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DESCRIPTIONH-Wave stimulation is 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 H-wave stimulation may be performed by physicians, physiatrists, chiropractors, or podiatrists, H-wave devices are also available for home use. H-wave stimulation 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. H-wave stimulation has also been used to accelerate healing of wounds, such as diabetic ulcers.
H-wave electrical stimulation must be distinguished from the H-waves that are a component of electromyography.
A variety of devices may be used for H-wave stimulation. The U.S. Food and Drug Administration (FDA) has classified them as "powered muscle stimulators." As a class, the FDA describes these devices as "an electronically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area."
In 1992, the H-Wave® muscle stimulator (Electronic Waveform Lab, Huntington Beach, CA) was cleared for marketing by the FDA through the 510(k) process. The U.S. Food and Drug Administration (FDA) classified H-wave stimulation devices as “powered muscle stimulators.” As a class, the FDA describes these devices as being “intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.” According to the FDA, manufacturers 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; and, 6) maintaining or increasing range of motion.”
Uses of the device not cleared by the FDA include, but are not limited to, treatment of diabetic neuropathy and wound healing.
POLICYH-wave stimulation is considered investigational for all indications, including but not limited to:
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 GUIDELINESThe coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative 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.
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.
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.