CurrentUnitedHealthcarePolicy CS087.AZ

Omnibus/Category III and Proprietary CPT/HCPCS codes — coverage determinations

UnitedHealthcare Medical Policy CS087.AZ lists many specific CPT/HCPCS (including Category III and proprietary U-codes) procedures and provides coverage conclusions (primarily 'Unproven'); it applies to commercial lines except where state-specific omnibus code guidelines are specified.

Policy Summary

PayerUnitedHealthcare

PolicyOmnibus/Category III and Proprietary CPT/HCPCS codes — coverage determinations

Policy CodePolicy CS087.AZ

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation when requesting coverage for listed services; many listed codes are designated Unproven and may be denied.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CS087.AZpolicy identifier

manycodes Unproven

~100+omnibus codes listed

11states with separate policies

Somecovered/conditional

Coverage Criteria and Determinations

Omnibus Codes — Coverage Conclusions

Coverage conclusions for listed codes

Code-level conclusion: Each listed CPT/HCPCS code in the Omnibus section is followed by a short conclusion statement; the entries in the provided chunks are labeled 'Conclusion = Unproven'.

No clinical criteria or patient-selection rules provided in these chunks.

Coverage conclusions

Coverage conclusions associated with listed codes

Unproven services: Multiple listed CPT/HCPCS codes are concluded as 'Unproven' indicating insufficient evidence of safety and/or efficacy (examples include 0600T, 0601T, 0631T, 0640T, many listed codes).

These entries are assigned a policy conclusion of 'Unproven'.

Covered in certain circumstances: Some services (e.g., remote monitoring of a wireless pulmonary artery pressure sensor) are noted as 'Covered in certain circumstances'.

Conditional coverage statements appear for a small number of codes.

Proven in certain circumstances: At least one listed procedure (example in coding list) is described as 'Proven in certain circumstances' in the coding table entries, indicating limited or conditional acceptance for specific uses.

See coding module for code-level conclusions.

SFDI (0061U) — Not medically necessary

SFDI (0061U) coverage stance

SFDI not medically necessary: Transcutaneous measurement of biomarkers using spatial frequency domain imaging (SFDI) (CPT 0061U) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Policy cites ECRI assessment and observational studies that lack outcome data.

Extracranial vertebral artery stenting — General stance and guideline context

Extracranial vertebral artery stenting (0075T/0076T)

Stenting considered unproven for broad use: Transcatheter placement of extracranial vertebral artery stent(s) (0075T/0076T) is considered unproven and not medically necessary due to insufficient evidence of efficacy in general.

Policy statement references limited registry data and ESVS guidance.

Guideline-based exceptions: Revascularization may be considered in narrowly selected patients (see conditional revascularization criteria) such as recurrent vertebrobasilar symptoms despite best medical therapy, per ESVS guidance; routine stenting is not recommended for asymptomatic lesions or routine management of vertebrobasilar TIA/stroke with 50–99% stenosis.50-99% stenosis

ESVS 2023 guidance cited; evidence from VIST and registry analyses is limited and heterogeneous.

Revascularization (vertebral artery) - conditional

Covered when ALL of the following are met (per guidelines and trial context):

Vertebral artery revascularization coverage criteria: 1) Patient has recurrent vertebrobasilar territory symptoms despite best medical therapy; 2) Imaging confirms 50–99% extracranial vertebral artery stenosis; 3) Procedure is intended for symptomatic treatment (not for asymptomatic atherosclerotic lesions); 4) Multidisciplinary assessment documents that risks and benefits were considered given limited evidence;50-99% stenosis

Based on ESVS 2023 guidance and trial/registry contexts (VIST, BASILAR/PERSIST).

Argus II retinal prosthesis - HDE-aligned criteria

Covered when ALL of the following are met (reflecting FDA HDE indications and post-approval expectations):

Argus II eligibility: 1) Age ≥ 25 years; 2) Bare light perception or no light perception in both eyes (if no light perception, evidence of intact inner retinal function must be confirmed); 3) Prior useful form vision; 4) Eye status compatible with implantation (aphakic or pseudophakic, or lens removal planned as part of the procedure); 5) Patient willing and able to comply with required post-implant follow-up, device fitting, and visual rehabilitation;

Aligns with FDA HDE labeling and required post-approval study follow-up; device manufacturing has ceased but HDE criteria described in evidence.

Computer-aided detection (CAD) for chest radiographs

Coverage stance based on available evidence:

CAD chest radiograph coverage: Computer-aided detection (CAD) for chest radiographs (0174T, 0175T) is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy; randomized trials have not demonstrated improved diagnostic sensitivity or reduced false positives in clinical use.

Supported by policy summary and RCTs (Hwang 2023) and technology assessments noting inadequate evidence and lack of guideline support.

Eyelid thermal pulsation (LipiFlow and similar devices)

Coverage stance and evidence summary:

Thermal pulsation coverage: Thermal pulsation procedures and wearable open-eye eyelid heating devices for meibomian gland evacuation are considered unproven and not medically necessary for routine evaluation or evacuation of meibomian glands; evidence includes RCTs and systematic reviews with low-to-very-low certainty and manufacturer-funded trials with methodological limitations.

Guidelines position thermal pulsation as a second-line option after basic lid hygiene; trials show mixed results and limited long-term data.

Blood-based colorectal cancer (CRC) biomarker panels

Coverage stance and evidence summary:

Blood-based CRC biomarker coverage: Blood-based colorectal cancer biomarker panels (including multiplex protein assays and algorithmic panels such as BeScreened/0163U) are unproven and not medically necessary for population CRC screening due to insufficient prospective screening-population validation and heterogeneity in study findings.

Systematic reviews and pilot studies show promising markers but lack independent, prospective screening data and consistent performance vs established tests.

