Currentsierra health and lifePolicy 2026T0535WWW

Omnibus/Category III CPT and Proprietary Codes Coverage

This policy lists numerous Category III and other temporary/new CPT/HCPCS codes and provides UnitedHealthcare Commercial and Individual Exchange coverage conclusions for each code, primarily indicating an 'Unproven' conclusion for the services.

Policy Summary

Payersierra health and life

PolicyOmnibus/Category III CPT and Proprietary Codes Coverage

Policy CodePolicy 2026T0535WWW

Change TypeMinor update — no material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation when submitting claims for listed services designated as 'Unproven' to support medical necessity and avoid denials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

70+listed codes in extract

Mostly Unprovencoverage stance

Applies toCommercial plans

Applies toIndividual Exchange plans

0061USFDI code

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

Coverage Criteria and Evidence-based Stances

Listed Codes - Unproven

Coverage conclusions provided per code in the table

Default policy conclusions: Each listed CPT/HCPCS code in the extract shows a coverage conclusion of 'Unproven' as stated immediately after the code description.

Provider should treat these services as unproven per this policy unless other sections (not in this extract) specify differently.

Not medically necessary / Unproven services

Covered when ALL of the following are met

SFDI not covered: Transcutaneous SFDI measurement (0061U) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Observational studies exist but lack outcome data showing improved patient outcomes; ECRI assessment inconclusive.

Extracranial VA stenting not covered: Transcatheter placement of extracranial vertebral artery stents (0075T, 0076T) is considered unproven and not medically necessary due to insufficient evidence of efficacy.

Recent registry observational data suggest possible benefit but limitations and guideline statements advise against routine stenting in many asymptomatic or routine cases.

Extracranial vertebral artery stenting during EVT

Considered in select acute PCTL cases when ALL of the following apply:

PCTL stenting potential criteria

Timing: Treatment performed within 24 hours of estimated occlusion timewithin 24 hours
Registry analyses described timing as an inclusion/analysis factor [[36]]
Documented justification: Proceduralist documents clinical and imaging rationale for extracranial VA stent placement (e.g., facilitate intracranial access or secure extracranial flow) and expected benefit to revascularization
Randomized controlled trial evidence lacking; decisions should be individualized and documented [[36],[41]]

Retinal prosthesis (Argus II) coverage criteria

Covered only when ALL HDE-specified criteria are met:

Argus II HDE criteria: Patient age ≥ 25 years; bare light perception or no light perception in both eyes (if no light perception, confirm intact inner-retinal function); prior useful form vision; aphakic or pseudophakic status (phakic eyes require removal at implant); and patient able and willing to comply with postimplant follow-up, device fitting, and visual rehabilitation per HDE requirements.

Per FDA HDE indications and post-approval study requirements for Argus II; manufacturing ceased but HDE criteria remain the basis for coverage decisions.

Blood-based CRC biomarker panels (e.g., BeScreened™-CRC)

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

Not covered criteria: Use of a blood-based biomarker panel algorithmic analysis test (example: BeScreened™-CRC / 0163U) to screen for colorectal cancer or advanced adenomas is unproven and not medically necessary.

USPSTF does not include serum tests for CRC screening; evidence for analytic and clinical validity and demonstration of screening benefit is insufficient.

Computer-aided detection (CAD) for chest radiographs

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

Not covered criteria: Computer-aided detection (CAD) applied to chest radiographs (0173T/0174T/0175T) is unproven and not medically necessary for routine clinical use or population screening.

Trials and technology assessments show no clear improvement in diagnostic outcomes or established population benefit; further high-quality randomized studies needed.

Eyelid thermal pulsation devices (LipiFlow®, iLUX, wearable heat devices)

Mixed evidence; policy classifies thermal pulsation and wearable eyelid heat devices as unproven / not medically necessary for evaluation or evacuation of meibomian glands in this excerpt.

Unproven interventions: Device-based thermal pulsation (e.g., LipiFlow®), iLUX, and wearable open-eye eyelid heat devices for meibomian gland evacuation or evaluation are considered unproven and not medically necessary in this policy segment due to insufficient high-quality evidence.

Systematic reviews and RCTs report mixed results with low-to-very-low certainty and many trials at risk of bias; manufacturer funding common.

Device-based eyelid thermal pulsation — conditional coverage

Coverage consideration when device therapy is requested

Initial coverage considerations: Patient has symptomatic dry eye disease (DED) related to meibomian gland dysfunction with objective baseline measures (eg, reduced meibomian gland secretion scores, abnormal TBUT) and significant symptoms; AND conservative therapy (eg, warm compresses, lid hygiene) has been attempted or documented as inappropriate; AND treating clinician documents rationale that device therapy is expected to improve gland function or symptoms based on available trial data and patient-specific factors.

Evidence shows some short-term improvements vs warm compresses in select trials but overall certainty is low; TFOS positions LipiFlow as a second-line option; prior conservative therapy is expected before device use.

Mobile/automated audiometry (clinical context and limitations)

Mobile and automated audiometry—evidence summary and clinical considerations

mobile audiometry evidence points: Some smartphone/tablet-based and automated audiometry applications/devices can approximate conventional pure tone audiometry thresholds (many within ±10 dB) and may be useful for screening or remote monitoring when validated equipment and protocols are used; however these tools lack bone conduction testing and formal masking and therefore cannot replace diagnostic pure tone audiometry for clinical decision-making.

Accuracy affected by device, environment (noise), user age, and protocol; caution advised and validation against clinic PTA recommended.

Atherectomy of visceral/renal/abdominal/brachiocephalic arteries

Transluminal peripheral atherectomy (visceral/renal/abdominal/brachiocephalic)

atherectomy unproven stance: Transluminal peripheral atherectomy of visceral, renal, abdominal aorta, or brachiocephalic trunk vessels (0234T–0237T) is unproven and not medically necessary due to insufficient evidence of safety and efficacy beyond case reports and small series.

Effectiveness and comparative safety versus established treatments are not demonstrated in the literature.

