UnitedHealthcare Omnibus Codes Coverage Update

CPT / HCPCS codes and code groups

Sample codes listed (excerpt)CPT

0061U	Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]) , using frequency domain imaging (SFDI) and multi-spectral analysis spatial
00761	Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation; each additional vessel
0163U	Oncology (colorectal) screening; biochemical enzyme-linked immunosorbent assay (ELISA) of 3 plasma or serum proteins with proprietary algorithm
01741	Computer-aided detection (CAD) with further physician review; chest radiograph(s) performed concurrent with primary interpretation
01751	Computer-aided detection (CAD) remote from primary interpretation

Additional codes listed (excerpt)CPT

0207T	Evacuation of meibomian glands, automated, using heat and intermittent pressure, unilateral
02081	Pure tone audiometry (threshold), automated; air only
02341	Transluminal peripheral atherectomy; renal artery
0330T	Tear film imaging; unilateral or bilateral, with interpretation and report
0347T	Placement of interstitial device(s) in bone for radiostereometric analysis (RSA)
0394T	High dose rate electronic brachytherapy, skin surface application, per fraction
0440T	Ablation, percutaneous, cryoablation, includes imaging guidance; upper extremity distal peripheral nerve
0559T	Anatomic model 3D-printed from image data set(s); first individually prepared and processed component

Listed CPT/HCPCS Codes (selected excerpts)mixed

0061U	Transcutaneous measurement of biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2]; deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]), spatial frequency domain imaging (SFDI) and multi-spectral analysis
0608T	Remote monitoring of an external continuous pulmonary fluid monitoring system; transmitted to a remote 24-hour attended surveillance center; set-up and patient education
0614T	Removal and replacement of substernal implantable defibrillator pulse generator
0615T	Automated analysis of binocular eye movements without spatial calibration for assessment of concussion
06311	Transcutaneous visible light hyperspectral imaging measurement of oxyhemoglobin, deoxyhemoglobin, and tissue oxygenation, per extremity
06401	Noncontact near-infrared spectroscopy, image acquisition, interpretation, and report; first anatomic site
0647T	Insertion of gastrostomy tube, percutaneous; with magnetic gastropexy, under ultrasound guidance
06581	Electrical impedance spectroscopy of skin lesions for automated melanoma risk score
06591	Transcatheter intracoronary infusion of supersaturated oxygen in conjunction with PCI during acute MI
06921	Therapeutic ultrafiltration

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Additional listed CPT codesCPT

64454	Injection(s), anesthetic agent(s) and/or steroid; genicular nerve branches, including imaging guidance
64624	Destruction by neurolytic agent, genicular nerve branches including imaging guidance
17999	Unlisted procedure, skin; mucous membrane and subcutaneous tissue
61715	Stereotactic ablation of target; intracranial, including stereotactic navigation and frame placement
63268	Laminectomy for excision or evacuation of intraspinal lesion other than neoplasm, extradural; sacral

Retinal prosthesis CPT/HCPCS 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, in person, with iterative adjustment including visual training; with review and report.
0473T	Device evaluation and interrogation of intraocular retinal electrode array, 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 (BeScreened-like) U-codeCPT

0163U

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

CAD chest radiograph CPT codesCPT

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

CAD CPT/HCPCS codes mentionedCPT

0174T	Computer-aided detection (CAD) with further physician review for interpretation and report; with or without digitization of film radiographic images, chest radiograph(s), performed concurrent with primary interpretation
0175T	Computer-aided detection (CAD) with further physician review for interpretation and report, performed remote from primary interpretation

Eyelid thermal pulsation / wearable device procedure codesCPT

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

No procedure codes listed in these chunksmixed

No codes listed

Baroreflex activation device procedure codesCPT

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

Tear film imaging (unproven / not_covered)CPTNot Covered

0330T

Tear film imaging; unilateral or bilateral, with interpretation and report (tear film imaging)

Myocardial sympathetic innervation imaging (123I‑MIBG)CPTNot Covered

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

Listed CPT/HCPCS related to VEP and sinus tarsi implant proceduresmixed

0333T	Visual evoked potential, screening of visual acuity, automated, with report
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, percutaneous approach; unilateral
0339T	Transcatheter renal sympathetic denervation, percutaneous approach; bilateral

Unproven / Not medically necessary imaging/assessment CPT Category III codesCPTNot Covered

0347T	Placement of interstitial device(s) in bone for radiostereometric analysis (RSA).
0348T	Radiologic examination, radiostereometric analysis (RSA); spine, (includes cervical, thoracic and lumbosacral, when performed).
0349T	Radiologic examination, radiostereometric analysis (RSA); upper extremity(ies), (includes shoulder, elbow, and wrist; when performed).
0350T	Radiologic examination, radiostereometric analysis (RSA); lower extremity(ies), (includes hip, proximal femur; knee, and ankle, when performed).
0358T	Bioelectrical impedance analysis whole body composition assessment, with interpretation and report.

