CurrentBlue Cross Blue Shield - KansasPolicy N/A

Electrical Bone Growth Stimulation of the Appendicular Skeleton

Governs use and coverage of implantable, semi‑invasive, and noninvasive electrical bone growth stimulators for fractures and post‑surgical healing of the appendicular skeleton for Blue Cross and Blue Shield of Kansas members.

Policy Summary

PayerBlue Cross Blue Shield - Kansas

PolicyElectrical Bone Growth Stimulation of the Appendicular Skeleton

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes noted

Effective DateN/A

Next Review DateJul 8, 2025

Key ActionObtain prior authorization with documentation of fracture chronology and serial radiographs showing lack of progressive healing (typically ≥3 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthspolicy nonunion timeframe

9 monthsFDA nonunion labeling time

5–10%approx delayed-healing rate

2 RCTs (nonunion)largest RCTs (nonunion)

15 trialstrials in Aleem review

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Coverage Criteria for Electrical Bone Growth Stimulation

inv-01: Noninvasive electrical bone growth stimulation — Medically Necessary

Covered when ALL of the following are met

Noninvasive stimulator coverage criteria: 1) At least 3 months have passed since the date of fracture; AND 2) Serial radiographs have confirmed that no progressive signs of healing have occurred; AND 3) The individual can be adequately immobilized; AND 4) The individual is of an age likely to comply with non-weight bearing for fractures of the pelvis and lower extremities.time-based (>=3 months)

Applies to noninvasive electrical bone growth stimulation for fracture nonunions or congenital pseudoarthroses of the appendicular skeleton

inv-02: Experimental / Investigational Applications

Experimental/Investigational applications: Delayed union, fresh fracture, immediate post-surgical treatment after appendicular skeletal surgery, stress fractures, or for the treatment of arthrodesis or failed arthrodesis are considered experimental/investigational.

These applications are listed as not established by the policy.

inv-03: Implantable / Semi-invasive Stimulators

Implantable and semi-invasive stimulators: Implantable and semi-invasive electrical bone growth stimulators are considered experimental/investigational.

Implantable devices remain without FDA-cleared semi-invasive/implantable devices per review; implantable devices have increased procedural risks.

inv-04: Initial therapy: noninvasive electrical stimulation for nonunion/delayed union

Covered when evidence supports use for established nonunion or possibly for delayed union in selected cases and when clinical documentation matches study populations

Nonunion evidence group

Modality: Noninvasive electrical stimulation modality is pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields (devices studied include transcutaneous coils or surface electrodes)device-type
Document device modality as in trials.
Prior management: Conservative therapy or prior surgical management considered or attempted as appropriate per comparator contextconservative/surgical consideration
Comparators in studies included conservative therapy and surgery.

inv-05: Evidence summaries by indication

Summary of evidence-based findings by indication

Delayed union: Randomized sham-controlled trials of pulsed electromagnetic field for delayed union show mixed results: Sharrard (1990) showed improved radiographic healing at 12 weeks but no significant clinical outcome differences; Shi et al (2013) showed a statistically significant higher success rate at an average of 4.8 months but no difference in time to union and uncertainty whether that endpoint was prespecified. Additional studies are needed.

Fresh fractures: Five RCTs (N=366) and a meta-analysis found a non-significant ~17% lower risk of radiographic nonunion with electrical stimulators versus sham; no differences in functional outcomes or time to healing were observed in individual trials (Adie et al, Hannemann et al).

Stress fractures: A well-conducted RCT of capacitively coupled stimulation for acute tibial stress fractures found no difference in clinical healing rates between active and placebo; increased daily use was associated with shorter time to healing but overall rate differences were not significant.

inv-06: Evidence-based criteria and limitations

Evidence-based coverage considerations

Noninvasive stimulation for stress fractures: RCT evidence (Beck et al, N=44) showed no difference in healing rates between stimulation and placebo; therefore clinical benefit for stress fractures is not supported by this trial

Clinical healing not improved in RCT

Noninvasive stimulation after appendicular skeletal surgery: Two small RCTs reported radiographic improvements in some measures but did not assess relevant clinical outcomes, limiting conclusions about efficacy

Radiographic benefit without clinical outcome data

Implantable/semi-invasive stimulation for fractures/pseudoarthrosis/arthrodesis: Evidence limited to small case series with variable union rates and complications (e.g., infections, hardware issues); prospective controlled trials are needed

High complication rate reported in some series

inv-07: Supplemental coverage statements & investigational indications

Supplemental statements and investigational indications from this portion of the document

Support for noninvasive stimulation in nonunions: Clinical input supported use of noninvasive electrical bone growth stimulation for treatment of fracture nonunions or congenital pseudarthrosis of the appendicular skeleton.

