ModifiedUnitedHealthcarePolicy CS037.S

Electrical and Ultrasound Bone Growth Stimulators

Policy governing medical necessity and coverage criteria for invasive and non‑invasive electrical bone growth stimulators and low‑intensity ultrasound stimulators for spinal fusion and long-bone nonunions; applies to UnitedHealthcare commercial members except where state-specific policies apply.

Policy Summary

PayerUnitedHealthcare

PolicyElectrical and Ultrasound Bone Growth Stimulators

Policy CodePolicy CS037.S

Change TypeMaterial updates to documentation and state applicabilityreference updates

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionObtain and submit required medical records documentation to demonstrate that the member meets clinical criteria for coverage; prior authorization is required for listed procedure and HCPCS codes.

SourceLink

POLICY UPDATE CHANGES

Added language that medical records documentation may be required to assess whether the member meets clinical criteria for coverage and does not guarantee coverage.

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

Noted that policy application excludes certain states (Idaho and Kansas) in a later revision.

ProvenAdjunct to lumbar fusion

ProvenNonunion long bone

MultipleCodes listed

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Skeletally mature only

InsufficientEvidence gaps

AANS/CNS & NASSGuideline alignment

Coverage Criteria

Adjunct to lumbar spinal fusion

Electrical Bone Growth Stimulator for spinal fusion is proven and medically necessary as an adjunct when ALL of the following are met:

Spinal EBGS indication: Radiographic evidence of skeletal maturity

Increased risk for fusion failure (one or more required): Previously failed fusion at the same site (minimum of 6 months since last surgical procedure) OR spinal fusion performed or to be performed at more than one level during a single surgery OR comorbid conditions associated with compromised bone healing (e.g., diabetes, obesity, osteoporosis, current tobacco use) OR spondylolisthesis grade II or greater

Ultrasound for long-bone nonunion

Ultrasonic Bone Growth Stimulator for nonunion of long bone fractures is proven and medically necessary when ALL of the following are met:

Ultrasound nonunion criteria: Fracture gap less than or equal to 1 cm<= 1 cm

Ultrasound nonunion criteria: Radiographic evidence of a persistent fracture line without bridging callus present for 3 months or more>= 3 months

Ultrasound nonunion criteria: Fracture reduced and immobilized

Ultrasound nonunion criteria: Less than 6 months have passed since the date of the most recent surgical operation< 6 months

Ultrasound nonunion criteria: Fracture is not pathological or associated with malignancy

Ultrasound nonunion criteria: Radiographic evidence of skeletal maturity

Unproven / Not medically necessary indications

Not covered / unproven uses

Other indications: Use of invasive or noninvasive electrical bone growth stimulators for all other indications is considered unproven and not medically necessary due to insufficient evidence of efficacy and/or safety

Ultrasound other indications: Use of ultrasonic bone growth stimulators for all other indications is considered unproven and not medically necessary due to insufficient evidence of efficacy and/or safety

Spinal fusion augmentation (electrical stimulation)

Covered when ALL of the following are met for spinal fusion augmentation (per specialty guidance):

Spinal fusion - high risk: Patient undergoing spinal fusion AND considered high risk for nonunion based on factors such as fusion of three or more vertebrae, revision spinal fusion, ongoing smoking that cannot be stopped, or presence of significant comorbidities; device selection (e.g., CCS vs PEMFS) should consider surgical approach

Based on AANS/CNS and NASS recommendations

Fracture nonunion (ULTRASONIC LIPUS)

Covered/considered when ALL of the following are met for fracture nonunion (LIPUS/UBGS):

Fracture nonunion: Patient has a nonunion of a long bone fracture (commonly tibia, humerus, radius, ulna, femur) with fracture age typically >= 3 months (stricter definitions use >= 8 months); systematic reviews report pooled heal rates (~82–84%) but study heterogeneity exists; gap size > 1 cm is associated with treatment failurefracture age >= 3 months or >= 8 months for stricter definition; gap <= 1 cm preferred

Evidence supports use in nonunion but quality and heterogeneity vary; favorable results when used as alternative to surgery and when interval without surgery is < 6 months

This policy does not apply to states with state‑specific policies. Providers should refer to the state‑specific policy or guideline listed for those states (for example: Idaho and Kansas) when determining coverage and authorization requirements.

Electrical stimulation for spinal fusion is limited to use as an adjunct when the patient is at increased risk for fusion failure (for example, fusion of three or more vertebrae, revision fusion, ongoing tobacco use that cannot be stopped, or significant comorbidities). Electrical stimulation is not indicated for a primary spinal fusion without risk factors, for spinal fusion of two vertebral levels without risk factors, in the presence of malignancy, as an adjunct for primary bone healing of a spinal fracture, or as nonsurgical treatment of an established pseudoarthrosis.

