ModifiedUnitedHealthcarePolicy CS041KY.11

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

This policy governs medical necessity and coverage stance for extracorporeal shock wave therapy (ESWT) for musculoskeletal and soft tissue indications for UnitedHealthcare members in Kentucky; it specifies age-based distinctions and references InterQual criteria for plantar fasciitis adults.

Policy Summary

PayerUnitedHealthcare

PolicyExtracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Indications (for Kentucky Only)

Policy CodePolicy CS041KY.11

Change TypeRevised clinical evidence and updated coverage sections

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionFor adults with plantar fasciitis, follow InterQual criteria and payer prior authorization processes to establish medical necessity for high-energy ESWT.

SourceLink

POLICY UPDATE CHANGES

Title changed and Coverage Rationale and Members Under 18 years of age sections were updated; previous instruction to refer to InterQual for high-energy ESWT for plantar fasciitis was removed.

Supporting clinical evidence and references were updated to reflect current information.

Kentucky-onlyState applicability

InterQualAdult plantar fasciitis referral

UnprovenGeneral coverage stance

6 codes

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Procedure codes listed

Coverage criteria and evidence summaries

Coverage stance and routing to InterQual

Covered when ALL of the following are met:

Adults with plantar fasciitis: For members 18 years of age and older, medical necessity clinical coverage criteria for extracorporeal shock wave therapy (ESWT), high energy, for plantar fasciitis refer to the InterQual CP: Procedures, Plantar Fasciitis, Extracorporeal Shock Wave Therapy (ESWT).see InterQual

InterQual criteria define the detailed eligibility and are the governing clinical tool referenced by this policy.

Other adult musculoskeletal/soft tissue indications: ESWT (low energy, high energy, or radial wave) is considered unproven and not medically necessary for all other musculoskeletal or soft tissue indications due to insufficient evidence of efficacy.N/A

Applies to adults for indications other than plantar fasciitis.

Pediatrics (<18): ESWT (low energy, high energy, or radial wave) is unproven and not medically necessary for any musculoskeletal or soft tissue indications in members under 18 years of age due to insufficient evidence of efficacy.N/A

Pediatric exclusion applies across indications.

Evidence summaries by indication

Evidence summaries and conclusions by indication (document provides mixed/limited evidence; use when assessing medical necessity):

Chronic Plantar Fasciitis: Multiple randomized controlled trials and meta-analyses report that ESWT (focused and radial) can reduce pain and improve function in chronic plantar fasciitis; many studies and the ACFAS consensus note approximately 70% of patients experience meaningful improvement by 12 weeks. H-ESWT protocols in some RCTs showed greater short-term benefit versus low-energy protocols, but heterogeneity in device type, energy settings, and session number limits generalizability.

Short-term improvements well-documented; longer-term outcomes and optimal parameters remain variable.

Delayed or Nonunion Fractures: Evidence is inconclusive: systematic reviews report variable union rates across observational series and limited RCT data; Cochrane and other reviews found low- to very-low–certainty evidence and uncertainty about effects on patient-reported outcomes, so routine use is not supported without high-quality data.

Considered investigational/insufficient evidence for routine recommendation.

Erectile Dysfunction (ED): Meta-analyses of low-intensity ESWT (Li-ESWT) report mixed results with some improvements in erectile function scores versus sham; heterogeneity of protocols, small sample sizes, and guideline statements (e.g., AUA: investigational) limit definitive conclusions and indicate need for additional high-quality standardized RCTs.

Coverage considerations by indication

Summary of evidence-based findings by indication

Lateral epicondylitis (LE): Evidence from multiple RCTs and meta-analyses is mixed; ESWT may provide medium-term pain and functional benefit in some analyses and improve grip strength, but other high-quality trials and pooled analyses report no consistent clinically important benefit versus sham. When considered, use of ESWT for LE should follow evidence-based protocols and be reserved for patients who have failed appropriate conservative care.

Clinical use may be considered when prior conservative treatments have failed and when device/protocol details match those supported by trials; benefits are more evident in some analyses at 3–6 months.

Greater trochanteric pain syndrome (GTPS)/gluteal tendinopathy: Systematic reviews report exercise and education as core management; focused ESWT (f-ESWT) has demonstrated superiority to corticosteroid injection for long-term pain in some trials and systematic reviews, but overall evidence is heterogeneous. ESWT may be considered as an adjunct after failure of core conservative measures with attention to device energy and protocol.

ESWT may be considered after failure of core conservative management; device energy and protocol matter.

Diabetic foot ulcers (DFU)/wounds:

This policy does not address extracorporeal shock wave lithotripsy (ESWL) used for the treatment of gallstones, kidney stones, pancreatic stones, or salivary stones. Separately, extracorporeal shock wave therapy (ESWT) — whether low energy, high energy, or radial wave — is considered unproven and not medically necessary for musculoskeletal or soft tissue indications except where adult plantar fasciitis is evaluated by InterQual criteria.

