| Durable Medical Equipment Section - Electrical
Bone Growth Stimulators (Osteogenic Stimulation)
| Topic: Electrical Bone Growth
Stimulators (Osteogenic Stimulation) |
Date of Origin: 01/1996
|
| Section: DME |
Policy No: 10 |
| Approved Date: 01/12/2010 |
Effective Date: 01/12/2010 |
| Next Review Date: 01/2011 |
|
IMPORTANT REMINDER
Regence Medical Policies are developed to provide guidance for members and providers regarding
coverage in accordance with contract terms. Benefit determinations are based in all cases on
the applicable contract language. To the extent there may be any conflict between the Medical
Policy and contract language, the contract language takes precedence.
PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that
are considered investigational or cosmetic. Providers may bill members for services or
procedures that are considered investigational or cosmetic. Providers are encouraged to inform
members before rendering such services that the members are likely to be financially responsible
for the cost of these services.
DESCRIPTION
Electrical bone growth stimulators (EBGS) are devices
that use electrical currents to promote bone growth
and healing. Three types of EBGS are available:
- Noninvasive EBGS
Noninvasive EBGS are externally worn devices that
generate a weak electric current within the target
site using either pulsed electromagnetic fields,
capacitive coupling, or combined magnetic fields.
The electrodes are usually placed on the skin and,
depending on the technology, worn from ½ to 24 hours
per day until healing occurs (up to 9 months).
- Invasive EBGS
Invasive EBGS use direct current and require surgical
implantation of both the current generator and an
electrode. Usually, the generator is implanted in
an intramuscular or subcutaneous space, and an electrode
is implanted within the target bone site. The device
typically remains functional for six to nine months
after implantation. Upon completion of treatment,
the generator is removed in a second surgical procedure.
The electrode may or may not be removed.
- Semi-invasive EBGS
Semi-invasive (semi-implantable) EBGS use direct
current supplied by an external power generator and
percutaneously placed electrodes.
U.S. Food and Drug Administration (FDA) Approvals
A number of bone growth stimulators from several manufacturers
have received premarket approval from the FDA
POLICY/CRITERIA
| I. |
Non-invasive
electrical bone growth stimulation (EBGS) may be
considered medically necessary as treatment of
any of the following conditions: |
| |
A. |
Failed
joint fusion following arthrodesis
Failed joint fusion is defined as a joint fusion
which has not healed at a minimum of 6 months after
the arthrodesis, as evidenced by serial x-rays
over a course of 3 months. |
| |
B. |
Failed
spinal fusion
Failed spinal fusion is defined as a spinal fusion
which has not healed at a minimum of 6 months after
the original surgery, as evidenced by serial x-rays
over a course of 3 months. |
| |
C. |
Congenital pseudoarthroses |
| |
D. |
Fracture
nonunions meeting all of the following criteria: |
| |
|
1. |
Location
in the appendicular skeleton (the appendicular
skeleton includes the bones of the shoulder girdle,
upper extremities, pelvis, and lower extremities); |
| |
|
2. |
At least 3 months have
passed since the date of fracture; |
| |
|
3. |
Serial radiographs
have confirmed that no progressive signs of healing
have occurred over the most recent three month
period following fracture or open reduction; |
| |
|
4. |
The fracture gap is one cm or less; and |
| |
|
5. |
The patient can be adequately immobilized and
is of an age where he/she is likely to comply with
non-weight bearing. |
| II. |
Either
invasive or noninvasive EBGS may be considered
medically necessary as an adjunct to spinal fusion
surgery for patients with any of the following
risk factors for failed fusion: |
| |
A. |
One or
more previous failed spinal fusion(s) |
| |
B. |
Grade III
or worse spondylolisthesis |
| |
C. |
Fusion
to be performed at more than one level |
| |
D. |
Current
smoking habit (Note: Other tobacco use such as chewing
tobacco is not considered a risk factor) |
| |
E. |
Diabetes |
| |
F. |
Renal disease |
| |
G. |
Alcoholism |
| |
H. |
Significant
osteoporosis which has been demonstrated on radiographs. |
| |
I. |
Systemic
steroid use (e.g. daily dose ≥5 mg prednisone or
equivalent for ≥ three months) associated with
low bone mass or bone loss |
| III. |
Either
invasive or noninvasive EBGS is considered investigational
for the treatment of all other conditions, including
but not limited to the following: |
| |
A. |
Fresh fractures,
defined as receiving treatment within one week
of injury or open reduction |
| |
B. |
Delayed
union, defined as a decelerating fracture healing
process as identified by serial x-rays |
| |
C. |
Acute or
chronic spondylolysis (pars interarticularis defect)
with or without spondylolisthesis |
| IV. |
Semi-invasive
EBGS is considered investigational for the treatment
of all conditions. |
POSITION STATEMENT
Despite the lack of reliable evidence, both invasive
and non-invasive EBGS have evolved into a standard
of care for certain conditions. The focus of this position
statement is on the uses of EBGS that are considered
to be investigational.