Use of electrical or ultrasonic bone growth stimulators for indications other than those explicitly listed in this policy (adjunct to spinal fusion when criteria are met, and ultrasonic treatment of long‑bone nonunion when criteria are met) is considered unproven and not medically necessary due to insufficient evidence of efficacy and/or safety.

Additional noncoverage notes: the use of electrical stimulation for primary spinal fusion without risk factors is not supported by current guideline recommendations. Similarly, NICE recommends that low‑intensity pulsed ultrasound (LIPUS) should not be used for fresh fractures at low risk of non‑healing; LIPUS is supported only for selected long‑bone nonunions meeting specific criteria.

Coding

CPT codes for bone growth stimulationCPT

20974	Electrical stimulation to aid bone healing; noninvasive (nonoperative)
20975	Electrical stimulation to aid bone healing; invasive (operative)
20979	Low intensity ultrasound stimulation to aid bone healing, noninvasive (nonoperative)

HCPCS codes for bone growth stimulationHCPCS

E0747	Osteogenesis stimulator, electrical, noninvasive, other than spinal applications
E0748	Osteogenesis stimulator, electrical, noninvasive, spinal applications
E0749	Osteogenesis stimulator, electrical, surgically implanted
E0760	Osteogenesis stimulator, low intensity ultrasound, noninvasive

FDA product codes referencedmixed

LOE	Product Code - stimulator, invasive bone growth
LOF	Product Code - stimulator, bone growth, non-invasive
LPQ	Product Code - ultrasound bone growth stimulators

Fracture gap — key parameter (<= 1 cm)

Fracture gap thresholdFracture gap is less than or equal to 1 cm

ContextApplies to ultrasonic bone growth stimulator treatment of long-bone nonunion

ImplicationGap >1 cm is associated with treatment failure and is not eligible under this criterion

Persistent fracture line without bridging callus duration — key parameter (>= 3 months)

Minimum durationRadiographic evidence of a persistent fracture line without bridging callus present for 3 months or more

Applies toUltrasonic bone growth stimulator treatment of long-bone nonunion

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Coding

Prior authorization is required for services reported with the CPT and HCPCS codes listed in this policy. Utilize HCPCS code E0748 when reporting noninvasive bone growth stimulation for spinal applications; other relevant codes include 20974, 20975, 20979, E0747, E0749, and E0760. Prior authorization does not guarantee coverage; benefit plan, federal, state, or contractual requirements govern.

Prior authorization required for listed CPT/HCPCS codes
Use HCPCS E0748 for spinal non-invasive electrical stimulators

Note

Authorization and Benefit Verification

Benefit coverage is determined by federal, state, or contractual requirements. Before applying this policy, verify the member's applicable benefit plan and any state-specific policy that may supersede the standard policy. This policy is informational and does not replace contractual terms.

Check applicable federal, state, or contractual requirements before applying this policy

Background

Bone healing is a complex, multistage biological process influenced by fracture type, stability, blood supply, soft tissue injury, and patient factors such as smoking, diabetes, and malnutrition. Bone growth stimulators (electrical or ultrasonic) are applied as adjunctive therapies to promote healing in difficult fractures or to augment spinal fusion. Ultrasonic stimulators (LIPUS) deliver low‑intensity pulsed ultrasound externally, while electrical stimulators may be invasive (implantable) or noninvasive (external). Devices addressed by this policy are indicated only for skeletally mature individuals and their effectiveness varies by indication and the quality of available evidence.

Definitions

Electrical Bone Growth Stimulator — definition and types

DefinitionDevice that uses an electric field or current to stimulate the growth of bone tissue; may be implanted or worn externally

Invasive (implanted)Implantable current generator and electrodes surgically placed, typically functional for 6–9 months and often removed in a second procedure

Non-invasive (external)External power source delivering current via pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields

Ultrasonic Bone Growth Stimulator — definition (LIPUS) and basic application details

Definition (LIPUS)A non‑invasive device that emits low intensity, pulsed ultrasound to accelerate bone repair; applied externally with a treatment head centered over the fracture site

Typical application

Revision History

2025-06-01policy_updateLatest

Added language that the medical policy does not apply to the states of Idaho and Kansas and updated reference to the protocol 'Medical Records Documentation Used for Reviews'.

2024-12-01policy_update

Added language clarifying that medical records documentation may be required to assess whether the member meets clinical criteria for coverage and referenced the protocol 'Medical Records Documentation Used for Reviews'; updated Clinical Evidence and References and archived previous policy version CS037.R.

