ModifiedUnitedHealthcarePolicy CS041TN.S

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

Defines UnitedHealthcare Tennessee Medicaid/CoverKids coverage stance and clinical rationale for ESWT (low, high, radial) for musculoskeletal and soft tissue conditions; applies to providers treating Tennessee Medicaid and CoverKids members.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS041TN.S

Change TypeTitle and supporting evidence/reference updates

Effective DateNov 1, 2025

Next Review Date

Key ActionDocument diagnosis and prior conservative therapies in any prior authorization request; expect likely denial for ESWT for musculoskeletal or soft tissue indications without high-quality supporting evidence.

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Wounds (for Tennessee Only)' to the current title.

Supporting Information section updated to reflect the most current information in Clinical Evidence and References.

CS041TN.SIdentifier

Not medically necessaryCoverage stance

Tennessee MedicaidProgram applicability

Multiple RCTs

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.

2 RCTsdermaPACE RCTs

Coverage Criteria for ESWT

Not medically necessary (policy-wide)

Covered when ALL of the following are met

Main 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-wide determination of not medically necessary for covered population in Tennessee Medicaid/CoverKids.

Indication-specific evidence summaries

Evidence summaries by indication (used to inform medical necessity determinations)

Plantar Fasciitis (chronic/subacute): Several randomized controlled trials and meta-analyses report pain and function improvement at 12 weeks for many patients; some RCTs show ESWT superior to corticosteroid injection or sham (e.g., Lai 2018, Gollwitzer 2015) while other trials show no additive benefit over standard care. Limitations include short follow-up, small sample sizes, and heterogeneity across devices and protocols.

Approximately 70% of patients in some studies experienced meaningful improvement at 12 weeks.

Delayed or Nonunion Fractures: Systematic reviews and meta-analyses report heterogeneous results with low-to-moderate or low-certainty evidence; union rates in observational series vary and high-quality RCT evidence is lacking, so conclusive recommendation for ESWT is not supported.

Cochrane and Willems reviews call for higher-quality RCTs and standardized protocols.

Erectile Dysfunction: Recent systematic reviews and meta-analyses include many heterogeneous studies (case series, cohort studies, and RCTs) with inconsistent results; while some pooled analyses show statistical score improvements, clinical meaningfulness and optimal protocols are unclear and guideline groups consider ESWT investigational for ED.

Substantial heterogeneity across device types and treatment protocols in 2024–2025 reviews.

Lateral Epicondylitis (Tennis Elbow): Systematic reviews and RCTs show mixed findings: ESWT may be inferior to local corticosteroid injection at 1 month but superior at 3 and 6 months in some analyses; other RCTs found no difference versus sham. Heterogeneity in devices, dosing, and study quality limits definitive conclusions.

See Zhang 2024, Liu 2022, Yao 2020 and Capan 2016 for differing outcomes and limitations.

Evidence summaries by condition

Condition-specific evidence summaries that should inform coverage determination

Lateral epicondylitis (LE): Multiple randomized trials and meta-analyses report mixed results: some analyses find ESWT inferior to corticosteroid injection at 1 month but superior at 3 and 6 months for pain and function; network meta-analyses and systematic reviews cite heterogeneity in devices, protocols, and variable follow-up as key limitations.

See Zhang 2024, Liu 2022, Yao 2020, Capan 2016 for details.

Greater trochanteric pain syndrome (GTPS): Evidence is inconclusive: systematic reviews and some RCTs report potential benefit of focused ESWT (often combined with a home exercise program) with sustained success to 6 months in selected trials, but methodological heterogeneity and risk of bias persist; exercise and education remain core recommended therapies.

See Bremer 2025, Ramon 2020, ECRI 2020 for trial sizes and limitations.

Diabetic foot ulcers (DFU) / wounds: Systematic reviews of randomized trials (e.g., Wu et al. 2024) including 10 RCTs (754 participants) report higher rates of complete healing and improved transcutaneous oxygen pressure with ESWT versus controls, though studies are small and heterogeneous; a specific device (dermaPACE) has FDA De Novo clearance for DFUs based on limited trials.

This policy excludes extracorporeal shock wave lithotripsy (ESWL) for non-orthopedic indications. Specifically, it does not address ESWL used to treat gallstones, kidney stones, pancreatic stones, or salivary stones.

A detailed literature search identified no clinical studies evaluating extracorporeal shock wave therapy (ESWT) for the treatment of hammer toe; therefore there is no peer-reviewed evidence to support ESWT use for this indication.

Searches of the peer-reviewed literature found no clinical studies evaluating ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis. Because studies are lacking, these tendon indications are unsupported by the cited evidence base.

