CurrentKaiser PermanentePolicy N/A

Ultrasound and Electric Osteogenesis Stimulators

Policy governs medical necessity and coverage criteria for low-intensity pulsed ultrasound (LIPUS) and electric bone stimulators for fracture healing and nonunion in members of the Kaiser Permanente Georgia region.

Policy Summary

PayerKaiser Permanente

PolicyUltrasound and Electric Osteogenesis Stimulators

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 27, 2023

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization and document serial radiographs, fracture gap (≤1 cm), and ability to immobilize before approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

20 mintypical LIPUS treatment duration

3 monthstime without visible healing

≤1 cmmaximum fracture gap

skull/vertebraanatomic exclusions

Coverage Criteria for LIPUS and Electrical Bone Stimulators

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Indications for coverage

Covered when ALL of the following are met (criteria differ by indication):

Fresh closed fractures (adjunct): LIPUS or electrical stimulator used as an adjunct to conventional management (closed reduction and cast immobilization) for skeletally mature individuals who are high risk for delayed fracture healing or nonunion.

Risk factors include patient comorbidities (diabetes, steroid therapy, history of alcoholism, osteoporosis, history of smoking) and fracture locations (scaphoid/navicular, Jones fracture of the fifth metatarsal, metatarsal fractures, or fractures with extensive soft tissue or vascular damage).

Delayed union: Treatment of delayed union of bones, including delayed union of previously surgically treated fractures.Delayed union determined by serial radiographs with lack of clinical and radiologic evidence of union.

Excludes skull and vertebra.

Nonunion: Treatment of established fracture nonunion, including nonunion of previously surgically treated fractures.All of the following: at least 3 months since the date of fracture; serial radiographs confirming no progressive signs of healing; fracture gap ≤ 1 cm; member can be adequately immobilized and is likely to comply with non–weight bearing.

Excludes skull and vertebra; selection criteria reflect FDA labeling for nonunion treatment.

Provider Actions and Authorization Requirements

Prior Authorization

Medical necessity prior authorization

Prior authorization is required when requesting LIPUS or electrical bone stimulators for delayed union or nonunion. Requests will be reviewed against the medical necessity criteria; approvals will be granted only when documentation requirements and selection criteria are met.

Applies to requests for treatment of delayed union and nonunion (excluding skull and vertebra).
Ensure prior authorization is obtained before device provision.

Note

Adjunct to conventional management

For fresh closed fractures in skeletally mature individuals, LIPUS (low-intensity pulsed ultrasound) may be considered an adjunct to conventional management (e.g., closed reduction and cast immobilization) for candidates at high risk for delayed healing or nonunion. Risk factors include certain fracture locations and patient comorbidities.

Patient comorbidities: diabetes; chronic steroid therapy; history of alcoholism; osteoporosis; history of smoking.
Fracture locations: scaphoid (navicular of the wrist); Jones fracture (fifth metatarsal diaphysis); metatarsal fractures; fractures with extensive soft tissue or vascular damage.

Documentation Required

Required documentation for approval

Providers must submit adequate documentation to support approval. Documentation should demonstrate delayed union or nonunion per policy criteria and confirm that the patient meets device selection requirements.

Serial radiographs showing lack of progressive healing.
For nonunion: at least 3 months since date of fracture.
Fracture gap measurement documented and ≤ 1 cm for nonunion.
Clinical notes confirming inability to achieve adequate healing with conventional measures and that the member can be adequately immobilized and is likely to comply with non–weight bearing when required.
Date of fracture and dates of relevant imaging studies; documentation of prior surgical treatment if applicable.

Denial Risk

Experimental/Investigational applications — denial risk

Requests for low-intensity ultrasound or electrical bone stimulation for indications considered experimental or investigational will be denied. There is insufficient clinical evidence to support these applications.

Experimental/investigational denials include: congenital pseudarthroses; fresh surgically-treated closed fractures; open fractures; stress fractures; arthrodesis; failed arthrodesis.
Applications for skull and vertebra fractures are excluded from approval.

Definitions

Delayed union — definition and time thresholds

DefinitionA decelerating healing process determined by serial radiographs with lack of clinical and radiologic evidence of union for no less than 3 months from the index injury or most recent intervention.

Typical time thresholdNo less than 3 months without clinical or radiologic evidence of union as shown on serial radiographs.

Exclusions relevant to delayed unionTreatment of skull and vertebrae are excluded from LIPUS/electrical stimulator indications.

Fresh (acute) fracture — timeframe

DefinitionA fracture most commonly defined as 'fresh' for 7 days after the fracture occurs.

Clinical implicationLIPUS used as an adjunct in fresh closed fractures only when indicated; fresh surgically-treated closed fractures are listed as experimental/investigational and will not be approved.

Related exclusionsFresh surgically-treated closed fractures are considered experimental/investigational and will not be approved for low-intensity ultrasound treatment.

Nonunion — definition and thresholds

Proposed definitionFailure of progression of fracture-healing for at least 3 consecutive months and at least 6 months following the fracture, with clinical symptoms of delayed/nonunion; FDA labeling suggests nonunion when no visibly progressive signs of healing are seen.

Radiographic requirementSerial radiographs must confirm no progressive signs of healing before diagnosing nonunion.

Treatment-related thresholdFor coverage consideration, fracture gap ≤1 cm and ability to immobilize and comply with weight-bearing restrictions are required (per coverage criteria).

Policy Revision History

2025-02-02last_reviewLatest

Policy last reviewed by Utilization Management Committee on 02/2025; review type noted as Reviewed/Revised.

2023-07-27effective_date

Policy effective date established as 7/27/2023 for Ultrasound and Electric Osteogenesis Stimulators.

2000-02FDA_label_update

FDA labeling expanded in February 2000 to include treatment of established nonunion (excluding skull and vertebra).

1994-10FDA_clearance

Initial FDA marketing clearance in October 1994 for treatment of certain fresh, closed distal radius and tibial fractures with LIPUS devices (e.g., Exogen).

OpenPayer

Ultrasound and Electric Osteogenesis Stimulators

Coverage Criteria for LIPUS and Electrical Bone Stimulators

Billing and Coding

Provider Actions and Authorization Requirements

Background

Definitions

Policy Revision History