Medicare Coverage Policy ~ Decisions
Electrical Stimulation for Fracture Healing (#CAG-00043)
Decision Memorandum
TO: |
File: CAG-00043 Electrical Stimulation for Fracture
Healing |
FROM: |
Grant P. Bagley, MD, JD Director, Coverage and Analysis
Group
Perry Bridger Analyst, Coverage and Analysis Group
John J. Whyte, MD, MPH Medical Officer, Coverage and
Analysis |
RE: |
National Coverage Policy Revision |
DATE: |
November 9, 1999 |
This memo serves four purposes: (1) outlines the description of
bone physiology and fracture nonunion; (2) reviews the history of
Medicare’s coverage policies on electrical stimulation for fracture
healing; (3) analyzes the relevant scientific data related to
electrical stimulation for fracture healing; (4) delineates the
reasons supporting a revision of Coverage Issues Manual section
35-48 to change the time frame definition of nonunion.
Physiology of Bone Healing and Fracture Nonunion
Described as the body’s "living framework," the human skeleton -
comprised of 206 bones -provides protection for the vital organs,
allows adequate movement against the forces of gravity, stores
minerals and salts necessary for vital function, and produces red
blood cells necessary for cellular oxygenation. The skeletal system
is divided into two major subdivisions, the axial and the
appendicular skeletons. The axial skeleton consists of the skull,
vertebral column, and the thorax. The appendicular skeleton consists
of the shoulder girdle and bones of the upper extremity and the
pelvis and bones of the lower extremity. Typically, bones have been
classified into four major areas. The primary bones belonging to
these classes are listed below:
Table 1:
LONG BONES |
SHORT BONES |
FLAT BONES |
IRREGULAR BONES |
clavicle, humerus, radius, ulna, femur, tibia, fibula,
metacarpal and metatarsal |
Bones of the carpus and tarpus |
occipital, parietal, frontal, nasal, lachrymal, vomer,
scapula, os innominatum, sternum, ribs, patella |
vertebrae, sacrum, coccyx, temporal, sphenoid, ethmoid,
malar, superior and inferior maxillary, palate, inferior
turbinated, hyoid |
Bone is comprised of two particular types of tissue, compact
(cortical bone) and cancellous (cancellous or trabecular bone).
Cortical bone is described as dense, compact bone, while cancellous
bone is described as spongy, porous-like bone typically found at the
distal and proximal ends of long bones. Although the quantity of
these two types of tissue differs dependent on the specific bone
identified, and the structural composition of these two tissue types
differs, the basic cellular structure of both is the same.
Normal bone healing consists primarily of five stages and is
dependent on mechanical factors, biological factors, and bioelectric
factors. These stages include:
- Inflammation/hematoma, where callus formation occurs within
days of injury;
- The osteoblastic migratory stage and the beginnings of the
viscoelastic bridge (approximately 2 weeks post injury);
- Calcification of the fibrocartilage and bridging of the
fracture gap (approximately 4 weeks post injury);
- Acceleration of the calcification process, with fibrocartilage
replaced by fibrous bone and revascularization at the fracture
site (approximately 8 weeks post injury); and
- Rigid bone development and return of stasis between
osteoblasts and osteoclasts (2 months to 2 years post injury).
Most patients who sustain bone fractures and who receive
appropriate medical therapy heal with conventional treatment
modalities such as splinting, casting, or fixation (either
internal/external). However, secondary to certain specific causes,
the normal reparative process of bone healing can be affected.
These causes include but are not limited to: infection at the
fracture site, inadequate blood supply to the affected area,
excessive movement between bone fragments, interposition of soft
tissue between the bone fragments, loss of apposition between bone
fragments, destruction of bone, presence of corroding metal, and
dissolution of the fracture hematoma by synovial fluid.1
Other systemic factors affecting normal bone healing include the
patient’s metabolic and nutritional status, general health, and
activity level. These factors are particularly relevant to the
elderly Medicare population and can predispose these patients to an
increased incidence of delayed or absent healing. Furthermore, the
incidence of delayed or absent healing has increased as the
treatment options for fractures previously requiring amputation has
led to an increase in the possibility of new problems in fracture
union and rehabilitation.
