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Electrical Bone Growth Stimulation of the Appendicular Skeleton

Policy Number: MP-082

Latest Review Date: April 2021

Category:  DME      

Policy Grade:  B

POLICY:

For dates of service March 26, 2020 and after:

Noninvasive electrical bone growth stimulation (E0747) may be considered medically necessary as treatment of fracture nonunions or congenital pseudarthrosis in the appendicular skeleton (the appendicular skeleton includes bones of the shoulder girdle, upper extremities, pelvis  and lower extremities) for the following: 

  • The diagnosis of fracture nonunion when meets all the following criteria:

    • The fracture must be of at least 90 days duration;

    • Serial imaging confirms that no progressive healing has occurred;

    • Fracture gap is ≤1 cm; and

    • The individual can be adequately immobilized and is of an age likely to comply with non-weight bearing for fractures of the pelvis and lower extremities.

  • Failed joint fusion following arthrodesis ankle or knee (failed joint fusion is defined as a joint fusion that has not healed at a minimum of 6 months after the arthrodesis, as evidenced by serial imaging over a course of 3 months);

  • When used in conjunction with surgical intervention for treatment of an established nonunion;

  • Stress fracture that has a failed union after 90 days of treatment.

Electrical bone growth stimulation is considered investigational for the following applications:

  • Immediate post-surgical treatment after appendicular skeletal surgery

  • Treatment of fresh fractures

  • Delayed or incomplete union fractures

  • Fractures of the skull

  • Lunate fractures

  • Spondylosis

  • Synovial pseudarthrosis

  • Draining osteomyelitis

  • Fresh bunionectomies

  • Severe osteoporosis

  • Significant motion at the fracture site

  • In patients with a demand-type pacemaker or an implantable cardioverter defibrillator

  • As an adjunct to limb lengthening procedures

Invasive and semi-invasive electrical bone growth stimulators (E0749) are considered investigational.

For dates of service prior to March 26, 2020:

Noninvasive electrical bone growth stimulation (E0747) may be considered medically necessary as treatment of fracture nonunions or congenital pseudarthroses in the appendicular skeleton (the appendicular skeleton includes bones of the shoulder girdle, upper extremities, pelvis and lower extremities) for the following: 

  • The diagnosis of fracture nonunion when meets all the following criteria:
    • The fracture must be of at least 90 days duration;
    • Serial imaging confirms that no progressive healing has occurred;
    • Fracture gap is ≤1 cm; and
    • The individual can be adequately immobilized and is of an age likely to comply with non-weight bearing for fractures of the pelvis and lower extremities.
  • Failed joint fusion following arthrodesis ankle or knee (failed joint fusion is defined as a joint fusion that has not healed at a minimum of 6 months after the arthrodesis, as evidenced by serial imaging over a course of 3 months);
  • When used in conjunction with surgical intervention for treatment of an established nonunion;
  • Stress fracture that has a failed union after 90 days of treatment.

Electrical bone growth stimulation is considered investigational for the following applications:

  • Immediate post-surgical treatment after appendicular skeletal surgery
  • Treatment of fresh fractures
  • Delayed or incomplete union fractures
  • Fractures of the skull
  • Lunate fractures
  • Spondylosis
  • Synovial pseudarthroses
  • Draining osteomyelitis
  • Fresh bunionectomies
  • Severe osteoporosis
  • Significant motion at the fracture site
  • In patients with a demand-type pacemaker or an implantable cardioverter defibrillator

Invasive and semi-invasive electrical bone growth stimulators (E0749) are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

In the appendicular skeleton, electrical stimulation with either implantable electrodes or noninvasive surface stimulators has been investigated to facilitate the healing of fresh fractures, stress fractures, delayed union, nonunion, congenital pseudoarthrosis, and arthrodesis.

Treatment of Delayed and Nonunion Fractures

Individuals with recognized delayed fracture unions might begin by reducing the risk factors for delayed unions or nonunions but may progress to surgical repair if it persists.

Different applications of electrical and electromagnetic fields have been used to promote healing of delayed and nonunion fractures: invasive, noninvasive, and semi-invasive.

Invasive stimulation involves the surgical implantation of a cathode at the fracture site to produce direct current electrical stimulation. Invasive devices require surgical implantation of a current generator in an intramuscular or subcutaneous space, while an electrode is implanted within the fragments of bone graft at the fusion site. The implantable device typically remains functional for 6 to 9 months after implantation, and, although the current generator is removed in a second surgical procedure when stimulation is completed, the electrode may or may not be removed. Implantable electrodes provide constant stimulation at the nonunion or fracture site but carry increased risks associated with implantable leads.

Noninvasive electrical bone growth stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the fusion site and worn for 24 hours a day until healing occurs or up to 9 months. In contrast, pulsed electromagnetic fields are delivered via treatment coils placed over the skin and worn for 6 to 8 hours a 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.

