CurrentAetnaPolicy 0746

Ultrasound Therapy for Wound Healing

Clinical policy bulletin on the use of ultrasound therapy (including high-frequency and non-contact low-frequency devices) for wound healing, governing Aetna coverage determinations for members receiving wound care.

Policy Summary

PayerAetna

PolicyUltrasound Therapy for Wound Healing

Policy CodePolicy 0746

Change TypeNo material changes noted

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document failure of guideline-defined standard wound care before requesting ultrasound therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Experimental/InvestigationalCoverage stance

FDA cleared (MIST 2004)Regulatory status example

8Trials in Cochrane review (VLUs)

444Patients in Driver et al meta-analysis

Multiple RCTs & reviewsEvidence summarized

Coverage Determinations

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Experimental and Investigational

Coverage determination

Experimental/Investigational Determination: Aetna considers ultrasound therapy (including high-frequency ultrasound and non-contact low-frequency ultrasound devices) for wound healing and reduction of chronic wound pain experimental and investigational because its effectiveness for these indications has not been established.

Examples of devices include FAST, MIST, Qoustic, Sonoca 180/185.

Covered with conditions (select populations)

Evidence suggests potential benefit of certain ultrasound modalities in specific contexts; coverage may be considered with documentation of prior failure of standard care and appropriate wound characteristics.

General coverage conditions: Ultrasound therapy (for example, non-contact low-frequency ultrasound [NLFU]) may be considered when ALL of the following are met: documented chronic wound (e.g., venous leg ulcer > 30 days), demonstrated adequate arterial flow, and guideline-defined standard care (compression, moist dressings, and regular debridement) has been provided and failed to achieve sufficient wound size reduction during a protocol-defined run-in period.examples from trials: VLU > 30 days; wound area 4–50 cm2; <30% reduction during 2-week run-in

Supported by multicenter RCTs that enrolled VLUs unresponsive to optimized standard care and used NLFU regimens 3×/week.

Populations with RCT evidence of benefit: Include patients with: venous leg ulcers not responding to optimized standard care (per trials enrolling VLU >30 days and limited percent area reduction during run-in), split-thickness skin graft donor sites, selected diabetic foot ulcers in small pilot studies, and other chronic wounds studied with NLFU/HFU where trials reported greater percent area reduction or faster time-to-healing versus standard care alone.examples from trials: NLFU 3×/week; donor site median area ~136 cm2; VLU enrollment criteria 4–50 cm2; many trials required documented arterial flow

Key supporting trials: Gibbons et al (multicenter RCT of 40 kHz NLFU in VLUs), Olyaie et al (HFU and NCLFU vs standard care), Beheshti et al and small DFU pilot studies.

Evidence-based coverage considerations

Summary of coverage-relevant findings from the evidence base

Evidence summary: Systematic reviews and randomized trials report heterogeneous methods, small sample sizes, and generally low-to-very-low quality evidence. For therapeutic ultrasound (high- and low-frequency) the effect on proportion healed and other clinically important endpoints is uncertain; some small RCTs report greater percent area reduction or faster healing with adjunctive ultrasound, but overall findings are inconsistent and downgraded for risk of bias and imprecision.

This uncertainty supports cautious, conditional coverage approaches and the need for prior authorization and rigorous documentation when considered.

LIPUS — non-union

LIPUS for fracture non-union

LIPUS outcomes: Systematic reviews of low-intensity pulsed ultrasound (LIPUS) for non-union report pooled healing rates approximately 82% for instrumented and infected non-unions and about 91% for fragility fracture non-unions; however, the literature is dominated by case series and other low-quality studies, and high-quality comparative trials are lacking.

LIPUS may be considered as a conservative non-surgical option for non-unions when surgery is high risk or declined; documentation should include characterization of non-union and prior management attempts.

Aetna classifies ultrasound therapy for wound healing — including high-frequency ultrasound and non‑contact low‑frequency devices — as experimental and investigational because its effectiveness for wound healing and reduction of chronic wound pain has not been established. As a result, these uses are excluded from coverage under this policy. Examples of devices cited in the policy include FAST, MIST, Qoustic, and the Sonoca 180/185. CPT/HCPCS and ICD‑10 codes related to these indications are listed in the coding section for administrative reference.

