ModifiedUnitedHealthcarePolicy CSO4ITN.R

Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Wounds (for Tennessee Only)

Medicaid and CoverKids policy for Tennessee governing coverage and medical necessity of extracorporeal shock wave therapy (ESWT) for musculoskeletal and soft tissue indications; excludes ESWL for stone disease.

Policy Summary

PayerUnitedHealthcare

PolicyExtracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Wounds (for Tennessee Only)

Policy CodePolicy CSO4ITN.R

Change TypeCoding update (0864T added)related policy reference removed

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionDocument prior conservative care and follow plan-specific prior authorization rules when seeking coverage for ESWT; services for musculoskeletal/soft tissue indications are generally considered unproven and not medically necessary.

SourceLink

POLICY UPDATE CHANGES

Applicable CPT code 0864T was added to the policy's coding list.

Related policy reference to Lithotripsy for Salivary Stones (for Tennessee Only) was removed.

15pages

6codes listed

Tennesseestate

Not medically necessarycoverage stance

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

250RCT subjects (plantar fasciitis)

Coverage determinations and evidence summaries

inv-01: Not medically necessary for musculoskeletal and soft tissue indications

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.

Policy applies to Medicaid and CoverKids in Tennessee.

inv-02: Evidence-based coverage considerations by indication

The following summarizes indication-specific evidence considerations and practical guidance drawn from randomized trials, systematic reviews, and guideline statements (not formal coverage rules):

Plantar Fasciitis (chronic/refractory): Randomized trials and meta-analyses report heterogeneous results: some RCTs and pooled analyses (e.g., Sun et al., Gollwitzer et al., Lai et al.) show benefit of focused ESWT or ESWT versus comparator in chronic plantar fasciitis, while other trials find no additive benefit versus usual care; ESWT is not supported as first-line therapy for acute plantar fasciitis and many authors suggest use only for chronic or refractory cases with standardized protocols and documentation.

Evidence limited by small samples, heterogeneity of devices/protocols, and inconsistent long-term data.

Delayed or Nonunion Fractures: Systematic reviews and cohort studies report variable union rates after ESWT (reported range ~41%–100% across studies; Willems et al. reported 86% for delayed-unions and 73% for nonunions) and one RCT (Cacchio et al.) found healing comparable to surgery for long-bone hypertrophic nonunions; overall evidence is promising but heterogeneous and high-quality RCTs are needed before routine coverage can be recommended.

Heterogeneity in fracture types, energy settings, and endpoints limits firm conclusions.

Lateral Epicondylitis (Tennis Elbow): Randomized trials and meta-analyses provide inconsistent findings: pooled analyses (Yao et al., Liu et al.) report some reductions in pain and potential benefit for grip strength, while other RCTs (e.g., Capan et al.) found radial ESWT no more effective than sham at 1–3 months; heterogeneity in modality (radial vs focused), protocols, and study quality limit definitive conclusions.

Benefit may depend on device type, symptom duration, and protocol; effects may not persist beyond ~24 weeks in some analyses.

Greater Trochanteric Pain Syndrome (GTPS): Systematic reviews and RCTs report insufficient or inconclusive evidence: some trials show short-term improvements but pooled analyses (Harding et al., Ramon et al.) conclude no clear sustained benefit over control; additional robust RCTs with standardized protocols are needed.

Current evidence rated moderate to low quality with methodological heterogeneity.

Wounds including Diabetic Foot Ulcer (DFU): Systematic reviews and device assessments (Hitchman 2023, Huang 2020, ECRI/dermaPACE, Zhang 2018) suggest ESWT may increase healing rates and shorten time to healing for DFUs and some chronic soft tissue wounds, with dermaPACE data showing improved DFU healing at 24 weeks; however, certainty is limited by small, heterogeneous trials and low-to-moderate quality evidence, requiring further rigorous studies before broad adoption.

Promising but low certainty—case selection and optimal dosing remain uncertain.

Indications with No or Insufficient Evidence: No clinical studies were identified for hammer toe, tenosynovitis of the foot or ankle, and tibialis tendonitis; these indications lack supporting clinical evidence.

Lack of evidence implies inability to demonstrate clinical benefit.

inv-03: Evidence summaries by condition

Summarized study-level findings, key conclusions, and quality notes by condition:

Lateral Epicondylitis (LE): Meta-analyses (Yao et al. 2020; Liu et al. 2022) pooled multiple RCTs and found reductions in pain measures and ranked ESWT favorably for grip strength recovery, but heterogeneity in devices, protocols, and study quality limit certainty; several RCTs (e.g., Capan et al. 2016) found radial ESWT no more effective than sham at one and three months, highlighting inconsistent results across trials.

High heterogeneity and variable risk of bias across trials.

Greater Trochanteric Pain Syndrome (GTPS): Systematic reviews (Harding et al. 2024; Mani-Babu 2015) report moderate-strength but inconclusive evidence: some RCTs (Ramon et al. 2020) report high short-term success with focused ESWT plus exercise, yet pooled analyses do not show significant benefit over control across timepoints; methodological heterogeneity and limited long-term data were noted.