For Electrical Bone Stimulation for the Spine, please refer to policy #524, Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion.

KEY POINTS:

The policy is updated on a regular basis using the MEDLINE database.  The most recent literature update was conducted through January 11, 2021.

SUMMARY OF EVIDENCE:

Noninvasive Electrical Bone Growth Stimulation

For individuals who have fracture nonunion who receive noninvasive electrical bone growth stimulation, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The U.S. Food and Drug Administration has approved noninvasive electrical bone growth stimulation for fracture nonunions and congenital pseudoarthroses in the appendicular skeleton, based largely on studies with patients serving as their own controls. There is also evidence from 2 small sham-controlled randomized trials that noninvasive electrical stimulators improve fracture healing for patients with fracture nonunion. However, there are few nonsurgical options in this population, and the pre-post studies of patients with nonhealing fractures support the efficacy of the treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have delayed fracture union who receive noninvasive electrical bone growth stimulation, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. RCTs on delayed union of fractures were limited by small sample sizes and did not show significant differences in outcomes between study groups. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have fresh fracture(s) who receive noninvasive electrical bone growth stimulation, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. A metaanalysis of 5 RCTs found no statistically significant benefit of electrical bone growth stimulation for fresh fractures. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have stress fracture(s) who receive noninvasive electrical bone growth stimulation, the evidence includes an RCT. Relevant outcomes are symptoms, change in disease status, and functional outcomes. This well-conducted RCT found that, 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. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have had surgery of the appendicular skeleton who receive noninvasive electrical bone growth stimulation, the evidence includes 2 small RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Although the results of 1 trial suggest benefits to the bone stimulation in decreased time to union, clinical outcomes were not assessed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Implantable and Semi-Invasive Bone Growth Stimulation

For individuals who have fracture, pseudoarthrosis, or who have had surgery of the appendicular skeleton who receive implantable and semi-invasive electrical bone growth stimulation, the evidence includes a small number of case series. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Fracture, nonunion, delayed union, bone growth stimulator, electrical bone growth stimulator, osteogenesis stimulator, invasive, semi-invasive, non invasive, electrical current, percutaneous, pseudarthrosis, pseudoarthrosis, Exogen 2000™, Exogen 3000, SAFHS® Model 2A, SAFHS® Model 2000, EBI Bone Healing System®, EBI OsteoGen OrthoPak®, Physio-Stim Lite®, Dynatron STS, Zimmer Direct Bone Growth Stimulator, Orthofix, OsteoStim®, limb lengthening

APPROVED BY GOVERNING BODIES:

In 1984, the noninvasive OrthoPak® Bone Growth Stimulator (BioElectron, now Zimmer Biomet) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for treatment of fracture nonunion. Pulsed electromagnetic field systems with the FDA premarket approval (all noninvasive devices) include Physio-Stim® (Orthofix), first approved in 1986, and OrthoLogic® 1000, approved in 1997, both indicated for the 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® (Electrobiology, now Zimmer Biomet), which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthrosis. No distinction was made between long and short bones. The FDA has approved labeling changes for electrical bone growth stimulators that remove any time frame for the diagnosis. As of September 2020, under consideration is the reclassification of noninvasive electrical bone growth stimulators from Class III to the lower-risk Class II category.

No semi-invasive electrical bone growth stimulator devices with the FDA approval or clearance were identified.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT Codes:

20974

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

20975

Electrical stimulation to aid bone healing; invasive (operative)

0594T Osteotomy, humerus, with insertion of an externally controlled intramedullary lengthening device, including intraoperative imaging, initial and subsequent alignment assessments, computations of adjustment schedules, and management  of the intramedullary lengthening device (Effective 07/01/2020)

 

HCPCS Codes:

E0747

Osteogenesis stimulator, electrical, noninvasive, other than spinal application

E0749

Osteogenesis stimulator, electrical (surgically implanted)

REFERENCES:

