UnitedHealthcare Unproven CPT/HCPCS Coverage Update

Coverage determinations and rationale

General: Unproven — not supported by evidence

Covered when ALL of the following are met

Policy-level conclusion: Each CPT/HCPCS code listed in the policy excerpt is assigned a conclusion of 'Unproven'

Code-specific coverage rationale and evidence available via code links in full policy

Unproven / Not Medically Necessary

Coverage determinations stated in excerpt

Unproven interventions: Listed CPT/HCPCS codes and unlisted procedures described in the Coverage Summary are concluded to be Unproven due to insufficient evidence of safety and/or efficacy (examples include 0577T, 0600T, 0061U, 33289, 61715, etc.).

Providers should expect claim denials or requests for additional evidence for these codes.

Covered in Certain Circumstances

Selected codes are covered under limited circumstances

Covered in certain circumstances: Certain services (e.g., 93264 remote monitoring up to 30 days; G0555 replacement patient electronics) are described as 'Covered in certain circumstances' which implies coverage when payer-determined conditions are met.

Exact conditions not detailed in this excerpt.

Extracranial vertebral artery stenting - Not medically necessary

Coverage stance for extracranial vertebral artery stenting

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

Supported by statement in document declaring procedure unproven/not medically necessary and associated CPT codes 0075T/0076T.

Retinal prosthesis systems - Not medically necessary

Coverage stance for retinal prosthesis devices (Argus II and similar)

Not medically necessary: Retinal prosthetic devices are considered unproven and not medically necessary for inducing visual perception in individuals with retinitis pigmentosa due to insufficient evidence of safety and/or efficacy.

Although Argus II had an HDE and some post-approval data, manufacturing has ceased and overall evidence deemed insufficient.

Biomarker panel screening for colorectal cancer - Not medically necessary

Coverage stance for biomarker panel CRC screening

Not medically necessary: Algorithmic biomarker panel tests (e.g., 3-protein ELISA panels such as BeScreened™-CRC) for colorectal cancer or advanced adenoma screening are considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Explicit statement in document declaring use unproven and not medically necessary.

Blood-based CRC biomarker panels — Not medically necessary / unproven

Blood-based colorectal cancer biomarker panels (example: BeScreened™-CRC) coverage stance:

Not medically necessary: Use of multi-protein blood-based biomarker panels for colorectal cancer screening (including BeScreened™-CRC, ELISA-based panels measuring TDGF-1/Cripto-1, CEA, ECM) is considered unproven and not medically necessary due to insufficient evidence of safety and/or efficacy.

Systematic reviews and guideline statements cite limited evidence and lack of prospective screening-population validation.

CAD for chest radiographs — Not medically necessary / unproven

Computer-aided detection (CAD) for chest radiographs coverage stance:

Not medically necessary: CAD systems used to analyze chest radiographs for lesion detection are considered unproven and not medically necessary due to insufficient evidence demonstrating improved patient outcomes or consistent diagnostic performance.

Randomized and comparative studies show mixed results; HTAs and guidelines call for further research.

Thermal pulsation for MGD — Not medically necessary / unproven

Thermal pulsation and wearable eyelid heat devices for meibomian gland dysfunction coverage stance:

Not medically necessary (per this section): Thermal pulsation (automated evacuation using heat and intermittent pressure) and wearable open-eye eyelid heat devices are considered unproven and not medically necessary for evaluation or evacuation of meibomian glands due to insufficient evidence of safety and/or efficacy.

Evidence includes mixed RCTs and systematic reviews; some specialty guidance lists as second-stage option but long-term benefit is unclear.

Efficacy summary for vectored thermal pulsation

Summary of evidence-based coverage-relevant conclusions

Evidence for LipiFlow/VTP efficacy: Multiple randomized trials and systematic reviews report that a single 12-minute vectored thermal pulsation (LipiFlow) session can improve subjective and objective measures of MGD/DED compared with no treatment and often versus warm compress therapy in short-term follow-up; however evidence certainty is low and durability and comparative superiority are uncertain.

Strength of evidence limited by risk of bias, manufacturer funding, and limited long-term data.

Efficacy summary for TearCare and similar devices

Summary of evidence for wearable open-eye heat devices (TearCare)

TearCare evidence: Randomized trials and observational studies suggest TearCare can improve TBUT, meibomian gland function, and symptom scores versus some comparators; head-to-head trials show similar short-term outcomes to LipiFlow in small trials, but evidence is limited by manufacturer funding, short follow-up, and potential bias.

