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The H-WAVE® stimulator uses a form of electrical stimulation that differs from other forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), in terms of its wave form. While the device may be used by physicians, physiatrists, chiropractors, or podiatrists, it is also available for home use. The H-WAVE® stimulation device has been used for the treatment of pain related to a variety of etiologies, such as diabetic neuropathy, muscle sprains, temporomandibular joint dysfunctions or reflex sympathetic dystrophy. It has also been used to accelerate healing of wounds, such as diabetic ulcers.
In 1992, the H-WAVE® muscle stimulator (Electronic Waveform Lab, Inc.) was cleared for marketing by the FDA through the 510(k) process. The U.S. Food and Drug Administration (FDA) classified the H-WAVE® stimulation device as a powered muscle stimulator. The FDA describes this device as an electronically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. According to the FDA, the manufacturer may make the following claims regarding the effect of the device: “1) relaxation of muscle spasms; 2) prevention or retardation of disuse atrophy; 3) increasing local blood circulation; 4) muscle re-education; 5) immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; 6) maintaining or increasing range of motion; 7) treatment of chronic pain; 8) acute pain; 9) post-surgical pain; and, 10) temporary pain.” Additional FDA cleared indications for use include: anesthesia in general dentistry, amalgams, composites, crown preparations, periodontal scaling and root planing, muscle spasms associated with TMJ, and muscle re-education, as in regaining joint control in TMJ.
Uses of the device not cleared by the FDA include, but are not limited to, treatment of diabetic neuropathy and wound healing.
The H-WAVE® stimulation device is considered investigational for all indications.
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.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY7/27/2006: Approved by Medical Policy Advisory Committee (MPAC)
1/24/2008: Policy reviewed, no changes
04/09/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Policy guidelines updated regarding medical necessity criteria.
12/28/2010: Policy description updated regarding devices. Added verbiage to the policy statement to clarify that H-wave electrical stimulation is considered investigational for all indications.
12/13/2011: Policy reviewed; no changes.
08/25/2015: Code Reference section updated for ICD-10.
11/19/2015: Policy description updated regarding the H-WAVE® device and its indications. Policy statement revised to state that the H-WAVE® stimulation device is considered investigational for all indications. It previously stated: H-wave stimulation is considered investigational for all indications, including but not limited to: treatment of pain; wound healing; post-operative treatment to improve function and/or range of motion. Investigative definition updated in policy guidelines section.
SOURCE(S)Blue Cross Blue Shield Association Policy # 1.01.13
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.