BlueCross and BlueShield of Montana Medical Policy
Medical Policy

Bone Growth Stimulators: Ultrasound Accelerated Fracture Healing Device

 

Chapter: Durable Medical Equipment

© Blue Cross and Blue Shield of Montana

 

Current Effective Date: 12/18/2009
Original Effective Date: 12/18/2009

 

DESCRIPTION


Most freshly closed fractures heal without complications with the use of standard fracture care, (i.e., closed reduction and cast immobilization). Therefore, the most appropriate candidates for ultrasound treatment may be those at high risk for delayed fracture healing or nonunion. These risk factors may include both locations of fractures and patient
comorbidities and include the following:


Patient
comorbidities:

• Diabetes

• Steroid therapy

• Osteoporosis

• History of alcoholism

• History of smoking

Fracture locations:

• Jones fracture

• Fracture of navicular bone in the wrist (also called the scaphoid)

• Fracture of metatarsal

• Fractures associated with extensive soft tissue or vascular damage


Low-intensity pulsed ultrasound had been principally investigated as a technique to accelerate healing of fresh fractures. More recently it has been assessed as a treatment of fracture
nonunions. Ultrasound can be delivered noninvasively with the use of a transducer applied to the skin surface overlying the fracture site. Ultrasound treatment can be self-administered with one daily 20-minute treatment, and continues until the fracture is healed. The mechanism of action at the cellular level is not precisely known, but is thought to be related to a mechanical effect on cell deformation or indirectly by an electrical effect caused by cell deformation. The ultimate effect on fracture healing may be mediated by enhanced vascularity at the fracture site or enhanced chondrocyte maturation.


The Sonic Accelerated Fracture Healing System, SAFHS® (also referred to as
Exogen 2000®) was initially cleared for marketing by the U.S. Food and Drug Administration (FDA) in October 1994 as a treatment of fresh, closed, posteriorly displaced distal radius (Colles’) fractures and fresh, closed, or grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. In February 2000, the labeled indication was expanded to include the treatment of established nonunions, excluding skull and vertebra. According to the FDA labeling, a nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.

Refer to the Blue Cross and Blue Shield of Montana medical policies:

 

• Bone Growth Stimulation of the Appendicular Skeleton, Electrical

• Bone Growth Stimulators: Electrical Stimulation of the Spine as an Adjunct to Spinal Fusion Procedures


POLICY


Prior authorization is recommended
. To authorize, call Blue Cross and Blue Shield of Montana (BCBSMT) Customer Service at 1-800-447-7828 or fax your request to the Medical Review Department at 406-437-7863. A retrospective review is performed if services are not prior authorized.

Medically Necessary


BCBSMT considers low-intensity ultrasound treatment medically necessary:

• When used as an adjunct to conventional management (i.e., closed reduction and cast immobilization) for the treatment of fresh, closed fractures in skeletally mature individuals. This is based in part on a 1995 TEC Assessment that concluded ultrasound fracture healing met the TEC criteria for the indications labeled by the U.S. Food and Drug Administration (FDA) as a treatment of closed, fresh fractures of the tibia or distal radius (i.e., Colles’) fractures. (1) The current policy does not limit the use of the device to specific fracture sites. Depending on their function, bones are composed of a varying combination of cortical and trabecular bone. However, at the cellular level, the type of bone cannot be distinguished histologically. The expansion of the policy to include all bones regardless of the anatomic site is based on this histologic similarity of all bones; it is not anticipated that the efficacy of ultrasound-accelerated healing would vary according to the anatomic site and function of the bone.

• As a treatment of fracture nonunions of bones, excluding the skull and vertebra who meet the following criteria:

• At least three months have passed since the date of the fracture

• Serial radiographs have confirmed that no progressive signs of healing have occurred

• The fracture gap is 1 cm or less

• The patient can be adequately immobilized and is of an age when he/she is likely to comply with non-weight bearing.


The FDA labeling suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without giving any guidance regarding the time frame of observation.
The three month time frame appears to be consistent with the definition of nonunion, as described in the clinical literature. The policy regarding nonunion of fractures is based on data presented to the FDA as part of the approval process for SAFHS® as a treatment of fracture nonunions. The following data were reported and are included in the package insert for the device (2):

• Data were collected on 74 cases of established nonunion with a mean fracture age of nearly three years. The principal outcome measure was the percentage of patients with healed nonunions, as determined clinically and by radiographic analysis. Each case served as its own control, based on the definition of nonunion that suggests that nonunions have a 0% probability of achieving a healed state without an intervention.

