MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Electrical Bone Growth Stimulation of the Appendicular Skeleton

Number 7.01.529*

Effective Date March 25, 2014

Revision Date(s) 03/10/14; 02/11/13; 03/13/12; 03/08/11; 02/09/10; 03/10/09; 05/13/08; 04/08/08; 06/12/07; 07/11/06; 06/16/06; 06/14/05; 05/11/04; 04/15/03; 06/02/00; 03/02/99; 05/05/97

Replaces 7.01.07

*Medicare has a policy.

Policy

Noninvasive electrical bone growth stimulation may be considered medically necessary as treatment of 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 non-union must meet BOTH of the following criteria:

  • At least 3 months have passed since the date of fracture or osteotomy; AND
  • Serial radiographs have confirmed that no progressive signs of healing have occurred.

Noninvasive electrical bone growth stimulation may be considered medically necessary as treatment for fractures that may have a high incidence of non-union or delayed union, such as carpal navicular fractures without meeting the criteria above.

Investigational applications of electrical bone growth stimulation include, but are not limited to, the treatment of fresh fractures or delayed union of fractures which are not considered to be in high-risk areas. Delayed union is defined as a decelerating fracture healing process, as identified by serial x-rays.

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

Related Policies

1.01.05

Ultrasound Accelerated Fracture Healing Device

1.01.27

Electrical Stimulation for the Treatment of Arthritis

2.01.40

Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions

7.01.85

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

8.03.01

Functional Neuromuscular Electrical Stimulation

Policy Guidelines

Fresh Fractures

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.

Nonunions

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 definition of non-union in the FDA labeling simply suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without giving any guidance regarding the timeframe of observation. However, it is suggested that a reasonable time period for lack of visible signs of healing is 3 months. The following patient selection criteria are suggested, consistent with those proposed for electrical stimulation* as a treatment of non-unions:

  • At least 3 months have passed since the date of the fracture, AND
  • Serial radiographs have confirmed that no progressive signs of healing have occurred, AND
  • The fracture gap is 1 cm or less, AND
  • The patient can be adequately immobilized and is of an age when he/she is likely to comply with non-weight bearing.

Any information indicating a fracture gap of greater than 1cm would suggest that treatment using bone growth stimulator would be ineffective.

Note: Electrical stimulation of the spine and ultrasound devices for bone growth stimulation are both considered in a separate medical policies. (See Related Policies)

Description

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

Background

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. This concept has led to controversy regarding what constitutes long vs. short bones. According to orthopedic anatomy, the skeleton consists of long bones, short bones, flat bones, and irregular bones. Long bones act as levers to facilitate motion, while short bones function to dissipate concussive forces. Short bones include those composing the carpus and tarsus. Flat bones, such as the scapula or pelvis, provide a broad surface area for attachment of muscles. Thus the metatarsal is considered a long bone, while the scaphoid bone of the wrist is considered a short bone. Both the metatarsals and scaphoid bones are at a relatively high risk of nonunion after a fracture.

Despite their anatomic classification, all bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Cortical bone is always located on the exterior of the bone, while the trabecular bone is found in the interior. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. However, at a cellular level, both bone types are composed of lamellar bone and cannot be distinguished microscopically.

Regulatory Status

The non-invasive OrthoPak® Bone Growth Stimulator (BioElectron) received FDA premarket approval in 1984 for treatment of fracture nonunion. Pulsed electromagnetic field systems with FDA premarket approval (all non-invasive devices) include Physio-Stim® from Orthofix, Inc., first approved in l986, and OrthoLogic® 1000, approved in l997, both indicated for treatment of established nonunion secondary to trauma, excluding vertebrae and all flat bones, in which the width of the nonunion defect is less than one-half the width of the bone to be treated; and the EBI Bone Healing System® from Electrobiology, Inc., which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses. No 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 were identified with FDA approval or clearance.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations. This policy does not apply to Medicare Advantage.

Benefit Application

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 update was conducted through January 2014.

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 FDA-labeled indications. The FDA approval was based on a number of case series in which patients with nonunions, primarily of the tibia, served as their own control. These studies suggest that electrical stimulation results in subsequent unions in a significant percentage of patients.(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 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 (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 anatomical sites the treatment is most effective.

Delayed Union

Shi et al reported a randomized sham-controlled trial that included 58 patients with delayed union of surgically-reduced long-bone fractures (femur, tibia, humerus, radius or ulna).(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 out of 4 cortices on blinded assessment. Three months of treatment resulted in a slight, but not statistically significant, improvement in the rate of union between PEMF-treated patients and controls (38.7% vs 22.2%). The success rate was significantly greater with PEMF (77.4% vs 48.1%) after an average of 4.8 months of treatment. The time to union was not significantly different between PEMF (4.8 months; range, 2-12) 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 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,(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 reviewed above, 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.

