This document addresses the use of invasive, noninvasive, and semi-invasive electrical bone growth stimulation devices for the treatment of orthopedic and neurosurgical conditions including fresh fractures, fracture nonunions, delayed unions, pseudoarthroses, and failed spinal fusions.

Note: Please refer to the following document for additional information related to devices used to stimulate bone growth:

• DME.00027 Ultrasound Bone Growth Stimulation

Medically Necessary:

Invasive and Noninvasive Electrical Stimulation of the Spine

Invasive (inserted at the time of surgery) or noninvasive (beginning at any time from the time of surgery until up to 6 months after surgery) electrical bone growth stimulation is considered medically necessary for spinal fusion surgery in individuals at high risk for pseudoarthroses with one or more of the following risk factors for fusion failure:

• One or more previously failed spinal fusion(s); or
• Grade III or worse spondylolisthesis; or
• Fusion to be performed at more than one level; or
• History of tobacco use or alcoholism; or
• Diabetes, renal disease, or other metabolic diseases where bone healing is likely to be compromised or growth is poor; or
• Nutritional deficiency; or
• Obese individuals with a Body Mass Index (BMI) greater than 30 or who are at greater than 50% over their ideal body weight (IBW) (Note: See Definition section for calculation of IBW); or
• Severe anemia; or
• Steroid therapy.

Noninvasive electrical bone growth stimulation is considered medically necessary as a treatment for individuals with failed spinal fusion when both of the following criteria are met:

• a minimum of 6 months has passed since the date of the original surgery; and
• serial radiographs or appropriate imaging studies confirm there is no evidence of progression of healing for 3 months during the latter portion of the 6 month period.

Noninvasive Electrical Stimulation of the Appendicular Skeleton

Noninvasive electrical bone growth stimulation is considered medically necessary as a treatment for fracture nonunion or congenital pseudoarthroses of all long and short bones of the appendicular skeleton when all of the following criteria are met: 

• at least 45 days have passed since the date of fracture or the date of surgical treatment of the fracture; and
• serial radiographs or appropriate imaging studies confirm that no progressive signs of healing have occurred; and
• the fracture gap is less than 1 centimeter. 

Noninvasive electrical bone growth stimulation is considered medically necessary as a treatment for joint fusion secondary to failed arthrodesis of the ankle or knee.

Not Medically Necessary:

Noninvasive electrical bone growth stimulation is considered not medically necessary when either of the following contraindications are present:

• synovial pseudoarthroses; or
• draining osteomyelitis.

Investigational and Not Medically Necessary:

Noninvasive electrical bone growth stimulation is considered investigational and not medically necessary when the above criteria are not met, including, but not limited to treatment of any of the following:

• fresh fractures; or
• delayed/incomplete union fractures; or
• as an adjunct to (i.e. at the time of or immediately after) bunionectomy procedures (Note: When such surgery results in nonunion, the medically necessary criteria above may apply); or
• as an adjunct to (i.e., at the time of or immediately after) distraction osteogenesis procedures for any indication (e.g., limb lengthening, nonunion, or tibial defects); or
• patellar tendinopathy; or
• pathological fractures due to bone pathology or tumor/malignancy; or
• spondylolysis or pars interarticularis defect; or
• stress fractures.

Invasive electrical bone growth stimulation is considered investigational and not medically necessary for the following:

• when the above criteria are not met for spinal indications; or
• for all non-spinal indications. 

Semi-invasive electrical bone growth stimulation is considered investigational and not medically necessary for any indication.

Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures

The efficacy of electrical bone stimulation as an adjunct to spinal fusion surgery or as a treatment of failed spinal fusion surgery (i.e. salvage therapy) is based on: 1) data from a randomized, controlled clinical trial of subjects meeting the criteria for high risk for development of failed fusion, suggesting that invasive or noninvasive electrical bone stimulation as an adjunct to spinal fusion surgery is associated with a significantly higher fusion success rate in the treated group compared with the control group (Foley, 2007; Goodwin, 1999; Kane, 1988; Linovitz, 2002; Mooney, 1990), and 2) data from uncontrolled case series of subjects with failed spinal fusion suggesting that noninvasive electrical stimulation results in a significantly higher fusion rate. The lack of controlled clinical trials is balanced by the fact that the participants served as their own control. The following discussion focuses on different types of fusion procedures and different types of electrical stimulation.

Instrumented Spinal Fusion

Kucharzyk (1999) reported on a controlled prospective nonrandomized trial of implantable electrical stimulation in individuals undergoing instrumented posterior spinal fusion with pedicle screws. A case series of 65 subjects who did not use electrical stimulation was compared with a later series of similar subjects who did receive implantable electrical stimulation. Fusion success was 95.6% in the stimulated group compared to 87% in the nonstimulated group, a statistically significant difference. It appears that all subjects had at least one or more high risk factor for failed fusion, i.e. smoking history, prior surgery, multiple fusion levels, diabetes, etc.

