Coverage Policy Manual
Policy #: 1997057
Category: Medicine
Initiated: September 1993
Last Review: January 2019
  Bone Growth Stimulation, Electrical, Appendicular Skeleton

Description:
In the appendicular skeleton, electrical stimulation (with either implantable electrodes or non-invasive surface stimulators) is used in the treatment of fracture nonunion. Noninvasive electrical bone growth stimulators generate a weak electrical current using a variety of technologies, i.e., pulsed electromagnetic fields, capacitative coupling, or combined magnetic fields. Semi-invasive (semi-implantable) stimulators use percutaneous electrodes and an external power supply obviating the need for a surgical procedure to remove the generator when treatment is finished.
 
The definition of a fracture nonunion has remained controversial. The original U.S. Food and Drug Administration (FDA) labeling defined nonunion as follows: "A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for minimum of 3 months." Others have contended that 9 months represents an arbitrary cut-off point that does not reflect the complicated variables that are present in fractures, i.e., degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock. Other proposed definitions of nonunion involve 3 to 6 months’ time from original healing, or simply when serial x-rays fail to show any further healing. The FDA has recently approved labeling changes that do not impose a time frame for the diagnosis of nonunion.
 
Delayed union refers to a decelerating bone healing process, as identified in serial x-rays. (In contrast, nonunion serial x-rays show no evidence of healing.) When lumped together, delayed union and nonunion are sometimes referred to as "ununited fractures."
 
In the appendicular skeleton, electrical stimulation has been used primarily to treat tibial fractures, and thus this technique has often been thought of as a treatment of the long bones. This concept has led to controversy regarding what constitutes long versus short bones. According to orthopedic anatomy, the skeleton consists of long bones, short bones, flat bones, and irregular bones. Long bones act as levers to facilitate motion, while short bones function to dissipate concussive forces. Short bones include those composing the carpus and tarsus. Flat bones, such as the scapula or pelvis, provide a broad surface area for attachment of muscles. Thus the metatarsal is considered a long bone, while the scaphoid bone of the wrist is considered a short bone. Both the metatarsals and scaphoid bones are at a relatively high risk of nonunion after a fracture.
 
Despite their anatomic classification, all bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Cortical bone is always located on the exterior of the bone, while the trabecular bone is found in the interior. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. However, at a cellular level, both bone types are composed of lamellar bone and cannot be distinguished microscopically.
 
The non-invasive OrthoPak® Bone Growth Stimulator (BioElectron) received FDA premarket approval in 1984 for treatment of fracture nonunion. Pulsed electromagnetic field systems with FDA premarket approval (all non-invasive devices) include Physio-Stim® from Orthofix Inc., first approved in 1986, and OrthoLogic® 1000, approved in 1997, both indicated for treatment of established nonunion secondary to trauma, excluding vertebrae and all flat bones, in which the width of the nonunion defect is less than one-half the width of the bone to be treated; and the EBI Bone Healing System® from Electrobiology, Inc., which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses.
 
No semi-invasive electrical bone growth stimulator devices were identified with FDA approval or clearance.
 
Electrical bone growth stimulators used as an adjunct to spinal fusion surgery are discussed in policy # 2009048.
 

Policy/
Coverage:
Effective, November 2009
Noninvasive electrical bone growth stimulation meets member benefit Primary Coverage Criteria for effectiveness and is covered for:
    • Treatment of fracture nonunions when all of the following are met:
      • At least three months have passed since the date of fracture
      • Serial radiography has confirmed that no progressive signs of healing have occurred
      • The fracture gap is less than one centimeter; and
      • The patient can be adequately immobilized and is of an age when likely to comply with non weight bearing for fractures of the pelvis and lower extremities
    • Congenital pseudoarthroses in the appendicular skeleton
    • Treatment of failed joint fusion secondary to failed arthrodesis of the ankle or knee.  
 
The following applications of electrical bone growth stimulation do not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes:
    • Avascular necrosis (AVN)
    • Osteoporosis
    • The treatment of fresh fractures or delayed union (defined as deceleration fracture healing process as identified by serial x-rays)
    • Wide fracture gaps, greater than one cm;
    • Fractures where there is significant motion at the fracture site; or.
    • Stress fractures (Effective January 2014).
 