• A total of 64 of 74 cases (86%) were healed with use of low-intensity ultrasound. The time to healing was 173 days. The healed rate of scaphoid bones was lower at 33% (2 of 6 cases), which was partially responsible for a significant difference between the healing rates of long bones (92%) vs. other bones (67%).

• Fracture age also affected healing rates, with fractures over five years old having a healing rate of 50% compared to a healing rate of 95% in those present for no more than one year.


Not Medically Necessary


BCBSMT considers all other applications of low-intensity ultrasound treatment not medically necessary, including, but not limited to:

• Treatment of delayed unions (defined as a decelerating healing process as determined by serial x-rays). No studies of sufficient size, design, and duration to allow conclusions to be drawn have been done demonstrating improved outcomes.

• Congenital pseudarthroses. There are no controlled studies in the published literature that specifically address the use of low-intensity ultrasound as a treatment of congenital pseudarthroses.

• Open fractures. Data are conflicting regarding the efficacy of ultrasound for the treatment of open fractures, specifically those treated surgically with placement of an intramedullary nail. For example, Emami and colleagues conducted a study that randomized 32 patients with a fresh tibial fracture that was fixed with an intramedullary rod to undergo additional treatment with an active or inactive ultrasound device. (3) The time to healing was not significantly different in the two groups. These observations are consistent with a meta-analysis conducted by Busse and colleagues, (4) whose analysis supported the use of low-intensity ultrasound as a technique for fractures treated nonoperatively. However, the authors concluded that there was no benefit in operatively treated fractures. In contrast, Leung and colleagues reported on the results of a study that randomized 30 fractures in 28 patients with complex tibial fractures treated with internal or external fixation to receive or not receive additional treatment with low-intensity ultrasound. (5) Based on radiologic assessment, the time to callus formation was significantly less in those in the ultrasound group.


Advanced Member Notice of Financial Liability for Denied Services

When the criteria for coverage is not met, BCBSMT encourages all participating providers to have a member complete and sign
an Advanced Member Notification (AMN) form stating that BCBSMT will not cover this service, supply, device, or drug. If an AMN is signed prior to delivery of the service, participating providers can balance bill the patient. If an AMN is not signed, participating providers are financially liable and cannot balance bill the BCBSMT member for denied services. Services provided by an out-of-state provider that are denied as not medically necessary are the financial responsibility of the patient even if an AMN is signed.

Refer to the Advanced Member Notification medical policy for more information. The AMN form is available at
https://www.bcbsmt.com (Click on Providers and then Forms).

Policy Guidelines

Fresh Fractures

Most freshly closed fractures heal without complications with the use of standard fracture care, i.e., closed reduction and cast immobilization. Therefore, the most appropriate candidates for ultrasound treatment may be those at high risk for delayed fracture healing or nonunion. These risk factors may include both locations of fractures and patient comorbidities and include the following:


Patient
comorbidities:

• Diabetes

• Steroid therapy

• Osteoporosis

• History of alcoholism

• History of smoking


Fracture locations:

• Jones fracture

• Fracture of navicular bone in the wrist (also called the scaphoid)

• Fracture of metatarsal

• Fractures associated with extensive soft tissue or vascular damage


Nonunions:


The FDA labeling simply suggests that nonunion is considered established when the fracture site shows no visibly progressive signs of healing, without giving any guidance regarding the time frame of observation. However, it is suggested that a reasonable time period for lack of visible signs of healing is 3 months. The following patient selection criteria are suggested, consistent with those proposed for electrical stimulation as a treatment of
nonunions (see policy No. 7.01.07):

• At least 3 months have passed since the date of the fracture, AND

• serial radiographs have confirmed that no progressive signs of healing have occurred, AND

• the fracture gap is 1 cm or less, AND

• the patient can be adequately immobilized and is of an age when he/she is likely to comply with non-weight bearing.


Rationale


Fresh Fractures


The policy regarding fresh fractures is based in part on a 1995 TEC Assessment that concluded that ultrasound fracture healing met the TEC criteria for the indications labeled by the U.S. Food and Drug Administration (FDA) as a treatment of closed, fresh fractures of the tibia or distal radius (i.e.,
Colles’) fractures. (1) The current policy does not limit the use of the device to specific fracture sites. Depending on their function, bones are composed of a varying combination of cortical and trabecular bone. However, at the cellular level, the type of bone cannot be distinguished histologically. The expansion of the policy to include all bones regardless of the anatomic site is based on this histologic similarity of all bones; it is not anticipated that the efficacy of ultrasound-accelerated healing would vary according to the anatomic site and function of the bone.


