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MP 7.01.07 Electrical Bone Growth Stimulation of the Appendicular Skeleton

Medical Policy
Section
Surgery 		 Original Policy Date
12/1/95		 Last Review Status/Date
Reviewed with literature search/9:2009
Issue
9:2009		 Return to Medical Policy Index

Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

In the appendicular skeleton, electrical stimulation (with either implantable electrodes or non-invasive surface stimulators) is used in the treatment of fracture nonunion. Noninvasive electrical bone growth stimulators generate a weak electrical current using a variety of technologies, i.e., pulsed electromagnetic fields, capacitative coupling, or combined magnetic fields. 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.

The definition of a fracture nonunion has remained controversial. The original U.S. Food and Drug Administration (FDA) labeling defined nonunion as follows: '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.' Others have contended that 9 months represents an arbitrary cut-off point that does not reflect the complicated variables that are present in fractures, i.e., degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock. Other proposed definitions of nonunion involve 3 to 6 months’ time from original healing, or simply when serial x-rays fail to show any further healing. The FDA has recently approved labeling changes that do not impose a time frame for the diagnosis of nonunion.

Delayed union refers to a decelerating bone healing process, as identified in serial x-rays. (In contrast, nonunion serial x-rays show no evidence of healing.) When lumped together, delayed union and nonunion are sometimes referred to as 'ununited fractures.'

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

Despite their anatomic classification, all bones are composed of a combination of cortical and trabecular (also called cancellous) bone. Cortical bone is always located on the exterior of the bone, while the trabecular bone is found in the interior. Each bone, depending on its physiologic function, has a different proportion of cancellous to trabecular bone. However, at a cellular level, both bone types are composed of lamellar bone and cannot be distinguished microscopically.
The non-invasive OrthoPak® Bone Growth Stimulator (BioElectron) received FDA premarket approval in 1984 for treatment of fracture nonunion. Pulsed electromagnetic field systems with FDA premarket approval (all non-invasive devices) include Physio-Stim® from Orthofix Inc., first approved in 1986, and OrthoLogic® 1000, approved in 1997, both indicated for treatment of established nonunion 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; and the EBI Bone Healing System® from Electrobiology, Inc. which was first approved in 1979 and indicated for nonunions, failed fusions, and congenital pseudarthroses.
No semi-invasive electrical bone growth stimulator devices were identified with FDA approval or clearance.
Note: Noninvasive electrical stimulation of the spine is considered in a separate policy No. 7.01.85
Note: Ultrasound devices for bone growth stimulation are considered in a separate policy No. 1.01.05.

Policy

Noninvasive 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:

  • at least 3 months have passed since the date of fracture;
  • serial radiographs have confirmed that no progressive signs of healing have occurred;
  • the fracture gap is 1 cm or less; and
  • the patient can be adequately immobilized and is of an age likely to comply with non-weight bearing.

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

Implantable electrical bone growth stimulators are considered investigational.

Policy Guidelines

No applicable information

Benefit Application

BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all 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.

Claims for noninvasive electrical stimulation devices may be adjudicated as durable medical equipment.

Rationale

This policy was initially developed in December 1995. Since that time, the policy has been updated on a regular basis using MEDLINE literature searches. The most recent literature search was conducted using MEDLINE through July 2009.

The policy regarding electrical bone stimulation as a treatment of nonunion of fractures of the appendicular skeleton is based on the FDA-labeled indications. The FDA approval was based on a number of case series in which patients with nonunions, primarily of the tibia, served as their own control. These studies suggest that electrical stimulation results in subsequent unions in a significant percentage of patients. (1-5) It should be noted that the labeled indications include nonunions or congenital pseudoarthroses of bones of the appendicular skeleton. No distinction is made between long and short bones. The original FDA labeling of fracture nonunions defined nonunions as those fractures that had not shown progressive healing after at least 9 months from the original injury. 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. As mentioned, the presence of a nonunion is related to a variety of factors, such as fracture type and location, degree of soft tissue damage, vascularization, and 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. At the present time, the FDA has approved labeling changes for electrical bone growth stimulators that remove any time frame for the diagnosis. The current policy of requiring a 3-month time frame is still arbitrary, but appears to be consistent with the definition of nonunion, as described in the clinical literature.