Phase 3 and longer-term data are pending; additional independent validation needed.

Automated/mobile audiometry — covered with criteria (informational)

Automated / mobile audiometry — evidence summary and stance

Automated/mobile audiometry: Automated or self‑administered audiometry has emerging evidence showing variable accuracy; some smartphone/tablet tests correlate well with pure tone audiometry in adults and may be useful for screening, but limitations (lack of bone conduction/masking, variable performance in children, environmental noise) prevent routine replacement of audiologist‑performed PTA at this time.

Additional high-quality validation studies and standardization are required before equivalence to clinical PTA can be assumed.

Atherectomy — Not Medically Necessary

Atherectomy for visceral/renal/abdominal/brachiocephalic arteries

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

Published literature limited to case reports and small series; superiority to standard treatments not established.

PreTRM — Not Medically Necessary

PreTRM proteomic test for spontaneous preterm birth

PreTRM not medically necessary: Serum‑based proteomic biomarker test measuring IBP4/SHBG (PreTRM) to screen asymptomatic pregnant individuals for risk of spontaneous preterm birth is unproven and not medically necessary due to insufficient evidence that screening and consequent interventions reduce spontaneous preterm birth rates or improve neonatal outcomes.Positive test defined as ≥14% in trial context

Randomized trial in a low-risk population did not show significant reduction in sPTB <37 weeks; clinical utility is unproven.

Overall coverage logic

Coverage stance and evidentiary summary

Coverage considerations: Evidence demonstrates baroreflex activation therapy (BAT) can improve symptoms, quality of life, and exercise capacity in selected HFrEF patients, but evidence is mixed for mortality and hospitalization outcomes; for resistant hypertension and other uses evidence is inconclusive.

Randomized trials show functional improvements but not consistent mortality benefit; device has FDA approvals with specific indications.

Baroreflex activation therapy (evidence summary)

Evidence summary for Baroreflex Activation Therapy (BAT):

BAT evidence nodes: Pooled RCTs in selected NYHA class III HFrEF patients on guideline-directed therapy showed improvements in functional status, exercise capacity, and QOL with BAT; safety endpoints (MANCE) were favorable, but mortality and hospitalization benefits were not consistently significant across trials.

See BeAT-HF and pooled analyses; long-term benefit on major clinical endpoints remains uncertain.

Tear film imaging — Not medically necessary

Tear film imaging coverage stance and rationale:

Tear film imaging not medically necessary: Tear film imaging techniques (interferometry, meniscometry, video topography, OCT-based measures) are considered unproven and not medically necessary due to insufficient evidence of diagnostic accuracy, variable reproducibility, and lack of demonstrated impact on clinical outcomes.

Studies report poor reproducibility and poor agreement across devices; AAO recommends slitlamp biomicroscopy as standard.

123I-MIBG imaging — Not medically necessary

123I-MIBG myocardial sympathetic innervation imaging coverage stance and rationale:

123I-MIBG imaging not medically necessary for routine prognostication: Myocardial sympathetic innervation imaging with 123I-MIBG (planar or SPECT) is considered unproven and not medically necessary as a routine prognostic marker in heart failure because evidence is heterogeneous, largely single-center, and has not shown that imaging-guided management improves outcomes.

Studies show associations with events (e.g., late H/M ratio thresholds) but randomized, management-changing evidence is lacking.

Cardiac 123I-MIBG imaging - prognostic evidence (interpretive)

Coverage stance is informed by prognostic evidence but benefit from imaging-guided management is not established in randomized interventional studies.

Cardiac 123I-MIBG imaging evidence: Observational and cohort studies show that late H/M ratio and SPECT total defect score (TDS) are associated with cardiac events and mortality; however, thresholds (example H/M < 1.60) and prognostic associations have not been prospectively shown to change management or improve outcomes in randomized trials.H/M threshold example: 1.60

Documented prognostic associations do not equate to proven clinical utility for guiding therapy.

Automated VEP screening - evidence summary

Automated or instrument-based VEP screening for visual acuity in children:

VEP screening evidence: VEPs can estimate visual acuity in infants and selected populations, but guideline groups and systematic reviews do not support routine automated VEP-based population screening in children due to insufficient evidence of benefit or practicality.n/a

Automated VEP screening is considered unproven and not medically necessary for population screening.

