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DESCRIPTIONLow-frequency ultrasound in the kiloherz range may improve wound healing. Several devices are available, including the MIST Therapy® system, which delivers ultrasonic energy to wounds via a saline mist without direct skin contact.
Ultrasound is defined as a mechanical vibration above the upper threshold of human hearing (> 20 KHz). Ultrasound in the MHz range (1-3 MHz) has been used for the treatment of musculoskeletal disorders, primarily by physical therapists. Although the exact mechanism underlying its clinical effects is not known, therapeutic ultrasound has been shown 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. More recently, the therapeutic effects of ultrasound energy in the kilohertz range have been examined. It has been proposed that low frequency ultrasound in this range may improve wound healing via the production, vibration and movement of micron-sized bubbles in the coupling medium and tissue.
The mechanical energy from ultrasound is typically transmitted to tissue through a coupling gel. Several high-intensity ultrasound devices with contact probes are currently available for wound debridement. A non-contact low-intensity ultrasound device has been developed that does not require use of a coupling gel or other direct contact. The MIST Therapy™ System (Celleration) delivers a saline mist to the wound with low frequency ultrasound (40 KHz); it includes a generator, a transducer, and a disposable applicator for discharge of prepackaged saline.
In 2004, the U.S. Food and Drug Administration (FDA) reclassified these devices from class III to class II at the request of Celleration (K032378). As part of the reclassification, the FDA named this type of device as a "low energy ultrasound wound cleaner" which they defined as “a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.” In 2005, the Celleration MIST therapy device 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.” Several wound drainage and wound vacuum systems were listed as predicate devices.
The FDA’s 510(k) process does not require data regarding clinical efficacy; this device was considered essentially equivalent to predicate powered suction pump devices based on the “use of mechanical energy to promote wound healing through means such as the removal of infectious material and other wound exudates.”
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 ultrasound 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.”
Vacuum-Assisted Closure of Chronic Wounds is addressed in a separate policy.
Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds is addressed in a separate policy.
POLICYNon-contact ultrasound treatment for wounds is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY1/10/2008: Policy added
3/27/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC)
10/7/2008: Policy reviewed, no changes made
12/07/2009: Policy Description revised as follows: Purpose for low-frequency ultrasound added to description. Links added to related policies, Vacuum-Assisted Closure of Chronic Wounds and Electrostimulation and Electromagnetic Therapy for the Treatment fo Chronic Wounds. Policy Exclusion revised to include FEP verbiage. Coding Section revised to add verbiage, "This is not an all inclusive list of Non-Covered Procedure Codes". ICD9 Diagnosis section revised to add "Investigational for all codes".
12/29/2010: Policy reviewed; no changes.
11/10/2011: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 2.01.79
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.