|MP 7.01.07||Electrical Bone Growth Stimulation of the Appendicular Skeleton|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/12:2014
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
Electrical and electromagnetic fields can be generated and applied to bones through the following methods:
- Surgical implantation of a cathode at the fracture site with the production of direct current electrical stimulation. Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation, and, although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.
- Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and worn for 24 hours per day until healing occurs or up to 9 months. In contrast, pulsed electromagnetic fields are delivered via treatment coils that are placed over the skin and are worn for 6–8 hours per day for 3 to 6 months. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field. This device involves a 30-minute treatment per day for 9 months. Patient compliance may be an issue with externally worn devices.
- 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.
In the appendicular skeleton, electrical stimulation has been primarily used to treat tibial fractures, and thus this technique has often been thought of as a treatment of the long bones. According to orthopedic anatomy, the skeleton consists of long bones, short bones, flat bones, and irregular bones. Long bones act as levels 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. Despite their anatomic classification, all bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. At a cellular level, however, both bone types are composed of lamellar bone and cannot be distinguished microscopically.
The noninvasive OrthoPak® Bone Growth Stimulator (BioElectron) received U.S. Food and Drug Administration (FDA) premarket approval in 1984 for treatment of fracture nonunion. Pulsed electromagnetic field systems with FDA premarket approval (all noninvasive 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 pseudoarthroses. No distinction was made between long and short bones. FDA has approved labeling changes for electrical bone growth stimulators that remove any timeframe for the diagnosis.
No semi-invasive electrical bone growth stimulator devices with FDA approval or clearance were identified.
Noninvasive electrical bone growth stimulation may be considered medically necessary as treatment of fracture nonunions or congenital pseudoarthroses in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities). The diagnosis of fracture nonunion must meet ALL of the following criteria:
- at least 3 months have passed since the date of fracture;
- serial radiographs have confirmed that no progressive signs of healing have occurred;
- the fracture gap is 1 cm or less; and
- the patient can be adequately immobilized; and
- is of an age likely to comply with nonweight bearing for fractures of the pelvis and lower extremities.
Investigational applications of electrical bone growth stimulation include, but are not limited to, immediate postsurgical treatment after appendicular skeletal surgery, stress fractures, or for the treatment of fresh fractures, delayed union, arthrodesis or failed arthrodesis.
Implantable and semi-invasive electrical bone growth stimulators are considered investigational.
A fracture is most commonly defined as “fresh” for 7 days after the fracture occurs. Most fresh closed fractures heal without complications with the use of standard fracture care, ie, closed reduction and cast immobilization.
Delayed union is defined as a decelerating healing process as determined by serial x-rays, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention. In contrast, nonunion serial xrays (described next) show no evidence of healing. When lumped together, delayed union and nonunion are sometimes referred to as “ununited fractures.”
There is not a consensus for the definition of nonunions. One proposed definition is failure of progression of fracture healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing).(1)
The original FDA labeling of fracture nonunions defined nonunions as fractures that had not shown progressive healing after at least 9 months from the original injury. The original 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.” This timeframe 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. Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables that are present in fractures, ie, degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying 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. The current policy of requiring a 3-month timeframe for lack of progression of healing is consistent with the definition of nonunion as described in the clinical literature.
BlueCard/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Claims for noninvasive electrical stimulation devices may be adjudicated as durable medical equipment.
This policy was initially developed in December 1995. Since that time, the policy has been updated on a regular basis using MEDLINE literature searches. The most recent literature review was conducted through November 4, 2014. Noninvasive Bone Growth Stimulation
This policy was initially developed in December 1995. Since that time, the policy has been updated on a regular basis using MEDLINE literature searches. The most recent literature review was conducted through November 4, 2014.
Noninvasive Bone Growth Stimulation
The policy regarding electrical bone stimulation as a treatment of nonunion of fractures of the appendicular skeleton is based on the labeled indications by the U.S. Food and Drug Administration (FDA). 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.(2-6)
A 2008 systematic review of electromagnetic bone growth stimulation by Griffin et al included 49 studies, 3 of which were randomized controlled trials (RCTs).(7) The 2 RCTs that included patients with nonunion, and the single RCT that included patients with delayed union, are described next.