A focused literature review for hammer toe did not identify any clinical studies evaluating ESWT for this indication. Therefore, ESWT for hammer toe lacks evidence to support its use.

Searches of the peer‑reviewed literature did not identify clinical studies of ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis. Requests for ESWT for these tendon indications lack supporting clinical evidence and are therefore unsupported by published studies.

Evidence specific to the dermaPACE system was identified only for diabetic foot ulcers (DFUs). The ECRI assessment and available RCT data indicate dermaPACE has favorable signals versus standard care for DFU healing, but no published studies were found evaluating dermaPACE for other chronic wound types.

Except where adult plantar fasciitis is managed via InterQual criteria, extracorporeal shock wave therapy (ESWT) — including low energy, high energy, and radial wave modalities — is considered unproven and not medically necessary for most musculoskeletal and soft tissue indications due to insufficient evidence of efficacy.

The evidence is inconclusive for ESWT in acute, delayed, or nonunion fractures. Systematic reviews report heterogeneous results, limited high‑quality trials, and low‑certainty evidence for effects on patient‑reported outcomes and fracture union; routine coverage for fractures (acute, delayed, or nonunion) is not supported without stronger, higher‑quality data.

Randomized placebo‑controlled data for radial ESWT in lateral epicondylitis (tennis elbow) have not consistently shown superiority to sham. For example, a double‑blind RCT found no significant difference between radial ESWT and sham at one and three months, which supports caution when claiming superiority of radial ESWT over placebo.

FDA device classification and clearance information is provided for informational purposes only. FDA approval or PMA classification (product code NBN) is not by itself a basis for coverage decisions; coverage depends on the clinical evidence and applicable benefit plan terms.

Procedure and device codes

Applicable procedure codes (reference list)CPT

0101T	Extracorporeal shock wave involving musculoskeletal system, not otherwise specified.
0102T	Extracorporeal shock wave performed by a physician, requiring anesthesia other than local, and involving the lateral humeral epicondyle.
0512T	Extracorporeal shock wave for integumentary wound healing, including topical application and dressing care; initial wound.
0513T	Extracorporeal shock wave for integumentary wound healing, including topical application and dressing care; each additional wound (List separately in addition to code for primary procedure).
0864T	Low-intensity extracorporeal shock wave therapy involving corpus cavernosum, low energy.
28890	Extracorporeal shock wave, high energy, performed by a physician or other qualified health care professional, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia.

FDA device product code (informational)mixed

NBN	FDA product code: generator, shockwave, for pain relief

Prior authorization, documentation, and reviewer guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for ESWT requests when InterQual criteria apply for adults (e.g., plantar fasciitis) or when benefit plan/contractual rules specify prior review. Reviewers must determine authorization decisions consistent with InterQual, UnitedHealthcare Medical Policies, Coverage Determination Guidelines, and applicable Utilization Review Guidelines.

Prior authorization required when InterQual criteria apply for adults (plantar fasciitis)
Determinations must follow InterQual and UnitedHealthcare guidelines and applicable state/federal/contractual requirements

Prior Authorization

Prior Authorization Recommended for Low‑Certainty Indications

For indications with limited or low-certainty evidence (for example: delayed/nonunion fractures, diabetic foot ulcers, erectile dysfunction), prior authorization is recommended so reviewers can perform a focused pre-review. Such requests should include rationale and supporting literature when available; absence of sufficient evidence may lead to denial.

Prior authorization recommended for low‑certainty or emerging indications (delayed/nonunion fractures, ED, some wound indications)

Devices, modalities, and contextual information

Extracorporeal shock wave therapy (ESWT) devices generate acoustic shock waves that can be delivered as either focused or radial waves and at differing energy levels (commonly described as low‑energy or high‑energy). Focused ESWT concentrates energy at a point within tissue, whereas radial ESWT delivers more defocused surface‑applied waves; energy flux density and device focus distinguish low‑ versus high‑energy protocols and influence reported clinical effects.

Key definitions and modality descriptions

Low-energy vs High-energy ESWT — energy & typical uses

DefinitionLow-energy ESWT: defocused or soft-focused acoustic shock waves used principally for wound healing; High-energy ESWT: focused higher energy flux density protocols used in orthopedic indications (device pulses similar to lithotripters but ~10x less energy).

Energy flux density descriptorDistinguished by energy flux density (EFD) and device focus; low-energy defined in source as <0.08 mJ/mm2 in some trials and high-energy examples include 0.26 mJ/mm2 in trials.

Typical usesLow-energy/defocused: acute and chronic soft tissue wounds and burn wounds (adjunct to standard care); High-energy/focused: orthopedic conditions such as plantar fasciitis and refractory tendinopathies.

