Ultrasound Accelerated Fracture Healing Device
DESCRIPTION
Ultrasound accelerated fracture healing involves a non-invasive device (e.g., SAFHS® by Exogen, Inc.) that uses a low-intensity pulsed ultrasound signal applied to the skin surface overlying the fracture site. The ultrasound signal is transmitted to the skin via a conductive coupling gel, which coats the skin surface. In the event a cast is present, a hole is created in the cast so the device can be applied to the skin. The intensity of the applied ultrasound energy is comparable to that used in conventional fetal monitoring. Ultrasound treatment can be self-administered with one daily 20-minute treatment until there is evidence of clinical fracture repair.
The scientific literature does not reveal a consensus of definition for nonunion and delayed union fractures. The following definitions will be used for the purpose of this policy. Nonunion fractures show no visibly progressive signs of healing at the fracture site as determined by serial x-rays. Delayed union fractures show slower than expected signs of a visibly progressive healing process at the fracture site as determined by serial x-rays.
POLICY
Fresh Fractures
Ultrasound accelerated fracture healing devices when used as an adjunct to conventional treatment in individuals at high risk for delayed fracture healing or nonunion is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Nonunions
Ultrasound accelerated fracture-healing devices for the treatment of nonunion fractures of bones, excluding the skull and vertebrae, are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Other Applications
Ultrasound accelerated fracture-healing devices used for other applications, including, but not limited to the following are considered investigational:
fresh fractures at locations other than radius or tibial diaphysis (See above)
delayed unions
tibial stress fractures
congenital pseudarthroses
Charcot foot disorder
chronic epicondylitis
loosened prosthesis following arthroplasty
pathological fracture ( e.g. fracture related to a malignancy)
Paget’s disease of the bone
Any ultrasound device utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
See also: Electrical Bone Growth Stimulation
MEDICAL APPROPRIATENESS
MEDICAL APPROPRIATENESS
Ultrasound accelerated fracture healing devices are considered medically appropriate if ALL the following criteria are met:
The individual is skeletally mature
ANY ONE of the following:
Used for the treatment of fresh fractures with ALL of the following:
ANY ONE of the following conditions :
Treatment of fresh, closed, or grade 1 open tibial diaphysis fractures
Treatment of fresh, closed posteriorly displaced distal radius (Colles') fractures
Used as an adjunct to conventional management (i.e., closed reduction and cast immobilization)
The individual has ANY ONE of the following comorbidities:
Diabetes
History of alcoholism
Current smoker
Steroid therapy (Daily enteral or parenteral use for greater than 3 months)
The fracture is stable and appropriate for closed reduction and casting
No other invasive osteogenic device is being used
Used for the treatment of the non union of fracture, excluding the skull and vertebrae, with ALL the following:
At least three months without clinical evidence of progressive healing (i.e. 2 or more appropriate imaging studies with multiple views 90 days apart with written documentation by the treating physician)
The fracture gap is one cm or less
The individual can be adequately immobilized and is of an age allowing for compliance with non-weight bearing
No other invasive osteogenic device is being used
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
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 February 2000, the labeled indication was expanded to include the treatment of established nonunions,
The FDA approval for ultrasound accelerated devices specifically excludes use in skull and vertebral fractures.
Scientific data is inadequate to permit conclusions regarding the application of an ultrasound accelerated fracture healing device for the conditions listed as investigational. The literature does not validate the impact of this technology on the final health outcomes.
Congenital pseudarthrosis is a rare defect, often of the distal tibia. The congenital pseudarthrosis bone is cystic, bowed and eventually fractures. This bone also has no spontaneous healing potential and requires surgery to attempt a union.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2009). Ultrasound accelerated fracture healing device (1.01.05). Retrieved December 27, 2010 from BlueWeb.
Busse, J. W., Bhandari, M., Kulkarni, A. B. & Tunks, E. (2002). The effect of low-intensity pulsed ultrasound therapy on time to fracture healing: A meta-analysis. Canadian Medical Association Journal, 166 (4), 437 - 441. (Level 4 Evidence - Independent)
Busse, J., Kaur, J., Mollon, B., Bhandari, M., Tornetta, P. Schunemann, H., et al. (2009). Low intensity pulsed ultrasonography for fractures: systematic review of randomized controlled trials. BMJ, 338 (b351). (Level 2 Evidence - Industry sponsored)
Complete Guide to Medicare coverage Issues [Computer software]. (2009, July). Osteogenic stimulation (NCD 150.2, p. 2-67 to 2-68). The Ingenix Complete Guide to Medicare Coverage Issues.
Rue, J., Armstrong,D., Frassica, F., Deafenbaugh, M., & Wilckens, J. (2004). The effect of pulsed ultrasound in the treatment of tibial stress fractures. Orthopedics, 27 (11), 1192 - 1195. (Level 1 Evidence - Independent)
Technology Evaluation Center. (1995, June). Ultrasound accelerated fracture healing (Vol. 10, No. 14). Chicago: BlueCross BlueShield Association. (8 articles and/or guidelines reviewed)
U. S. Food and Drug Administration (2000, February). Center for Devices and Radiological Health. 2000 Summary of safety and effectiveness. Retrieved January 23, 2009 from http://www.fda.gov/ohrms/dockets/dailys/00/mar00/031300/aav0001.pdf.
Winifred S. Hayes. Medical Technology Directory. (2009, September). Ultrasound bone growth stimulation. Retrieved November 20, 2007 from www.Hayesinc.com/subscribers. (56 articles and/or guidelines reviewed)
Yadav, Y., Salgotra, K., & Banerjee, A. (2008). Role of ultrasound therapy in the healing of tibial stress fractures. Medical Journal Armed Forces India (MJAFI), 64 (3), 234 - 236. (Level 2 Evidence - Independent)
Young, A., & McAllister, D. (2006). Evaluation and treatment of tibial stress fractures. Clinical Sports Medicine, 25 (1), 117 - 128. (Level 5 Evidence)
ORIGINAL EFFECTIVE DATE: 3/1/1996
MOST RECENT REVIEW DATE: 6/11/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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