Subtalar arthroereisis - evidence and coverage stance

Subtalar arthroereisis / sinus tarsi implant:

Arthroereisis evidence: Systematic reviews and case series report radiographic and functional improvements after subtalar arthroereisis, but studies are low quality, heterogeneous, and report variable complication and implant removal rates; overall evidence is insufficient to support routine use.implant removal rates reported 0%–48.1%

Procedure is labeled unproven and not medically necessary in this document absent higher-quality comparative data.

Subtalar arthroereisis — pediatric

Summary of coverage-relevant clinical conclusions from evidence reviews and guidelines:

Pediatric subtalar arthroereisis: For symptomatic idiopathic flexible pediatric flatfoot refractory to conservative therapy, low-quality evidence suggests possible symptomatic benefit from subtalar arthroereisis but definitive long-term comparative data are lacking and patient selection should document failure of conservative measures.clinical failure of conservative measures documented

Hayes and ECRI assessments call for further well-designed studies.

Subtalar arthroereisis — adult

Adult subtalar arthroereisis and sinus tarsi implants:

Adult subtalar arthroereisis: Systematic reviews report improvements but also high implant removal rates and heterogeneity from concomitant procedures; expert consensus advises SA should not be used as the sole corrective procedure for stage IIB adult acquired flatfoot.consider adjunctive procedures and patient selection

Caution urged; evidence insufficient for routine standalone use.

Renal denervation — selection

Renal denervation (RDN) for hypertension:

RDN candidate selection: Candidate selection should follow multidisciplinary assessment and include patients with resistant or uncontrolled hypertension despite optimized lifestyle and pharmacologic therapy; shared decision-making required and center capability and governance should be confirmed.resistant HTN or intolerance to medications

Professional society and NICE guidance recommend use within governance or research arrangements.

RDN: Evidence synthesis

Evidence-based considerations and contexts in which RDN has been studied

RDN evidence summary: Sham-controlled randomized trials demonstrate modest, short- to medium-term reductions in ambulatory and office blood pressure; longer-term durability and impact on clinical outcomes remain uncertain, and trial heterogeneity and sham effects complicate interpretation.

Multiple RCTs and meta-analyses provide modest BP reductions (e.g., RADIANCE II, SYMPLICITY follow-up) but long-term clinical endpoint data are limited.

Implementation and patient selection

Practice and implementation considerations

Recommended program features: Consider RDN only after confirming uncontrolled or resistant hypertension despite optimized therapy with ambulatory BP confirmation; perform procedures in centers with multidisciplinary governance, informed consent, capability to manage complications, and audit or research oversight.

Per NICE, ESC/EAPCI and professional statements.

RSA: Not medically necessary / research-only

RSA coverage stance

RSA coverage: Radiostereometric analysis (RSA) is considered unproven and not medically necessary for routine clinical indications due to insufficient evidence of improved patient outcomes; its primary accepted role is in research and phased implant evaluation.

RSA requires specialized markers, calibration cages, software and trained personnel; evidence supports research use.

RSA — evidence-supported use and limitations

Informational: evidence summaries and recommended roles

RSA for orthopedic implant evaluation: RSA is a precise technique to detect early migration of orthopedic implants and is useful for phased introduction and research monitoring of new prostheses, but lacks evidence that routine clinical RSA monitoring improves outcomes.

Serial RSA radiographs commonly performed at day 1, 3 months, 1 year, and later timepoints in studies.

RSA in fracture healing

RSA for fracture healing assessment: RSA may be promising to assess biomechanical fracture healing and early detection of nonunion, but is technically demanding and currently limited to research settings pending further validation.

Marker-free/model-based RSA and CT-based approaches may expand future applicability.

BIA — coverage stance and limitations

Stance on BIA

Bioelectrical impedance analysis (BIA): BIA whole-body composition assessment is considered unproven and not medically necessary for routine clinical use due to inconsistent accuracy, variability with hydration and obesity, and limited evidence of clinical utility; it may be acceptable for group-level or research use with standardized protocols.

Evidence shows variable agreement with reference methods; pre-measurement standardization is important.

Electronic brachytherapy — coverage stance

Stance on electronic brachytherapy

Electronic brachytherapy: High-dose-rate electronic brachytherapy is considered unproven and not medically necessary for routine treatment of breast, skin, vaginal cuff, and other indications due to insufficient long-term comparative evidence; specialty societies recommend use only in prospective trials or registries for many indications.

