CurrentUnitedHealthcarePolicy 2025T0535UUU

Omnibus (New/Unproven) CPT/HCPCS Codes Coverage

This UnitedHealthcare policy lists multiple new or miscellaneous CPT/HCPCS (T and U) codes and gives the coverage conclusion for each (primarily 'Unproven') for UnitedHealthcare plans in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicyOmnibus (New/Unproven) CPT/HCPCS Codes Coverage

Policy CodePolicy 2025T0535UUU

Change TypeNo material clinical or coverage changes in this revision

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionWhen submitting claims for the listed T/U codes, expect that codes concluded as 'Unproven' are unlikely to be supported and may be denied; include documentation and justification if requesting review.

SourceLink

~80+listed T/U codes

Unprovencoverage stance

1-6pages in extract

1FDA-cleared device referenced

Coverage Conclusions and Evidence Summaries

Omnibus codes — Unproven

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Each listed CPT/HCPCS code in these chunks is given the conclusion 'Unproven'.

Omnibus codes conclusion: Each listed CPT/HCPCS code in these chunks is given the conclusion 'Unproven'.

No clinical criteria or medical necessity conditions provided in these chunks.

Coverage conclusions (excerpt)

Coverage conclusions given per listed code in this excerpt:

Unproven group: Many listed CPT/HCPCS codes and supplies are labeled 'Conclusion = Unproven'.

Examples across multiple procedure and supply codes indicate insufficient evidence or not established as medically necessary.

Covered in certain circumstances: Select codes (e.g., 93264, G0555) are labeled 'Covered in certain circumstances'.

These items may be reimbursed when specific clinical or program conditions are met (details not provided in this excerpt).

SFDI — informational / investigational

SFDI (spatial frequency domain imaging) for assessment of foot microvascular disease or ulcer risk:

Evidence summary: Observational studies report SFDI-derived measures (e.g., papillary hemoglobin HbT1 and tissue oxygen saturation StO2) correlate with microvascular disease severity in the plantar foot, but studies are small, lack direct microvascular gold standards and do not demonstrate improved wound or clinical outcomes.

Further prospective outcome studies needed to demonstrate clinical utility.

Vertebral artery revascularization

Endovascular treatment (angioplasty/stenting) for symptomatic vertebral artery stenosis:

Guideline-concordant approach: Initial management should include best medical therapy (risk factor control, antiplatelet therapy, statins, individualized blood pressure/diabetes management).

Per ESVS 2023 and systematic reviews.

Revascularization consideration: Revascularization (stenting) may be considered for recurrent vertebrobasilar symptoms despite best medical therapy and for selected extracranial stenosis; routine stenting is not recommended for asymptomatic lesions.

ESVS 2023 guidance; RCT evidence shows no clear overall benefit of ET plus MT vs MT alone.

Coverage stance: Transcatheter placement of extracranial vertebral artery stent(s) is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Policy conclusion in document.

Retinal prosthesis (Argus II)

Argus II retinal prosthesis system for advanced retinitis pigmentosa:

Device indication and regulatory status: Argus II received FDA Humanitarian Device Exemption (HDE) for adults ≥25 years with bare light or no light perception and other criteria; device intended for one worse-seeing eye and requires postimplant follow-up and rehabilitation.

HDE requirements include post-approval studies.

Evidence summary: Single-arm trials and case series report improved device-on versus device-off visual function and some quality-of-life measures, but studies are small, nonrandomized, and associated with adverse events and limited long-term data.

AHRQ and technology assessments note insufficient evidence to estimate the proportion benefiting.

Coverage stance: Use of retinal prosthetic devices is unproven and not medically necessary for inducing visual perception in individuals with retinitis pigmentosa due to insufficient evidence of safety and/or efficacy.

Policy conclusion in document.

Biomarker panel for CRC screening

Proprietary biomarker panel algorithm for colorectal cancer (BeScreened™-type):

Coverage stance: Use of a biomarker panel algorithmic analysis test to screen for colorectal cancer or advanced adenomas is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Policy conclusion in document.

Not Medically Necessary — Blood-based CRC biomarker panels

Tests considered not medically necessary for CRC screening:

BeScreened-like blood-based CRC biomarker panels: Use of a biomarker panel-based algorithmic blood test (e.g., BeScreened-CRC measuring TDGF-1/Cripto-1, CEA, ECM) to screen for colorectal cancer or advanced adenomas is unproven and not medically necessary.

Deemed unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Not Medically Necessary — Thermal Pulsation for Meibomian Glands

Thermal pulsation devices for meibomian gland evaluation or evacuation:

Thermal pulsation and wearable eyelid heat devices: Thermal pulsation (heat plus intermittent pressure) systems (e.g., LipiFlow) and wearable open-eye eyelid heat devices are listed as unproven and not medically necessary for evaluation or evacuation of meibomian glands due to inconsistent evidence and methodological limitations in trials, despite guideline placement as a second-line option.

Evidence limitations include risk of bias, manufacturer funding, short follow-up, and analyses sensitive to within-patient eye correlation.

Informational / Insufficient Evidence — CAD for Chest Radiographs

CAD for chest radiograph screening:

CAD for chest radiograph mass screening: Computer-aided detection (CAD) for chest radiographs is an adjunctive tool but current evidence is inadequate that CAD-based mass screening improves detection of smaller cancers or reduces mortality; high-quality randomized trials are needed.

Published literature is primarily technical with variable sensitivity and false-positive rates; further outcome studies required.

General coverage context

Evidence summary and guidance-based stance:

Evidence and guideline context: Systematic reviews and randomized trials show vectored thermal pulsation (VTP) can improve some subjective and objective measures (OSDI, SPEED, MG function, TBUT), but studies have methodological limitations (risk of bias, manufacturer funding, small sizes, limited follow-up); professional guidance lists VTP/LipiFlow as a second-line option; further well-designed RCTs are needed.

Consider individual trial results and guideline context when making coverage determinations.

Comparative effectiveness

Comparative effectiveness findings (distinct criteria group):

Comparative trial findings: Some randomized controlled trials show VTP is superior to warm compresses or comparable/better than doxycycline for improving meibomian gland function and symptoms; device studies sometimes show sustained benefit up to 12 months but have potential bias and limited masking.

Use trial-level data when considering clinical coverage decisions.

Automated/mobile audiometry — evidence and limits

Evidence summary for mobile/automated audiometry:

Summary: Automated and mobile audiometry demonstrate promising accuracy and reliability with pooled sensitivity ~89% and specificity ~93%, and mean threshold differences generally below clinically significant levels (~1–2 dB), but evidence is heterogeneous and limited in children, elderly, and certain pathologies; not validated as equivalent to audiologist-performed pure-tone audiometry for definitive diagnosis.Sensitivity 89%, Specificity 93%

Documentation should include device, environment, calibration, and testing conditions.

Atherectomy — Not medically necessary

Atherectomy for visceral, renal, abdominal, or brachiocephalic arteries:

Coverage stance: Transluminal peripheral atherectomy of visceral, renal, abdominal, or brachiocephalic arteries is considered unproven and not medically necessary due to insufficient evidence of safety and efficacy.

Published evidence limited to case reports and small studies; ongoing trials exist.

PreTRM testing — Not medically necessary

PreTRM proteomic biomarker testing for prediction of spontaneous preterm birth:

Coverage stance: Use of the PreTRM proteomic test (IBP4/SHBG ratio) for screening asymptomatic pregnant individuals to predict preterm birth is considered unproven and not medically necessary due to insufficient evidence that testing improves outcomes.

Large studies exist but limitations and lack of guideline endorsement limit clinical adoption.

Carotid sinus baroreflex activation — Not medically necessary/general restrictions

Carotid sinus baroreflex activation:

Coverage stance: Chronic baroreceptor stimulation of the carotid sinus is unproven and not medically necessary for hypertension, heart failure, or other cardiovascular conditions due to insufficient evidence of safety and/or efficacy; limited HDE/PMA approvals exist for narrow indications.

Refer to device-specific FDA approvals and member benefit documents for replacement/revision coverage guidance.

Overall coverage stance

Coverage stance and supporting evidence summaries:

Coverage statements: Chronic baroreceptor stimulation of the carotid sinus is considered unproven and not medically necessary for treating hypertension, heart failure or other cardiovascular conditions due to insufficient evidence of safety and/or efficacy.

Statement present in document.

FDA/regulatory context: Barostim neo received FDA PMA for treatment of heart failure; a limited HDE was granted in 2014 for legacy device replacement in select trial patients.