Additional large, well-designed RCTs needed.

Diabetic Foot Ulcer and Other Wounds: Systematic reviews and assessments (Hitchman 2023; Huang 2020; ECRI/dermaPACE; Zhang 2018; Omar 2017) indicate ESWT may shorten time to healing, increase healing rates, and reduce wound area compared with standard care in DFUs and some soft tissue wounds; dermaPACE RCTs reported improved DFU healing at 24 weeks, but overall evidence certainty is low-to-moderate due to small trials, heterogeneity, and potential bias.

This policy excludes extracorporeal shock wave lithotripsy (ESWL) used for stone disease. ESWL for the treatment of kidney stones, gallstones, 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) for musculoskeletal and soft tissue indications.

A systematic 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 is not supported for this indication in the reviewed literature.

The literature search did not identify clinical trials or peer‑reviewed studies evaluating ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis. These conditions therefore lack supporting clinical evidence in the reviewed sources.

Based on the evidence review, ESWT is considered unproven and not medically necessary for any musculoskeletal or soft tissue indications. The available studies are heterogeneous in device type, energy level, protocols, and quality, and do not provide consistent, high‑quality evidence of clinical benefit across indications.

For plantar fasciitis, current guidance and evidence reviews indicate ESWT is not supported as a first‑line therapy for acute cases. ESWT has been studied more in chronic or refractory plantar fasciitis, and many authors and guideline statements recommend reserving ESWT for patients with persistent symptoms after an adequate course of conservative therapy, or using ESWT only within governance, consent, audit, or research arrangements when evidence is inconsistent or limited.

In a double‑blind, randomized, placebo‑controlled trial of radial ESWT for lateral epicondylitis, radial ESWT was not more effective than sham radial ESWT for pain, function, or grip strength at one and three months post‑treatment. Both groups improved, but there were no significant differences between active and sham therapy in that RCT.

Procedure and CPT/HCPCS codes referenced

Applicable procedure codesCPT

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

Applicable CPT CodesCPT

0864T

CPT code added to policy (as listed in Summary of Changes)

Provider guidance, prior authorization and billing notes

Prior Authorization

Prior authorization and coding note

Prior authorization may be required for extracorporeal shock wave therapy (ESWT) services. The following procedure codes are provided for reference; inclusion does not imply coverage. Check plan-specific prior authorization and coverage rules before scheduling or billing.

Provider must verify member benefits and obtain prior authorization if required by the member's plan before performing ESWT.
Listing of codes is for reference only and does not imply that the service is a covered benefit under all UnitedHealthcare plans.
In cases where evidence is inconsistent or evolving (for example, chronic plantar fasciitis or delayed/nonunion fractures), consider prior authorization and referral to plan medical policy staff for case review or consideration of special arrangements (e.g., coverage with evidence development, registry participation, or documented research protocols).

Note

Use with governance, audit or research

ESWT for musculoskeletal and soft tissue indications is considered unproven and not medically necessary by this policy for general coverage; for indications with inconsistent evidence, special governance, audit, or research arrangements may be appropriate before authorizing treatment.

Clinical background and context

Extracorporeal shock wave therapy (ESWT) devices generate acoustic shock waves that are delivered to targeted soft tissues. Devices vary by modality and energy delivery: focused shock waves concentrate energy at a focal point, while radial (defocused) systems disperse lower‑intensity waves over a broader area. Orthopedic ESWT typically uses substantially lower energy levels than urologic lithotripsy. Proposed mechanisms include mechanical disruption, cavitation, transient inflammatory stimulation, and biological responses that may enhance tissue perfusion and healing, but the clinical effects vary by indication and the published evidence is inconsistent.

Key terms and modality definitions

ESWT energy levels — low-energy and high-energy definitions

Low-energy ESWTOrthopedic ESWT uses low-energy pulses (~one-tenth the energy of urologic lithotripsy) and is described as defocused/soft-focused acoustic wave patterns commonly used for wound healing and soft-tissue indications.

High-energy ESWTHigh-energy pulses have greater per-pulse energy and are the levels traditionally used for indications requiring deeper or more disruptive mechanical effect; orthopedic shock waves are substantially lower energy than urologic lithotripsy but distinguished as high- versus low-energy in studies and practice.

Energy comparison to lithotripsyShock waves for orthopedic indications are the same type as those used to break up kidney stones but have about ten times less energy.

ESWT modalities — radial vs focused shock waves and typical use cases

Focused (F-ESWT)Shock waves are focused to concentrate energy at a target tissue boundary; some RCTs and meta-analyses (e.g., Sun et al., Lai et al.) evaluated focused ESWT and reported higher success rates versus sham in chronic plantar fasciitis in some analyses.

Policy changes and effective dates

2025-06-01related_policy_removed

Related policy reference to 'Lithotripsy for Salivary Stones (for Tennessee Only)' was removed and that policy was retired.

2024-12-01code_addedLatest

Applicable CPT code 0864T was added to the policy's coding list.