Evidence synthesis and clinical stance

Evidence summary and implications for coverage decisions

Evidence for LipiFlow: Systematic reviews and RCTs show LipiFlow (vectored thermal pulsation) can improve some subjective and objective dry eye measures versus comparators, but many trials have risk of bias, inconsistent analysis accounting for paired eyes, and limited long-term comparative effectiveness data.

Cochrane/HTA and meta-analyses cite low/very-low certainty and need for larger unbiased trials.

Evidence for TearCare: Randomized and comparative studies indicate TearCare may improve TBUT, meibomian gland function, and symptoms at short-term follow-up and is generally similar to LipiFlow, but studies are limited by short follow-up, manufacturer involvement, and heterogeneity.

Masked RCTs show noninferiority at short-term endpoints; long-term outcomes remain uncertain.

Guideline position: Professional guidance (AAO/TFOS summaries) positions thermal pulsation as a second-line option after basic lid hygiene rather than routine first-line therapy.

Policy suggests requiring prior conservative therapy documentation when coverage is considered.

Not Medically Necessary / Unproven technologies

Atherectomy-visceral/renal/abdominal/brachiocephalic: Transluminal peripheral atherectomy of visceral, renal, abdominal, or brachiocephalic arteries (CPT 0234T–0237T) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Policy conclusion based on lack of comparative outcome data.

PreTRM proteomic test: Use of the PreTRM serum-based proteomic biomarker test (0247U/81599) to screen asymptomatic pregnant individuals for spontaneous preterm birth risk is unproven and not medically necessary due to insufficient evidence of clinical benefit.

Randomized trial data do not demonstrate reduction in sPTB; independent assessments find insufficient evidence.

Carotid sinus baroreflex activation (BAT): Chronic baroreceptor stimulation of the carotid sinus (BAT; CPT Category III codes 0266T–0273T) is unproven and not medically necessary for treating hypertension, heart failure, or other cardiovascular conditions due to insufficient high-quality evidence of improved clinical outcomes.

Some devices have HDE/PMA regulatory status but payer stance is NMN based on evidence limitations.

General coverage stance

Coverage stance as stated in this section of the document:

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

Policy text explicitly states noncoverage/unproven status.

Tear film imaging — Not medically necessary

Not medically necessary when used to monitor or assess tear film disorders

Tear film imaging NMN: Tear film imaging (CPT 0330T) to monitor or assess tear film disorders is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy; standard clinical evaluations (slit-lamp biomicroscopy, TBUT, Schirmer) remain recommended.

Policy references comparative device studies and AAO benchmarks recommending slit-lamp exam.

123I-MIBG imaging — Not medically necessary

Not medically necessary as a prognostic marker in heart failure

123I-MIBG imaging NMN: Myocardial sympathetic innervation imaging with 123I‑MIBG (CPT 0331T/0332T) is unproven and not medically necessary as a routine prognostic marker in patients with heart failure due to insufficient evidence that imaging-directed management improves outcomes.H/M ratio used in studies (e.g., <1.60 vs ≥1.60)

Cohort studies show prognostic associations but not evidence of improved patient outcomes when used for prognostication.

Not medically necessary / Unproven

Coverage stance

Not medically necessary: The use of a sinus tarsi implant (0335T, 0510T, 0511T, S2117) is unproven and not medically necessary for any indication due to insufficient clinical evidence of safety and/or efficacy.

Policy cites systematic reviews and NICE guidance noting inadequate evidence and high implant removal rates.

Subtalar arthroereisis — evidence considerations

Summary of evidence-based considerations for subtalar arthroereisis

Patient selection for pediatric subtalar arthroereisis: Symptomatic flexible pediatric flatfoot that has failed conservative measures and negatively impacts activities of daily living; evidence is low-quality and largely retrospective with heterogeneity in indications and techniques.failure of conservative therapy often required

Systematic reviews report encouraging results but call for higher-quality prospective studies.

Adult subtalar arthroereisis: Used as sole or adjunct procedure for adult-acquired flatfoot with reported improvements in small case series, but heterogeneity of concomitant procedures and limited prospective data make causal attribution uncertain; implant removal rates can be substantial (reported up to ~29%).

Adult evidence limited; high implant removal rates reported in reviews.

Renal denervation — evidence considerations

Summary of evidence-based considerations for renal denervation (RDN)

Patient selection for RDN: Patients considered for RDN should have resistant or uncontrolled hypertension despite optimized lifestyle and pharmacologic therapy, confirmation with ambulatory blood pressure measurement, and multidisciplinary evaluation with shared decision-making.resistant HTN often defined as BP uncontrolled on ≥3 medications including a diuretic

Guidance from ESC/ EAPCI and NICE recommends governance, audit, or research settings for RDN use.

Efficacy evidence: Randomized sham-controlled trials and meta-analyses demonstrate modest short-term reductions in ambulatory and office systolic BP (examples: RADIANCE II: −6.3 mm Hg daytime SBP at 2 months; pooled trials ~4–6 mm Hg), but heterogeneity, short follow-up, and variable device types limit conclusions about long-term clinical outcomes.example numeric differences provided

Systematic reviews and recent RCTs summarized in policy.

RSA - Not Medically Necessary

RSA coverage determination

RSA not medically necessary: Radiostereometric analysis (RSA; CPT 0347T–0350T) is unproven and not medically necessary for routine clinical indications due to insufficient evidence that its use improves patient outcomes; RSA is primarily supported as a research tool for implant surveillance and fracture-healing assessment.

Policy notes technical complexity, need for markers, calibration cage, dedicated software and trained personnel; recommends RSA use mainly in research settings.

Radiostereometric analysis (RSA) — evidence summary

Coverage stance based on evidence summaries in these chunks:

RSA evidence summary: RSA is a highly precise technique for detecting early implant migration and assessing fracture healing in research settings, but available studies are small, heterogeneous, and do not establish routine clinical utility.

Further large randomized studies comparing RSA to conventional methods are needed.

