Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (>20 kHz).Ultrasound is defined as a mechanical vibration above the upper threshold of human hearing. The therapeutic effect of US energy in the kilohertz range has been examined for the treatment of wounds. Non-contact low-intensity US devices (e.g., MIST Therapy™ System) have been developed that do not require use of a coupling gel or other direct contact. These devices deliver ultrasonic energy to wounds via a saline mist without direct skin contact.Although the exact mechanism underlying its clinical effects is not known, therapeutic ultrasound has been proposed to have a variety of effects at a cellular level, including angiogenesis, leukocyte adhesion, growth factor, and collagen production, and increases in macrophage responsiveness fibrinolysis, and nitric oxide levels.
Non-contact ultrasound treatment for wounds is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
Current clinical studies do not permit conclusions concerning the effect of this technology on health outcomes. Additional well-designed studies that include relevant outcomes are needed to evaluate this treatment. Therefore, non-contact ultrasound treatment for wounds is considered investigational.
Association for the Advancement of Wound Care (AAWC). (2014, February). Venous ulcer guideline. Retrieved July 15, 2016 from http://aawconline.org/professional-resources/resources/.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2018). Non-contact ultrasound treatment for wounds (2.01.79). Retrieved June 20, 2018 from BlueWeb. (19 articles and/or guidelines reviewed)
Gibbons, G. W., Orgill, D. P., Serena, T. E., Novoung, A., O’Connell, J. B., Li, W. W., et al. (2015). A prospective, randomized, controlled trial comparing the effects of noncontact, low-frequency ultrasound to standard care in healing venous leg ulcers. Ostomy Wound Manage, 61 (1), 16-29. (Level 2 evidence)
Olyaie, M., Rad, F., Elahifar, M. Garkaz, A., Mahsa, G. (August 2013) High-frequency and Noncontact Low-frequency Ultrasound Therapy for Venous Leg Ulcer Treatment: A Randomized, Controlled Study. Ostomy-Wound Management. 2013; Volume 59 - Issue 8, p 14-20. (Level 2 evidence)
Prather, J. L., Tummel, E. K., Patel, A. B., Smith, D. J, & Gould, L. J. (2015). Prospective randomized controlled trial comparing the effects of noncontact low-frequency ultrasound with standard care in healing split-thickness donor sites. Journal of the American College of Surgeons, 221 (2), 309-318. Abstract retrieved July 15, 2016 from PubMed database.
Tricco, A., Jesmin, A., Vafaei, A., Khan, P., Harrington, A., Cogo, E., et. al., (2015) Seeking effective interventions to treat complex wounds: an overview of systematic reviews. BMC Medicine; 13:89. (Level 2 evidence)
U. S. Food & Drug Administration. (May 2005). Center for Devices and Radiologic Health. 510k Pre-market Notification Database K050129 (MIST™ Therapy System). Retrieved August 31, 2015 from http://www.fda.gov.
Watson, J., Kang’ombe, A., Soares, M., Chaung, L., Worthy, G., Bland, M., et al. (2011). Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomized controlled trial. British Medical Journal. 2011; 342:d1092. (Level 4 evidence)
Winifred S. Hayes, Inc. Health Technology Brief (2016, July; last updated search July 2017) Noncontact low-frequency ultrasound using the MIST therapy system (Celleration, Inc.) for treatment of lower extremity arterial and diabetic foot ulcers. Retrieved June 20, 2018 from http://www.hayesinc.com/subscribers.
ORIGINAL EFFECTIVE DATE: 4/4/2011
MOST RECENT REVIEW DATE: 8/9/2018
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.
This document has been classified as public information.