Radial vs Focused ESWT — modality definitions

Radial ESWT (RSW)Generates non-focused, surface-applied pressure waves (defocused) that propagate radially from the applicator; commonly used in trials comparing to other modalities for plantar fasciitis and lateral epicondylitis.

Policy Summary

PayerUnitedHealthcare

PolicyExtracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Indications (for Kentucky Only)

Policy CodePolicy CS041KY.11

Change TypeRevised clinical evidence and updated coverage sections

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionFor adults with plantar fasciitis, follow InterQual criteria and payer prior authorization processes to establish medical necessity for high-energy ESWT.

SourceLink

On This Page

Additional high-quality standardized RCTs needed.

Lateral Epicondylitis (Tennis Elbow): Systematic reviews and RCTs provide conflicting results: some analyses find ESWT inferior to corticosteroid injection at 1 month but superior at 3 and 6 months for pain and function, while other high-quality trials find no clinically important benefit versus sham; heterogeneity in devices and protocols and limited long-term data limit certainty.

Evidence supports possible medium-term benefit but uncertainty persists.

Meta-analyses of randomized trials (including 10 RCTs) indicate ESWT is associated with higher rates of complete ulcer healing and improved TcPO2 versus standard care or hyperbaric oxygen, suggesting ESWT is a promising adjunct to standard wound care; heterogeneity and small trial sizes limit certainty and documentation of wound characteristics and prior treatments is important.

Consider ESWT as a promising adjunct for DFU when standard of care has been applied; document wound baseline characteristics and prior treatments.

Other tendon indications (tenosynovitis of foot/ankle, tibialis tendonitis): No clinical studies were identified for ESWT in tenosynovitis of the foot or ankle or for tibialis tendonitis; lack of evidence prevents routine coverage for these indications.

Lack of evidence prevents routine coverage for these indications.

Lack of conclusive evidence may trigger denial after clinical review

Documentation Required

Documentation and Protocol Details Required

Requests must include the clinical indication, documentation of prior conservative care, and specific ESWT protocol details (device type, energy setting, number of shocks, number and frequency of sessions, anesthesia if used). Reviewers will assess these elements when determining medical necessity.

Required submission elements: indication, prior conservative treatments and response, ESWT device and protocol (energy, shocks, sessions, interval)
Document whether InterQual or other guideline criteria are being used to justify the request

Prior Authorization

Conservative Therapy Expected Before ESWT

Conservative therapy is expected prior to ESWT for most musculoskeletal indications. ESWT is generally considered adjunctive after adequate trial of core conservative measures (e.g., exercise/education, orthotics, NSAIDs, activity modification). For greater trochanteric pain syndrome (GTPS), conservative care (exercise and education ± other adjuncts) should be attempted before considering ESWT.

Documented trial of conservative care (type, duration, response) is required prior to authorization
For GTPS, conservative exercise/education is the core approach; ESWT is adjunctive

Denial Risk

Denial Risk for Unproven Indications

Requests for indications that are unproven or not medically necessary (for example, most musculoskeletal or soft tissue uses in pediatric patients, or indications lacking clinical studies) are at risk for denial. Providers should supply high‑quality evidence and clear justification when requesting ESWT for such uses.

Pediatric musculoskeletal/soft tissue indications are considered unproven and not medically necessary
Tenosynovitis of foot/ankle and tibialis tendonitis have no identified clinical studies and are at higher risk for denial

Denial Risk

Evidence Insufficiency May Trigger Denial

Insufficiency of evidence for certain indications (e.g., delayed/nonunion fractures, ED, some wound protocols) may lead to denial. When the literature is heterogeneous, small, or methodologically weak, reviewers may require additional documentation or decline coverage.

Evidence gaps (heterogeneity, small sample sizes, variable protocols) increase chance of denial
High‑quality RCTs or robust systematic reviews may be requested to support coverage

Billing Rule

Coding Reference and Documentation Note

Coding is provided for reference only and does not imply coverage or payment. Inclusion of a code does not guarantee reimbursement; reviewers must confirm benefit plan applicability and any coding/billing rules.

Reference codes include: 0101T, 0102T, 0512T, 0513T, 0864T, 28890 (not exhaustive)
Listing of codes does not imply coverage — verify benefit contract and billing rules

Documentation Required

Suggested Documentation to Support ESWT Use

Suggested documentation to support ESWT requests: detailed history and indication, prior conservative treatments (types and duration), pain/function scores (e.g., VAS, AOFAS, Roles and Maudsley), imaging or objective findings, ESWT device and protocol parameters, and expected treatment goals and timeline.