Bioelectrical impedance analysis (BIA) — coverage stance

Statements on BIA validity and utility:

BIA: Bioelectrical impedance analysis (BIA) whole body composition assessment (CPT 0358T) is unproven and not medically necessary for many clinical indications due to variable accuracy influenced by hydration status, BMI, device-specific algorithms, and population differences; valid for group-level assessments but limited for individual clinical decision-making without standardized conditions.

ECRI and systematic reviews report inconsistent agreement with reference methods and sensitivity to hydration/BMI.

Electronic brachytherapy — coverage stance

Statements on electronic brachytherapy:

Electronic brachytherapy: High-dose-rate electronic brachytherapy (CPT 0394T/0395T and related systems) is unproven and not medically necessary for routine treatment of breast, skin, gynecologic, and other indications outside of clinical trials or registries due to limited comparative and long-term outcome data.

Society statements (ABS, NICE) and ECRI assessments call for randomized comparative trials and long-term follow-up.

Not Medically Necessary / Informational

Coverage stance and contextual criteria

Not medically necessary stance: Confocal laser endomicroscopy (CLE) is considered unproven and not medically necessary for routine clinical use due to insufficient evidence of safety and/or efficacy; routine replacement of standard biopsy protocols (e.g., Seattle protocol for Barrett's esophagus) is not supported.

Guidelines recommend limited use in expert centers and further high-quality studies.

Limited / Specialized Use

Contexts with supportive but limited evidence (may be considered in expert centers or research settings):

Potential appropriate uses in expert centers: Adjunctive CLE/pCLE use may be considered in expert, high-volume centers for targeting biopsies in Barrett's esophagus surveillance, evaluation of indeterminate biliary strictures (with cholangioscopy), and targeted assessment of gastric lesions where meta-analyses show high sensitivity/specificity; deployment should be limited to centers with appropriate expertise and governance.

Meta-analyses demonstrate promising diagnostic performance but generalizability and outcome impact are limited.

CLE clinical evidence and limits

CLE: evidence synthesis and surveillance context

CLE evidence summary: Systematic reviews and meta-analyses report that CLE increases per-lesion detection of neoplasia in Barrett's esophagus and shows high diagnostic accuracy for gastric and biliary lesions in specialized centers; however evidence is heterogeneous, often from expert centers, and CLE has not been shown to reliably replace Seattle protocol biopsy sampling for routine surveillance.

ASGE and other society guidance caution against routine replacement of standard protocols; training and fluorescein use are additional considerations.

CCM clinical evidence and limits

CCM: evidence synthesis and guideline context

CCM evidence and regulatory status: Cardiac contractility modulation (CCM) devices (Optimizer system family) have FDA approval for a narrow population (NYHA class III, LVEF 25–45%, normal sinus rhythm, not CRT candidates) and RCTs/meta-analyses show improvements in functional status and quality of life but inconsistent or no mortality/hospitalization benefit; evidence quality and long-term outcomes remain uncertain and broader use is not supported by high-quality evidence.

Guidelines and HTAs recommend use in controlled or research settings and call for further large RCTs.

Cryoablation — Not Medically Necessary

Not medically necessary when the following device/procedure is used for these indications due to insufficient evidence:

Cryoablation exclusion: Percutaneous cryoablation of peripheral or truncal nerves (CPT 0440T–0442T) for treatment of chronic pain is unproven and not medically necessary due to insufficient evidence of safety and/or sustained efficacy.

Policy cites limited clinical evidence and recommends further trials/registries.

Drug-eluting ocular inserts — Not Medically Necessary

Not medically necessary:

Ocular inserts exclusion: Placement of drug-eluting ocular inserts under the eyelid(s) (CPT 0444T/0445T) is unproven and not medically necessary due to insufficient evidence of safety and efficacy.

Available randomized/phase II studies are limited and do not establish outcome benefit.

Middle ear OCT — Not Medically Necessary

Not medically necessary:

Middle ear OCT exclusion: Optical coherence tomography (OCT) of the middle ear (CPT 0485T/0486T) for assessing and managing middle ear disorders is unproven and not medically necessary due to insufficient evidence that its use improves clinical outcomes despite promising diagnostic accuracy in small studies.

Small studies show high imageability and diagnostic accuracy but lack outcome data and larger independent studies are needed.

This Medical Policy does not apply to the states listed in the Application section. For services furnished to members in those states, refer to the applicable state-specific Omnibus Codes policy cited (Idaho, Indiana, Kansas, Kentucky, Nebraska, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, Tennessee).

UnitedHealthcare designates many of the procedures and codes listed in this Omnibus section as Unproven. Services concluded in this document as Unproven are considered to lack sufficient evidence of safety and/or efficacy and are therefore effectively excluded from coverage as not medically necessary under the policy.

Transcatheter placement of extracranial vertebral artery stent(s) (e.g., 0075T/0076T) is generally considered unproven and not medically necessary. Guideline statements (ESVS 2023) and trial/registry evidence emphasize medical therapy first and reserve revascularization for recurrent vertebrobasilar territory symptoms despite best medical therapy with confirmed extracranial stenosis of 50–99%; routine stenting for asymptomatic lesions or as first-line therapy is not recommended.

Eyelid thermal pulsation systems (e.g., LipiFlow, TearCare and similar devices) and related automated/mechanical meibomian gland evacuation technologies are described as unproven and not medically necessary for routine evaluation or evacuation of meibomian glands. The evidence includes systematic reviews and randomized trials with inconsistent analytic methods, manufacturer funding, and limited long-term comparative data; these devices are generally positioned, if at all, after documented failure of conservative measures.

The document highlights significant limitations and evidence gaps across multiple technologies: risks of bias in trials, small sample sizes, inconsistent analytic approaches (for paired-eye analyses), short follow-up, and frequent manufacturer funding. These limitations reduce certainty about benefit and are a primary reason many services are labeled Unproven or not medically necessary.

