Clinical UM Guideline

 

Subject: Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton
Guideline #: CG-DME-40 Publish Date:    01/01/2019
Status: Revised Last Review Date:    11/08/2018

Description

This document addresses the use noninvasive electrical bone growth stimulation devices for the treatment of orthopedic and neurosurgical conditionsof the appendicular skeleton. This document does not address invasive electrical bone growth stimulation of any body area or noninvasive electrical bone growth stimulation of the spine.

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

Clinical Indications

Medically Necessary:

  1. Noninvasive electrical bone growth stimulation of the appendicular skeleton is considered medically necessary as a treatment for fracture nonunion or congenital pseudoarthroses of all long and short bones of the appendicular skeleton when all of the following criteria are met: 
    1. At least 45 days have passed since the date of fracture or the date of surgical treatment of the fracture; and
    2. Serial radiographs or appropriate imaging studies confirm that no progressive signs of healing have occurred; and
    3. The fracture gap is less than 1 centimeter.
  2. Noninvasive electrical bone growth stimulation of the appendicular skeleton is considered medically necessary as a treatment for joint fusion secondary to failed arthrodesis of the ankle or knee.

Not Medically Necessary:

  1. Noninvasive electrical bone growth stimulation of the appendicular skeleton is considered not medically necessary when either of the following contraindications is present:
    1. Draining osteomyelitis; or
    2. Synovial pseudoarthroses.
  2. Noninvasive electrical bone growth stimulation of the appendicular skeleton is considered not medically necessary when the above criteria are not met, including, but not limited to treatment of any of the following:
    1. As an adjunct to (that is, at the time of or immediately after) bunionectomy procedures (Note: When such surgery results in nonunion, the medically necessary criteria above may apply); or
    2. As an adjunct to (that is, at the time of or immediately after) distraction osteogenesis procedures for any indication (for example, limb lengthening, nonunion, or tibial defects); or
    3. Delayed/incomplete union fractures; or
    4. Fresh fractures; or
    5. Patellar tendinopathy; or
    6. Pathological fractures due to bone pathology or tumor/malignancy; or
    7. Stress fractures.
Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

 

20974

Electrical stimulation to aid bone healing; noninvasive (nonoperative)

 

 

HCPCS

 

E0747

Osteogenesis stimulator; electrical, noninvasive, other than spinal applications

 

 

ICD-10 Diagnosis

 

 

For diagnoses related to the appendicular skeleton, including the following:

M96.0

Pseudarthrosis after fusion or arthrodesis [ankle or knee]

Q68.3

Congenital bowing of femur

Q68.4

Congenital bowing of tibia and fibula

Q68.5

Congenital bowing of long bones of leg, unspecified

Q68.8

Other specified congenital musculoskeletal deformities

Q74.0

Other congenital malformations of upper limb(s), including shoulder girdle (includes congenital pseudarthrosis of clavicle)

S32.301K-S32.9XXK

Fracture of ilium, acetabulum, pubis, ischium, other pelvis, subsequent encounter for fracture with nonunion (code range with seventh digit K)

S42.001K-S42.92XK

Fracture of shoulder and upper arm, subsequent encounter for fracture with nonunion (code range with seventh digit K)

S52.001K-S52.92XN

Fracture of forearm, subsequent encounter for fracture with nonunion (code range with seventh digit K, M or N)

S59.001K-S59.299K

Physeal fracture of ulna and radius, subsequent encounter for fracture with nonunion (code range with seventh digit K)

S62.001K-S62.92XK

Fracture at wrist and hand level, subsequent encounter for fracture with nonunion (code range with seventh digit K)

S72.001K-S72.92XN

Fracture of femur, subsequent encounter for fracture nonunion (code range with seventh digit K, M or N)

S79.001K-S79.199K

Physeal fracture of femur, subsequent encounter for fracture nonunion (code range with seventh digit K)

S82.001K-S82.92XN

Fracture of lower leg, including ankle, subsequent encounter for nonunion (code range with seventh digit K, M or N)

S89.001K-S89.399K

Physeal fracture of tibia, fibula, subsequent encounter for nonunion (code range with seventh digit K)

S92.001K-S92.919K

Fracture of foot and toe, except ankle, subsequent encounter for fracture with nonunion (code range with seventh digit K)

