DraftColorado Rocky Mountain Health PlansPolicy CS041.U

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

Defines coverage stance and specific criteria for extracorporeal shock wave therapy (ESWT) across musculoskeletal and soft tissue indications, identifies evidence‑supported contexts (e.g., diabetic foot ulcers, chronic plantar fasciitis with prior conservative therapy) and states with separate policies.

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS041.U

Change TypeState‑specific applicability and content refresh

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionDocument prior conservative therapy, device and dosing (EFD), and planned follow-up when requesting prior authorization for ESWT.

SourceLink

POLICY UPDATE CHANGES

Added language to indicate this Medical Policy does not apply to the states of Nebraska and North Carolina; refer to the state-specific policy versions.

Title changed from 'Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Wounds' and previous policy version archived (CS041.T).

Updated Clinical Evidence and References sections to reflect the most current information.

All indicationsUnproven / not medically necessary

10+ codesProcedure codes listed

10+ RCTsDFU RCTs

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Plantarfasc improvement

De NovodermaPACE status

Coverage Criteria for ESWT

Prior Authorization

Prior Authorization Required

Prior authorization is required for extracorporeal shock wave therapy (ESWT). Submit clinical documentation supporting indication, prior conservative therapy, device and treatment parameters, and expected treatment course. Lack of required documentation or failure to meet policy criteria may result in denial.

Prior authorization required for ESWT prior to service.
Include documentation of prior conservative therapy and failure (see criteria groups).
Document device make/model, type of shockwave (focused, radial), energy flux density (EFD), number of shocks per session, number of sessions, and treatment intervals.
For wound and selected tendon indications, include wound measurements, photographs, and standard of care treatments tried; for tendinopathies include duration of symptoms and prior therapies.
Provider note: insufficient or conflicting evidence for many foot/ankle tendon indications and nonunion fractures may trigger denial or request for additional information.

Extracorporeal shock wave therapy (ESWT), whether low energy, high energy, focused, or radial wave, is unproven and not medically necessary for musculoskeletal/soft tissue indications when criteria are not met.

Chronic Plantar Fasciitis (Including Plantar Fibromatosis and Plantar Nerve Lesion)

Covered when ALL of the following are met:

ALL of the following

Clinical diagnosis of chronic plantar fasciitis (symptoms ≥ 6 months) or plantar fibromatosis/plantar nerve lesion causing functional impairment or pain despite conservative measures.
Documentation of failure of an adequate course of conservative therapy, which must include at minimum: rest/modification of activities, stretching/physical therapy, and at least one of: orthotics, NSAIDs, or corticosteroid injection, for a minimum combined period of 6–12 weeks (unless contraindicated).
Conservative therapy must be documented in the medical record prior to ESWT authorization.
Treatment parameters documented: device type (focused vs radial), energy flux density (EFD), number of shock waves per session, number of sessions, and interval between sessions.
Provider documents intended treatment course (e.g., up to 3 sessions weekly) and planned follow-up assessments (pain scores, function).
No contraindications to ESWT (e.g., local infection, malignancy at treatment site, pregnancy, coagulation disorders or anticoagulation not managed).

Delayed or Nonunion Fractures

Considered of uncertain benefit / limited coverage — authorization may be granted on case-by-case basis when documentation supports expected benefit and alternative therapies have failed:

ALL of the following

Clinical diagnosis of delayed union or nonunion fracture confirmed by imaging and treating physician assessment.
Documentation of prior appropriate fracture management and any surgical interventions tried or contraindications to surgery.
Provider supplies evidence of fracture chronicity and rationale for ESWT (including prior treatments, goals of therapy, and expected measurable outcomes).
Detailed treatment parameters: device, EFD, number of shocks, number of sessions, and timing relative to injury/surgery.

Refractory Greater Trochanteric Pain Syndrome (GTPS)

Covered when ALL of the following are met for refractory greater trochanteric pain syndrome (GTPS):

ALL of the following

Clinical diagnosis of GTPS (gluteal tendinopathy) with symptoms refractory to a core program of conservative therapy, including exercise and education, for a minimum of 12 weeks.
Documentation of prior conservative therapies tried (structured exercise program, activity modification, analgesics, and selective injections if applicable) and insufficient clinical improvement.
Provider documents treatment parameters: focused ESWT preferred in published studies; include EFD, shocks/session, number of sessions (commonly 1–3 weekly sessions), and device details.
Planned home exercise or adjunctive program documented; ESWT should be supplemental to exercise/education rather than sole therapy.

Lateral Epicondylitis (Tennis Elbow)

Lateral epicondylitis (tennis elbow) — conditional coverage when documentation meets the following:

paragraphs[]? omitted

Wounds (Diabetic Foot Ulcers)

Wounds — Diabetic Foot Ulcers (DFU): covered when ALL of the following are met:

paragraphs[]? omitted

No clinical studies were identified for tenosynovitis of the foot/ankle or tibialis tendonitis; authorization for these indications will generally be denied due to lack of evidence unless compelling peer-reviewed rationale and objective data are provided. Hammer toe has no evidence and is not supported.

