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Threshold electrical stimulation is described as the delivery of low-intensity electrical stimulation to target spastic muscles during sleep at home. The stimulation is not intended to cause muscle contraction. Although the mechanism of action is not understood, it is thought that low-intensity stimulation may increase muscle strength and joint mobility, leading to improved voluntary motor function. The technique has been used most extensively in children with spastic diplegia related to cerebral palsy, but also in those with motor disorders, such as spina bifida.
Devices used for threshold electrical stimulation are classified as “powered muscle stimulators.” As a class, the U.S. Food and Drug Administration (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.”
POLICYThreshold electrical stimulation as a treatment of motor disorders, including but not limited to cerebral palsy, is considered not medically necessary.
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.
Threshold electrical stimulation may be associated with routine physical therapy visits over the course of the entire 12-month course of treatment. In addition, the therapy requires the rental or purchase of an electrical stimulation device, which may be coded as E0745 (neuromuscular stimulator, electronic shock unit).
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 HISTORY05/18/2006: Approved by Medical Policy Advisory Committee (MPAC)
03/19/2008: Policy reviewed, no changes
04/12/2010: Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Expanded the description of CPT code 97110.
05/17/2011: Policy statement changed from investigational to not medically necessary.
12/13/2011: Policy reviewed; no changes.
03/13/2013: Policy reviewed; no changes.
07/23/2015: Code Reference section updated for ICD-10.
04/26/2016: Policy Guidelines updated to revise investigative definition.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.19
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
Not Medically Necessary Codes