ModifiedUnitedHealthcarePolicy CSNCT0269.04

Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Indications (for North Carolina Only)

Medical policy governing the use of extracorporeal shock wave therapy (ESWT) for musculoskeletal and soft tissue conditions for UnitedHealthcare members in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicyExtracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Indications (NC only)

Policy CodePolicy CSNCT0269.04

Change TypeState-specific versionclinical evidence and references updatedtitle expanded

Effective DateNov 1, 2025

Next Review Date

Key ActionVerify plan-specific prior authorization requirements and document indication, prior conservative treatments, and device/energy parameters when requesting ESWT.

SourceLink

POLICY UPDATE CHANGES

Created state-specific policy version for the state of North Carolina.

Updated Clinical Evidence and References sections to reflect the most current information.

Title changed to include soft tissue wounds (previously focused on musculoskeletal conditions).

NC-onlypolicy application state

Not medically necessarycoverage stance

0101T, 0102T, 0512T, 0513T, 0864T, 28890example procedure codes

~70%

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ACFAS reported improvement

86% / 73%reported union rates (delayed/nonunion)

dermaPACE (DFU)FDA De Novo clearance

Coverage Determinations and Evidence Summary

Overall policy stance

Covered when ALL of the following are met:

General coverage stance: Extracorporeal shock wave therapy (ESWT), whether low energy, high energy, or radial wave, is unproven and not medically necessary for any musculoskeletal or soft tissue indications due to insufficient evidence of efficacy.

See evidence summaries for indication-specific considerations.

Evidence summaries by indication — grouped findings and implications

Evidence-based findings and implications by indication (coverage subject to full policy text elsewhere):

Chronic Plantar Fasciitis: Trials and meta-analyses report that focused ESWT may be associated with greater pain reduction versus sham; multiple RCTs show improvements in pain and function with ESWT but results and quality vary. Some RCTs report ESWT superior to corticosteroid injection at certain time points and ACFAS notes ~70% of patients had meaningful improvement at 12 weeks. Other trials find comparable outcomes to dextrose prolotherapy or no additive benefit over standard care; limitations include small sample sizes, heterogeneity, and variable blinding.patient with chronic PF after failed conservative care

Chunks 18-23.

Delayed or Nonunion Fractures: Systematic reviews report uncertain or low‑certainty evidence for ESWT effectiveness in delayed or nonunion fractures; reported union rates in nonrandomized series vary widely and high‑quality RCTs are lacking.—

Chunks 24-26.

Erectile Dysfunction: Evidence for ESWT in erectile dysfunction is heterogeneous with low confidence; guideline assessments consider low‑intensity ESWT investigational and additional research is needed.—

Chunks referenced in briefs (27-32 in source summary).

Lateral Epicondylitis (Tennis Elbow): Systematic reviews and RCTs provide conflicting and inconsistent evidence: some analyses show inferior short‑term but superior medium‑term outcomes for ESWT versus local corticosteroid injection, while other trials show no clinically important benefit versus sham or alternative therapies; heterogeneity in devices and protocols limits definitive conclusions.—

Chunks 34-36 and related trials (37-38,41).

Evidence summaries by indication — continuation

Summary of evidence per indication from this document segment:

Lateral Epicondylitis (LE) evidence summary: Multiple RCTs and meta-analyses report mixed results: some trials and reviews show ESWT superior to massage or corticosteroid injection at specific time points while others show no clinically important improvement compared with sham; heterogeneity in devices, protocols, and limited long-term data are consistent limitations.N/A

Chunks 36-41 provide trial and meta-analysis details.

Greater Trochanteric Pain Syndrome (GTPS) evidence summary: Systematic reviews and RCTs show inconsistent evidence; some trials report favorable outcomes for focused ESWT plus exercise with high short-term success rates, but overall evidence is inconclusive and limited by heterogeneity and risk of bias.N/A

Chunks 44-46.

Tenosynovitis of foot/ankle and Tibialis tendonitis:

Evidence summaries supporting potential medical necessity considerations (wound healing / soft tissue wounds)

Clinical evidence summaries for ESWT in wound healing and soft tissue wounds

Diabetic Foot Ulcers (DFU): Multiple RCTs and systematic reviews (including Huang et al. and Wu et al.) report improved wound surface area reduction, increased re-epithelialization, higher rates of complete healing, and favorable TcPO2 changes for ESWT compared with standard care or HBOT; evidence limitations include varied protocols and small trial sizes. dermaPACE received FDA De Novo clearance for DFUs based on limited RCTs.RCTs and meta-analyses cited

Chunks 52, 54, 55.

