ModifiedUnitedHealthcarePolicy CSOAIOH.C

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

This policy governs medical necessity, coverage rationale, and applicable coding for extracorporeal shock wave therapy (ESWT) for musculoskeletal conditions and soft tissue wounds for UnitedHealthcare members in Ohio.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSOAIOH.C

Change TypeCoverage rationale clarifiedCPT code added

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionRefer plantar fasciitis high-energy ESWT requests to InterQual; obtain prior authorization and document prior conservative therapy and imaging for nonunion or other indications.

SourceLink

POLICY UPDATE CHANGES

Replaced language narrowing ESWT as unproven/not medically necessary in "all other musculoskeletal or soft tissue indications" to a broader statement that ESWT is unproven and not medically necessary for any musculoskeletal or soft tissue indications due to insufficient evidence of efficacy.

Added CPT code 0864T to the list of applicable codes.

Ohio-onlyjurisdiction

0101T–0864T, 28890applicable codes

InterQual referencedexternal criteria

Not medically necessary

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30+ studiesevidence cited

Coverage Criteria and Evidence Summary

Covered with criteria / Evidence-dependent indications

Coverage stance summarized by indication

Plantar fasciitis (high-energy): Medical necessity clinical coverage criteria for ESWT, high energy, for plantar fasciitis are referred to the InterQual CP: Procedures, Plantar Fasciitis, Extracorporeal Shock Wave Therapy (ESWT).refer to InterQual

InterQual contains the specific AND/OR criteria for approval.

Other musculoskeletal or soft tissue indications: For most other musculoskeletal and soft tissue indications (e.g., Achilles tendinopathy, calcific rotator cuff tendinitis, delayed/nonunion fractures), the policy states evidence is insufficient to conclude efficacy for many indications and that ESWT is unproven or promising but not established; coverage decisions require evaluation of medical necessity and condition-specific evidence review.condition-specific evidence review

Specific study summaries are provided in the document to support the insufficient/low-quality evidence stance.

Evidence summaries by indication

Evidence synthesis and clinical conclusions from cited studies and reviews

Fracture delayed/nonunion: Multiple systematic reviews and cohort studies report union rates for ESWT ranging approximately 65%–86% in delayed/nonunion fractures; an RCT found ESWT comparable to surgery for long-bone hypertrophic non‑unions. Heterogeneity in energy settings, treatment number, and study design limits definitive conclusions and high-quality RCTs are recommended.

References: Searle 2023; Kwok 2022; Willems 2019; Cacchio 2009

Lateral epicondylitis (LE): Randomized trials and multiple meta-analyses show mixed results for ESWT in LE: some RCTs report superior pain and function versus comparators while other trials and pooled analyses find inconsistent or no clinically important improvements. Results vary by ESWT device type, protocol, and symptom duration.

References: Cetin 2024; Liu 2022; Yao 2020; Yoon 2020; Ozmen 2021; Atalay 2020

Greater trochanteric pain syndrome (GTPS): Systematic reviews and RCTs produce inconclusive evidence; some RCTs report benefit with focused ESWT plus exercise but overall evidence is limited by small trials and heterogeneity; further robust RCTs are needed.

Not Medically Necessary — Musculoskeletal and Soft Tissue Indications

Covered when ALL of the following are met

Not medically necessary 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 replacement language effective 12/01/2024.

Evidence summaries — Wounds (informational)

Evidence summaries for wound applications (informational)

Diabetic foot ulcer (DFU) evidence: Systematic reviews/meta-analyses report ESWT may improve DFU healing rates and reduce wound surface area/time to healing, but trials are small, heterogeneous, and optimal dosing is unclear; overall certainty is low to moderate.

Sources: Huang et al. 2020; Hitchman et al. 2023; ECRI assessment.

Soft tissue wound evidence: Meta-analysis of acute and chronic soft tissue wounds (Zhang et al. 2018) found ESWT increased healing rates (OR ~3.73), improved wound‑healing area percentage, and reduced healing time versus conventional wound therapy; authors recommend higher‑quality RCTs to confirm findings.

Informational; does not alter noncoverage stance.

Chronic lower‑extremity wound evidence: Systematic reviews (Omar et al. 2017) provide mild to moderate support for ESWT as an adjunct to standardized wound care for chronic lower‑extremity wounds but methodological limitations preclude firm conclusions.

Informational only.

This policy does not address extracorporeal shock wave lithotripsy (ESWL) procedures used for the treatment of renal or biliary calculi and other non-musculoskeletal indications. Specifically, ESWL for kidney stones, gallstones, pancreatic stones, and salivary stones is outside the scope of this policy.

