CurrentKaiser PermanentePolicy N/A

Extracorporeal Shock Wave Therapy (ESWT)

Clinical review criteria for use of ESWT for chronic plantar fasciitis, lateral epicondylitis (tennis elbow), and non-union or delayed union fractures for Kaiser Foundation Health Plan of Washington members and providers.

Policy Summary

PayerKaiser Permanente

PolicyExtracorporeal Shock Wave Therapy (ESWT)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionReserve ESWT for patients who have failed conservative therapy and submit the last 6 months of clinical notes when requesting review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3indications listed

6–12 wksexpected time to observe beneficial effects

19articles for delayed/nonunion fractures

200+publications for plantar fasciitis

Coverage and Evidence Summary

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Indications listed in this document: chronic plantar fasciitis, lateral epicondylitis (tennis elbow), non-union or delayed union fractures.

From policy indication list

Chronic plantar fasciitis evidence summary: Evidence from randomized controlled trials is mixed; several well-conducted RCTs and MTAC reviews found inconsistent or no long-term benefit and Kaiser concluded ESWT does not meet Medical Technology Assessment Criteria for effectiveness for chronic plantar fasciitis.

Multiple MTAC reviews and RCTs summarized; long-term effectiveness lacking

Lateral epicondylitis evidence summary: ESWT has FDA‑cleared devices for chronic lateral epicondylitis in adults with prior unsuccessful conservative treatments, but RCTs and a Cochrane review produced mixed results and the MTAC review concluded the therapy does not meet effectiveness criteria overall.

FDA device approvals listed; MTAC negative conclusion

Non-union/delayed union fractures: ESWT has been investigated for delayed/non-union fractures but evidence is limited to case series and animal data; ESWT is not FDA‑approved for fracture healing and effectiveness cannot be determined from available studies.

Background and limited evidence

Lateral Epicondylitis (Tennis Elbow)

Coverage stance based on evidence appraisal

Evidence summary: Randomized controlled trials of ESWT for lateral epicondylitis produced mixed results: some RCTs found no significant benefit versus sham while others found short-term pain benefit; a Cochrane review concluded little or no benefit overall and MTAC concluded the treatment does not meet effectiveness criteria.

Differences in trial methods (device, anesthesia use, concurrent treatments) may explain conflicting results.

Delayed or Nonunion Fractures

Coverage stance based on evidence appraisal

Evidence summary: Evidence is insufficient: only case series (no controlled studies) were identified; therefore effectiveness cannot be determined and ESWT is not an FDA-approved indication for nonunion/delayed union fractures.

Authors call for randomized controlled trials.

Extracorporeal shock wave therapy (ESWT) has been investigated for promoting bone healing in delayed union and non‑union fractures, but ESWT has not been approved by the FDA for treating non‑union or delayed union fractures. The literature consists primarily of animal studies and early clinical case series rather than controlled trials, and the policy notes that treatment of delayed unions or non‑unions is not an FDA‑approved indication for ESWT.

The evidence base for ESWT in delayed union and non‑union fractures is limited to case series with no randomized or controlled studies; therefore effectiveness cannot be determined. Because this is not an FDA‑approved indication, the policy identifies the relevant CPT/HCPCS codes as Considered Not Medically Necessary. Providers should refer to the coding section for the specific codes listed and verify authorization requirements via the Pre‑authorization Code Check.

For chronic plantar fasciitis, randomized controlled trials and MTAC updates have produced mixed results: some RCTs show short‑term benefit while others do not, and long‑term effectiveness is not established. Kaiser concluded that ESWT does not meet the Medical Technology Assessment Criteria for effectiveness for chronic plantar fasciitis due to methodological limitations, inconsistent findings, and lack of long‑term follow‑up, and therefore evidence is insufficient to support routine use.

The body of evidence for ESWT in lateral epicondylitis (tennis elbow) and for delayed/nonunion fractures is inconsistent or inadequate. Multiple double‑blind sham‑controlled RCTs and systematic reviews for lateral epicondylitis produced mixed findings and a Cochrane review concluded little or no benefit overall; MTAC determined ESWT does not meet effectiveness criteria. For delayed/nonunion fractures, only case series were available and randomized trials are lacking. As a result, ESWT for lateral epicondylitis and for delayed or nonunion fractures is considered not medically necessary for the listed procedure codes.

CPT/HCPCS Codes and Status

Considered Not Medically NecessaryCPTNot Covered

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.

Considered Not Medically NecessaryHCPCSNot Covered

0101T

Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy.

Considered Not Medically NecessaryHCPCSNot Covered

0102T

Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle.