Acute and Chronic Soft Tissue Wounds: A meta-analysis (Zhang et al.) of 10 RCTs found ESWT increased healing rates, improved wound‑healing area percentage, shortened healing time, and reduced infection risk compared with conventional wound therapy, but authors called for higher-quality RCTs despite favorable pooled results.10 RCTs, 473 patients

Chunk 56.

This policy specifically excludes extracorporeal shock wave lithotripsy (ESWL) used for stone fragmentation. ESWL for the treatment of gallstones, kidney stones, pancreatic stones, and salivary stones is not addressed by this policy and is outside the scope of the coverage rationale for extracorporeal shock wave therapy (ESWT).

A targeted literature search did not identify any clinical studies evaluating ESWT for the treatment of hammer toe. Because no peer-reviewed clinical evidence was found, ESWT for hammer toe is unsupported by published clinical data in this policy segment.

Detailed searches of the peer-reviewed literature did not identify clinical studies evaluating ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis. These indications are therefore not supported by clinical study evidence in this policy.

The dermaPACE system has received FDA De Novo clearance specifically for the treatment of diabetic foot ulcers (DFU) only. The ECRI assessment cited pooled RCT data favoring dermaPACE for DFU healing at 24 weeks, but no published studies were identified that evaluated dermaPACE effectiveness for chronic wound types other than DFUs.

UnitedHealthcare considers extracorporeal shock wave therapy (ESWT), whether low energy, high energy, or radial wave, to be unproven and not medically necessary for any musculoskeletal or soft tissue indications due to insufficient evidence of efficacy.

For certain indications the evidence is judged insufficient or of low certainty. Systematic reviews and guideline assessments report that ESWT evidence for delayed or nonunion fractures is heterogeneous with variable reported union rates and a lack of high-quality randomized trials; for erectile dysfunction meta-analyses and ECRI assessments note substantial heterogeneity and low confidence in meaningful benefit; the American Urological Association considers low-intensity ESWT for ED investigational.

Randomized controlled trials and meta-analyses for lateral epicondylitis (tennis elbow) are inconsistent. Notably, a double-blind RCT by Capan et al. (2016) found no significant difference between radial ESWT and sham in pain or function at one and three months, while pooled analyses in systematic reviews have reported mixed results depending on device type and timing of outcome measurement.

Across indications the evidence base is limited by heterogeneity in devices, energy settings, treatment protocols, and outcome assessment, and by methodological limitations in many trials. Systematic reviews and meta-analyses for wounds and musculoskeletal conditions consistently call for higher-quality, well-controlled randomized trials to resolve inconsistency and establish reliable estimates of efficacy.

Procedure and Device Codes

Provider Requirements, Prior Authorization, and Documentation

Billing Rule

Reference procedure codes — prior authorization may apply

Reference procedure and diagnosis codes are provided for billing and prior authorization reference only; inclusion does not guarantee coverage or payment. Verify plan-specific requirements before submission.

Listing of a code in this policy does not imply coverage or payment.
Prior authorization may be required by the member's plan — check plan terms.

Prior Authorization

Prior authorization likely required

Prior authorization is likely required for extracorporeal shock wave therapy (ESWT) when coverage is contingent on indication‑specific evidence or plan limits. Submit clinical documentation consistent with medical necessity criteria before scheduling.

Background and Definitions

Extracorporeal shock wave therapy (ESWT) delivers focused or radial acoustic shock waves at substantially lower energy than lithotripsy. It is proposed to reduce pain, disintegrate calcifications, alter scar tissue, and stimulate tissue healing through mechanical stimulation and enhanced perfusion, although the precise therapeutic mechanisms are not fully established.

ESWT (extracorporeal shock wave therapy) overview

TermExtracorporeal shock wave therapy (ESWT)

DescriptionNoninvasive treatment that generates low- or high-energy acoustic shock waves (acoustic pulses) propagated through tissues to target musculoskeletal or soft tissue areas.

Energy and deliveryShock waves used for orthopedic indications have about one-tenth the energy of lithotripsy; waves can be focused and propagated through water; low-energy defocused ESWT (soft focused acoustical wave pattern) is used for wound healing.

