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Low-frequency ultrasound in the kilohertz range may improve wound healing. Several non-contact low-frequency ultrasound (NLFU) devices have received regulatory approval for wound treatment.
Ultrasound (US) delivers mechanical vibration above the upper threshold of human hearing (>20 kHz). Ultrasound in the MHz range (1-3 MHz) has been used to treat musculoskeletal disorders, often 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. The therapeutic effects of ultrasound energy in the kilohertz range have also been examined. Although the precise effects are not known, 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. Low-intensity ultrasound devices have been developed that do not require coupling gel or other direct contact. The MIST Therapy System delivers a saline mist to the wound with low frequency ultrasound (40 KHz). A second device, the Qoustic Wound Therapy System, also uses sterile saline to deliver US energy (35 KHz) for wound debridement and irrigation.
The primary end points of interest for trials of wound closure are as follows, consistent with guidance from the U.S. Food and Drug Administration for industry in developing products for treatment of chronic cutaneous ulcer and burn wounds:
In 2005, the MIST Therapy® device (Celleration) was cleared for marketing by the FDA through the 510(k) process, “to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.” In February 2015, Celleration was acquired by Alliqua Biomedical (Langhorne, PA).
In 2007, the AR1000 Ultrasonic Wound Therapy System (Arobella Medical, Minnetonka, MN) was cleared for marketing by FDA through the 510(k) process, listing the MIST Therapy® system and several other ultrasonic wound debridement and hydrosurgery systems as predicate devices. The AR1000 system probe uses "contact or noncontact techniques to achieve intended wound therapy modalities to promote wound healing." The indications in the 510(k) summary are listed as: “Selective and non-selective dissection and fragmentation of soft and or hard tissue" and "Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter." This device is now known as the Qoustic Wound Therapy System™.
Several other devices have been approved as being substantially equivalent to the earlier devices.
Negative Pressure Wound Therapy 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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
02/26/2014: Policy reviewed; no changes to policy statement. Added the following new 2014 CPT code(s) to the Code Reference section: 97610.
01/07/2015: Policy reviewed; description updated regarding devices. Policy statement unchanged. Removed the following deleted CPT code from the Code Reference section: 0183T.
07/31/2015: Code Reference section updated for ICD-10.
03/07/2016: Policy description updated regarding devices. Policy statement unchanged. Investigative definition updated in policy guidelines.
06/01/2016: Policy number A.2.01.79 added.
01/27/2017: Policy description updated regarding primary points of interest and devices. Policy statement unchanged.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 2.01.79
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.