Delayed Union
Although definitions of delayed union and nonunion vary widely in
the published medical literature, in general union is considered
delayed when healing has not advanced at the "average" rate for the
location and type of fracture. Delayed union is often characterized
by slow radiographic progress and continued mobility and pain at the
fracture site. Delayed union differs from nonunion in that in the
former, there are no indications that union will fail, while in the
latter, there are no longer any visible signs that union will occur.
Nonunion
In general, nonunion occurs when characteristic changes are
observed radiographically and clinically which suggest that fracture
healing has ceased and additional intervention is necessary as the
standard for treatment. Nonunions can be identified by
fibrocartilage which remains in the fracture gap, impeding
vascularization and subsequent calcification, and can present on
radiographs as sclerotic bone ends around a fracture gap with a
visible fracture line.
Typical signs of nonunion that have been utilized in scientific
studies are: Clinically – motion or pain at the fracture site and
local tenderness, and Radiographically – anteroposterior (AP) and
lateral radiographs performed at frequent intervals showing no
progression of healing, (healing usually defined as cortical and/or
trabecular bridging with major modifications of the radiolucent
gap).
Nonunions are typically subdivided in two principle categories -
hypertrophic and atrophic - according to the viability of the ends
of the affected bone fragments. Hypertrophic nonunions are capable
of biological reaction and have the ability to spontaneously heal,
while atrophic nonunions do not.
Treatment of Nonunions
Currently there are a large number of surgical and nonsurgical
treatment modalities available for the treatment of delayed unions
and nonunions. These include immobilization and/or casting, open or
closed reduction, compression plates, pins, screw fixation,
intramedullary rods, bone grafts, and electrical stimulation.
Historically, nonunion has been treated with bone grafting
procedures, although more recently other techniques have been
utilized in order to minimize the risks inherent in bone graft
operations. In the elderly Medicare population, noninvasive
techniques for nonunion treatment are particularly important as they
can be utilized to avoid the potential complications resulting from
major surgery.
In general, the method of treatment is best determined on a case
by case basis, dependent on fracture location and patient
characteristics.
Medicare’s Coverage Policies on Electrical Stimulation for
Fracture Healing
Description of Electrical Stimulation for Fracture Healing
It has been suggested that mechanical loading may induce signals
that initiate the bone remodeling process. This hypothesis predicts
that bone is responsive to extremely low-energy endogenous electric
fields and suggests that bone remodeling can be regulated by
exogenous electromagnetic fields.2
It has also been suggested that electromagnetic fields (EMFs) may
have direct biological effects on endochondrial cells. These include
promotion of decreased synthesis of growth factors caused by
disruption of endosteal bone formation at the fracture site and
enhanced expression of bone morphogenetic protein-2 (BMP-2) and
BMP-4.3
Three primary electrical and electromagnetic methods are used in
the treatment of nonunions. These include invasive, semi-invasive,
and noninvasive devices. Noninvasive devices that use pulsed
electromagnetic fields (PEMFs) designed to induce electrical
currents to replace those lost in the absence of normal mechanical
loading were approved for human use by the Food and Drug
Administration (FDA) in 1979. These devices typically use conductive
or inductive coupling utilizing treatment coils placed externally
around the fracture sight for a certain time period each day. Weak
pulsing electrical currents created by the low energy
electromagnetic field produced by passing current through the
treatment coil are applied at the fracture site. Length of treatment
is dependent on patient characteristics, fractures location, and
physician determination.
Device Manufacturers
Currently there are four primary manufacturers of noninvasive
electrical bone growth stimulators in the United States:
- Electro-Biology, Inc. EBI manufactures the EBI Bone Healing
System® and FLX Flexible Treatment Coil. This system is available
in three different models and utilizes a battery charger cradle,
control unit, and FLX® flexible treatment coil. Required FDA
labeling for this device indicates its use for "the treatment of
fracture nonunions, failed fusions, and congenital pseudarthrosis
in the appendicular system." System configuration is dependent on
the patient profile and physician prescription.
- Orthologic, Inc. Orthologic manufactures the Orthologic 1000®
– Single Coil (OL1000SC) and Dual Coil (OL1000) bone growth
stimulators. These devices are available in a number of models
designed for application at specific fracture locations. Both
devices utilize Combined Magnetic Field (CMF) technology, which
combines dynamic magnetic fields and static magnetic fields for
treatment. The OL1000® is indicated for the noninvasive treatment
of an established nonunion acquired secondary to trauma, excluding
vertebrae and all flat bones.