A 1994 RCT by Scott and King compared capacitive coupled electric fields with sham treatment (dummy unit) 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.(8) 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, 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).
In 2003, Simonis et al compared pulsed electromagnetic field stimulation and placebo treatment for tibial shaft fractures ununited at least 1 year after fracture, no metal implant bridging the fracture gap, and no radiologic progression of healing in the 3 months before treatment.(9) All 34 patients received operative treatment with osteotomy and unilateral external fixator before 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 (p=0.02). 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 pulsed electromagnetic field (PEMF) therapy in the treatment of nonunion of the tibia and suggest that future trials should consider which modality of electromagnetic stimulation and in which anatomic sites the treatment is most effective.
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 ulna).(10) 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 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, 2-12) and sham controls (4.4 months; range, 2-7).
In a double-blind RCT by Sharrard from 1990, PEMF stimulation was compared with a sham procedure using a dummy device in 45 patients with delayed union of the tibia.(11) 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 (20 treatment, 25 control). 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, 1 had probably united, 3 progressed toward union, and 17 showed no progress.
The policy regarding electrical stimulation of delayed unions is based on a 1992 TEC Assessment of the RCT by Sharrard,(12) which offered the following conclusions:
Sharrard reported radiographic evidence of healing at the end of the 12-week treatment period. Radiographs were rated separately by a radiologist and an orthopedic surgeon. Their inconsistent rating methods and uncertain comparability in their findings make the radiographic evidence difficult to interpret. In addition, it is uncertain whether radiographic evidence of healing after 12 weeks of treatment, an intermediate outcome, predicts health outcomes such as healing and need for subsequent surgery. In this study, there were no statistically significant differences between the active and sham groups on clinical outcomes such as movement at the fracture site, pain, and tenderness. Thus, Sharrard’s health outcome data do not show that noninvasive electrical bone growth stimulation delivers an advantage over placebo.
In 2011, Griffin et al published a Cochrane review of electromagnetic field stimulation for treating delayed union or nonunion of long bone fractures in adults.(13) In addition to the 3 RCTs previously reviewed, the systematic review included a 1984 study by Barker et al that randomized 17 participants with tibial nonunion to electromagnetic field stimulation or sham treatment.(14) Thus, 4 studies with a total of 125 participants were included for analysis. The primary outcome measure was the proportion of participants whose fractures had united at a fixed time point. For this outcome, the overall pooled effect size was small and not statistically significant (risk ratio, 1.96; 95% confidence interval, 0.86 to 4.48). Interpretation is limited due to the substantial clinical and statistical heterogeneity in the pooled analysis. In addition,
there was no reduction in pain found in 2 trials, and none of the studies reported functional outcomes. The authors concluded that electromagnetic stimulation may offer some benefit in the treatment of delayed union and nonunion, but the evidence is inconclusive and insufficient to inform current practice.
Two randomized sham-controlled trials have been identified on the treatment of delayed union with PEMF. In the Sharrard study, radiographic healing was improved at 12 weeks, but there were no statistically significant differences between groups for clinical outcomes. In the study by Shi et al, only the rate of healing at an average of 4.8 months was statistically significant, and it is not clear if this is a prespecified end point. The time to healing was not reduced by PEMF. Additional study is needed to
permit greater certainty regarding the effect of this technology on delayed unions.
Appendicular Skeletal Surgery
A comprehensive search found 2 small RCTs on noninvasive electrical bone growth stimulation after orthopedic surgery. In 1988, Borsalino et al reported a randomized double-blind sham-controlled trial of pulsed electromagnetic field stimulation (8 h/d) in 32 patients who underwent femoral intertrochanteric osteotomy for osteoarthritis of the hip.(15) Radiographic measurements at 90 days revealed significant increases in the periosteal bone callus and in trabecular bone bridging at the lateral, but not the medial cortex. The study is limited by the small sample size and the lack of clinical outcomes.
