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In the appendicular skeleton, electrical stimulation with either implantable electrodes or non-invasive surface stimulators) has been investigated to facilitate the healing of fresh fractures, stress fractures, delayed union, nonunion, congenital pseudoarthroses, and arthrodesis.
Electrical and electromagnetic fields can be generated and applied to bones through the following methods:
In the appendicular skeleton, electrical stimulation has been used primarily to treat tibial fractures, and thus this technique has often been thought of as a treatment of the long bones. According to orthopedic anatomy, the skeleton consists of long bones, short bones, flat bones, and irregular bones. Long bones act as 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. Despite their anatomic classification, all bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. However, at a cellular level, both bone types are composed of lamellar bone and cannot be distinguished microscopically.
In 1984, the non-invasive OrthoPak® Bone Growth Stimulator (BioElectron) 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 FDA premarket approval (all non-invasive devices) include Physio-Stim® (Orthofix), first approved in 1986, and OrthoLogic® 1000, approved in 1997, both indicated for treatment of established nonunion secondary to trauma, excluding vertebrae and all flat bones, in which the width of the nonunion defect is less than one-half the width of the bone to be treated; and the EBI Bone Healing System® (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. FDA has approved labeling changes for electrical bone growth stimulators that remove any timeframe for the diagnosis.
No semi-invasive electrical bone growth stimulator devices with FDA approval or clearance were identified.
Note: Noninvasive electrical stimulation of the spine is addressed in the Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures policy.
Note: Ultrasound devices for bone growth stimulation is addressed in the Ultrasound Accelerated Fracture Healing Device policy.
POLICYNoninvasive electrical bone growth stimulation may be considered medically necessary as treatment of fracture nonunions or congenital pseudoarthroses in the appendicular skeleton (the appendicular skeleton includes the bones of the shoulder girdle, upper extremities, pelvis, and lower extremities). The diagnosis of fracture nonunion must meet ALL of the following criteria:
Investigational applications of electrical bone growth stimulation include, but are not limited to, immediate post-surgical treatment after appendicular skeletal surgery, stress fractures, or for the treatment of fresh fractures, delayed union, arthrodesis or failed arthrodesis. 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.
POLICY EXCEPTIONSFederal Employee Program: FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 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. In contrast, nonunion serial xrays (described next) show no evidence of healing. When lumped together, delayed union and nonunion are sometimes referred to as “ununited fractures.”
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).
The original FDA labeling of fracture nonunions defined nonunions as fractures that had not shown progressive healing after at least 9 months from the original injury. 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 timeframe is not based on physiologic principles but was included as part of the research design for FDA approval as a means of ensuring homogeneous populations of patients, many of whom were serving as their own controls. Others have contended that 9 months represents an arbitrary cutoff point that does not reflect the complicated variables that are present in fractures, ie, degree of soft tissue damage, alignment of the bone fragments, vascularity, and 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 timeframe for lack of progression of healing is consistent with the definition of nonunion as described in the clinical literature.
Electrical Bone Growth Stimulators are covered as part of the Durable Medical Equipment (DME) benefit, and are subject to any applicable DME co-insurance maximums.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY6/6/2007: Policy added. The "Fracture Healing Devices: Electrical Bone Growth Stimulation & Ultrasound-Accelerated Healing" policy has been replaced with the "Noninvasive Electrical Bone Growth Stimulation of the Appendicular Skeleton" policy
7/19/2007: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
2/18/2008: Policy concerning implantable electrical bone growth stimulators added
2/26/2008: CPT 20975, ICD-9 procedure codes 78.90-78.99, and HCPCS E0749 added to non-covered table. "Noninvasive" removed from policy title
9/30/2009: Code reference section updated. New ICD-9 diagnosis codes 813.46 and 813.47 added to covered table fracture of upper limb code range.
04/07/2010: Description section updated with FDA devices; Policy statement updated to add semi-invasive stimulators as investigational; and Policy Exceptions section updated to include FEP language.
10/21/2010: Policy reviewed; no changes.
12/13/2011: Added "immediate post-surgical treatment after appendicular skeletal surgery" to the investigational policy statement.
01/09/2013: Policy statement unchanged. Added the definitions of fresh fracture, delayed union, and nonunion to the policy guidelines.
03/12/2014: Policy statement updated for clarification of compliance with non-weight bearing. Added "stress fractures, arthrodesis or failed arthrodesis" to the investigational policy statement.
01/30/2015: Policy description updated regarding methods in which electrical and electromagnetic fields can be generated and applied to bones. Policy statements unchanged. Policy guidelines updated regarding delayed union and nonunion.
08/28/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number added. Policy Guidelines updated to add medically necessary and investigative definitions.
06/17/2016: Policy description updated. Policy statements unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 7.01.07
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Electrical stimulation to aid bone healing; invasive (operative)
Osteogenesis stimulator; electrical, surgically implanted
Insertion of bone growth stimulator
Insertion of Bone Growth Stimulator into Upper Bone, Open Approach
Insertion of Bone Growth Stimulator into Upper Bone, Percutaneous Approach
Insertion of Bone Growth Stimulator into Upper Bone, Percutaneous Endoscopic Approach
Insertion of Bone Growth Stimulator into Lower Bone, Open Approach
Insertion of Bone Growth Stimulator into Lower Bone, Percutaneous Approach
Insertion of Bone Growth Stimulator into Lower Bone, Percutaneous Endoscopic Approach