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DESCRIPTIONPulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis (OA) unresponsive to other standard therapies. Electrical stimulation is provided by an electronic device that non-invasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered via treatment coils that are placed over the skin. See the Electrical Bone Growth Stimulation of the Appendicular Skeleton medical policy.
Electrical stimulation is being investigated to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis unresponsive to other standard therapies. Noninvasive electrical stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads/electrodes are placed on either side of the knee or wrist. Electrical stimulation is provided by an electronic device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered via treatment coils that are placed over the skin. Combined magnetic fields deliver a time-varying field by superimposing the time-varying magnetic field onto an additional static magnetic field.
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.
The BioniCare Bio-1000™ stimulator (VQ OrthoCare) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process to deliver pulsed electrical stimulation for the treatment of osteoarthritis of the knee and rheumatoid arthritis of the hand. The FDA determined that this device was substantially equivalent to transcutaneous electrical nerve stimulation (TENS) devices. The BioniCare system consists of an electronic stimulator device with electrical leads 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 can be worn while sleeping. It is proposed that the device treats the underlying cause of the disease by stimulating the joint tissue and improving the overall health of the joint and that it provides a slow-acting, but longer-lasting improvement in symptoms.
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.
The OrthoCor™ Active Knee System (OrthoCor Medical) uses pulsed electromagnetic field energy at a radio frequency of 27.12 MHz to treat pain. In 2009, the OrthoCor Knee System was cleared for marketing by the FDA through the 510(k) process and is classified as a shortwave diathermy device for use other than applying therapeutic deep heat (K091996, K092044). It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue and for the treatment of muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis. The system includes single-use packs (pods) that deliver hot or cold and are supplied in packets of 15. The predicate devices are the OrthoCor (K091640) and Ivivi Torino II™ (K070541).
In 2008, the SofPulse™ (also Torino II, 912-M10, and Roma3™, Ivivi Health Sciences - renamed Amp Orthopedics) was cleared for marketing by FDA through the 510(k) process as a short-wave diathermy device that applies electromagnetic energy at a radio frequency of 27.12 MHz (K070541). The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Palermo is a portable battery-operated device.
The Magnetofield (F& B International, Italy) and Elettronica Pagani (Energy Plus Roland Series, Italy) devices provide pulsed electromagnetic field therapy. They are currently marketed in Europe.
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.
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)
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.
03/11/2014: Policy reviewed; no changes.
01/15/2015: Policy description updated regarding pulsed electrical and electromagnetic stimulation. Added information regarding devices. Policy statement unchanged.
08/18/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 procedure code 93.39 from the Code Reference section.
04/26/2016: Policy Guidelines updated to revise investigative definition.
05/31/2016: Policy number A.1.01.27 added.
07/18/2016: Policy description updated regarding devices. Policy statement unchanged.
SOURCE(S)Blue Cross Blue Shield Association Policy # 1.01.27
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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