Regulatory details reported.

Tear film imaging — Not medically necessary

Coverage stance for tear film imaging:

Tear film imaging - coverage: Tear film imaging to monitor or assess tear film disorders is categorized as unproven and not medically necessary due to insufficient evidence of diagnostic performance, repeatability, and demonstrated clinical utility.

Studies show variable repeatability and poor device agreement; imaging should not replace clinical exam and conventional tests.

123I‑MIBG myocardial imaging — Not medically necessary

Coverage stance for myocardial 123I‑MIBG imaging:

123I‑MIBG imaging - coverage: Myocardial sympathetic innervation imaging with 123I‑MIBG is unproven and not medically necessary as a routine prognostic marker in heart failure because while studies show prognostic associations, there is insufficient evidence that imaging-directed management improves clinical outcomes.

Standardization and prospective outcome trials are lacking.

I-123 MIBG prognostic evidence (coverage considerations)

I-123 MIBG myocardial scintigraphy findings and implications:

Prognostic association: ADMIRE-HF follow-up showed H/M < 1.60 associated with higher all-cause and cardiac mortality and arrhythmic events over median 62.7 months; however, no clinical decisions in ADMIRE-HF were based on imaging, so benefit from imaging-guided management is unproven.H/M 1.60

Report provides prognostic association but not evidence that using imaging to guide therapy improves outcomes.

Visual evoked potentials — evidence and limitations

Automated and pattern VEP evidence summary:

VEP evidence: Studies indicate VEPs can estimate or predict visual acuity in selected pediatric and special-needs cohorts (e.g., infants with cerebral visual impairment, amblyopic children) with variable correlation to behavioral acuity; evidence is limited by small heterogeneous studies and guidelines do not endorse automated VEP for routine screening.

Provide patient age, indication and VEP type if submitted for review; limited generalizability.

Subtalar arthroereisis (sinus tarsi implant) — not medically necessary / investigational evidence

Arthroereisis evidence and coverage stance:

Current evidence: Systematic reviews and case series report radiographic and clinical improvements after subtalar arthroereisis in pediatric and adult flexible flatfoot, but overall evidence quality is low, heterogeneous, often noncomparative, with notable complication and implant removal rates reported.none

Evidence insufficient to establish consistent long-term benefit or clear selection criteria.

Clinical use consideration: Arthroereisis is typically considered only after failure of conservative measures; documentation of failed conservative therapy is recommended for any authorization consideration.failure of conservative therapy

Recommendation aligns with professional guidance and evidence limitations.

RDN candidate criteria (evidence-derived)

Consider RDN for patients meeting ALL of the following (as supported by clinical trial inclusion and society guidance):

RDN candidacy: 1) Adult patient with resistant or uncontrolled hypertension despite guideline-directed antihypertensive therapy and lifestyle modification; 2) Elevated BP confirmed by ambulatory monitoring per trial criteria; 3) Multidisciplinary evaluation with shared decision-making and informed consent; 4) Procedure performed at centers with appropriate operator experience and capability to manage complications.

Derived from RADIANCE trials, SCAI/ESH/NICE guidance and trial inclusion criteria.

Efficacy and evidence limitations

Evidence-based expectations and limitations:

Efficacy and limitations: Randomized sham-controlled trials and meta-analyses show modest reductions in ambulatory systolic BP (approx. 3–8 mm Hg) at short- to mid-term follow-up; evidence for long-term durability and impact on cardiovascular events is insufficient.

Sham effects and trial design influence observed differences; larger trials with longer follow-up needed.

Renal denervation — evidence and limitations

Summary of evidence-based stance for renal denervation:

RDN BP impact: Randomized, placebo-controlled trials and systematic reviews found RDN produces modest reductions in ambulatory and office blood pressure (approximately 3–6 mm Hg systolic), with similar effects in medicated and unmedicated patients.

See RADIANCE, SPYRAL, Ahmad et al. meta-analyses.

Evidence limitations: Existing trials have relatively short follow-up, risk of bias in some studies, and insufficient evidence for effects on cardiovascular events, renal function, or long-term outcomes.

Cochrane and systematic reviews conclude need for larger high-quality trials.

Clinical recommendation context: RDN may be considered as an adjunct for selected patients (e.g., unable or unwilling to add medications) within structured pathways and shared decision-making; routine broad use is limited pending additional evidence.

Position statements recommend specialized center capabilities and audit/research arrangements.

Radiostereometric analysis (RSA)

RSA — research utility vs routine clinical use:

Precision and research role: Radiostereometric analysis (RSA) is a highly precise technique for detecting early implant migration and is useful in orthopedic research and phased introduction of implants.

RSA provides micromotion measurements and is valuable in multicenter research protocols.

Clinical efficacy: Despite precision, evidence is limited regarding standardized reporting and demonstrated clinical efficacy for routine patient care; therefore RSA is considered unproven/not medically necessary for general clinical indications in this document.

Policy concludes RSA unproven for routine use due to insufficient evidence of clinical benefit.

Bioelectrical impedance analysis (BIA)

BIA — diagnostic validity and limitations:

Method description: Bioelectrical impedance analysis (BIA) estimates body composition (TBW, fat-free mass, fat mass) from electrical impedance; results are affected by hydration status, device, and predictive equations.

Pre-measurement conditions (fluid intake, timing) affect results.

Accuracy and utility: Systematic reviews show inconsistent accuracy versus reference methods, acceptable performance at group level but limited accuracy at individual level, particularly with higher BMI; evidence insufficient to support routine clinical use for obesity screening or individual management decisions.

Device- and equation-dependent variability noted across studies.

Policy stance: BIA whole body composition assessment (CPT 0358T) is considered unproven and not medically necessary due to insufficient evidence of safety and efficacy for evaluated indications.

Document explicitly states not medically necessary.

Coverage stance and evidence-based conclusions

Evidence summaries and professional society positions included in the document indicate the following coverage stance:

Electronic brachytherapy general: Evidence is inconclusive for many indications (breast APBI, nonmelanoma skin cancer, gynecologic cancers); professional societies and evidence assessments recommend limiting use to clinical trials or registries or consider it investigational outside trials.

ABS, ECRI, NICE and guideline statements cited.

Breast - APBI with electronic brachytherapy: Randomized data show higher recurrence in at least one trial and available studies are small and short-term; not recommended for routine APBI outside trials.

Evidentiary limitations and guideline cautions noted.

Nonmelanoma skin cancer: Evidence is very low quality and inconclusive; comparisons to Mohs surgery and other radiotherapy are lacking; consider use only in prospective registries or clinical trials.

AAD and ECRI assessments referenced.

Gynecologic cancers: Case series are small and retrospective; evidence inconclusive and does not demonstrate superiority to conventional brachytherapy; use limited to research settings.

ECRI reviews cited.

BIA for body composition: BIA and variants show variable agreement with reference methods; acceptable for group-level assessments in some contexts but limited accuracy at individual level and device-dependent validity.

Systematic reviews and ECRI findings cited.

Not Medically Necessary

Coverage stance:

Primary coverage stance: Confocal laser endomicroscopy (CLE) and optical endomicroscopy are considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Direct policy statement; studies show variable accuracy and applicability.

Adjunctive / Specialized Use Considerations (CLE)

Context where CLE may be considered investigational or adjunctive:

Adjunctive use in expert centers: Evidence shows CLE can provide high sensitivity/specificity in selected settings (e.g., indeterminate biliary strictures, specialized Barrett's esophagus centers) but randomized trials and guideline panels do not support routine use over standard approaches; CLE may be considered adjunctive at expert centers after standard diagnostics have been attempted.

Meta-analyses show high sensitivity for pCLE in biliary strictures but limitations in applicability and need for fluorescein and trained interpreters.

CCM (Optimizer) - Covered with criteria

Covered when ALL of the following are met (per FDA approval and guideline/evidence context):

CCM coverage criteria: 1) Patient has symptomatic heart failure consistent with NYHA class III; 2) Patient remains symptomatic despite guideline-directed medical therapy; 3) Patient is in normal sinus rhythm; 4) Patient is not indicated for cardiac resynchronization therapy (CRT); 5) Left ventricular ejection fraction (LVEF) between 25% and 45%; 6) Device implantation and programming performed by qualified clinicians using an FDA-approved Optimizer system.LVEF 25%–45%

Evidence supports improvements in functional capacity and quality of life but not mortality; document candidacy per FDA labeling.

