ModifiedCignaPolicy 0084

Bone growth stimulators (ultrasound and electrical)

Defines medical necessity and not-medically-necessary indications for ultrasound and electrical (invasive and noninvasive) bone growth stimulators for fracture healing and nonunion, for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyBone growth stimulators (ultrasound and electrical)

Policy CodePolicy 0084

Change TypeFocused content removal (spine) and terminology update

Effective Date

Next Review DateMay 15, 2025

Key ActionObtain prior authorization when coverage is available and document imaging, timing (≥3 months where required), and prior conservative management as specified.

SourceLink

POLICY UPDATE CHANGES

Removed all spine related content from this policy; spinal growth stimulators are addressed in separate Cigna/EviCore guidelines.

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

E0760Ultrasound stimulator HCPCS code called out

≥3 moMin elapsed time for many nonunion indications

≤1 cmMax acceptable fracture gap

20–30 min/dTypical home use duration

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medicare determinations cited

Coverage Criteria — Indications and Limitations

inv-01: Ultrasound Bone Growth Stimulator (HCPCS E0760) — Medically Necessary

An ultrasound bone growth stimulator is considered medically necessary for ANY of the following indications:

Adjunct to closed reduction and immobilization for acute fractures: Closed or grade I open tibial diaphyseal fractures; closed distal radius (Colles') fractures; closed fractures when there is suspected high risk for delayed fracture healing or nonunion due to poor blood supply related to anatomical location (e.g., scaphoid, 5th metatarsal) or when at least one comorbidity likely compromises healing (e.g., nicotine dependence, diabetes, renal disease)

Nonunion of fractures: Treatment is for nonunion of bones other than the skull (e.g., radius, ulna, humerus, clavicle, tibia, femur, fibula, carpal, metacarpal, tarsal, or metatarsal)fracture gap ≤ 1 cm; ≥ 3 months from date of injury or initial treatment; nonunion not related/secondary to malignancy; nonunion documented by at least two sets of appropriate imaging studies separated by a minimum of 90 days confirming lack of clinically significant fracture healing

Nonunion of a stress fracture: It is ≥ 3 months from initial identification of the stress fracture; failure of a minimum of 90 days of conventional, nonsurgical management (e.g., rest, bracing); radiographic imaging at least 90 days from initial identification demonstrates a persistent fracture line that has not healed

inv-02: Non-spinal Invasive Electrical Bone Growth Stimulator — Medically Necessary

A non-spinal electrical (invasive) bone growth stimulator is considered medically necessary for ANY of the following indications:

Fracture nonunion: Nonunion located in a long bone (clavicle, humerus, radius, ulna, femur, tibia, fibula, metacarpal or metatarsal) or the carpal and tarsal bones; fracture gap is ≤ 1 cm; fracture nonunion is documented by at least two sets of appropriate imaging studies separated by a minimum of 90 days confirming lack of clinically significant healing

Also when used in conjunction with surgical intervention for established fracture nonunion

Failed joint fusion: Failed fusion of a joint other than the spine when a minimum of three months has elapsed since the joint fusion was performed

Nonunion of a stress fracture: It is ≥ 3 months from initial identification of the stress fracture; failure of a minimum of 90 days of conventional, nonsurgical management (e.g., rest, bracing); radiograph imaging studies at least 90 days from initial identification demonstrate a fracture line that has not healed

inv-04: Invasive electrical stimulation (non-spinal): Covered when ALL of the following are met for invasive electrical stimulators:

Covered when ALL of the following are met for invasive electrical stimulators:

Indication and device: Fracture nonunion of long bones (e.g., tibia, femur, humerus) with clinical justification for invasive stimulation

FDA-approved invasive devices exist for fracture nonunion

Prior conservative treatment: Documentation of prior standard treatments (e.g., immobilization, fixation) or clinical rationale why invasive stimulation is preferred to avoid further surgery