Considered Not Medically NecessaryHCPCSNot Covered

0512T	Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; initial wound.
0513T	Extracorporeal shock wave for integumentary wound healing, high energy, including topical application and dressing care; each additional wound (List separately in addition to code for primary procedure)

Number of shocks / energy — study-reported ranges

Total number of shocks reported in trialsStudy-reported ranges: 1,500 to 4,000 total shocks

Energy per impulse reportedReported energy range in studies: 0.02 to 0.36 mJ/mm2

Negative vs positive trial rangesNegative RCTs reported 2,000–4,000 shocks; positive RCTs reported 1,500–3,800 shocks

Provider Requirements, Prior Authorization, and Documentation

Note

Use Non‑Medicare criteria for Medicare members

For Medicare members: In the absence of an active NCD, LCD, or other CMS coverage guidance for Extracorporeal Shock Wave Therapy (ESWT), Kaiser Permanente will apply the Non‑Medicare clinical criteria in this policy for medical necessity determinations.

Note

Insufficient evidence for non‑Medicare members

Kaiser Permanente has concluded there is insufficient evidence that ESWT is as safe and provides better long‑term outcomes than standard therapies for the indications listed in this policy for Non‑Medicare members.

Documentation Required

Required documentation

Providers must submit the last 6 months of clinical notes from the requesting provider and/or specialist when requesting review for ESWT.

Last 6 months of clinical notes from requesting provider and/or specialist

Step Therapy

Conservative therapy prerequisite

Conservative therapy must be attempted and documented prior to ESWT. Examples of conservative measures include orthotics, physical therapy, night splints, heel cups, bracing or splinting, local steroid injections, and treatment with NSAIDs.

Documented failure of conservative therapy (examples: orthotics, physical/occupational therapy, night splints, heel cups, bracing/splinting, local steroid injections, NSAIDs)

Prior Authorization

Pre-authorization and NMN codes

The following CPT/HCPCS codes are considered NOT MEDICALLY NECESSARY for ESWT. To verify authorization requirements for a specific code by plan type, providers must use the Pre‑authorization Code Check prior to scheduling or billing.

CPT 28890 — Extracorporeal shock wave, high energy, involving the plantar fascia (requires anesthesia other than local) — Considered Not Medically Necessary
CPT 0101T — Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy — Considered Not Medically Necessary
CPT 0102T — Extracorporeal shock wave, high energy, involving lateral humeral epicondyle — Considered Not Medically Necessary
CPT 0512T — Extracorporeal shock wave for integumentary wound healing, high energy; initial wound — Considered Not Medically Necessary
CPT 0513T — Extracorporeal shock wave for integumentary wound healing, high energy; each additional wound — Considered Not Medically Necessary

Background and Rationale

Extracorporeal shock waves are high‑pressure pulses concentrated into small focal areas (approximately 2–8 mm) that are generated by different mechanisms. Devices produce shock waves by electrohydraulic, electromagnetic, or piezoelectric methods; shock waves are characterized by a rapid rise to a high positive pressure followed by an exponential decrease, and short (microsecond) duration. ESWT is a noninvasive modality that delivers focused shock waves and is sometimes localized with imaging (for example, ultrasound) when used for musculoskeletal conditions.

Key Terms and Definitions

Shock wave characteristics — focal area size, pressure, duration, generation methods

Focal area sizeShock waves concentrated into small focal areas of approximately 2–8 mm

Pressure and durationHigh positive pressure with rapid rise time and very short (microsecond) duration, followed by exponential decrease in pressure

Generation methodsGenerated by electrohydraulic, electromagnetic, or piezoelectric mechanisms; focused by reflectors and can be localized with imaging (e.g., ultrasound)

Non-union — definition and factors influencing delayed union/non-union

DefinitionA fracture generally considered a non-union if it has not healed by 6–9 months after the injury

Contributing factorsFactors influencing delayed union/non-union: fracture location and severity, extent of soft tissue damage, adequacy of stabilization/fixation

Lifestyle risk factorsLifestyle influences include smoking and high alcohol intake

Extracorporeal Shock Wave Therapy (ESWT) — concise definition of the therapy

Concise definitionExtracorporeal Shock Wave Therapy (ESWT) is a noninvasive treatment that delivers focused high‑pressure shock waves (2–8 mm focal areas) to target tissues using electrohydraulic, electromagnetic, or piezoelectric devices; imaging such as ultrasound may be used to localize treatment

Typical use casesUsed as a noninvasive alternative to surgery for chronic soft‑tissue conditions (e.g., plantar fasciitis, lateral epicondylitis) and investigated for fracture healing

Expected time to effectBeneficial effects are generally expected to be observed between 6–12 weeks after treatment

Nonunion fracture — considered not healed by 6–9 months

Clinical threshold for nonunion fractureA fracture is generally considered not healed (nonunion) if healing has not occurred by 6–9 months after injury

Prevalence of delayed healingHealing is delayed in approximately 10% of fractures

Regulatory status for fracture healingESWT has not been approved by the FDA for treating non‑union or delayed union fractures

Policy Summary

PayerKaiser Permanente

PolicyExtracorporeal Shock Wave Therapy (ESWT)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionReserve ESWT for patients who have failed conservative therapy and submit the last 6 months of clinical notes when requesting review.

SourceLink

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