CurrentAetnaPolicy 0372

Noncontact Normothermic/Nonthermal Wound Therapy and Noncontact Fluorescence Imaging of Wounds

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Defines Aetna's coverage stance on noncontact normothermic/nonthermal wound therapies (including Warm-Up Active Wound Therapy and low-frequency noncontact ultrasound) and noncontact fluorescence imaging devices (e.g., MolecuLight) for wound care, and indicates which procedures and codes are considered experimental/investigational for Aetna members and providers.

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CurrentAetnaPolicy 0372

Noncontact Normothermic/Nonthermal Wound Therapy and Noncontact Fluorescence Imaging of Wounds

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Policy Summary

PayerAetna

PolicyNoncontact Normothermic/Nonthermal Wound Therapy and Noncontact Fluorescence Imaging of Wounds

Policy CodePolicy 0372

Change TypeNo material change

Effective DateFeb 7, 2000

Last ReviewJun 6, 2023

Next Review DateApr 11, 2024

Key ActionDocument fluorescence imaging findings and correlate with microbiologic sampling when species-level identification or deeper infection assessment is needed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3procedures/devices experimental

6 codessample CPT/HCPCS codes

multipleICD-10 examples not covered

350patients in FL study

1.5 mmmax detection depth

Coverage Criteria and Evidence Summary

Experimental and Investigational — Procedures considered experimental and investigational

The following procedures are considered experimental and investigational because effectiveness has not been established:

Experimental/Investigational list: 1) MolecuLight hand-held device for point-of-care fluorescence imaging of wounds; 2) Noncontact, nonthermal, low-frequency ultrasound therapy for treatment of wounds and other indications (e.g., bacterial infections, deep tissue pressure injury); 3) Warm-Up Active Wound Therapy (noncontact normothermic wound therapy)

Exact wording from policy.

NLFU adjunctive clinical findings

Clinical findings reported in studies where noncontact low-frequency ultrasound (NLFU) was used adjunctively with standard of care (no explicit Aetna coverage criteria provided):

NLFU adjunctive use showing benefit: Studies reported that when NLFU was added to standard of care it was associated with reductions in wound surface area, decreased deep tissue pressure injury (DTPI) severity, and improved wound resolution in small prospective and retrospective studies.study-specific

Examples: Chang et al. summarized LFU evidence (20–60 kHz) as promising (smaller studies) (19); Honaker prospective study (n=60) showed greater decrease in DTPI surface area and lower DTPI severity scores with NLFU plus standard care (21); Wagner-Cox retrospective review (n=44) showed significant decrease in injury size and some wounds classified as resolved after NLFU (23).

Fluorescence imaging (MolecuLight) diagnostic findings

Findings on MolecuLight fluorescence imaging utility, diagnostic performance, and effects on management reported in observational and diagnostic studies:

FL diagnostic and management impact: Multiple observational and diagnostic studies report high sensitivity for detecting pathogenic bacteria and improved identification of wounds with bacterial loads >= 10^4 CFU/g when fluorescence (FL) imaging is added to clinical assessment, and that FL information frequently modified treatment plans and guided sampling or debridement.>=10^4 CFU/g

Examples: Hurley et al. reported sensitivity 100% and specificity 78% in outpatient setting (28); Serena pilot reported sensitivity improved from 22% (CSS alone) to 72% when FL plus CSS used and clinicians modified treatment plans in ~73% of wounds (32); Le et al. multicenter study (n=350) showed 4-fold increase in detection of >=10^4 CFU/g and FL-modified treatment plans in 69% of wounds (37); Raizman reported PPV 92.9% for cyan fluorescence predicting Pseudomonas aeruginosa (39).

Use and evidence considerations for fluorescence imaging

Consider fluorescence imaging as an adjunct to clinical assessment when detecting high bacterial burden or specific pathogens is clinically relevant:

Adjunctive use: Fluorescence imaging should be used in combination with clinical signs and symptoms (CSS) and, when necessary, microbiologic sampling because FL detects porphyrin-producing bacteria to a maximum subsurface depth of approximately 1.5 mm and does not identify all organisms.

Supported by study limitations noting 1.5 mm detection depth and inability to detect some non-porphyrin-producing bacteria (36,38,40).