Unproven / Not Medically Necessary - BIACPTNot Covered

0358T

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

Unproven / Not Medically Necessary - Electronic BrachytherapyCPTNot Covered

0394T	High dose rate electronic brachytherapy, skin surface application, per fraction; includes basic dosimetry, when performed.
0395T	High dose rate electronic brachytherapy, interstitial or intracavitary treatment; per fraction, includes basic dosimetry, when performed

Unproven / Not Medically Necessary - Confocal Laser EndomicroscopymixedNot Covered

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

CLE/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

MRgFUS intracranial ablation CPTCPT

61715

Magnetic resonance image guided high intensity focused ultrasound (MRgFUS), stereotactic ablation of target; intracranial, including stereotactic navigation and frame placement; when performed.

Listed procedure/revenue codes present in this section (unrelated device codes)CPT

0408T	Insertion or replacement of permanent cardiac contractility modulation system, including contractility evaluation when performed, and programming of sensing and therapeutic parameters; generator with transvenous electrodes
0409T	Insertion or replacement of permanent cardiac contractility modulation system; 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 of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, including review and report; implantable cardiac contractility modulation system

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CCM-related CPT/HCPCS Codesmixed

0408T	Insertion or replacement of permanent cardiac contractility modulation system; generator with transvenous electrodes
0409T	Insertion or replacement of permanent cardiac contractility modulation system; 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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Cryoablation and ocular insert CPT 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
0444T	Initial placement of a drug-eluting ocular insert under one or more eyelids, including training; insertion, unilateral or bilateral fitting
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

Drug-eluting ocular insert CPT codesCPTNot Covered

0444T	Initial placement of a drug-eluting ocular insert under one or more eyelids, including training; and insertion, unilateral or bilateral fitting
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 CPT 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

Macular pigment optical density CPT codeCPTNot Covered

0506T

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

Meibomian gland near-infrared imaging CPT codeCPTNot Covered

0507T

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

Prior authorization, documentation, and denial risks

Prior Authorization

Prior authorization note

Prior authorization may be required for certain services described in this policy. Providers should verify member benefits and obtain prior authorization when the benefit document or contract requires it; absence of prior authorization does not guarantee coverage. When submitting a prior authorization request, include sufficient clinical documentation to support medical necessity as outlined below.

Check member-specific benefit documents and contractual terms prior to scheduling.
Prior authorization does not imply payment if service is designated not medically necessary in this policy.

Prior Authorization

Prior authorization may be required for select remote monitoring codes

Some remote monitoring and device-management CPT/HCPCS codes (for example, 93264 — remote monitoring of a wireless pulmonary artery pressure sensor) are covered in specific circumstances but may require prior authorization. Confirm authorization requirements for these codes before billing.

Examples: CPT 93264 (remote pulmonary artery pressure sensor monitoring) — covered in certain circumstances; prior authorization may be required.
Verify requirements for other remote monitoring codes that appear in the coverage table.

Documentation Required

Prior authorization: evidence considerations

Evidence limitations or mixed-quality data may affect prior authorization decisions. Treatments or devices with limited, short-term, small-sample, or industry-sponsored evidence are more likely to require detailed documentation and may be denied when outcomes versus comparators are not well demonstrated.

Small randomized trials, short follow-up, or lack of independent replication may trigger additional review.
Guideline recommendations (or lack thereof) influence authorization and denial risk.

Prior Authorization

Prior authorization for implantation/revision/interrogation codes

Request prior authorization for implantation, revision, removal, or interrogation of implantable devices when the procedure relates to a device listed in this policy. Include device labeling, indication for the procedure, and documentation of complications or device malfunction when applicable.

Include operative report and device identification (model, serial number) when available.
If revision/removal is for complication, include coding and rationale linking complication to device (and reference benefit/contract language).

Prior Authorization

Prior authorization recommendation for BAT

For baroreflex/baroreceptor activation therapy (BAT) requests, prior authorization is recommended. Provide trial identifiers, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) class, NT-proBNP levels when relevant, and documentation that BAT is being considered as an adjunct to guideline-directed medical therapy (GDMT).

Document prior and current GDMT, reason for adjunctive BAT, and specific trial cohort or device instructions for use when applicable.
Include baseline and follow-up functional measures (e.g., 6-minute walk distance, QOL scores) if available.

Denial Risk

Denial risk for Unproven items

Services and codes designated Unproven or Not Medically Necessary in this policy carry a high denial risk. Prior authorization does not convert an unproven service into a covered one; requests for these services should include compelling, high-quality evidence that addresses gaps noted in this policy.

Common denial-trigger codes include many listed as Unproven (see coverage table).
Providers should expect claim denial when documentation does not address the specific evidence concerns raised in the policy.

Denial Risk

Guideline-based denial risk

When practice guidelines recommend against routine use (for example, routine vertebral artery stenting), authorization requests should demonstrate that strict guideline-based criteria are met (e.g., recurrent vertebrobasilar symptoms despite best medical therapy and appropriate degree of stenosis). Without meeting guideline-aligned indications, prior authorization is unlikely to be approved.