PreTRM proteomic test (IBP4/SHBG)

PreTRM (IBP4/SHBG proteomic biomarker) evidence synthesis

PreTRM evidence summary: Prospective observational studies (PAPR, TREETOP) show that the IBP4/SHBG proteomic ratio predicts increased risk of spontaneous preterm birth in some cohorts, but randomized intervention trials of screening plus risk‑reduction protocols did not demonstrate reduction in sPTB; guideline assessments and independent reviews conclude evidence is insufficient to support routine clinical use for screening asymptomatic pregnant individuals.

NICE and Hayes have not endorsed routine use; randomized trial (Branch et al.) failed to show significant benefit on primary outcome.

Tear film imaging

tear film imaging unproven: Tear film imaging (0330T and related platforms) to monitor or assess tear film disorders is unproven and not medically necessary due to device variability, poor reproducibility across platforms, and lack of demonstrated impact on clinical outcomes.

Studies report poor agreement between devices and recommend concurrent clinical examination; policy designates as unproven.

Not medically necessary — Tear film imaging and 123I‑MIBG imaging

Coverage stance summarized from evidence:

Tear film imaging not medically necessary: Tear film imaging to monitor or assess tear film disorders is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Device variability and lack of demonstrated clinical utility cited in studies; interpret with concurrent exam if used investigationally.

123I‑MIBG myocardial innervation imaging not medically necessary: Myocardial sympathetic innervation imaging with 123I‑MIBG (0331T/0332T) is unproven and not medically necessary as a prognostic marker in heart failure because available studies are small, single‑center, and do not show management-impact evidence.

Although associations with outcomes exist (eg, H/M ratio), no prospective data show improved outcomes when management is guided by 123I‑MIBG.

Not medically necessary

Coverage stance summary

Not medically necessary: Use of a sinus tarsi implant (subtalar arthroereisis) is unproven and not medically necessary for any indication due to insufficient clinical evidence of safety and/or efficacy.

Systematic reviews and consensus statements report low-quality evidence and high implant removal/complication rates.

Subtalar Arthroereisis (SA) — Evidence-based stance

Evidence summary and implied coverage considerations for SA:

evidence_limitations: Most studies of subtalar arthroereisis are single‑center case series or low‑quality evidence with heterogeneous concomitant procedures; long‑term comparative trials are lacking.

Implies limited strength of evidence for broad coverage.

potential_benefit: Some reports show clinical and radiographic improvement in symptomatic flexible flatfoot in selected pediatric and adult cohorts when SA is used alone or with adjunct procedures.

Benefit often confounded by concomitant procedures and selection factors.

complications: Sinus tarsi pain and implant removal are common complications; reported unplanned implant removal rates up to ~24–29% in some series.

High reoperation/removal rates influence risk–benefit assessment.

Renal Denervation (RDN) — Evidence-based stance

Evidence summary and implied coverage considerations for catheter-based RDN:

device_approvals: Some renal denervation (RDN) systems (eg, Paradise, Symplicity Spyral) have received FDA PMA approval for adjunctive treatment of hypertension; regulatory status exists for select devices.

PMA approvals cited but clinical benefit and patient selection remain areas of active evaluation.

efficacy_evidence_mixed: Randomized sham‑controlled trials and meta‑analyses show modest reductions in office and ambulatory systolic blood pressure with heterogeneity across studies; some trials show no significant difference vs sham and effect durability varies.

Magnitude of BP lowering modest (eg, ~4–8 mm Hg) with heterogeneity and notable sham effects; longer‑term outcome data limited.

safety: Short‑term safety profiles in trials are acceptable with recognized procedural risks (eg, renal artery injury); long‑term safety and impact on clinical outcomes remain uncertain.

Centers and operators should document monitoring and follow‑up plans.

RSA — Not medically necessary

RSA coverage determination

RSA not medically necessary: Radiostereometric analysis (RSA) is unproven and not medically necessary for routine clinical use due to insufficient evidence that it improves patient outcomes; RSA remains a specialized research tool.

RSA requires marker implantation, specialized biplanar radiographs through a calibration cage, dedicated software and trained personnel; clinical utility beyond research not established.

Electronic brachytherapy — not routinely covered except in trials

Coverage stance summarized from evidence and professional guidance

Electronic brachytherapy general coverage stance: Electronic brachytherapy (EBT) is considered unproven and not recommended for routine use outside prospective clinical trials or registries for accelerated partial breast irradiation, non‑melanomatous skin cancers, and vaginal cuff brachytherapy due to limited long‑term evidence and concerns about dosimetry and recurrence.

ABS and technology assessments advise limiting EBT to trials; randomized data raised concerns for breast recurrence.

EBT for other indications — investigational

Other / investigational indications

Other indications (investigational): Evidence for EBT in other gynecologic and non‑breast/skin indications is limited and inconclusive; use outside trials is investigational.

Current data largely from small case series and high risk‑of‑bias studies.

BIA — limited clinical utility

Bioelectrical impedance analysis (BIA) coverage considerations

BIA general stance: Whole‑body bioelectrical impedance analysis (BIA) is considered unproven and not medically necessary for individual clinical decision‑making due to inconsistent agreement with reference methods, variability across populations, and lack of standardized predictive equations; it may be useful for group‑level or longitudinal research under standardized conditions.

Accuracy affected by hydration, device, predictive equations and patient population (eg, obesity, pediatrics, oncology).

RSA — investigational/limited use

Radiostereometric analysis (RSA) context

RSA utility and limitations: RSA may provide precise assessment of implant migration and fracture micromotion in research settings but is operationally complex (marker implantation, calibration cage radiographs, dedicated software, trained personnel) and lacks demonstrated clinical‑outcome benefit to support routine use.

Marker‑free or CT‑based RSA approaches are being explored but not yet established for widespread clinical use.