Rogozinski and Rogozinski (1996) reported on the outcomes of two consecutive series of subjects undergoing posterolateral fusions with autologous bone graft and pedicle screw fixation. The first series of 41 subjects were treated without electrical stimulation, while the second group of 53 subjects received invasive electrical stimulation. Those receiving electrical stimulation reported a 96% fusion rate, compared to an 85% fusion rate in the unstimulated group. The fusion rate for subjects receiving stimulation compared to no stimulation was also significantly higher among those considered at high risk due to previous back surgery or multiple fusion levels. There was not a significant increase in the fusion rate among non-smokers (i.e. without a risk factor), but the comparative fusion rates for all subjects without high risk factors was not presented.

Noninvasive Electrical Stimulation

Goodwin and colleagues (1999) reported on the results of a study that randomized 179 subjects undergoing lumbar spinal fusions to receive or not receive capacitive coupling (CC) electrical stimulation. A variety of surgical procedures, both with and without instrumentation, were used; subjects were not limited to "high risk" participants. Inclusion criteria did not describe an exact time of postoperative application of the device. The overall successful fusion rate was 84.7% for those in the active group compared to 64.9% in the placebo group, a statistically significant difference. While the actively treated group reported increased fusion success for all stratification groups (i.e. according to fusion procedure, single or multilevel fusion, smoking or nonsmoking group); in many instances the differences did not reach statistical significance because of small numbers. For example, the subgroups in which there was not a significant difference in fusion between the active and placebo groups included subjects who had undergone previous surgery, smokers and those with multilevel fusion. In addition, there were numerous dropouts in the study and a 10% noncompliance rate with wearing the external device for up to nine months.

Mooney and colleagues (1990) reported on the results of a double-blinded study that randomized 195 subjects undergoing initial attempts at interbody lumbar fusions with or without fixation to receive or not receive pulsed electromagnetic fields (PEMF) stimulation. Subjects were not limited to high-risk groups. The active treatment group were fitted postoperatively (onset of application was not described) with a special brace with electromagnetic coils, which they were instructed to wear at least eight hours per day. The treatment group reported a 92% success rate with PEMF, compared to a 65% success rate in the placebo group. On subgroup analysis, the treatment group consistently reported an increased success rate. Subgroups included graft type, presence or absence of internal fixation, or presence or absence of smoking.

Linovitz and colleagues (2002) conducted a double-blinded clinical trial that randomized 201 subjects undergoing one or two level posterolateral fusion without instrumentation to undergo active or placebo electrical stimulation using a combined magnetic field (CMF) device. Unlike CC or PEMF devices, the CMF device requires a single 30-minute treatment per day with the device centered over the fusion site. In this trial, subjects applied the device within 30 days postoperatively and were treated for nine months. Among all subjects, 64% of those in the active group showed fusion at nine months compared to 43% of those with placebo devices, a statistically significant difference. On subgroup analysis, there was a significant difference among women, but not men.

Foley and colleagues (2008) reported results from a multicenter, single-blinded, randomized, placebo-controlled trial (n=323) using the Cervical-Stim^® (Orthofix, Inc., McKinney, TX), a noninvasive, PEMF bone growth stimulator indicated as an adjunct to cervical spinal fusion surgery in subjects at high risk for nonunion, based either on smoking history or multilevel fusion procedures. In the treatment arm of the trial (n=163), the PEMF device was applied one week after cervical fusion; the device was worn for four hours per day for three months. At six months postoperatively, the PEMF group had a significantly higher fusion rate than the control group (83.6% versus 68.6%, p=.0065), which disappeared at 12 months (92.8% versus 86.7%, p=.1129).

In summary, studies in the peer-reviewed literature suggest that electrical stimulation may improve fusion rates in individuals undergoing instrumented or non-instrumented spinal surgery. These studies focus on individuals at high risk for fusion failure due to prior failed spinal fusion, Grade III or worse spondylolisthesis, and fusion performed at more than one level. Other comorbid risk factors for spinal fusion failure exist, including tobacco use or alcoholism, diabetes, renal or other metabolic diseases, nutritional deficiency, obesity, severe anemia or steroid therapy. Li and colleagues (2011) recently evaluated the effect of perioperative nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective inhibitors) on the success rate of spinal fusion procedures. The analysis included five retrospective comparative studies, suggesting that short-time (less than 14 days) exposure to normal-dose NSAIDs (i.e., celecoxib, diclofenac sodium, ketorolac, or rofecoxib) was safe after spinal fusion, whereas short-time (greater than 14 days) exposure to high-dose ketorolac increased the risk of nonunion, suggesting that the effect of perioperative NSAIDs on spinal fusion may be dose-dependent. The authors concluded that additional studies are needed to determine whether long-time exposure to normal-dose NSAIDs could increase the risk of nonunion and which type of NSAIDs would most likely have the worse effect on spinal fusion. At this time, there are no randomized controlled trials in the peer-reviewed literature that demonstrate an effect between NSAID use and spinal fusion failure.