Transluminal peripheral atherectomy procedures targeted to visceral, renal, abdominal, or brachiocephalic arteries (CPT Category III codes such as 0234T–0237T) are explicitly described as unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

The PreTRM serum-based proteomic biomarker test (reported with codes such as 0247U/81599) for population screening to predict spontaneous preterm birth is considered unproven and not medically necessary because available studies do not provide sufficient evidence of benefit to support screening asymptomatic pregnant individuals.

Chronic baroreceptor stimulation (carotid sinus baroreflex activation/BAT) for cardiovascular indications is designated unproven and not medically necessary. Although certain systems have FDA HDE or PMA status, evidence is insufficient to support routine use for hypertension, heart failure, or other cardiovascular conditions in this policy.

Specifically, chronic baroreceptor stimulation of the carotid sinus is considered unproven and not medically necessary for treating hypertension, heart failure, or other cardiovascular disorders because the current evidence does not demonstrate consistent clinical benefit or adequate safety to justify coverage.

Several imaging modalities are explicitly described as unproven and not medically necessary in this policy. Examples include computer-aided detection (CAD) for chest radiographs (0174T/0175T), tear film imaging (0330T), and myocardial sympathetic innervation imaging with 123I-MIBG (0331T/0332T). The policy provides no routine clinical indications for these services and states they lack sufficient evidence to support medical necessity.

Insertion of a sinus tarsi implant (e.g., S2117, 0335T, 0510T) is classified as unproven and not medically necessary for any indication. NICE guidance (2009) similarly found evidence inadequate and recommended that use be restricted to settings with special arrangements for clinical governance, consent, audit or research.

NICE interventional procedures guidance concluded that evidence for sinus tarsi implant insertion is inadequate in quality and quantity and recommended use only with special arrangements (research, audit, and governance), reinforcing the policy position that routine coverage is not supported.

Radiostereometric analysis (RSA) is discussed primarily as a research tool. Although RSA provides highly precise measurements of implant micromotion, the policy states evidence is insufficient to support routine clinical use and indicates RSA is appropriate mainly in research or specialized evaluation rather than standard care.

Bioelectrical impedance analysis (BIA) for whole body composition assessment (0358T) and high-dose-rate electronic brachytherapy (0394T/0395T) are labeled unproven and not medically necessary because studies show variable accuracy and limited comparative evidence, respectively, and do not establish improved patient outcomes.

The policy suggests against routine use of confocal laser endomicroscopy (CLE) for Barrett's esophagus surveillance compared with the standard Seattle biopsy protocol. CLE is considered of limited adoption, operator-dependent, and appropriate primarily in expert centers or research; routine CLE surveillance is therefore regarded as not medically necessary for general practice.

Cardiac contractility modulation (CCM) using an implantable device (e.g., Optimizer system codes) is described as unproven and not medically necessary for treatment of chronic heart failure because existing trials do not provide conclusive evidence of meaningful clinical outcome benefits.

Percutaneous cryoablation of peripheral or truncal nerves for chronic pain (CPT codes 0440T–0442T) is considered unproven and not medically necessary due to insufficient evidence of sustained benefit and safety for chronic pain indications.

The policy explicitly classifies cryoablation of peripheral and truncal nerves for chronic pain as unproven and not medically necessary, noting inadequate clinical data to support routine therapeutic use.

Placement of drug-eluting ocular inserts under the eyelid(s) (e.g., 0444T/0445T) is designated unproven and not medically necessary because current evidence does not adequately demonstrate safety or clinical effectiveness for routine use.

Optical coherence tomography (OCT) of the middle ear (0485T/0486T) is considered unproven and not medically necessary for assessing or managing middle ear disorders; although small studies report promising diagnostic accuracy, evidence is insufficient to support routine clinical application.

Code Listings and Code Table

Omnibus / Listed Codes (sample)mixedNot Covered

0061U	Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]), using spatial frequency domain imaging (SFDI) and multi-spectral analysis.
0075T	Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; initial vessel.
0076T	Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous; each additional vessel (List separately in addition to code for primary procedure).

Omnibus / Listed Codes (continued)mixedNot Covered

0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy.
0163U	Oncology (colorectal) screening, biochemical ELISA of 3 plasma or serum proteins with proprietary algorithm.
0174T	Computer-aided detection (CAD) chest radiograph(s), performed concurrent with primary interpretation.
0175T	Computer-aided detection (CAD) chest radiograph(s), performed remote from primary interpretation.
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.

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Omnibus codes and described codesmixed

0600T	Ablation, irreversible electroporation; 1 or more tumors per organ, including imaging guidance, percutaneous
0601T	Ablation, irreversible electroporation; 1 or more tumors, including fluoroscopic and ultrasound guidance, open
0614T	Removal and replacement of substernal implantable defibrillator pulse generator
0615T	Automated analysis of binocular eye movements without spatial calibration for assessment of concussion
0631T	Transcutaneous visible light hyperspectral imaging measurement per extremity
0640T	Noncontact near-infrared spectroscopy, other than for screening for peripheral arterial disease, image acquisition, interpretation, and report, first anatomic site
0647T	Insertion of gastrostomy tube, percutaneous, with magnetic gastropexy, under ultrasound guidance, image documentation and report
0651T	Magnetically controlled capsule endoscopy, esophagus through stomach, including intraprocedural positioning of capsule
0658T	Electrical impedance spectroscopy of 1 or more skin lesions for automated melanoma risk score
0659T	Transcatheter intracoronary infusion of supersaturated oxygen in conjunction with percutaneous coronary revascularization during acute MI

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Retinal prosthesis CPT/HCPCSmixed

0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array, with vitrectomy.
0472T	Device evaluation, interrogation, and initial programming of intraocular retinal electrode array (e.g., retinal prosthesis), in person, with iterative adjustment and 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 testHCPCSNot Covered

0163U

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

CAD CPT CodesCPTNot Covered

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

Eyelid thermal pulsation CPT CodesCPTNot Covered

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

Automated audiometry CPT II-like codes referencedCPT

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

Atherectomy CPT Category III codesCPTNot Covered

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

PreTRM biomarker test codesCPT | HCPCSNot Covered

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

Carotid sinus baroreflex activation device CPT Category III codesCPTNot Covered

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 with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report.
0273T	Interrogation device evaluation (in person), carotid sinus baroreflex activation system; with programming.