General coverage considerations

Coverage stance and application notes derived from evidence summary

General stance: Confocal laser endomicroscopy (CLE/pCLE) is promising for targeted diagnostic applications (eg, indeterminate biliary strictures, targeted gastric/colorectal lesion characterization) but overall evidence is limited and heterogeneous; routine use is not supported and performance depends on operator expertise and center experience.

Meta‑analyses report high sensitivity/specificity in specialized centers but generalizability and impact on outcomes are uncertain.

Biliary strictures — adjunctive use

Indeterminate biliary strictures

When pCLE may be reasonable: pCLE may be considered adjunctive for evaluation of indeterminate biliary strictures when conventional ERCP tissue sampling is non‑diagnostic or inadequate, particularly when used with cholangioscopy; pooled sensitivity ~88% and specificity ~79% reported in meta‑analysis.

Most studies retrospective; prospective trials needed to confirm impact on management and outcomes.

Barrett's esophagus — adjunctive, not routine

Barrett's esophagus (BE)

Surveillance use: CLE/pCLE may be used adjunctively by experienced endoscopists/centers to target biopsies in Barrett's esophagus surveillance, but current evidence does not support routine replacement of Seattle protocol biopsy sampling; CLE is best considered adjunctive rather than a replacement.

Guidelines (ASGE/ACG) and RCT data advise against routine replacement of standard surveillance protocols; operator proficiency required.

Upper GI and colorectal indications

Gastric and colorectal lesions

Diagnostic performance: Meta‑analyses report high sensitivity and specificity for CLE in detecting gastric cancer and colorectal neoplasms in specialized centers, but generalizability is limited and CLE cannot survey entire organs; evidence insufficient to recommend routine use outside expert centers or research.

Learning curve and center experience substantially influence diagnostic accuracy.

Cardiac contractility modulation (CCM)

Coverage stance for CCM:

CCM coverage stance: Cardiac contractility modulation (CCM) implants are unproven and not medically necessary for treatment of chronic heart failure in general due to insufficient high‑quality evidence demonstrating improved clinical outcomes.

Although Optimizer received FDA PMA for a specific subgroup, overall policy stance in this excerpt describes CCM as unproven for broad HF treatment.

Confocal laser endomicroscopy (CLE/pCLE)

Interpretation of CLE/pCLE evidence and use:

CLE evidence summary: Systematic reviews and meta‑analyses indicate high sensitivity and specificity for CLE in various GI indications in specialized centers, but heterogeneity, operator dependence, and limited community data mean CLE should be adjunctive and not routinely replace standard biopsy protocols (eg, Seattle protocol for BE).

Evidence strongest for biliary strictures with ERCP and targeted gastric/colorectal lesion characterization; RCTs show mixed results for routine addition of pCLE to HDWL.

When CLE may be appropriate: CLE/pCLE may be appropriate when performed by endoscopists proficient in the technique and used adjunctively with standard endoscopic evaluation; documentation of operator expertise and correlation with histopathology is recommended.

Wallace RCT found no additional benefit of pCLE over HDWL in surveillance setting; use in indeterminate biliary strictures may be more justifiable.

Cryoneurolysis (Not medically necessary)

Not medically necessary / unproven indications covered in this section:

Cryoneurolysis for chronic pain: Percutaneous cryoablation/cryoneurolysis of peripheral or truncal nerves for chronic pain is unproven and not medically necessary due to insufficient evidence of long‑term safety and efficacy.

Randomized trials exist but overall evidence and generalizability are limited; ECRI assessment inconclusive for some indications.

Drug‑eluting ocular inserts (Not medically necessary)

Not medically necessary / unproven indications covered in this section:

Drug‑eluting ocular inserts: Placement of drug‑eluting ocular inserts under the eyelids (0444T/0445T) is unproven and not medically necessary due to limited evidence of safety and efficacy and insufficient long‑term outcome data.

Randomized trials are limited in size and duration; guideline endorsements absent.

Middle ear OCT (Not medically necessary)

Not medically necessary / unproven indications covered in this section:

Middle ear OCT: Optical coherence tomography (OCT) of the middle ear (0485T/0486T) is unproven and not medically necessary for routine assessment and management of middle ear disorders despite promising diagnostic metrics in small studies.

Studies show good sensitivity/accuracy for effusion and biofilm detection but lack evidence that OCT improves clinical outcomes; imaging may be limited by anatomy or obstructions.

Coverage stances by technology

Coverage stances and criteria summarized from document excerpts:

OCT for middle ear: OCT otoscopy and handheld OCT show promising diagnostic performance for middle ear effusion and biofilm detection in small studies, but clinical utility and outcome benefit are not established; larger, standardized studies are required before routine coverage.

Imaging feasibility may be limited by narrow/curved ear canals or obstruction (eg, otorrhea, cerumen).

HFP (MPOD) not covered: Heterochromatic flicker photometry for macular pigment optical density (0506T) is unproven and not medically necessary for evaluation of age‑related macular degeneration due to insufficient evidence.

Further robust studies needed to establish clinical utility.

Near‑IR meibography not covered: Near‑infrared dual imaging of meibomian glands (0507T) is unproven and not medically necessary due to insufficient evidence of diagnostic impact on management.

Manufacturer claims and device clearances exist but evidence and guidelines are lacking.

Per the policy and cited guideline evidence, open or endovascular interventions are not recommended for individuals with asymptomatic vertebral artery atherosclerotic lesions. The policy cites the 2023 ESVS Clinical Practice Guidelines that specifically advise against routine intervention in asymptomatic vertebral disease and note that routine stenting is not recommended for vertebrobasilar TIA or stroke with 50–99% stenosis. Any consideration of revascularization should follow guideline-based exceptions (for example, recurrent vertebrobasilar symptoms despite optimal medical therapy) and be justified with contemporaneous imaging and clear clinical rationale.

The policy states that routine stenting of vertebral artery atherosclerotic lesions is not recommended, including routine stenting for vertebrobasilar TIA or stroke with 50–99% stenosis as described in the ESVS 2023 guidance. Requests for retinal prosthesis or other device implants are separately addressed as unproven except when HDE-specified criteria are met. For vertebral stenting, requests that fall outside guideline-concordant indications (or lack supporting imaging/clinical justification consistent with the ESVS statements) are not routinely supported and are at higher risk for denial.