ECRI and ABS assessments cite inconclusive evidence and advise caution outside clinical trials.

Electronic brachytherapy — covered_with_restrictions

Coverage stance for electronic brachytherapy:

Electronic brachytherapy general stance: Evidence is inconclusive to support routine use of electronic surface brachytherapy for accelerated partial breast irradiation, nonmelanomatous skin cancers, or vaginal cuff brachytherapy; surgical management often remains preferred and electronic brachytherapy should be limited to trials or registries.

ABS consensus and ECRI reviews recommend limiting use outside prospective studies.

Optical endomicroscopy — informational / adjunctive

Coverage stance for confocal/optical endomicroscopy:

CLE/pCLE diagnostic utility: Confocal laser endomicroscopy (CLE/pCLE) shows promising diagnostic accuracy for selected GI indications (e.g., Barrett's esophagus adjunctive use, gastric cancer targeted biopsies, indeterminate biliary strictures) but evidence is limited by study quality, operator dependence, and generalizability; routine replacement of standard biopsy protocols is not supported.

May be adjunctive in expert centers or research settings; IV fluorescein is required for imaging.

CCM coverage considerations

Summary of CCM coverage considerations drawn from evidence and guideline statements:

FDA-approved indication for CCM (Optimizer system): CCM (Optimizer) has FDA PMA indication to improve 6-minute walk distance, quality of life, and functional status for NYHA Class III HF individuals who remain symptomatic despite guideline-directed medical therapy, are in normal sinus rhythm, are not indicated for CRT, and have LVEF 25% to 45%.LVEF 25%-45%; NYHA Class III; not CRT candidate; sinus rhythm

Long-term mortality/hospitalization benefit not established; evidence supports symptomatic benefit in select patients.

Guideline and assessment positions: Professional society guidance and technology assessments note CCM may improve exercise capacity and QOL but have not demonstrated mortality or hospitalization benefit; selective use or further study is recommended.

Evidence limited by small RCTs and heterogeneity.

Evidence strength considerations: Multiple RCTs and meta-analyses show improvements in functional capacity and QOL but limited evidence for hard outcomes; long-term data are limited and device recalls or safety considerations may affect use.

CLE/pCLE coverage considerations

Summary of CLE/pCLE coverage considerations drawn from systematic reviews, trials, and guideline statements:

CLE diagnostic performance: Systematic reviews and meta-analyses show CLE/pCLE has high sensitivity and specificity for selected GI indications (e.g., biliary strictures, gastric cancer) and can increase targeted biopsy yield, but most studies come from expert centers and are limited in generalizability.

Training and center experience materially affect performance.

Limitations and generalizability: Heterogeneity, small study sizes, and operator dependence limit widespread adoption; CLE should not replace standard surveillance protocols (e.g., Seattle protocol for Barrett's esophagus) in routine practice.

ASGE and AGA guidance recommend adjunctive or expert-center use only.

Guideline stance for BE surveillance: CLE is not recommended as a routine replacement for Seattle protocol biopsy sampling; may be considered adjunctive in expert centers or research settings.

Conditional recommendations due to low-quality evidence.

Percutaneous cryoablation — Coverage stance

Unproven / not medically necessary statements (as stated in document)

Percutaneous cryoablation for chronic pain: Percutaneous cryoablation of peripheral nerves (upper/lower extremity distal nerves, plexuses, or truncal nerves) for chronic pain is considered unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy.

Randomized trial data limited to specific targets (e.g., IPBSN) and short follow-up; routine use not supported.

Drug-eluting ocular inserts — Coverage stance

Unproven / not medically necessary statements (as stated in document)

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

Limited randomized data and lack of long-term outcomes support noncoverage.

Middle ear OCT — Coverage stance

Unproven / not medically necessary statements (as stated in document)

Middle ear OCT: Optical coherence tomography (OCT) for assessment and management of middle ear disorders is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy, despite preliminary data suggesting potential diagnostic advantages.

Interim RCT data suggest reduced antibiotic prescribing but clinical outcome benefits remain unestablished.

This policy excerpt summarizes the payer's coverage stance for a large set of CPT/HCPCS and related codes: each procedure or test listed in the table is assessed individually and, in the portions of the document represented here, has been assigned a conclusion of Unproven. Providers should consult the code-level rationale and evidence links in the full policy for the detailed clinical justification and for any narrow exceptions or documentation expectations that might apply to a specific code or clinical context.