From 2012 clinical input summary.

Investigational applications: Noninvasive electrical bone growth stimulation is considered investigational for treatment of fresh fractures, immediate postsurgical treatment after appendicular skeletal surgery, delayed union, arthrodesis, failed arthrodesis, and stress fractures.

Listed as experimental/investigational applications in policy history and revisions.

Device code medical necessity condition: Codes 20974/20975/E0747/E0749 are medically necessary ONLY if the procedure is performed according to the 'Policy' section of this document.

Coding caveat from coding section.

Per policy, use of noninvasive electrical bone growth stimulation is explicitly not indicated for several clinical situations. The policy lists the following as experimental/investigational and therefore excluded: delayed union, fresh fracture, immediate post‑surgical treatment after appendicular skeletal surgery, stress fractures, and treatment of arthrodesis or failed arthrodesis. These applications are not supported by the policy’s coverage criteria and are identified as not established for routine coverage.

Implantable and semi‑invasive stimulators are also considered experimental/investigational and are not part of the noninvasive coverage pathway; their use for appendicular skeleton indications is therefore excluded from approval under this policy.

Clinical trials that informed the policy commonly excluded patients with specific findings or comorbidities. Examples cited include fracture gaps greater than 0.5 cm after reduction, the presence of systemic disease or ongoing steroid therapy (excluded in some trials), and the presence of metal implants bridging the fracture gap. These trial exclusions identify populations that were not represented in the evidence base and therefore may be inappropriate for routine application of stimulation.

Because the evidence base compared stimulation to conservative care or surgery, trials also tended to exclude patients with marked bony atrophy or hypertrophy and those with long‑standing nonunion beyond study definitions; such clinical situations should be considered when assessing eligibility and prior to authorization.

Trial protocols frequently specified more detailed exclusion criteria. For example, the Sharrard (1990) and Shi et al (2013) trials excluded patients with a fracture gap >0.5 cm after reduction, those with significant systemic disease or receiving steroid therapy, and patients with marked bony atrophy or hypertrophy. Shi et al also excluded patients who met the trial definition of nonunion (>9 months since injury).

The policy’s operational definitions are relevant: nonunion in some trials was defined as failure to heal after more than 9 months, while delayed union definitions in trials included failure to heal after at least 16 weeks but not more than 9 months. These time‑ and radiographic‑based definitions guided trial eligibility and the populations for which evidence is available.

Although the document does not list additional formal exclusions for implantable devices, the evidence review reports substantial complication rates in case series of implantable stimulators. Complications included deep infections, hardware/cable breakage, painful or prominent stimulators requiring removal, and other device‑related issues.

Given the limited evidence base for implanted and semi‑invasive stimulators (small case series with variable union rates and a notable frequency of complications), these safety signals are a key reason the policy designates implantable and semi‑invasive devices as experimental/investigational.

The policy explicitly identifies a range of investigational applications. Noninvasive electrical bone growth stimulation is listed as experimental/investigational for delayed union, fresh fractures, immediate postsurgical treatment after appendicular skeletal surgery, stress fractures, arthrodesis, and failed arthrodesis. This listing is supported by clinical input (2012) that concurred noninvasive stimulation is investigational for many of these indications.

Implantable and semi‑invasive stimulators are likewise characterized as investigational for appendicular skeletal indications given the limited higher‑quality evidence and higher procedural risk profiles.

The policy position is clear: implantable and semi‑invasive electrical bone growth stimulators are considered experimental/investigational and not medically necessary for appendicular skeleton indications. This reflects the lack of prospective controlled trial evidence and the safety and complication concerns described in small case series.

Consequently, requests for implantable or semi‑invasive stimulators would not meet the policy’s medical necessity criteria and are subject to denial absent robust supporting evidence.

Regarding delayed union, the policy summarizes randomized trials and systematic reviews and concludes the evidence is inconclusive. Systematic reviews pooled small, heterogeneous trials and reported a non‑definitive effect on radiographic union; reviewers concluded the evidence was insufficient to guide practice.