The policy regarding electrical stimulation of delayed unions is based on a 1993 TEC Assessment (6), which offered the following conclusions:

  • While data from a double-blind randomized controlled clinical trial (and additional long-term outcome data provided by the investigator) of patients with delayed unions suggests that a 12-week course of noninvasive electrical bone stimulation is associated with a significantly higher healing rate than a control group with a dummy device, there are inadequate data regarding the final health outcome of the patient, i.e., regained use of limb, minimal pain, avoidance of subsequent surgery. All patients in the trial had an unhealed fracture at an average of 23.8 weeks after injury; all fracture gaps were under 0.5 cm. In terms of long-term outcome, a significantly greater proportion of the treated patients avoided any further surgery.

 

A comprehensive search for implantable bone stimulators identified a small number of case series, all of which focused on foot and ankle arthrodesis in patients at high risk for nonunion (summarized in reference 8). Risk factors for nonunion included smoking, diabetes mellitus, Charcot (diabetic) neuroarthropathy, steroid use and previous nonunion. The largest case series described outcomes of foot or ankle arthrodesis in 38 high-risk patients. (9) Union was observed in 65% of cases by follow-up evaluation (n =18), or chart review (n =20). Complications were reported in 16 (40%) cases, including 6 cases of deep infection and 5 cases of painful or prominent bone stimulators necessitating stimulator removal. A multicenter retrospective review described outcomes from 28 high-risk patients with arthrodesis of the foot and ankle. (10) Union was reported for 24 (86%) cases at an average of 10 weeks; complications included breakage of the stimulator cables in 2 patients and hardware failure in one patient. Five patients required additional surgery. Prospective controlled trials are needed to evaluate this procedure.

A 2008 systematic review by Griffin and colleagues included 49 studies, 3 of which were randomized controlled trials. (10) The first, a double-blind randomized controlled trial (RCT) by Sharrard, compared pulsed electromagnet field (PEMF) stimulation with a sham procedure using a dummy device, in 45 patients with nonunion of the tibia. (11) Stimulators were positioned on the surface of the plaster cast. Treatment began 16 to 32 weeks after injury. Patients with fracture gaps greater than 0.5 cm after reduction, systemic disease, or taking steroids were excluded as well as patients with marked bony atrophy or hypertrophy. Fifty-one patients were recruited, and 45 completed the protocol (20 treatment and 25 control). In the treatment group, 3 patients achieved union, 2 achieved probable union, 5 showed progression to union, and 10 showed no progress after 12 weeks. In the control group, none had united, one had probably united, 3 progressed towards union, and 17 showed no progress. Scott and King compared PEMF with sham treatment (dummy unit) in 23 patients with nonunion (fracture at least 9 months old and without clinical or radiographic sign of progression to union within the last 3 months) of a long bone. (12) Patients with systemic bone disorders, synovial pseudoarthrosis, or fracture gap of greater than half the width of the bone were excluded. In this trial, electrodes were passed onto the skin surface through holes in the plaster cast. Twenty-one patients completed the protocol (10 treatment and 11 controls). Six months after beginning treatment, an orthopedic surgeon and a radiologist, neither of them involved in the patients’ management, examined radiographs and determined that 6 of 10 in the treatment group healed, while none of those in the control group healed (p =0.004). Simonis et al. compared PEMF and placebo treatment for tibial shaft fractures un-united at least a year after fracture, no metal implant bridging the fracture gap, and no radiological progression of healing in the 3 months before treatment. (13) All 34 patients received operative treatment with osteotomy and unilateral external fixator prior to randomization. Treatment was delivered by external coils. Patients were assessed monthly for 6 months, and clinical and radiographic assessed at 6 months. Treatment was considered a failure if union was not achieved at 6 months. In the treatment group, 89% of fractures healed compared with 50% in the control group (p =0.02). While a larger percentage of smokers in the treatment group healed than of smokers in the control group, the number of smokers in each group was not comparable, and the difference in healing rates between groups was not statistically significant. The authors conclude that the available evidence supports the use of PEMF in the treatment of nonunion of the tibia and suggest that future trials should consider which modality of electromagnetic stimulation and in which anatomical sites the treatment is most effective.

No studies of semi-invasive (semi-implantable) stimulators were identified during the most recent literature search of MEDLINE through July 2009. In addition, none of these devices has FDA clearance or approval.

In summary, based on the 2009 update, the existing policy statements are unchanged. No new relevant clinical studies were identified. The use of semi-invasive electrical bone growth stimulators is added as investigational due to lack of FDA cleared/approved devices.