CPT/HCPCS/PLA Codes and Coverage Status

Omnibus / Unproven CPT codesCPTNot Covered

0061U	Transcutaneous measurement of five biomarkers using SFDI and multi-spectral analysis
0075T	Transcatheter placement of extracranial vertebral artery stent(s); initial vessel
0076T	Transcatheter placement of extracranial vertebral artery stent(s); each additional vessel
0100T	Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intra-ocular retinal electrode array
0163U	Oncology (colorectal) screening, biochemical ELISA of 3 plasma/serum proteins with proprietary algorithm
0174T	Computer-aided detection (CAD) chest radiograph concurrent with primary interpretation
0175T	Computer-aided detection (CAD) chest radiograph 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

1–10 of 143

1/15

Listed CPT/HCPCS codes (neutral)mixed

77425	Intraoperative radiation treatment delivery, electrons, single treatment session
77469	Intraoperative radiation treatment management
80145	Adalimumab (drug monitoring)
80230	Infliximab (drug monitoring)
80280	Vedolizumab (drug monitoring)
80299	Quantitation of therapeutic drug, not elsewhere specified
81490	Autoimmune (rheumatoid arthritis) 12-biomarker immunoassay with algorithmic analysis
90999	Unlisted dialysis procedure (when used to report aquapheresis/ultrafiltration)
93145	Interrogation device evaluation (in person), carotid sinus BAT system; without programming
93146	Interrogation device evaluation (in person), carotid sinus BAT system; with programming

1–10 of 15

1/2

Omnibus HCPCS/Codes (not_covered) and DMEHCPCSNot Covered

A4542	Supplies and accessories for external upper limb tremor stimulator of the wrist
C1839	Iris prosthesis
C2624	Implantable wireless pulmonary artery pressure sensor with delivery catheter
E0734	External upper limb tremor stimulator of the peripheral nerves of the wrist
E1399	Durable medical equipment, miscellaneous (used for non-invasive bimodal neuromodulation or robotic exoskeleton)
E2001	Suction pump, home model, for external urine management system
G0555	Provision of replacement patient electronics system for home pulmonary artery pressure monitoring
K1007	Bilateral HKAFO device, powered, includes pelvic component
L8699	Prosthetic implant, not otherwise specified (used for 3-D printed cranial implants)
L8701	Powered upper extremity range of motion assist device, elbow/wrist/hand, custom fabricated

1–10 of 12

1/2

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization for Listed Codes

Prior authorization is recommended or required for services described by the CPT/HCPCS codes listed in this policy. Many of the codes enumerated in the Coverage Summary and Omnibus Codes tables are concluded to be Unproven or Not Medically Necessary; submission should include prior authorization and clinical documentation to support medical necessity when coverage is being requested.

Affected codes include, but are not limited to: 0061U, 0075T, 0076T, 0100T, 0163U, 0174T–0175T, 0207T–0212T, 0234T–0237T, 03289, 33289, 43206, 43252, 47384, 53451–53454, 53860, 53899, 55899, 61715, 0640T, 0647T, 0651T, 0658T, 0659T, 0664T–0670T, 0672T, 0686T, 0692T, 0694T–0696T, 0735T, 0234T–0237T, 0347T–0350T, 0440T–0442T, 0444T–0445T, 0485T–0486T, 0506T, 0563T, 0207T, 0174T, 0175T, 0335T, 0510T, 0511T, S2117 and other temporary/PLA codes cited in the evidence sections.
Clinical documentation should reference the specific code(s) billed, the indication, prior conservative therapies attempted (when applicable), and any device regulatory status (FDA clearance/PMA/HDE/recall information).

Prior Authorization

Prior Authorization Expectation for Unproven Services

For services designated 'Unproven' or 'Not Medically Necessary' in this policy (including many omnibus and temporary CPT/PLA codes), prior authorization is expected. Clinical review will be required and claims are at risk for denial without adequate supporting documentation.

Situations Where Use May Be Considered (Adjunctive / Research / Limited Exceptions)

Prior Authorization and Governance Notes

Prior Authorization

Prior authorization expected for implantable device procedures and long‑term monitoring

For implantable device procedures and long‑term monitoring (e.g., wireless PA sensor, wireless LV pacing), expect prior authorization and device‑specific review given device complexity and regulatory status.

Examples: 33289 (wireless PA sensor), 0515T–0522T and related 05xx/08xx series for wireless LV pacing; include device PMA/clearance details when applicable.

Prior Authorization

Prior authorization required for retinal prosthesis implantation and programming (HDE devices)

Retinal prosthesis implantation and device programming/interrogation require prior authorization because of HDE status and specialized device codes; include HDE criteria documentation.

Codes: 0100T, 0472T, 0473T, L8608 — document HDE eligibility criteria and follow-up plan.

Definitions and Key Terms

SFDI — Spatial Frequency Domain Imaging (SFDI)

DefinitionSpatial Frequency Domain Imaging (SFDI): a noncontact optical imaging technique that quantitatively maps superficial tissue oxygenation and hemoglobin content (StO2, ctHbO2, ctHbR, ctHb1, ctHb2).

Intended use depthSuperficial tissues (cutaneous/pedal microcirculation) as an adjunct to other clinical assessments.

Regulatory status (example device)Clarifi Imaging System — FDA 510(k) cleared for measuring superficial tissue oxygenation (manufacturer notes it does not provide a standalone diagnosis).

Clarifi Imaging System — Clarifi Imaging System — FDA 510(k) clearance

Device descriptionClarifi Imaging System: a non-contact, noninvasive tissue oxygenation measurement system using SFDI to report approximate oxygen saturation and oxy-/deoxyhemoglobin in 2D/3D visualizations.