The policy therefore does not support routine, unconditional use of noninvasive stimulation for delayed union without careful consideration of study‑like inclusion criteria and additional supportive documentation.

For fresh fractures, multiple RCTs and a meta‑analysis are summarized. Although a pooled estimate suggested a roughly 17% lower risk of radiographic nonunion with electrical stimulation versus sham, this difference was not statistically significant and individual trials did not demonstrate consistent improvements in functional outcomes or reductions in secondary surgical interventions.

As a result, routine use of electrical stimulation for fresh fractures is not clearly supported by the evidence and is considered investigational outside defined criteria.

For stress fractures, the policy cites a well‑conducted randomized trial (Beck et al. 2008, N=44) of capacitively coupled stimulation that found no difference in the rate of clinical healing between active and placebo treatment. Although greater daily device use correlated with shorter time to healing in secondary analyses, the trial did not demonstrate an overall clinical benefit.

Accordingly, noninvasive electrical stimulation for stress fractures lacks demonstrated clinical efficacy based on the available RCT and is considered investigational.

The policy reiterates that use of noninvasive electrical bone growth stimulation is investigational for several applications beyond established nonunion: fresh fractures, immediate postoperative treatment after appendicular skeletal surgery, delayed union (unless specific nonunion criteria are met), arthrodesis, failed arthrodesis, and stress fractures. Clinical input and policy revisions support classifying these indications as investigational given insufficient or inconsistent evidence.

Providers requesting stimulation for these indications should be aware that the policy does not consider them established indications for coverage.

Regulatory and Billing Codes

Regulatory / FDA product codemixed

LOF	FDA product code for electrical bone growth stimulators (device classification)

Codes referenced in this segmentmixed

No codes listed

Included procedure/device codesmixed

20974	Electrical stimulation to aid bone healing; noninvasive (nonoperative)
20975	Electrical stimulation to aid bone healing; invasive (operative)
E0747	Osteogenesis stimulator, electrical, noninvasive, other than spinal applications
E0749	Osteogenesis stimulator, electrical, surgically implanted

inv-21: Nonunion diagnostic timeframe — operational criterion

Operational timeframeAt least 3 months have passed since the date of fracture and serial radiographs confirm no progressive signs of healing

Radiographic requirementSerial radiographs demonstrating lack of progressive healing

Additional clinical requirementsIndividual can be adequately immobilized and, for pelvic/lower extremity fractures, is of an age likely to comply with non–weight bearing

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior authorization: clinical justification for stimulation

Prior authorization is recommended for noninvasive electrical bone growth stimulation for fracture nonunion or congenital pseudoarthroses. Requests should include clinical justification that the indication meets policy criteria (see Policy: nonunion definition and timing). Include the fracture date and serial radiographs demonstrating lack of progressive healing, and document baseline symptoms and planned follow-up (at least 6 months or until healing).

Indication must meet policy criteria for nonunion: ≥3 months since fracture and serial radiographs showing no progressive healing.
Document fracture chronology (date of injury and any interventions) and serial radiographs demonstrating lack of progressive healing.
Include baseline symptoms (eg, pain, inability to bear weight), risk factors for nonunion (eg, smoking, diabetes, steroid use, osteoporosis), and prior conservative or surgical treatments with dates and duration.
Planned follow-up imaging and clinical assessment at least every 6 months or until healing documented.

Background and Scope

Electrical stimulation—whether implantable, semi‑invasive, or noninvasive—has been evaluated across multiple fracture‑related contexts. The policy notes that devices have been investigated for fresh fractures, stress fractures, delayed union, nonunion, congenital pseudarthrosis, and arthrodesis.

Noninvasive stimulators (pulsed electromagnetic fields, capacitive coupling, combined magnetic fields) were the primary modalities studied in randomized trials; implantable and semi‑invasive approaches have limited evidence restricted to small case series with higher reported complication rates.

Definitions

inv-44: Nonunion — operational definition

Policy operational definitionLack of progressive healing on serial radiographs for at least 3 months since the index injury

Contextual note (FDA)FDA labeling defines nonunion as minimum 9 months since injury with no visibly progressive signs of healing for at least 3 months

Clinical alternative definitionsOther literature definitions range from 3–6 months or require 6 months plus 3 months of no progression

inv-45: Noninvasive stimulators — device characterization

Pulsed electromagnetic fields (PEMF)Delivered via treatment coils placed over the skin; typical wear time 6–8 hours/day for 3–6 months

Capacitive couplingSmall skin pads/electrodes placed on either side of the site; may be worn up to 24 hours/day until healing or up to 9 months

Policy Revision History

2018-05-23coding update

Removed references to ICD-9 coding in the Coding section.