For vertebral artery stenting, document recurrent symptoms despite optimal medical therapy and confirm stenosis severity (typically 50–99%) with imaging.
If using drug-eluting stents, include rationale per guideline preference when applicable.

Documentation Required

Evidence limitations that may affect authorization

Evidence limitations that commonly affect authorization decisions include small sample sizes, short duration of follow-up, lack of independent or blinded trials, and inconsistent outcome measures vs comparators. When such limitations exist, provide additional longitudinal data, registry enrollment, or rationale for extrapolating benefit to the requested patient.

If only industry-sponsored or pilot studies exist, include available independent data or post-market surveillance.
When follow-up is short, include any available longer-term outcomes or plans for monitoring.

Denial Risk

BIA denial risk

Bioelectrical impedance analysis (BIA) (CPT 0358T) is listed as unproven and not medically necessary; claims for this code are at high risk of denial. Prior authorization requests should include strong, condition-specific justification and any alternative validated body composition measures used for clinical decision making.

If requesting BIA, supply rationale why alternative validated methods (DXA, CT, MRI) are not suitable.
Include clinical context and how results would change management.

Denial Risk

Ocular drug‑eluting inserts not medically necessary (risk of denial)

Placement of drug‑eluting ocular inserts (CPT 0444T/0445T) is considered unproven and not medically necessary in this policy. Prior authorization requests for these inserts are likely to be denied unless robust, device-specific evidence and a clear demonstration of clinical necessity compared with standard therapies are provided.

Document prior topical therapy trials, response, and why topical/systemic alternatives are inadequate.
Include device labeling, trial data, and any regulatory status or study enrollment information.

Documentation Required

Drug‑eluting ocular inserts not medically necessary

Drug‑eluting ocular inserts: providers seeking authorization should submit clinical trial identifiers, prior medical therapy trials and outcomes, and a comparison to standard of care. Absence of such comparative evidence will increase the chance of denial.

Provide prior topical medication names, durations, adherence, and outcomes.
If available, include phase trial results (e.g., intraocular pressure reduction studies) and FDA status.

Documentation Required

Coverage table and evidence links

Coverage table links, clinical evidence references, and key guideline citations should be included with authorization requests to support medical necessity determinations. Use the codes listed in the coverage summary as the authoritative billing-guide for what is considered Covered, Covered in Certain Circumstances, Unproven, or Not Medically Necessary.

Attach relevant peer‑reviewed studies, guideline excerpts, and trial identifiers that directly support the requested service.
List the CPT/HCPCS codes being requested and reference their status in the coverage table.

Documentation Required

Device labeling and documentation

When device-related information is material to the request, include device labeling, instructions for use, and any applicable FDA clearance/approval documentation. For devices with limited approvals or HDE/PMA status, document how the patient's situation aligns with the labeled indications.

Include model/serial numbers and manufacturer information when available.
For HDE or trial-only device use, provide trial enrollment or HDE-eligible patient documentation.

Documentation Required

Required supporting clinical documentation

Required supporting clinical documentation should be comprehensive and linked directly to the requested service. Submit recent imaging, objective measures, medication trials, symptom severity scores, and prior conservative therapy details as applicable to the indication.

Operative notes, imaging reports, and device interrogation reports when applicable.
Baseline and recent clinical metrics (e.g., LVEF, NT‑proBNP, 6MWD for heart failure; CRST scores for essential tremor).

Documentation Required

Documentation for thermal pulsation

For eyelid thermal pulsation (e.g., LipiFlow, iLUX, TearCare), prior authorization requests should document prior conservative therapy, including warm compresses and lid hygiene, and the duration and response to those measures. Step therapy preference for medical management is expected before device treatment.

Document trials of warm compresses (frequency and duration) and other conservative measures.
If step therapy was bypassed, provide clinical justification (e.g., intolerance or failure of conservative therapy).

Documentation Required

Situations where services may be covered (conditional)

Covered indications not specified in excerpt — placeholder node

Not specified in excerpt: The excerpted coverage table lists codes and conclusions but does not supply detailed per‑code covered indications within this excerpt; refer to linked full‑text rationales for code‑level indications.

This node indicates absence of explicit covered‑indication detail in the provided excerpt.

Assessment of lower extremity microvascular disease/foot ulcer risk using SFDI — conditional/ investigational node

Assessment of lower extremity microvascular disease/foot ulcer risk using SFDI

SFDI investigational indication: SFDI may be used investigationally to assess lower extremity microvascular disease severity or estimate foot ulcer risk, but clinical utility for changing outcomes is unproven.

Observational studies (Jett et al., Weinkauf et al.) and ECRI assessment suggest promise but call for prospective wound‑outcome studies.

