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MP 7.01.07 Electrical Bone Growth Stimulation of the Appendicular Skeleton

Medical Policy    
Section
Surgery
 
Original Policy Date
12/1/95
Last Review Status/Date
Reviewed with literature search/12:2012
Issue
12:2012
  Return to Medical Policy Index

Disclaimer

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. 


Description

In the appendicular skeleton, electrical stimulation (with either implantable electrodes or noninvasive surface stimulators) has been investigated for the treatment of delayed union, nonunion, and fresh fractures.

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 (DC) 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 used primarily 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.

Nonunion

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.

Delayed Union

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."

Regulatory Status

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. The 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.


Policy

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 non-weight bearing.

Investigational applications of electrical bone growth stimulation include, but are not limited to, immediate post-surgical treatment after appendicular skeletal surgery, or for the treatment of fresh fractures, delayed union, arthrodesis or failed arthrodesis.

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


Policy Guidelines

 Fresh Fracture

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, i.e., closed reduction and cast immobilization.

Delayed Union

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.

Nonunion

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. 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. 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


Benefit Application
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.


Rationale

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 search was conducted using MEDLINE for the period of August 2011 through July 2012.

Noninvasive Bone Growth Stimulation

Nonunion

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). 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. (2-6)

A 2008 systematic review of electromagnetic bone growth stimulation by Griffin and colleagues 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 below.

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 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).

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 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 (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 therapy (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.

Delayed Union

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. (10) 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 and 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, (11) 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 non-union of long bone fractures in adults. (12) In addition to the 3 RCTs reviewed above, the systematic review included a 1984 study by Barker et al. that randomized 17 participants with tibial non-union to electromagnetic field stimulation or sham treatment. (13) 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 [RR]: 1.96; 95% confidence interval [CI]: 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 non-union, but the evidence is inconclusive and insufficient to inform current practice.

Appendicular Skeletal Surgery

A comprehensive search found 2 small randomized controlled trials on non-invasive 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 hours a day) in 32 patients who underwent femoral intertrochanteric osteotomy for osteoarthritis of the hip. (14) 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. (15) Patients at high risk of non-fusion (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.

Fresh Fractures

A multicenter, double-blind, randomized sham-controlled trial evaluated 12 weeks of pulsed electromagnetic field stimulation for acute tibial shaft fractures. (16) 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 (Short Form) 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.

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 (17)). 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. (18) 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. (19) 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.

No studies of invasive or semi-invasive (semi-implantable) stimulators were identified during the most recent literature search of MEDLINE from August 2010 through July 2011. The 1992 TEC Assessment indicated that semi-invasive bone growth stimulators are no longer in wide use. (11)

Clinical Input Received through 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.

2012

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 post-surgical treatment after appendicular skeletal surgery and treatment of fresh fractures. A majority of 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

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 non-union. 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 non-union, 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 evaluate the efficacy of noninvasive electrical bone growth stimulation following surgery of the appendicular skeleton or for the treatment of delayed union. In addition, a recent randomized trial 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.

Medicare National Coverage

Noninvasive stimulators are covered for the following indications (20):

  • 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.

References:

 

  1. 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 2012; 94(15):e1091-6.
  2. Ahl T, Andersson G, Herberts P et al. Electrical treatment of non-united fractures. Acta Orthop Scand 1984; 55(6):585-8.
  3. Connolly JF. Selection, evaluation and indications for electrical stimulation of ununited fractures. Clin Orthop Relat Res 1981; (161):39-53.
  4. Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am 1984; 15(1):89-106.
  5. 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 1986; (208):55-8.
  6. 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):189-93.
  7. 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):419-29.
  8. 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 1994; 76(6):820-6.
  9. Simonis RB, Parnell EJ, Ray PS et al. Electrical treatment of tibial non-union: a prospective, randomised, double-blind trial. Injury 2003; 34(5):357-62.
  10. Sharrard WJ. A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J Bone Joint Surg Br 1990; 72(3):347-55.
  11. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical bone growth stimulation for delayed union or nonunion of fractures. TEC Evaluations 1992: Volume 7:332-51.
  12. 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.
  13. Barker AT, Dixon RA, Sharrard WJ et al. Pulsed magnetic field therapy for tibial non-union. Interim results of a double-blind trial. Lancet 1984; 1(8384):994-6.
  14. Borsalino G, Bagnacani M, Bettati E et al. Electrical stimulation of human femoral intertrochanteric osteotomies. Double-blind study. Clin Orthop Relat Res 1988; (237):256-63.
  15. Dhawan SK, Conti SF, Towers J et al. The effect of pulsed electromagnetic fields on hindfoot arthrodesis: a prospective study. J Foot Ankle Surg 2004; 43(2):93-6.
  16. 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 2011; 93(17):1569-76.
  17. 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):609-20, vii-viii.
  18. 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) 2007; 36(7):354-7.
  19. 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 2005; 44(6):450-4.
  20. Centers for Medicare and Medicaid Services. National Coverage Determination for Osteogenic Stimulators (150.2). 2005. Available online at: https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=150.2&ncd_id=150.2&ncd_version=2&basket=ncd%25253A150%25252E2%25253A2%25253AOsteogenic+Stimulators&bc=gAAAAAAAAAAA&. Last accessed August, 2011.

 

Codes

Number

Description

CPT  20974  Electrical stimulation to aid bone healing; noninvasive (non-operative) 
  20975 invasive (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 10/1/14) Q74.0 Other congenital malformations of upper limb(s), including shoulder girdle (includes congenital pseudarthrosis of clavicle)  
   

S32.2xxK – S32.9xxK;  
S42.00xK – S42.92xK;  
S49.00xK – S49.199K;  
S52.00xK – S52.92xN; 
S59.00xK – S59.299K;  
S62.00xK – S62.92xK;  
S72.00xK – S72.92xN;  
S79.00xK – S79.199K;  
S82.00xK – S82.92xN;  
S89.00xK – S89.399K;  
S92.00xK – S92.919K

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 10/1/14)    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 

Home  
Inpatient  
Outpatient
Physician’s Office 


Index

Bone growth stimulation, electrical, appendicular skeleton
Electrical bone growth stimulation, appendicular skeleton
Stimulation, electrical bone growth, appendicular skeleton


Policy History
Date Action Reason
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
06/14/07 Replace policy
  Policy reviewed with literature search for the period of December 2005 through May 2007; no new references added. No change in policy statement. Policy status changed to no further review scheduled. 
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