For members with contracts without primary coverage criteria, the following applications of electrical bone growth stimulation are considered investigational. Investigational services are exclusions in the member benefit certificate of coverage.
    • Avascular necrosis (AVN)
    • Osteoporosis
    • The treatment of fresh fractures or delayed union (defined as deceleration fracture healing process as identified by serial x-rays)
    • Wide fracture gaps, greater than one cm;
    • Fractures where there is significant motion at the fracture site; or
    • Stress fractures (Effective January 2014)
 
Semi-invasive, invasive or implantable electrical bone growth stimulators for any condition do not meet Primary Coverage Criteria that there be scientific evidence of effectiveness in improving health outcomes.
  
For members with contracts without primary coverage criteria, semi-invasive, invasive or implantable electrical bone growth stimulators, for any condition, is considered investigational.  Investigational services are exclusions in the member certificate of coverage.
 
Effective, June 2000-October 2009
Noninvasive electrical bone growth stimulation meets primary coverage criteria for effectiveness and is covered for:
    • Treatment of fracture nonunions when all of the following are met:
      • At least three months have passed since the date of fracture
      • Serial radiography has confirmed that no progressive signs of healing have occurred
      • The fracture gap is less than one centimeter; and
      • The patient can be adequately immobilized and is of an age when likely to comply with non weight bearing
    • Congenital pseudoarthroses in the appendicular skeleton
    • The noninvasive method in the treatment of failed joint fusion secondary to failed arthrodesis of the ankle or knee.  
 
Noninvasive electrical bone growth stimulation for any other condition is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, noninvasive electrical bone growth stimulation for any other condition is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Either the invasive and the noninvasive method may be covered when used as an adjunct to spinal fusion surgery, for patients at high risk for pseudarthrosis, including the following:
    • One or more previous failed spinal fusions
    • Grade III or worse spondylolisthesis
    • Fusion to be performed at more than one level
    • Current smoking habit
    • Diabetes
    • Renal disease
    • Alcoholism.  
 
The following applications of electrical bone growth stimulation, all methods:
    • Avascular necrosis (AVN)
    • Osteoporosis
    • The treatment of fresh fractures or delayed union (defined as deceleration fracture healing process as identified by serial x-rays)
    • Wide fracture gaps, greater than one cm; or
    • Fractures where there is significant motion at the fracture site.
are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, the following applications of electrical bone growth stimulation, all methods:
    • Avascular necrosis (AVN)
    • Osteoporosis
    • The treatment of fresh fractures or delayed union (defined as deceleration fracture healing process as identified by serial x-rays)
    • Wide fracture gaps, greater than one cm; or
    • Fractures where there is significant motion at the fracture site
are considered not medically necessary.  Medically unnecessary services are an exclusion in the member certificate of coverage.
 
The following applications of invasive and semi-invasive bone growth stimulation:
    • Use in the appendicular skeleton
    • Treatment of infantile nonunion
    • Treatment of failed joint fusion secondary to failed arthrodesis of the ankle or knee
    • The treatment of delayed union on long bone fractures secondary to trauma
are not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, the following applications of invasive and semi-invasive bone growth stimulation:
    • Use in the appendicular skeleton
    • Treatment of infantile nonunion
    • Treatment of failed joint fusion secondary to failed arthrodesis of the ankle or knee
    • The treatment of delayed union on long bone fractures secondary to trauma
are considered not medically necessary.  Medically unnecessary services are an exclusion in the member certificate of coverage.

Rationale:
The policy regarding electrical bone stimulation as a treatment of nonunion of fractures of the appendicular skeleton is based on the FDA-labeled indications. The FDA approval was based on a number of case series in which patients with nonunions, primarily of the tibia, served as their own control. These studies suggest that electrical stimulation results in subsequent unions in a significant percentage of patients.  It should be noted that the labeled indications include nonunions or congenital pseudoarthroses of bones of the appendicular skeleton. No distinction is made between long and short bones. The original FDA labeling of fracture nonunions defined nonunions as those fractures that had not shown progressive healing after at least 9 months from the original injury. This time frame is not based on physiologic principles, but was included as part of the research design for FDA approval as a means of ensuring homogeneous populations of patients, many of whom were serving as their own controls. As mentioned above, the presence of a nonunion is related to a variety of factors, such as fracture type and location, degree of soft tissue damage, vascularization, and bone stock. Some fractures may show no signs of healing, based on serial radiographs, as early as 3 months, while a fracture nonunion may not be diagnosed in others until well after 9 months. At the present time, the FDA has approved labeling changes for electrical bone growth stimulators that remove any time frame for the diagnosis. The current policy of requiring a 3-month time frame is still arbitrary, but appears to be consistent with the definition of nonunion, as described in the clinical literature.
 