Documentation Required

Device and Treatment Parameter Documentation

Device and treatment parameter documentation is required as part of prior authorization and claims submission. Lack of these details may result in denial or request for additional information.

Document device manufacturer and model, wave type (focused vs radial), and FDA clearance status if applicable.
Record energy flux density (EFD) in mJ/mm2, number of shock waves per session, number of sessions planned, and interval between sessions.
Provide objective outcome measures and follow-up plan (e.g., pain scales, function scores, wound measurements).

Coding and Device Classification

Procedure codes listed for referenceCPT

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.

Covered CPT CodesCPT

No codes listed

Coding — not specified in excerptmixed

No CPT/HCPCS codes listed

The provided excerpt does not list specific procedure or billing codes.

FDA device product codemixed

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

Follow-up duration used in trials

Common trial follow-up timepoints6 weeks, 12 weeks, 3 months and 6 months

Plantar fasciitis RCT assessmentsAsheghan et al. assessed outcomes at 6 and 12 weeks (VAS, FAAM, plantar fascia thickness)

GTPS trial follow-upRamon et al. assessed participants at baseline and 1, 2, 3, and 6 months after last session

Energy flux density

Example active vs control EFD0.20 mJ/mm2 (active) vs 0.01 mJ/mm2 (control) reported in Ramon et al. GTPS trial

EFD reported with device-specific dosing

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior authorization — include listed ESWT procedure codes

Procedure codes for ESWT are listed for reference and should be used on prior authorization requests when applicable; listing of a code does not imply the service is a covered benefit.

0101T, 0102T, 0512T, 0513T, 0864T, 28890 (listed in policy for reference)

Prior Authorization

Prior authorization — document conservative therapy failure and treatment parameters

Prior authorization submissions must document the diagnosis, duration of symptoms, and failure of conservative therapy, and specify the planned ESWT device type, energy/settings, and number of sessions.

Document prior conservative treatments (e.g., exercise program, orthotics, analgesics, injections) and lack of sufficient improvement
Provide device model/type (focused or radial), energy flux density (EFD) or settings, and planned number/timing of sessions

Background and Scope

Extracorporeal shock wave therapy (ESWT) delivers acoustic shock waves—either focused or radial—propagated through tissues at substantially lower energy than lithotripsy used for stones. Proposed mechanisms include mechanical disruption, cavitation effects, transient inflammation, and stimulation of tissue healing, but the precise therapeutic mechanism remains unproven. Devices are distinguished by energy settings and delivery (focused vs radial), which contributes to heterogeneity in study protocols and clinical outcomes.

Definitions

Extracorporeal Shock Wave Therapy (ESWT)

DefinitionExtracorporeal Shock Wave Therapy (ESWT) uses low- or high-energy acoustic shock waves, focused or defocused, propagated through tissues for orthopaedic or wound healing indications

MechanismProposed effects include mechanical disruption, cavitation, transient inflammation, and stimulation of tissue healing; mechanism not established

Clinical contextsUsed in musculoskeletal conditions (e.g., plantar fasciitis, GTPS) and wound healing (low energy defocused ESWT for wounds)

Focused shock wave (FSW) vs radial shock wave (RSW)

FSW vs RSW distinctionFocused shock wave (FSW) and radial shock wave (RSW) are different ESWT delivery systems with heterogeneous protocols across studies

Evidence signal

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy CS041.U

Change TypeState‑specific applicability and content refresh

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionDocument prior conservative therapy, device and dosing (EFD), and planned follow-up when requesting prior authorization for ESWT.

SourceLink

On This Page

Acknowledge evidence limitations: high heterogeneity in published studies; authorization may be denied if clinical documentation does not justify ESWT over standard surgical or conservative care.

Trials report EFD as a device-specific parameter that determines dose per session

Wound device dosing contextdermaPACE trials report dosing in RCTs used to evaluate DFU healing at 24 weeks

Prior authorization for DFU and selected tendon indications — include device and dosing

For diabetic foot ulcers (DFUs) and selected tendon indications (e.g., refractory GTPS) where RCT evidence or device-specific clearance exists, prior authorization should include indication, prior wound care or conservative therapy, device model, dosing (EFD), and treatment plan.

For DFU: document prior standard of care steps and reference device (e.g., dermaPACE) and trial follow-up timeline
For GTPS: document prior exercise/education program and the proposed ESWT dosing (EFD and session schedule)

Prior Authorization

Check plan-specific prior authorization processes

Verify and follow the payer’s plan-specific prior authorization processes and any third-party utilization tools; this policy is informational and does not replace plan or contractual requirements.

Confirm whether InterQual® or other tools are used by the payer
Follow state- or contract-specific prior authorization rules where they differ

Documentation Required

Provider actions — submit clinical history, objective measures, and treatment plan

When requesting ESWT, include clinical evidence of prior conservative care failure, treatment plan details (device, energy/settings, number of sessions), and objective baseline measures to support medical necessity.