Nonunions


The policy regarding nonunion of fractures is based on data presented to the FDA as part of the approval process for SAFHS® as a treatment of fracture
nonunions. The following data were reported and are included in the package insert for the device (2):

• Data were collected on 74 cases of established nonunion with a mean fracture age of nearly 3 years. The principal outcome measure was the percentage of patients with healed nonunions, as determined clinically and by radiographic analysis. Each case served as its own control, based on the definition of nonunion that suggests that nonunions have a 0% probability of achieving a healed state without an intervention.

• A total of 64 of 74 cases (86%) were healed with use of low-intensity ultrasound. The time to healing was 173 days. The healed rate of scaphoid bones was lower at 33% (2 of 6 cases), which was partially responsible for a significant difference between the healing rates of long bones (92%) vs. other bones (67%).

• Fracture age also affected healing rates, with fractures over 5 years old having a healing rate of 50% compared to a healing rate of 95% in those present for no more than 1 year.


2002-5 Update


A search of the literature based on the MEDLINE database was performed for the period of 2000 to May 2005. There were no controlled studies in the published literature that specifically addressed the use of low-intensity ultrasound as a treatment of delayed unions, congenital
pseudarthroses, or spinal fusions; therefore, this portion of the policy statement is unchanged. For healing of fresh fractures, the current policy limits its use to the treatment of closed fractures. Data are conflicting regarding the efficacy of UAFHS for the treatment of open fractures, specifically those treated surgically with placement of an intramedullary nail. For example, Emami and colleagues conducted a study that randomized 32 patients with a fresh tibial fracture that was fixed with an intramedullary rod to undergo additional treatment with an active or inactive ultrasound device. (3) The time to healing was not significantly different in the 2 groups. These observations are consistent with a meta-analysis conducted by Busse and colleagues, (4) whose analysis supported the use of low-intensity ultrasound as a technique for fractures treated nonoperatively. However, the authors concluded that there was no benefit in operatively treated fractures. In contrast, Leung and colleagues reported on the results of a study that randomized 30 fractures in 28 patients with complex tibial fractures treated with internal or external fixation to receive or not receive additional treatment with low-intensity ultrasound. (5) Based on radiologic assessment, the time to callus formation was significantly less in those in the ultrasound group. Due to the inconsistent results in the 2 small randomized studies, and the negative results of the meta-analysis, low-intensity ultrasound is still considered investigational for open fractures.


2006 Update


A literature search was conducted for the period of May 2005 through July 2006. No clinical studies were identified that would alter the policy statements above. Thus, the policy is unchanged.


2007-2008 Update


A search of the MEDLINE database was performed for the period of August 2006 through January 2008.
Jingushi and colleagues analyzed data from a previous multicenter study on low-intensity pulsed ultrasound treatment for postoperative delayed union and nonunion of long bone fractures. (6) Delayed union was defined as more than 3 months without union or radiological bone reaction; nonunion was defined as additional operative treatment being indicated. The study included 72 long bone fractures (42% open and 56% closed) at an average 11.5 months (range: 3 to 68) since the most recent operation. Monthly clinical and radiological evaluation indicated a 75% union rate, with a mean of 219 (range: 56–588) treatment days until union; data for the different subgroups were not reported. There was a significant association with the time of the most recent operation; beginning treatment within 6 months from the most recent operation resulted in a higher union rate (90%) than when treatment was started 12 months after surgery (65%).


Another study used prospectively defined criteria for analysis of all Dutch patients (96 participating clinics) who had been treated with ultrasound for established nonunion of the tibia (characterized by a total stop of all fracture repair processes). (7) Included in the analysis were 71 patients who were at least 3 months from the last surgical intervention and did not show any healing improvements in the 3 months before ultrasound treatment (average fracture age: 257 days; range: 180–781). All patients were followed up (average 2.7 years) by questionnaire, or by phone, if needed. There was an overall healing rate of 73%, at an average 184 days to healing (range: 52–739). No difference in healing rate for open or closed fractures was observed.