A 2004 trial randomized 64 patients (144 joints with triple arthrodesis or subtalar arthrodesis) to pulsed electromagnetic field stimulation for 12 hours a day or to an untreated control condition.(16) Patients at high risk of nonfusion (rheumatoid arthritis, diabetes mellitus, or on oral corticosteroids) were excluded from the study. Blinded radiographic evaluation found a significant decrease in the time to union (12.2 weeks for talonavicular arthrodesis vs 17.6 weeks in the control group; 13.1 weeks for calcaneocuboid fusion vs 17.7 weeks for the control group). Clinical outcomes were not assessed.
A multicenter, double-blind, randomized sham-controlled trial evaluated 12 weeks of pulsed electromagnetic field stimulation for acute tibial shaft fractures.(17) The end points 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 36-Item Short-Form Health Survey Physical Component Summary score (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.
Hanneman et al reported a multicenter double-blind, randomized, sham-controlled trial (N=102) that found little advantage of 6 weeks of PEMF for the treatment of fresh (≤5 days from injury) scaphoid fractures.(18) Outcomes included the time to clinical and radiologic union and functional outcome at 6, 9, 12, 24, and 52 weeks. Radiologic union measured by computed tomography was not significantly different between the 2 groups. The median time to clinical union was 6 weeks in both groups. The return to normal range of movement at the wrist was 12 weeks in both groups. Grip strength of the dominant hand returned to normal earlier with PEMF, but there was no significant difference in return of grip strength of the nondominant hand.
These sham-controlled RCTs do not support a benefit for electromagnetic stimulation as an adjunctive treatment for fresh fractures.
In 2008, Beck et al reported a well-conducted RCT (N=44) of capacitively coupled electric fields (OrthoPak) for healing acute tibial stress fractures.(19) 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.
Invasive Bone Growth Stimulation
A comprehensive search for implantable bone stimulators identified a small number of case series, all of which focused on foot and ankle arthrodesis in patients at high risk for nonunion (summarized in reference in Petrisor and Lau20 ). Risk factors for nonunion included smoking, diabetes mellitus, Charcot (diabetic) neuroarthropathy, steroid use, and previous nonunion. The largest case series described outcomes of foot or ankle arthrodesis in 38 high-risk patients.(21) 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 6 cases of deep infection and 5 cases of painful or prominent bone stimulators necessitating stimulator removal. A multicenter retrospective review described outcomes from 28 high-risk patients with arthrodesis of the foot and ankle.(22) Union was reported for 24 (86%) cases at an average of 10 weeks; complications included breakage of the stimulator cables in 2 patients and hardware failure in 1 patient. Five patients required additional surgery. Prospective controlled trials are needed to evaluate this procedure.
The 1992 TEC Assessment indicated that semi-invasive bone growth stimulators are no longer in wide use.(12)
Clinical Input Received From Physician Specialty Societies and Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.
In response to requests, input was received from 5 academic medical centers while this policy was under review in 2012. The input supported use of noninvasive electrical bone growth stimulation for the treatment of fracture nonunions or congenital pseudoarthroses of the appendicular skeleton. Input agreed that noninvasive electrical bone growth stimulation is investigational for immediate postsurgical treatment after appendicular skeletal surgery and treatment of fresh fractures. Most reviewers considered the use of noninvasive electrical bone growth stimulation to be investigational for the treatment of delayed union, for arthrodesis, or for the treatment of failed arthrodesis.
Summary of Evidence
There is evidence from randomized controlled trials (RCTs) and systematic reviews of clinical trials that noninvasive electrical stimulators improve fracture healing for patients with fracture nonunion. This evidence is not from high-quality RCTs, however, and systematic reviews provide qualified support for this conclusion. Based on the available evidence and the lack of other options for patients with nonunion, electrical stimulation may be considered medically necessary for the U.S. Food and Drug Administration (FDA)‒approved indications of fracture nonunions or congenital pseudoarthroses in the appendicular skeleton when specific criteria are met.
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. In addition, 2 recent randomized trials found no benefit of electrical bone growth stimulation for fresh fractures. Use of noninvasive electrical bone growth stimulation for these conditions is considered investigational.