A targeted search of the peer-reviewed literature did not identify clinical studies evaluating ESWT for hammer toe or tibialis tendonitis. Because no clinical evidence was found for these indications, the policy does not support coverage based on published clinical trials for these conditions.

Based on the current evidence synthesis, extracorporeal shock wave therapy (ESWT) — whether low energy, high energy, or radial wave — is considered unproven and not medically necessary for any musculoskeletal or soft tissue indications due to insufficient evidence of efficacy.

Evidence is inconclusive for several commonly considered orthopedic indications. For Achilles tendinopathy, existing randomized trials and systematic reviews provide low- to very low–quality evidence and do not demonstrate consistent clinical benefit, and animal-model studies predominate. For delayed or nonunion fractures, systematic reviews and cohort series report variable union rates and heterogeneous protocols, and conclusive evidence of ESWT efficacy is lacking.

Randomized trials and meta-analyses of lateral epicondylitis (LE) report mixed outcomes. Some pooled analyses show early reductions in pain and improved grip strength, while other trials — including sham-controlled radial ESWT studies — found no clinically important difference versus control. Results vary by device type (radial versus focused), protocol, and symptom duration, and several studies report improvements in both active and sham groups, limiting definitive conclusions about radial ESWT superiority for lower-extremity or elbow presentations.

More broadly, and reflecting the totality of the evidence and its heterogeneity across devices and protocols, ESWT (all modalities) remains unproven and not medically necessary for the expanded set of musculoskeletal and soft tissue indications addressed in this policy.

Applicable Procedure and Billing Codes

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.

Coding referenced (none listed)mixed

not specified

No specific CPT/HCPCS/ICD-10 codes provided in this document fragment.

Applicable CPT Codes (policy-added)CPT

0864T

CPT code added to policy (as applicable code)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization / Medical Necessity Guidance

Prior authorization may be required and medical necessity will be determined using InterQual as the primary criteria source for high-energy ESWT for plantar fasciitis. Providers should verify prior authorization requirements with the member's plan before scheduling therapy.

InterQual is the primary source for medically necessary criteria for high-energy ESWT for plantar fasciitis.
Verify prior authorization requirements with the member's plan prior to service.

Prior Authorization

Prior Authorization and Criteria Sources

Prior authorization is advised for ESWT when evidence is inconsistent or limited (for example, fracture nonunion or various tendinopathies). When InterQual does not have applicable criteria, UnitedHealthcare may use its Medical Policies, Coverage Determination Guidelines, or Utilization Review Guidelines.

Recommend prior authorization for ESWT in indications with limited or heterogeneous evidence (e.g., delayed/nonunion fractures, GTPS, other tendinopathies).
If InterQual lacks applicable criteria, UnitedHealthcare policies and guidelines may be used.

Background and Definitions

Extracorporeal shock wave therapy delivers focused or defocused acoustic shock waves at energy levels lower than lithotripsy and is intended to stimulate tissue responses such as transient inflammation, disintegration of calcifications, and potentially enhanced healing. The exact mechanism is not fully established but may involve mechanical effects, cavitation, increased tissue perfusion, and angiogenesis. In practice, low-energy (defocused) ESWT is typically applied in wound-healing contexts, whereas focused/high-energy ESWT is used for musculoskeletal indications.

Low-energy vs high-energy ESWT — definition and typical uses

DefinitionLow-energy (defocused/soft-focused) ESWT: acoustic shock waves with lower energy flux, typically delivered as defocused or soft-focused waveforms and most often used for wound healing applications.

DefinitionHigh-energy (focused) ESWT: acoustic shock waves with greater energy flux, delivered in focused patterns and commonly used for orthopedic indications such as tendinopathies and fracture nonunions.

Typical uses — Low-energyWound healing applications (e.g., diabetic foot ulcers, soft-tissue wounds) where defocused/soft-focused ESWT is intended to stimulate tissue repair.

Typical uses — High-energy

Policy Revision History

2025-07-01revisionLatest

Removed reference link to the Medical Policy titled Lithotripsy for Salivary Stones (related policies removed).

2024-12-01material_revision

Coverage rationale clarified to state ESWT is unproven and not medically necessary for any musculoskeletal or soft tissue indications; CPT code 0864T was added; supporting clinical evidence and references were updated and prior policy version CSO41OH.B was archived.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CSOAIOH.C

Change TypeCoverage rationale clarifiedCPT code added

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionRefer plantar fasciitis high-energy ESWT requests to InterQual; obtain prior authorization and document prior conservative therapy and imaging for nonunion or other indications.