There is insufficient evidence in the peer-reviewed medical literature to determine the magnitude of benefit associated with electrical stimulation in individuals considered at average risk for fusion failure (Akai, 2002) and for the treatment of spondylolysis or pars interarticularis defect (Fellander-Tsai and Micheli, 1998; Pettine, 1998). These two small case series suggest a treatment benefit of noninvasive electrical stimulation by decreasing pain and healing of the pars defects. Stasinopoulos (2004) performed a critical review of the literature which included these two case series, reporting that conclusions cannot be draw concerning whether noninvasive electrical stimulation "is more effective than other conservative interventions or whether it can be used for the treatment of this condition, because the size of sample is too small and the results cannot be generalized to the rest of the population. Further studies with more patients and more detailed procedures are needed to establish what the exact role of external electrical stimulation should be in the management of patients with spondylolysis."

Finally, in the treatment arm of the clinical trials when noninvasive electrical bone growth stimulation was used as an adjunct to spinal fusion procedures, the timing of application of the device was variable, from one week to 30 days postoperatively. These clinical trials suggested significantly higher fusion success rates in the treatment group compared with the control group, despite the variation in device application time.

Electrical Stimulation for Non-Spinal Indications

A number of systematic reviews and meta-analyses of the randomized trials assessing electrical stimulation have been published in the peer-reviewed medical literature. Three of these meta-analyses suggest there is a treatment effect from electrical stimulation on bony union (Akai, 2002; Griffin, 2008; Walker, 2007). A meta-analysis conducted by Mollon and colleagues (2008) reviewed 11 articles using PEMF (8 trials) or CC field (3 trials) in the treatment of a variety of long-bone lesions, including fresh fractures, delayed or nonunions, osteotomies, and stress fractures. Evidence from four trials reporting on 106 delayed union or nonunions demonstrated an overall nonsignificant pooled relative risk of 1.76 (95% confidence interval [CI], 0.8 to 3.8; p=0.15) in favor of electrical stimulation. However, as evidenced by the confidence interval, this effect failed to reach significance. Single studies found a positive benefit of electrical stimulation on callus formation in femoral intertrochanteric osteotomies, a limited benefit for conservatively managed Colles fracture or for lower limb-lengthening, and no benefit on limb-length imbalance and the need for reoperation in surgically managed pseudarthroses or on time to clinical healing in tibial stress fractures (Beck, 2008). Clinical outcomes were examined in three of the trials, suggesting minimal or no benefit in pain reduction or fracture site tenderness when electrical stimulation was used as an adjunct to surgery for femoral neck fractures or to treat tibial shaft nonunions. Pooled analysis did not show a significant impact of electrical stimulation on delayed or nonunion long bone fractures as a number of limitations were apparent in methodological quality across the studies, including significant heterogeneity among the studies (I[2]=60.4%). This meta-analysis also suggests the current evidence from randomized controlled trials is insufficient "to conclude a benefit of electromagnetic stimulation in improving the rate of union in patients with a fresh fracture, osteotomy, delayed union or nonunion" (Mollon, 2008). Goldstein and colleagues (2010) concluded that these meta-analyses "highlighted the fact that small methodologically limited trials make up the best available evidence on the use of electrical stimulation and fracture healing," despite limitations including wide confidence intervals with results and significant heterogeneity between trials.

In a recent Cochrane review/meta-analysis, Griffin and colleagues (2011) pooled data from four studies involving 125 participants to assess the effects of electromagnetic stimulation for treating delayed union or nonunion of long bone fractures in adults. Three studies evaluated the effects of PEMF and one study, CC electric fields; most data related to nonunion of the tibia. Although all studies were blinded randomized placebo-controlled trials, each study had limitations. The primary measure of the clinical effectiveness of electromagnetic stimulation was the proportion of participants whose fractures had united at a fixed time point. The overall pooled effect size was small and not statistically significant (risk ratio 1.96; 95% CI, 0.86 to 4.48; 4 trials). There was substantial clinical and statistical heterogeneity in this pooled analysis (I[2]=58%). A sensitivity analysis conducted to determine the effect of multiple follow-up time-points on the heterogeneity amongst the studies showed that the effect size remained non-significant at 24 weeks (risk ratio 1.61; 95% CI 0.74 to 3.54; 3 trials), with similar heterogeneity (I[2]=57%). No study reported functional outcome measures. The authors concluded that though the available evidence suggests that electromagnetic stimulation may offer some benefit in the treatment of delayed union and nonunion of long bone fractures, it is inconclusive and insufficient to inform current practice. More definitive conclusions on treatment effect await further well-conducted randomized controlled trials.

