker photometry (0506T) for macular pigment optical density measurement is investigational; studies show measurement assumptions that may bias results and alternative techniques may be more accurate.

Measurement variability and methodological concerns noted in observational studies

Meibomian gland structural assessment — adjunctive only; clinical utility not established as sole diagnostic test.

Meibography use case: Non-contact infrared meibography may document meibomian gland atrophy and correlate with functional dry eye parameters, but should be used as an adjunct to clinical examination rather than as a sole diagnostic test.

Meibography correlates with function but lacks standalone diagnostic validity

Myocardial sympathetic innervation imaging with iodine‑123 metaiodobenzylguanidine (123I‑MIBG) is concluded to be unproven and not medically necessary as a prognostic marker in heart failure because, although prognostic associations exist, evidence is insufficient that imaging‑guided care improves outcomes.

Cardiac contractility modulation (CCM) implantation and programming and percutaneous cryoablation/cryoneurolysis procedures (including genicular nerve cryoablation) are listed as unproven and not medically necessary in this policy excerpt because evidence remains insufficient to show durable clinical benefit and acceptable safety for routine use.

The policy explicitly identifies heterochromatic flicker photometry (CPT 0506T) and near‑infrared dual imaging of meibomian glands (CPT 0507T) as unproven and not medically necessary, and also treats wireless left ventricular endocardial cardiac resynchronization therapy (WiSE CRT procedure codes) as unproven or restricted without high‑quality supporting evidence.

SFDI definitionSpatial Frequency Domain Imaging (SFDI): a non-contact, noninvasive optical technique to quantify superficial tissue oxygenation and chromophore concentrations (e.g., oxy-/deoxyhemoglobin)

System exampleClarifi® Imaging System reports 2D/3D maps of tissue oxygenation, oxyhemoglobin and deoxyhemoglobin and is intended as part of an assessment battery, not standalone diagnostic

Intended useUsed to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise

inv-190: Definition — PCTL

PCTL definitionPosterior circulation tandem lesion (PCTL): combined extracranial vertebral artery lesion occurring with an intracranial posterior circulation occlusion, often managed during endovascular treatment of acute ischemic stroke

Clinical contextPCTL management has been described in registry analyses of EVT with/without extracranial VA stenting

ImplicationDecisions for stenting in PCTL often made during acute EVT and influenced by imaging availability (e.g., angiographic CT)

inv-191: Definition — PCTL extended

PCTL extended contextPCTL refers to synchronous extracranial vertebral artery stenosis/occlusion with intracranial posterior circulation occlusion treated during EVT; evidence includes pooled registry data suggesting potential benefit but limited by retrospective design

Evidence cautionRandomized data are limited; guideline recommendations (ESVS) restrict routine stenting for many scenarios

Outcome measuresFunctional outcomes assessed by mRS at 90 days and 1 year in registry analyses

inv-192: Definition — HDE

HDE definitionHumanitarian Device Exemption (HDE): FDA pathway permitting marketing of devices for small populations with limited evidence, subject to post-approval studies and specific labeling/indications

Argus II exampleArgus II retinal prosthesis was approved under an HDE with specified patient criteria and post-approval study requirements

ImplicationHDE devices require confirmation of labeled indications and follow-up commitments for coverage considerations

inv-193: Definition — BeScreened CRC example

BeScreened™ -CRC exampleExample ELISA-based multiplexed blood biomarker panel measuring TDGF-1 (Cripto-1), CEA, and ECM proteins with proprietary algorithm to report likelihood of colorectal cancer or advanced adenomas

Coverage stanceSuch biomarker panel tests for CRC screening are considered unproven and not medically necessary in this policy

Guidance noteUSPSTF does not recommend serum tests for CRC screening; documentation and strong rationale required if ordered

inv-194: Definition — CAD

CAD definitionComputer-aided detection (CAD): computer algorithm analysis of radiographic image data for lesion detection with physician review

Coding examplesCodes 0174T/0175T reference CAD for chest radiographs (concurrent or remote interpretation)

Policy stanceCAD for chest radiographs is considered unproven and not medically necessary due to insufficient evidence

inv-195: Definition — Eyelid thermal pulsation devices

Eyelid thermal pulsation devicesAutomated devices delivering heat and intermittent pressure (e.g., LipiFlow®, iLUX) or wearable open-eye heat devices intended to evacuate meibomian glands