The literature for implantable bone stimulators of the appendicular skeleton consists of a small number of case series. In addition, no semi-invasive devices have FDA clearance or approval. The use of invasive or semi-invasive electrical bone growth stimulators is considered investigational.
Practice Guidelines and Position Statements
U.S. Preventive Services Task Force Recommendations
Medicare National Coverage
Noninvasive stimulators are covered for the following indications(23):
- Nonunion of long bone fractures
- Failed fusion, where a minimum of 9 months has elapsed since the last surgery
- Congenital pseudarthroses
Invasive stimulators are covered for:
- Nonunion of long bone fractures
Effective for services performed on or after April 1, 2000, nonunion of long bone fractures, for both noninvasive and invasive devices, is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.
- Bhandari M, Fong K, Sprague S, et al. Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am. Aug 1 2012;94(15):e1091-1096. PMID 22854998
- Ahl T, Andersson G, Herberts P, et al. Electrical treatment of non-united fractures. Acta Orthop Scand. Dec 1984;55(6):585-588. PMID 6335345
- Connolly JF. Selection, evaluation and indications for electrical stimulation of ununited fractures. Clin Orthop Relat Res. Nov-Dec 1981(161):39-53. PMID 6975690
- Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am. Jan 1984;15(1):89-106. PMID 6607443
- de Haas WG, Beaupre A, Cameron H, et al. The Canadian experience with pulsed magnetic fields in the treatment of ununited tibial fractures. Clin Orthop Relat Res. Jul 1986(208):55-58. PMID 3720140
- Sharrard WJ, Sutcliffe ML, Robson MJ, et al. The treatment of fibrous non-union of fractures by pulsing electromagnetic stimulation. J Bone Joint Surg Br. 1982;64(2):189-193. PMID 6978339
- Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established nonunion of long bone fractures: what is the evidence? Injury. Apr 2008;39(4):419-429. PMID 18321512
- Scott G, King JB. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. J Bone Joint Surg Am. Jun 1994;76(6):820-826. PMID 8200888
- Simonis RB, Parnell EJ, Ray PS, et al. Electrical treatment of tibial non-union: a prospective, randomised, double-blind trial. Injury. May 2003;34(5):357-362. PMID 12719164
- Shi HF, Xiong J, Chen YX, et al. Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study. BMC Musculoskelet Disord. 2013;14:35. PMID 23331333
- Sharrard WJ. A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J Bone Joint Surg Br. May 1990;72(3):347-355. PMID 2187877
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical bone growth stimulation for delayed union or nonunion of fractures. TEC Assessment. 1992:Volume 7:332-351. PMID
- Griffin XL, Costa ML, Parsons N, et al. Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults. Cochrane Database Syst Rev. 2011(4):CD008471. PMID 21491410
- Barker AT, Dixon RA, Sharrard WJ, et al. Pulsed magnetic field therapy for tibial non-union. Interim results of a double-blind trial. Lancet. May 5 1984;1(8384):994-996. PMID 6143970
- Borsalino G, Bagnacani M, Bettati E, et al. Electrical stimulation of human femoral intertrochanteric osteotomies. Double-blind study. Clin Orthop Relat Res. Dec 1988(237):256-263. PMID 3191636
- Dhawan SK, Conti SF, Towers J, et al. The effect of pulsed electromagnetic fields on hindfoot arthrodesis: a prospective study. J Foot Ankle Surg. Mar-Apr 2004;43(2):93-96. PMID 15057855
- Adie S, Harris IA, Naylor JM, et al. Pulsed electromagnetic field stimulation for acute tibial shaft fractures: a multicenter, double-blind, randomized trial. J Bone Joint Surg Am. Sep 7 2011;93(17):1569-1576. PMID 21915570
- Hannemann PF, van Wezenbeek MR, Kolkman KA, et al. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, double-blind, placebo-controlled trial. Bone Joint J. Aug 2014;96-B(8):1070-1076. PMID 25086123
- 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. Mar 2008;36(3):545-553. PMID 18055921
- Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin. Dec 2005;10(4):609-620, vii-viii. PMID 16297822
- Lau JT, Stamatis ED, Myerson MS, et al. Implantable direct-current bone stimulators in high-risk and revision foot and ankle surgery: a retrospective analysis with outcome assessment. Am J Orthop (Belle Mead NJ). Jul 2007;36(7):354-357. PMID 17694182
- Saxena A, DiDomenico LA, Widtfeldt 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. Nov-Dec 2005;44(6):450-454. PMID 16257674
- Centers for Medicare and Medicaid Services. National Coverage Determination for Osteogenic Stimulators (150.2). 2005; https://www.cms.gov/medicare-coverage-database/search/document-id-searchresults.aspx?DocID=150.2&ncd_id=150.2&ncd_version=2&basket=ncd%25253A150%25252E2%25253A2%25253AOsteogenic+Stimulators&bc=gAAAAAAAAAAA&. Accessed August, 2011.