Overall, there are no well-designed, prospective, randomized controlled trials on the effectiveness of invasive electrical stimulation for fracture nonunion, or invasive or noninvasive electrical stimulation for the treatment of fresh fractures, delayed/incomplete unions, patellar tendinopathy, or stress fractures, It is uncertain whether electrical stimulation offers an additional benefit compared to standard treatment alone (e.g., cast or brace immobilization, or surgery) for these types of fractures or joint deficiency/deformity.

Fracture Nonunions

Externally used CC and PEMF stimulation results in success rates for fracture nonunion that are consistently reported between 80-89% in appropriately selected individuals (Simonis, 2003). There is, however, no substantive clinical evidence to predict a specific duration of treatment when treating fracture nonunions with electrical stimulation. The location and type of fracture, risk factors of the individual, the duration of nonunion prior to treatment, and past failed bone graft or failed electrical therapy are factors that may affect the duration of electrical stimulation therapy. The medical literature, including prospective, double-blind, randomized controlled trials and retrospective case series, are limited in reporting time-to-heal outcomes as measured by radiographic evidence of bone healing. For those individuals where healing outcomes were reported for long bone fracture nonunions treated with electrical stimulation, healing rates were documented within three months of initiation of treatment to greater than one year (AHRQ, 2005).

While electrical stimulation for the treatment of orthopedic conditions has been shown to be of benefit in the treatment of long bone and short bone fracture nonunions, it is considered as either an alternative to surgical treatment or a salvage treatment for failed surgical interventions. It should not be used as an adjunct to surgical treatment. In these cases, surgical treatment is considered the definitive therapy and an adequate period of time should be allowed for evaluation of positive results. 

Hallux valgus, commonly referred to as a bunion, is a complex group of disorders consisting of a lateral deviation of the great toe, outward angulation of the metatarsal toward the other foot, separation of the heads of the first and second metatarsals, and prominent soft-tissue thickening over the medial surface of the head of the first metatarsal. When conservative measures such as pads and cushions and functional foot orthotics fail to reduce the associated pain or slow the progression of the deformity, surgical correction may be indicated. The choice of surgical procedure is based on a biomechanical and radiographic examination of the foot. A bunionectomy procedure (e.g., Akin, Chevron, Keller, Lapidus, Mitchell metatarsal osteotomies) may be performed to correct a symptomatic hallux valgus by reconstructing the bones and joint to restore normal, pain-free function. The most common bunionectomy procedure performed is the first metatarsal neck osteotomy, which involves a controlled 'surgical fracture' of the bone by cutting and realigning the first metatarsal near the level of the joint; additional procedures may involve soft tissue correction along with concomitant bony correction. Complications following a bunionectomy procedure vary depending on the surgical technique and procedure, including, but are not limited to delayed healing of the incision, osseous malunion or nonunion, osteomyelitis, or avascular necrosis. The recent peer-reviewed medical literature includes prospective, comparative and evaluation studies and retrospective case series reporting low postsurgical complication rates following specific osteotomy procedures for hallux valgus (Dennis, 2011; Enan, 2010; Lee, 2010; Miller, 2011). While there is a lack of published, randomized controlled trials comparing the efficacy of electrical bone growth stimulation to sham treatment for postsurgical  bunionectomy nonunion, the stimulation device may be a treatment option for individuals to reduce the need for further surgical revision when the individual's osteotomy site has demonstrated no evidence of progression of healing.

There are no studies in the peer-reviewed literature specifically focused on improved healing rates following uncomplicated bunionectomy procedures (e.g. first metatarsal osteotomy) as compared to a period of immobilization and limited weight bearing; in addition, these surgeries are not considered at high risk for post surgical nonunion.

Arthrodesis of the Ankle or Knee

The use of noninvasive electrical stimulation has been studied as an adjunct treatment for joint fusion secondary to failed arthrodesis of the ankle and knee. While the evidence for this application is not extensive, there are several reports that illustrate the usefulness of this therapy. In this situation, the initial joint fusion should be considered the definitive treatment for these types of fractures. In the event that this treatment fails, it may be appropriate to apply electrical stimulation immediately following the revision procedure. The level of evidence to support this conclusion is reported in multiple case series in the medical literature.