Routine use of ultrasound for pressure ulcers, venous leg ulcers, and other chronic wounds is not supported by strong, high‑quality evidence. Systematic reviews and health technology assessments have found the available trials to be few, small, heterogeneous, and at risk of bias; consequently routine adoption for these indications cannot be recommended and is not established as medically necessary.

Clinical guideline and systematic review authors have concluded that recommendations for ultrasound use in certain populations — for example, arterial ulcers or older patients with pressure ulcers — cannot currently be made because of insufficient randomized trial data and variability in study settings and methods. These sources explicitly call for further high‑quality research before routine clinical recommendations can be issued.

The reviewed sections do not specify any additional explicit exclusions beyond the policy’s experimental/investigational classification and the coding references provided; no separate, specific exclusion list is stated in these chunks.

Systematic reviews found no reliable evidence that ultrasound hastens healing of venous leg ulcers. The Cochrane review and related assessments reported that included trials were small, of unclear or high risk of bias, underpowered, and heterogeneous in follow‑up and ultrasound regimens, limiting confidence in any apparent short‑term benefits.

The overall body of evidence for therapeutic ultrasound in chronic wounds is characterized as low‑to‑very‑low quality in systematic reviews. Because of methodological limitations (risk of bias, imprecision, heterogeneity) and inconsistent findings across trials, the clinical benefit of therapeutic ultrasound for venous leg ulcers and other chronic wounds remains uncertain.

Meta‑analysis authors reviewing ultrasound‑assisted wound debridement conclude that while pooled estimates may favor ultrasound in some outcomes, the small sample sizes, between‑study heterogeneity, and methodological limitations mean that higher‑quality evidence is needed to confirm these findings before definitive conclusions or routine coverage decisions can be made.

Prior Authorization, Documentation, and Billing Guidance

Billing Rule

Coding and Prior Authorization Note

The policy includes a specific listing of CPT/HCPCS and ICD-10 codes related to ultrasound wound therapy; these codes and the policy's coverage stance should be reviewed when preparing authorization or billing requests.

See CPT/HCPCS/ICD-10 code list in policy (includes codes such as 97610 and multiple ICD-10 codes for ulcers, infections, and related conditions).
The policy identifies CPT codes not covered for indications listed in the CPB and lists ICD-10 codes not covered for the listed indications.

Prior Authorization

Prior Authorization for Ultrasound Therapy

Prior authorization may be required for certain ultrasound modalities used for wound therapy. Confirm PA requirements with the payer before initiating treatment.

PA should be checked for both high-frequency and low-frequency/ non-contact ultrasound devices.
Provide device type, treatment regimen, and clinical rationale in the PA request.

Prior Authorization

Prior Authorization for Therapeutic Ultrasound

Because the evidence for therapeutic ultrasound (HFUS and LFUS) is inconsistent and generally low to very low quality for many wound indications, obtain prior authorization that documents adjunctive use to optimized standard care and justification for ultrasound as an adjunctive therapy.

Document why standard wound care alone is insufficient or why adjunctive therapy is being considered.
Include expected treatment frequency/duration and measurable goals for therapy.

Denial Risk

Insufficient Evidence for Routine Coverage

The available evidence is insufficient to support routine coverage of ultrasound therapy for chronic wound healing. Requests for routine use may be denied based on the policy's classification of ultrasound therapy for wound healing as experimental and investigational.

Policy labels ultrasound therapy (including high-frequency and non-contact low-frequency devices) as experimental and investigational for wound healing.
Expect denials for requests seeking routine coverage without strong supporting evidence or clinical justification.

Denial Risk

Uncertain Clinical Benefit May Risk Denial

Uncertain or low-quality evidence of clinical benefit (particularly for venous leg ulcers) increases the risk that PA requests will be denied. Highlight high-quality, condition-specific evidence if available.

Many trials are small, heterogeneous, and at high risk of bias; benefits seen at early time points often are not sustained at later follow-up.
Adverse events were variably reported; some data suggest increased non-serious adverse events with HFUS in one trial.

