CurrentCignaPolicy N/A

Bone Growth Stimulators: Electrical (Invasive), Ultrasound

Coverage policy for electrical (invasive) and ultrasound bone growth stimulators for fracture healing and nonunion, describing indications, limitations, and coding guidance for Cigna-administered health benefit plans and affected providers.

Policy Summary

PayerCigna

PolicyBone Growth Stimulators: Electrical (Invasive), Ultrasound

Policy CodePolicy N/A

Change TypeContent removed (spine) and wording clarified

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization per the member's benefit plan and document required imaging and clinical details (e.g., two radiographs ≥90 days apart, fracture gap ≤1 cm, and that the patient is skeletally mature).

SourceLink

POLICY UPDATE CHANGES

Removed all spine related content and redirected spinal growth stimulators to Cigna/EviCore cobranded guidelines.

Replaced the word 'smoking' with 'nicotine dependence' as one of the co-morbidities that delay wound healing.

E0760Ultrasound code referenced

≥2 x‑raysImaging requirement

≤1 cmMax fracture gap

Skeletally maturePatient requirement

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Invasive stim CPT listed

Coverage Criteria for Bone Growth Stimulators

Not Medically Necessary — Ultrasound and Electrical

ANY of the following

Use of an ultrasound bone growth stimulator (HCPCS E0760) for ANY indication other than those listed as medically necessary, including but not limited to: as part of acute treatment (preoperative or immediately postoperative) of any fracture requiring open reduction and internal fixation (ORIF); fresh (acute) fractures (except the specific acute fracture indications listed as medically necessary); stress fractures (except for stress fracture nonunion meeting the nonunion criteria).
Use of a non‑spinal invasive electrical bone growth stimulator for ANY other indication, including but not limited to: treatment of fresh fractures; use to enhance healing of fractures that are considered to be at high risk for delayed union or nonunion (e.g., nicotine dependence, diabetes, renal disease); stress fractures (except for stress fracture nonunion meeting the nonunion criteria).
Use of an electrical bone growth stimulator (non‑spinal, invasive) for any of the following is considered not medically necessary: toe fracture; sesamoid fracture; avulsion fracture; osteochondral lesion; displaced fractures with malalignment; synovial pseudoarthrosis; when the bone gap is > 1 cm or > one‑half the diameter of the bone; stress fracture (other than stress fracture nonunion meeting the nonunion criteria).

Coding and Code-Based Limits

Covered HCPCS Codes (ultrasound)HCPCSCovered

E0760

Ultrasound bone growth stimulator

Ultrasound HCPCS CodesHCPCSCovered

E0760

Osteogenesis stimulator, low intensity ultrasound, noninvasive

Electrical Stimulation CPT Codes (non-spinal, invasive)CPTCovered

20975

Electrical stimulation to aid bone healing; invasive (operative)

inv-13: Maximum fracture gap for stimulator coverage

Maximum fracture gap for stimulator coverageFracture gap ≤ 1 cm

Applies to ultrasound and invasive electrical stimulatorsPolicy requires gap ≤ 1 cm for nonunion treatment across applicable devices

Exclusion when gap exceeds criterionDevices are not indicated when bone gap > 1 cm or > one-half the diameter of the bone

inv-14: Imaging interval for nonunion documentation

Required imaging interval for nonunion documentationAt least two appropriate imaging studies separated by a minimum of 90 days

Imaging modalities referenced

Provider Actions, Authorization & Documentation

Prior Authorization

Benefit-plan dependent prior authorization

Coverage depends on the member's specific benefit plan. Refer to the customer's benefit plan document (Evidence of Coverage/Certificate of Coverage/Group Service Agreement) to determine whether ultrasound or electrical bone growth stimulators are a covered benefit for the member.

Benefits are plan-dependent; where a customer's plan document controls, it supersedes this policy.

Billing Rule

Coding compliance required

Claims submitted for services billed with codes that are not covered under the applicable Coverage Policy will be denied as not covered. Use the most appropriate and effective codes as of the date of service.

Deleted or non‑effective codes at the time of service may render the service ineligible for reimbursement.