A recent search for implantable bone stimulators identified a small number of case series that focused on foot and ankle arthrodesis in individuals at high risk for nonunion (Petrisor, 2005). Risk factors for nonunion included smoking, diabetes mellitus, Charcot (diabetic) neuropathy, steroid use and previous nonunion. The largest case series described outcomes of foot or ankle arthrodesis in 38 high-risk subjects (Lau, 2007). Union was observed in 65% of cases by follow-up evaluation (n=18), or chart review (n=20). Complications were reported in 16 (40%) cases, including six cases of deep infection, five cases of painful or prominent bone stimulators necessitating stimulator removal. A multicenter retrospective review described outcomes from 28 high-risk subjects with arthrodesis of the foot and ankle (Saxena, 2005). Union was reported for 24 (86%) cases at an average of ten weeks; complications included breakage of the stimulator cables in two subjects and hardware failure in one subject. Five subjects required additional surgery. There continues to be insufficient evidence to support the efficacy of invasive or semi-invasive electrical stimulation for these non-spinal indications.

Other Considerations 

There is currently a lack of large, randomized, sham-controlled trials of homogeneous study populations to support the use of PEMF for enhancing bone formation in distraction osteogenesis (DO) following limb-lengthening procedures. In a recent review, Sabharwal (2011) reported that a small number of adolescents who underwent limb lengthening during DO did not demonstrate a difference in the rate or amount of new bone formation in participants who received treatment from an active PEMF coil compared to sham coil treatment (Eyres, 1996). Luna Gonzalez and colleagues (2005) evaluated a small group of adolescents (n=30) of short stature who underwent bilateral humeral lengthening. At day 10 after surgery, PEMF stimulation was started on one side, for eight hours/day. The extremity managed with PEMF was reported as exhibiting faster callus formation and greater bone density then did the contralateral control side. Sabharwal (2010) concluded, however, that "Because of limited data and multiple variables, including duration of PEMF treatment and its use in upper versus lower extremities, the role of PEMF during DO remains unclear."

Definitive selection criteria of candidates for noninvasive electrical bone growth stimulation have not been firmly established. However, there is sufficient evidence to conclude that this technology can provide benefit for individuals with persistent long bone nonunions. According to the product labeling for a noninvasive pulsed electromagnet bone growth stimulator used as an adjunct to cervical fusion surgery in individuals at high risk for nonunion (Cervical-Stim^®_, Orthofix, Inc., McKinney, TX), the device has not been evaluated in the treatment of individuals with the following conditions: osseous or ligamentous spinal trauma, spondylitis, infection, Paget's disease, moderate to severe osteoporosis, metastatic cancer, renal disease, rheumatoid arthritis, uncontrolled diabetes mellitus, individuals prone to vascular migraine headache, seizure, epilepsy, thyroid conditions or neurological diseases. The product label of the Physio-Stim^® bone growth stimulator (Orthfix^® Inc., McKinney, TX) states the device "is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site show no visibly progressive signs of healing." Similar safety and effectiveness information is identified on the U.S. Food and Drug Administration's (FDA) premarket approval (PMA) applications for other devices. These summaries state the devices are contraindicated in individuals lacking skeletal maturity, individuals with a demand-type pacemaker or implantable cardioverter defibrillator (ICD), and pregnant women. Although indications vary among devices, the safety and effectiveness of electrical bone growth stimulation has not been established with a nonunion secondary to or in connection with a pathological condition (PhysioStim^® device), is not indicated for misaligned fracture nonunion, when a synovial pseudarthrosis exists (Physio-Stim^® device), when the bone gap is equal to or greater than one centimeter or greater than one-half the diameter of the bone, and for individuals who are unable to be compliant with the appropriate use of a noninvasive device and treatment regimens.

Electrical bone growth stimulation describes the use of a device, either implanted into the body or worn externally, that uses an electric field or current to stimulate the growth of bone tissue. These devices have proven effective in the treatment of failed bone growth, such as fracture nonunions or failed bone fusion procedures. Spinal fusion is a procedure that involves surgically fusing two or more vertebrae using bone grafts or bone graft substitutes. Various types of instrumentation may be used to promote union.  

Standard management of fractures includes fracture site stabilization with external or internal fixation, compression devices, with or without casting. Risk factors for fracture nonunion include insufficient blood supply as a result of severe trauma, inadequate immobilization at the fracture site, contamination at the fracture site, a gap with no bone spanning the fracture site, infection, bone tissue loss, and other risk factors such as alcoholism, smoking/tobacco use, advanced age, poor nutrition, diabetes, osteoporosis, or metabolic dysfunctions. Delayed or incomplete fracture union occurs when fracture healing has not progressed within the expected timeframe for the site and type of fracture in a given individual despite ongoing bone growth activity. In contrast, fracture nonunion is the cessation of all healing processes, the absence of spontaneous healing, and the need for intervention for healing to resume. The diagnosis of fracture nonunion is based on pain and motion at the fracture site and on findings from radiographs, fluoroscopy, bone scintigraphy, and bone scanning. Further evaluation of healing and fracture nonunion may be established with computed tomography (CT) scans, x-ray tomograms, and magnetic resonance imaging (MRI).