Peripheral cryoablation / iovera - Not medically necessary

Not covered / considered not medically necessary when used for the following:

Cryoablation/IOVERA: Percutaneous cryoablation of peripheral nerves (including genicular or truncal nerves) for chronic pain, including knee osteoarthritis, is considered unproven and not medically necessary due to insufficient or conflicting evidence of safety and efficacy.

Some randomized trials show short-term benefit up to ~150 days but overall evidence judged unclear.

Drug-eluting ocular inserts - Not medically necessary

Drug-eluting ocular insert under eyelid: Placement of drug-eluting ocular inserts under the eyelid(s) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Small trials and limited follow-up; not supported for routine use.

Drug-eluting ocular inserts — Not medically necessary

Drug-eluting ocular inserts:

Coverage determination: Placement of drug-eluting ocular inserts under the eyelid(s) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Based on limited small trials and short follow-up; non-inferiority not consistently demonstrated.

Middle ear OCT — Not medically necessary

Optical coherence tomography (OCT) of the middle ear:

Coverage determination: OCT of the middle ear is unproven and not medically necessary due to insufficient evidence that its use improves clinical outcomes, despite promising diagnostic visualization of effusion, biofilm, and tympanic membrane features in small studies.

Studies are small, nonrandomized, and clinical utility on outcomes not established.

Meibomian gland near-infrared imaging — Not medically necessary

Near-infrared dual imaging of meibomian glands:

Coverage determination: Near-infrared dual imaging of meibomian glands (e.g., Dynamic Meibomian Imager/LipiScan) is unproven and not medically necessary due to insufficient evidence that imaging changes management or improves patient outcomes.

Manufacturer claims exist but no robust outcome or guideline support.

Macular pigment optical density measurement — Informational

Macular pigment optical density measurement (MPSII):

Clinical summary: Macular pigment optical density measurement by heterochromatic flicker photometry (MPSII) is informational; small studies report associations with age and AMD but clinical utility for risk modification or management is unproven.

Further studies needed to define role in clinical care.

This excerpt functions as an omnibus code listing and short coverage summary: it enumerates a large set of recently established CPT/HCPCS codes and provides the payer’s short coverage conclusion for each code—most commonly "Unproven". The listing is intended to direct readers to the full coverage rationale pages for the detailed evidence review underlying each per‑code conclusion.

The extracted excerpt does not provide discrete exclusion criteria or conditional exceptions beyond the per-code conclusions. Instead, many codes are labeled "Unproven", which in this policy context functions as the operative coverage determination: services billed with those T/U/CPT codes lack sufficient evidence to be considered medically necessary for routine coverage. Where specific items are discussed in the evidence narrative (for example, vertebral artery stenting or proprietary biomarker panels), the policy text explicitly states those services are "unproven and not medically necessary" rather than listing separate, enumerated exclusion conditions.

The policy excerpt explicitly identifies several interventions as unproven or not medically necessary based on the evidence summaries: proprietary blood-based colorectal cancer biomarker panels using algorithmic outputs (e.g., BeScreened‑type tests) are concluded unproven/not medically necessary (0163U); thermal pulsation and wearable open‑eye eyelid heat devices for meibomian gland evacuation (e.g., LipiFlow/TearCare type technologies) are described as unproven/not medically necessary for evaluation or evacuation of meibomian glands (0207T/0563T); and optical coherence tomography (OCT) of the middle ear (0485T/0486T) is identified as unproven and not medically necessary for assessing and managing middle ear disorders.

The document gives explicit noncoverage conclusions for several technologies and procedures: transcatheter placement of extracranial vertebral artery stent(s) (0075T/0076T) is labeled unproven and not medically necessary due to insufficient evidence of efficacy; myocardial sympathetic innervation imaging with 123I‑MIBG is described as unproven and not medically necessary as a routine prognostic tool in heart failure; and placement of drug‑eluting ocular inserts under the eyelid(s) (0444T/0445T) is stated to be unproven and not medically necessary because safety and efficacy data are inadequate.

CPT / HCPCS Codes and Status

Omnibus Codes (excerpt)CPT

0174T	Computer-aided detection (CAD) with physician review, chest radiograph(s) (List separately)
0175T	Computer-aided detection (CAD) remote with physician review, chest radiograph(s)
0207T	Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral
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
0234T	Transluminal peripheral atherectomy; renal artery
0235T	Transluminal peripheral atherectomy; visceral artery (except renal), each vessel

1–10 of 16

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Omnibus Codes (continued)CPT

0272T	Interrogation device evaluation (in person), carotid sinus baroreflex activation system
0273T	Interrogation device evaluation (in person) with programming, carotid sinus baroreflex activation system
0330T	Tear film imaging, unilateral or bilateral, with interpretation and report
0331T	Myocardial sympathetic innervation imaging, planar qualitative and quantitative assessment
0332T	Myocardial sympathetic innervation imaging; with tomographic SPECT
0333T	Visual evoked potential, screening of visual acuity, automated, with report
0335T	Insertion of sinus tarsi implant
0338T	Transcatheter renal sympathetic denervation, percutaneous; unilateral
0339T	Transcatheter renal sympathetic denervation; bilateral
0347T	Placement of interstitial device(s) in bone for radiostereometric analysis (RSA)

1–10 of 13

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Omnibus / Selected CPT Codes (excerpt)CPT

0397T	ERCP with optical endomicroscopy (List separately)
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
0414T	Removal and replacement of permanent cardiac contractility modulation system pulse generator only
0440T	Ablation, percutaneous, cryoablation; upper extremity distal/peripheral nerve
0441T	Ablation, percutaneous, cryoablation; lower extremity distal/peripheral nerve

1–10 of 11

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Additional CPT/HCPCS and Monitoring Codesmixed

0506T	Macular pigment optical density measurement by heterochromatic flicker photometry
0507T	Near-infrared dual imaging of meibomian glands, with interpretation and report
0515T	Insertion of wireless cardiac stimulator for left ventricular pacing; complete system
0516T	Insertion of wireless cardiac stimulator for left ventricular pacing; electrode only
0517T	Insertion of wireless cardiac stimulator for left ventricular pacing; battery/transmitter components only
0525T	Insertion or replacement of intracardiac ischemia monitoring system; complete system
0526T	Insertion or replacement of intracardiac ischemia monitoring system; electrode only
0527T	Insertion or replacement of intracardiac ischemia monitoring system; implantable monitor only
0607T	Remote monitoring of an external continuous pulmonary fluid monitoring system; set-up and education
0608T	Remote monitoring of an external continuous pulmonary fluid monitoring system; analysis and reports

DME and Supply Codes (excerpt)HCPCS

A4542	Supplies and accessories for external upper limb tremor stimulator of the peripheral nerves of the wrist
A9999	Miscellaneous DME supply or accessory, not otherwise specified
E0734	External upper limb tremor stimulator of the peripheral nerves of the wrist
E1399	Durable medical equipment, miscellaneous
G0555	Provision of replacement patient electronics system for home pulmonary artery pressure monitoring

Vertebral artery stenting CPT/HCPCS codesCPT

0075T	Transcatheter placement of extracranial vertebral artery stent(s); initial vessel
0076T	Transcatheter placement of extracranial vertebral artery stent(s); each additional vessel

Retinal prosthesis procedure/device 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
0473T	Device evaluation and interrogation of intraocular retinal electrode array; reprogramming and visual training
L8608	Miscellaneous external component, supply or accessory for use with the Argus II Retinal Prosthesis System

Biomarker CRC panel (proprietary algorithm)CPT

0163U

Oncology (colorectal) screening; ELISA of 3 plasma proteins with proprietary algorithm reported as likelihood of CRC or advanced adenomas

Not medically necessary — Blood-based CRC biomarker panelCPTNot Covered

0163U

Oncology (colorectal) screening; ELISA of 3 plasma proteins with proprietary algorithm reported as likelihood of CRC or advanced adenomas

Unproven / Not medically necessary — Meibomian gland thermal/evacuation 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

Listed CPT/HCPCS codes (audiometry codes shown in this segment)CPT

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, automated

Atherectomy CPT Category III CodesCPT

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

Carotid sinus baroreflex activation system CPT CodesCPT

0266T	Implantation or replacement of carotid sinus baroreflex activation device; total system
0267T	Implantation or replacement; lead only, unilateral
0268T	Implantation or replacement; pulse generator only
0269T	Revision or removal; total system
0270T	Revision or removal; lead only, unilateral
0271T	Revision or removal; pulse generator only
0272T	Interrogation device evaluation (in person)
0273T	Interrogation device evaluation (in person) with programming