T84.318A-T84.318S

Breakdown (mechanical) of other bone devices, implants and grafts

T84.498A-T84.498S

Other mechanical complication of other internal orthopedic devices, implants and grafts

Z98.1

Arthrodesis status

Discussion/General Information

Delayed Nonunions

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

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

Shi and colleagues (2013) conducted a prospective, randomized controlled trial of PEMF as an adjunct for the management of delayed union (that is, between 16 weeks and 6 months) in 58 individuals with long-bone fractures. Clinical and radiological assessments were performed to evaluate the healing status. Treatment efficacy was assessed at 3-month intervals. At the end of the study, only the rate of healing at an average of 4.8 months with PEMF treatment was statistically significant; however, it was not clear if this was a prespecified endpoint. Participants in the PEMF group showed a higher rate of union than those in the control group after the first 3 months of treatment, but this difference failed to achieve statistical significance.

According to the U.S. Food and Drug Administration’s (FDA) labeling for the various devices, electrical stimulation has not been cleared or indicated for use to enhance healing of fresh fractures that are considered to be at high risk for delayed or nonunion. Two multicenter, randomized, double-blind trials evaluating the use of electrical stimulation to accelerate healing in acute scaphoid fractures (Hannemann, 2012) or reduce the rate of surgical revision because of delayed union or nonunion in acute tibial shaft fractures (Adie, 2011) failed to demonstrate the effectiveness of PEMF stimulation for these indications. In follow-up to the 2012 pilot trial, Hannemann and colleagues (2014) found little advantage of 6 weeks of PEMF for the treatment of fresh (≤ 5 days from injury) scaphoid fractures when healing was assessed by computed tomography (CT) scans versus conventional scaphoid radiographs. Outcomes included the time to clinical and radiologic union and functional outcome at 6, 9, 12, 24, and 52 weeks. Radiologic union measured by CT was not significantly different between the two 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. This sham-controlled trial does not support a benefit for PEMF stimulation as an adjunctive treatment for fresh scaphoid fractures.

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

Fracture Nonunions

Externally used CC and PEMF stimulation results in success rates for fracture nonunion that are consistently reported between 80% to 89% in appropriately selected individuals (Simonis, 2003). There is, however, no substantive clinical evidence to predict a specific duration of treatment when treating fracture nonunions with electrical stimulation. The location and type of fracture, risk factors of the individual, the duration of nonunion prior to treatment, and past failed bone graft or failed electrical therapy are factors that may affect the duration of electrical stimulation therapy. The medical literature, including prospective, double-blind, randomized controlled trials and retrospective case series, are limited in reporting time-to-heal outcomes as measured by radiographic evidence of bone healing. For those individuals where healing outcomes were reported for long bone fracture nonunions treated with electrical stimulation, healing rates were documented within 3 months of initiation of treatment to > 1 year (AHRQ, 2005).

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

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

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

Arthrodesis of the Ankle or Knee

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

A search of the peer-reviewed literature evaluating the use of implantable bone stimulators for lower extremity joint arthrodesis identified a small number of case series that focused on foot and ankle arthrodesis in individuals at high risk for nonunion (Petrisor, 2005). Risk factors for nonunion included smoking, diabetes mellitus, Charcot (diabetic) neuropathy, steroid use and previous nonunion. The largest case series described outcomes of foot or ankle arthrodesis in 38 high-risk subjects (Lau, 2007). Union was observed in 65% of cases by follow-up evaluation (n=18), or chart review (n=20). Complications were reported in 16 (40%) cases, including 6 cases of deep infection, 5 cases of painful or prominent bone stimulators necessitating stimulator removal. A multicenter retrospective review described outcomes from 28 high-risk subjects with arthrodesis of the foot and ankle (Saxena, 2005). Union was reported for 24 (86%) cases at an average of 10 weeks; complications included breakage of the stimulator cables in 2 subjects and hardware failure in 1 subject. Five subjects required additional surgery. There continues to be insufficient evidence to support the efficacy of invasive or semi-invasive electrical stimulation for these non-spinal indications.

