Latest Review Date: April 2024

Category: Durable Medical Equipment (DME)      

POLICY:

Noninvasive electrical bone growth stimulation (E0747) may be considered medically necessary as treatment of fracture nonunion or congenital pseudarthrosis in the appendicular skeleton (the appendicular skeleton includes bones of the shoulder girdle, upper extremities, pelvis and lower extremities). The diagnosis of fracture nonunion must meet ALL the following criteria:

• at least 3 months have passed since the date of fracture;
• serial imaging has confirmed that no progressive signs of healing have occurred;
• the fracture gap is ≤1 cm;
• the individual can be adequately immobilized; and
• the individual is of an age likely to comply with non-weight bearing for fractures of the pelvis and lower extremities.

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

• arthrodesis/failed arthrodesis
• stress fracture
• immediate post-surgical treatment after appendicular skeletal surgery
• 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 individuals 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.

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.

Electrical and Electromagnetic Bone Growth Stimulators

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.

POLICY GUIDELINES

Fracture Nonunion

No consensus on the definition of fracture nonunion currently exists. One proposed definition is failure of progression of fracture healing for at least 3 consecutive months (and for at least 6 months following the fracture), accompanied by clinical symptoms of delayed union or nonunion (pain, difficulty bearing weight) (Bhandari et al, 2012).

The original U.S. Food and Drug Administration (FDA) labeling of fracture nonunions defined them as fractures not showing progressive healing after at least 9 months from the original injury. The labeling states: “A nonunion is considered to be established when a minimum of 9 months has elapsed since injury and the fracture site shows no visibly progressive signs of healing for minimum of 3 months.” This time frame is not based on physiologic principles, but was included as part of the research design for FDA approval as a means of ensuring homogeneous populations of patients, many of whom were serving as their own controls. Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables present in fractures (i.e., degree of soft tissue damage, alignment of the bone fragments, vascularity, quality of the underlying bone stock). Some fractures may show no signs of healing, based on serial radiographs as early as 3 months, while a fracture nonunion may not be diagnosed in others until well after 9 months. The current policy of requiring a 3-month time frame for lack of progression of healing is consistent with the definition of nonunion as described in the clinical literature.

Delayed Union

Delayed union is defined as a decelerating healing process as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention. In contrast, nonunion serial radiographs (described above) show no evidence of healing. When lumped together, delayed union and nonunion are sometimes referred to as “ununited fractures.”

Fresh Fracture

A fracture is most commonly defined as “fresh” for 7 days after its occurrence. Most fresh closed fractures heal without complications with the use of standard fracture care (i.e., closed reduction, cast immobilization).

KEY POINTS:

This evidence review has been updated regularly with searches of the PubMed database. The most recent literature update was conducted through March 11, 2024.

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 meta-analysis 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. 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, PhysioStim

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. In September 2020, FDA considered the reclassification of noninvasive electrical bone growth stimulators from Class III to the lower-risk Class II category. As of March 2024, however, the devices remain Class 3.

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.

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

 

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. 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.
3. Bhandari M, Fong K, Sprague S, et al. Variability in the definition and perceived causes of delayed unions and nonunion: a cross-sectional, multinational survey of orthopaedic surgeons. J Bone Joint Surg Am. Aug 1 2012; 94(15):e1091-1096.
4. Buza JA, 3rd, Einhorn T. Bone healing in 2016. Clin Cases Miner Bone Metab. May-Aug 2016; 13(2):101-105.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. 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.
13. Pountos I, Georgouli T, et al. Pharmacological agents and impairment of fracture healing: What is the evidence? Injury, April 2008; 39(4): 384-394.
14. 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.
15. 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.

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.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (6): Updates to Key Points and References.

Medical Policy Group, August 2022 (6): Policy statement updated to include non-coverage indications for stress fractures and arthrodesis/failed arthrodesis. Updates to Key Points and References. Policy on draft: August 1, 2022- September 30, 2022.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023 (6): Updates to Key Points, Benefit Application and Key Words.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (6): Updates to Key Points and Governing Bodies.

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.