Policy Summary

PayerUnitedHealthcare

PolicyExtracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Wounds (for Tennessee Only)

Policy CodePolicy CSO4ITN.R

Change TypeCoding update (0864T added)related policy reference removed

Effective DateDec 1, 2024

Next Review DateN/A

SourceLink

On This Page

Promising results but further high-quality trials required to define optimal dosing and generalizability.

Delayed/Nonunion Fractures: Systematic reviews (Willems et al. 2019) and an RCT (Cacchio et al. 2009) report that ESWT can achieve union rates similar to surgery in some series (Willems: delayed-union ~86%, nonunion ~73%), but studies vary widely in patient populations, ESWT parameters, and outcome definitions; high-quality randomized evidence is still limited.

Evidence heterogeneous; consensus on protocols and endpoints lacking.

Other conditions with no identified evidence: Literature searches did not identify clinical trials for hammer toe, tenosynovitis of the foot or ankle, or tibialis tendonitis, indicating absence of evidence to support ESWT for these indications.

No evidence found in the reviewed literature.

Follow local governance and auditing requirements when ESWT is provided as part of a research protocol or registry; obtain informed consent and document enrollment in such programs.
NICE (2009) recommended use of ESWT for refractory plantar fasciitis only with special arrangements for governance, consent, and audit — similar safeguards should be considered when allowing ESWT under exceptional or research pathways.

Documentation Required

Documentation and conservative therapy requirements

Document clinical rationale and prior conservative care in the medical record prior to ESWT.

Document symptom duration and prior conservative treatments (e.g., stretching programs, orthotics, physical therapy, activity modification, NSAIDs, corticosteroid injections) and response to those therapies.
For plantar fasciitis, ESWT is generally considered for chronic or refractory cases after an adequate trial of conservative therapy; document duration (typically several months) and lack of improvement.
For all indications, clearly record the indication, prior treatments tried, objective findings, and rationale for pursuing ESWT (including any multidisciplinary evaluations or specialist consultations).

Billing Rule

Code listing, billing and plan-specific governance

Billing and plan governance reminders.

The code listing in this policy (0101T, 0102T, 0512T, 0513T, 0864T, 28890) is provided for reference and does not imply coverage or payment.
Providers must reference federal, state, or contractual benefit requirements when determining coverage; such requirements govern if they conflict with this policy.
Claims for ESWT for musculoskeletal/soft tissue indications may be subject to denial where the service is considered unproven or not medically necessary under the member's plan.
Verify whether 0864T or other newer codes require separate prior authorization or have specific billing instructions under the member's plan.

Denial Risk

Denial risk / Step therapy

Denial risk and step therapy considerations.

Claims for ESWT for musculoskeletal or soft tissue indications carry risk of denial because the policy finds these uses unproven/not medically necessary.
There are no universal step therapy requirements specified in this policy; follow the member's plan rules for any step-therapy or quantity-limit programs that may apply.

Radial (R-ESWT)Radial or defocused shock waves produce a softer, more dispersed acoustic pattern often used for wound healing and some soft-tissue indications; trials have evaluated radial devices separately and results are heterogeneous.

Typical use casesFocused ESWT is often studied for chronic tendinopathies and plantar fasciitis where concentrated energy is desired; radial ESWT is used for wound healing and some soft-tissue musculoskeletal conditions where a defocused pattern is preferred.

Chronic plantar fasciitis — definition used in policy/studies (duration, refractory to conservative care)

Duration requirementStudies and systematic reviews generally include plantar fasciitis of at least several months' duration; some pooled analyses and RCTs required ≥6 months of symptoms for inclusion.

Refractory to conservative careChronic plantar fasciitis in the policy is defined as symptoms refractory to conservative management (e.g., prior conservative treatments without improvement); many trials required prior conservative therapy and/or documented failure before ESWT.

Not first‑lineThe policy and guidelines note ESWT is not recommended as first-line therapy for acute plantar fasciitis and is typically considered for chronic or refractory cases with documented prior care.

Delayed union / Nonunion — definition and study-based criteria for fractures

Operational definitionDelayed union/nonunion refers to fractures that fail to demonstrate expected radiographic healing within expected timeframes; studies vary but often use radiographic/CT evidence at least six months after injury/treatment with no progressive healing for a defined period.

Study-based healing thresholdsWillems et al. reported union rates for delayed-unions (86%) and nonunions (73%) across studies and noted heterogeneity in definitions, energy settings, and end-point criteria; the review emphasizes need for standardized timing and parameters.

Comparative findingsSome RCTs and cohort studies (e.g., Cacchio et al.) compared ESWT to surgery and found comparable union rates in selected long-bone hypertrophic nonunions, but high-quality RCTs remain limited.

ESWT (device regulatory classification) — FDA product code/classification and clearance context

FDA device classificationThe FDA has classified extracorporeal shock wave therapy (ESWT) products as Class III devices under the premarket approval program with product code NBN (generator, shockwave, for pain relief).

Informational contextFDA information is provided for informational purposes only; FDA approval or classification alone is not a basis for coverage decisions under this policy.

Manufacturer/device searchThe policy directs users to FDA device listings (accessdata.fda.gov) to review specific ESWT products and clearances as needed; device listings are extensive and should be searched by product name.