- Orthofix, Inc. Orthofix manufactures the Physio-Stim Lite.
This system is available in a variety of models with different
transducer capabilities dependent on the fracture site being
stimulated. It is indicated for all nonunions excluding vertebrae
and flat bones.
- Biolectron, Inc. Bioelectron manufactures the Orthopak Bone
Growth Stimulator. This system utilizes capacitive coupling to
produce a time-varying electric field, which can be applied to a
large volume of tissue and bone at the fracture site. It is
indicated for all nonunions excluding flat bones.
History of Coverage Process
Medicare coverage for electrical stimulation for fracture healing
has been in effect since September 15, 1980 (Coverage Issues Manual
35-48). Initial coverage was limited to noninvasive
devices for the treatment of nonunion of long bone fractures, failed
fusion, and congenital pseudarthroses.
Coverage of electrical stimulation for fracture healing was based
on an assessment done by the National Center for Health Care
Technology. This assessment analyzed the findings of a clinical
trial undertaken by EBI as part of their premarket approval
application (PMA) that involved 308 patients (318 fractures) which
found an overall "success" rate (functional union) of 77 percent for
patients with nonunion, delayed union, failed fusion, and congenital
pseudarthrosis. Additionally, expert opinion from a workshop
convened by the National Institute of Arthritis, Metabolism and
Digestive Diseases (NIAMDD) and the American Academy of Orthopaedic
Surgeons entitled "Electrically Induced Osteochondrogenesis" was
solicited. These experts came to the conclusion that "non-invasive
pulsing electromagnetic fields are both safe and effective in
treating nonunion of long bones, failed fusion, and congenital
pseudarthroses ... and that this treatment should be used only in
cases unresponsive to conventional treatment modalities."
In February 1981, the HCFA Physicians Panel addressed the issue
of invasive bone growth stimulators and the
question of how nonunion should be defined. The Panel decided that
HCFA should prepare a national instruction covering invasive
stimulators, but only for nonunion of long bone fractures; nonunion
to be defined as a fracture in which a minimum of six months had
elapsed without healing. In October 1982 the Coverage Issues Manual
35-48 was revised to reflect these recommendations.
Following a manufacturer's request to expand the coverage of the
direct current (invasive) stimulator as a surgical adjunct to
enhance spinal fusion in 1990, the HCFA Physicians Panel suggested
referral of the issue to the Office of Health Technology Assessments
(OHTA).4
In May of 1994 the Technology Advisory Committee (TAC) suggested
that CIM 35-48 be amended to include use of the invasive stimulator
for extensive bone grafting for multiple level fusion and history of
one or more previous failed spinal fusions. In addition, the TAC
recommended that the definition of nonunion be changed to nine
months of no healing from six months. This recommendation was based
on FDA requirements for labeling of bone growth stimulators which
stipulated that "nonunion is considered to be established when a
minimum of nine months have elapsed since injury and the fracture
site shows no visibly progressive signs of healing for a minimum of
three months."
Following the TAC's recommendation, strong opposition from bone
growth stimulator manufacturers and confusion caused by the
discrepancy between HCFA national policy and the FDA labeling
delayed revision of the manual. In June of 1996 the CIM was expanded
to include (1) the use of invasive and noninvasive osteogenic
stimulation as an adjunct to spinal fusion surgery for certain
patients; and (2) clarification was added when noninvasive
osteogenic stimulation is indicated after failed fusion ("where a
minimum on nine months have elapsed since the last surgery"). No
change was made in the definition of nonunion.
Recent Developments
On April 27 and 28th, 1999, the FDA’s Orthopaedics and
Rehabilitation Devices Advisory Panel met to discuss and make
recommendations about a draft guidance document for bone growth
stimulators FDA staff had prepared. The purpose of the FDA’s
guidance document was to update the original recommendations FDA had
issued which helps guide manufacturers of bone growth stimulators in
preparing investigational device exemption (IDE) and PMAs.
