Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    QualChoice does not cover low frequency non-contact ultrasound wound therapy because there is insufficient evidence that this therapy is effective.

1)    Low frequency non-contact ultrasound wound therapy, including but not limited to the Focused Aspiration of Soft Tissue procedure, the MIST Therapy System, the Qoustic Wound Therapy System, and the Sonoca 180/185 Wound Care System, is considered experimental and investigational because its effectiveness has not been established.

Codes Used In This BI:

97610             Low frequency, non-contact, non-thermal ultrasound

1)    Many different techniques have been used to treat the difficult problem of leg and foot ulcers caused by venous stasis, pressure, or diabetes.  Various applications of ultrasound are among these techniques.  To date there is little clear evidence to support the contention that use of high or low frequency ultrasound is beneficial.

2)    A 2008 Cochrane meta-analysis of randomized controlled trials of ultrasound therapy in the treatment of pressure ulcers found three trials with a total of 146 patients.  In the two trial comparing ultrasound to sham treatment, there was no difference in healing rates.  In a three arm trial that compared ultrasound and UV light to laser and to standard treatment, there were no significant differences in healing between the arms.

3)    A 2010 Cochrane review of randomized controlled trials of ultrasound therapy for venous ulcers concluded that there was no evidence that low frequency ultrasound improves healing of venous leg ulcers.  There was some weak evidence from poor-quality research that high-frequency ultrasound may increase the healing of venous leg ulcers in the short term.  All studies had unknown or high risk of bias.

4)    The Medical Advisory Secretariat of Ontario conducted a systematic review on interventions to treat pressure ulcers in 2008.  They concluded that “The efficacy of other adjunctive physical therapies [electromagnetic therapy, low-level laser therapy, ultrasound therapy, ultraviolet light therapy, and negative pressure therapy] in improving complete closure of pressure ulcers has not been established.

5)    A recent study comparing low frequency ultrasound to standard therapy in healing venous leg ulcers has reported positive results to the Clinical Trials database, but this study has not yet been reported in peer reviewed literature.  This study was sponsored by the device manufacturer.

6)    Michailidis has published a study protocol for comparison of healing in diabetes-related foot ulcers with low frequency ultrasonic debridement versus standard debridement, which is projected to enroll over 100 patients, and will become one of the larger studies in this field.  This study, once completed and published, may help better inform use of this technology.

1)    Cullum N, et al. Ultrasound therapy used for healing venous (varicose) leg ulcers and to improve symptoms.  Cochrane Library, accessed online 4 Jan 2016

2)    Akbari SA, et al.  The effect of therapeutic ultrasound on pressure ulcers.  Cochrane Library, accessed online 4 Jan 2016

3)    Health Quality Ontario.  Management of Chronic Pressure Ulcers.  Ont Health Technol Assess Ser. 2009;9(3): 1-203

4)    Effects of Non-Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers.  NCT01549860.  Accessed from ClinicalTrials.gov on 4 Jan 2016

5)    Michailidis L, et al.  Comparison of healing rate in diabetes-related foot ulcers with low frequency ultrasonic debridement versus non-surgical sharps debridement:  a randomized trial protocol.  Jnl Foot and Ankle Res. 2014, 7:1.