Policy Summary

PayerUnitedHealthcare

PolicyElectrical and Ultrasound Bone Growth Stimulators

Policy CodePolicy CS037.S

Change TypeMaterial updates to documentation and state applicabilityreference updates

Effective DateDec 1, 2024

Next Review DateN/A

SourceLink

On This Page

Clinical meaningIndicates lack of progression toward radiographic healing consistent with nonunion definition

Time since most recent surgical operation for ultrasound nonunion — key parameter (< 6 months)

Surgical interval requirementLess than 6 months have passed since the date of most recent surgical operation

Evidence noteAn interval without surgery of less than 6 months prior to LIPUS was associated with a more favorable result (Leighton et al.)

Applies toUltrasonic bone growth stimulator treatment of long-bone nonunion

Verify member benefit plan and state-specific policy versions

Denial Risk

Denial Risk for Unsupported Indications

Providers should be aware that requests for bone growth stimulators for indications outside of those specified in the Coverage Rationale (for example, uses other than as an adjunct to spinal fusion or for ultrasonic treatment of nonunion long bone fractures meeting criteria) carry a risk of denial.

Denial risk for devices requested for unsupported indications

Documentation Required

Required Clinical Documentation

Documentation should include radiographic evidence of skeletal maturity and clear clinical information demonstrating the specific criteria for the requested intervention (for example, evidence of increased risk for fusion failure when used as an adjunct to spinal fusion).

Radiographic evidence of skeletal maturity required
Clinical documentation demonstrating the specific indication and any risk factors (e.g., prior failed fusion, multilevel fusion, comorbidities, spondylolisthesis ≥ grade II)

Documentation Required

Medical Records Documentation

Medical records may be requested to determine whether a member meets the clinical criteria for coverage. Failure to provide requested records may result in denial or inability to confirm coverage.

Provision of medical records for review does not guarantee coverage
Failure to provide requested records may lead to denial or inability to confirm criteria

Step Therapy

Step Considerations for Spinal Fusion

For spinal fusion cases, consider guidance from specialty societies: electrical stimulation is indicated as an adjunct for individuals at high risk of pseudoarthrosis (for example, multilevel fusion, revision fusion, smokers who cannot stop, and relevant comorbidities). It is not indicated for primary spinal fusion without risk factors or for primary bone healing of spinal fractures.

Use electrical stimulation for spinal fusion adjunct only in high-risk cases per NASS guidance
Not indicated for primary fusion without risk factors or for primary spinal fracture healing

Billing Rule

Provider Action — Documentation and Submission

Providers must ensure all prior authorization submissions include supporting medical records and clearly reference the applicable CPT/HCPCS codes and the clinical criteria being met. Submission of records is subject to review and does not guarantee approval.

Include supporting medical records with prior authorization requests
Clearly list CPT/HCPCS codes and document how clinical criteria are satisfied

Main operating unit with external power supply connected to a treatment head module affixed over the fracture site

Evaluated useUsed and evaluated for treatment of nonunion and delayed union fractures; evidence supports use for long-bone nonunion when criteria met

Nonunion; Skeletal Maturity — definitions

Nonunion definitionDefined by motion at the fracture site, persistent fracture line without bridging callus, and incomplete progression toward radiographic healing with further healing not expected

Skeletal maturityIndicated by closed growth plates (epiphysis fused with shaft); devices are indicated only for skeletally mature individuals

Clinical implicationRadiographic evidence of skeletal maturity is required for coverage of bone growth stimulators

Electrical bone growth stimulator types — CCS and PEMFS descriptions

Capacitive coupling stimulation (CCS)A noninvasive electrical bone growth stimulation technology; device choice should consider the surgical approach (supported for posterior lumbar fusion in high-risk patients)

Pulsed electromagnetic field stimulation (PEMFS)A noninvasive electrical stimulation technology used to augment spinal fusion, with recommended use in high-risk patients following interbody fusion

Usage contextNoninvasive electrical stimulators are used as adjuncts to spinal fusion; selection influenced by surgical approach and procedure

Ultrasonic bone growth stimulator (UBGS / LIPUS) — technology description and evaluated uses

Technology (LIPUS)Low-intensity pulsed ultrasound (LIPUS) delivers low intensity, pulsed ultrasound via an external treatment head to promote accelerated fracture healing

Evaluated indicationsEvaluated for treatment of nonunion and delayed-union fractures; evidence supports use for long-bone nonunion when specific criteria are met

Evidence summarySystematic reviews report pooled heal rates ~82–84% for nonunions (fracture age >=3 months or >=8 months) but study heterogeneity exists; NICE states evidence does not show efficacy for some indications