Medical Policy: 01.01.25
Original Effective Date: May 2014
Reviewed: March 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
A non-contact low-frequency US device has been developed that does not require use of a coupling gel or other direct contact. In 2005, the MIST Therapy™ System (Celleration, Inc.) received marketing clearance (K050129) through the FDA's 510(k) process, “to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.” The MIST Therapy™ System delivers a saline mist to the wound with low-frequency US (40 KHz); it includes a generator, a transducer, and a disposable applicator for discharge of prepackaged saline. Several wound drainage and wound vacuum systems were listed as predicate devices.
In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical) received marketing clearance, listing the Celleration MIST system and several other ultrasonic wound debridement and hydrosurgery systems as predicate devices. The AR1000 system uses a combination of irrigation and US with a contact probe to debride and cleanse wounds. The indications are similar to that of the MIST system, listed as: “selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.”
Low frequency ultrasound is used as an adjunct (supplement) to wound care. A noncontact low frequency ultrasound device is intended to provide debridement and cleansing to a wound. The device is held 0.5 to 1.5 cm from the wound and saline is delivered to the wound bed, which purportedly promotes healing through stimulation of cellular activity. Therapy is usually given in three to twelve minute sessions, three times per week.
The American College of Foot and Ankle Surgeons' clinical practice guideline on diabetic foot disorders (Frykberg et al, 2006) noted that low-intensity pulsed ultrasound has been suggested as a useful adjunct in promoting healing of Charcot fractures. Although promising in theory, this approach has yet been conclusively proven effective through large, prospective, multi-center, randomized trials.
American Society of Plastic Surgeons' evidence-based clinical practice guideline on chronic wounds of the lower extremity (2007) did not mention the use of ultrasound therapy as an option of treatment.
The Association for the Advancement of Wound Care (AAWC) published a guideline on care of pressure ulcers. Non-contact ultrasound therapy was included as a potential second-line intervention if first-line treatments did not result in wound healing. (Level C)
Level C recommendations indicates that there is limited evidence for this technology.
The Association for the Advancement of Wound Care (AAWC) guideline on treatment of venous ulcers, updated in 2010, states that low-frequency ultrasound treatment requires additional evidence before it can be considered an appropriate treatment.
Use of low-frequency, non-contact, non-thermal, ultrasound therapy is considered investigational for wound care and all other applications.
At the present time, the published evidence is insufficient and limited to demonstrate the safety and efficacy of low-frequency, non-contact ultrasound therapy for wound care management, as compared to conventional treatment options. The available studies lack blinding, unbiased results and are frequently based on one institution, a minimal number of case studies, and nonclinical applications.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- 97610 Low frequency, non-contact, non-thermal ultrasound, including topical application(s) when performed, wound assessment, and instruction(s) for ongoing care; per day
Wellmark's policy is based on:
Akbari Sari A, Flemming K, Cullum NA, Wollina U. Therapeutic ultrasound for pressure ulcers. Cochrane Database Syst Rev. 2006; (3):CD001275.
American Society of Plastic Surgeons (ASPS). Evidence-based clinical practice guideline: Chronic wounds of the lower extremity. 2007.
Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders: A clinical practice guideline. J Foot Ankle Surg. 2006; 45(5):S2-S66.
Institute for Clinical Systems Improvement (ICSI). Health Care Protocol: Pressure ulcer treatment. Third Edition, January 2012.
National Institute for Health and Clinical Excellence. Medical technology guidance 5. The MIST Therapy system for the promotion of wound healing, July 2011.
U.S. Food and Drug Administration 510(k) Premarket Notification Database. Celleration MIST Therapy System Summary of Safety and Effectiveness. No. K032378. Rockville, MD: FDA. June 25, 2004. No. K050129. May 2005.
Association for the Advancement of Wound Care (AAWC). Venous Ulcer Guideline. Association for the Advancement of Wound Care (AAWC). Pressure Ulcer Guideline.
ECRI Institute. Emerging Technology Reports. Noncontact, low-frequency ultrasound for chronic wounds. March 2012.
Serena T, Lee K, et al. The impact of noncontact, nonthermal low-frequency ultrasound on bacterial counts in experimental and chronic wounds. OWM V.55, 2009.
Prather JL, Tummel EK, Patel AB, et al. Prospective randomized controlled trial comparing the effects of noncontact low-frequency ultrasound with standard care in healing split-thickness donor sites. J Am Coll Surg. 2015;221(2):309-318.
Tricco AC, Antony J, Vafaei A, et al. Seeking effective interventions to treat complex wounds: An overview of systematic reviews. BMC Med. 2015;13:89.
Velez-Diaz-Pallares M, Lozano-Montoya I, Abraha I, et al. Nonpharmacologic interventions to heal pressure ulcers in older patients: An overview of systematic reviews (The SENATOR-ONTOP Series). J Am Med Dir Assoc. 2015;16(6):448-469.
Date Reason Action
May 2014 New policy
April 2015 Annual review Policy renewed
March 2016 Annual review Policy renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.