UnitedHealthcare ESWT Coverage Update

Coverage Determination and Clinical Indications

General coverage determination

Overall policy determination

Policy 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.

Applies to musculoskeletal and soft tissue indications; excludes Extracorporeal Shock Wave Lithotripsy (ESWL) for stone disease which is not addressed by this policy.

Chronic Plantar Fasciitis

Selected evidence and guideline statements for chronic plantar fasciitis (PF):

Plantar Fasciitis Evidence Summary: Multiple randomized controlled trials and meta-analyses report that ESWT can reduce pain and improve function in chronic plantar fasciitis compared with sham or some comparators; some trials show comparable outcomes to other interventions (e.g., dextrose prolotherapy) while at least one RCT reported ESWT superior to corticosteroid injection at 12 weeks.

ACFAS consensus (2017) states ESWT is safe and effective for plantar fasciitis and reports approximately 70% of chronic/subacute PF patients experience meaningful improvement at 12 weeks.

Delayed or Nonunion Fractures

Evidence for delayed or nonunion fractures:

Delayed/Nonunion Fractures Evidence Summary: Systematic reviews report limited and low-to-moderate certainty evidence for ESWT in delayed or nonunion fractures; reported union rates vary across uncontrolled series and cohort studies, and high-quality randomized trials are lacking, making effectiveness uncertain.

Willems et al. reported pooled union rates (delayed unions 86%, nonunions 73%) but noted heterogeneity in bones, energy settings, and treatment parameters; Cochrane and other reviews conclude evidence is inconclusive.

Lateral Epicondylitis (Tennis Elbow)

Evidence for lateral epicondylitis (LE):

Lateral Epicondylitis Evidence Summary: Systematic reviews and randomized trials show mixed and heterogeneous results: ESWT may be inferior to local corticosteroid injection in short‑term outcomes but superior at 3- and 6-month follow-up in some meta-analyses; other high-quality RCTs found no benefit versus sham radial ESWT at one to three months. Heterogeneity in devices, protocols, and follow-up limits certainty.

Adverse events reported are generally mild and similar between ESWT and comparators.

Erectile Dysfunction

Evidence and guideline positions for erectile dysfunction (ED):

Erectile Dysfunction Evidence Summary: Systematic reviews and meta-analyses report mixed results with heterogeneous trials; some meta-analyses show small improvements in IIEF-EF and EHS with low-intensity ESWT versus sham, but guideline bodies (e.g., AUA) consider ESWT investigational and quality of evidence is variable.

Additional high-quality RCTs with standardized protocols are needed to establish clinical effectiveness.

Diabetic Foot Ulcers (DFU)

Conditions where moderate evidence supports potential benefit (DFU):

DFU evidence summary: Randomized trials and meta-analyses report that ESWT is associated with higher complete healing rates and improved TcPO2 in diabetic foot ulcers compared with standard care or hyperbaric oxygen in pooled analyses, although study protocols, sizes, and quality vary.

Device-specific evidence exists for dermaPACE (de Novo FDA clearance) based on low-quality RCTs; further high-quality studies to define optimal dosing and applicability are recommended.

Lateral Epicondylitis (Tennis Elbow) — mixed evidence

Lateral epicondylitis (LE / tennis elbow) — mixed and heterogeneous evidence:

LE study outcomes: Network meta-analyses and systematic reviews synthesize direct and indirect comparisons showing ESWT can outperform placebo for medium-term pain and rank highly for grip-strength recovery, yet individual RCTs and some meta-analyses report no clinically important benefit over sham or alternative treatments; heterogeneity in shockwave type, dosing, and study quality complicates interpretation.

Includes network meta-analysis (Liu 2022) and multiple RCTs/reviews highlighting inconsistent findings.

Greater Trochanteric Pain Syndrome (GTPS) / Gluteal Tendinopathy

Greater trochanteric pain syndrome (GTPS) / gluteal tendinopathy:

GTPS evidence summary: Systematic reviews and RCTs report inconsistent evidence: exercise and education have moderate-strength support as core treatment, while focused ESWT shows mixed findings with some trials suggesting long-term benefit but heterogeneity and risk of bias limit firm conclusions.

Authors recommend ESWT be considered as a supplement to conservative therapy and call for larger, well-designed RCTs to confirm effectiveness.

No Evidence Identified — unsupported indications

Conditions lacking evidence:

No evidence conditions: No clinical studies were identified evaluating ESWT for tenosynovitis of the foot or ankle, tibialis tendonitis, or hammer toe; clinical usefulness for these indications is unproven.

These indications are at higher risk for coverage denial due to lack of published evidence.

Evidence summary and applicability for wounds and DFU

Clinical evidence summarized in this section supports potential benefit of ESWT for diabetic foot ulcers and some soft tissue wounds but notes heterogeneity and need for higher-quality trials.

Evidence for DFUs: Systematic reviews and RCTs (pooled analyses of up to 10 RCTs, n=754) report ESWT is associated with higher rates of complete ulcer healing, reductions in wound surface area, and improved transcutaneous oxygen measurements compared with control therapies.

DermaPACE-specific trials contributed to the evidence base and dermaPACE has de Novo FDA clearance for DFUs.

Evidence for acute and chronic soft tissue wounds: Meta-analyses of RCTs for acute and chronic soft tissue wounds report increased healing rates, greater wound area reduction, and shorter time to closure with ESWT compared with conventional wound therapy, but studies varied in protocol and quality.

Higher-quality, well-controlled RCTs are recommended to confirm these findings.

Limitations: Studies reviewed use heterogeneous devices, energy settings, session frequency and duration, and variable outcome assessment times; many trials are small or of limited quality, so applicability beyond DFUs is uncertain.