Proposed usesIntended to relieve pain, disintegrate calcifications, break down scar tissue, and stimulate tissue healing depending on indication.

Policy Summary

PayerUnitedHealthcare

PolicyExtracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Indications (NC only)

Policy CodePolicy CSNCT0269.04

Change TypeState-specific versionclinical evidence and references updatedtitle expanded

Effective DateNov 1, 2025

Next Review Date

Key ActionVerify plan-specific prior authorization requirements and document indication, prior conservative treatments, and device/energy parameters when requesting ESWT.

SourceLink

On This Page

No clinical studies were identified evaluating ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis in the reviewed literature.

Chunks 49-50 (not shown fully in this segment) referenced in the brief.

Diabetic Foot Ulcers (DFU) / Wounds: Systematic reviews and multiple RCTs report that ESWT is associated with higher complete healing rates and shorter time to healing versus standard care or hyperbaric oxygen in several trials; however, studies vary in protocols, sample sizes are often small, and certainty of evidence ranges low to moderate. The dermaPACE device has FDA De Novo clearance for DFU based on limited RCT data.N/A

Chunks 52 and 55 and dermaPACE assessment in chunk 54.

Lower Extremity Chronic Wounds:

A systematic review (Omar et al.) including 11 studies (n=925) concluded there is mild to moderate evidence supporting ESWT as an adjunct to standardized wound care but noted substantial heterogeneity and methodological limitations preventing firm conclusions.

Burn Wounds: A phase II randomized trial reported accelerated epithelialization with a single defocused ESWT in superficial second‑degree burns, but authors recommended confirmation in a larger phase III trial.phase II RCT

Chunk 57 (Ottomann trial).

Prior authorization requests should reference the relevant procedure code(s).
Indication-specific evidence may be requested (e.g., RCTs, systematic reviews).

Prior Authorization

Prior authorization recommended — documentation expected

Prior authorization is recommended for ESWT to allow review of indication, prior conservative care, device/energy parameters, and expected follow-up. Obtaining authorization reduces risk of claim denials.

Provide documentation of indication and prior conservative therapies.
Report device type (focused, radial), energy settings, number of sessions, and treatment dates.

Prior Authorization

Verify prior authorization and plan-specific requirements

Verify prior authorization and plan-specific requirements and document adherence to federal, state, and contractual benefit terms. Plan terms govern over this policy.

Confirm member eligibility and benefit language.
If benefit rules conflict with this policy, follow federal/state/contractual requirements.

Denial Risk

ESWT considered unproven and not medically necessary

ESWT is considered unproven and not medically necessary for musculoskeletal and most soft tissue indications due to insufficient or low‑certainty evidence; claims for these indications may be denied.

ESWT (low, high, radial) is unproven/not medically necessary for musculoskeletal/soft tissue indications.
Denial risk higher when submitted without strong, indication‑specific evidence.

Note

Insufficient or low‑certainty evidence for multiple indications

Evidence is insufficient or of low certainty for many indications (e.g., delayed/nonunion fractures); high‑quality RCTs and consistent device/parameter data are often lacking.

Delayed or nonunion fractures: heterogeneous studies, variable protocols, and lack of high‑quality RCTs.
Clinical trial evidence often has small sample sizes, heterogeneous devices/settings, and short follow‑up.

Denial Risk

No evidence for specific foot/ankle tendon conditions

There is a lack of clinical evidence supporting ESWT for specific foot and ankle tendon conditions such as tenosynovitis of the foot or ankle and tibialis tendonitis; requests for these indications may be denied.

No peer‑reviewed clinical studies identified for tenosynovitis of the foot/ankle or tibialis tendonitis.
Provide strong supporting evidence if requesting ESWT for these conditions.

Billing Rule

Procedure codes provided for reference

The following procedure codes are provided for reference only; inclusion does not imply coverage. Confirm coding and billing rules and submit with prior authorization when required.

0101T — Extracorporeal shock wave involving musculoskeletal system, not otherwise specified
0102T — Extracorporeal shock wave performed by a physician, requiring anesthesia other than local, lateral humeral epicondyle
0512T — ESWT for integumentary wound healing; initial wound
0513T — ESWT for integumentary wound healing; each additional wound
0864T — Low‑intensity ESWT involving corpus cavernosum, low energy
28890 — Extracorporeal shock wave, high energy, plantar fascia (requires anesthesia other than local)

Note

Clinical trial evidence includes RCTs and systematic reviews

Clinical trial evidence cited in the policy includes randomized controlled trials and systematic reviews/meta‑analyses for indications such as plantar fasciitis, lateral epicondylitis, GTPS, delayed/nonunion fractures, and diabetic foot ulcers.