Overall, the evidence for the investigational indications
is limited and considered unreliable because:
- There are no well-designed, well-executed, prospective,
randomized controlled trials (RCT) on the effectiveness
of:
- Invasive EBGS for the treatment of any conditions
except as an adjunct to spinal fusion surgery
- Noninvasive EBGS for the treatment of delayed
unions
- Semi-invasive EBGS for the treatment of any conditions
- It is uncertain whether EBGS offers any additional
benefit compared to standard treatments alone (e.g.
immobilization with casts or braces, surgery etc.)
for the investigational indications.
- The evidence from the only published RCT on EBGS
in treatment of the delayed union in long bones is
limited by the lack of data on the long-term outcomes
of functional healing or need for subsequent surgical
interventions. In addition, the radiographic (intermediate
outcome) data was unreliable due to inconsistent
methodology (e.g. use of different radiographic definitions
or rating systems among the raters).
Effectiveness
Invasive EBGS (except as an adjunct to spinal fusion
surgery)
Technology assessments
The 1992 BlueCross BlueShield Association (BCBSA)
Technology Evaluation Center (TEC) assessment of invasive
EBGS for the treatment of delayed union or nonunion
in long bones was based on a case series of 84 patients,
the only published study on the topic at the time.
(3) The assessment concluded that “the evidence does
not permit conclusions about whether health outcomes
are improved, for either nonunion or delayed union”
as a result of EBGS therapy.
Randomized Controlled Trials (RCT)
There are no published randomized controlled trials
on the use of invasive EBGS for any indications other
than as an adjunct to spinal fusion surgery.
Case series, retrospective reviews, and other
non-randomized comparative studies
Two small observational studies reported experiences
of patients at high risk for nonunion who received
invasive EBGS to enhance the foot and ankle arthrodeses.
(4, 5) While these studies contribute to the body of
knowledge by providing direction for future research,
evidence from these studies is unreliable due to inherent
design flaws, such as non-random allocation of treatment
and lack of appropriate comparison groups.
Noninvasive EBGS for Delayed Unions
Technology assessments
The 1992 BCBSATEC assessment (3) did not find sufficient
evidence to support the use of noninvasive EBGS for
the treatment of delayed union in long or short bones.
The assessment of EBGS for the treatment of delayed
union in long bones was based on one published randomized
controlled trial. The assessment concluded that “the
health outcomes data in this study do not show that
noninvasive EBGS delivers an advantage over placebo.”
(REF) In addition, the assessment identified two significant
limitations of this trial:
- The long-term follow-up data on functional healing
and need for subsequent surgery were not reported.
- Radiographic (intermediate outcome) evidence was
difficult to interpret due to inconsistent rating
methods and uncertain comparability in their findings.
The assessment identified no randomized trials of
noninvasive EBGS for the treatment of delayed union
in short bones. Instead, the assessment is based on
three small case series and it concludes that the “evidence
does not permit conclusions about whether health outcomes
are improved” as a result of EBGS therapy.
Randomized Controlled Trials (RCT)
There are no new published randomized controlled trials
on the use of noninvasive EBGS for the treatment of
delayed unions.
Case series, retrospective reviews, and other
non-randomized comparative studies
There are no new published observational studies on
the use of noninvasive EBGS for the treatment of delayed
unions.
Semi-invasive EBGS
Semi-invasive EBGS is no longer in wide use. (3) Consequently,
there are no recently published studies of semi-invasive
EBGS for the treatment of any condition.
Safety
Overall, EBGS is considered safe and well tolerated.
No major side effects or complications were reported
in the literature. (6-9)
REFERENCES
- BlueCross BlueShield Association Medical Policy
Reference Manual, Policy No. 7.01.07
- BlueCross BlueShield Association Medical Policy
Reference Manual, Policy No. 7.01.85
- BlueCross and BlueShield Association Technology
Evaluation Center TEC Assessment: Electrical Bone
Growth Stimulation for Delayed Union or Nonunion
of Fractures, 1992; Vol. 7, Tab III p. 332
- 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
- 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
- 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
- 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
- Foley KT, Mroz TE, Arnold PM et al. Randomized,
prospective, and controlled clinical trial of
pulsed electromagnetic field stimulation for cervical
fusion. Spine J 2007;[Epub ahead of print]
- Goodwin CB, Brighton CT, Guyer RD et al. A double-blind
study of capacitively coupled electrical stimulation
as an adjunct to lumbar spinal fusions. Spine 1999;24(13):1349-57
CROSS REFERENCES
None
| CODES |
NUMBER |
DESCRIPTION |
| CPT |
20974 |
Electrical stimulation to aid bone healing; non-invasive
(non-operative) |
| |
20975 |
Electrical stimulation to aid bone healing; invasive
(operative) |
| HCPCS |
E0747 |
Osteogenesis stimulator, electrical, non-invasive,
other than spinal applications |
| |
E0748 |
Osteogenesis stimulator, electrical, non-invasive,
spinal applications |
| |
E0749 |
Osteogenesis stimulator, electrical, surgically
implanted |
Durable Medical Equipment Section Table of Contents
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