When FL may change management: FL may be particularly useful when CSS miss high bacterial burden (Le et al. found CSS missed 85% of wounds >10^4 CFU/g) and when clinicians need immediate, point-of-care information to guide wound bed preparation, targeted swabbing, debridement, or treatment selection; FL frequently resulted in treatment plan modifications in reported studies.

Based on Le et al. multicenter results (37) and Serena pilot (32).

Organism-specific detection: Cyan fluorescence is highly predictive of Pseudomonas aeruginosa (PPV 92.9% in Raizman et al.), but FL cannot determine all bacterial species and will not detect non-porphyrin-producing organisms; confirmatory sampling is indicated when species-level identification or deeper infection assessment is needed.

The policy lists ICD-10 diagnosis code ranges and examples that are cited as indications not covered for the procedures/devices addressed. Examples include infectious disease ranges such as A00.0–A09 (intestinal infectious diseases), A20.0–A28.9 and A30.0–A49.9 (selected zoonotic and other bacterial diseases), multiple diabetes complication codes (e.g., E10.40–E10.49, E11.40–E11.49; E10.51–E10.59, E11.51–E11.59; E10.610–E10.69, E11.610–E11.69), peripheral vascular disease and atherosclerosis with ulceration or gangrene (e.g., I70.231–I70.25, I70.261–I70.269, I73.9), venous/varicose ulcer codes (e.g., I83.001–I83.029), cellulitis/abscess ranges (multiple L02.* and L03.* codes), pilonidal cyst codes (L05.01–L05.02, L05.91–L05.92), pressure ulcer codes (L89.000–L89.95), and post-procedural wound complication codes (e.g., T81.31x–T81.32x+, T81.40xA–T81.49xS, T81.89x+).

The policy identifies several device limitations and relative contraindications for fluorescence imaging. Active bleeding or highly vascularized tissue appears dark or black on fluorescence photographs and was considered a relative contraindication because it can render images unusable; irrigation was sometimes required to obtain images. Dressings containing silver also produce black images and may prevent use of the device. Additionally, the procedure requires controlled lighting (darkness) or use of an accessory DarkDrape to obtain quality images, which may limit routine clinic use.

The policy notes important limitations of fluorescence (FL) detection: the device has a maximum subsurface detection depth of approximately 1.5 mm, so organisms located deeper than this may not be detected. FL detects endogenous porphyrin-related fluorescence and therefore does not detect non-porphyrin-producing bacteria (examples cited include some species of Streptococcus, Enterococcus, and Finegoldia). Because FL cannot reliably identify all organisms or non-bacterial components, the policy recommends using FL in combination with clinical signs and, when necessary, microbiologic sampling for species-level identification or assessment of deeper infection.

Aetna considers the MolecuLight fluorescence imaging device and certain noncontact wound therapies experimental and investigational because effectiveness has not been established. Specifically, the policy names MolecuLight hand-held fluorescence imaging, noncontact, nonthermal low-frequency ultrasound therapy, and Warm-Up Active Wound Therapy (noncontact normothermic wound therapy) as procedures that are experimental/investigational and not supported as established treatments.

The document states there is currently insufficient evidence to support use of the MolecuLight device for identification and management of wounds with bacterial burden. Limitations cited include lack of longitudinal outcome data linking FL-guided decisions to improved clinical outcomes and incomplete microbiology in some studies, supporting the conclusion that the evidence is inadequate to establish the device as standard management.

Study limitations described in the policy restrict conclusions about FL-guided management. Several studies were single-visit observational trials without longitudinal follow-up to validate whether changes in treatment based on FL led to better outcomes. Microbiology confirmation was incomplete in some reports (e.g., culture results available for only a subset of wounds), and there was a low proportion of true-negative wounds in certain populations, which limits specificity and negative predictive value estimates. The policy therefore emphasizes caution in interpreting diagnostic accuracy and outcome impact from these limited studies.

Coding and Diagnosis Examples

CPT/HCPCS codes listedmixed

0598T	Noncontact real-time fluorescence wound imaging, for bacterial presence, location, and load, per session; first anatomic site (eg, lower extremity).
0599T	Noncontact real-time fluorescence wound imaging, for bacterial presence, location, and load, per session; each additional anatomic site (eg, upper extremity) (List separately in addition to code for primary procedure).
97610	Low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day.
A6000	Non-contact wound warming wound cover for use with the non-contact wound warming device and warming card.
E0231	Non-contact wound warming device (temperature control unit, AC adaptor and power cord) for use with warming card and wound cover.
E0232	Warming card for use with the non-contact wound warming device and non-contact wound warming cover.