2019-05-21documentation update

Updated Description, Rationale, and References sections.

2021-02-01documentation update

Updated Description, Rationale, and References sections.

Policy Summary

PayerBlue Cross Blue Shield - Kansas

PolicyElectrical Bone Growth Stimulation of the Appendicular Skeleton

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes noted

Effective DateN/A

Next Review DateJul 8, 2025

Key ActionObtain prior authorization with documentation of fracture chronology and serial radiographs showing lack of progressive healing (typically ≥3 months).

SourceLink

On This Page

Billing Rule

Code inclusion and medical necessity caveat

The codes listed in the policy are informational. Inclusion of a code does not imply that the service is covered. Devices and procedures are considered medically necessary only when all applicable policy criteria are met and documentation supports the indication.

Use ICD-10 diagnosis codes consistent with the medical criteria and the clinical intent of the treatment.
Listed procedure/device codes (eg, 20974, 20975, E0747, E0749) are medically necessary ONLY when the service meets the Policy section criteria.

Denial Risk

Implantable / semi-invasive devices not approved

Implantable and semi-invasive electrical bone growth stimulators are considered experimental/investigational and will not be approved. Requests for implantable or semi-invasive devices lack sufficient high-quality evidence and are subject to denial.

Examples: surgically implanted stimulators and devices that require implantation or semi-invasive access.
Evidence for implantable/semi-invasive devices is limited to small case series; prospective controlled trials are needed.

Denial Risk

Trial outcomes relevant to authorization

Randomized trials for many indications (fresh fractures, stress fractures, post-appendicular surgery) have not consistently demonstrated clear clinical benefit in important outcomes (eg, reduction in secondary surgery or improved functional status). Authorization decisions will consider this limited or negative trial evidence.

RCTs for fresh fractures: modest or non-significant radiographic benefit; no demonstrated functional improvement.
Stress fracture RCT: no difference in healing rates between stimulation and placebo.
Appendicular surgery RCTs: some radiographic benefit but clinical outcomes not well assessed.

Documentation Required

Limited/negative RCT evidence for clinical outcomes

High-quality randomized controlled trial evidence is limited or negative for many clinical outcomes of interest. Where trials are negative or show no clear patient-centered benefit, prior authorization requests should include stronger clinical justification and complete documentation to support medical necessity.

Provide rationale when requesting stimulation for indications where RCTs did not show functional benefit or reduction in secondary surgery.
For indications supported mainly by case series (eg, implantable devices), expect denials absent compelling evidence.

Note

Coverage contingent on policy criteria

Coverage is contingent on meeting all policy criteria. Inclusion of codes or mention of a device/procedure in this document does not guarantee coverage or reimbursement — member contract benefits and the Policy section determine eligibility.

Verify member benefits with BCBSKS Customer Service; contract language and mandates may supersede policy.
Approval is conditional on documentation that fulfills the Policy (eg, timing, imaging, immobilization, compliance expectations).

Documentation Required

Document radiographic evidence (serial radiographs and fracture chronology)

Document serial radiographs showing lack of progressive healing and record the date of fracture and any subsequent interventions. Radiographic and clinical criteria together determine nonunion or delayed union status.

Attach dated serial radiographs with provider interpretation demonstrating no progression of healing.
If using an alternate nonunion definition (eg, FDA labeling, 9 months with 3 months no progression), include rationale and supporting evidence in the record.

Step Therapy

Policy contemplates conservative therapy or surgery as comparators

Policy contemplates conservative therapy or surgery as comparators. Requests should document prior conservative management or provide a rationale if surgery is preferred or has already occurred.

Conservative therapies include immobilization, protected weight bearing, activity modification, and other nonoperative management.
If conservative therapy was not pursued, document contraindication or previous surgical management and why stimulation is being considered instead.

Step Therapy

Step therapy: consider prior conservative or surgical treatment

Step therapy expectation: document a trial of conservative therapy or standard postsurgical management for the relevant timeframe used in clinical studies, or document a contraindication to such therapies. Many studies used conservative care or surgery as comparators; authorization will consider whether comparators were attempted.