The panel heard presentations from several manufacturers of bone
growth stimulators and had discussions which included the labeling
issues regarding bone growth stimulators and the definition of
nonunion. In conclusion, the panel recommended the removal of the
"nine month" clinical study time frame from the definition of
nonunion in bone growth stimulator labeling. Subsequent to this
recommendation, FDA has granted approval to several bone growth
stimulator manufacturers to change the labeling of their devices to
read "nonunion is considered to be established when the fracture
site shows no visibly progressive signs of healing." This change
resulted from general agreement among panel members that the time
frame definition for nonunion differed clinically from that of the
original FDA document. According to FDA personnel, the original
timeframe definition was essentially determined based on the need in
clinical trials for patients to act as their own controls, and
current clinical application of this timeframe were inappropriate
(personal communication with Angel Torres-Cabassa, MD).
Formal Requests to HCFA Regarding Electrical Stimulation For
Fracture Healing
HCFA is currently reviewing this issue at the request of two bone
growth stimulator manufacturers, Orthologic, Inc., and EBI Inc.
Orthologic
Orthologic requests that HCFA revise its coverage policies
regarding osteogenic stimulation to remove the current time frame
limitation in defining when a nonunion is considered to exist.
Orthologic based its request on the following points:
- They assert that there is a significant body of published
medical evidence favorably supporting the safety and efficacy of
electromagnetic osteogenic stimulation in treating nonunion of
bone fractures in a wide spectrum of patients.
- FDA has changed the labeling to remove the time frame
definition.
- They assert that there is compelling post-marketing registry
data that shows significant overall success rates involving a
variety of bone fracture sites and high success rates for the
elderly occurring with time from injury between 2 and 4 months.
- There are over 80 third party payors that have adopted a
policy covering the OL-1000 when used to treat nonunion of bone
fractures with less than 6 months of evidence showing no
progression in healing.
Orthologic has submitted material to HCFA staff during the course
of this analysis (Appendix B). This material included:
- Peer-reviewed medical literature and clinical evidence
- Detailed analysis of Orthologic PMA data
- General and "patients over 65" registry data
- Third part payor policies regarding osteogenic stimulation
EBI
EBI requests that HCFA revise its coverage policies regarding
osteogenic stimulation to remove the current time frame limitation
as well as expand coverage to include all bones of the appendicular
skeleton. EBI based its request on the following points:
- They assert that Medicare coverage for bone stimulation is out
of step with approved FDA labeling and the standard of care as
used by today’s orthopedic community.
- They assert that Medicare’s outdated policy will not cover
necessary orthopedic conditions.
- They assert that Medicare’s national policy forces patients to
surgery and prolonged disability.
- They assert that Medicare’s policy prevents any discretion by
the Durable Medical Equipment Regional Carriers.
EBI has submitted and presented material to HCFA staff during the
course of this analysis (Appendix B). This material included:
- Peer-reviewed medical literature and clinical evidence
- An analysis of Medicare data regarding bone grafting of
nonunion fracture
- Detailed analysis of EBI PMA data
- An outcome assessment of patients 65 and older treated at
periods earlier than 6 months post fracture
- Other third part payor policies regarding osteogenic
stimulation
Timeline of Activities
On July 1, 1999, HCFA accepted Orthologic’s formal request for
revision of Medicare’s national policy regarding osteogenic
stimulation and notified the company of our intention to forward a
response within 90 days. This request included the materials noted
above.
On August 18, 1999, HCFA accepted EBI’s formal request for
revision of the same policy and notified both manufacturers that
these requests were being combined so that a single decision could
be made on this issue. Both companies were notified that a new 90
day time frame was initiated with the receipt and acceptance of a
duplicate request. This request included the materials noted
above.
HCFA staff engaged in significant dialogue with both
manufacturers regarding their respective requests. Both companies
also provided additional written information to HCFA throughout the
course of the analysis and arranged conference calls to clarify
details provided in their requests.
HCFA staff also supplemented the information provided by
Orthologic and EBI by independently conducting a literature review,
consulting experts in the field, and communicating with other
manufacturers and specialty societies.
On October 13, 1999, representatives from EBI met with HCFA staff
in Baltimore to present their materials.
Analysis of Scientific Data
A detailed analysis of the materials that HCFA staff critically
evaluated can be found in Appendix A. These include unpublished
registries as well as peer-reviewed, published scientific
articles.