Omnibus/Procedure CPT-like codesCPT

0330T	Tear film imaging
0331T	Myocardial sympathetic innervation imaging, planar
0332T	Myocardial sympathetic innervation imaging; SPECT
0333T	Visual evoked potential, automated, screening

Tear film imaging (specified CPT/Category III)CPT

0330T	Tear film imaging, with interpretation and report
0507T	Near-infrared dual imaging of meibomian glands, with interpretation and report

Myocardial 123I‑MIBG imaging (specified CPT/Category III)CPT

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

Unproven / Not Medically Necessary - VEPCPTNot Covered

0333T

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

Unproven / Not Medically Necessary - Sinus Tarsi ImplantCPTNot 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 CodesCPT

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

Radiostereometric analysis (RSA) CPT III codesCPT

0347T	Placement of interstitial device(s) in bone for RSA
0348T	Radiologic examination, RSA; spine
0349T	Radiologic examination, RSA; upper extremity
0350T	Radiologic examination, RSA; lower extremity

Bioelectrical impedance analysis CPT III codeCPT

0358T

Bioelectrical impedance analysis whole body composition assessment, with interpretation and report

Optical endomicroscopy CPT/HCPCSmixed

0397T	ERCP with optical endomicroscopy (List separately)
43206	Esophagoscopy, flexible, transoral; with optical endomicroscopy
43252	Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy
88375	Optical endomicroscopic image(s), interpretation and report, each endoscopic session

Additional unrelated CPT/HCPCS codes listedmixed

17999	Unlisted procedure, skin, mucous membrane and subcutaneous tissue
19105	Ablation, cryosurgical, of fibroadenoma, including ultrasound guidance
23929	Unlisted procedure, shoulder
27299	Unlisted procedure, pelvis or hip joint

CCM-related CPT/T and HCPCS codesmixed

0408T	Insertion or replacement of permanent cardiac contractility modulation system; complete
0409T	Insertion or replacement; pulse generator only
0417T	Programming device evaluation (in person) with iterative adjustment, implantable CCM system
K1030	External recharging system for battery for use with implanted CCM generator (replacement only)

Cryoablation and ocular insert CPT/T codesCPT

0440T	Ablation, percutaneous, cryoablation; upper extremity distal/peripheral nerve
0441T	Ablation, percutaneous, cryoablation; lower extremity distal/peripheral nerve
0444T	Initial placement of a drug-eluting ocular insert under one or more eyelids
0445T	Subsequent placement of a drug-eluting ocular insert under one or more eyelids

Drug-eluting ocular insert CPT II/Category III codesCPT

0444T	Initial placement of a drug-eluting ocular insert under one or more eyelids
0445T	Subsequent placement of a drug-eluting ocular insert under one or more eyelids

Middle ear OCT Category III codesCPT

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

Meibomian gland near-infrared dual imaging (Category III)CPT

0507T	Near-infrared dual imaging of meibomian glands, unilateral or bilateral, with interpretation and report
0563T	Evacuation of meibomian glands, using heat delivered through wearable, open-eye eyelid treatment devices and manual gland expression, bilateral

Remote monitoring duration thresholdCPT

0578T	Interrogation device evaluation(s) (remote), up to 90 days, substernal lead ICD system
93264	Remote monitoring of a wireless pulmonary artery pressure sensor for up to 30 days

Diagnostic performance thresholds (smartphone audiometry)CPT

0208T	Pure tone audiometry (threshold), automated; air only
0209T	Pure tone audiometry (threshold), automated; air and bone

H/M ratio thresholdkey_value

0331T

Heart/mediastinum (H/M) ratio threshold < 1.60 associated with higher mortality in studies

Resistant hypertension definitionmixed

0338T

Resistant hypertension defined as BP > 130/80 mm Hg despite three medications with maximally tolerated doses

Left ventricular ejection fraction (LVEF)mixed

0408T

CCM indicated for certain patients with LVEF 25% to 45% per FDA approval

Insertion of gastrostomy tube with magnetic gastropexyCPT

0647T

Insertion of gastrostomy tube, percutaneous, with magnetic gastropexy, under ultrasound guidance, image documentation and report

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Expected

Prior authorization is commonly required for many of the novel device- and procedure-related CPT/HCPCS codes listed in this policy. Providers should verify member-specific benefit plan requirements and obtain prior authorization where the plan requires it before scheduling services to avoid claim denials or delays.

Verify prior authorization requirements for all listed codes in the policy table (including omnibus and implant/device codes).
For remote monitoring and pulmonary artery pressure sensor codes (e.g., 93264 and related G-codes), follow payer-specific PA rules; some codes may be covered in certain circumstances.
Implantation, interrogation, revision, removal, and related device CPT/omnibus codes (e.g., 0266T–0273T, 0408T–0418T, 0575T–0581T, 0347T–0350T) typically require prior authorization and review of indication and supporting documentation.

Denial Risk

Denial Risk for Unproven Services

When an unproven, investigational, or inconclusive-service is being considered (e.g., many electronic brachytherapy indications, unproven omnibuses, novel imaging/device uses), expect prior authorization scrutiny and a higher risk of denial if documentation does not clearly demonstrate enrollee benefit, trial enrollment, or inclusion in a registry.

Electronic brachytherapy (skin, breast, vaginal cuff, etc.) is generally considered investigational/inconclusive; prior authorization is recommended only for trial or registry use.
Implantation/revision/removal of novel implantable neuromodulation or substernal lead devices often are labeled unproven — expect denial risk without strong supporting evidence or approved indication.

Documentation Required

Documentation Requirements for Authorization

Document clinical rationale, prior conservative management, objective baseline findings, and anticipated outcomes when seeking authorization for device-based or novel interventions. Include device model, FDA status (510(k)/PMA/HDE), and whether treatment is part of an approved clinical trial or registry.

Include objective baseline measures and measurable clinical outcomes that will be used to evaluate benefit (e.g., 24‑hour ambulatory BP for RDN candidacy, validated dry eye questionnaires and gland function scores for meibomian interventions).
When a procedure/device is FDA-cleared (510[k]) or PMA-approved, include the clearance/approval documentation and intended indication; note HDE or limited-use authorizations where applicable.
If the service is provided within a clinical trial or prospective registry, include trial/registry identifiers, inclusion/exclusion criteria, and monitoring plan.

Step Therapy

Conservative/Stepwise Therapy Documentation

For services that require demonstration of prior conservative therapy or staged management (e.g., many ophthalmic, orthopaedic, and some neurovascular procedures), provide records documenting nonresponse or intolerance to standard therapies.

Ophthalmology: For thermal pulsation or wearable open‑eye devices and tear film imaging, document prior conservative measures (warm compresses, lid hygiene, topical therapies), objective tests (TBUT, MGSS, OSDI/SPEED), and specific tear film imaging findings if used.
Surgery/oncology: For skin and breast cancer, document why surgical management (e.g., Mohs or standard lumpectomy ± standard radiotherapy) is not appropriate if proposing electronic brachytherapy as an alternative.
For procedures with step therapy expectations (where applicable), include dates and duration of prior therapies and reasons for escalation.

Billing Rule

Billing/Coding Guidance

Specific device- and procedure-related billing and coding considerations: use approved CPT/HCPCS/omnibus codes for implantation, interrogation, evaluation, and revision; report appropriate remote monitoring or DME codes for home monitoring systems.

When billing implantable device services, use the designated implantation, revision, interrogation, or removal CPT/omnibus codes as listed in the policy (e.g., 0266T–0273T for carotid baroreflex devices; 0408T–0418T for CCM; 0575T–0579T omnibus codes as applicable).
Remote monitoring codes (e.g., 93264 and G‑codes listed in the policy) may be covered only in certain circumstances — verify coverage rules and PA requirements.
For device-related DME or supply claims (e.g., K-codes, E-codes), ensure the device description aligns with the intended clinical use and attach supporting documentation per payer guidelines.

Documentation Required

Documentation When Tear Film or Meibomian Imaging Used

When tear film imaging, near-infrared dual imaging, or meibography is used, include supporting images, objective scores, and how imaging findings change management. Note that tear film imaging and near-infrared dual imaging are considered unproven and carry coverage restrictions.