Intended role

Not Covered / Unproven Services

This policy extract lists numerous temporary and Category III CPT/HCPCS codes whose coverage conclusion in the table is Unproven. Because these services are designated Unproven in this section, they are not supported by the policy for routine coverage; examples include imaging, device implantation, and novel procedure codes summarized across the omnibus code lists. Claims for the listed codes are therefore at risk for denial unless specific, exceptional, guideline-supported criteria (not included in this excerpt) are documented.

The policy explicitly designates tear film imaging (0330T) for monitoring or assessment of tear film disorders as unproven and not medically necessary due to insufficient evidence of safety and clinical utility. Similarly, myocardial sympathetic innervation imaging with 123I‑MIBG (0331T/0332T) is considered unproven and not medically necessary when used as a prognostic marker in heart failure because available studies are limited and do not demonstrate clear management‑impact benefit.

Procedures that insert a sinus tarsi implant (subtalar arthroereisis) are described in the policy as unproven and not medically necessary for any indication. The document cites systematic reviews and guideline positions noting insufficient clinical evidence, variable complication and implant‑removal rates, and professional guidance that restricts routine use; accordingly, coverage for sinus tarsi implant procedures is not supported in this excerpt.

The policy section summarizes several explicit noncoverage positions: routine imaging-driven stenting for asymptomatic vertebral lesions is not supported per ESVS guidance; retinal prosthesis implantation is considered unproven and not medically necessary except when all HDE-specified criteria are met; and blood-based colorectal cancer biomarker panel tests (example: BeScreened™-CRC / 0163U) are unproven and not medically necessary for CRC or advanced adenoma screening due to insufficient evidence.

Background and Scope

Background: this partial extract presents a tabulated list of many temporary and Category III CPT/HCPCS codes with short descriptions and the policy’s coverage conclusions. For the codes shown in this window the predominant conclusion is Unproven, and the policy applies to UnitedHealthcare Commercial and Individual Exchange plans; claims for these listed codes therefore require supporting clinical documentation and are at risk for denial absent evidence that meets the plan’s medical necessity criteria.

Policy Revision History

Policy Summary

Payersierra health and life

PolicyOmnibus/Category III CPT and Proprietary Codes Coverage

Policy CodePolicy 2026T0535WWW

Change TypeMinor update — no material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and provide documentation when submitting claims for listed services designated as 'Unproven' to support medical necessity and avoid denials.

SourceLink

On This Page

guidance_restriction:

Professional guidance (eg, ACFAS, NICE) recommends restricting use and avoiding SA as a sole corrective procedure for certain adult-acquired flatfoot presentations; use may be limited to research or special governance arrangements.

Suggests conditional or restricted coverage pending higher-quality evidence.

patient_selection: Consensus statements recommend considering RDN for patients with resistant or uncontrolled hypertension despite guideline‑directed pharmacotherapy, confirmed by ambulatory blood pressure measurement and after shared decision‑making; multidisciplinary evaluation is advised.

Implies coverage may be limited to defined patient selection criteria and documented prior therapy attempts.

Wireless LV pacing (WiSE) stance: Wireless LV endocardial CRT is described as unproven and not medically necessary in this document excerpt, although separate FDA PMA information for WiSE exists; policy stance is mixed and requires plan‑specific review.

Evidence and regulatory status should be reconciled on a case‑by‑case basis with device PMA details considered.

Examples: SFDI (0061U), extracranial vertebral artery stenting (0075T/0076T), retinal prosthesis implantation (0100T), CRC biomarker panels (0163U), PreTRM (reported via 81599), tear film imaging, 123I‑MIBG cardiac innervation imaging, electronic surface brachytherapy, radiostereometric analysis (0347T–0350T), and others listed as Unproven.
Include prior authorization submissions describing why the test/procedure is indicated and why standard, guideline‑based alternatives are not appropriate for the patient.

Step Therapy

Prior Therapy Consideration / Step Therapy

When device-based or procedural therapies are requested after a trial of conservative management, prior therapy documentation is often expected. For certain technologies, a stepwise approach is recommended before authorization is approved.

Eyelid thermal pulsation (e.g., LipiFlow, 0207T/0563T): document failure/intolerance of conventional therapy (warm compresses, eyelid hygiene, topical therapies) prior to considering device therapy.
Renal denervation: document trials of lifestyle modification and guideline-directed pharmacotherapy (including adherence and intolerances) before referral or authorization; shared decision-making and specialist evaluation are recommended.
Where a policy cites a 'step therapy' preference (e.g., tear film imaging, vertebral interventions), document prior standard treatments tried and outcomes.

Prior Authorization

Prior Authorization for Unproven Imaging and Diagnostic Tests

Certain imaging and diagnostic services identified as unproven (e.g., tear film imaging, optical endomicroscopy/confocal laser endomicroscopy, 123I‑MIBG myocardial innervation imaging) require prior authorization and robust clinical justification if submitted.

Tear film imaging: claims may be denied; include clinical signs/symptoms, prior treatments, and how the imaging result will change management.
Confocal laser endomicroscopy (88375/43206/43252): document adjunctive role (e.g., with ERCP) and that it is not being used to replace recommended biopsy or surveillance protocols.
123I‑MIBG: include specific indication, how results would alter therapy, and reference to guideline recommendations given its unproven prognostic role in HF.

Denial Risk

Denial Risk for Unproven Codes

Some services and devices that are unproven carry a high denial risk. When billing these codes, ensure documentation addresses the policy's evidence limitations and rationale for use.

High denial-risk examples: 0061U (SFDI), 0075T/0076T (extracranial vertebral artery stenting), 0163U (CRC biomarker panel) and other algorithm-based serum biomarker panels, 81599 used for PreTRM, and many temporary CPT codes listed as Unproven.
Documentation should explicitly address why the service is being used, what comparative evidence supports its use (if any), and why guideline‑recommended alternatives are insufficient.

Denial Risk

Specific Denial Triggers and Documentation Notes

Specific code-level denial triggers and documentation expectations are highlighted for notable services in the evidence sections; include device regulatory status and indication-specific records when applicable.