The dermaPACE system has been granted FDA De Novo clearance only for treating diabetic foot ulcers (DFUs). Evidence assessments (ECRI) reviewed two low-quality multicenter RCTs and additional smaller studies showing some favorable outcomes for DFU healing, but reviewers did not find published studies evaluating dermaPACE for other chronic wound types.

Overall, ESWT—whether low-energy, high-energy, focused, or radial—is considered unproven and not medically necessary for musculoskeletal and soft tissue indications due to insufficient and inconsistent evidence of efficacy. The policy therefore does not support routine coverage of ESWT for these indications.

For delayed or nonunion fractures, systematic reviews and meta-analyses report heterogeneous results with generally low-to-moderate certainty; conclusive evidence supporting ESWT is lacking. The Cochrane-style review noted low-certainty or uncertain effects on union rates and patient-reported outcomes and concluded higher-quality trials are needed.

Low-intensity ESWT for erectile dysfunction (ED) has an inconsistent evidence base. Recent systematic reviews report substantial heterogeneity across studies, and guideline guidance (American Urological Association) considers low-intensity ESWT for ED investigational.

Randomized controlled trial evidence for radial ESWT in lateral epicondylitis (tennis elbow) is mixed. In a double-blind RCT (Capan et al. 2016) radial ESWT did not demonstrate superiority over sham at one- and three-month follow-up, with both groups improving and no significant between-group differences.

Coding

Procedure codes listedCPT

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

Provider Actions and Administrative Requirements

Prior Authorization

Prior Authorization Expectation

Prior authorization is recommended for extracorporeal shock wave therapy (ESWT). Document prior conservative care and clinical rationale in the medical record to support medical necessity determinations.

Prior authorization recommended — document prior conservative care, including duration and response to therapies (e.g., activity modification, physical therapy, orthoses, NSAIDs, injections where applicable).
Verify member benefit and prior authorization requirements with UnitedHealthcare before scheduling ESWT.
When requesting authorization, include detailed clinical rationale and prior treatment documentation (see items below).

Prior Authorization

Prior Authorization Recommended for ESWT (GTPS, DFU)

For Tennessee members, prior authorization is recommended for ESWT when used to treat refractory Greater Trochanteric Pain Syndrome (GTPS) and for diabetic foot ulcers (DFU) where ESWT is being considered as adjunctive wound therapy. Include supporting trial of conservative care and indication-specific details.

Prior authorization recommended for ESWT use in GTPS (documented failure of core conservative therapy such as exercise/education and home exercise program).

Background

Extracorporeal shock wave therapy (ESWT) delivers acoustic shock waves—either focused or radial—propagated through tissues at energy levels much lower than lithotripters used for kidney stones. Proposed effects include mechanical disruption of calcifications, modulation of pain, and stimulation of biological responses (for example, increased tissue perfusion and angiogenesis) that may enhance healing; however, the precise therapeutic mechanisms are not fully established.

Definitions and Device Information

Extracorporeal Shock Wave Therapy (ESWT) — device/energy overview

What ESWT devices produceLow- or high-energy acoustic shock waves (pulses of acoustic energy) that are focused and propagated through tissues; orthopedic ESWT uses about ten times less energy than lithotripters used for kidney stones.

Energy deliveryShock waves can be focused (high‑energy) or defocused/soft‑focused (low‑energy); low‑energy defocused ESWT is used for wound healing.

Proposed tissue effectsMechanical forces (positive pressure, bubble implosion) may reduce pain signal transmission, disintegrate calcium deposits, break down scar tissue, induce transient inflammation, and stimulate tissue healing.

Typical clinical useApplied to musculoskeletal and soft tissue conditions (e.g., tendinopathies, plantar fasciitis) and investigational wound indications.

Focused vs. Radial ESWT

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS041TN.S

Change TypeTitle and supporting evidence/reference updates

Effective DateNov 1, 2025

Next Review Date

SourceLink

On This Page

Evidence suggests promise but remains limited by study size and heterogeneity.

Other tendon indications (tenosynovitis of foot/ankle, tibialis tendonitis): No clinical studies were identified evaluating ESWT for tenosynovitis of the foot/ankle or tibialis tendonitis in the literature search; therefore evidence is lacking for these indications.

Absent trial data for these specific tendon conditions.

Prior authorization recommended for ESWT use in diabetic foot ulcers (DFU) — document prior wound care, standard of care measures, wound characteristics, and HbA1c.

Include device settings, treatment frequency, number of sessions planned, and treating provider specialty in the authorization request.

Prior Authorization

Verify Benefit and Prior Authorization Requirements

Verify member benefit coverage and any plan-specific prior authorization, step therapy, or quantity limit rules before providing ESWT. Benefit terms, state mandates, and contractual provisions may affect coverage.