Include baseline and follow‑up outcome measures (pain/function scores)
Provide imaging or objective measures when relevant and ESWT protocol specifics (energy, shocks, sessions)

Note

Document Benefit Plan Applicability

Benefit plan applicability must be checked and documented for every request. Federal, state, or contractual requirements may supersede this policy; when conflicts exist, the applicable benefit terms govern coverage.

Reviewers must document the relevant plan, any contract exclusions or mandates, and the legal authority used for the determination
In event of conflict, federal/state/contractual requirements control

Focused ESWT (FSW)Concentrates acoustic energy to a focal point within tissues using focused shock waves propagated through a coupling medium; used in many RCTs and meta-analyses and may provide greater tissue penetration and effect size in some conditions.

Clinical implicationModality (radial vs focused) influences device energy delivery, penetration depth, and may affect comparative effectiveness observed in trials and meta-analyses.

Focused shock wave (FSW) vs Radial shock wave (RSW) — trial comparisons

Comparative distinctionFSW (focused shock wave) concentrates energy at a focal point while RSW (radial shock wave) disperses energy superficially; meta-analyses for plantar fasciitis and lateral epicondylitis compare these modalities due to differing effectiveness profiles.

Evidence contextSun et al. and other pooled analyses noted FSW may be associated with higher success rates and greater pain reduction versus sham in chronic plantar fasciitis; network/meta-analyses for lateral epicondylitis examine FSW vs RSW among many RCTs.

Trial interpretationHeterogeneity in device type, energy, and protocol complicates direct modality comparisons; modality-specific findings should be interpreted in the context of study parameters.

Low-intensity ESWT (Li-ESWT) — definition & ED use

DefinitionLow-intensity ESWT (Li-ESWT) refers to lower-energy protocols evaluated primarily for erectile dysfunction (ED), typically delivered as multiple sessions with many shocks per session.

Evidence baseMeta-analyses of RCTs (e.g., 12 RCTs / 862 men) report modest improvements in IIEF-EF and some erectile function measures versus sham but are limited by small, heterogeneous trials and lack of standardized protocols.

Guideline stanceThe American Urological Association (2018) considers low-intensity ESWT investigational for ED (conditional recommendation, Grade C).

Focused ESWT (f-ESWT) — focused delivery & trial examples

Modality descriptionFocused ESWT (f-ESWT) delivers concentrated energy flux density to a specific tissue depth and has been used in RCTs for gluteal tendinopathy/GTPS with specified EFDs (example: 0.20 mJ/mm2).

Trial examplesRamon et al. (2020) randomized multicenter trial (n=103) used F-ESWT at 0.20 mJ/mm2 with improved success rates maintained to six months; systematic reviews identify f-ESWT superiority to corticosteroid in some long-term outcomes for GTPS.

Clinical rolef-ESWT has been evaluated as an adjunct after conservative care for tendinopathies where protocol dosing and device type were specified in trials.

Radial ESWT — non-focused modality & trial context

Modality characteristicsRadial ESWT is a non-focused, surface-applied modality evaluated extensively for lateral epicondylitis; device heterogeneity and protocol differences are common across trials.

Trial contextNetwork and meta-analyses (e.g., Liu 2022; Yao/Yoon analyses) include many RCTs comparing radial ESWT to injections, sham, and other therapies, with mixed results regarding superiority to sham or other treatments depending on follow-up interval and outcomes assessed.

Interpretation limitsRandomized sham-controlled trials of radial ESWT have not consistently shown benefit over sham at all timepoints; heterogeneity in instruments and protocols limits pooled conclusions.

Diabetic foot ulcer (DFU) treatment with ESWT — adjunctive therapy & outcomes

Adjunctive useESWT for diabetic foot ulcers (DFU) is used as an adjunct to standard ulcer care or hyperbaric oxygen in trials; studies report improved healing rates and shorter time to healing in some analyses.

Outcomes observedMeta-analyses of RCTs (10 trials, 754 participants) found ESWT associated with higher complete-healing rates (RR 1.57) and improved TcPO2 versus controls, but studies were small and heterogeneous.

Evidence certaintySystematic reviews note low-to-moderate methodological quality and heterogeneity; further high-quality trials are needed to define optimal dosing and patient selection.

ESWT for acute and chronic soft tissue wounds — pooled outcomes

Pooled outcomesPooled RCTs for acute and chronic soft tissue wounds show increased healing rates, greater wound-healing area percentage, reduced healing time (e.g., 3 days for acute wounds, 19 days for chronic wounds), and lower infection risk versus conventional wound therapy.

Study volumeSystematic reviews/meta-analyses include approximately 10 RCTs for mixed soft tissue wounds (473 patients) and 11 studies for chronic lower-extremity wounds (925 patients), showing generally favorable but heterogeneous results.

LimitationsAuthors consistently call for higher-quality, well-controlled RCTs because heterogeneity in wound types, follow-up timing, and ESWT dosing reduces certainty of pooled estimates.