Many trials enroll patients after failure of conservative therapies.
Heterogeneity in devices, energy settings, and protocols is common across trials.

Documentation Required

Documentation expectations for DFU ESWT

For diabetic foot ulcer (DFU) ESWT requests, include comprehensive wound and clinical documentation: ulcer characteristics, duration, prior standard of care, wound measurements, vascular status, relevant lab values (including HbA1c), and glycemic control.

Document baseline ulcer size, depth, infection status, and previous treatments (off‑loading, debridement, dressings).
Provide HbA1c and other relevant metabolic control data; report transcutaneous oxygen measurements if available.
Include treatment plan, device parameters, and expected follow‑up intervals.

Note

Conservative therapy should precede ESWT

Evidence summaries generally evaluate ESWT after failure of conservative therapies; conservative management (e.g., splinting, exercise, orthotics, injections when appropriate) should precede consideration of ESWT.

Include documentation of prior conservative treatments tried and duration.
Randomized trials frequently enrolled patients who failed conservative care.

Therapeutic mechanisms are not fully established; transient adverse effects reported in studies include pain, bruising, and swelling.

Chronic Plantar Fasciitis (PF)

TermChronic Plantar Fasciitis (PF)

DefinitionPersistent heel pain due to plantar fascia pathology, typically studied after failure of conservative care and measured using outcomes such as VAS pain, Roles and Maudsley, FAAM, and plantar fascia thickness.

Trial enrollment criteria (examples)Studies often enroll patients who failed prior conservative treatments (e.g., >1 month) and excluded recent injections (e.g., >2 months without injection).

Evidence summaryRandomized trials and meta-analyses report that focused ESWT may reduce pain and improve function versus sham; one double-blind RCT (n=250) reported 69.2% vs 34.5% reduction in VAS composite scores at 12 weeks for ESWT vs placebo.

Delayed or Nonunion Fracture

TermDelayed or Nonunion Fracture

DefinitionFractures that fail to heal within expected time frames (delayed union or nonunion).

Evidence characteristicsAvailable ESWT evidence is heterogeneous with variable study designs; systematic reviews report variable union rates and call for high-quality RCTs.

Reported union ratesIn Willems et al. (2019) review: delayed unions treated with ESWT had a union rate of 86% (n=314) and nonunions 73% (n=1782); authors noted heterogeneity in bones treated, energy settings, and protocols.

ESWT focused vs radial

TermFocused ESWT (f-ESWT)

DefinitionShock waves concentrated to a focal point to deliver higher energy density to a targeted tissue volume; commonly evaluated in trials for musculoskeletal tendinopathies and some soft-tissue indications.

TermRadial ESWT (r-ESWT)

DefinitionRadialized shock waves produce a more dispersed, lower energy distribution across superficial tissues; trials and meta-analyses evaluate radial vs focused techniques with mixed results.

Clinical noteStudies vary in device, energy flux density, session frequency, and total sessions, contributing to heterogeneity in outcomes.

Proposed mechanism for wound healing with ESWT

Proposed mechanismMechanical stimulation of cells by shock waves triggers biological responses that may enhance tissue perfusion and angiogenesis.

Possible direct effectsRapid buildup of positive pressure and implosion of bubbles in interstitial fluid may reduce transmission of pain signals, disintegrate calcium deposits, and break down scar tissue.

Wound healing implicationShock-wave–induced mechanical effects are thought to stimulate angiogenesis and improve tissue perfusion, aiding re-epithelialization and wound closure though mechanisms are not fully elucidated.

dermaPACE device and FDA De Novo clearance limited to DFU

DevicedermaPACE System

Regulatory statusGranted FDA De Novo clearance specifically for treating diabetic foot ulcers (DFUs) only; De Novo clearance does not extend to other chronic wound types.

Evidence baseECRI reviewed randomized trials (two multicenter double-blind RCTs pooled, plus a third single-center open-label RCT) and concluded evidence is somewhat favorable for improved complete DFU healing rates at 24 weeks and decreased time to closure.

LimitationNo published studies evaluated dermaPACE effectiveness for chronic wound types other than DFUs in the reviewed evidence.