ICD-10 codes listed as examples of not covered indicationsICD-10Not Covered

A00.0 - A09	Intestinal infectious diseases.
A20.0 - A28.9	Certain zoonotic bacterial diseases.
A30.0 - A49.9	Other bacterial diseases.
E10.40 - E10.49, E11.40 - E11.49	Diabetes with neurological complications.
E10.51 - E10.59, E11.51 - E11.59	Diabetes with peripheral circulatory complications.
E10.610 - E10.69, E11.610 - E11.69	Diabetes with other specified complications.
I70.231 - I70.25	Atherosclerosis of the lower extremities with ulceration.
I70.261 - I70.269	Atherosclerosis of the lower extremities with gangrene.
I73.9	Peripheral vascular disease, unspecified.
I74.3	Embolism and thrombosis of arteries of the lower extremities.

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Bacterial burden threshold used in some studies — >10^5 CFU/g

Bacterial burden threshold (study inclusion)>10^5 CFU/g

ContextReported in Serena et al. as threshold for patient selection in a pressure-ulcer pilot (patients with counts >10^5 CFU/g received 2 weeks of noncontact ultrasound)

Observed effectQuantities of multiple bacterial organisms were reduced substantially from baseline to 2 weeks post-treatment in the cohort exceeding this threshold

Bacterial load threshold — >= 10^4 CFU/g (used in referenced studies)

>=10^4 CFU/g threshold definitionBacterial load defined in multiple studies as greater than or equal to 10^4 CFU/g to indicate moderate-to-heavy bacterial burden

Pilot study (Pijpe et al.)

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior authorization not expected for listed CPT/HCPCS codes

The policy identifies the listed CPT/HCPCS codes (0598T, 0599T, 97610, A6000, E0231, E0232) as procedures/devices for which effectiveness has not been established; coverage for these codes is not supported under this policy and prior authorization is unlikely to be approved.

Codes named in policy as experimental/investigational: 0598T, 0599T, 97610, A6000, E0231, E0232

Prior Authorization

Insufficient evidence for MolecuLight; no PA process specified here

The document states there is insufficient evidence to support use of the MolecuLight device for wound identification/management; the policy text does not specify particular prior authorization procedures or requirements for the device in these sections.

Policy notes insufficient evidence for MolecuLight device use to identify/manage wounds with bacterial burden
No prior authorization process or codes for MolecuLight are specified in these chunks

Background and Definitions

Background: Noncontact normothermic wound therapy (also called Warm-Up Active Wound Therapy or NNWT) and other noncontact therapies are described as adjunctive wound treatments that deliver warming or energy without direct contact. The Warm-Up system consists of a domed wound cover, an infrared heating card, and a battery-powered temperature control that warms the wound surface to a set temperature while allowing exudate drainage. Noncontact low-frequency ultrasound (NLFU) and other low-frequency ultrasound approaches have been studied for biofilm dispersal, debridement, and bacterial reduction, but evidence is limited. The MolecuLight device is a handheld, noncontact fluorescence imaging system using 405 nm light to visualize bacterial fluorescence and measure wound surface area in real time; while FL can highlight regions likely to have bacterial loads ≥ 10^4 CFU/g, overall clinical effectiveness and impact on long-term healing remain unproven according to the policy.

Warm-Up Active Wound Therapy / NNWT — noncontact radiant-heat bandage system definition

DefinitionA noncontact radiant-heat bandage system consisting of a domed wound cover, an infrared heating card, and a battery-powered temperature control that warms the wound to a predetermined temperature and contains a foam wick to drain exudate.

Typical indicationUsed to treat chronic venous ulcers when conventional wound-healing therapy has failed (Warm-Up Active Wound Therapy).

Regulatory/assessment noteCMS concluded literature does not support NNWT healing wounds better than conventional treatment; evidence insufficient to consider device reasonable and necessary.

Policy Summary

PayerAetna

PolicyNoncontact Normothermic/Nonthermal Wound Therapy and Noncontact Fluorescence Imaging of Wounds

Policy CodePolicy 0372

Change TypeNo material change

Effective DateFeb 7, 2000

Last ReviewJun 6, 2023

Next Review DateApr 11, 2024

Key ActionDocument fluorescence imaging findings and correlate with microbiologic sampling when species-level identification or deeper infection assessment is needed.