Revascularization for symptomatic extracranial vertebral artery stenosis after failed medical therapy — conditional coverage node

Revascularization for symptomatic extracranial vertebral artery stenosis after failed medical therapy

Revascularization consideration: Revascularization (including stenting) may be considered only for patients with recurrent vertebrobasilar territory symptoms despite best medical therapy and confirmed 50–99% extracranial vertebral artery stenosis; routine stenting for asymptomatic lesions is not recommended.50-99% extracranial stenosis

Guideline‑based conditional indication reflecting ESVS 2023 and RCT evidence limitations.

Vertebral artery stenting — limited indication

Limited stenting indication: Endovascular vertebral artery stenting may be considered in selected symptomatic patients with recurrent vertebrobasilar ischemic events despite optimal medical therapy and confirmed extracranial 50–99% stenosis; documentation of symptomatic status and confirmation of lesion location/severity required for review.50-99% stenosis for consideration

Evidence from VIST and systematic reviews does not support routine stenting; prior authorization should require documentation of prior medical therapy failure and imaging confirmation.

Use of CAD adjunctively for chest radiograph interpretation — conditional/adjunctive node

Use of CAD adjunctively for chest radiograph interpretation

Adjunctive/conditional use: CAD may be used adjunctively as a reader aid in selected diagnostic contexts but is unproven for population screening and not considered medically necessary as a replacement for standard interpretation without evidence of outcome benefit.

Evidence shows variable sensitivity and high false positive rates; use should be adjunctive with physician review.

Prognostic assessment of heart failure patients (investigational)

123I‑MIBG prognostic use (research/conditional): 123I‑MIBG imaging may provide prognostic information about myocardial sympathetic innervation in heart failure (association with outcomes documented) but remains investigational for routine prognostic decision‑making until standardized, reproducible methods and outcome‑impact trials are available.HMR thresholds reported in literature (e.g., <1.60)

Single‑center cohorts and systematic reviews show associations but not randomized evidence that imaging‑guided management improves outcomes.

Prognostic evaluation of myocardial sympathetic innervation in heart failure — conditional investigational node

Prognostic evaluation of myocardial sympathetic innervation in heart failure

Prognostic evaluation — conditional use: Imaging metrics such as heart‑to‑mediastinum ratio (HMR) and total defect score (TDS) are associated with cardiac event risk (HMR <1.60 and elevated TDS correlate with worse outcomes), but the clinical benefit of using these findings to guide therapy is unproven.HMR < 1.60 associated with higher risk

Further multicenter validation and trials linking imaging‑guided interventions to outcomes are required.

Objective visual acuity estimation in select clinical populations — automated VEP conditional use

Objective visual acuity estimation in select clinical populations

Automated VEP selective use: Automated VEPs may be appropriate for objective visual acuity estimation in select clinical populations (e.g., preverbal children, severe neurologic impairment) where behavioral testing is not feasible; automated VEP screening for general population vision screening is unproven and not medically necessary.

Systematic reviews support VEP utility in specific clinical contexts but not for routine population screening.

Subtalar arthroereisis for symptomatic flexible flatfoot — conditional/after-conservative-therapy node

Subtalar arthroereisis for symptomatic flexible flatfoot

STA conditional/after conservative therapy: Subtalar arthroereisis may be considered in selected symptomatic flexible pes planus patients after documented failure of conservative therapies (orthotics, physical therapy, activity modification); evidence is low quality and use outside research or specialized programs should be limited.failure of conservative therapy documented

High variability in surgical techniques, implant types, and outcome measures; complication and implant removal rates reported.

Early migration monitoring in research settings (RSA) — research-only node

Early migration monitoring in research settings

RSA research‑only: Radiostereometric analysis (RSA) may be used in research settings to monitor early implant migration or fracture healing as part of structured protocols, but RSA is unproven and not medically necessary for routine clinical surveillance.

RSA demonstrates high precision in research but lacks evidence of clinical outcome impact for routine use.

Selected adjunctive diagnostic use in specialized centers (CLE, optical endomicroscopy)

Selected adjunctive diagnostic use in specialized centers

CLE adjunctive use: Confocal laser endomicroscopy (CLE) may be considered adjunctively in specialized centers for targeted biopsy in Barrett's esophagus surveillance, indeterminate biliary strictures, and selected gastric/colorectal lesions to improve per‑lesion detection, provided experienced operators, appropriate training, fluorescein administration, and documentation of how results will change management.

Meta-analyses report improved sensitivity in high‑prevalence/expert settings but do not support routine general practice adoption.

Essential Tremor — unilateral MRgFUS thalamotomy — covered when trial-like criteria met

Essential Tremor — unilateral MRgFUS thalamotomy

MRgFUS ET (coverage criteria): Unilateral MRgFUS thalamotomy is covered for medication‑refractory essential tremor when patient meets trial‑like criteria (moderate‑to‑severe hand postural or intention tremor refractory to ≥2 trials of medical therapy including a first‑line agent) and procedure is performed by an experienced multidisciplinary team, consistent with RCT eligibility and FDA labeling.

Documentation of prior medication trials, tremor severity (e.g., CRST), and informed consent required.