Covered CPT Codes (device implantation/interrogation descriptions listed)CPT

0266T	Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed).
0267T	Implantation or replacement of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed).
0268T	Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed).
0269T	Revision or removal of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed).
0270T	Revision or removal of carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed).
0271T	Revision or removal of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed).
0272T	Interrogation device evaluation (in person), carotid sinus baroreflex activation system, including telemetric iterative communication with the implantable device to monitor device diagnostics and programmed therapy values, with interpretation and report (e.g., battery status, lead impedance, pulse amplitude, pulse width, therapy frequency, pathway mode, burst mode, therapy start/stop times each day).
0273T	Interrogation device evaluation (in person), carotid sinus baroreflex activation system ... with programming.

Tear film imaging (listed)CPTNot Covered

0330T

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

Myocardial sympathetic innervation imaging (listed)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

Unrelated code list (from references section)CPT

0333T

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

Sinus tarsi / arthroereisis procedure codesCPT | HCPCS

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

RDN CPT Category III CodesCPT

0338T	Transcatheter renal sympathetic denervation, percutaneous approach; unilateral
0339T	Transcatheter renal sympathetic denervation, percutaneous approach; bilateral

RSA procedure 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).

Unproven / Not medically necessary CPT CodesCPTNot Covered

0358T

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

Unproven / Not medically necessary CPT Codes (electronic brachytherapy)CPTNot 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

Optical endomicroscopy / CLE CPT and pathology interpretation codesCPT

0397T	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, each endoscopic session.

CCM and related device CPT/HCPCS codesCPT | HCPCSNot Covered

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

1–10 of 12

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Percutaneous cryoablation codesCPTNot Covered

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

Percutaneous cryoablation CPT/HCPCS codes (alternate listing)CPTNot Covered

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 (e.g., brachial plexus, pudendal nerve).

Drug-eluting ocular insert codesCPTNot Covered

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

Middle ear OCT 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.

Contextual and Limited Indications

Examples of imaging-related omnibus codes concluded Unproven

Imaging-related examples concluded Unproven: Selected imaging-related Category III and proprietary codes (for example, 0631T, 0640T, 0658T, 0694T) are listed in the Omnibus codes table and are concluded as 'Unproven' in this policy.

See coding sections and omnibus code listings for full code set.

Assessment of superficial tissue oxygenation/perfusion (e.g., foot microvascular disease)

SFDI clinical context: SFDI provides maps of superficial tissue oxygenation and hemoglobin for assessment of microvascular disease and may identify markers associated with severity, but evidence is insufficient to show that SFDI use improves wound or limb outcomes; clinical utility remains investigational.

Observational studies and ECRI assessment highlight promise but insufficient outcome data.

Prior Authorization, Documentation, and Billing Guidance

Note

Omnibus / commercial policy linkage

UnitedHealthcare commercial policies reference Omnibus Codes; for Commercial members, applicable omnibus/commercial policy terms and any state-specific omnibus code policies apply to services and codes listed below.

Omnibus/commercial linkage: Commercial policy uses Omnibus Codes; state-specific omnibus policies may apply.

Prior Authorization

Prior authorization for specialized devices and tests

Prior authorization may be required for implantation, interrogation, evaluation, or other specialized device procedures and for certain proprietary tests. When prior authorization is required, submit clinical documentation that supports medical necessity per the coverage rationale.

Specialized devices/tests that commonly require prior auth: retinal prosthesis implantation and device interrogation (e.g., CPT 0100T, 0472T, 0473T, L8608); colorectal cancer biomarker ELISA panel tests (e.g., 0163U); carotid baroreflex activation device implantation/interrogation (Category III CPT 0266T–0273T referenced); CCM device implantation (Optimizer) and related device programming (see device-specific codes).

Prior Authorization — Specific Notes

Note

Contrast / Agent Use Notes

Note

Summary of Services Not Covered

The policy lists numerous CPT/HCPCS codes with the coverage conclusion Unproven. Those codes (including proprietary U-codes and Category III codes) are grouped in the Not Covered section and examples include SFDI biomarker measurement (0061U) which is explicitly stated as not medically necessary because available data do not demonstrate clinical utility or improved outcomes.

Chronic carotid baroreceptor stimulation (baroreflex activation therapy) for cardiovascular indications is classified as unproven and therefore not covered by this policy for treatment of hypertension, heart failure, or other cardiovascular conditions.

Tear film imaging (0330T) and myocardial sympathetic innervation imaging with 123I-MIBG (0331T/0332T) are explicitly identified as unproven and not medically necessary and are therefore not covered when submitted for routine clinical use as described in the policy.

Bioelectrical impedance analysis whole body composition assessment (0358T) and high-dose-rate electronic brachytherapy codes (0394T/0395T) are described as unproven and not medically necessary and are included in the Not Covered group of services.

Optical coherence tomography (OCT) of the middle ear (0485T/0486T) is identified in the policy as unproven and not medically necessary and is therefore listed among services not covered.

Definitions and Abbreviations

Unproven — Coverage conclusion definition assigned by UnitedHealthcare.

DefinitionCoverage conclusion assigned by UnitedHealthcare indicating the service or procedure lacks sufficient evidence to be considered medically necessary under this policy.

ImplicationServices labeled 'Unproven' in this policy are considered not medically necessary and may be denied when billed to UnitedHealthcare.

ScopeApplied to the omnibus list of CPT/HCPCS codes in this policy (numerous Category III and proprietary U-codes).