Electrical stimulation devices can be categorized as invasive, semi-invasive, or noninvasive. Invasive devices use a direct current (DC) delivered directly to the fracture site by way of implantable electrodes. This surgical procedure involves implantation of an induction coil, creation of a passage under the skin for the cable, and securing of the powerpack/control module at some distance from the bone lesion. According to Goldstein and colleagues (2009), implantable devices have the benefits of providing constant stimulation of the bone at the nonunion or fracture site, thus increasing compliance of the user and optimizing electrode positioning. However, drawbacks include the risk of the surgical procedures for implantation and removal, the possibility of infection, prominent or painful implants, and the potential for lead breakage or electrode dislodgement. Semi-invasive direct current stimulation devices involve implantation of induction wires, but the power pack is worn externally. The cable connecting the two passes through the skin, requiring careful attention to prevent infection. To date, no semi-invasive electrical bone growth stimulator devices with FDA approval or clearance were identified in the FDA medical devices database.

Noninvasive devices deliver current by way of capacitive coupling (CC), pulsed electromagnetic field (PEMF) or combined electromagnetic field (CMF) technology. Some of the devices used for spinal indications may be worn like a belt or are in the form of patches attached to the skin with adhesive. For other indications, these devices may consist of a flexible foam covered metal ring that is molded to the area of concern and held in place with straps or adhesive. The power pack/control module is attached by wires and may be worn on a belt or placed in a pocket. The proper use of an externally applied device, whether CC or PEMF, requires compliance by the user and long-term immobilization of the limb using internal fixation, external fixation, casting or bracing. Adherence to the treatment plan is of particular importance with PEMF given the duration of daily treatment sessions required by the user.

Appendicular skeleton: Composed of bones of the upper and lower limbs, and the bones that anchor the upper and lower limbs to the axial skeleton:

• upper extremities (humerus, radius, ulna, carpal, metacarpal, and phalange bones)
• lower extremities (femur, tibia, fibula, patella, tarsal, metatarsal, and phalange bones)
• shoulder or pectoral girdle (clavicle and scapula bones)
• pelvic or hip girdle

Axial skeleton: Composed of bones that form the axis of the body and support and protect the organs of the head, neck, and trunk; includes the ribs, skull, sternum and vertebral column (including the coccyx and sacrum).

Bunionectomy: A surgical procedure to remove a bony bump (bunion) of the foot and realign the big toe (great toe).

Cervical: Referring to the bones of the neck.

Delayed/incomplete fracture union: A fracture that has not healed within the expected timeframe for the site and type of fracture in a given individual despite ongoing bone growth activity; demonstrated by slow radiographic progress and continued mobility and pain at the fracture site.

Distraction osteogenesis (DO): A procedure that moves two segments of a bone slowly apart in such a way that new bone fills in the gap.

Electrical bone growth stimulator: A medical device that uses an electric field or current to stimulate the growth of bone tissue. These devices may be worn on the outside of the body or can be surgically implanted around the area requiring treatment.

Flat bones: Bones that are thin and have broad surfaces; includes the scapula, ribs, and the sternum (breastbone).

Fracture nonunion: A fracture in which all evidence of bone growth activity at the fracture site has ceased, leaving a persistent unhealed fracture of the bone.

Fracture union: The point at which the fractured bone has regained sufficient strength and stiffness to function as a weight-bearing structure without external support.

Hallux valgus deformity (bunion): A medial deviation of the first metatarsal and lateral deviation and/or rotation of the hallux, with or without medial soft-tissue enlargement of the first metatarsal head. This condition can lead to painful motion of the joint or difficulty with footwear.

Ideal body weight (IBW): Obesity has been defined as anyone who is 50% over their ideal body weight. The ideal body weight is calculated according to the following formula (Note: 1 kg = 2.2 pounds):

• Females: IBW = 45.5 kg + 2.3 kg for each inch over 5 feet
• Males: IBW = 50 kg + 2.3 kg for each inch over 5 feet

Irregular bones: Bones that are irregular in size and shape and are usually quite compact; include the bones in the vertebral column, the carpal bones in the hands, tarsal bones in the feet, and the patella (kneecap).

Long bones: Bones found in the extremities comprised of a shaft (diaphysis) and two ends (epiphyses); includes the humerus, radius, ulna, femur, tibia, fibula, metatarsal, and metacarpal bones.

Osteotomy: A surgical procedure where a bone or segment of a bone is cut or removed, realigned, and allowed to heal in its new position; most often, performed to realign a deformed bone.

Pseudoarthrosis: A condition where a bone fracture has healed with fibrous material instead of bone tissue; referred to as pseudarthrosis or a "false joint."