Parkinson disease — selective/research use for focused ultrasound/stereotactic ablation

Parkinson disease — selective/research use

PD focused ultrasound research criteria: Focused ultrasound ablation (thalamotomy or subthalamotomy) for Parkinson disease is restricted to clinical trials or registries or highly selected patients after multidisciplinary review, given limited long‑term evidence and risks (speech, gait disturbances).

Randomized trials show treated‑side tremor improvement but small samples and adverse events warrant research‑restricted use.

Cryoneurolysis of IPBSN for knee OA — conditional/adjunctive node

Cryoneurolysis of infrapatellar branch of saphenous nerve for knee osteoarthritis (evidence shows short-term benefit in RCT)

IPBSN cryoneurolysis evidence: Randomized, double‑blind, sham‑controlled trial of cryoneurolysis targeting the infrapatellar branch of the saphenous nerve demonstrated statistically significant short‑term improvements in WOMAC and pain scores up to ~150 days; evidence supports conditional, short‑term benefit for this specific target.short‑term benefit demonstrated to 150 days

Follow‑up limited to 6 months; generalization to other nerve targets is unproven.

Diagnostic evaluation of suspected middle ear effusion or biofilm — conditional investigational node

Diagnostic evaluation of suspected middle ear effusion or biofilm

Middle ear OCT investigational: Optical coherence tomography (OCT) of the middle ear may detect effusion, distinguish fluid types, and identify biofilms in small feasibility studies, but clinical utility for changing management and outcomes is unproven and thus considered investigational.

Small diagnostic studies (Preciado, Porter, Monroy) show promise but lack larger validation and outcome trials.

Assessment of meibomian gland structure in suspected MGD — adjunctive node

Assessment of meibomian gland structure in suspected meibomian gland dysfunction

Meibography adjunctive use: Near‑infrared meibomian gland imaging (meibography) can document gland atrophy and correlates with functional dry eye parameters, but should not be used as a sole diagnostic test; imaging is adjunctive to clinical assessment and not sufficient alone to justify device therapy.

Studies show correlations but professional guidance lacks endorsement of imaging as the single diagnostic modality.

Prior authorization and related requirements

Note

Prior authorization not specified in excerpt — confirm with payer

This excerpt does not specify a prior authorization requirement for the listed services; providers should confirm prior auth needs with the payer since the table references coverage rationale pages but not authorization rules.

Prior Authorization

Remote hemodynamic monitoring (93264) — up to 30 days; prior auth may apply

Remote hemodynamic monitoring using an implantable pulmonary artery pressure sensor (code 93264) is described as covered in certain circumstances for up to 30 days and may require prior authorization per the plan.

93264: remote monitoring for up to 30 days, with weekly downloads and reporting — “Covered in certain circumstances.”
Plan prior authorization rules may apply to coverage of this service.

Prior Authorization

Endovascular vertebral artery stenting — prior auth to document recurrent symptoms and 50–99% stenosis

Endovascular vertebral artery stenting requests are expected to include documentation of recurrent vertebrobasilar symptoms despite best medical therapy and confirmation of 50–99% extracranial vertebral artery stenosis as part of prior authorization review.

Document prior best medical therapy and symptomatic recurrence.
Confirm extracranial stenosis severity (50–99%).

Prior Authorization

Thermal pulsation/wearable heat devices — prior auth: document failed conservative therapy

For procedural devices such as thermal pulsation or wearable eyelid‑heat systems, prior authorization should document that conservative therapies (e.g., warm compresses, lid hygiene) were attempted and failed.

Document diagnosis of MGD/evaporative dry eye, prior conservative therapy, and objective measures (TBUT, MGS, OSDI) when seeking prior authorization.

Prior Authorization

BAT implantation — prior auth: include NYHA class, LVEF, GDMT, and NT‑proBNP

Prior authorization for BAT implantation is recommended to include NYHA class, LVEF, documentation of guideline‑directed medical therapy, and NT‑proBNP where applicable to align with trial populations and coverage evaluation.

Document NYHA class, LVEF, GDMT status, and NT‑proBNP (e.g., <1,600 pg/mL used in BeAT‑HF cohort D) if available.

Prior Authorization

Sinus tarsi arthroereisis — prior auth recommended due to evolving technique/low-quality evidence

Prior authorization is recommended for sinus tarsi implant/arthroereisis procedures because techniques are evolving and evidence quality is low; include documentation of failed conservative care.

Document conservative therapy attempts (rest, PT, orthotics, NSAIDs) and functional impact before authorization.

Prior Authorization

RDN prior auth — require documentation of failed lifestyle and optimized medical therapy

Renal denervation prior authorization is indicated after documented failure of lifestyle measures and optimized antihypertensive therapy (e.g., three or more medications) with multidisciplinary assessment per society recommendations.

Document medication trials, adherence, intolerance, ambulatory BP confirmation, and multidisciplinary/shared decision‑making.

Prior Authorization

RSA and BIA — policy unproven; prior auth will not make routine coverage

RSA and BIA are labeled unproven/not medically necessary in this policy; prior authorization would not render routine clinical coverage unless usage is within approved research protocols.