Device examplesVectored thermal pulsation (VTP/LipiFlow) and TearCare wearable open-eye heat device described in policy

Policy noteThese devices are considered unproven/not medically necessary for evaluation/evacuation of meibomian glands due to limited evidence

inv-196: Definition — VTP / LipiFlow

VTP / LipiFlowVectored thermal pulsation (VTP) — an automated eyelid device delivering heat and pressure to evacuate meibomian glands

Evidence summarySystematic reviews and RCTs show short-term symptom/sign improvements but trials have limitations and durability questions

Guideline positionTFOS/AAO list VTP as a treatment option; payer labels as unproven/not medically necessary in many contexts

inv-197: Definition — TearCare

TearCareWearable, open-eye eyelid heat device that provides targeted thermal energy to tarsal plates and meibomian glands

Evidence considerationsECRI assessment found favorable evidence from several RCTs but with limitations (single-center bias, lack of masking); further trials needed

Policy implicationPolicy deems these devices unproven/not medically necessary for routine use without stronger evidence

inv-198: Definition — atherectomy

Atherectomy definitionEndovascular removal of atheromatous plaque by cutting, drilling, shaving, pulverizing, lasing, or sanding to enlarge treated lumen

Device typesIncludes directional, rotational, orbital, excimer laser, intravascular lithotripsy adjuncts, Crosser CTO recanalization systems

Evidence noteEvidence for atherectomy in visceral/renal/abdominal/brachiocephalic arteries limited to case reports; effectiveness not established

inv-199: Definition — PreTRM

PreTRM definitionPreTRM: serum proteomic biomarker test measuring IBP4 and SHBG with algorithmic analysis to predict risk of spontaneous preterm birth

Coding examples0247U and reporting via unlisted multianalyte assay 81599 when applicable

Coverage stanceConsidered unproven and not medically necessary for screening asymptomatic pregnant individuals

inv-200: Definition — Tear film imaging

Tear film imaging definitionTechniques that gather information from the tear film by processing reflected light or images (e.g., interferometry, meniscometry, high-speed video topography, OCT)

Intended useInvestigational use to characterize dry eye disease and guide treatment; concurrent clinical exam recommended

Policy stanceTear film imaging is considered unproven and not medically necessary for monitoring or assessing tear film disorders due to variability and limited evidence

inv-201: Definition — 123I‑MIBG imaging

123I‑MIBG imaging definitionNuclear medicine scintigraphy using iodine‑123 metaiodobenzylguanidine to assess myocardial sympathetic innervation, reported as heart‑to‑mediastinum (H/M) ratio or SPECT defect scores

Common metricLate H/M ratio reported and used prognostically (example threshold 1.60)

Policy stance123I‑MIBG prognostic associations reported but imaging-guided management benefit unproven; policy lists as not medically necessary for prognostic use

inv-202: Definition — Late H/M ratio

Late H/M ratio definitionLate heart/mediastinum (H/M) ratio on planar I‑123 MIBG imaging used as a prognostic metric (example threshold: <1.60 associated with higher mortality)

Evidence basisADMIRE‑HF follow-up showed higher mortality with H/M <1.60 across LVEF strata, but management changes based on imaging were not evaluated

Clinical implicationPrognostic value exists but clinical utility for altering treatment remains unproven

inv-203: Definition — Subtalar arthroereisis (SA)

Subtalar arthroereisis (SA) definitionSurgical placement of an implant in the sinus tarsi to limit excessive subtalar pronation and correct flexible flatfoot

Implant materialsCommonly titanium or resorbable PLLA implants placed in sinus tarsi

Evidence/complicationsStudies report clinical/radiographic improvement but also notable implant removal rates and low-quality evidence; policy labels as unproven/not medically necessary for routine use

inv-204: Definition — subtalar arthroereisis (SA) duplicate

Subtalar arthroereisis (alternate)Implant-based sinus tarsi procedure intended to limit excessive subtalar joint motion; may be used alone or with adjunctive procedures

Guidance noteACFAS and ECRI advise against using SA as sole corrective procedure for certain adult flatfoot stages; evidence quality low

Complication ratesSystematic reviews report implant removal rates and heterogeneity across studies

inv-205: Definition — renal denervation (RDN)

Renal denervation (RDN) definitionEndovascular ablation (ultrasound or radiofrequency) of renal sympathetic nerves to reduce blood pressure in resistant or uncontrolled hypertension