While data from a double-blind randomized controlled clinical trial (and additional long-term outcome data provided by the investigator) of patients with delayed unions suggests that a 12 week course of noninvasive electrical bone stimulation is associated with a significantly higher healing rate than a control group with a dummy device, there are inadequate data regarding the final health outcome of the patient, i.e., regained use of limb, minimal pain, avoidance of subsequent surgery. All patients in the trial had an unhealed fracture at an average of 23.8 weeks after injury; all fracture gaps were under 0.5 cm. In terms of long-term outcome, a significantly greater proportion of the treated patients avoided any further surgery.
 
2002 Update
A literature search of the MEDLINE database was performed for the period of 1998 to September 2002. The search focused in particular on citations addressing the use of noninvasive electrical stimulation for delayed unions. No additional controlled trials were identified.
 
2009 Update
A literature search of the MEDLINE database was conducted through November 2009.
 
A 2008 systematic review by Griffin and colleagues included 49 studies, 3 of which were randomized controlled trials (Griffin, 2008).  The first, a double-blind randomized controlled trial (RCT) by Sharrard, compared pulsed electromagnet field (PEMF) stimulation with a sham procedure using a dummy device, in 45 patients with nonunion of the tibia (Sharrard, 2009).  Stimulators were positioned on the surface of the plaster cast. Treatment began 16 to 32 weeks after injury. Patients with fracture gaps greater than 0.5 cm after reduction, systemic disease, or taking steroids were excluded as well as patients with marked bony atrophy or hypertrophy. Fifty-one patients were recruited, and 45 completed the protocol. In the treatment group, 3 patients achieved union, 2 achieved probable union, 5 showed progression to union, and 10 showed no progress after 12 weeks. In the control group, none had united, one had probably united, 3 progressed toward union, and 17 showed no progress. Scott and King compared PEMF with sham treatment  in 23 patients with nonunion (fracture at least 9 months old and without clinical or radiographic sign of progression to union within the last 3 months) of a long bone (Scott, 1994).  Patients with systemic bone disorders, synovial pseudoarthrosis, or fracture gap of greater than half the width of the bone were excluded. In this trial, electrodes were passed onto the skin surface through holes in the plaster cast. Twenty-one patients completed the protocol (10 treatment and 11 controls). Six months after beginning treatment, an orthopedic surgeon and a radiologist, neither of them involved in the patients’ management, examined radiographs and determined that 6 of 10 in the treatment group healed, while none of those in the control group healed (p=0.004). Simonis et al compared PEMF and placebo treatment for tibial shaft fractures un-united at least a year after fracture, no metal implant bridging the fracture gap, and no radiological progression of healing in the 3 months before treatment (Simonis, 2003).   All 34 patients received operative treatment with osteotomy and unilateral external fixator prior to randomization. Treatment was delivered by external coils. Patients were assessed monthly for 6 months, and clinical and radiographic assessments were conducted at 6 months. Treatment was considered a failure if union was not achieved at 6 months. In the treatment group, 89% of fractures healed compared with 50% in the control group. While a larger percentage of smokers in the treatment group healed than compared with those in the control group, the number of smokers in each group was not comparable, and the difference in healing rates between groups was not statistically significant. The authors conclude that the available evidence supports the use of PEMF in the treatment of nonunion of the tibia and suggest that future trials should consider which modality of electromagnetic stimulation and in which anatomical sites the treatment is most effective.
 
No studies of semi-invasive (semi-implantable) stimulators were identified during the most recent literature search of MEDLINE through November 2009. In addition, none of these devices has FDA clearance or approval.  There is a lack of scientific evidence that the use of semi-invasive stimulators improve health outcomes for any indication.
 