Note

None Specified in This Document Portion

No additional provider actions or PA procedures are specified in this portion of the document beyond the general guidance to confirm authorization requirements and provide supporting documentation.

Refer to payer-specific PA processes for submission steps, forms, and timelines.

Documentation Required

Suggested Documentation Elements from Trials

Suggested documentation elements — trials commonly used these measures and documentation can support the clinical rationale for ultrasound as an adjunctive therapy.

Objective wound measures (planimetry/digital wound area measurements at baseline and follow-up).
Details of standard-of-care (SOC) provided (compression protocols, dressing types, frequency of debridement, off-loading).
Pain scores and quality-of-life assessments (e.g., VAS, SF-36) when relevant.
Treatment regimen: device type, frequency (e.g., 3x/week), duration per session, and total planned course.

Documentation Required

Suggested Documentation for Prior Authorization Requests

When submitting prior authorization requests for ultrasound therapy, include clear documentation of the wound characteristics, prior standard care received, and the patient's response to prior therapy to justify adjunctive ultrasound.

Wound characteristics: size, duration, etiology, presence of slough/exudate, and arterial perfusion status.
Prior SOC: specifics of compression therapy, dressing regimen, frequency of debridement, and adherence.
Response to prior SOC: objective changes in wound size or clinical course, reasons SOC is considered inadequate, and documented goals for ultrasound therapy.
Planned metrics for assessing response (e.g., weekly planimetry, pain scores).

Step Therapy

Step Therapy: Require Standard Care First

Step therapy consideration: require a trial and optimization of guideline-defined standard care for venous leg ulcers (e.g., adequate compression, dressings, debridement, off-loading) before approving adjunctive ultrasound.

PA requests should document that guideline-directed standard VLU care was provided and optimized and that the ulcer did not respond (e.g., <30% reduction during a run-in or appropriate trial period).
Examples from trials: a 2-week run-in with protocol-defined compression and dressings was used to identify non-responders prior to randomization.

Note

Adjunct to Standard Care

Adjunct to standard care: Studies typically evaluated ultrasound as an adjunct to optimized standard wound care rather than as a replacement. Ensure standard care is documented and optimized prior to considering ultrasound.

Standard care components to document: compression (for VLUs), moist wound dressings, sharp debridement frequency, off-loading (for pressure/diabetic ulcers).
Describe how ultrasound will be integrated with ongoing SOC and the anticipated incremental benefit.

Note

No Step Therapy Requirements Are Stated

No explicit step therapy requirements are stated elsewhere in this policy text; however, clinical trial designs and the policy's emphasis on SOC imply that SOC optimization is expected before adjunctive ultrasound is considered.

If payer-specific step therapy rules exist, follow those local requirements; otherwise, include documentation of SOC optimization in PA requests.

Definitions and Device Descriptions

Non-contact low-frequency ultrasound — device description and typical session parameters

Device descriptionNon-contact low-frequency ultrasound device held ~0.5–1.5 cm from the wound that delivers a saline mist and ultrasound energy to cleanse and debride the wound bed and stimulate cellular activity.

Typical frequency exampleApproximately 40 kHz (examples of devices used at this range include MIST and other NLFU systems).

Session parametersTherapy sessions usually last 3 to 12 minutes, delivered approximately 3 times per week.

Intended effectProvides wound cleansing and maintenance debridement of slough, fibrin, exudate or bacteria and purportedly promotes healing via cellular stimulation.

Device examples and regulatory noteExamples include AR1000, AS1000, Jetox ND, MIST Therapy System, SonicOne O.R., and SONOCA-185; MIST Therapy System was FDA-cleared in August 2004 for wound cleaning and maintenance debridement.

LIPUS — definition and trial usage

DefinitionLow-intensity pulsed ultrasonography (LIPUS) is a non-invasive ultrasound modality used to promote bone healing and studied in trials of fracture healing and non-union.

Clinical contextExamined in randomized controlled trials for fresh fractures, stress fractures, distraction osteogenesis, and non-union; evidence quality ranges from moderate to very low with conflicting results.