Distraction Osteogenesis

There is currently a lack of large, randomized, sham-controlled trials of homogeneous study populations to support the use of PEMF for enhancing bone formation in distraction osteogenesis (DO) following limb-lengthening procedures. Sabharwal (2011) reported that a small number of adolescents who underwent limb lengthening during DO did not demonstrate a difference in the rate or amount of new bone formation in participants who received treatment from an active PEMF coil compared to sham coil treatment (Eyres, 1996). Luna Gonzalez and colleagues (2005) evaluated a small group of adolescents (n=30) of short stature who underwent bilateral humeral lengthening. At Day 10 after surgery, PEMF stimulation was started on one side, for 8 hours/day. The extremity managed with PEMF was reported as exhibiting faster callus formation and greater bone density then did the contralateral control side. Sabharwal (2010) concluded, however, that “Because of limited data and multiple variables, including duration of PEMF treatment and its use in upper versus lower extremities, the role of PEMF during DO remains unclear.”

Other Considerations

Definitive selection criteria of candidates for noninvasive electrical bone growth stimulation have not been firmly established. However, there is sufficient evidence to conclude that this technology can provide benefit for individuals with persistent long bone nonunions. The product label of the Physio-Stim® bone growth stimulator (Orthofix Inc., Lewisville, TX) states the device:

…is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site show no visibly progressive signs of healing.

The FDA premarket approval (PMA) applications for noninvasive electrical bone growth stimulation devices contain information on the safety and effectiveness of these devices. These summaries state the devices are contraindicated in individuals lacking skeletal maturity, individuals with a demand-type pacemaker or implantable cardioverter defibrillator (ICD), and pregnant women. Although indications vary among devices, the safety and effectiveness of electrical bone growth stimulation has not been established with a nonunion secondary to or in connection with a pathological condition, is not indicated for misaligned fracture nonunion, when a synovial pseudarthrosis exists, when the bone gap is ≥ 1 centimeter or > ½ the diameter of the bone, and for individuals who are unable to be compliant with the appropriate use of a noninvasive device and treatment regimens.

Definitions

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

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

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

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

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

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

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

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

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

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

Long bones: Bones found in the extremities comprised of a shaft (diaphysis) and 2 ends (epiphyses); includes the humerus, radius, ulna, femur, tibia, fibula, metatarsal, and metacarpal bones.

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

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

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

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

References

Peer Reviewed Publications:

  1. 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):1569-1576.
  2. Akai M, Kawashima, Kimura AT, Hayashi K. Electrical stimulation as an adjunct to fusion: a meta-analysis of controlled clinical trials. Bioelectromagnetics. 2002; 23(7):496-504.
  3. Beck BR, Matheson GO, Bergman G, et al. Do capacitively coupled electric fields accelerate tibial stress fracture healing? A randomized controlled trial. Am J Sports Med. 2008; 36(3):545-553.
  4. Brighton CT, Black J, Friedenberg ZB, et al. A multicenter study of the treatment of nonunion with constant direct current. J Bone Joint Surg. 1981; 63-A(1):2-13.
  5. Dennis NZ, Das De S. Modified Mitchell's osteotomy for moderate to severe hallux valgus--an outcome study. J Foot Ankle Surg. 2011; 50(1):50-54.
  6. Dunn AW, Rushi GA. Electrical stimulation in treatment of delayed union and nonunion of fractures and osteotomies. South Med J. 1984; 177(12):1530-1534.
  7. Enan A, Abo-Hegy M, Seif H. Early results of distal metatarsal osteotomy through minimally invasive approach for mild-to-moderate hallux valgus. Acta Orthop Belg. 2010; 76(4):526-535.
  8. Eyres KS, Saleh M, Kanis JA. Effect of pulsed electromagnetic fields on bone formation and bone loss during limb lengthening. Bone. 1996; 18(6):505-509.
  9. Goldstein C, Sprague S, Petrisor BA. Electrical stimulation for fracture healing: current evidence. J Orthop Trauma. 2010; 24(Suppl 1):S62-S65.
  10. Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evidence? Injury. 2008; 39(4):419-429.
  11. Hannemann PF, Göttgens 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):1403-1408.
  12. 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. 2014; 96-B(8):1070-1076.
  13. Jeffcoach DR, Sams VG, Lawson CM, et al. Nonsteroidal anti-inflammatory drugs' impact on nonunion and infection rates in long-bone fractures. J Trauma Acute Care Surg. 2014; 76(3):779-783.
  14. Lau JT, Stamatis ED, Myerson MS, Schon LC. Implantable direct-current bone stimulators in high-risk and revision foot and ankle surgery: a retrospective analysis with outcome assessment. Am J Orthop. 2007; 36(7):354-357.
  15. Lee HJ, Chung JW, Chu IT, Kim YC. Comparison of distal chevron osteotomy with and without lateral soft tissue release for the treatment of hallux valgus. Foot Ankle Int. 2010; 31(4):291-295.
  16. Luna Gonzalez F, Lopez Arévalo R, Meschian Coretti S, et al. Pulsed electromagnetic stimulation of regenerate bone in lengthening procedures. Acta Orthop Belg. 2005; 71(5):571-576.
  17. Mammi GI, Rocchi R, Cadossi R, et al. The electrical stimulation of tibial osteotomies: a double blind study. Clin Ortho Rel Res. 1993; 288:246-253.
  18. Miller JM, Ferdowsian VN, Collman DR. Inverted Z-scarf osteotomy for hallux valgus deformity correction: intermediate-term results in 55 patients. J Foot Ankle Surg. 2011; 50(1):55-61.
  19. Mollon B, da Silva V, Busse JW, et al. Electrical stimulation for long-bone fracture-healing: a meta-analysis of randomized controlled trials. J Bone Joint Surg Am. 2008; 90(11):2322-2330.
  20. Nelson FRT. Use of physical forces in bone healing. J Am Acad Ortho Surg. 2003; 11(5):344-354.
  21. Paterson DC, Simonis RB. Electrical stimulation in the treatment of congenital pseudoarthrosis of the tibia. J Bone Joint Surg. 1985; 67-B(3):454-462.
  22. Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin. 2005; 10(4):609-620.
  23. Ryaby JT. Clinical effects of electromagnetic and electric fields on fracture healing. Clin Orthop. 1998; 355(Suppl):S20515.
  24. Saxena A, DiDomenico L, Widfeldt A, et al. Implantable electrical bone stimulation for arthrodeses of the foot and ankle in high-risk patients: a multicenter study. J Foot Ankle Surg. 2005; 44(6):450-454.
  25. Scolaro JA, Schenker ML, Yannascoli S, et al. Cigarette smoking increases complications following fracture: a systematic review. J Bone Joint Surg Am. 2014; 96(8):674-681.
  26. 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.
  27. Simonis RB, Parnell EJ, Ray PS, Peacock JL. Electrical treatment of tibial non-union: a prospective randomised, double-blind trial. Injury. 2003; 34(5):357-362.
  28. Walker NA, Denegar CR, Preische J. Low-intensity pulsed ultrasound and pulsed electromagnetic field in the treatment of tibial fractures: a systematic review. J Athl Train. 2007; 42(4):530-535.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Agency for Healthcare Research and Quality (AHRQ). The role of bone growth stimulating devices and orthobiologics in healing nonunion fractures. Health Technology Assessments. September 2005. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id29TA.pdf. Accessed on October 16, 2018.
  2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination: Osteogenic Stimulators. NCD #150.2. Effective April 27, 2005. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on October 16, 2018.
  3. Griffin XL, Costa ML, Parsons N, Smith N. Electromagnetic field stimulation for treating delayed union or non-union of long bone fractures in adults. Cochrane Database Syst Rev. 2011; (4):CD008471.
Websites for Additional Information
  1. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Nonunions. March 2014. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00374. Accessed on October 16, 2018.
Index

Capacitive Coupling (CC) Stimulation
CMF OL1000 Bone Growth Stimulator
Combined Magnetic Field (CMF) Stimulation
Direct Current (DC) Stimulation
EBI Bone Healing System
OL-1000 Bone Growth Stimulator
OrthoLogic®
OrthoPak® 2 Bone Growth Stimulator
Physio-Stim
Pulsed Electromagnetic Field (PEMF) Stimulation

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

History

Status

Date

Action

Revised

11/08/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Revised document to only address noninvasive electrical bone growth stimulation of the appendicular skeleton (removed information related to invasive and semi-invasive electrical bone growth stimulation for all conditions and noninvasive bone growth stimulation for spinal conditions). Title changed to Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton. Updated Coding section to remove codes 20975, E0749 and ICD-10-PCS codes for invasive procedures, and E0748 and diagnosis codes for spinal indications for noninvasive procedures.

New

11/02/2017

MPTAC review. Initial document development. Moved content of DME.00004 to new clinical utilization management guideline document with the same title.