SFDI (0061U): considered Unproven — include rationale, reference studies if used, and clinical impact on management to mitigate denial risk.
CRC biomarker panels (0163U and similar): these algorithmic blood‑based panels are Unproven; provide documentation of why standard CRC screening modalities are not being used or are inappropriate.
PreTRM (81599): serum‑based proteomic algorithm tests for preterm birth prediction are Unproven; include obstetric risk factors and explanation of clinical utility.

Prior Authorization

Prior Authorization for Retinal Prosthesis / Device Documentation

Retinal prosthesis implantation and associated device programming/interrogation have specific regulatory and indication-related documentation requirements. The Argus II has an HDE with narrow indications and post‑approval study commitments; manufacturing status and HDE criteria should be documented.

If Argus II (0100T) or similar retinal prosthesis is submitted, include patient age, visual function (bare light or no light perception), prior useful form vision, lens status (aphakic/pseudophakic or planned cataract extraction), and documented ability to participate in postimplant rehabilitation.
Document device regulatory status (HDE, PMA, FDA clearance, manufacturer updates/recalls) and reference to any required post‑approval study enrollment or follow‑up obligations.

Documentation Required

Governance and Consent Requirements for Procedures with Limited Evidence

Governance, consent, and audit requirements apply for selected interventional procedures (for example, sinus tarsi implants and renal denervation) when evidence is limited. Prior authorization submissions should include consent discussions and institutional oversight plans when applicable.

Sinus tarsi implants (0335T, 0510T, 0511T, S2117): document that treatment is being performed under appropriate clinical governance and with informed consent acknowledging limited evidence; consider registry or trial participation.
Renal denervation: include multidisciplinary evaluation notes, patient selection rationale, evidence of guideline‑directed medication/lifestyle trial, and plan for follow-up and reporting of outcomes or complications.

Denial Risk

Risk of Denial for Routine Electronic Surface Brachytherapy

Electronic surface brachytherapy and other electronic brachytherapy applications have limited evidence and are generally expected to be confined to clinical trials or registries. Routine use may be denied without adequate justification.

For electronic brachytherapy (e.g., Axxent) used in breast or skin cancer, include trial enrollment, institutional review, comparator therapy rationale, and long‑term follow‑up plans; absence of these may lead to denial.
Document tumor type, stage, prior surgical management, and why standard therapies (surgery, external beam RT, established brachytherapy) are not appropriate.

Prior Authorization

Prior Authorization for Listed Temporary CPT Codes

Temporary CPT codes (experimental/omnibus codes) cited in the evidence sections should trigger prior authorization requests and must include a clear clinical rationale and supporting evidence references.

Examples include temporary CPT/PLA codes for CAD of chest radiographs (0174T/0175T), macular pigment measurement (0506T), middle ear OCT (0485T/0486T), optical endomicroscopy (43206/43252/88375), and others listed as Unproven.
When submitting, include literature citations, how the test will change management, and prior alternative testing attempted.

Denial Risk

Evidence Limitations May Trigger Denial — Documentation Expectations

Evidence limitations commonly cited in the policy (small studies, lack of contemporary comparison groups, short follow-up, industry sponsorship, heterogeneity across studies) may trigger denials when claims lack convincing, independent supporting data.

When studies are limited by lack of randomized controls, absence of contemporaneous comparison groups, or short-term follow-up (examples in retinal prostheses, eyelid thermal pulsation, LipiFlow trials, and many device studies), include rationale why the intervention is still clinically necessary for the individual patient.
If evidence is primarily industry‑sponsored or from single‑center series, state whether independent data exist and provide outcome measures relevant to the patient's care.

Documentation Required

Operator Proficiency, Image Acquisition, and Correlation with Reference Standard

Operator proficiency, procedural details, and correlation with reference standards should be provided for diagnostic imaging and specialized procedures to support medical necessity.

For procedures such as RSA (0347T–0350T), OCT middle ear (0485T/0486T), and body surface activation mapping (0695T/0696T), include operator/training credentials, imaging acquisition protocols, calibration methods, and how results are correlated with a recognized reference standard.
Image acquisition limitations (poor quality, noninterpretable studies) should be documented; repeat testing may not be covered without justification.

Prior Authorization

Prior Authorization Recommended for CCM Implant Codes and Device Documentation

Clinical cardiac device implantation services (e.g., cardiac contractility modulation — CCM) and related implant codes should be preauthorized with documentation of guideline‑based indications and device status.

For CCM implant codes, include NYHA class, LVEF, sinus rhythm status, prior guideline‑directed medical therapy, CRT candidacy, and any device recalls or manufacturer advisories (e.g., Optimizer device recall information).
Document expected clinical benefit (six‑minute walk distance, QOL measures) and plan for post‑implant programming and follow‑up.

Prior Authorization

Cryoneurolysis — Prior Authorization and Denial Trigger

Cryoneurolysis and related temporary codes for percutaneous nerve ablation are regarded as Unproven for some chronic pain indications; prior authorization submissions should include prior conservative treatments and functional outcome goals.

Cryoneurolysis (0440T–0442T): provide documentation of prior conservative care (medications, PT, injections), duration of symptoms, and expected benefit in pain/function.
Absence of prior conservative therapy or objective functional measures may result in denial.

Denial Risk

Atherectomy (visceral/renal/abdominal/brachiocephalic) — prior auth likely to result in denial

Transluminal peripheral atherectomy of visceral/renal/abdominal/brachiocephalic arteries is designated unproven/not medically necessary; prior authorization submissions are likely to be denied.

Relevant codes: 0234T–0237T.

Denial Risk

PreTRM proteomic assay — prior authorization will likely be denied

The PreTRM proteomic multianalyte assay is designated unproven and not medically necessary; prior authorization is likely to result in denial if submitted.

Reported via unlisted code 81599; include rationale but anticipate noncoverage.