Codes 0347T–0350T (RSA) and 0358T (BIA) are identified as unproven.
Submit research protocol documentation if proposing use within a study.

Prior Authorization

BIA / Electronic brachytherapy / CLE — unproven; prior auth may be required but coverage unsupported

BIA, electronic brachytherapy, and CLE are designated unproven; prior authorization processes may occur but the policy finds these services not medically necessary and denials are likely without research justification.

Expect medical necessity review; include trial/registry enrollment details to support exceptional coverage requests.

Prior Authorization

CLE and MRgFUS — subject to medical necessity review/prior authorization

Confocal laser endomicroscopy and MRgFUS intracranial ablation may be subject to medical necessity review or prior authorization given limited or mixed evidence and specific CPT codes referenced.

CLE codes (0397T, 43206, 43252, 88375) and MRgFUS code (61715) are highlighted for medical necessity review.

Prior Authorization

MRgFUS — prior auth to verify prior therapy failures and trial‑consistent eligibility

MRgFUS for essential tremor requires prior authorization to verify prior medication failures and eligibility consistent with RCT criteria (medication‑refractory moderate‑to‑severe tremor).

Confirm failed trials of at least two medications including a first‑line agent; document tremor severity and functional impairment.

Prior Authorization

Implantable device procedures/cryoablation/ocular insert placement — prior auth likely required

Prior authorization is likely required for many implantable device procedures, percutaneous cryoablation, and ocular insert placement codes listed; providers should follow payer rules and submit clinical justification.

Include device‑specific clinical rationale, prior treatments, and relevant trial data when requesting authorization.

Prior Authorization

All listed unproven modalities/procedures — prior authorization expected when requesting coverage

Because the policy designates multiple modalities/procedures as unproven or not medically necessary, prior authorization is expected when seeking coverage; robust supporting evidence is required to overcome the default noncoverage stance.

Anticipate a medical‑necessity review for unproven services and supply trial/registry or high‑quality evidence to support coverage.

Key terms and device definitions

Omnibus Codes — Louisiana context

DefinitionOmnibus Codes (Louisiana only): consolidated listing of CPT/HCPCS codes with associated coverage conclusions for use in Louisiana (Policy CSO87LA.AP, effective 2025-03-01).

ScopeApplies to listed CPT/HCPCS codes and coverage conclusions specific to the State of Louisiana; used as a cross-reference to detailed rationale pages.

Actionable noteClaims for codes listed as 'Unproven' may be denied under this state-specific omnibus listing.

SFDI definition

TermSpatial Frequency Domain Imaging (SFDI): an optical technique to quantify superficial tissue oxygenation, oxy‑ and deoxy‑hemoglobin in 2D/3D presentations.

Intended useUsed to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise; device intended as adjunct to other assessments (manufacturer statement).

Coverage stanceConsidered investigational/unproven due to insufficient evidence linking SFDI use to improved patient outcomes (prospective wound‑based outcome studies needed).

Vertebral artery stenting — definition

DefinitionExtracranial vertebral artery stenting: endovascular placement of stent(s) in the extracranial vertebral artery to treat stenosis.

Guideline contextESVS 2023: do NOT routinely stent for vertebrobasilar TIA/stroke with 50–99% stenosis; consider revascularization only for recurrent symptoms despite best medical therapy.

Clinical thresholdVertebral artery stenosis severity for consideration: 50–99% (extracranial), with recurrent vertebrobasilar symptoms despite optimal medical therapy.

Medical therapy (BMT) — definition / context

DefinitionBest medical therapy (BMT): medical management including risk factor control, antiplatelet agents, blood pressure control, statins, and individualized management of diabetes or other comorbidities.

RoleFirst-line approach; endovascular or surgical revascularization reserved for recurrent symptoms despite BMT per guideline recommendations.

DocumentationPrior authorization for revascularization should document recurrent vertebrobasilar symptoms and confirmation of 50–99% extracranial stenosis when applicable.

Argus II retinal prosthesis — device description

DeviceArgus II Retinal Prosthesis System: epiretinal implant plus external components that electrically stimulate the retina to provide some visual perception in severe-to-profound retinitis pigmentosa.

Regulatory statusReceived FDA Humanitarian Device Exemption (HDE) with post-approval study requirements; manufacturing has ceased but post-approval data exist.

Coverage stanceInvestigational/unproven for inducing visual perception outside HDE/post‑approval contexts and clinical study settings.

CAD (for chest radiographs) — definition / coverage note

DefinitionCoronary Atherosclerotic Disease (CAD) in this document refers to computer‑aided detection (CAD) systems applied to chest radiographs (algorithmic adjuncts for lesion detection).

Intended useCAD analyzes imaging features to flag potential lesions for physician review; primarily a decision‑support tool rather than standalone diagnosis.

Coverage stanceCAD for chest radiographs is considered unproven and not medically necessary due to insufficient evidence of improved outcomes.