When a service is labeled Unproven in this policy, the document treats the intervention as lacking sufficient evidence of safety and/or efficacy to support routine coverage; claims submitted with these codes may be denied or require prior authorization with supporting evidence.

Spatial frequency domain imaging (SFDI) reported under code 0061U (transcutaneous measurement of tissue oxygenation and hemoglobin metrics) is considered unproven and not medically necessary in this policy excerpt because available clinical evidence does not establish that SFDI improves patient outcomes or has sufficient safety/efficacy data to support routine clinical use.

Although device descriptions and small observational studies (and an ECRI assessment) are cited in the evidence summary, the policy explicitly concludes that SFDI lacks adequate prospective wound‑based outcome validation to justify coverage for routine clinical decision making.

Examples of procedures and tests explicitly named in the document as unproven / not medically necessary include: extracranial vertebral artery stenting (CPT 0075T/0076T), retinal prosthesis implantation and related device services, blood‑based biomarker panels for colorectal cancer screening (e.g., 0163U / BeScreened™‑CRC), computer‑aided detection for chest radiographs (CPT 0174T/0175T), thermal pulsation or wearable eyelid heat devices for meibomian gland evacuation (CPTs such as 0207T/0563T), and transluminal peripheral atherectomy for visceral/renal/abdominal/brachiocephalic arteries (CPTs 0234T–0237T).

These examples are illustrative of the many specific codes and technologies in the policy that the payer has judged to be not supported by sufficient evidence for routine coverage.

The policy explicitly notes multiple distinct technologies and test classes are unproven, covering both diagnostic assays and device-based therapies: blood‑based CRC biomarker panels (e.g., 3‑protein ELISA algorithms), CAD algorithms for chest radiography, vectored thermal pulsation systems (LipiFlow) and wearable eyelid heat devices (TearCare), and others.

For several device classes the document contrasts limited positive findings from small or manufacturer‑funded studies with an overall absence of high‑quality, long‑term, independent effectiveness data, and therefore concludes these technologies are unproven for routine clinical use.

The evidence summaries cited in the policy emphasize limitations that underlie the unproven designations: many randomized trials are small, some analyses do not account for within‑patient correlation (e.g., two‑eye data), and several positive studies have risk of bias or industry funding that limits generalizability.

Health‑technology assessments (for example ECRI) and systematic reviews referenced in the document call out inconsistent results across trials, short durations of follow‑up, and lack of prospective outcome studies showing that use of the technology changes management or improves clinically meaningful outcomes; these limitations form the basis for the policy's coverage decisions.

CPT/HCPCS codes and coverage status

Unproven / Not Medically Necessary CPT codesCPTNot Covered

0061U	Transcutaneous measurement of five biomarkers using spatial frequency domain imaging (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, with vitrectomy
0163U	Oncology (colorectal) screening biochemical ELISA of 3 plasma/serum proteins with proprietary algorithm
0174T	Computer-aided detection (CAD) for chest radiograph(s) concurrent with primary interpretation
0175T	Computer-aided detection (CAD) for 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

1–10 of 191

1/20

Situations where use may be considered

What providers must document and expect

Denial Risk

Denial risk — Biomarker panel (BeScreened™-CRC)

UnitedHealthcare may deny coverage for the BeScreened™-CRC biomarker panel (algorithmic serum protein panel for colorectal cancer/advanced adenoma screening) because current evidence is insufficient to demonstrate safety or effectiveness. Providers submitting claims for this screening test should be aware of the denial risk and include supporting clinical justification and documentation when requesting coverage consideration.

Affected code: 0163U
Action: Anticipate denial unless compelling, peer-reviewed evidence submitted
Documentation: submit clinical rationale and relevant literature if requesting prior review

Documentation Required

Documentation expectation — NICE guidance: sinus tarsi (mobile flatfoot)

NICE concluded that evidence for insertion of sinus tarsi (subtalar arthroereisis) implants for mobile flatfoot is inadequate in quality and quantity and recommended use only with special arrangements for clinical governance, consent, audit, or research. Providers should document that the procedure is being performed under appropriate governance (e.g., registry or research protocol) when considering this intervention.