Attach representative images, measurement metrics, and a clear interpretation tied to clinical decision-making.
Document how imaging findings will alter treatment (e.g., candidate selection for thermal pulsation or surgical interventions) and provide pre- and post-treatment outcome measures.
Be aware that tear film imaging and LipiScan/LipiScan DMI claims are likely to be denied as unproven unless part of a research protocol or exceptional circumstances with detailed justification.

Documentation Required

Thermal Pulsation / Wearable Open-Eye Devices — Provider Actions

For eyelid thermal pulsation and wearable open‑eye eyelid heat devices: professional society guidance supports use as a later-line or second-stage option, and payer coverage typically requires documentation of prior conservative therapy and objective outcome measures.

Include prior conservative therapy documentation (e.g., warm compresses, lid hygiene) and objective baseline measures (TBUT, MGYSS/MGSS/MGS, OSDI/SPEED).
If submitting for LipiFlow or similar VTP, document that it is being considered as a second-stage therapy per AAO/TFOS guidance and list prior treatments and durations.
Provide planned outcome measures and follow-up intervals to support medical necessity (e.g., symptom scores, TBUT changes, gland secretion scores at defined timepoints).

Prior Authorization

Renal Denervation (RDN) — Authorization and Documentation

Renal denervation (RDN) and related procedures require careful documentation of prior ambulatory blood pressure monitoring and pharmacologic optimization; many guidelines recommend use only with special governance, registry, or research oversight.

Provide documented ambulatory 24‑hour BP measurements confirming uncontrolled hypertension despite maximally tolerated guideline-directed antihypertensive therapy.
Include medication regimen details, adherence assessment, lifestyle modification attempts, and reasons for inability or unwillingness to escalate medication if relevant.
If RDN is pursued, note NICE guidance: use only under special clinical governance, consent, audit, or research arrangements; include registry/trial identifiers where applicable.

Prior Authorization

Electronic Brachytherapy — Provider Expectations

Electronic brachytherapy for breast, skin, or vaginal cuff indications is generally considered investigational or inconclusive; if proposed outside a clinical trial, expect detailed justification and prior authorization review and consider recommending referral to standard surgical or radiation options first.

Document why conventional treatments (e.g., Mohs surgery for skin cancers or standard external beam brachytherapy/external beam radiation for breast) are not appropriate or feasible.
If electronic brachytherapy is provided within a prospective trial or registry, include trial ID and informed consent documentation.
Attach device manufacturer labeling, FDA status, and contemporaneous literature supporting the proposed use; absent robust comparative evidence, expect denials for routine use.

Documentation Required

Use of Limited Evidence — Documentation Expectations

When relying on small prospective, nonrandomized, or single-arm studies to justify an intervention, clearly acknowledge limitations and provide local outcome tracking, planned follow-up duration, and patient counseling documentation.

State that evidence is limited and describe the local or institutional rationale for use, patient selection criteria, and documented shared decision-making.
Provide a plan for objective outcome measurement and long-term follow-up to monitor safety and effectiveness, and include data submission to registries when available.

Note

Surgical Standard‑of‑Care Consideration

Surgical management (e.g., Mohs micrographic surgery for skin cancers, standard lumpectomy and established radiation approaches for breast cancer) remains the standard of care for many indications; documentation must explain why nonstandard device-based alternatives are preferable for a specific patient.

When proposing alternatives to standard surgical management, document tumor characteristics, patient comorbidities, contraindications to surgery, or patient preference after informed discussion of risks/benefits.
Attach multidisciplinary notes (dermatology, surgical oncology, radiation oncology) when deviating from standard care, and provide comparative rationale versus established therapies.

Contexts Where Use May Be Supported or Considered

inv-213: Not specified in this extract

Not specified in this extract.

No indication criteria in extract: The policy extract provides descriptions and 'Unproven' conclusions only; no detailed indication-based coverage rules are provided in these chunks.

Full coverage rationale pages referenced but not included in this part.

inv-214: Assessment of tissue oxygenation and microvascular disease risk (research/adjunctive use)

SFDI (Clarifi) may be considered for research or adjunctive assessment of tissue oxygenation:

Research/adjunctive use: Use of SFDI to assess superficial tissue oxygenation and microvascular metrics (StO2, HbT1) may be appropriate in research settings or as adjunctive information in complex vascular assessments, but routine clinical use is not supported pending prospective outcome studies.

FDA 510(k) clearance exists for Clarifi but clinical utility for outcomes not demonstrated.

inv-215: Assessment of foot microvascular disease/perfusion using SFDI

SFDI mapping of plantar foot perfusion is investigational for routine clinical use:

SFDI evidence note: SFDI maps StO2 and papillary/reticular hemoglobin in the plantar foot and observational data suggest correlation with microvascular disease severity, but outcome-based validation and direct microvascular gold standard comparisons are lacking.

Further prospective wound-based outcome studies recommended.

inv-216: Retinal prosthesis implantation and device evaluations

Retinal prosthesis implantation and device evaluations — contextual summary:

Retinal prosthesis indication: Argus II (and similar retinal prostheses) are intended for severe-to-profound retinitis pigmentosa meeting HDE/clinical criteria and require postimplant follow-up, rehabilitation and device interrogation; evidence limited to nonrandomized trials and case series.

Manufacturing ceased for Argus II; further devices remain investigational.

inv-217: Chest radiograph—use of CAD

CAD for chest radiograph use — evidence considerations:

CAD adjunct for chest radiograph interpretation: CAD may be used as an adjunct to radiologist interpretation, but current evidence is insufficient to support CAD for population-based screening; effectiveness on hard outcomes remains uncertain.

Technical studies predominate; randomized outcome trials lacking.

inv-218: Eyelid/meibomian gland treatment—thermal pulsation

Eyelid/meibomian gland thermal pulsation — use context and limits:

Thermal pulsation for MGD: Thermal pulsation devices may be considered after failure of conservative measures; evidence shows mixed results with some trials reporting symptom and gland function improvements but analyses accounting for within-patient eye correlation reduce effect consistency.failure of conservative therapy

Professional bodies list VTP as a second-line option; insurer policy deems device use unproven for routine coverage.

inv-219: Mobile/automated audiometry usage and limitations

Mobile/automated audiometry — intended uses and limitations:

Indication: Mobile or automated audiometry may be used for screening or preliminary assessment where conventional audiometry is unavailable, with documentation of device, environment, calibration, and limitations; not validated as equivalent to audiologist-performed pure-tone audiometry for definitive diagnosis in all populations.Sensitivity 89%, Specificity 93%

Accuracy reduced in children, elderly, and certain pathologies; calibration and noise control required.

inv-220: Heart failure with reduced ejection fraction (selected trial populations)

Heart failure populations studied for device therapies (selected trials):

BeAT-HF cohort D: Selected trial populations for CCM included HFrEF patients (e.g., NYHA class III) with NT-proBNP <1600 pg/mL and LVEF within trial-specified ranges; improvements in 6MWD, QOL, and NT-proBNP were demonstrated in some cohorts at 6 months.NT-proBNP <1600 pg/mL; LVEF 25%-45%

FDA labeling and trial cohorts inform covered candidacy.

inv-221: Dry eye disease / tear film assessment

Dry eye disease — tear film imaging context:

Tear film imaging indications: Tear film imaging lacks demonstrated diagnostic performance or clinical utility as a standalone test; when used, it should be paired with slit-lamp exam and conventional tests (TBUT, Schirmer, staining) to inform management, but routine coverage is not supported.

Device agreement and repeatability are variable across platforms.

inv-222: Heart failure prognostication

Heart failure prognostication — imaging context:

123I‑MIBG indications: I-123 MIBG imaging assesses myocardial sympathetic innervation and shows prognostic associations (e.g., H/M ratio) but lacks evidence that imaging-directed management alters outcomes; routine prognostic use is unproven.H/M 1.60

ADMIRE-HF data demonstrate association but not management benefit.

inv-223: I-123 MIBG myocardial scintigraphy — prognostic assessment (evidence of association only)

I-123 MIBG myocardial scintigraphy — prognostic assessment (evidence of association only):

I-123 MIBG indication context: I-123 MIBG planar H/M ratio <1.60 is associated with higher mortality and arrhythmic risk in follow-up analyses, but clinical utility for guiding therapy is not established.H/M 1.60

No trials demonstrate improved outcomes from imaging-guided management.

inv-224: Visual evoked potentials — selective diagnostic use (not routine screening)

Visual evoked potentials — selective diagnostic use (not routine screening):

VEP possible uses: VEPs may be useful to estimate visual acuity in select pediatric or special-needs populations where behavioral testing is unreliable, but evidence is limited and automated VEP screening for general populations is unproven.none

Provide indication, VEP type, and how results would change management when submitting for review.

inv-225: Subtalar arthroereisis (sinus tarsi implant) — considered only after conservative therapy failure; evidence low-quality

Subtalar arthroereisis — coverage context:

Arthroereisis consideration: Subtalar arthroereisis may be considered only after failure of conservative therapy for symptomatic flexible flatfoot; evidence is low-quality with heterogeneous outcomes and meaningful complication/implant removal rates, so routine coverage is not supported.failure of conservative therapy

Documentation should include prior conservative treatments and functional limitations.

inv-226: Orthopedic implant migration monitoring (research context)

Orthopedic implant migration monitoring — research context:

Research/phased introduction: RSA may be appropriate within research protocols, phased introduction of new implants, or studies monitoring early migration with standardized reporting and ISO adherence rather than routine clinical use.