Currently, electrical stimulation for fracture healing is an
accepted therapeutic modality in the treatment of long bone
nonunions, although the point at which stimulators are applied, and
with what other therapies they are used in conjunction with, remains
controversial. Several studies published since HCFA’s initial
coverage determination was made have illustrated the clinical
effectiveness of this therapy, and the purpose of this analysis was
to determine whether there was clinical and scientific evidence to
allow HCFA to revise coverage of electrical stimulation for fracture
nonunions. In this regard, Coverage and Analysis staff have framed
the following questions to serve as guidelines for evaluating this
issue.
Questions Related to the Analysis
- From a clinical and scientific perspective, is there data to
support a change in the time frame definition of nonunion?
- Is there significant clinical and scientific evidence to
support the use of electrical bone growth stimulators for the
treatment of nonunion for bones of the entire appendicular
skeleton?
- Does the strict language of the national policy prevent
clinical decision making which may improve clinical benefit to
Medicare patients with established nonunions?
Time Frame Definition of Nonunion
Currently, the published literature is inconclusive with respect
to a universally recognized time frame definition for nonunion.
Various time frame definitions have been used to define nonunion.
Campbell’s Operative Orthopedics reports that "the time when a given
fracture should be united cannot be arbitrarily set" but notes that
"a fracture of the shaft of a long bone should not be considered a
nonunion until at least 6 months after injury because often union
requires more time…"5 Adams
and Hamblen states that "in adults, the time usually required for
consolidation of a fractured long bone, in favorable conditions, is
about 3 months, though in many cases it extends to 4 or 5 months,
especially in the case of a large bone such as a femur. Other
sources describe nonunion as "a lack of healing at 6 to 8
months."6
Orthologic submitted nearly 500 references gathered from a review
of nonunion literature spanning the last three decades. This review
included published articles, abstracts, presentations, and textbook
citations regarding various nonunion definitions. From this review,
it is clear that two different components are used to describe
nonunion: 1) Time-referent descriptions that identify the time
elapsed since injury, and/or 2) Radiographic accounts describing
healing activity at the fracture site.
The Orthologic review stated that of the nonunion definition and
descriptions included in their analysis, 36% of the articles cited
identified a time equal to or less than six months post-fracture,
17% included descriptions of nonunions between six and nine months,
and 47% described a time since injury of nine months or greater as
their criteria for union classification. Of the 91 articles that
identified a definition for nonunion, 19% used a lack of
radiographic progression in their definition, with a minimum of
three months with no progression toward healing as criteria.7
In three randomized double-blind clinical trials that have
involved electrical stimulation for fracture healing,8 Parnell
and Simonis supplied no definition for nonunion, Borsalino’s study
used patients three days post intertrochantic osteotomy, and
Sharrard’s investigation determined nonunion by the presence of
movement at the fracture site and radiologically by the presence of
a fracture line. In an early case series by Bassett,9 all
patients had to have had no change in the clinical and radiographic
features of the nonunion for a minimum of four months. In this
study, Bassett defined delayed union as occurring when "no clinical
or radiographic evidence of union at four to nine months after
fracture." Nonunion was described as "a fracture that had not united
by nine months after the fracture." A retrospective case series
published by Brighton et al. in Clinical Orthopaedics and
Related Research stated that "diagnosis of nonunion was made
radiographically when no progressive signs of healing of the callus
were seen during a three month period."10
Both EBI and Orthologic provided HCFA with unpublished patient
registries which examined the "heal" rates of patients who had
received electrical stimulation for various nonunions. This
unpublished data indicated that success rates for patients with
nonunions less than 6 months in duration were equal to if not better
than those of patients who had nonunions older than 6 months.
However, these registries do not equate to rigorously controlled
scientific studies. The possible biases that exist in these types of
registries make it difficult to make any statements about causality,
and coverage decisions cannot be based on these registries alone.
Further analysis by HCFA and discussions with the orthopedic
community confirmed that there were no established criteria for
determining when a fracture has reached a stage of nonunion. Most
clinicians agreed that a strict time frame limitation for
considering nonunion was unreasonable given the differing nature of
fracture patterns and existing patient comorbidities. Many agreed
that the 6 month limitation appeared arbitrary and was not based on
the limited research there has been to date.