Device may be used to preclude surgical intervention where appropriate

inv-05: Ultrasound and noninvasive electrical stimulation: Covered/considered when:

Covered/considered when:

Ultrasound stimulation for nonunion: Low-intensity pulsed ultrasound (HCPCS E0760) for treatment of nonunion when evidence and CMS decision memoranda and randomized trials/meta-analyses support efficacy for promoting healing

Stress fractures: Use in acute stress fractures has mixed evidence; initial treatment is generally conservative, and stimulators may be considered in cases of delayed healing or compromised vascular supply

Evidence for stress fractures is mixed (see referenced randomized trials and observational studies)

inv-03: Not Medically Necessary — Ultrasound and Electrical (selected indications): The following uses are considered not medically necessary:

The following uses are considered not medically necessary:

Ultrasound — examples: As part of the acute treatment (preoperative or immediately postoperative) of any fracture requiring open reduction and internal fixation (ORIF); fresh fractures other than the listed indications; stress fracture other than stress fracture nonunion

Non-spinal electrical (invasive) — examples: Treatment of fresh fractures; use to enhance healing of fractures considered at high risk for delayed union/nonunion (e.g., nicotine dependence, diabetes, renal disease); stress fracture other than stress fracture nonunion

Additional electrical limitations: Toe fracture, sesamoid fracture, avulsion fracture, osteochondral lesion, displaced fractures with malalignment, synovial pseudoarthrosis, bone gap > 1 cm or > one-half the diameter of the bone

Devices are not indicated for individuals who are not skeletally mature (i.e., growth plates not closed), for pregnant or nursing persons, or for fractures related to bone pathology or malignancy. Ultrasound stimulators’ manufacturers state safety and effectiveness have not been established for fractures outside specified sites (e.g., other than distal radius or tibial diaphysis), for fractures with >50% post-reduction displacement, open Grade II/III fractures, fractures requiring surgical intervention or external fixation, or fractures not sufficiently stable for closed reduction and cast immobilization. Electrical stimulators similarly are not indicated when bones are malaligned, a synovial pseudoarthrosis exists, or the bone gap exceeds 1 cm or is greater than one-half the diameter of the bone; patients who cannot comply with device use are also not candidates.

Use is not established for bone diseases and conditions that impair healing or alter bone biology, including osteomyelitis, spondylitis, Paget’s disease, metastatic cancer, advanced osteoporosis, and arthritis. Electrical stimulation has not been shown to be safe or effective for avascular or necrotic bone tissues. Patients with these underlying bone pathologies, those who are not skeletally mature, pregnant women, and individuals with demand pacemakers or implantable cardioverter-defibrillators are not appropriate candidates for bone growth stimulator therapy.

The following uses are considered not medically necessary: application of ultrasound or invasive electrical stimulators as part of acute (preoperative or immediate postoperative) management for fractures requiring ORIF, treatment of fresh fractures outside the listed covered fracture types, and treatment of most stress fractures (except stress fracture nonunion). Additional noncovered examples include toe, sesamoid, avulsion, and osteochondral fractures; displaced fractures with malalignment; synovial pseudoarthrosis; and fractures where the bone gap is > 1 cm or > one-half the bone diameter. Using electrical stimulation simply to attempt enhancement of fractures at high-risk for delayed union (e.g., owing to nicotine dependence, diabetes, renal disease) is also considered not medically necessary.

Semi-invasive direct current stimulation systems (cathode implanted in cortex with an external power supply and an anode on the skin) currently have no FDA‑approved devices. Because semi-invasive techniques lack FDA‑approved products and supportive regulatory labeling, their use is considered experimental or unproven and may be subject to denial or additional review.