|CPT||20974||Electrical stimulation to aid bone healing; noninvasive (non-operative)|
|ICD-9 Procedure||78.90-78.99||Insertion of bone growth stimulator, code range|
|99.86||Non-invasive placement of bone growth stimulator|
|ICD-9 Diagnosis||733.81||Malunion of fracture|
|733.82||Nonunion of fracture (code includes pseudoarthrosis/pseudarthrosis)|
|HCPCS||E0747||Osteogenesis stimulator, electrical, noninvasive, other than spinal applications|
|E0749||Osteogenesis stimulator, electrical, surgically implanted|
|ICD-10-CM (effective 10/1/15)||Q74.0||Other congenital malformations of upper limb(s), including shoulder girdle (includes congenital pseudarthrosis of clavicle)|
S32.2xxK – S32.9xxK;
|Fracture nonunion codes for the appendicular skeleton – 7th digit “K” is subsequent encounter for nonunion (in forearm, femur, lower leg & ankle fractures 7th digits “M” and “N” are also nonunion for certain types of open fractures – in fractures of the shoulder, humerus, wrist, hand and foot there isn’t separation of open vs. closed nonunions).|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services. There isn’t a specific ICD-10-PCS code for application of this stimulation.|
|3E00XGC||Administration, physiological systems and anatomical regions, introduction, skin and mucous membranes, external, other therapeutic substance|
|Type of Service||Surgery|
|Place of Service||
Bone growth stimulation, electrical, appendicular skeleton
Electrical bone growth stimulation, appendicular skeleton
Stimulation, electrical bone growth, appendicular skeleton
|12/01/95||Add to Surgery section||New policy|
|11/01/98||Replace policy||Policy reviewed, policy indications revised|
|12/18/02||Replace policy||Policy updated; policy statement unchanged|
|12/17/03||Replace policy||Policy reviewed by consensus without literature review; no changes in policy.|
|3/7/06||Replace policy||Policy reviewed with literature search for the period of 2002 through December 2005; no change in policy statement|
|02/14/08||Replace policy||Policy returned to active review and updated; references 7-10 added; implantable stimulators added to policy (investigational); no other changes in policy statements. “Noninvasive” removed from policy title|
|09/10/09||Replace policy||Policy updated with literature search, rationale extensively edited, references 10 to 14 added. No change to existing policy statements; semi-invasive stimulators added as investigational|
|09/16/10||Replace policy||Policy updated with literature review through July 2010; no change in policy statements|
|09/01/11||Replace policy||Policy updated with literature review through July 2011; reference 11 added and references reordered; policy statements unchanged|
|9/13/12||Replace policy||Policy updated with literature review through July 2012; references 1, 16 added and references reordered; arthrodesis added to investigational policy statement; definitions of fresh fractures, delayed union, and non-union added to policy guidelines for consistency with policy No. 1.01.05|
|12/13/12||Replace policy||Clinical input reviewed; policy statements unchanged|
|1/09/14||Replace policy||Policy updated with literature review through November 25, 2013; references 10, 18, and 19 added; stress fractures added to investigational statement; compliance with non-weight bearing clarified|
|12/11/14||Replace policy||Policy updated with literature review through November 4, 2014; reference 18 added; policy statement unchanged|