SourceLink

On This Page

Supported by Raizman (39) and limitations described in other studies (36,38).

Limitations and follow-up: Because FL has limited excitation depth (~1.5 mm), cannot detect certain non-porphyrin-producing bacteria (e.g., some Streptococcus, Enterococcus, Finegoldia), and most studies are single-visit or observational, providers should correlate FL findings with cultures or biopsy when indicated and recognize that longitudinal RCT outcome data on FL-guided treatment remain limited.

Derived from multiple chunks noting depth limits, organism detection gaps, culture limitations, and the need for longitudinal randomized trials (36,38,40,41).

High-fluorescent area corresponded to bacterial load >10^4 CFU/g; diagnostic agreement with swabs reported

Serena pilotUse of FL + CSS improved sensitivity and accuracy for identifying wounds ≥10^4 CFU/g (sensitivity 72% vs 22% with CSS alone)

Multi-center study (Le et al.)Biopsy-confirmed comparison used ≥10^4 CFU/g as outcome for FL diagnostic performance

Bacterial burden threshold — > 10^4 CFU/g

Bacterial burden threshold reported> 10^4 CFU/g

Clinical relevanceThreshold used to classify moderate-to-heavy bacterial loads that FL imaging aims to detect and that often prompts treatment modifications

Study findingsLe et al. found 82% of wounds had >10^4 CFU/g and FL increased detection 4-fold compared with CSS

Prior Authorization

Policy history present; no explicit prior authorization code-level guidance

The policy history and review dates are provided, but the document does not give explicit, code-level prior authorization instructions in the cited sections.

Last review: 06/06/2023; Effective date: 02/07/2000; Next review: 04/11/2024
No explicit prior-authorization code-level requirements are listed in these chunks

Step Therapy

Step therapy not established despite background discussion

The background discussion references use of these therapies after conventional wound-healing approaches or added to standard care, but the policy does not establish formal step therapy requirements.

Policy background discusses adjunctive use following standard care or when conventional therapy fails
No formal step therapy directives or mandated treatment sequencing are specified

Step Therapy

NLFU studied as adjunct to standard of care (implies stepwise use)

Studies of noncontact low-frequency ultrasound (NLFU) reported its use adjunctively with standard of care rather than as a sole therapy, implying clinicians applied NLFU in a stepwise fashion alongside conventional treatments.

Honaker (prospective study) examined NLFU plus standard of care vs standard care alone
Wagner-Cox retrospective review reported NLFU used in treated patients alongside existing care

Step Therapy

No step therapy directives in policy sections reviewed

The policy sections reviewed do not include step therapy directives or mandatory sequencing of therapies.

No explicit step therapy policies or required prior treatment trials are listed in these chunks

Billing Rule

Use listed CPT/HCPCS codes when billing; reference policy

When billing for these services, use the CPT/HCPCS codes listed in the policy (examples include 0598T, 0599T, 97610, A6000, E0231, E0232) and reference the policy; the policy also provides ICD-10 examples of diagnoses for which the codes are listed as not covered.

Example procedure codes: 0598T, 0599T, 97610
Example HCPCS/device codes: A6000, E0231, E0232
Policy lists ICD-10 diagnosis examples that are not covered for the indications listed

Documentation Required

Include wound assessment, FL results, and microbiology in clinical documentation

Clinical documentation should include a wound assessment (clinical signs and symptoms), fluorescence imaging results if used, and microbiology swab or biopsy results when available to support clinical decisions.

Document CSS findings and wound assessment measurements
Record FL imaging findings and how they informed care
Include microbiology swab/biopsy results when obtained

Documentation Required

Document FL results and confirm with cultures when indicated

If fluorescence imaging is used, document the imaging findings and correlate them with microbiologic sampling (biopsy or curettage) when species-level identification or confirmation of bacterial load is clinically indicated.

Record FL signals and any image-guided sampling locations
Correlate FL findings with culture or curettage samples when needed to identify organisms (e.g., Pseudomonas confirmed by curettage in Raizman)

Denial Risk

Denial risk for procedures/devices labeled experimental/investigational

Because the policy classifies MolecuLight fluorescence imaging, NLFU, and Warm-Up Active Wound Therapy as experimental and investigational, claims for these procedures or devices may be denied.

