Medical Policy: 01.01.25
Original Effective Date: May 2014
Reviewed: March 2018
Revised: March 2018
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.”
Other ultrasound therapy that may be used includes the Qoustic Wound Therapy System, the Sonoca 180/185 Wound Care System, VERSAJET II Hydrosurgery System, SonicOne O.R.. Jetox ND, AS1000 Ultrasound Wound Therapy System.
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 not been conclusively proven effective through large, prospective, multi-center, randomized trials.
The 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 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 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.
The American Podiatric Medical Association in collaboration with the Society for Vascular Surgery and the Society for Vascular Medicine developed a 2016 clinical practice guideline for the management of diabetic foot. Their recommendations do not include warming therapy, noncontact normothermic wound therapy or low frequency ultrasound for the treatment of wounds.
Use of low-frequency, non-contact, non-thermal, ultrasound therapy is considered investigational for wound care and all other applications.
For individuals who have any wound type (acute or nonhealing) who receive noncontact ultrasound therapy plus standard wound care, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. The single double-blinded, sham-controlled randomized trial, which included patients with nonhealing diabetic foot ulcers, had substantial methodologic flaws (eg, high dropout rate, baseline differences between groups) that limit the validity of the findings. In the remaining studies comprising the evidence base most studies compare non-contact ultrasound with standard wound care reported improved (statistically significant) results on the primary outcome with non-contact ultrasound. However, these studies also had several methodologic limitations. Complete healing is the most clinically relevant outcome. None of the RCTs evaluating venous leg ulcers reported complete healing as its primary outcome measure, and none had blinded outcome assessment. Another limitation of the body of evidence is that some standard of care interventions involved fewer visits than the non-contact ultrasound intervention, and the differences in intensity of care resulting from this differential in face-to-face contact could partially explain the difference in findings between intervention and control groups. In general, most of the studies did not have many participants, had short follow-up times and had poor study design. The evidence is insufficient to determine the effects of the technology on health outcomes.
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.
*CPT® is a registered trademark of the American Medical Association.