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DESCRIPTIONThis policy describes potential use of pulsed electrical stimulation for the treatment of arthritis.
Electrical stimulation has been used to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard therapies. Electrical stimulation is provided by an electronic device that non-invasively delivers a low voltage, monophasic electrical field to the target site of pain. In basic research studies, pulsed electrical stimulation has been shown to alter chondrocyte-related gene expression in vitro and to have regenerative effects in animal models of cartilage injury. Therefore, pulsed electrical stimulation is proposed to be similar to bone stimulator therapy for fracture nonunion. See the Electrical Bone Growth Stimulation of the Appendicular Skeleton medical policy.
The BioniCare Bio-1000™ stimulator is a device that has received Food and Drug Administration (FDA) 510(k) marketing clearances to deliver pulsed electrical stimulation for the treatment of osteoarthritis of the knee and rheumatoid arthritis of the hand. The FDA gave the BioniCare Bio-1000™ clearance after finding it to be substantially equivalent to transcutaneous electrical nerve stimulation devices. The BioniCare system consists of an electronic stimulator device with electrical leads that are placed over the affected area and held in place with a lightweight, flexible wrap and velcro fasteners. The battery-powered device delivers small pulsed electrical currents of 0.0 to 12.0 volt output. It is recommended that the device be worn for at least 6 hours per day and patients are reported to often wear the device while sleeping.
The FDA's 510(k) summaries specify the BioniCare Stimulator, Model Bio-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and:
The BioniCare system is contraindicated in patients with demand-type pacemakers and may interfere with other electronic devices.
POLICYElectrical stimulation is considered investigational for the treatment of osteoarthritis or rheumatoid arthritis.
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 GUIDELINESInvestigative 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.
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
04/13/2010: Policy title updated to change "Electromagnetic" to "Electrical." Policy description updated regarding research study findings. “501(k)” added to the FDA information in the policy description. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Definition of investigative service added to the policy guidelines.
12/29/2010: Policy reviewed; no changes.
11/10/2011: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association Policy # 1.01.27
CODE REFERENCEThis is not an all-inclusive list of non-covered procedure codes.
All codes billed for this procedure are considered investigational and not eligible for coverage.