UnitedHealthcare ESWT Policy Update Coverage

Coverage Criteria for ESWT

Not medically necessary — general

Covered only when meeting policy criteria — see stance below

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.

Policy-level conclusion applies to all musculoskeletal and soft tissue indications in this document.

Coverage summary by indication

Coverage stance varies by indication and is evidence-driven:

Chronic Plantar Fasciitis: ESWT has multiple randomized controlled trials and consensus support showing benefit for many patients with chronic plantar fasciitis; it is generally considered after failure of conservative care and pooled observations report clinically meaningful improvement in approximately 70% of patients at 12 weeks.

Supported by RCTs (Gollwitzer et al. 2015; Lai et al. 2018) and ACFAS consensus though heterogeneity in devices and protocols exists.

Delayed or Nonunion Fractures: Evidence is inconclusive: systematic reviews report heterogeneous results with varying union rates and low-to-moderate certainty; high-quality randomized trials are limited.

Cochrane review and Willems systematic review highlight low certainty and heterogeneity in protocols and outcomes.

Erectile Dysfunction: Insufficient high-quality consistent evidence exists to conclude ESWT is definitively effective for erectile dysfunction; meta-analyses and guideline assessments report mixed results and conflicting recommendations.

Guideline bodies and systematic reviews indicate evidence heterogeneity and limited certainty.

Lateral Epicondylitis (Tennis Elbow): Evidence is conflicting: some meta-analyses and RCTs show ESWT may provide superior long-term pain relief and function versus comparators, while other trials show no benefit versus sham or standard therapies; heterogeneity limits firm conclusions.

See systematic reviews and recent RCTs reporting short-term inferiority but potential long-term benefit in pooled analyses.

Other indications (e.g., Hammer Toe): No peer-reviewed clinical studies were identified for some indications (for example, hammer toe), so effectiveness is unestablished and evidence is lacking.

Absence of data means no evidence-based support for coverage.

Coverage by indication

Coverage conclusions and strength of evidence summarized by indication in the provided document text:

Lateral Epicondylitis (Tennis Elbow): Evidence is mixed: multiple randomized trials and meta-analyses report variable outcomes. Some analyses show ESWT improves long-term pain and grip strength versus certain comparators, while other RCTs show no benefit over sham or standard therapies. Methodological heterogeneity of devices, protocols, and follow-up limits generalizability and additional high-quality RCTs are recommended.

See meta-analyses and RCTs summarized in chunks 36 and 41 for conflicting results and limitations.

Greater Trochanteric Pain Syndrome (GTPS): Evidence is insufficient and heterogeneous: systematic reviews and RCTs report some benefits for focused ESWT in select studies, but overall conclusions are limited by methodological heterogeneity; exercise and education are recommended core approaches with ESWT considered a possible adjunct pending further trials.

See chunks 44 and 45 for systematic review findings and recommendations.

Tendonitis/Tenosynovitis (Foot/Ankle, Tibialis): No clinical studies were identified for tenosynovitis of the foot or ankle or tibialis tendonitis in the searched literature; effectiveness is unestablished.

Wound and Soft Tissue Evidence Summaries

Clinical evidence and device regulatory context for wound and soft tissue indications:

Diabetic foot ulcers (DFU): Systematic reviews and randomized trials report that ESWT (including dermaPACE) may improve DFU healing rates, reduce wound surface area, increase re-epithelialization, and decrease time to closure; dermaPACE has FDA De Novo clearance specifically for DFUs.

Supported by ECRI review (dermaPACE De Novo) and multiple meta-analyses (Wu et al., Huang et al.).

Acute and chronic soft tissue wounds: Meta-analyses demonstrate ESWT increased healing rates, improved wound area percentage, reduced time to healing for acute and chronic soft tissue wounds, and reduced infection risk compared with conventional wound therapy, though authors call for higher-quality RCTs to confirm findings.

Zhang et al. 2018 pooled ten RCTs showing improved healing metrics but noted need for better trials.

Chronic lower extremity wounds: Systematic reviews of chronic lower-extremity wounds found mild to moderate evidence supporting ESWT as an adjunct to standardized wound care, but firm conclusions are limited by study quality and heterogeneity; further high-quality research is required.

This policy does not address extracorporeal shock wave lithotripsy (ESWL) used for the treatment of gallstones, kidney stones, pancreatic stones, or salivary stones. ESWT modalities referenced in this policy (low-energy, high-energy, or radial wave) are distinct from ESWL and the policy conclusion that ESWT is unproven and not medically necessary for musculoskeletal or soft tissue indications does not apply to lithotripsy procedures.