Document duration and details of conservative therapy (eg, immobilization, activity restriction) and dates.
If the request follows surgery, document standard postsurgical management and reason for adjunctive stimulation.
If conservative or surgical therapy was not appropriate, provide explicit clinical rationale and supporting documentation.

Combined magnetic/electric fieldsTime-varying magnetic field superimposed on static field; example regimen involves 30 minutes/day for up to 9 months

inv-46: Nonunion (FDA labeling) — FDA definition

FDA labeling (trial-based)A nonunion is established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for a minimum of 3 months

RationaleThe 9-month minimum in FDA labeling was used to ensure homogeneous study populations during device approval; it is not physiologic-based

Relation to policyPolicy requires a 3-month timeframe for lack of progression as the operational criterion, consistent with clinical literature

inv-47: Delayed union — generally failure to heal between 3 and 9 months or decelerating healing on serial radiographs

General definitionGenerally considered failure to heal between 3 and 9 months post-fracture, or decelerating healing on serial radiographs

Radiographic featureDecelerating progression of healing on serial x-rays (reduced callus formation or bridging)

Clinical featuresMay include persistent pain, inability to bear weight, and tenderness at the fracture site

inv-48: Delayed union (alternate) — failure to heal after at least 16 weeks but not more than 9 months following surgical reduction and fixation

Shi et al (trial) definitionFailure to heal after at least 16 weeks but not more than 9 months following surgical reduction and fixation

Trial exclusion for longer-duration nonunionPatients with failure to heal after more than 9 months were excluded from the trial

inv-49: Nonunion (trial definition) — failure to heal after more than 9 months (trial exclusion criterion)

Trial-based nonunion thresholdFailure to heal after more than 9 months (used as an exclusion criterion in Shi et al 2013)

ApplicationUsed to exclude established nonunions from delayed-union trials; distinguishes delayed union from chronic nonunion

inv-50: Clinical healing confirmation (tibial stress fracture trial)

Functional testAbility to hop 10 cm high for 30 seconds without pain as confirmation of clinical healing (Beck et al 2008)

Use caseApplied as the clinical healing endpoint in a tibial stress fracture RCT

inv-51: Noninvasive electrical bone growth stimulation — devices generating weak electrical currents by PEMF, capacitive coupling, or combined modalities

Noninvasive device modalitiesDevices generate weak electrical currents at the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields

External applicationDelivered via skin coils or surface electrodes placed over the fracture/nonunion site without surgical implantation

Wear-time variabilityWear time varies by modality (e.g., PEMF 6–8 hrs/day; capacitive coupling up to 24 hrs/day; combined fields ~30 mins/day)

inv-52: Implantable electrical bone growth stimulation — surgically implanted cathode/electrode and generator delivering direct current

Implantable system componentsSurgically implanted cathode/electrode and a subcutaneous or intramuscular generator to deliver direct current electrical stimulation

Therapy characteristicsProvides continuous stimulation but requires surgical implantation and carries procedural and lead-related risks

inv-53: Semi-invasive (semi-implantable) stimulation — percutaneous electrodes with external power supply

Percutaneous electrodesUse of percutaneous electrodes connected to an external power supply, avoiding the need for surgical generator removal

ClassificationConsidered semi-invasive or semi-implantable in the policy; treated as experimental/investigational

inv-54: Noninvasive device description — external osteogenesis stimulators delivering electrical or electromagnetic fields to skin overlying fracture/nonunion

General descriptionExternal osteogenesis stimulators deliver electrical or electromagnetic fields to the skin overlying a fracture or nonunion to promote healing

Modalities listedIncludes pulsed electromagnetic fields, capacitive coupling, and combined magnetic fields delivered noninvasively

Typical applicationDevices are applied externally (coils, pads, or electrodes) and worn per prescribed daily regimens until healing or for a set duration

2021-06-16documentation update

Updated Description, Rationale, and References sections.

2022-06-01documentation update

Updated Description, Rationale, and References sections.

2023-05-23coding and documentation update

Updated Description, Rationale, References, and Coding sections; removed ICD-10 diagnoses box.

2024-05-28documentation update

Updated Description, Rationale, and References sections.

2025-07-08documentation updateLatest

Updated Description, Rationale, and References sections (latest review date).