Physician Specialty Society and Academic Medical Center Input


In response to the request for input from Physician Specialty Societies and Academic Medical Centers, input was received from one Physician Specialty Society while this policy was under review. Physician input obtained through the American Academy of
Orthopaedic Surgeons agreed with the positions regarding the criteria for medical necessity and the conditions that are considered investigational (e.g., delayed union and open/unstable Grade II or III fractures) in the Febrrary 2008 policy update.


Medicare Policy


The Centers for Medicare and Medicaid Services (CMS) expanded its policy on the use of low-intensity ultrasonic stimulation for the treatment of nonunion bone fractures on April 27, 2005, and concluded that it would no longer require that the patient fail “at least one surgical intervention for the treatment of the fracture” prior to ultrasound stimulation. (8) Therefore, CMS found “that non-invasive ultrasound stimulation for the treatment of nonunion bone fractures prior to surgical intervention is reasonable and necessary.” CMS has also indicated it “will perform post-coverage analysis of claims data to examine the net health benefit of ultrasound stimulation for nonunion fractures without prior surgery.”


Rationale for Benefit Administration

This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to
policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana
recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.


Coding

CPT Codes

20979
US BONE STIMULATION

HCPCS Codes

This CPT code describes the physician’s work related to positioning the device over the cast, and instructing the patient in the use of the device. The device itself will be coded for using the following HCPCS code:


E0760
OSTEOGENESIS STIMULATOR, LOW INTENSITY ULTRASOUND, NONINVASIVE

ICD-9 Codes

733.82 NON UNION OF FRACTURE

810 FRACTURE OF CLAVICLE

811 FRACTURE OF SCAPULA

812 FRACTURE OF HUMERUS

813 FRACTURE OF RADIUS AND ULNA

814 FRACTURE OF CARPAL BONE(S)

815 FRACTURE OF METACARPAL BONE(S)

816
FRACTURE OF ONE OR MORE PHALANGES OF HAND
817
MULTIPLE FRACTURES OF HAND BONES
818
ILL-DEFINED FRACTURES OF UPPER LIMB
819
MULTIPLE FRACTURES INVOLVING BOTH UPPER LIMBS, AND UPPER LIMBWITH RIB(S) AND STERNUM  
820
FRACTURE OF NECK OF FEMUR    
821
FRACTURE OF OTHER AND UNSPECIFIED PARTS OF FEMUR
822
FRACTURE OF PATELLA
823
FRACTURE OF TIBIA AND FIBULA
824
FRACTURE OF ANKLE    
825
FRACTURE OF ONE OR MORE TARSAL AND METATARSAL BONES        
826
FRACTURE OF ONE OR MORE PHALANGES OF FOOT
827
OTHER, MULTIPLE, AND ILL-DEFINED FRACTURES OF LOWER LIMB
828
MULTIPLE FRACTURES INVOLVING BOTH LOWER LIMBS, LOWER WITHUPPER LIMB, AND LOWER LIMB(S) WITH RIB(S) AND STERNUM  
829
FRACTURE OF UNSPECIFIED BONES


References

1. 1995 TEC Assessments; Tab 14
2.
Summary of Safety and Effectiveness Data. Exogen 2000® or Sonic Accelerated Fracture Healing System (SAFHS®). Exogen®, a Smith and Nephew Company, Piscataway, NJ.
3.
Emami A, Petren-Mallmin M, Larsson S. No effect of low-intensity ultrasound on healing time of intramedullary fixed tibial fractures. J Orthop Trauma 1999; 13(4):252-7.
4.
Busse JW, Bhandari M, Kulkarni AV et al. The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: a meta-analysis. CMAJ 2002; 166(4):437-41.
5. Leung KS, Lee WS,
Tsui HF et al. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol 2004; 30(3):389-95.
6.
Jingushi S, Mizuno K, Matsushita T et al. Low-intensity pulsed ultrasound treatment for postoperative delayed union or nonunion of long bone fractures. J Orthop Sci 2007; 12(1):35-41.
7.
Rutten S, Nolte PA, Guit GL et al. Use of low-intensity pulsed ultrasound for posttraumatic nonunions of the tibia: a review of patients treated in the Netherlands. J Trauma 2007; 62(4):902-8.
8.
https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=135
9.
Blue Cross and Blue Shield Association medical policy 1.01.05 Ultrasound Accelerated Fracture Healing Device. Last updated February 2008.

 

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®Registered Marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans.

 

 

History of Development

 
An independent licensee of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans.
Bone Growth Stimulators: Ultrasound Accelerated Fracture Healing Device Bone Growth Stimulators: Ultrasound Accelerated Fracture Healing Device