Typical trial usageTrials assessed effects on radiographic healing time, return to function, and non-union healing; designs included randomized comparisons versus control with various outcomes reported.

NLFU / NCLFU — definition and context in chronic wound/VLU studies

DefinitionNoncontact low-frequency ultrasound (NLFU / NCLFU) refers to ultrasound delivered without direct contact to the wound bed (device held above the wound) typically at low frequencies (e.g., ~40 kHz).

Use in chronic woundsNLFU has been evaluated as an adjunct to standard wound care in chronic wounds including venous leg ulcers, with trials delivering NLFU 3 times per week in many studies.

Evidence contextMeta-analyses and RCTs (e.g., Driver et al and Gibbons et al) report substantial wound area and volume reductions in observational series and some RCTs showing greater percent area reduction when added to standard care, but overall evidence is heterogeneous and of variable quality.

MIST Therapy — branded noncontact ultrasound system description and evidence context

Branded system descriptionMIST Therapy is a branded non-contact low-frequency ultrasound wound therapy system that delivers saline mist and ultrasound energy to wounds and has been evaluated in observational studies and a small number of RCTs.

Evidence contextManufacturer-supplied evidence includes numerous publications and unpublished case reports; independent assessments (e.g., NICE) found the evidence low-quality with few small RCTs and inadequate follow-up to support routine adoption.

Regulatory statusMIST Therapy System 5.0 was cleared by the U.S. FDA in August 2004 for wound cleaning and maintenance debridement of wounds containing yellow slough, fibrin, exudate, or bacteria.

NLFU / NCLF — additional definition emphasizing debridement function

Definition emphasizing debridementNLFU / NCLF refers to non-contact low-frequency ultrasound used principally for wound debridement and cleansing to remove devitalized tissue and disrupt biofilm while delivering saline mist near—but not touching—the wound.

Adjunct roleTypically used as an adjunct to standard wound care measures (e.g., compression, dressings, sharp debridement) rather than as a standalone therapy.

Applicability across wound typesEvaluated in pressure ulcers, diabetic foot ulcers, venous leg ulcers, and other chronic wounds; study regimens and outcomes vary across trials.

LIPUS — alternate definition focusing on bone-healing application

Alternate definition (bone-healing focus)LIPUS (low-intensity pulsed ultrasound) is a non-invasive therapy used to promote bone union in delayed or non-union fractures and has been studied in systematic reviews and RCTs for fracture healing outcomes.

Reported healing rates in non-unionsSystematic reviews report pooled non-union healing rates with LIPUS of approximately 82% for instrumented and infected non-unions and ~91% for fragility non-unions, derived largely from case series and lower-quality studies.

Evidence limitationsAvailable studies include many retrospective case series and small trials; authors emphasize need for higher-quality, larger randomized trials to establish definitive benefit.

I70.231 - I70.25	Atherosclerosis of the lower extremities with ulceration.
I70.261 - I70.269	Atherosclerosis of the lower extremities with gangrene.
I83.001 - I83.029	Varicose veins of lower extremities with ulcer.
L02.01	Cellulitis/abscess (examples listed).
L02.11	Cellulitis/abscess (examples listed).
L02.211 - L02.219	Cellulitis/abscess (examples listed).
L02.31	Cellulitis/abscess (examples listed).
L02.411 - L02.419	Cellulitis/abscess (examples listed).
L02.511 - L02.519	Cellulitis/abscess (examples listed).
L02.611 - L02.619	Cellulitis/abscess (examples listed).

L05.01	Pilonidal cyst or sinus with abscess, sacrococcygeal region.
L05.02	Pilonidal cyst or sinus with abscess, other specified site.
L05.91	Pilonidal cyst or sinus without mention of abscess, sacrococcygeal region.
L05.92	Pilonidal cyst or sinus without mention of abscess, other specified site.

OpenPayer

Ultrasound Therapy for Wound Healing

Coverage Determinations

Coding References

Prior Authorization, Documentation, and Billing Guidance

Clinical Background

Definitions and Device Descriptions

Policy Revision History