Check the member’s benefit plan for medical necessity language, exclusions, and any state-specific mandates that override this policy.
Confirm whether ESWT codes (e.g., 0101T, 0102T, 0512T, 0513T, 0864T, 28890) require prior authorization under the member’s plan.
If benefits are unclear, obtain an eligibility and benefits determination and a prior authorization prior to scheduling treatment.

Documentation Required

Conservative Therapy and Clinical Documentation Requirements

Documentation must include conservative therapy details, clinical rationale, and indication-specific supporting information. Insufficient documentation may result in denial.

Conservative therapy documentation: dates, duration, specific therapies (e.g., supervised physical therapy — frequency and duration, home exercise program, orthotics, activity modification, NSAIDs), and objective response.
Clinical rationale and prior treatment documentation: history and physical exam findings, imaging or diagnostic tests (if performed), baseline pain and functional measures, prior procedures or injections (dates and outcomes).
Documentation of benefit applicability: the specific indication being treated, relationship to diagnosis codes, and why ESWT is being considered over or in addition to established therapies.

Step Therapy

Step Therapy and Conservative Care Expectations

Step therapy considerations: where step therapy or a requirement for prior conservative care applies, document trial and inadequate response to conservative measures before requesting ESWT. For GTPS, a trial of exercise and education is recommended prior to ESWT.

Step therapy: require prior conservative care — document a trial of conservative therapies and lack of adequate improvement.
Step therapy recommendation for GTPS: document trial (and failure) of core approaches such as exercise and education, with or without adjunctive short-term corticosteroid injection, before authorization for ESWT is requested.
Step therapy (no explicit requirements): for some indications the policy does not list explicit step thresholds; nonetheless, providers should document reasonable trials of conservative care consistent with standard clinical practice.

Denial Risk

Evidence Limitations and Denial Risk

Evidence gaps and indication limits: ESWT is not supported by sufficient evidence for several indications; include this in decision-making and documentation.

Delayed/nonunion fractures — evidence insufficient: high-quality RCTs are lacking; document alternative treatments attempted and rationale if ESWT is considered.
Lack of evidence for specific tendon indications: for conditions such as tibialis tendonitis and tenosynovitis of the foot/ankle there is insufficient published clinical evidence — include this limitation when requesting coverage.
Denial risk: ESWT for musculoskeletal and soft-tissue indications may be considered not medically necessary when documentation does not demonstrate adequate conservative care trials or when the indication lacks supportive evidence.

Billing Rule

Coding and Documentation Note

Coding and documentation note: include relevant procedure and diagnosis codes and ensure claims and authorization requests match the documented clinical indication and services provided.

Include applicable CPT codes (e.g., 0101T, 0102T, 0512T, 0513T, 0864T, 28890) and relevant ICD-10 diagnosis codes on authorization requests and claims.
Ensure clinical notes reference the same indication, laterality, and treatment parameters as the authorization to avoid claim denials or audits.
Provide device parameters (focused vs radial, energy flux density, number of shocks, number of sessions) and treating provider credentials in the documentation.

Focused shock wave (FSW)

Shock waves concentrated at a target depth (used in many RCTs for plantar fasciitis); some analyses suggest FSW may have higher success versus sham in chronic plantar fasciitis.

Radial shock wave (RSW)Deliver energy radially from the applicator surface with a more superficial dispersion; used in trials but results are heterogeneous across indications.

Clinical distinctionFSW and RSW differ in energy distribution and penetration; trials and meta-analyses report variable efficacy between modalities for conditions like plantar fasciitis.

Mechanism of action (wounds)

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

Cellular/biologic effectsForces from shock waves (pressure, cavitation) may stimulate angiogenesis and increase perfusion in wound tissue, though mechanisms are not fully elucidated.

Therapeutic implicationsThese biologic responses are the rationale for using low‑energy/defocused ESWT in wound healing, despite incomplete mechanistic understanding.

FDA device classification

FDA classificationESWT products are classified by the FDA as Class III devices under the premarket approval (PMA) program, product code NBN (generator, shock wave, for pain relief).

Regulatory noteThis information is provided for informational purposes only; FDA classification alone is not a basis for coverage determinations.

Device registryExtensive list of ESWT devices available via the FDA PMA searchable database (access device name/product information online).

dermaPACE

dermaPACE clearancedermaPACE has been granted FDA De Novo clearance specifically for treatment of diabetic foot ulcers (DFUs).

Evidence baseECRI reviewed dermaPACE and based conclusions on two low‑quality double‑blinded RCTs (n=206, n=130) and an additional open‑label RCT (n=77; 84 ulcers).

Published findingsECRI concluded evidence was somewhat favorable versus standard of care, showing improved complete DFU healing rates at 24 weeks and decreased time to wound closure in pooled data, but studies were small and heterogenous.

LimitationsNo published studies were identified evaluating dermaPACE for chronic wound types other than diabetic foot ulcers.