Submit clinical notes documenting failed conservative care and symptom duration
Include baseline outcome measures (e.g., VAS, FAAM, AOFAS) and planned follow-up assessments

Step Therapy

Step therapy expectation — chronic plantar fasciitis

For chronic plantar fasciitis, step therapy expectations reflect that ESWT was generally studied after failure of conservative care; prior authorization should document trials of standard conservative measures before ESWT is considered.

Document trials of exercise programs, orthotics, analgesics, and prior injections when applicable
Note duration of conservative care attempts as reported in trials (e.g., >1–2 months)

Step Therapy

Conservative therapy required first — GTPS

For refractory GTPS/gluteal tendinopathy, exercise and education are the core initial treatments; ESWT should be considered only after adequate trial of these conservative measures and documentation of ongoing symptoms.

Document participation in an exercise and education program prior to ESWT
Provide rationale for ESWT versus corticosteroid injection or other options

Note

No specific step-therapy mandated in policy

This policy segment does not specify a formal step-therapy protocol; absence of a specified step-therapy requirement means providers must follow plan-specific rules and document prior conservative care where clinically expected.

Billing Rule

Coding on claims — include listed procedure codes

Include the listed procedure codes on claims for ESWT services as appropriate; listing in the policy is for reference only and does not guarantee coverage or reimbursement.

Use codes such as 0101T, 0102T, 0512T, 0513T, 0864T, 28890 when billing, per the policy’s Applicable Codes table

Documentation Required

Required clinical documentation — conservative care and baseline measures

Required clinical documentation for prior authorization or claim review should include failed conservative treatments, symptom duration, objective baseline outcome scores, and relevant trial data when available.

Document prior conservative therapies and duration
Provide baseline VAS, FAAM, AOFAS, or other validated measures used in trials

Documentation Required

Document device and treatment parameters (EFD, sessions)

Document device model/type and treatment parameters (e.g., energy flux density, number and timing of sessions) on authorization requests and in the medical record to align with clinical trial reporting.

Record EFD values when available (example reported EFDs: 0.20 mJ/mm2 vs 0.01 mJ/mm2)
Include number of sessions and session schedule (e.g., three weekly sessions)

Documentation Required

Confirm governing benefit terms and applicable state/contract rules

Confirm and follow governing federal, state, and contractual benefit terms when applying this policy; contractual terms override the policy where conflicts exist.

Verify whether state-specific policy versions or contractual provisions apply
Reference federal/state/contractual requirements if coverage conflicts arise

Denial Risk

Denial risk — musculoskeletal/soft tissue ESWT considered unproven

Claims for musculoskeletal or soft tissue ESWT indications may be denied because ESWT (low, high, or radial) is considered unproven and not medically necessary for these indications under this policy.

Denial Risk

Denial risk — evidence limitations may trigger denial

Evidence limitations such as small sample sizes, short follow-up, and heterogeneity in protocols increase the risk of claim denial for indications lacking sufficient high-quality evidence.

Be prepared to supply higher-quality supporting evidence for indications with small or short trials

Denial Risk

Denial risk — no evidence for foot/ankle tendon indications

No clinical studies were identified for ESWT in tenosynovitis of the foot or ankle or tibialis tendonitis; requests for these indications risk denial for insufficient supporting evidence.

Denial Risk

State-specific applicability — confirm correct state policy

Coverage decisions may differ by state; this policy does not apply to Nebraska and North Carolina — failing to use the correct state-specific policy may result in coverage exceptions or denials.

Consult the state-specific policy versions for NE and NC prior to submission

Meta-analyses suggest FSW may have higher success rates vs sham in chronic plantar fasciitis, but comparisons remain inconclusive

Trial examplesRamon et al. used focused ESWT for GTPS; plantar fasciitis RCTs evaluated both FSW and RSW modalities

Energy flux density (EFD)

What EFD isEnergy flux density (EFD) is a device-specific energy parameter reported in trials that influences dose delivered per ESWT session

Reported values exampleRamon et al. reported EFD values of 0.20 mJ/mm2 (test) and 0.01 mJ/mm2 (control)

Documentation importanceClinical documentation and prior authorization should include device and EFD/dose per trial reporting conventions

dermaPACE (device with De Novo clearance)

dermaPACE descriptiondermaPACE is a specific ESWT system granted FDA De Novo clearance for treatment of diabetic foot ulcers (DFUs)

Evidence baseECRI reviewed randomized trials and concluded evidence is somewhat favorable for improved complete DFU healing at 24-week follow-up

Regulatory scopedermaPACE De Novo clearance is for DFUs; no published studies were found evaluating dermaPACE for other chronic wound types

ESWT devices (regulatory classification)

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

Regulatory noteFDA clearance/approval status varies by device; FDA information is informational and not a basis for coverage determination

Device registry referenceFDA device listings searchable via the CDRH PMN/PMN database (access provided in policy)

dermaPACE (duplicate device definition entry)

Device identitydermaPACE: an ESWT system with FDA De Novo clearance specifically for diabetic foot ulcers

Evidence summaryECRI concluded dermaPACE appears to improve DFU healing rates at 24 weeks based on pooled low-quality RCT data

LimitationsNo published studies identified evaluating dermaPACE for chronic wound types other than DFUs