Prior Authorization

0330T/0331T/0332T require prior authorization; case‑by‑case review for exceptions

When CPT codes 0330T, 0331T, 0332T (tear film imaging and 123I‑MIBG imaging) are submitted, prior authorization is required given their not medically necessary designation; exceptional circumstances may be reviewed case‑by‑case.

Document clinical impact on management to support case‑by‑case consideration.

Prior Authorization

Require detailed prior therapy documentation for RDN prior authorization

Renal denervation (ultrasound or radiofrequency) prior authorization must document prior lifestyle and pharmacologic treatment failure, confirm ambulatory BP criteria, and multidisciplinary review per consensus guidance.

Include ambulatory BP results, medication list/doses, documented adherence, and documentation of shared decision-making.

Denial Risk

RSA and BIA — unproven/not medically necessary; prior authorization unlikely to permit routine coverage

Radiostereometric analysis (RSA) and bioelectrical impedance analysis are described as unproven/not medically necessary; prior authorization is not specifically detailed but noncoverage is the policy position.

RSA codes: 0347T–0350T; BIA code: 0358T — plan review will likely reflect not medically necessary stance.

Prior Authorization

Prior authorization for electronic brachytherapy limited — favor trial/registry use

Electronic brachytherapy should be limited to prospective clinical trials or registries; prior authorization requests for routine use should include trial/registry documentation or detailed justification.

Include device and applicator details, fractionation, follow-up plan, and trial identifiers when applicable.

Prior Authorization

CLE/pCLE — prior authorization expected; document adjunctive role and prior nondiagnostic sampling

Confocal laser endomicroscopy (CLE/pCLE) is regarded as unproven for routine use; prior authorization is expected when requested and documentation should show adjunctive intent and prior nondiagnostic sampling if applicable.

Support requests with prior ERCP/biopsy results and operator experience.

Prior Authorization

Prior authorization for CCM implants requires FDA‑indication documentation

CCM (Optimizer) implant authorization should include documentation consistent with FDA approval: NYHA class III symptoms, LVEF 25–45%, sinus rhythm, and not a CRT candidate; coverage will be reviewed against these criteria.

Relevant codes: 0408T–0418T, K1030; include device PMA reference and clinical documentation.

Prior Authorization

Middle ear OCT (0485T/0486T) — prior authorization expected; policy labels as unproven

Optical coherence tomography (OCT) of the middle ear (0485T/0486T) is listed as unproven for all uses; prior authorization or denial is expected when submitted.

Include any intraoperative or corroborating findings (myringotomy, CLSM/PCR) if arguing for investigational use.

Prior Authorization

Prior authorization likely required for wireless LV pacing device implantation (WiSE) with PMA documentation

Wireless LV pacing (WiSE) device implantation and related device procedure codes are complex and tied to PMA status; prior authorization and thorough device/indication documentation are likely required.

Include PMA details, indication (failed coronary sinus lead or ineligible for standard CRT), and device-specific operative plan.

Intended to be part of a larger clinical assessment battery, not a standalone diagnostic or treatment decision tool.

Regulatory noteCleared by FDA via 510(k) as substantially equivalent to predicate devices; clinical outcome benefit not established in available studies.

PCTL — posterior circulation tandem lesion (PCTL)

DefinitionPosterior circulation tandem lesion (PCTL): concurrent extracranial vertebral artery lesion with intracranial posterior circulation occlusion encountered and treated during endovascular therapy (EVT).

ContextDescribed in registry-based EVT data assessing outcomes when extracranial VA stenting is performed for PCTL during mechanical thrombectomy.

Timing considerationStudies suggest benefit when treated within 24 hours of estimated occlusion time (registry evidence).

HDE — Humanitarian Device Exemption

DefinitionHumanitarian Device Exemption (HDE): an FDA regulatory pathway permitting marketing of devices for rare conditions with specified post-approval study requirements.

Example deviceArgus II Retinal Prosthesis System received an HDE and is indicated under HDE-specified criteria for severe to profound retinitis pigmentosa.

Post-approval requirementsHDE approval may require post-approval studies (e.g., multicenter follow-up and long-term device monitoring).

BeScreened test description — ELISA-based multiplex blood test

Test typeBeScreened™-CRC: ELISA-based multiplex blood test measuring three plasma/serum proteins (TDGF-1/Cripto-1, carcinoembryonic antigen [CEA], and an extracellular matrix protein).

Result algorithmProprietary algorithm combines biomarker levels (and demographic data per manufacturer) to report likelihood of colorectal cancer or advanced adenomas.

Clinical stanceUSPSTF does not include serum tests for CRC screening due to limited evidence; policy considers such biomarker panels unproven/not medically necessary.

CAD for chest radiographs — definition

DefinitionComputer-aided detection (CAD) for chest radiographs: computer algorithm analysis of digital chest x-ray images to flag potential lesions for physician review (concurrent or remote).

Reporting modelCAD outputs are intended to be reviewed by a physician—performed concurrent with or remote from primary interpretation (codes 0173T/0174T/0175T).

Coverage stancePolicy labels CAD for chest radiographs as unproven and not medically necessary due to insufficient evidence of benefit.

Eyelid thermal pulsation — definition (LipiFlow®, iLUX)

DefinitionEyelid thermal pulsation (vectored thermal pulsation, VTP): devices that apply localized heat and intermittent/pulsatile pressure to the eyelids to evacuate meibomian glands (examples include LipiFlow® and iLUX).

Wearable variantWearable open-eye eyelid heat devices deliver targeted heat while eyes remain open (examples: TearCare, earCare-type systems).

Intended useThermal pulsation devices are intended to improve meibomian gland function for meibomian gland dysfunction/dry eye disease; evidence is mixed and often industry‑sponsored.

Atherectomy — definition

DefinitionAtherectomy: endovascular removal of atheromatous plaque by cutting, drilling, shaving, pulverizing, lasing, or sanding to enlarge lumen and improve vessel compliance.