Coding — Relevant Billing Codes and Key Measures

Ultrasound stimulator HCPCSHCPCSCovered

E0760

Ultrasound bone growth stimulator

Ultrasound HCPCS CodesHCPCSCovered

E0760

Osteogenesis stimulator, low intensity ultrasound, noninvasive

Electrical Bone Growth Stimulator CPT CodesCPTCovered

20975

Electrical stimulation to aid bone healing; invasive (operative)

inv-13: Minimum imaging separation for nonunion

RequirementTwo sets of appropriate imaging studies separated by a minimum of 90 days documenting lack of clinically significant fracture healing

Imaging modalitiesRadiographs are primary; CT, MRI, fluoroscopy or bone scintigraphy may be used as needed to confirm nonunion

Timing contextImaging sets must be obtained prior to starting device treatment

inv-14: Minimum elapsed time for nonunion indication

Minimum elapsed time≥ 3 months from date of injury or initial treatment

Stress fracture specific

Provider Actions — Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization required when coverage is available per the customer's benefit plan; verify benefit plan for applicability before submission.

Prior authorization required when coverage available per customer's benefit plan.

Billing Rule

Coding and Submission

Claims submitted for services that are not accompanied by covered code(s) under the applicable Coverage Policy will be denied as not covered. Use current, appropriate codes when submitting claims.

Claims for services without covered codes will be denied.
Confirm and use the most appropriate codes as of the date of submission.

Background and Evidence

Bone healing requires adequate blood supply, mechanical stabilization, and the capacity to form new tissue; interventions aim to support these processes. Patient comorbidities and behaviors that impair healing include nicotine dependence, diabetes, malnutrition, advanced age, and certain medications (for example, chronic corticosteroids or some NSAIDs). Radiographic nonunion is typically documented by at least two sets of appropriate imaging studies separated by a minimum of 90 days showing lack of progressive healing. For many nonunion indications the policy requires a minimum elapsed time of ≥ 3 months from injury or initial treatment and a fracture gap of ≤ 1 cm when applicable.

Definitions

inv-28: Skeletally mature

DefinitionA person whose growth plates have closed and no longer proliferate; all bone growth is complete

Clinical implicationDevices are indicated only for individuals who are skeletally mature

Radiographic correlateEpiphysis is closed or fused with the shaft when skeletal maturity achieved

inv-29: Nonunion

DefinitionA state in which bone healing has stopped prematurely and will not likely continue without medical intervention

Radiographic criteriaTypically defined by at least two sets of radiographs (or appropriate imaging) separated by ≥90 days showing no evidence of healing

Revision History and Policy Changes

2025-05-15terminology_updateLatest

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

2024-11-01content_removal

Removed all spine-related content; spinal growth stimulators are now addressed in separate Cigna/EviCore guidelines.

2024-05-15annual_review

Policy Summary

PayerCigna

PolicyBone growth stimulators (ultrasound and electrical)

Policy CodePolicy 0084

Change TypeFocused content removal (spine) and terminology update

Effective Date

Next Review DateMay 15, 2025

Key ActionObtain prior authorization when coverage is available and document imaging, timing (≥3 months where required), and prior conservative management as specified.

SourceLink

On This Page

For stress fracture nonunion: ≥ 3 months from initial identification plus failure of ≥ 90 days of conventional nonsurgical management

Joint fusion contextFailed joint fusion (non-spinal) requires a minimum of 3 months since fusion before invasive stimulation considered

inv-15: Maximum fracture gap for nonunion indications

Maximum acceptable gapFracture gap ≤ 1 cm for nonunion indications

Exclusion noteFracture gaps > 1 cm or bone gap > half bone diameter listed among limitations for electrical stimulators

Applies toLong bone nonunions and carpal/tarsal bones when device criteria are otherwise met

Denial Risk

Not Medically Necessary Indications

Ultrasound or electrical bone growth stimulators used for fresh fractures (except listed acute tibial diaphyseal and distal radius indications), for acute treatment associated with ORIF, or for stress fractures (except documented stress fracture nonunion) are considered not medically necessary and should not be billed as covered.

Not medically necessary: use in fresh fractures (other than listed acute indications).
Not medically necessary: as part of acute treatment (pre/postoperative) of fractures requiring ORIF.
Not medically necessary: treatment of stress fractures except for stress fracture nonunion meeting criteria.