A targeted search of the peer-reviewed literature did not identify any clinical studies evaluating ESWT for the treatment of hammer toe. Because no clinical evidence was found in the reviewed literature, the effectiveness of ESWT for hammer toe is unestablished and there is no evidence-based support for coverage.

Searches of the published literature did not identify clinical studies evaluating ESWT for tenosynovitis of the foot or ankle or for tibialis tendonitis. In the absence of peer-reviewed clinical data, the effectiveness of ESWT for these foot and ankle tendon conditions is unknown and cannot be supported for coverage.

The dermaPACE system has received FDA De Novo clearance specifically for the treatment of diabetic foot ulcers (DFUs). ECRI reviewed available randomized trials and concluded the evidence is somewhat favorable for dermaPACE versus standard care for DFU healing at 24 weeks, but the published RCTs were limited in quality and size. No published studies were identified evaluating dermaPACE for other chronic wound types; thus dermaPACE's regulatory clearance is limited to DFUs and evidence for broader wound indications is lacking.

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 in this policy due to insufficient evidence of efficacy. This general conclusion reflects the overall assessment of the available evidence across multiple soft tissue and musculoskeletal conditions.

For delayed or nonunion fractures, conclusive evidence that ESWT improves clinically important outcomes is lacking. Systematic reviews and meta-analyses report heterogeneous results and low- to very low-certainty evidence for fracture healing, functional outcomes, and pain; high-quality RCTs are limited and results do not consistently demonstrate benefit. As a result, ESWT for delayed or nonunion fractures is not supported by conclusive evidence.

Evidence for low-intensity ESWT for erectile dysfunction remains insufficient and heterogeneous. Multiple reviews and guideline assessments note conflicting results across studies, and major guideline bodies (for example, the American Urological Association) consider low-intensity ESWT for ED to be investigational pending higher-quality, consistent evidence.

Evidence for ESWT in lateral epicondylitis (tennis elbow) is mixed. Systematic reviews and meta-analyses report variable results—some pooled analyses indicate reduced pain and improved grip strength, while high-quality RCTs (including double-blind, placebo-controlled trials) have shown no significant difference versus sham at certain follow-up points. Heterogeneity in devices, protocols, and study quality limits firm conclusions about benefit.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Verify Prior Authorization Requirements

Verify prior authorization requirements with the member's plan or contract prior to scheduling ESWT. Authorization rules vary by employer group, state mandates, and benefit plan; some plans may require prior authorization or have specific criteria for coverage.

Check member-specific eligibility and benefits
Confirm any prior authorization number and valid date range
If applicable, review step therapy or conservative management prerequisites

Prior Authorization

Prior Authorization Likely Required

Prior authorization is likely required for ESWT in many UnitedHealthcare plans and may be required for both musculoskeletal and wound indications despite the policy's clinical coverage rationale. Failure to obtain required authorization may result in claim denial or member liability.

Affected codes may include: 0101T, 0102T, 0512T, 0513T, 0864T, 28890
Check plan-specific prior auth portals or contact provider services for confirmation

Procedure and Billing Codes

Procedure codes referencedCPT

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

Definitions and Key Terms

ESWT definition

TermExtracorporeal shock wave therapy (ESWT)

DescriptionDelivery of low- or high-energy acoustic shock waves (focused or radial) propagated through tissues to treat musculoskeletal or soft tissue conditions; orthopedic ESWT uses approximately one-tenth the energy of lithotripsy devices.

Typical effects proposedMechanical disruption, cavitation, transient inflammatory response, modulation of pain signaling, and stimulation of tissue healing (exact mechanism not established).

Low-energy defocused ESWT definition

TermLow-energy defocused ESWT

DescriptionA lower-energy, soft-focused acoustical wave pattern used to deliver shock waves in a defocused manner, sometimes employed specifically for wound healing applications.

Background and Evidence Overview

Extracorporeal shock wave therapy (ESWT) delivers acoustic shock waves—either focused or radial, at low or high energy—through tissues to treat musculoskeletal and soft tissue conditions. Orthopedic ESWT uses substantially lower energy than lithotripsy. The proposed therapeutic mechanisms include mechanical effects on cells that trigger biological responses, modulation of pain signaling, stimulation of angiogenesis, and enhancement of tissue perfusion, but the precise mechanism and optimal treatment parameters are not well established.

OpenPayer

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

Coverage Criteria for ESWT

Provider Actions, Prior Authorization, and Documentation

Procedure and Billing Codes

Definitions and Key Terms

Background and Evidence Overview

Policy Revision History