Device typesIncludes directional, rotational, orbital, intravascular lithotripsy, excimer laser, and CTO recanalization systems (e.g., Crosser™).

Evidence contextFor visceral, renal, abdominal, and brachiocephalic arteries, published evidence is limited to case reports; effectiveness and safety relative to standard treatments are unestablished.

PreTRM — proteomic biomarker test (IBP4/SHBG)

DefinitionPreTRM: a serum-based proteomic biomarker test measuring the IBP4/SHBG ratio to predict risk of spontaneous preterm birth in asymptomatic pregnant individuals.

Coding/reportingReported using unlisted multianalyte assay with algorithmic analysis code (81599) in many contexts.

Evidence/actionable noteLarge prospective cohorts show predictive associations but randomized intervention trials did not demonstrate reduced sPTB with screening-based interventions; policy considers PreTRM unproven/not medically necessary for routine screening.

Tear film imaging parameters — LLT, TMH, NIBUT, meibography

Parameters measuredTear film imaging can assess lipid layer thickness (LLT), tear meniscus height (TMH), non-invasive tear break-up time (NIBUT/NIKBUT), and meibography.

Intended roleUsed as adjunctive objective measures to characterize tear film and meibomian gland status; device/platform variability limits reproducibility.

Policy stanceTear film imaging is considered unproven and not medically necessary for routine monitoring/assessment due to insufficient evidence of clinical utility.

123I‑MIBG imaging metrics — H/M ratio and SDS/TDS

Key metrics123I‑MIBG myocardial innervation imaging metrics include heart‑to‑mediastinum ratio (H/M) on planar imaging and summed defect score (SDS) or total defect score (TDS) on SPECT.

Clinical useMetrics have been associated with prognosis in heart failure cohorts (eg, H/M <1.60 linked to higher mortality) but management‑impact evidence is lacking.

Policy stance123I‑MIBG imaging is considered unproven and not medically necessary as a routine prognostic marker in heart failure due to limited evidence.

Subtalar arthroereisis — definition and implant description

DefinitionSubtalar arthroereisis (SA): surgical placement of an implant in the sinus tarsi (commonly titanium or resorbable PLLA) intended to limit excessive subtalar motion and correct flexible flatfoot.

Typical indicationUsed to address symptomatic flexible pes planus after failure of conservative therapy; often performed with concomitant procedures.

Safety/complicationsReported complications include sinus tarsi pain and implant removal; evidence quality is limited and consensus recommends caution.

Renal denervation (RDN) — definition

DefinitionRenal denervation (RDN): endovascular catheter-based procedures that deliver energy (ultrasound or radiofrequency) to the renal artery adventitia to disrupt renal sympathetic nerves and lower blood pressure.

Regulatory statusSelect systems (e.g., Paradise, Symplicity Spyral) have received FDA PMA approvals as adjunctive treatment options for hypertension with specified indications and clinical requirements.

Evidence summaryRandomized sham‑controlled trials show modest BP reductions with variable durability; patient selection and demonstration of prior guideline-directed therapy failure are emphasized.

Radiostereometric analysis (RSA) — definition

DefinitionRadiostereometric analysis (RSA): an imaging technique using implanted tantalum markers and serial biplanar radiographs through a calibration cage analyzed by dedicated RSA software to calculate 3‑D micromotion (maximal total point motion) between implant and bone.

Operational requirementsRequires implantation of markers, calibrated biplanar x‑rays, specialized software, and trained personnel; CT‑based RSA is being explored as a lower‑dose alternative for research use.

Use casePrimarily used in research to monitor early implant migration or fracture healing; routine clinical utility for improving outcomes is not established.

confocal laser endomicroscopy (CLE) — endoscopic technique

DefinitionConfocal laser endomicroscopy (CLE): endoscopic technique that obtains high‑resolution, real‑time microscopic images of mucosal tissue (optical biopsy) using laser and fluorescent contrast.

FormatsPerformed via probe‑based CLE (pCLE) passed through the endoscope accessory channel or integrated endoscope systems; often requires intravenous fluorescein for contrast.

Clinical roleCLE/pCLE can provide adjunctive, real‑time histologic assessment in GI and pancreatobiliary indications (eg, indeterminate biliary strictures) but routine replacement of standard biopsy protocols is not supported by current evidence.

CLE/pCLE — Probe-based confocal laser endomicroscopy

DefinitionProbe‑based CLE (pCLE): a CLE system using a probe passed through the endoscope accessory channel to obtain in vivo microscopic images, commonly used adjunctively with ERCP or cholangioscopy for biliary strictures and targeted GI lesion assessment.

Adjunctive roleMeta-analyses report high pooled sensitivity for indeterminate biliary strictures when pCLE is combined with ERCP, but studies are heterogeneous and largely from specialized centers.

Operational noteTypically requires operator proficiency and may need intravenous fluorescein; not recommended as routine replacement for standard biopsy protocols in Barrett's surveillance.

iovera — iovera system reference

Deviceiovera system: a cryoneurolysis/cryoneuroablation system cleared by FDA (501(k)) for certain indications; applies cold to peripheral nerves to produce temporary analgesic lesions.

Clinical evidenceRandomized sham‑controlled trial data show short‑term pain/function improvement for some uses (eg, knee OA) with diminishing effects by 6 months; further high‑quality studies are needed.

Regulatory noteCleared by FDA 501(k); additional indications and evidence vary by application and supporting trials.

Middle ear OCT — optical coherence tomography (middle ear)

DefinitionMiddle ear optical coherence tomography (OCT): noninvasive imaging of the middle ear and tympanic membrane that can detect effusion, biofilm, and TM pathology with high-resolution cross‑sectional images.

Reported performanceSmall studies report high diagnostic accuracy (~90% readable images in some series) and detection of middle ear effusion and biofilm compared with intraoperative findings, but clinical utility for outcomes is unproven.

Policy stanceOCT of the middle ear is considered unproven and not medically necessary for assessment/management due to insufficient evidence of clinical benefit and limitations in image acquisition in some patients.