Spatial Frequency Domain Imaging (SFDI) — Definition and technique summary.

TechniqueAn optical, noncontact imaging method that quantitatively characterizes turbid (multiple scattering) tissues and maps superficial biomarkers such as tissue oxygenation (StO2), oxyhemoglobin and deoxyhemoglobin.

Frequency and Follow-up Guidance

RSA (radiographic) — Serial imaging schedule in research settings (postoperative day 1, 3 months, 1 year, and at intervals).

Research imaging scheduleRadiostereometric analysis (RSA) radiographs are commonly obtained postoperatively on day 1, then at 3 months, 1 year, and at subsequent intervals (2, 5, 7, and 10 years) in research studies monitoring implant migration.

ContextThese serial imaging time points derive from RSA research protocols assessing implant migration and correlation with patient‑reported outcomes over long-term follow-up.

Use limitationSuch serial RSA schedules are typical in research settings; RSA is considered unproven for routine clinical use by UnitedHealthcare.

pCLE frequency notes (chunk reference).

pCLE frequency/contextProbe-based CLE (pCLE) has been evaluated in randomized and observational studies; some RCTs (e.g., Wallace et al. 2012) found no advantage when added to HDWL for Barrett's esophagus surveillance and meta-analyses highlight heterogeneous results from specialized centers.

Background and Scope

Background: The Omnibus Codes section enumerates numerous newer, miscellaneous, Category III CPT, and proprietary HCPCS codes with concise descriptions and a coverage conclusion for each. Many of the entries are concluded as Unproven, reflecting limited or low-quality evidence and guiding the policy’s not-medically-necessary determinations.

Policy Revision History

2026-02-01policy_effective_dateLatest

UnitedHealthcare Omnibus Codes medical policy (CS087.AZ) effective date.

Policy Summary

PayerUnitedHealthcare

PolicyOmnibus/Category III and Proprietary CPT/HCPCS codes — coverage determinations

Policy CodePolicy CS087.AZ

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation when requesting coverage for listed services; many listed codes are designated Unproven and may be denied.

SourceLink

On This Page

Safety and evidence quality:

Short-term safety in trials appears acceptable, but long-term safety, durability of BP lowering, and effect on clinical cardiovascular outcomes remain uncertain; use is recommended in context of registries or research until further data are available.

NICE and society consensus call for monitoring and further trials; FDA approvals noted for specific devices.

Various intraoperative imaging and therapy procedures

Intraoperative procedures unproven: Multiple intraoperative imaging/therapy codes (e.g., IORT delivery and management, histotripsy) are listed as 'Unproven' due to limited comparative effectiveness and long-term outcome data.

Policy treats many intraoperative novel techniques as investigational pending stronger evidence.

Imaging confirmation for vertebral artery stenosis prior to consideration of EVT

Imaging confirmation prior to EVT: Before considering extracranial vertebral artery revascularization, imaging must confirm symptomatic 50–99% extracranial vertebral artery stenosis that correlates with recurrent vertebrobasilar territory symptoms despite best medical therapy; angiographic imaging and multidisciplinary assessment should be documented.50-99% stenosis

Derived from ESVS guideline language and VIST trial context.

Use of CAD/AI for chest radiograph interpretation in acute respiratory illness

AI/CAD use limitation: Randomized trial evidence does not show improved sensitivity or false-positive rates when AI-CAD assists radiograph interpretation in acute respiratory illness; CAD/AI for chest x-ray interpretation remains unproven for routine clinical implementation.

Hwang et al. 2023 RCT cited showing no diagnostic improvement with AI‑CAD.

Treatment of meibomian gland dysfunction/dry eye after conservative therapy

Thermal pulsation positioning: Thermal pulsation or wearable eyelid heating devices may be considered after failure or inability to perform basic lid hygiene/warm compress therapy; evidence shows mixed benefit and limitations, so documentation of prior conservative therapy is advised when requests for advanced device therapy are considered.

AAO technology assessments and RCT meta-analyses summarize limited/high-bias evidence and recommend conservative therapy first.

Mobile/automated audiometry — diagnostic accuracy and limitations

Mobile audiometry evidence: Smartphone- and tablet-based audiometry and automated audiometry demonstrate high pooled sensitivity and specificity in meta-analyses but accuracy is affected by age, device, environment, and lack of standardized protocols; usefulness is greater where conventional audiology is unavailable but limitations should be documented.

Meta-analyses report sensitivity ~89% and specificity ~93% with heterogeneity across studies.

Hypertension and heart failure (HFrEF) indications discussed in clinical evidence

BAT in hypertension evidence: For resistant hypertension, BAT evidence is limited and mixed; observational studies and small trials suggest possible effects on BP and dipping profiles but randomized data are insufficient to support routine coverage outside research or registries.

Rheos and subsequent observational data cited; NICE recommends research contexts.

BAT/CCM in heart failure evidence: For HFrEF, device-based therapies (including BAT and CCM) show improvements in functional status and QOL in some trials, but effects on mortality and hospitalization are inconsistent; regulatory approvals exist for narrow populations and further large RCTs are recommended.

BeAT‑HF and meta-analyses summarized; policy emphasizes evidence uncertainty.

Dry eye disease / tear film disorders

Tear film imaging investigational: Tear film imaging technologies are investigational; studies show variable repeatability and agreement across platforms and do not establish improved patient outcomes compared with standard clinical assessment (slit-lamp exam, TBUT, Schirmer); therefore routine coverage is not supported.

Policy references device comparison studies and AAO benchmarks recommending slit-lamp exam.

Heart failure prognostication

123I-MIBG prognostic evidence: 123I‑MIBG imaging metrics (e.g., H/M ratio, SPECT-derived TDS) show associations with outcomes in cohort studies but evidence is insufficient to support routine prognostic use that changes management and improves outcomes.H/M thresholds (e.g., <1.60 vs ≥1.60) cited

ADMIRE‑HF follow-up and smaller cohorts report prognostic associations but lack randomized data showing benefit of imaging‑guided care.