RSA is highly precise but lacks standardized routine clinical application evidence.

inv-227: Adjuvant accelerated partial breast irradiation (APBI)

Adjuvant accelerated partial breast irradiation (APBI) — electronic brachytherapy context:

Breast APBI using electronic brachytherapy: Electronic brachytherapy for APBI has inconclusive evidence with some randomized data indicating higher recurrence; use should be limited to prospective trials or registries and not routine practice.

ABS, ECRI and NICE guidance recommend caution and research settings.

inv-228: Basal cell carcinoma, squamous cell carcinoma of skin

Nonmelanoma skin cancer — electronic brachytherapy context:

Nonmelanoma skin cancer - electronic surface brachytherapy: Evidence for electronic surface brachytherapy in basal cell and squamous cell carcinoma is low quality and inconclusive; surgical management (Mohs) remains standard of care and electronic brachytherapy should be limited to trials/registries or special circumstances.

NCCN and AAD statements referenced.

inv-229: Endometrial and cervical cancers

Gynecologic cancers — electronic brachytherapy evidence:

Gynecologic cancers - electronic brachytherapy: Available case series for endometrial and cervical cancers are small and retrospective; evidence is inconclusive and does not demonstrate superiority to conventional brachytherapy; use should be limited to prospective studies.

ECRI review and systematic literature cited.

inv-230: Indeterminate biliary strictures

Indeterminate biliary strictures — CLE evidence summary:

Indeterminate biliary strictures: Probe-based CLE (pCLE) shows higher sensitivity than ERCP brush sampling in meta-analyses and may aid diagnosis of indeterminate biliary strictures, but studies are heterogeneous and limitations exist; routine adoption is not supported in this policy.

Meta-analysis sensitivity ~88% with variable specificity; prospective validation needed.

inv-231: Barrett's esophagus surveillance

Barrett's esophagus surveillance — CLE role and guideline position:

Barrett's esophagus surveillance: Meta-analyses show variable sensitivity/specificity for CLE versus histopathology; guideline panels do not recommend routine CLE over Seattle protocol and high-definition white light; CLE may be adjunctive at expert centers after standard surveillance applied.

RCTs show no clear improvement in outcomes when adding pCLE to standard HDWL surveillance.

inv-232: Gastric and colorectal neoplasms

Gastric and colorectal neoplasms — CLE evidence:

Gastric and colorectal lesions: Small RCTs and meta-analyses suggest CLE may increase biopsy yield or show high sensitivity/specificity for some gastric and colorectal neoplasms, but limited study quality and generalizability restrict routine clinical adoption.

Further validation in larger prospective studies required.

inv-233: Imaging guidance for CCM device implantation and lead placement

Imaging guidance for CCM device implantation and lead placement:

Imaging for CCM implantation: Imaging guidance is implied for lead placement and device pocket creation during CCM implantation; providers should use appropriate imaging modalities per standard surgical practice and document device programming and testing.

Specific modality guidance not detailed in this extract.

inv-234: Middle ear imaging for otitis media evaluation and biofilm assessment

Middle ear imaging — investigational applications:

Investigational indications for middle ear OCT: OCT may visualize middle ear effusion, biofilms, and tympanic membrane thickness and shows promising diagnostic accuracy in small studies, but clinical utility for changing management or improving outcomes is unproven.

Studies are small and preliminary; further validation required.

inv-235: Meibomian gland imaging

Meibomian gland imaging — current evidence:

Indication summary: Imaging to assess meibomian gland structure (near-infrared or dynamic meibomian imaging) is described but lacks evidence that imaging improves outcomes; use remains investigational.

Professional guidance emphasizes clinical exam and conventional tests; imaging may be adjunctive in research or specialty centers.

Prior Authorization Expectations

Prior Authorization

Unproven codes imply denial/noncoverage without guidance

Many codes listed in the omnibus table are concluded to be “Unproven,” which implies noncoverage or denial absent additional payer guidance; providers should not assume prior authorization will secure coverage for these codes.

Prior Authorization

Remote pulmonary artery pressure monitoring / home monitoring devices PA

Remote pulmonary artery pressure monitoring and related home monitoring device support/replacement codes (e.g., 93264, G0555) are noted as covered in certain circumstances and may require prior authorization when billed.

Prior Authorization

Endovascular vertebral artery stenting; proprietary biomarker tests

Endovascular vertebral artery stenting and proprietary biomarker CRC tests are explicitly described as unproven and not medically necessary in the policy; prior authorization requests for these services are unlikely to result in approval.

Prior Authorization

Procedural/device prior auth per member benefit

For unproven procedural or device interventions, prior authorization or clinical review per the member’s benefit plan may be required and is recommended to determine if any exception or coverage applies.

Prior Authorization

Tear film imaging; 123I‑MIBG imaging prior auth expectation

The policy states prior authorization is expected for tear film imaging and for I‑123 MIBG myocardial imaging and notes approvals are unlikely because both modalities are concluded to be not medically necessary for routine prognostic or monitoring use.

Prior Authorization

Surgical implant procedures; automated VEP prior auth

Surgical implant procedures (such as sinus tarsi implants) and automated VEPs are designated unproven/not medically necessary; prior authorization is recommended and requests should document failure of conservative therapy and how the intervention will alter management.

Prior Authorization

RSA or BIA coded services prior auth likely

RSA or BIA coded services (Category III codes) are identified as unproven and prior authorization or clinical review is likely required when billed.

0347T–0350T (RSA) and 0358T (BIA) specifically listed as at risk for denial and likely subject to prior authorization/clinical review ([[chunk 191],[chunk 199]]).

Prior Authorization

Electronic brachytherapy prior auth recommended outside trials

Electronic brachytherapy is recommended to be prior‑authorized when proposed outside of a prospective clinical trial or registry because the evidence is inconclusive for many indications.

Prior Authorization

CLE / Optical Endomicroscopy prior auth / medical review likely

Confocal laser endomicroscopy (CLE) / optical endomicroscopy is considered not medically necessary for routine use; requests are likely to require denial or medical review rather than routine prior authorization approval.

Prior Authorization

Implantable device procedures prior auth suggested

Implantable device procedures (implantation, replacement, interrogation, programming) such as for CCM or other implantable systems are suggested to require prior authorization; include device and candidacy documentation.

Note

Billing Rule

Contrast rules — fluorescein note for CLE

Confocal laser endomicroscopy requires intravenous fluorescein for imaging; this contrast requirement is an explicit consideration documented in the policy and should be noted when submitting authorization or coverage requests.

Note

Billing Rule

Contrast rules — middle ear OCT (no contrast rules)

No contrast‑specific billing rules are discussed for middle ear OCT in the policy; document that OCT does not rely on contrast in the submission when relevant.

Services Deemed Not Medically Necessary / Denial Subjects

Across the omnibus listing the policy treats the many new T/Category III codes as lacking sufficient evidence: the codes that appear in the table are presented with the conclusion "Unproven". Examples include diagnostic, monitoring, and device interrogation codes (multiple 05xx–06xx series codes) and procedure codes; when a code is designated Unproven the policy communicates that routine coverage is not supported and claims may be denied.

Multiple procedure and device‑related CPT/HCPCS entries in the extract are grouped under the same coverage conclusion. Examples in the excerpt include interrogation/evaluation and removal/replacement device procedures (0575T–0580T and similar codes), implantable device pocket and generator relocation codes (0861T–0863T), and a range of unlisted or procedural codes used to report device work (29799, 27599). The policy consistently lists these multiple procedure/device codes as Unproven, indicating they are not supported for routine coverage in the absence of stronger evidence.