  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):1569-76.
  2. Ahl T, Andersson G, Herberts P and Kalen R. Electrical treatment of non-united fractures. Acta Orthop Scand 1984; 55(6):585-8.
  3. Aleem IS, Aleem I, Evaniew N, et al. Efficacy of electrical stimulators for bone healing: a meta-analysis of randomized sham-controlled trials. Sci Rep. Aug 19 2016; 6:31724.
  4. 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.
  5. 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.
  6. Bhandari M, Fong K, Sprague S, et al. Variability in the definition and perceived causes of delayed unions and nonunions: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am. Aug 1 2012; 94(15):e1091-1096.
  7. 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.
  8. 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.
  9. Buza JA, 3rd, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. May-Aug 2016; 13(2):101-105.
  10. Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am 1984; 15(1):89-106.
  11. Connolly JF. Selection, evaluation and indications for electrical stimulation of ununited fractures.  Clin Orthop 1981; 161:39-53.
  12. 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 1986; 208:55-8.
  13. 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.
  14. Gaston MS and Simpson AH. Inhibition of fracture healing. Br J Bone Joint Surg, December 2007; 89(12): 1553-1560.
  15. Faldini C, Cadossi M, Luciani D, et al. Electromagnetic bone growth stimulation in patients with femoral neck fractures treated with screws: prospective randomized double-blind study. Curr Orthop Pract. 2010; 21(3):282-287.
  16. 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.
  17. Griffin XL, Warner F and Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: What is the evidence?  Injury, April 2008; 39(4): 419-429.
  18. Hannemann PF, Essers BA, Schots JP, et al. Functional outcome and cost-effectiveness of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a cost-utility analysis. BMC Musculoskelet Disord. Apr 11 2015; 16:84.
  19. 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. Oct 2012; 94(10):1403-1408.
  20. 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.
  21. Hannemann PF, van Wezenbeek MR, Kolkman KA, et al. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, double-blind, placebo-controlled trial. Bone Joint J. Aug 2014; 96-B (8):1070-1076.
  22. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  23. 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 2007; 36(7):354-7.
  24. Martinez-Rondanelli A, Martinez JP, Moncada ME, et al. Electromagnetic stimulation as coadjutant in the healing of diaphyseal femoral fractures: a randomized controlled trial. Colomb Med (Cali). Apr-Jun 2014; 45(2):67-71.
  25. Petrisor B and 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.
  26. Pountos I, Georgouli T, et al. Pharmacological agents and impairment of fracture healing: What is the evidence? Injury, April 2008; 39(4): 384-394.
  27. 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.
  28. Scott G and King JB. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. Am J Bone Joint Surg, May 1995; 77(5): 809.
  29. 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.
  30. Sharrard WJ. A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. Br J Bone Joint Surg 1990; 72-B: 347-355.
  31. 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.
  32. Simonis RB, Parnell EJ, et al. Electrical treatment of tibial non-union: a prospective, randomized, double-blind trial.  Injury, May 2003; 34(5): 357-362.
  33. U.S. Food and Drug Administration (FDA). Summary Minutes: Center for Devices and Radiological Health Orthopaedic and Rehabilitation Devices Panel. 2020; https://www.fda.gov/media/145157/download. Accessed March 8, 2021.

POLICY HISTORY:

Medical Policy Group, October 2008 (4)

Medical Policy Administration Committee, November 2008

Available for comment November 20, 2008-January 5, 2009

Medical Policy Group, February 2009 (4)

Medical Policy Administration Committee, March 2009

Available for comment February 27-April 13, 2009

Medical Policy Group, October 2009 (1)

Medical Policy Administration Committee, October 2009

Available for comment October 20-December 3, 2009

Medical Policy Group, November 2009 (1)

Medical Policy Administration Committee, December 2009

Available for comment December 4, 2009-January 19, 2010

Medical Policy Group, February 2010 (1)

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Group, February 2010; Regular update (1)

Medical Policy Group, November 2011 (1): Electrical bone growth stimulators separated from policy #331; Update to Key Points and References; no change in policy statement

Medical Policy Administration Committee, January 2012

Available for comment January 11 – February 27, 2012

Medical Policy Panel, October 2012

Medical Policy Group, March 2013 (1): Electrical Stimulation of the Spine separated from this policy and moved to new policy #524, information box added to direct to new policy; Title change to reflect Appendicular Skeleton; Update to Key Points and Reference; no change in policy statement

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, December 2014

Medical Policy Group, December 2014 (5): Updates to Description, Key Points and References.  No change to policy statement.

Medical Policy Group, August, 2015 (6): Reorganized policy statement text; no change to policy intent.

Medical Policy Group, February 2016 (6):  Clarification to policy statement regarding coverage of pelvis and scapula; no change to policy intent.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6):  Updates to Description and Key Points; no change to policy statement.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (6): Updates to Description, Key Points, Governing Bodies and References.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Key Points.

Medical Policy Panel, April 2019

Medical Policy Group, April 2019 (6) Updates to Description and Key Points.

Medical Policy Group, March 2020 (6): Updated non-covered indications to include “As an adjunct to limb lengthening procedures”, added Key Word (limb lengthening).

Medical Policy Panel, April 2020

Medical Policy Group, April 2020 (6): Updates to Policy (pseudarthroses changed to pseudarthrosis) Description, Key Points and Governing Bodies.

Medical Policy Group, June 2020: Quarterly coding update.  Added 0594T to Current Coding section.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (6): Updates to Key Points, Governing Bodies and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.