Orthopedic implant migration monitoring and fracture healing assessment (research use)

RSA research use: RSA may be used in research and implant surveillance to detect early micromotion and predict long-term implant performance; serial RSA imaging schedules (postoperative day 1, 3 months, 1 year, then periodic intervals up to 10 years) are described in research contexts but routine clinical utility is unproven.serial imaging at specified postoperative intervals in research settings

RSA requires markers, calibration cage, dedicated software, and trained staff.

Radiostereometric analysis for orthopedic implant migration / fracture healing

RSA for implant migration: RSA provides precise measurement of implant micromotion and migration and can contribute to implant evaluation in research; limitations include technical complexity, need for markers, and small-study evidence base, limiting routine clinical adoption.precision ranges reported per site

Further larger studies adhering to ISO guidelines are needed.

Suggested limited/adjunctive use in expert centers for biliary strictures, gastric lesions, and targeted BE assessment

CLE adjunctive use: Confocal endomicroscopy (CLE/pCLE) may be considered as an adjunct in expert centers for evaluation of indeterminate biliary strictures (with cholangioscopy), targeted diagnosis of gastric lesions, and adjunctive assessment in Barrett's esophagus where prevalence is high; use should be limited to experienced operators and ideally within research or registry settings.

Meta-analyses report high sensitivity/specificity in specialized centers but generalizability is limited.

Evaluating neoplasia in Barrett's esophagus, colorectal lesions, gastric/duodenal lesions, and indeterminate biliary strictures

CLE diagnostic contexts: Systematic reviews/meta-analyses report that CLE improves per-lesion detection of neoplasia in Barrett's esophagus and demonstrates high sensitivity/specificity for gastric and colorectal lesions and for diagnosing indeterminate biliary strictures when used adjunctively, but evidence originates mainly from specialized centers and does not support replacing standard biopsy protocols in routine practice.

High pooled sensitivity/specificity reported in meta-analyses, but operator dependence and training are limiting factors.

Middle ear assessment when concern for effusion or biofilm and when otoscopy/tympanometry are insufficient

Middle ear OCT potential use: Middle ear OCT may provide improved visualization of effusion, tympanic membrane-adherent biofilm, and fluid characterization when otoscopy or tympanometry are inconclusive; small studies report high imageability and reader accuracy, but clinical impact on outcomes is unproven and further research is needed.

Single-site and small cohort studies show promising diagnostic accuracy but lack outcome data.

Prior authorization requests should reference device approval status, indications, and supporting evidence.

Documentation Required

Prior authorization — baseline measures and prior therapy

For device-based or procedural coverage that is considered "Covered in certain circumstances" or when device therapy is considered after conservative care, prior authorization requests should include baseline measures and documentation of prior conservative therapy.

Eyelid thermal pulsation/evacuation: document baseline dry eye measures (e.g., OSDI/SPEED, TBUT, MG scores) and prior conservative management (warm compresses, eyelid hygiene) before approval of device-based therapy.
Renal denervation: document baseline ambulatory and office BP measurements, prior medication regimens, and attempts at guideline-directed medical therapy.
Subtalar arthroereisis and similar implants: document trials of conservative care (orthotics, PT, NSAIDs) and functional impact.
When available, include objective baseline imaging or test results (e.g., tear film imaging metrics, RSA baseline studies).

Denial Risk

Prior authorization risk for unproven services

Services and technologies labeled "Unproven" or "Not medically necessary" in this policy carry a high denial risk. Prior authorization requests for these services should include robust, peer-reviewed evidence and a clear rationale why standard, accepted therapies are not appropriate or have failed.

Examples of high denial-risk services: CAD for chest radiographs (0174T/0175T); tear film imaging (0330T); eyelid thermal pulsation (0207T/0563T) — policy considers these unproven/not medically necessary in general.
When submitting prior authorization for an unproven service, provide comparative evidence, patient-specific factors, and prior conservative therapy documentation.

Billing Rule

Prior authorization reference for BAT CPT codes

When requests concern baroreflex activation therapy (BAT) or carotid sinus stimulation devices, reference the Category III interrogation/programming CPT codes (e.g., 0273T and related 0266T–0273T series) and include documentation of indication, prior therapies, device model, FDA status, and device telemetry/interrogation findings.

Provide device implant date, device identification, interrogation reports (battery status, lead impedance, programmed values) and clinical rationale for implantation or for revision/removal procedures.
If coverage request is for revision/removal, check member-specific benefit documents for complication coverage provisions.

Prior Authorization

Prior authorization for listed CPT codes

Certain listed CPT/HCPCS codes in this policy are identified as unproven and prior authorization is expected if submitted. Submit detailed clinical notes and evidence when requesting coverage for codes identified as unproven.

Examples: SFDI (0061U) — unproven; Tear film imaging (0330T) — unproven; RSA codes (0347T–0350T) — unproven; Middle ear OCT (0485T/0486T) — unproven; Electronic brachytherapy and other listed codes in coverage table.
Include imaging, prior test results, and justification of why alternative standard tests are inadequate.

Prior Authorization

RDN patient selection check

For renal denervation (RDN) procedures, document selection criteria consistent with guideline/position statements: resistant hypertension confirmed by ambulatory BP measurement, multidisciplinary evaluation/shared decision-making, and a record of medication management attempts and adherence.

Include ambulatory BP values, office BP trends, current antihypertensive drug regimen (names, doses, adherence), and reasons additional medical therapy is unsuitable.
Document informed consent, multidisciplinary HTN team evaluation, and center/operator experience to address potential procedure-related complications.

Prior Authorization

Prior authorization and coding for RSA

Radiostereometric analysis (RSA) and associated procedural codes (0347T–0350T) are considered unproven for routine clinical use. Prior authorization submissions should include the specific clinical question being addressed, justification for RSA over standard imaging, and available supporting evidence.