BAT / Barostim Neo / BeAT‑HF key values

DefinitionBaroreflex activation therapy (BAT): implantable device system delivering electrical stimulation to carotid sinus baroreceptors to modulate cardiovascular reflexes.

BeAT‑HF cohort thresholdNT‑proBNP threshold used in BeAT‑HF intended‑use Cohort D: < 1,600 pg/mL.

Regulatory/device exampleBarostim Neo: second‑generation BAT device with FDA premarket approval for heart failure; coverage/authorization reviews should reference trial cohorts and NT‑proBNP when applicable.

123I‑MIBG imaging and HMR definition / threshold

Definition123I‑MIBG imaging: cardiac planar and/or SPECT imaging with iodine‑123 metaiodobenzylguanidine to assess myocardial sympathetic innervation.

HMR definitionHeart‑to‑mediastinum ratio (HMR): semi‑quantitative planar measure comparing myocardial to mediastinal tracer uptake used in prognostic assessments.

Actionable thresholdLate HMR < 1.60 has been associated with higher mortality and arrhythmic risk in cohort studies (ADMIRE‑HF follow‑up analyses).

Total defect score (TDS) — definition for MIBG SPECT

DefinitionTotal defect score (TDS) for 123I‑MIBG SPECT: summed 5‑point segmental scores across 17 myocardial regions on polar maps to quantify sympathetic denervation.

Prognostic useHigher TDS values have been associated with greater risk of cardiac events in cohort studies, though clinical benefit of acting on TDS is unproven.

Measurement contextCalculated from regional scores on SPECT polar maps; used alongside HMR in research/prognostic assessments.

Radiostereometric analysis (RSA) — definition

DefinitionRadiostereometric Analysis (RSA): technique using implanted tantalum markers and calibrated biplanar X‑rays analyzed with specialized software to calculate 3‑D micromotion (maximal total point motion) of implants relative to bone.

Primary useUsed primarily in research settings to monitor early implant migration and predict long‑term implant stability; CT‑based low‑dose RSA is evolving as a research alternative.

Coverage stanceConsidered investigational/unproven for routine clinical use despite high precision in research contexts.

BIA — definition and pre-measurement note

DefinitionBioelectrical impedance analysis (BIA): method measuring electrical impedance through body tissues to estimate total body water, from which fat‑free mass and body fat are calculated.

Measurement sensitivityResults are sensitive to hydration status and recent fluid intake; standardized pre‑measurement nutrition/hydration procedures are necessary but not specified in the evidence base.

Coverage stanceBIA whole body composition assessment (CPT 0358T) is considered unproven and not medically necessary for routine clinical use due to variable accuracy and lack of standardization.

Electronic brachytherapy — definition

DefinitionElectronic brachytherapy: electronic/X‑ray based brachytherapy delivering high dose rates using miniaturized sources as an alternative to radionuclide brachytherapy.

Clinical contextApplied to skin, breast, gynecologic and other sites in early studies; professional societies advise use mainly in prospective trials/registries due to dosimetry and outcome concerns.

Coverage stanceConsidered unproven and not medically necessary for routine use outside clinical trials for many indications.

Confocal laser endomicroscopy (CLE) — definition and usage

DefinitionConfocal laser endomicroscopy (CLE; optical endomicroscopy): endoscopic technique (probe‑based or endoscope‑integrated) providing real‑time microscopic in vivo imaging of mucosa, often requiring intravenous fluorescein.

Diagnostic contextsUsed adjunctively in specialized centers for Barrett's esophagus, indeterminate biliary strictures, and targeted biopsy to improve per‑lesion sensitivity in selected settings.

Coverage stanceDesignated unproven and not medically necessary for routine clinical use due to insufficient evidence of safety, efficacy, and generalizability.

MRgFUS (ExAblate) and MRgFUS thalamotomy — definition / context

DefinitionMR‑guided focused ultrasound (MRgFUS, ExAblate): noninvasive procedure combining MRI guidance and high‑intensity focused ultrasound to thermally ablate intracranial targets (e.g., VIM thalamotomy for ET).

Regulatory statusFDA approved for unilateral MRgFUS thalamotomy in medication‑refractory essential tremor (label expanded 2022 for idiopathic ET).

Clinical criteriaUsed for medication‑refractory moderate‑to‑severe hand tremor after failure of at least two trials of medical therapy; candidate selection consistent with RCTs and trial protocols.

CCM — definition and FDA LVEF range

DefinitionCardiac contractility modulation (CCM): implantable device delivering non‑excitatory electrical signals during the absolute refractory period to enhance myocardial contractility.

FDA indication (key numeric),FDA PMA indication LVEF range: 25%–45% (NYHA class III, normal sinus rhythm, not CRT candidates).

Coverage stanceConsidered unproven/not medically necessary in this policy due to insufficient evidence for mortality or hospitalization benefits despite short‑term improvements in QoL and exercise capacity.