Medicare National Coverage (14)
Noninvasive stimulators are covered for the following indications:

  • Nonunion of long bone fractures
  • Failed fusion, where a minimum of 9 months has elapsed since the last surgery
  • Congenital pseudarthroses

Invasive stimulators are covered for

  • Nonunion of long bone fractures

Effective for services performed on or after April 1, 2000, nonunion of long bone fractures, for both noninvasive and invasive devices, is considered to exist only when serial radiographs have confirmed that fracture healing has ceased for 3 or more months prior to starting treatment with the electrical osteogenic stimulator. Serial radiographs must include a minimum of 2 sets of radiographs, each including multiple views of the fracture site, separated by a minimum of 90 days.

 

References:

  1. 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.
  2. Ahl T, Andersson G, Herberts P et al. Electrical treatment of non-united fractures. Acta Orthop Scand 1984; 55(6):585-8.
  3. Connolly JF. Electrical treatment of nonunions. Its use and abuse in 100 consecutive fractures. Orthop Clin North Am 1984; 15(1):89-106.
  4. 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.
  5. Connolly JF. Selection, evaluation and indications for electrical stimulation of ununited fractures. Clin Orthop 1981; 161:39-53.
  6. 1993 TEC Assessment, p. 332-51.
  7. Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin 2005; 10(4):609-20.
  8. 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.
  9. 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.
  10. Petrisor B, Lau JT. Electrical bone stimulation: an overview and its use in high risk and Charcot foot and ankle reconstructions. Foot Ankle Clin 2005; 10(4):609-20.Griffin XL, Warner F, Costa M. The role of electromagnetic stimulation in the management of established non-union of long bone fractures: what is the evidence? Injury 2008; 39(4):419-29.
  11. Sharrard WJ. A double-blind trial of pulsed electromagnetic fields for delayed union of tibial fractures. J Bone Joint Surg Br 2009; 72(3):347-55.
  12. Scott G, King JB. A prospective, double-blind trial of electrical capacitive coupling in the treatment of non-union of long bones. J Bone Joint Surg Am 1994; 76(6):820-6.
  13. Simonis RB, Parnell EJ, Ray PS et al. Electrical treatment of tibial non-union: a prospective, randomized, double-blind trial. Injury 2003; 34(5):357-62.
  14. Centers for Medicare and Medicaid Services. National Coverage Determination for Osteogenic Stimulators (150.2). Accessible at http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=150.2&ncd_version=2&basket=ncd%3A150%2E2%3A2%3AOsteogenic+Stimulators.

 

Codes

Number

Description
CPT  20974  Electrical stimulation to aid bone healing; noninvasive (non-operative) 
20975 invasive (operative)
ICD-9 Procedure  78.90-78.99  Insertion of bone growth stimulator, code range
  99.86 Non-invasive placement of bone growth stimulator
ICD-9 Diagnosis  733.81  Malunion of fracture 
  733.82  Nonunion of fracture (code includes pseudoarthrosis/pseudarthrosis) 
HCPCS  E0747  Osteogenesis stimulator, electrical, noninvasive, other than spinal applications
E0749 Osteogenesis stimulator, electrical, surgically implanted
Type of Service  Surgery 
Place of Service 

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Index

Bone growth stimulation, electrical, appendicular skeleton
Electrical bone growth stimulation, appendicular skeleton
Stimulation, electrical bone growth, appendicular skeleton

Policy History

Date Action Reason
12/01/95 Add to Surgery section New policy
11/01/98 Replace policy Policy reviewed, policy indications revised
12/18/02 Replace policy Policy updated; policy statement unchanged
12/17/03 Replace policy Policy reviewed by consensus without literature review; no changes in policy.
3/7/06 Replace policy Policy reviewed with literature search for the period of 2002 through December 2005; no change in policy statement
06/14/07 Replace policy
Policy reviewed with literature search for the period of December 2005 through May 2007; no new references added. No change in policy statement. Policy status changed to no further review scheduled. 
02/14/08 Replace policy Policy returned to active review and updated; references 7-10 added; implantable stimulators added to policy (investigational); no other changes in policy statements. “Noninvasive” removed from policy title
09/10/09 Replace policy Policy updated with literature search, rationale extensively edited, references 10 to 14 added. No change to existing policy statements; semi-invasive stimulators added as investigational

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