Provide operative reports showing marker placement, RSA software reports, repeat measurement intervals, and any research/registry enrollment details if applicable.
Note that RSA is routinely used in clinical research; provide rationale if requested for routine clinical management.

Prior Authorization

Prior auth for CCM device implantation

Cardiac contractility modulation (CCM) device implantation (Optimizer) is described as having limited/uncertain evidence. Prior authorization is recommended for CCM implantation requests and should include detailed clinical documentation and device-specific evidence.

Include NYHA class, LVEF, prior guideline-directed medical therapy, rhythm status (sinus rhythm), contraindications to CRT, device model, and FDA approval/PMA details.
If device recall or device safety notices exist (e.g., Optimizer Smart Mini/Lite recall), include risk assessment and alternative management plans.

Prior Authorization

Prior authorization / coding headline

When submitting prior authorization or claims for services using the policy-listed CPT/HCPCS codes, recognize that many are labeled Unproven and may be denied as not medically necessary unless compelling, peer-reviewed evidence and comprehensive clinical documentation are provided.

Policy-coded services labeled 'Unproven' (see coverage table) are subject to denial risk. Provide literature, prior treatment history, and objective measures to support requests.
If the service is part of a clinical trial or registry, include trial/registry identifiers and enrollment confirmation.

Denial Risk

Services coded with the listed CPT/HCPCS

Services coded with the listed CPT/HCPCS codes that the policy concludes are 'Unproven' may be denied as not medically necessary. Prior authorization does not guarantee payment for these services.

Review the coverage summary table before submission; include peer-reviewed evidence and member-specific benefit plan references.
Denials are more likely for services without sufficient independent evidence of clinical benefit.

Denial Risk

Eyelid thermal pulsation denial risk

Eyelid thermal pulsation devices and wearable open-eye heat devices are designated unproven/not medically necessary by this policy in many contexts; claims for these services face denial risk unless prior conservative therapy and objective baseline measures are documented.

Document failure of warm compress/eyelid hygiene and include baseline OSDI/SPEED, TBUT, meibomian gland scores (MGYLS/MGSS), and prior treatment durations.
If prior RCTs or independent studies are cited in support, include full citations and patient applicability.

Denial Risk

Evidence insufficiency risk

Where evidence is insufficient or inconsistent (e.g., limited RCTs, small sample sizes, industry sponsorship, lack of long-term outcomes), prior authorization requests should include high-quality supporting literature and a rationale addressing evidence gaps.

Suggested supporting literature: randomized trials, systematic reviews, meta-analyses, independent (non–industry-sponsored) studies, guideline recommendations.
If evidence is primarily industry-sponsored or short-term, explain why it applies to the member and include plans for outcome monitoring.

Documentation Required

The use of the PreTRM serum-based proteo

The proprietary PreTRM serum-based proteomic test and other biomarker panels (e.g., colorectal cancer panels such as 0163U) are considered unproven; prior authorization requests must include analytic validity, clinical validity, clinical utility evidence, and how results will change management.

Provide test name, laboratory performing the assay, FDA status/cleared indications, algorithm details, and peer-reviewed validation studies.
Explain alternative standard screening or diagnostic approaches and why the proprietary test is necessary for this patient.

Denial Risk

Tear film imaging denial risk

Tear film imaging (0330T) is unproven and not medically necessary for routine evaluation. Prior authorization should include documentation of prior conventional diagnostic methods and justification for imaging use, plus device/method details and interpretation plans.

Document prior tests (Schirmer, TBUT, OSDI, staining), clinical correlation, and why tear film imaging results would alter management.
Include device make/model, operator qualifications, repeatability/reproducibility data, and interpretation/reporting protocols.

Documentation Required

NICE guidance governance requirement

When a technology is governed by NICE or other interventional guidance (e.g., RDN), the policy expects use only with appropriate clinical governance, consent, audit, or research arrangements. Prior authorization should document compliance with such governance requirements.

For procedures subject to NICE governance: include documentation of institutional oversight, audit plans, informed consent covering uncertainties, and registry enrollment where applicable.

Documentation Required

Setting and operator proficiency may affect coverage

Setting and operator proficiency can affect outcomes for specialized procedures (e.g., RDN, CLE, CCM). Prior authorization should document operator experience, center volume, and available resources to manage complications.

Include operator credentialing, case volumes, multidisciplinary team composition, and whether the center participates in registries or clinical trials.
For CLE and other advanced endoscopic imaging, note that the technique is difficult to master and may be best limited to expert centers.

Documentation Required

Documentation for SFDI use

For Spatial Frequency Domain Imaging (SFDI) (0061U) and other investigational imaging platforms, provide detailed documentation of intended clinical use, device regulatory status, validation studies, and how results will change management.

Include device model, FDA/CE status, peer-reviewed validation studies, and any participation in prospective registries or trials.
Provide objective baseline and follow-up measures to demonstrate clinical impact.

Documentation Required

Clinical documentation expectations

Clinical documentation expectations across services: provide relevant history, prior conservative treatments and durations, objective baseline measures, prior imaging/test reports, device model and FDA status, operator qualifications, and relevant peer-reviewed literature supporting the requested service.

Suggested documentation elements: clinical indication, prior treatments and response, objective metrics (e.g., BP, OSDI, TBUT, imaging), device details, informed consent, and multidisciplinary evaluations when indicated.
For services with high denial risk, include independent literature, trial identifiers, and registries if available.

Documentation Required

Supporting literature for CAD submissions

When submitting CAD (computer-aided detection) for chest radiograph claims or prior auths, include supporting literature on algorithm performance (sensitivity/specificity), comparison to radiologist-only interpretation, and justification for clinical need.

Provide version of algorithm, FDA clearance status, validation studies, and how CAD output will be integrated into clinical workflow and reporting.
Include examples of prior cases where CAD changed management if available.

Documentation Required