Because clinical indications of nonunion such as motion, pain,
and tenderness at the fracture site are subjective measures which
are difficult to validly and reliably measure, it is evident that
radiographic studies over a fixed time period are a better
indication of nonunion. Repeated AP and lateral images showing no
progressive healing in a fracture over a three month period has
become the standard which most large commercial payors use to define
nonunion. Coupled with clinical evidence gathered from patient
interview and examination, this radiographic evidence can provide a
clinical picture of nonunion which requires further intervention. By
revising our policy to better reflect current scientific evidence
and clinical practice, we feel that shortening the time frame
definition of nonunion will benefit those beneficiaries for which
this device is necessary.
Electrical Stimulation for Nonunion Fractures in the Appendicular
Skeleton Other Than Long Bones
There is limited scientifically valid evidence to support
electrical stimulation for fracture nonunions in bones of the
appendicular skeleton other than the long bones. Both the Sharrard
and Parnell randomized double-blind studies related to tibial
fractures only, and Borsalino et al. examined only intertrochantic
osteotomies.
Bassett et al. found an overall heal rate of 77% in 1,007
patients with ununited fractures and 71 cases of failed
fusion.11 This
case series involved patients from the US and international
locations, with long bones representing 97% of the total ununited
fractures treated (65% tibia). A follow up study of a subset of
these patients published in the Journal of Bone and Joint
Surgery12 found
a success rate of 87% in 125 patients with 127 tibial lesions. This
study did not involve any fracture nonunions of other bones of the
appendicular skeleton.
Another case series published by Dunn and Rush in the
Southern Medical Journal13
investigating PEMF technology found a success rate of 81%, with
union determined by examining x-rays taken at 6 week intervals to
evaluate healing. This study examined 35 nonunion patients, with the
tibia, femur, and humerus representing 83% of all nonunions.
Nonunions of the carpal navicular, metacarpal, and proximal phalanx
of the thumb were reported in only 5 patients.
Garland et al. published results from a prospective
non-randomized trial using PEMF therapy in patients who had
established nonunions that underwent a bone grafting procedure or
internal fixation.14 Of
the 181 subjects enrolled, 139 patients completed treatment (defined
as use of a pulsed electromagnetic stimulation device for a minimum
of eight hours per day for six months or until union). Of these 139
patients, the success rates in 13 patients (14 fractures) of those
patients who averaged less than 3 hours of daily device use was
found to be statistically different from those patients who
underwent the entire course of treatment. The authors concluded that
this difference implied a dosage threshold and excluded these
patients from further analysis. Of the remaining 126 patients (135
fractures), only 34 fractures were classified as non-long bone
(scaphoid, metatarsal, ankle fusion, other fusion, and "other.")
Although heal rates in these bones ranged from 60% to 80%, these
fractures represent only a small percentage of the total number of
nonunions in this trial. Furthermore, the limited statistical
analysis, no mention of an intent to treat analysis on the
drop-outs, and no randomization or matching utilized in this study
raises serious methodological questions.
Although Holmes15
provided an analysis comparing his study to others involving
surgical intervention, the nine Jones fractures with clinical and
radiographic signs of delayed union and nonunion treated with PEMFs
(resulting in a 100% heal rate) represent a very small sample size
in an uncontrolled case series. Furthermore, of these nine patients,
5 were classified as having delayed union.
Beckenbaugh provided results of a case series in Orthopaedic
Transactions describing 24 patients with 24 established
nonunions of the scaphoid treated with electrical stimulation and
casting.16 In
this series, 10 patients were treated in a short arm cast for a
stimulation period of 2 to 9 months and 14 patients were treated in
a long arm cast for a stimulation period of 4.5 to 6 months. Because
the short arm casted group had an initial heal rate of less than
50%, a protocol change to a long arm cast for the remainder of
treatment led to an eventual heal rate of 87% for the combined
group. This was a short report without statistical analysis or any
description of exclusion/exclusion criteria or patient
characteristics.
Frykman et al. retrospectively reviewed 50 patients with
nonunited schaphoid fractures treated with PEMFs from
1979-1984.17 44
patients were included in the analysis, which showed a heal rate of
80%. The study provided good analysis of the failures and also
included follow-up to 33 months. However, patient selection and the
possibilities of bias resulting from the uncontrolled nature of this
review bring into question its validity.