The policy names several specific technologies as not medically necessary: a proprietary blood‑based colorectal cancer biomarker panel using a 3‑protein ELISA algorithm (0163U/BeScreened‑type) is stated to be unproven and not medically necessary for CRC screening; thermal pulsation/meibomian gland evacuation devices and wearable eyelid heat systems are likewise described as unproven/not medically necessary for gland evaluation or evacuation; and the policy also concludes that OCT of the middle ear (0485T/0486T) and near‑infrared dual meibomian imaging (0507T) lack sufficient evidence and are not medically necessary for routine management.

Baroreflex activation therapy (BAT) for resistant hypertension is addressed in the evidence narrative: randomized and observational studies have produced mixed and limited-quality results and guideline assessments (including NICE) have found evidence inadequate for routine use. The policy therefore treats carotid sinus baroreflex stimulation and related device procedures as unproven and not medically necessary for resistant hypertension outside narrow, evidence‑based indications or research settings.

Tear film imaging modalities (e.g., interferometry/topography) and near‑infrared meibomian gland imaging are noted to have limited, inconsistent evidence and lack professional guideline endorsement; accordingly tear film imaging and near‑infrared dual meibomian imaging are described as unproven/not medically necessary for routine assessment. Similarly, myocardial sympathetic innervation imaging with 123I‑MIBG is summarized as showing prognostic association in cohort analyses but lacking prospective data demonstrating that imaging‑guided management improves outcomes; the policy designates routine MIBG prognostic imaging as unproven and not medically necessary.

The policy explicitly lists placement of drug‑eluting ocular inserts (0444T/0445T) under the eyelid(s) as unproven and not medically necessary. Other technologies called out with the same conclusion in the excerpt include optical coherence tomography of the middle ear (0485T/0486T) and near‑infrared dynamic meibomian gland imaging (0507T). These entries are cited by the policy as lacking adequate evidence of safety and/or efficacy to support routine coverage.

Policy Background and Evidence Context

This policy section is an omnibus listing of numerous recently established CPT and HCPCS codes (primarily Category III/T and select U codes). For all codes shown in the excerpt, the policy assigns the coverage conclusion "Unproven", indicating that the payer does not consider existing evidence sufficient to support routine medical necessity for the listed services and that claims using these codes may be denied absent other payer guidance or additional supporting documentation. The table of codes and the brief coverage conclusions are provided to direct reviewers to the full coverage rationale and evidence summaries for each code where available.

The policy includes evidence summaries and cites professional society positions when available. For example, systematic reviews and RCTs for vectored thermal pulsation (VTP) are summarized and the American Academy of Ophthalmology/TFOS place VTP as a second‑line option for meibomian gland dysfunction; ECRI assessments and HTAs (referenced for several topics) are used to support determinations where evidence quality is limited or inconsistent. These evidence and guideline references are the basis for the policy’s conclusions that many of the listed technologies are unproven or not medically necessary for routine use.

Key Terms and Device Definitions

inv-181: 0061U (example) — transcutaneous measurement of biomarkers

Test descriptionTranscutaneous measurement of five biomarkers using SFDI and multi-spectral analysis: tissue oxygenation (StO2), oxyhemoglobin (ctHbO2), deoxyhemoglobin (ctHbR), papillary and reticular dermal hemoglobin concentrations (ctHb1 and ctHb2)

Example CPT code0061U

Intended use noteReported as noninvasive tissue oxygenation mapping; policy conclusion in extract = Unproven

inv-182: Clarifi Imaging System — SFDI device description and clearance

DeviceClarifi Imaging System (Modulated Imaging, Inc.)

TechnologyNon-contact spatial frequency domain imaging (SFDI) optical system producing 2D/3D maps of tissue oxygenation and hemoglobin content

Regulatory statusFDA 510(k) clearance referenced (K181623)

inv-183: SFDI metrics (StO2, HbT1)

StO2Tissue oxygen saturation mapped by SFDI

HbT1Papillary dermal hemoglobin (HbT1) representing microcirculatory hemoglobin content

Usage in researchMetrics evaluated in studies for peripheral microvascular disease assessment and correlation with clinical vascular tests

inv-184: SFDI (spatial frequency domain imaging) definition

DefinitionSpatial frequency domain imaging (SFDI): optical technique generating spatially resolved maps of tissue scattering and absorption to estimate parameters such as StO2 and hemoglobin content

ApplicationUsed to assess superficial tissue oxygenation and microvascular metrics in research settings (e.g., foot microvascular disease)

LimitationsEvidence limited to observational studies; clinical outcome utility not established

inv-185: HDE definition

DefinitionHumanitarian Device Exemption (HDE): FDA pathway allowing marketing of devices for rare conditions when probable benefit exists and safety is acceptable

Context in policyArgus II received HDE; HDE may require post-approval studies and limits generalizability of evidence

Regulatory implicationHDE status does not equate to broad clinical effectiveness; coverage considerations remain evidence-dependent

inv-186: BeScreened-CRC definition (ELISA-based multiplex panel)

Test typeBeScreened-CRC: ELISA-based multiplexed CLIA laboratory-developed CRC screening test

AnalytesMeasures three plasma/serum proteins: CEA, ECM protein, and TDGF-1 (Cripto-1) with an algorithmic output

Policy conclusionDescribed in policy extract as unproven (coverage conclusion = Unproven)

inv-187: Thermal pulsation / VTP devices definition (LipiFlow, iLUX examples)

DefinitionThermal pulsation / Vectored Thermal Pulsation (VTP): device-delivered eyelid procedure applying localized heat and intermittent pulsatile pressure to express meibomian glands (examples: LipiFlow, iLUX)

Procedure durationSingle device-delivered treatment commonly performed in a single 12-minute session (example: LipiFlow)

Evidence contextAAO lists VTP as a second-stage option; RCTs show mixed quality and manufacturer involvement; policy labels use as unproven/not medically necessary in extract

inv-188: CAD for chest radiographs definition

DefinitionComputer-aided detection (CAD) for chest radiographs: computer algorithms analyzing chest x-rays to flag suspicious findings and augment radiologist interpretation

Evidence notePublished literature mainly technical; insufficient evidence that CAD mass screening reduces mortality or substantially improves detection

Clinical roleAdjunct to radiologist interpretation rather than stand-alone screening tool based on current evidence

inv-189: Vectored thermal pulsation (VTP) definition

DefinitionVectored thermal pulsation (VTP): a device-delivered 12-minute procedure applying heat and pulsatile pressure to eyelids to express meibomian glands (example: LipiFlow)

Intended effectEvacuation of meibomian gland contents to improve gland function and tear film quality

Typical useUsed for meibomian gland dysfunction/dry eye after conservative therapies; evidence mixed

inv-190: Wearable open-eye eyelid heat device definition

DefinitionWearable open-eye eyelid heat device: software-controlled wearable delivering targeted adjustable heat to eyelids/meibomian glands while eyes remain open (example: TearCare)

Clinical evidenceRCTs comparing TearCare to LipiFlow show short-term equivalence but limited long-term data and study limitations

Guideline statusNot specifically addressed in AAO preferred practice patterns; evidence insufficient for routine coverage per policy extract

inv-191: Mobile audiometry (MA) definition

DefinitionMobile audiometry (MA): audiometric testing using mobile devices (smartphones, tablets, computers) with dedicated apps and calibrated hardware to estimate pure-tone thresholds or screen for hearing loss

Performance metricsMeta-analyses report pooled sensitivity/specificity (e.g., sensitivity 89%, specificity 93%) and mean threshold differences generally <10 dB in many settings

LimitationsAccuracy lower in children and elderly, heterogeneous devices/settings, and may not replace audiologist-performed diagnostic audiometry

inv-192: Atherectomy definition

DefinitionAtherectomy: endovascular removal of atheromatous plaque by cutting, drilling, shaving, pulverizing, lasing, or sanding to enlarge the treated lumen

Device typesIncludes directional, rotational, orbital, excimer laser, lithotripsy and CTO recanalization systems

Policy noteEvidence for atherectomy in visceral/renal/abdominal/brachiocephalic arteries is limited to case reports and small series

inv-193: PreTRM test definition

DefinitionPreTRM test: serum proteomic test measuring IBP4 and SHBG to predict risk of spontaneous preterm birth

Intended usePredictive-risk stratification for spontaneous preterm birth in asymptomatic pregnant individuals

Policy conclusionInsufficient evidence to support use for screening; considered unproven in extract

inv-194: Baroreflex activation therapy (BAT) definition

DefinitionBaroreflex activation therapy (BAT): implanted pulse generator and leads delivering electrical stimulation to carotid sinus baroreceptors to influence blood pressure and autonomic balance

Device examplesBarostim neo™ and Rheos® systems referenced; Barostim neo received FDA PMA for heart failure and limited HDE for legacy hypertension indications

Clinical stanceEvidence for BAT in hypertension/heart failure considered insufficient for routine use in many indications (policy: unproven/not medically necessary)

inv-195: Tear measurement metrics (LLT, TMH, NIBUT etc.)

