Pulsed electrical and electromagnetic stimulation (e.g., BioniCare Bio-1000™, OrthoCor™ Active Knee System, SofPulse™, ActiPatch®, Magnetofield®). are being investigated to improve functional status and relieve pain related to osteoarthritis and rheumatoid arthritis that is 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 or electrodes are placed on either side of the knee or wrist. Electrical stimulation is provided by an electronic device that noninvasively delivers a sub-sensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered using coils placed over the skin Combined magnetic fields deliver a time-varying field by superimposing that field onto an additional static magnetic field.
Electrical or electromagnetic stimulation for the treatment of osteoarthritis or rheumatoid arthritis is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Evidence is lacking to demonstrate improved health outcomes with the use of electrical stimulation in comparison to other available treatments for arthritis.
American Academy of Orthopaedic Surgeons. (2013). Treatment of osteoarthritis of the knee; evidence based guideline, 2nd ed. Retrieved September 22, 2016 from http://www.aaos.org/guidelines.
American College of Rheumatology. (2016). 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Retrieved August 9, 2017 from www.arthritisrheum.org.
Bagnato, G.L., Miceli, G., Marino, N., Sciortino, D. & Bagnato, G.F. (2016). Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology, 55, 755-762. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (4:2019). Electrical stimulation for the treatment of arthritis (1.01.27). Retrieved August 9, 2019 from https://www.evidencepositioningsystem.com/. (17 articles and/or guidelines reviewed)
CGS Administrators, LLC. (2017, January). Local Coverage Determination (LCD): Transcutaneous electrical joint stimulation devices (TEJSD). L34821). Retrieved August 9, 2017 from www.cms.gov.
Dündar, Ű., Aşik,G., Ulaşi, A.M., Sinici, Ş. Yaman, F., Solak, Ő., et al. (2016). Assessment of pulsed electromagnetic field therapy with serum YKL-40 and ultrasonography in patients with knee osteoarthritis. International Journal of Rheumatic Diseases, 19 (3), 287-293. Abstract retrieved August 9, 2019 from PubMed database.
National Institute for Health and Care Excellence. (2014). Osteoarthritis: care and management. Retrieved August 9, 2017 from www.nice.org.uk/guidance/cg177.
Negm, A., Lorbergs, A., & Macintyre, N.J. (2013). Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis. Osteoarthritis Cartilage, 21 (9), 1281-1289. Abstract retrieved August 9, 2017 from PubMed database.
Nelson, F., Zvirbulis, R., & Pilla, A. (2013). Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study. Rheumatology International, 33 (8), 2169-2173. Abstract retrieved September 22, 2016 from PubMed database.
U. S. Food and Drug Administration. (2008, December). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K07541. Retrieved August 9, 2017 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2008, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K073386. Retrieved September 10, 2012 from http://www.accessdata.fda.gov.
Wuschech, H., von Hehn, U., Mikus, E., & Funk, R.H. (2015). Effects of PEMF on patients with osteoarthritis: results of a prospective, placebo-controlled, double-blind study. Bioelectromagnets, 36 (8), 576-585. Abstract retrieved August 9, 2019 from PubMed database.
Zeng, C., Li, H., Yang, T., Deng, Z., Yang, Y., Zhang, Y., et al. (2015). Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage, 23 (2), 189 – 202. Abstract retrieved October 21, 2015 from the PubMed database.
ORIGINAL EFFECTIVE DATE: 3/14/2013
MOST RECENT REVIEW DATE: 9/26/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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