Device examplesParadise™ Ultrasound RDN (FDA approved P220023) and Symplicity Spyral™ (PMA approved) are cited in policy

Candidate definitionTypically considered for resistant HTN: BP >130/80 mm Hg despite three meds at maximally tolerated doses; shared decision-making recommended

inv-206: Definition — RSA

RSA definitionRadiostereometric analysis (RSA): technique using implanted tantalum markers and postoperative biplanar x‑rays through a calibration cage to calculate micromotion and maximal total point motion (MTPM)

ApplicationUsed in research to monitor implant migration and fracture healing; requires dedicated software and specialized imaging/technique

Clinical noteEvidence supports research use; utility for routine clinical practice is unproven

inv-207: Definition — MTPM

MTPM definitionMaximal total point motion (MTPM): RSA output representing maximal micromotion between implant and bone used to assess migration

Reporting timepointsOften reported at 6 months, 1 year, and beyond as measures of early migration and stabilization

Research useUsed in systematic reviews/meta-analyses evaluating implant migration patterns (e.g., tibial components)

inv-208: Definition — RSA duplicate

RSA (duplicate)Radiostereometric analysis requiring implantation of tantalum markers, calibration cage imaging, and specialized analysis to compute micromotion; high precision but resource intensive

LimitationsRequires marker implantation and trained personnel; marker-free/model-based methods under development to expand applicability

Primary roleRoutine use mainly in research and phased introduction of implants rather than standard clinical practice

inv-209: Definition — BIA

BIA definitionBioelectrical impedance analysis (BIA): method estimating total body water and body composition by measuring electrical impedance through tissues

Performance considerationsAccuracy influenced by hydration, recent intake, and protocol; useful at group level but variable for individual decisions

Policy stanceConsidered unproven/not medically necessary for many clinical indications due to standardization/accuracy concerns

inv-210: Definition — Electronic brachytherapy

Electronic brachytherapy definitionDelivery of high-dose radiation near tumors using a miniaturized X‑ray source instead of radionuclide sources

ApplicationsUsed for skin, breast, endometrial, cervix and other sites; intended to avoid radionuclide handling issues

Evidence cautionPolicy notes inconclusive/low-quality evidence for many indications; recommended use in trials/registries

inv-211: Definition — CLE / optical endomicroscopy

CLE / optical endomicroscopy definitionConfocal laser endomicroscopy (CLE): endoscopic technique providing in vivo high-resolution microscopic images of the mucosa (optical biopsy) using probe-based or endoscope-integrated systems

ModalitiesProbe-based CLE (pCLE) and endoscopy-integrated CLE; requires IV fluorescein for contrast in many applications

Diagnostic performanceMeta-analyses report high pooled sensitivity/specificity for select indications (e.g., biliary strictures, colorectal lesions) but generalizability limited

inv-212: Definition — Indeterminate biliary stricture

Indeterminate biliary strictureBiliary narrowing not definitively diagnosed by standard ERCP tissue sampling where additional diagnostics (e.g., pCLE) may be used

pCLE performanceMeta-analysis: pooled sensitivity ~0.88 and specificity ~0.79 for pCLE in indeterminate biliary strictures

Clinical rolepCLE may improve diagnostic accuracy when ERCP sampling is nondiagnostic, especially with cholangioscopic access

inv-213: Definition — pCLE

pCLE definitionProbe-based confocal laser endomicroscopy (pCLE): a CLE modality using a probe passed through the endoscope to provide in vivo microscopic imaging

Diagnostic metricspCLE shows variable sensitivity/specificity by organ; pooled analyses show high sensitivity for biliary strictures and colorectal/gastric lesions but require operator expertise

LimitationsMost studies from specialized centers; real-time interpretation and correlation with histopathology recommended

inv-214: Definition — CCM

CCM definitionCardiac contractility modulation (CCM): implantable device therapy delivering nonexcitatory electrical signals during the absolute refractory period to enhance myocardial contractility

Regulatory/indicationOptimizer CCM system FDA‑approved for NYHA Class III patients with LVEF 25%–45% in normal sinus rhythm not indicated for CRT

Evidence summaryRCTs show improvements in exercise capacity and QOL but no proven mortality/hospitalization benefit; further trials recommended

inv-215: Definition — Percutaneous cryoneurolysis (Iovera)