2012 Update
A search of the MEDLINE database was conducted through September 2012. One multicenter, double-blind, randomized sham-controlled trial was identified which evaluated 12 weeks of pulsed electromagnetic field stimulation for acute tibial shaft fractures (Adie, 2011). The endpoints examined were secondary surgical interventions, radiographic union, and patient-reported functional outcomes. Approximately 45% of patients were compliant with treatment (>6 hours daily use), and 218 patients (84% of 259) completed the 12-month follow-up. The primary outcome, the proportion of participants requiring a secondary surgical intervention because of delayed union or nonunion within 12 months after the injury, was similar for the 2 groups (15% active; 13% sham). Per protocol analysis comparing patients who actually received the prescribed dose of pulsed electromagnetic field stimulation versus sham treatment also showed no significant difference between groups. Secondary outcomes, which included surgical intervention for any reason (29% active; 27% sham), radiographic union at 6 months (66% active; 71% sham), and the SF-36 Physical Component Summary (44.9 active; 48.0 sham) and Lower Extremity Functional Scales at 12 months (48.9 active; 54.3 sham), also did not differ significantly between the groups. This sham-controlled RCT does not support a benefit for electromagnetic stimulation as an adjunctive treatment for acute tibial shaft fractures.  The results of this trial does not prompt a change in the coverage statement.
 
2014 Update
A literature search was conducted through December 2013. Randomized trials were identified in the treatment of delayed union of fractures and stress fractures. The policy statement is changed to add a non-coverage statement for the treatment of stress fractures based on the recently published results summarized below.
 
Delayed Union
Shi et al. reported a randomized sham-controlled trial that included 58 patients with delayed union of surgically-reduced long-bone fractures (femur, tibia, humerus, radius or ulna) (Shi, 2013). Delayed union was defined as a failure to heal after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture. Patients with fracture nonunion, defined as failure to heal after more than 9 months, were excluded from the study. Treatment with 8 hours of PEMF per day was stopped when no radiographic progression was observed over 3 months or when union was achieved, with union defined as no pain during joint stressing or during motion at the fracture site and callus bridging for 3 out of 4 cortices on blinded assessment. Three months of treatment resulted in a slight, but not statistically significant, improvement in the rate of union between PEMF-treated patients and controls (38.7% vs. 22.2%). The success rate was significantly greater with PEMF (77.4% vs. 48.1%) after an average of 4.8 months of treatment. The time to union was not significantly different between PEMF (4.8 months, range, 2 to 12) and sham controls (4.4 months, range 2 to 7). Additional study is needed to permit greater certainty regarding the effect of this technology on delayed unions.
 
Stress Fractures
In 2008, Beck et al. reported a well-conducted randomized controlled trial (n=44) of capacitively coupled electric fields (OrthoPak) for healing acute tibial stress fractures (Beck, 2008). Patients were instructed to use the device for 15 hours each day and usage was monitored electronically. Healing was confirmed when hopping 10 cm high for 30 seconds was accomplished without pain. Although an increase in the hours of use per day was associated with a reduction in the time to healing, there was no difference in the rate of healing between treatment and placebo. Power analysis indicated that this number of patients was sufficient to detect a difference in healing time of 3 weeks, which was considered to be a clinically significant effect. Other analyses, which suggested that electrical stimulation might be effective for the radiologic healing of more severe stress fractures, were preliminary and a beneficial effect was not observed for clinical healing. There is insufficient evidence to permit conclusions regarding the efficacy of noninvasive electrical bone growth stimulation for treatment of stress fractures or delayed union, or following surgery of the appendicular skeleton.
   
2015 Update
A literature search conducted through December 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Updated 2014 guidelines from the American Association of Neurological Surgeons and the Congress of Neurological Surgeons (AANS/CNS) state that there is no evidence published after their 2005 guidelines that conflicts with the previous recommendations regarding bone growth stimulation (Kaiser, 2014). Based on a single level II study from 2009, the routine use of direct current stimulation (DCS) in patients over the age of 60 years was not recommended. Use of DCS was recommended as an option for patients younger than 60 years of age, based on Level III and IV studies showing a positive impact on fusion rate. However, comments regarding the level III study were that it was a poorly designed and conducted cohort study consisting of an exceedingly small heterogeneous population of patients, and the overall recommendation was level C. There was insufficient evidence to recommend for or against the use of pulsed electromagnetic field stimulation (PEMFS) as a treatment alternative to revision surgery in patients presenting with pseudoarthrosis following posterolateral lumbar fusion (PLF, single level IV study). No additional studies investigating the efficacy of capacitive coupled electrical stimulation were identified.
 
2017 Update
A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search conducted using the MEDLINE database did not reveal any new literature that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement.
 

CPT/HCPCS:
20974Electrical stimulation to aid bone healing; noninvasive (nonoperative)
20975Electrical stimulation to aid bone healing; invasive (operative)
E0747Osteogenesis stimulator, electrical, noninvasive, other than spinal applications
E0749Osteogenesis stimulator, electrical, surgically implanted

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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