LLTLipid layer thickness — interferometry-derived metric of tear film lipid layer

TMHTear meniscus height — measure of tear volume at lid margin

NIBUT (NIF-BUT / NIKBUTav)Noninvasive tear break-up time measures of tear film stability (device-specific names vary)

inv-196: H/M ratio definition

DefinitionHeart/mediastinum (H/M) ratio: quantitative planar I-123 MIBG myocardial scintigraphy measure of cardiac sympathetic innervation

Prognostic thresholdH/M ratio < 1.60 reported as associated with higher mortality and arrhythmic risk in ADMIRE‑HF follow-up

Clinical limitationThough prognostic, imaging-directed management benefit not demonstrated in ADMIRE‑HF

inv-197: Heart/mediastinum (H/M) ratio — duplicate reference

Alternate labelHeart/mediastinum (H/M) ratio — duplicate reference confirming H/M <1.60 prognostic association

Evidence sourceADMIRE‑HF follow-up stratified 964 subjects and reported higher all-cause and cardiac mortality with H/M <1.60

InterpretationUseful as prognostic metric but lacks evidence that acting on result improves outcomes

inv-198: Subtalar arthroereisis (SA) definition

DefinitionSubtalar arthroereisis (SA): surgical placement of an implant in the sinus tarsi to limit excessive subtalar joint motion for correction of flexible flatfoot

Implant typesCommon implants include titanium screws or resorbable PLLA devices

Clinical contextConsidered after failure of conservative therapy; evidence heterogeneous with notable implant removal rates

inv-199: Visual evoked potentials (VEPs) definition

DefinitionVisual evoked potentials (VEPs): electrophysiologic tests (pattern, sweep, steady-state) measuring cortical responses to visual stimuli to estimate visual acuity or detect interocular differences

Common usesStudied in pediatric and special-needs populations to estimate acuity where behavioral testing is unreliable

Policy stanceAutomated VEP screening described as unproven and not medically necessary for routine screening

inv-200: Ultrasound renal denervation (uRDN) definition

DefinitionUltrasound renal denervation (uRDN): percutaneous renal sympathetic denervation using ultrasound energy (Paradise System) to ablate perirenal sympathetic nerves

Regulatory noteFDA approved ultrasound RDN system (Paradise) and PMA approvals for other systems noted in 2023

Intended effectAdjunctive BP lowering in patients with resistant or uncontrolled hypertension after optimization of medical therapy

inv-201: RDN CPT Category III codes

Codes0338T (unilateral) and 0339T (bilateral)

ProcedureTranscatheter renal sympathetic denervation, percutaneous approach (selective catheter placement, fluoroscopy, contrast, intraprocedural mapping)

Policy classificationListed as transcatheter RDN CPT Category III codes in document

inv-202: Radiostereometric analysis (RSA) definition

DefinitionRadiostereometric analysis (RSA): technique embedding small tantalum markers in bone and using calibrated biplanar x-rays and software to calculate 3D micromotion and implant migration

ApplicationHigh-precision research tool for early detection of implant migration and phased introduction of orthopedic implants

LimitationsClinical utility for routine care not established; considered unproven in policy extract

inv-203: Bioelectrical impedance analysis (BIA) definition

DefinitionBioelectrical impedance analysis (BIA): method estimating body composition by measuring electrical impedance to calculate total body water, fat-free mass, and fat mass

VariantsIncludes multi-frequency BIA (MF-BI), Bioelectrical Impedance Vector Analysis (BIVA), and BIS; device- and equation-dependent accuracy

LimitationsAccuracy variable at individual level; affected by hydration and measurement conditions

inv-204: BIA / MF-BI / BIVA / BIS definitions

BIA variantsMF-BI, BIVA, BIS: methods aiming to improve estimation of TBW, FM, and FFM with multi-frequency or vector analysis

Clinical validitySystematic reviews show variable agreement with reference methods; acceptable for group-level assessments but limited for individual clinical decisions

Policy noteDocument concludes insufficient evidence for routine clinical use in many indications

inv-205: Electronic brachytherapy definition

DefinitionElectronic brachytherapy: brachytherapy using a miniaturized X-ray source rather than radionuclide to deliver high-dose radiation close to target tissue

ApplicationsUsed experimentally for skin, breast APBI, endometrial/cervical indications; evidence inconclusive

Professional guidanceABS and other societies recommend limiting use to prospective trials/registries for many indications

inv-206: Probe-based confocal laser endomicroscopy (pCLE)

DefinitionProbe-based confocal laser endomicroscopy (pCLE): a CLE technique using a probe passed through an endoscope working channel to provide real-time microscopic imaging of mucosa and biliary ducts

ComparatorsOften compared to biopsy/histopathology and HD white light endoscopy; used adjunctively in specialized centers

LimitationsRequires intravenous fluorescein, specialized training, and has limited randomized outcome evidence

inv-207: Endoscope-based confocal laser endomicroscopy

DefinitionEndoscope-based confocal laser endomicroscopy: CLE system integrated into the endoscope for in vivo microscopic imaging during endoscopy

Commercial statusHistorically available but less commonly commercialized than probe-based systems; both platforms studied

Clinical roleMay increase per-patient sensitivity for select indications but not endorsed for routine surveillance over standard protocols

inv-208: Cardiac contractility modulation (CCM) — mechanism

MechanismCardiac contractility modulation (CCM) delivers nonexcitatory electrical signals during the cardiac refractory period to augment myocardial contractility

DeliveryProvided by an implanted pulse generator with transvenous right ventricular leads and tailored programming

Clinical effectsRCTs report improved functional capacity and quality of life but not mortality/hospitalization benefits to date

inv-209: Optimizer Smart System (PMA P180036)

DeviceOptimizer Smart System

Regulatory statusFDA premarket approval (PMA P180036) indicating selected indication

Indication summaryApproved for select NYHA class III HF patients with LVEF 25%–45% not indicated for CRT

inv-210: Drug-eluting ocular insert definition

DefinitionDrug-eluting ocular insert: thin drug-impregnated solid/semisolid device placed under the eyelid to release medication over weeks to months

Clinical evidenceFew published studies; small trials with short follow-up limit conclusions on outcomes

Policy conclusionPolicy extract lists placement as unproven/not medically necessary

inv-211: OCT of the middle ear definition

DefinitionOCT of the middle ear: noninvasive, real-time imaging using low-intensity light producing 2D/3D structural images of the middle ear with micron-scale resolution

Potential usesDifferentiate air vs fluid, characterize effusions and visualize biofilms; promising diagnostic capability reported in small studies

Evidence gapLack of high-quality outcome studies demonstrating improved patient management or outcomes

inv-212: Near-infrared dual imaging (Dynamic Meibomian Imager)

DefinitionNear-infrared dual imaging (Dynamic Meibomian Imager): imaging combining dynamic surface illumination and adaptive transillumination to render multidimensional views of meibomian gland structure

Manufacturer claimsProvides rapid high-definition gland imaging to assist clinical assessment (example: LipiScan Dynamic Meibomian Imager)

Policy noteEvidence on effectiveness for management is lacking and professional society guidance absent

Additional Coding Details and Thresholds

Policy Summary

PayerUnitedHealthcare

PolicyOmnibus (New/Unproven) CPT/HCPCS Codes Coverage

Policy CodePolicy 2025T0535UUU

Change TypeNo material clinical or coverage changes in this revision

Effective DateMay 1, 2025

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Omnibus (New/Unproven) CPT/HCPCS Codes Coverage

Coverage Conclusions and Evidence Summaries

CPT / HCPCS Codes and Status

Prior Authorization, Documentation, and Billing Guidance

Contexts Where Use May Be Supported or Considered

Prior Authorization Expectations

Services Deemed Not Medically Necessary / Denial Subjects

Policy Background and Evidence Context

Key Terms and Device Definitions

Additional Coding Details and Thresholds

Policy Updates