Calandra et al.18
provide a good review of schaphoid fractures, but other than
concluding that under certain conditions a scaphoid nonunion "may
effectively be treated with pulsed electromagnetic stimulation
combined with cast immobilization," this article provided little
comment or review about electrical stimulation for fracture healing
in the rest of the appendicular skeleton.
Both EBI and Orthologic included unpublished patient registry
data in their requests to HCFA. Although these registries were
reviewed by HCFA staff as part of the overall analysis, this type of
data alone is generally not adequate for us to use to make coverage
decisions. The possibilities for biases in these uncontrolled
registries make it difficult to make any statements about causality,
and therefore they cannot be relied upon to provide valid scientific
data.
We recognize that it is difficult to perform controlled,
prospective, randomized, double-blind studies of electrical
stimulation vs surgery or other treatment modalities. Given this
limitation, we carefully considered the studies presented, along
with information gathered from the clinical community, in examining
this issue. However, the quality and quantity of the evidence cited
above is not enough for us to make a positive determination on
expanding coverage of electrical bone growth stimulators to
nonunions other than for long bones. Furthermore, because of the
paucity of studies surrounding this therapy and its current
application, the current policy restricting coverage of this device
to only those indications outlined in the CIM is necessary for
protecting the integrity of the Medicare program and ensuring that
its beneficiaries receive the most appropriate care.
In conclusion, HCFA’s analysis suggests that maintaining the
current coverage limitation of electrical bone growth stimulators to
long bones while shortening the time frame definition of nonunion is
a reasonable and necessary action.
DECISION
Amend Coverage Issues Manual section 35-48 to include:
Fracture nonunion is considered to exist only when serial
radiographs have confirmed that fracture healing has ceased for
three or more months prior to starting treatment with the electrical
osteogenic stimulator. Serial radiographs must include a minimum of
two sets of radiographs, each including multiple views of the
fracture site, separated by a minimum of 90 days.
1 Adams JC and Hamblen D. Outlines of
Fractures, Including Joint Injuries, 17th ed. London: Churchill
Livingston; 1999.
2 Otter MW, McLeod KJ, and CT Rubin.
Effects of Electromagnetic Fields in Experimental Fracture Repair.
Clinical Orthopaedics and Related Research 1998;355 Suppl
:S90-104.
3 Fitzsimmons RJ, Ryaby JT, Mohan S, et
al. Combined Magnetic Fields Increase Insulin-Like Growth Factor-II
in the TE-85 Human Osteosarcoma Bone Cell Cultures.
Endocrinology 1995;136(7):3100-3106
4 In its 1993 report "Osteogenic Bone
Growth Stimulation as a Surgical Adjunct to Enhance Spinal Fusion",
the OHTA stated that "limited data suggest that the implantable bone
growth stimulator may be a useful surgical adjunct to enhance spinal
fusion in some patients, such as those who have had previous fusion
failure or have need for extensive bone grafting that require a
multiple level fusion."
5 LaVelle DG, Delayed Union and Nonunion
of Fractures, in Canale TS, editor., Campbell's Operative
Orthopaedics, 9th ed. St. Louis, Missouri: Mosby-Lifeline;
1998.
6 Caputo AE. Healing of Bone and
Connective Tissue, in Bronner F and Worrell RV, eds.,
Orthopaedics: Principles of Basic and Clinical Science. New
York: CRC Press; 1999.
7 Orthologic staff notes that a majority
of these studies were investigations completed by Dr. Brighton based
upon the FDA clinical trial data.
8 Borsalino G, Bagnacani M, Bettati E,
et al. Electrical Stimulation of Human Femoral Intertrochanteric
Osteotomies. Clinical Orthopaedics and Related Research
1988;237:256-263, Sharrard WJ. A Double-Blind Trial of Pulsed
Electromagnetic Fields For Delayed Union of Tibial Fractures.
Journal of Bone and Joint Surgery (British Volume)
1990;72(3):347-355, and Parnell EJ and RB Simonis. The Effect of
Electrical Stimulation in the Treatment of Non-Union of the Tibia.
Journal of Bone and Joint Surgery (British Volume)
1991;73-B(11) Suppl :178.
9 Bassett CA, Mitchell SN, and SR
Gaston. Treatment of Ununited Tibial Diaphyseal Fractures with
Pulsing Electromagnetic Fields. Journal of Bone and Joint
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