SourceLink

On This Page

References: Harding 2024; Ramon 2020; Mani-Babu 2015; ECRI 2020

Calcific rotator cuff tendinopathy: Recent systematic reviews suggest ESWT may be promising for calcific tendinopathy with improvements in pain and function for some patients, but conflicting findings, variable protocols, and limited trial quality prevent definitive conclusions; additional standardized high-quality studies are needed.

References: Xue et al. 2024; Hayes HTA 2022/2023

Wounds (diabetic foot ulcers and soft tissue wounds): Multiple RCTs and meta-analyses suggest ESWT can improve healing rates, increase re-epithelialization, reduce wound surface area and shorten time to healing (e.g., OR ~3.73 for acute/chronic soft tissue wounds; reduced chronic wound healing time by ~19 days). Evidence quality is variable and optimal dosing protocols remain unclear.

References: Hitchman 2023; Huang 2020; ECRI 2020; Zhang 2018

Denial Risk

Evidence Insufficiency May Trigger Denial

Insufficient or low-quality evidence (heterogeneous studies, limited RCT data, inconsistent energy settings/dosing) may lead to denial as not medically necessary or to requests for additional documentation.

Lack of high-quality, consistent RCT evidence may trigger claim denials or requests for further information.
Heterogeneity in study populations, energy settings, number of treatments, and outcomes increases denial risk.

Documentation Required

Coding and Documentation

Providers should document procedure and diagnosis coding exactly as listed in the Applicable Codes section and include clinical justification tied to InterQual or UnitedHealthcare criteria when submitting prior authorization requests and claims.

Document CPT/HCPCS codes and corresponding diagnosis codes per the Applicable Codes list.
Include clinical notes demonstrating how the case meets InterQual or UnitedHealthcare medical necessity criteria.

Note

State / Contractual Requirements

Benefit coverage is governed by federal, state (for Ohio: OAC), and contractual requirements. Always check applicable federal, state (OAC), or contractual plan terms; those terms govern if there is a conflict with this policy.

Verify federal, state (OAC), and contractual requirements for the member's plan prior to authorization and billing.
In event of conflict, federal/state/contractual requirements supersede this policy.

Step Therapy

ESWT After Conservative Therapy

ESWT is generally considered after failure of appropriate conservative, nonoperative therapies for musculoskeletal and soft-tissue conditions; prior conservative management should be documented in the medical record and prior authorization submission.

Document prior nonoperative treatments (e.g., physical therapy, activity modification, injections, medications) and duration before ESWT is considered.
Refer to InterQual for step therapy/coverage criteria specific to plantar fasciitis high-energy ESWT.

Musculoskeletal/orthopedic indications (e.g., tendinopathies, delayed or nonunion fractures) where focused high-energy ESWT protocols have been applied.

Note on standardsDocument notes lack of standardized numeric cutoffs for ‘low’ versus ‘high’ energy; differentiation in practice is by device focus and clinical application rather than a single universal energy threshold.

Fracture nonunion (as used in cited studies) — operational definition and time thresholds

Operational definitionFracture nonunion in cited studies: determined by radiographic or CT analysis at least six months following operative or nonoperative treatment, with at least three months of no radiographic change.

Outcome assessmentFracture healing or union was determined by radiographic or CT analysis at follow-up; reported healing rates varied by study (e.g., 80% in a tibia nonunion series).

Treatment details relevant to definitionStudies included patients treated with one to three ESWT sessions; factors influencing healing included number of shock wave treatments, pulses delivered, and prior orthopedic operations.

Mechanism for wound healing — biological effects: perfusion and angiogenesis

Core mechanismMechanical effects of shock waves on cells trigger biological responses that enhance tissue perfusion and angiogenesis.

Proposed cellular effectsShock-wave–induced forces (including rapid positive pressure changes and cavitation) may stimulate transient inflammation, breakdown of scar or calcific deposits, and signaling that promotes healing.

Clinical implicationThese biological responses are the rationale for using ESWT to accelerate wound healing and improve re-epithelialization and wound perfusion in trials of diabetic foot ulcers and other soft-tissue wounds.

FDA classification of ESWT devices — class III devices, product code NBN (informational)

FDA classificationESWT products are classified by the U.S. Food and Drug Administration as Class III devices through the Premarket Approval (PMA) program.

Product codeProduct code: NBN (generator; shock-wave, for relief).

Informational noteFDA classification is provided for informational purposes only; FDA approval alone is not a basis for coverage decisions per the document.