Percutaneous cryoneurolysis (Iovera) definitionA cryotherapy system intended to ablate peripheral sensory nerves (e.g., genicular nerves) to reduce pain by freezing targeted nerve tissue

IndicationsStudied for knee OA pain and as adjunct in TKA; trials show mixed results with short-term benefit in some RCTs

Evidence cautionECRI and Hayes conclude evidence unclear; high risk of bias and inconsistent results limit routine coverage

inv-216: Definition — Iovera System

Iovera SystemFDA‑cleared system applying freezing cold to destroy peripheral nervous tissue to block pain; indicated for relief of knee OA symptoms for up to 90 days and for use with nerve stimulation to facilitate target localization

Regulatory noteCleared 501(k) pathway; indications expanded in 2022 to include electrical nerve stimulation facilitation

Policy implicationEvidence insufficient for routine coverage of many indications; may be considered in trial contexts

inv-217: Definition — OCT otoscopy

OCT otoscopy definitionOptical coherence tomography (OCT) otoscopy: noninvasive real-time imaging using low-intensity light to produce 2‑ and 3‑D structural images of the middle ear and tympanic membrane with micron-scale resolution

CapabilitiesCan differentiate air vs fluid, characterize effusions and detect biofilm structures attached to the TM in small studies

Evidence noteClinical utility for improved patient outcomes not yet established; policy labels investigational/not medically necessary for routine middle ear management

inv-218: Definition — OCT (optical coherence tomography)

OCT (optical coherence tomography) definitionNoninvasive imaging modality producing depth-resolved cross-sectional images; applied in handheld otoscope devices for tympanic membrane and middle ear assessment

ApplicationsUsed intraoperatively and in outpatient settings to assess TM perforations, retraction, effusion characteristics and postoperative healing

LimitationsMost studies small; clinical outcome benefit versus standard otoscopy/tympanometry not proven

inv-219: Definition — HFP (macular pigment optical density)

HFP (macular pigment optical density) definitionHeterochromatic flicker photometry (HFP): psychophysical technique to measure macular pigment optical density (MPOD) by assuming uniform retinal spectral sensitivity

Measurement limitationAssumption of uniform spectral sensitivity may be flawed and can underestimate peak MPOD; caution recommended

Policy stanceHFP for MPOD/AMD evaluation is considered unproven and not medically necessary due to insufficient evidence

inv-220: Definition — WiSE CRT system

WiSE CRT system definitionWireless LV endocardial CRT (WiSE) System: external ultrasonic transmitter and implanted wireless receiver electrode enabling LV endocardial pacing without coronary sinus lead

Intended populationAdults ≥22 years with indication for CRT who failed coronary sinus lead implantation or are not candidates for standard CRT

Regulatory noteFDA PMA granted April 11, 2025; evidence includes small single-arm studies with procedural success but notable complication rates

Examples in documentMultiple omnibus codes and technology-specific codes are listed with conclusion = Unproven in coverage summary

inv-189: SFDI definition

SFDI definition (repeat)Spatial Frequency Domain Imaging (SFDI): optical technique to quantify superficial tissue oxygenation and chromophores via noncontact multispectral imaging

Intended roleReported as adjunctive assessment to other clinical tests; Clarifi® not intended to provide diagnosis or prescribe treatment alone

Policy stance0061U (SFDI) concluded Unproven and not medically necessary in this policy section

inv-190: PCTL definition

PCTL / PCTL definition (PCTL) — concisePosterior circulation tandem lesion: extracranial vertebral artery lesion concurrent with intracranial posterior circulation occlusion; managed during EVT in some cases

Clinical threshold referencedESVS 2023 guidance: revascularization may be considered for recurrent vertebrobasilar symptoms with 50–99% extracranial stenosis; routine stenting not recommended

Evidence noteRegistry data (BASILAR/PERSIST) show mRS improvements at 90 days/1 year for stented subgroup but are limited by retrospective design and selection bias

inv-201: 123I‑MIBG definition

123I‑MIBG (concise)I-123 metaiodobenzylguanidine myocardial scintigraphy assesses cardiac sympathetic innervation reported as heart/mediastinum (H/M) ratio or SPECT defect scores

Prognostic thresholdExample late H/M cutoff used in studies: <1.60 vs ≥1.60 with lower H/M associated with higher mortality

Policy implicationAlthough prognostic associations exist, imaging-guided management benefit is unproven; policy lists 123I‑MIBG as not medically necessary for prognostic use