Background and Clinical Context

Bone healing depends on an adequate blood supply, mechanical stabilization and new tissue formation, and is influenced by patient comorbidities and fracture characteristics. Conditions that impair healing include nicotine dependence (previously referenced as smoking), diabetes, malnutrition, renal disease, and other systemic illnesses. The presence of these factors can increase risk of delayed union or nonunion and should be documented in the clinical record when considering stimulation therapies; however, stimulators are not indicated to correct mechanical problems such as malalignment or large bone defects.

Definitions

inv-24: Skeletally mature — definition

DefinitionSkeletally mature: all bone growth is complete; growth plates have closed and the epiphysis is fused with the shaft

Clinical implicationBone growth stimulators are indicated only for individuals who are skeletally mature

Physiologic descriptionCartilage cells of the growth plate cease proliferation, the growth plate is replaced by bone and disappears

inv-25: Nonunion (long bone) — definition requiring two radiographs separated by ≥ 90 days

DefinitionNonunion (long bone): existence of nonunion when a minimum of two sets of radiographs, obtained prior to treatment and separated by at least 90 days, show no evidence of fracture healing

Applies toLong bones including clavicle, humerus, radius, ulna, femur, tibia, fibula, metatarsals, metacarpals

Policy Summary

PayerCigna

PolicyBone Growth Stimulators: Electrical (Invasive), Ultrasound

Policy CodePolicy N/A

Change TypeContent removed (spine) and wording clarified

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Radiographs are primary; CT, MRI, bone scan may be used to confirm nonunion as needed

Timing relative to treatmentImaging sets must be obtained prior to starting stimulator treatment to document lack of clinically significant healing

Confirm code eligibility and effective dates before billing.

Denial Risk

Coding/claims eligibility risk

Use of deleted, retired, or otherwise non‑effective CPT/HCPCS codes at the time the service is rendered may create a claims eligibility risk and lead to denial or non‑payment.

Verify code status and effective date prior to claim submission.
Codes listed in this policy may not be exhaustive; consult AMA/CMS updates.

Documentation Required

Required clinical documentation

Clinical documentation must support the medical necessity and the specific indication for the device (e.g., fracture nonunion, stress‑fracture nonunion, adjunct to closed reduction). Documentation should include relevant imaging, treatment history, and procedure/coding details.

For fracture nonunion: at least two sets of appropriate imaging studies separated by a minimum of 90 days showing lack of clinically significant healing.
For stress‑fracture nonunion: documentation that ≥ 3 months have elapsed since initial identification and failure of a minimum of 90 days of conservative nonsurgical management (e.g., rest, bracing).
Include date of injury/initial treatment, fracture gap measurement (≤ 1 cm when required), absence of malignancy if applicable, and device/procedure codes (e.g., HCPCS E0760; CPT 20975 for invasive non‑spinal electrical stimulators).
When applicable, document that the patient is skeletally mature.

Step Therapy

Step therapy

No step therapy requirements are specified in this policy.

Providers do not need to meet any prior step‑therapy sequence prior to use of a bone growth stimulator per this policy.

Documentation requirementRadiographic nonhealing must be confirmed before initiating stimulator therapy for nonunion

inv-26: Invasive bone growth stimulator — definition (implanted device delivering electrical energy)

DefinitionInvasive bone growth stimulator: an implanted device that delivers electrical energy (direct current via implanted electrode) to a nonhealing fracture or fusion site to induce osteogenesis

Delivery methodDirect current delivered to the fracture site via an implanted cathode and implanted anode/power supply in soft tissue

Indications notedIndicated for nonunion of the tibia, femur, and humerus; several FDA‑approved devices exist (e.g., OsteoGen™, Zimmer DC stimulator)

inv-27: Low-intensity pulsed ultrasound (LIPUS) — definition and link to HCPCS E0760

DefinitionLow‑intensity pulsed ultrasound (LIPUS): a noninvasive osteogenesis stimulator delivering low‑intensity ultrasound for fracture healing

CodingRepresented by HCPCS code E0760 (Osteogenesis stimulator, low intensity ultrasound, noninvasive)

Use caseApplied as a noninvasive, typically home‑use therapy for specified acute fractures and nonunion per policy indications