Key terms and device names

Spatial Frequency Domain Imaging (SFDI)

DefinitionSpatial Frequency Domain Imaging (SFDI): a non‑contact optical technique to map superficial tissue oxygenation and hemoglobin content

Example systemClarifi® Imaging System: non‑contact, noninvasive tissue oxygenation measurement system intended as adjunct to clinical assessment

Coverage stanceTranscutaneous SFDI measurement (CPT 0061U) is designated unproven and not medically necessary due to insufficient evidence

Clarifi Imaging System

Device descriptionClarifi® Imaging System: non‑contact, noninvasive tissue oxygenation measurement system reporting approximate StO2, oxy‑ and deoxyhemoglobin in 2D/3D visual outputs

Intended use

Prior authorization and review expectations

Note

Study schedules and monitoring frequency

RSA radiographs (study schedules)

Radiograph schedule (studies)Serial RSA radiographs in studies taken day 1 post‑op, 3 months, 1 year, then 2, 5, 7, and 10 years; meta‑analyses commonly use 6‑month and 1‑year migration measures

Use in RSA researchRSA follow‑up timing commonly includes early (day 1), short (3–6 months), and 1‑year assessments to evaluate implant migration patterns

Outcome metricMTPM used to compare migration across follow‑up moments; one‑year follow‑up frequently used for meta‑analysis

Cryoneurolysis (monitoring frequency / endpoints)

Primary monitoring frequencyWOMAC pain primary endpoint at Day 30; follow‑up assessments reported through Day 150 in cryoneurolysis IPBSN trial

Efficacy endpoints

Contrast and procedural adjunct rules

Note

Services and codes not covered

Policy‑level conclusion: the CPT/HCPCS procedures and related services listed in this excerpt are designated Not Covered / Unproven for routine clinical use. Providers should expect denials or requests for supporting clinical evidence when billing the listed codes unless a specific code‑level section documents an exception.

Where the policy identifies services as 'Covered in certain circumstances' (a small subset of codes), coverage is conditional on payer‑determined criteria and documentation; providers should submit prior authorization requests with complete clinical rationale and supporting evidence when seeking coverage for such exceptions.

Transcatheter placement of extracranial vertebral artery stent(s) (codes 0075T and 0076T) is explicitly described in this policy excerpt as unproven and not medically necessary because available evidence does not demonstrate sufficient efficacy to support routine coverage.

High‑dose rate electronic brachytherapy (electronic surface or interstitial systems) is designated not covered outside prospective clinical trials or registries for key indications. The American Brachytherapy Society and evidence assessments cited in the policy advise against routine use of electronic brachytherapy for accelerated partial breast irradiation, non‑melanomatous skin cancers, and vaginal cuff brachytherapy outside of clinical trial contexts.

Because the evidence is limited and comparative trials are lacking or inconclusive, utilization of electronic brachytherapy outside of research settings may not meet coverage criteria.

Additional not‑covered items called out across the policy excerpt include (but are not limited to) SFDI transcutaneous measurement (0061U), biomarker panel CRC screening (e.g., 0163U), CAD for chest radiographs (0174T/0175T), thermal pulsation and wearable eyelid heat devices for MGD (0207T/0563T), transluminal peripheral atherectomy codes (0234T–0237T), and a broad list of Category III / proprietary codes and unlisted procedures that the document classifies as unproven.

Background and evidence summaries

Background: Spatial Frequency Domain Imaging (SFDI) is a noncontact optical imaging technique that maps superficial tissue optical properties to estimate parameters such as tissue oxygenation (StO2) and hemoglobin concentrations. The Clarifi Imaging System is one example of an SFDI‑based device; while such systems may be cleared by the FDA (510(k) pathways are referenced elsewhere in the policy), the clinical evidence to show they improve wound‑related outcomes or reliably guide management decisions is limited.

Clinically, SFDI and similar optical perfusion imaging technologies are described in the policy as investigational tools that could provide adjunct information about superficial perfusion, but the payer concluded that current evidence is insufficient to support routine coverage for wound risk stratification or treatment planning.

OpenPayer

Omnibus Codes (for Tennessee Only) — Unproven CPT/HCPCS list

Coverage determinations and rationale

CPT/HCPCS codes and coverage status

Situations where use may be considered

What providers must document and expect

Key terms and device names

Prior authorization and review expectations

Study schedules and monitoring frequency

Contrast and procedural adjunct rules

Services and codes not covered

Background and evidence summaries

Policy revision history