Sesamoid bones: An ovoid, nodular mass of bone or cartilage within a tendon or joint capsule, principally in the hands and lower extremities; the patella is the largest sesamoid bone in the body.

Short bones: Bones with a tubular shaft and articular surfaces at each end but much smaller in size; includes all of the metacarpals and phalanges in the hands, the metatarsals and phalanges in the feet, and the clavicle (collarbone).

Spinal fusion: A surgical procedure that connects one or more back bones with metal rods and/or bone grafts in an effort to stabilize a spine that is weakened, abnormal or injured.

Spondylolisthesis: A condition when one or more of the bones of the back slip forward in relation to the bone below it resulting in pressure on the spinal cord.

Spondylolysis (pars interarticularis defect): A unilateral or bilateral defect of the isthmic portion of the pars interarticularis of a vertebra, without forward displacement of that vertebra on the adjacent vertebra; a stress or fatigue fracture seen most often in children and adolescents.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  A draft of future ICD-10 Coding (effective 10/01/2014) related to this document, as it might look today, is included below for your reference.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Invasive Electrical Stimulation
When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When Services are also Investigational and Not Medically Necessary:

Noninvasive Electrical Stimulation of the Spine and Appendicular Skeleton
When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For procedure codes listed above for the following diagnoses, or for the situations indicated in the Position Statement section as not medically necessary.

When services are Investigational and Not Medically Necessary:
For procedure and diagnosis codes listed above when criteria are not met, for all other diagnoses not listed or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary. 

When Services are also Investigational and Not Medically Necessary:

Peer Reviewed Publications:

1. Akai M, Kawashima, Kimura AT, Hayashi K. Electrical stimulation as an adjunct to fusion: a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002; 23(7):496-504.
2. Andersen T, Christensen FB, Langdahl BL, et al. Fusion mass bone quality after uninstrumented spinal fusion in older patients. Eur Spine J. 2010; 19(12):2200-2208.
3. Beck BR, Matheson GO, Bergman G, et al. Do capacitively coupled electric fields accelerate tibial stress fracture healing? A randomized controlled trial. Am J Sports Med. 2008; 36(3):545-553.
4. Boden SD, Schimandle JH. Biologic enhancement of spinal fusion. Spine. 1995; 15(24 Suppl):113S-123S.
5. Brighton CT, Black J, Friedenberg ZB, et al. A multicenter study of the treatment of nonunion with constant direct current. J Bone Joint Surg. 1981; 63-A (1):2-13.
6. Dennis NZ, Das De S. Modified Mitchell's osteotomy for moderate to severe hallux valgus--an outcome study. J Foot Ankle Surg. 2011; 50(1):50-54.
7. Dunn AW, Rushi GA. Electrical stimulation in treatment of delayed union and nonunion of fractures and osteotomies. South Med J. 1984; 177(12):1530-1534.
8. Enan A, Abo-Hegy M, Seif H. Early results of distal metatarsal osteotomy through minimally invasive approach for mild-to-moderate hallux valgus. Acta Orthop Belg. 2010; 76(4):526-535.
9. Eyres KS, Saleh M, Kanis JA. Effect of pulsed electromagnetic fields on bone formation and bone loss during limb lengthening. Bone. 1996; 18(6):505-509.
10. Fellander-Tsai L, Micheli L. Treatment of spondylolysis with external electrical stimulation: a report of two cases. Clin J Sports Med. 1998; 8(3):232-234.
11. Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. 2008; 8(3):436-442.
12. Goldstein C, Sprague S, Petrisor BA. Electrical stimulation for fracture healing: current evidence. J Orthop Trauma. 2010; 24(Suppl 1):S62-65.
13. Goodwin CB, Brighton CT, Guyer RD, et al. A double blind study of capacitively coupled electrical stimulation as an adjunct to lumbar spinal fusions. Spine. 1999; 24(13):1349-1357.
14. Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evidence? Injury. 2008; 39(4):419-429.
15. Kane WJ. Direct current electrical bone growth stimulation for spinal fusion. Spine. 1988; 13(3):363-365.
16. Kucharzyk DW. Controlled prospective outcome study of implantable electrical stimulation with spinal instrumentation in a high-risk spinal fusion population. Spine. 1999; 24(5):465-468.
17. Lau JT, Stamatis ED, Myerson MS, Schon LC. Implantable direct-current bone stimulators in high-risk and revision foot and ankle surgery: a retrospective analysis with outcome assessment. Am J Orthop. 2007; 36(7):354-357.
18. Lee HJ, Chung JW, Chu IT, Kim YC. Comparison of distal chevron osteotomy with and without lateral soft tissue release for the treatment of hallux valgus. Foot Ankle Int. 2010; 31(4):291-295.
19. Li Q, Zhang Z, Cai Z. High-dose ketorolac affects adult spinal fusion: a meta-analysis of the effect of perioperative nonsteroidal anti-inflammatory drugs on spinal fusion. Spine (Phila Pa 1976). 2011; 36(7):E461-468.
20. Linovitz RJ, Pathria M, Bernhardt M, et al. Combined magnetic fields accelerate and increase spinal fusion: a double blind, randomized placebo controlled study. Spine. 2002; 27(13):1383-1389.
21. Luna Gonzalez F, Lopez Arévalo R, Meschian Coretti S, et al. Pulsed electromagnetic stimulation of regenerate bone in lengthening procedures. Acta Orthop Belg. 2005; 71(5):571-576.
22. Mammi GI, Rocchi R, Cadossi R, et al. The electrical stimulation of tibial osteotomies: a double blind study. Clin Ortho Rel Res. 1993; 288:246-253.
23. Miller JM, Ferdowsian VN, Collman DR. Inverted Z-scarf osteotomy for hallux valgus deformity correction: intermediate-term results in 55 patients. J Foot Ankle Surg. 2011; 50(1):55-61.
24. Mollon B, da Silva V, Busse JW, et al. Electrical stimulation for long-bone fracture-healing: a meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2008; 90(11):2322-2330.
25. Mooney V. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions. Spine. 1990; 15(7):708-712.
26. Nelson FRT. Use of physical forces in bone healing. J AM Acad Ortho Surg. 2003; 11(5):344-354.
27. Oishi M, Onesti ST. Electrical bone graft stimulation for spinal fusion: a review. Neurosurgery. 2000; 47(5):1041-1056.
28. Paterson DC, Simonis RB. Electrical stimulation in the treatment of congenital pseudoarthrosis of the tibia. J Bone Joint Surg. 1985; 67-B(3):454-462.
29. Pettine K, Salib R, Walker S. External electrical stimulation and bracing for treatment of spondylolysis. A case report. Spine 1993; 18(4):436-439.
30. Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin. 2005; 10(4):609-620.
31. Rogozinski A, Rogozinski C. Efficacy of implanted bone growth stimulation in instrumented lumbosacral spinal fusion. Spine. 1996; 21(21):2479-2483.
32. Ryaby JT. Clinical effects of electromagnetic and electric fields on fracture healing. Clin Orthop. 1998; 355(Suppl):S20515.
33. Saxena A, DiDomenico L, Widfeldt A, et al. Implantable electrical bone stimulation for arthrodeses of the foot and ankle in high-risk patients: a multicenter study. J Foot Ankle Surg. 2005; 44(6):450-454.
34. Simonis RB, Parnell EJ, Ray PS, Peacock JL. Electrical treatment of tibial non-union: a prospective randomised, double-blind trial. Injury. 2003; 34(5):357-362.
35. Stasinopoulos D. Treatment of spondylosis with external electrical stimulation in young athletes: a critical literature review. Br J Sports Med. 2004; 38(3):352-254.
36. Walker NA, Denegar CR, Preische J. Low-intensity pulsed ultrasound and pulsed electromagnetic field in the treatment of tibial fractures: a systematic review. J Athl Train. 2007; 42(4):530-535.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality (AHRQ). The role of bone growth stimulating devices and orthobiologics in healing nonunion fractures. Health Technology Assessments. September 2005. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id29TA.pdf. Accessed on June 6, 2012.
2. Centers for Medicare and Medicaid Services. National Coverage Determination: Osteogenic Stimulators. NCD #150.2. Effective April 27, 2005. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on June 6, 2012.
3. Griffin XL, Costa ML, Parsons N, Smith N. Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults. Cochrane Database Syst Rev. 2011; (4):CD008471.
4. U.S. Food and Drug Administration (FDA). Medical Devices. Approvals and Clearances. Available at: http://www.fda.gov/MedicalDevices/default.htm. Accessed on July 13, 2012.

1. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Nonunions. September 2007. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00374. Accessed on June 6, 2012.

Capacitive Coupling (CC) Stimulation
Cervical-Stim^®
CMF OL1000 Bone Growth Stimulator
CMF SpinaLogic^®
Combined Magnetic Field (CMF) Stimulation
Direct Current (DC) Stimulation
EBI Bone Healing System
OL-1000 Bone Growth Stimulator
OrthoLogic^®
OrthoPak^® 2 Bone Growth Stimulator
OsteoGen™ Bone Growth Stimulator
OsteoGen™-Dual Lead Bone Growth Stimulator
OsteoGen™-M Bone Growth Stimulator
Physio-Stim^®
Pulsed Electromagnetic Field (PEMF) Stimulation
SpinaLogic^® Bone Growth Stimulator
SpinalPak^® 2 Spine Fusion Stimulator

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.