This policy specifically does not address Extracorporeal Shock Wave Lithotripsy (ESWL) used to treat stone disease (for example, gallstones, kidney stones, pancreatic stones, or salivary stones). ESWL and its indications are outside the scope of this document and are not considered when determining coverage for extracorporeal shock wave therapy (ESWT) for musculoskeletal or soft tissue indications.

A targeted literature search found no clinical studies evaluating ESWT for the treatment of hammer toe. Because there are no peer-reviewed trials to support safety or effectiveness for this indication, ESWT for hammer toe is unsupported by the available evidence.

Searches of the peer-reviewed literature did not identify any clinical studies evaluating ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis. In the absence of clinical trial evidence, the clinical usefulness of ESWT for these specific foot and ankle tendon indications is unproven.

The dermaPACE system has been studied and reviewed primarily for diabetic foot ulcers (DFUs). ECRI’s assessment and the cited randomized trials evaluated dermaPACE in DFU patients and no published studies were identified that assessed dermaPACE for other chronic wound types. dermaPACE has received de Novo FDA clearance only for the treatment of DFUs; evidence for other chronic wound indications is lacking.

Overall, extracorporeal shock wave therapy (ESWT) — whether low energy, high energy, or radial wave — is considered unproven and not medically necessary for musculoskeletal and soft tissue indications because the body of evidence is inconsistent, heterogeneous in device types and protocols, and limited by the number and quality of high-quality randomized trials. While some wound and DFU studies suggest benefit, for most musculoskeletal and soft tissue indications the evidence does not establish clear, reproducible clinical effectiveness.

Current systematic reviews and trials do not provide conclusive evidence that ESWT is effective for acute fractures. The Cochrane and related reviews report very low- to low-certainty evidence and conclude the effectiveness of ESWT (and other ultrasound/shock-wave modalities) for acute fracture outcomes is uncertain; therefore ESWT is not supported as a proven treatment for acute fractures.

A double-blind randomized placebo-controlled trial of radial ESWT for lateral epicondylitis found no significant benefit of active treatment over sham at one and three months. In that study both active and sham groups improved, and radial ESWT did not demonstrate superiority in pain, function, or grip strength during the short-term follow-up.

Systematic reviews and meta-analyses report heterogeneous results across trials, with substantial variation in devices, energy settings, treatment frequency, and study quality. Because many trials are small, use differing protocols, or have methodological limitations, the evidence must be interpreted cautiously and higher-quality, standardized RCTs are needed to establish consistent conclusions for most indications.

Applicable Procedure and Product Codes

Applicable Procedure Codes (reference)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

Codes — not specified in this sectionmixed

No procedure or billing codes are listed in this section of the document.

FDA/Product Codes referencedmixed

NBN	FDA product code: generator, shock-wave, for pain relief

Administrative/billing notemixed

affected codes

Prior authorization / billing codes to be checked per plan

Coding and documentation note (reference)mixed

0101T,0102T,0512T,0513T,0864T,28890

Procedure codes listed for reference; inclusion does not imply coverage and benefit coverage is determined by federal, state, or contractual requirements.

Prior Authorization, Documentation, and Operational Notes

Prior Authorization

Prior Authorization / Codes Referenced

Prior authorization requirements vary by benefit plan and may be required for ESWT services. Listing of procedure or diagnosis codes below is for reference only and does not imply coverage or guarantee payment — verify member benefits and obtain any required prior authorization before scheduling.

Applicable codes (examples): 0101T, 0102T, 0512T, 0513T, 0864T, 28890. Inclusion of a code does not imply coverage.

Prior Authorization

Prior Authorization Likely Required — Delayed/Nonunion Fractures

Prior authorization is likely required when ESWT is requested for delayed union or nonunion fractures given the current lack of high-quality, consistent evidence supporting efficacy. Review and obtain authorization per plan criteria before treatment.

Evidence insufficiency for delayed/nonunion fractures may lead to denial without adequate documentation of prior conservative/surgical management and rationale for ESWT.

Background and Evidence Context

Extracorporeal shock wave therapy (ESWT) devices produce focused or defocused acoustic shock waves that are transmitted through tissues at far lower energy than lithotripters used for kidney stones. ESWT can be delivered as low- or high-energy focused waves or as radial wave variants; low-energy, defocused ESWT is commonly used in attempts to promote wound healing. Proposed mechanisms include mechanical stimulation, cavitation effects, and induction of biological responses such as increased tissue perfusion and angiogenesis, although the precise mechanisms remain incompletely established.

Definitions and Device Classifications

Extracorporeal shock wave therapy (ESWT) definition

DefinitionExtracorporeal shock wave therapy (ESWT) produces low- or high-energy acoustic shock waves that are focused and propagated through tissues; for orthopedic indications the shock waves have approximately ten times less energy than lithotripters used for kidney stones, and low-energy defocused ESWT is used for wound healing.

Energy formsDelivered as low- or high-energy pulses arising from acoustic energy; low-energy defocused or soft focused acoustical wave patterns are used for wound healing.

Therapeutic deliveryShock waves can be focused and propagated through water within body tissues and directed at tissue boundaries where energy is emitted.

ESWT — focused or radial delivery definition

Delivery typesESWT may be delivered as focused shock waves (e.g., focused shock wave, FSW) or as radial shock waves (RSW), with trials and meta-analyses evaluating both focused and radial approaches for tendon and soft-tissue conditions.

OpenPayer

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

Coverage Determination and Clinical Indications

Applicable Procedure and Product Codes

Prior Authorization, Documentation, and Operational Notes

Background and Evidence Context

Definitions and Device Classifications