Drug‑eluting ocular insert — definition and stance

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 with small samples and short follow‑up; comparative efficacy vs topical drops not established for long‑term outcomes.

Coverage stanceConsidered unproven and not medically necessary due to insufficient evidence of safety and efficacy (codes 0444T/0445T listed as not covered).

OCT of middle ear — definition

DefinitionOptical coherence tomography (OCT) of the middle ear: noninvasive, real‑time imaging using low‑intensity light to produce micron‑scale 2D/3D structural images of the middle ear.

Clinical contextsInvestigated to detect effusion, characterize fluid/biofilm, and overcome otoscopic obstructions; studies small and lacking high‑quality outcomes data.

Coverage stanceConsidered unproven and not medically necessary pending larger validation studies demonstrating impact on management and outcomes.

Near‑infrared dual imaging (LipiScan / DMI) — definition

DefinitionNear‑infrared dual imaging (Dynamic Meibomian Imager / LipiScan): device using dynamic surface illumination and adaptive transillumination to visualize meibomian gland structure noninvasively.

EvidenceMeibography correlates with gland atrophy and some functional measures but should not be used as a sole diagnostic test; professional guidance lacking.

Coverage stanceConsidered unproven and not medically necessary as standalone diagnostic modality; useful adjunct in specialized evaluation.

Services and codes designated not medically necessary

This policy section groups multiple CPT/HCPCS codes and states that many of the listed services are designated Unproven. The listing is intended as an omnibus reference: see the individual code entries and linked evidence pages for full rationale, but codes marked Unproven in the table generally indicate they are not supported as medically necessary under the policy and may be subject to denial.

Not Covered (examples): Routine extracranial vertebral artery stenting and related endovascular revascularization for asymptomatic lesions or routine treatment of vertebrobasilar TIA/stroke are considered Unproven and not covered per guideline‑based recommendations; retinal prosthesis implantation and associated device codes are likewise considered unproven for routine clinical use outside specific FDA HDE/post‑approval study scenarios.

Not Covered: Computer‑aided detection (CAD) of chest radiographs is listed as Unproven and not medically necessary; claims for CAD chest radiograph codes may be denied due to insufficient evidence of clinical benefit.

Not Covered: Tear film and related ocular surface imaging modalities (for example, CPT code 0330T and investigational tear film imaging techniques) are designated Unproven and not medically necessary for routine diagnosis or monitoring of dry eye disease; evidence does not demonstrate that these imaging measures alone change management or improve outcomes.

Not Covered: Myocardial sympathetic innervation imaging with 123I‑MIBG (CPT codes 0331T/0332T) is considered Unproven as a prognostic marker in heart failure because associations with outcomes have not been shown to translate into demonstrated improvements in clinical outcomes when used to guide management; such studies are therefore not supported for routine coverage.

Not Covered: Automated visual evoked potential (VEP) screening (e.g., CPT 0333T) for population or routine vision screening is designated Unproven and not medically necessary due to insufficient evidence of efficacy and utility in general screening populations.

Not Covered: Subtalar arthroereisis (sinus tarsi implants) is considered investigational and Unproven for broad indications because the body of evidence is low quality and heterogeneous; routine coverage is not supported outside well‑documented, selective cases or research settings.

Not Covered: Radiostereometric analysis (RSA, CPT codes 0347T–0350T) and whole‑body bioelectrical impedance analysis (BIA, CPT 0358T) are explicitly identified as Unproven and not medically necessary due to insufficient evidence of clinical utility; routine clinical use is not covered.

Not Covered: Percutaneous cryoablation of peripheral nerves for chronic pain is designated Unproven and not medically necessary for general chronic pain indications; placement of drug‑eluting ocular inserts under the eyelids (CPT 0444T/0445T) is also Unproven and not medically necessary.

Not Covered: Placement of drug‑eluting ocular inserts (CPT codes 0444T and 0445T) is explicitly stated as Unproven and not medically necessary due to insufficient evidence of safety and efficacy.

Not Covered: Optical coherence tomography (OCT) of the middle ear (CPT codes 0485T/0486T) is designated Unproven and not medically necessary for routine assessment or management of middle ear disorders because supporting clinical outcome data are insufficient.

Not Covered: Macular pigment optical density measurement by heterochromatic flicker photometry (CPT 0506T) is considered Unproven and not medically necessary due to insufficient evidence linking measurements to improved clinical outcomes.

Not Covered: Near‑infrared dual imaging of meibomian glands (CPT 0507T, e.g., LipiScan/DMI) is designated Unproven and not medically necessary because evidence is lacking that gland imaging alone improves diagnosis or management of meibomian gland dysfunction.

OpenPayer

Omnibus Codes (for Louisiana Only)

Coverage conclusions and rationale

CPT / HCPCS codes and code groups

Prior authorization, documentation, and denial risks

Situations where services may be covered (conditional)

Prior authorization and related requirements

Policy background and scope

Key terms and device definitions

Services and codes designated not medically necessary

Contrast and tracer considerations

Policy updates and effective dates