Section Summary

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 hours a day) 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.

Fresh Fractures

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 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.

Another smaller (n=53) multicenter double-blind, randomized sham-controlled trial found no advantage of PEMF for the conservative treatment of fresh (≤5 days from injury) scaphoid fractures.(18) Outcomes included the time to clinical and radiologic union and functional outcome.

Stress 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(20)). 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 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.

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. 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 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, 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 Policy

Noninvasive stimulators are covered for the following indications:

  • Nonunion of long bone fractures,
  • Failed fusion, where a minimum of 9 months has elapsed since the last surgery, and
  • 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 three or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of two 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. 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.
  11. 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.
  12. 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 7:332-51.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. Hannemann PF, Gottgens KW, van Wely BJ et al. The clinical and radiological outcome of pulsed electromagnetic field treatment for acute scaphoid fractures: a randomised double-blind placebo-controlled multicentre trial. J Bone Joint Surg Br 2012; 94(10):1403-8.
  19. 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):545-53.
  20. 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.
  21. 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.
  22. 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.
  23. Centers for Medicare and Medicaid Services. National Coverage Determination for Osteogenic Stimulators (150.2). 2005. Available online at:http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=65&ncdver=2&DocID=150.2&ncd_id=150.2&ncd_version=2&basket=ncd%2525253A150%2525252E2%2525253A2%2525253AOsteogenic+Stimulators&bc=gAAAAAgAAAAAAA%3d%3d&. Last accessed February, 2014.
  24. Blue Cross and Blue Shield Association. Electrical Bone Growth Stimulation of the Appendicular Skeleton. Medical Policy Reference Manual, Policy 7.01.07, 2014.

Coding

Codes

Number

Description

CPT

20974

Electrical stimulation to aid bone healing; non-invasive (non-operative)

 

20975

invasive (operative)

HCPCS

E0747

Osteogenesis stimulator, electrical, non-invasive, other than spinal applications

 

E0749

Osteogenesis stimulator, electrical, surgically implanted

Type of Service

Surgery

 

Place of Service

Home

Inpatient/
Outpatient

Physician’s Office

 

Appendix

N/A

History

Date

Reason

05/05/97

Add to Surgery Section - New Policy.

03/02/99

Replace policy. Policy reviewed, policy indications revised.

06/02/00

Replace policy. Added cross-references to other stimulation policies.

04/15/03

Replace policy. Policy updated; policy statement unchanged. Title changed from Electrical Bone Growth Stimulation.

05/11/04

Replace policy. Policy reviewed without literature review; no change to policy statement.

06/14/05

Replace policy. Policy reviewed with literature search; no change to policy statement.

06/16/06

Replace policy. Policy reviewed with literature search; no change to policy statement. Scope and Disclaimer language updated.

07/11/06

Policy Changed to a PR Policy - Policy reviewed and changed to PR policy, replacing policy BC.7.01.07, following review by a local orthopedic surgeon. Policy statement revised to include indications for non-union and osteotomy; criteria for immobilization of patient and non-weight bearing limitations removed; reference added.

06/12/07

Replace policy. Policy updated with literature review; references added. No change in policy statement. Reviewed by practicing orthopedic surgeon.

04/08/08

Replace policy. Policy updated with literature search; no change to the policy statement.

5/13/08

Replace policy. Policy updated with literature search. Policy statement revised to delete “the fracture gap is 1 CM or less”. Reviewed by practicing orthopedic surgeon.

3/10/09

Replace policy. Policy updated with literature search. No change to policy statement.

02/09/10

Replace policy. Policy updated with literature search. Policy statement added regarding Implantable and semi-invasive electrical bone growth stimulators as investigational. Title updated, Codes added.

03/08/11

Replace policy. Policy updated with literature search. No change to policy statement.

03/23/12

Replace policy. Policy updated. No change to policy statement. Related Policies updated with 1.01.27.

08/27/12

Update Related Policies – Add 2.01.40.

10/09/12

Update Related Policies – Add 8.03.01.

02/13/13

Replace policy. No change to policy statement. Added definitions of fresh fractures, delayed union, and non-union to policy guidelines for consistency with policy 1.01.05. Added reference 16, 17.

12/03/13

Coding Update. Add ICD-10 codes.

03/25/14

Replace policy. No change to policy statement. Rationale section extensively updated. Code 99.86 was removed per ICD-10 mapping project; this code is not utilized for adjudication of policy. ICD-9 and ICD-10 diagnosis codes removed; these were informational and not used for adjudication.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
©2014 Premera All Rights Reserved.