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DESCRIPTIONElectrostimulation (electrical stimulation) refers to the application of electrical current through electrodes placed directly on the skin. Electromagnetic therapy involves the application of electromagnetic fields, rather than direct electrical current. Both are proposed as treatments for wounds, generally chronic wounds.
The normal wound healing involves inflammatory, proliferative, and remodeling phases. When the healing process fails to progress properly and the wound persists for longer than 1 month, it may be described as a chronic wound. The types of chronic wounds most frequently addressed in studies of electrical stimulation for wound healing are 1) pressure ulcers, 2) venous ulcers, 3) arterial ulcers, and 4) diabetic ulcers. Conventional or standard therapy for chronic wounds involves local wound care as well as systemic measures including debridement of necrotic tissues, wound cleansing, and dressing that promotes a moist wound environment, antibiotics to control infection, and optimizing nutritional supplementation. Avoidance of weight bearing is another important component of wound management.
Since the 1950's, investigators have used electrical stimulation to promote wound healing, based on the theory that electrical stimulation may:
Electrical stimulation refers to the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. The types of electrical stimulation and devices can be categorized into four (4) groups based on the type of current: 1) low-intensity direct current (LIDC), 2) high-voltage pulsed current (HVPC), 3) alternating current, (AC), and 4) transcutaneous electrical nerve stimulation (TENS). Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields rather than direct electrical current.
No electrical stimulation or electromagnetic therapy devices have received approval from the U.S. Food and Drug Administration (FDA), specifically for the treatment of wound healing. A number of devices have been cleared for marketing for other indications. Use of these devices for wound healing is an off-label indication.
POLICYElectrical stimulation for the treatment of wounds, including but not limited to low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS) is considered investigational.
Electrical stimulation performed by the patient in the home setting for the treatment of wounds is considered investigational.
Electromagnetic therapy for the treatment of 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 HISTORY7/27/2006: Approved by Medical Policy Advisory Committee (MPAC)
5/10/2007: Policy reviewed. Code reference section updated; HCPCS E0761, E0769, G0281, G0282, G0295, and G0329 added to non-covered codes
5/9/2008: Policy reviewed, no changes
12/31/2008: Code Reference section updated per 2009 CPT/HCPCS revisions
04/13/2010: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.
12/30/2010: Policy description and statement unchanged. Removed the word "Chronic" from the policy title.
11/10/2011: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
06/13/2013: Policy reviewed; no changes to policy statement. Removed diagnosis code 707 from the Code Reference section.
03/19/2014: Policy statement updated to add "for the treatment of wounds, including but not limited to" for clarity purposes only. Intent of policy statement unchanged.
10/27/2014: Policy reviewed; no changes.
07/20/2015: Code Reference section updated for ICD-10.
11/09/2015: Policy description updated. Policy statement updated to change "alternative current" to "alternating current." Policy guidelines updated to add investigative definition.
03/07/2016: Policy reviewed; no changes.
06/01/2016: Policy number A.2.01.57 added.
SOURCE(S)Blue Cross Blue Shield Association Policy # 2.01.57
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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