Policy explicitly lists MolecuLight, noncontact LFU, and Warm-Up Active Wound Therapy as experimental/investigational
Claims for these services/devices may not be supported and can be denied

Denial Risk

Insufficient evidence for MolecuLight may lead to denials or coverage limits

The policy states there is insufficient evidence to support the MolecuLight device for identification and management of wounds with bacterial burden; this insufficiency may lead to prior authorization denials or coverage limitations for the device or its use.

Policy text: 'there is currently insufficient evidence to support its use in identification and management of wounds with bacterial burden'
Insufficient evidence may trigger denial of coverage or PA limitations

Note

Background and study limitations — no direct authorization instructions

The cited sections provide background, study limitations, and context but do not contain direct authorization or coverage instructions; use these details to inform clinical caution and documentation but not as authorization guidance.

Chunks describe study limitations (single-visit design, limited microbiology, detection depth) rather than authorization rules
Clinical teams should document limitations and reasoning in the absence of explicit coverage instructions

Noncontact real-time fluorescence wound imaging (MolecuLight example) — device description and function

Device descriptionHandheld, portable, non-invasive real-time camera that illuminates wounds with violet (405 nm) light and uses optical filtering to capture endogenous fluorescence from tissue and bacteria, producing images that show presence, location, and load of fluorescent bacteria.

Primary functionProvides point-of-care fluorescence imaging to indicate bacterial presence, location, and approximate load to guide swab location and treatment decisions.

Limitations notedPreliminary studies exist but evidence is insufficient to fully support its use for identification and management of wounds with bacterial burden.

Noncontact low-frequency ultrasound (LFU) — definition and intended uses

DefinitionUltrasound delivered at low frequencies (e.g., 20–60 kHz in reports) without direct contact, intended to reduce bacterial load, debride tissue, disperse biofilms, and stimulate wound healing.

Intended usesBacterial reduction, biofilm dispersion, wound debridement, decreased exudate and slough, and potential to decrease pain and increase healing when used adjunctively.

Evidence considerationsStudies are generally small and heterogeneous; Cochrane and other reviews found insufficient high-quality evidence to confirm benefit for wound healing.

Noncontact low-frequency ultrasound (NLFU) — definition and intended actions (biofilm disruption, debridement, bacterial reduction)

Definition and actionNoncontact low-frequency ultrasound (NLFU) delivers 20–60 kHz ultrasound to wounds without direct contact to disperse biofilms, assist debridement, and reduce bacterial burden.

Reported mechanismsMay disrupt biofilms, increase antibiotic penetration, and reduce bacterial colony counts in vitro and in vivo models.

Research limitationsParameter heterogeneity (frequency, intensity, pulse), limited pathogen range studied, and potential risks to implants/materials require further research before routine clinical adoption.

MolecuLight i:X (fluorescence imaging) — handheld device using 405 nm light to elicit fluorescence

Device specificsMolecuLight i:X is a handheld, noncontact wound imaging device that illuminates wounds with 405 nm (violet) light to elicit endogenous fluorescence from tissue and bacteria and displays real-time images highlighting fluorescent bacterial regions.

Use in practiceUsed to guide swab location, identify areas of high bacterial load, and inform wound assessment and treatment planning at the point of care.

Evidence noteEarly pilot studies showed correlation between fluorescence and microbiology, but larger well-designed studies are needed to validate impact on outcomes.

FL (fluorescence imaging) — point-of-care imaging detecting bacterial fluorescence indicating loads >10^4 CFU/g

Technique descriptionPoint-of-care fluorescence imaging using the MolecuLight i:X detects red or cyan bacterial fluorescence to indicate bacterial loads typically >10^4 CFU/g.

Clinical impactStudies report increased sensitivity and changes in treatment plans when FL is used in combination with clinical signs and symptoms (CSS).

Operational noteFluorescence imaging provides immediate, objective information on presence, location, and load of bacteria to facilitate wound bed preparation and treatment selection.

Detection depth — maximum subsurface detection depth approximately 1.5 mm

Maximum subsurface detection depthApproximately 1.5 mm

ImplicationOrganisms located deeper than ~1.5 mm may not be detected by fluorescence imaging, so biopsy/curettage and culture may be needed for deeper infections or species identification.

Practical limitationLimited depth contributes to false negatives for deeper pathogens; clinicians should interpret images alongside clinical assessment and microbiology when required.