Denial Risk

Contraindicated Patient Conditions

Do not use stimulators in patients with contraindicated bone pathology or patient conditions; these cases are not appropriate for device therapy.

Contraindicated/unsupported conditions: osteomyelitis, spondylitis, Paget's disease, metastatic cancer, advanced osteoporosis, arthritis.
Other exclusions: avascular necrosis, necrotic bone tissue.
Patient factors: patients lacking skeletal maturity, pregnant women, and patients with demand pacemakers or implantable defibrillators are not candidates.
Note: fixation devices made from magnetic materials may compromise electrical stimulators' effects.

Note

Semi‑invasive Device Status

Semi-invasive direct current devices currently have no FDA-approved models; claims for semi-invasive devices may be subject to review and potential denial.

Semi-invasive devices: no FDA-approved semi-invasive devices currently.
Invasive devices: several FDA-approved invasive devices exist (e.g., OsteoGen™, Zimmer direct current stimulator).
Claims for semi-invasive approaches may be reviewed/denied.

Documentation Required

Imaging and Timing Documentation

Documentation must demonstrate nonunion and the timing of imaging and conservative therapy prior to device use.

Fracture nonunion: document at least two sets of appropriate imaging studies separated by a minimum of 90 days showing no clinically significant healing.
Fracture gap criteria: include measurement when applicable (≤ 1 cm for covered nonunion indications).
Timing: for nonunion show it is ≥ 3 months from date of injury or initial treatment.
Stress fracture nonunion: document ≥ 3 months from initial identification and radiographs at least 90 days from initial identification demonstrating an unhealed fracture line.

Documentation Required

Required Clinical Documentation

Required clinical documentation must specify fracture nonunion site, prior treatments, and failure of conservative management when applicable; for invasive devices, document indication (e.g., nonunion of tibia, femur, humerus) and surgical context if used with operative intervention.

Specify nonunion site (long bones or carpal/tarsal bones as applicable).
Document prior treatments and whether surgical intervention is planned or previously attempted.
For invasive stimulators, document indication such as nonunion of tibia, femur, or humerus and whether device is used with surgical treatment.
Include imaging reports, dates of injury/identification, and dates/duration of prior therapies.

Step Therapy

Conservative Therapy Before Device Therapy

Conservative (nonsurgical) management is required before considering stimulator therapy for stress fractures and many nonunion indications.

Stress fractures: initial treatment is rest, orthotic bracing, or immobilization; stimulators considered only after failure of conservative care.
Requirement: failure of a minimum of 90 days of conventional nonsurgical management for stress fracture nonunion.
For many nonunion indications, document prior conservative management and failed nonsurgical care before device therapy is initiated.

Applies to long bones and short bones (carpal/tarsal) as specified in policy

inv-30: Invasive bone growth stimulators

DefinitionImplanted devices that deliver direct current via implanted electrodes to a nonhealing fracture or fusion site

PurposeInduce osteogenesis, stimulate bone growth and promote fracture healing

IndicationsIndicated for nonunion of the tibia, femur, and humerus

inv-31: Semi-invasive direct current stimulation

TechniqueCathode implanted in the cortex of one end of the nonunion site and attached to an external power supply; an anode on the skin completes the circuit

Regulatory statusThere are currently no FDA‑approved semi‑invasive devices

Distinguishing featureSemi‑invasive differs from invasive in that power supply is external rather than fully implanted

inv-32: Low-intensity ultrasound osteogenesis stimulator

DefinitionA noninvasive, low‑intensity pulsed ultrasound osteogenesis stimulator (HCPCS E0760) intended to stimulate bone healing

HCPCS codeE0760 — Osteogenesis stimulator, low intensity ultrasound, noninvasive

Typical useUsed as adjunctive treatment for certain acute fractures and for nonunion when criteria are met

Annual review completed with no clinical policy statement changes.