DESCRIPTION
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 using a device that noninvasively delivers a subsensory, 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.
POLICY
Electrical or electromagnetic stimulation for the treatment of osteoarthritis or rheumatoid arthritis is considered investigational.
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Evidence is lacking to demonstrate improved health outcomes with the use of electrical stimulation in comparison to other available treatments for arthritis.
SOURCES
American Academy of Orthopaedic Surgeons. (2022). Management of osteoarthritis of the knee (non-arthroplasty); appropriate use criteria, 3rd ed. Retrieved May 3, 2023 from http://www.aaos.org/guidelines.
American College of Rheumatology. (2019). 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Retrieved May 3, 2023 from https://www.rheumatology.org/.
American College of Rheumatology. (2021). 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Retrieved May 3, 2023 from https://www.rheumatology.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. (4:2023). Electrical stimulation for the treatment of arthritis (1.01.27). Retrieved May 3, 2023 from https://www.bcbsaoca.com/eps/. (31 articles and/or guidelines reviewed)
CMS.gov: Centers for Medicare & Medicaid Services. CGS Administrators, LLC. (2020, January). Transcutaneous electrical joint stimulation devices (TEJSD). (LCD ID: L34821). Retrieved May 19, 2020 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. (2022). Osteoarthritis in over 16s: diagnosis and management. Retrieved May 3, 2023 from www.nice.org.uk/guidance/ng226.
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.
Osteoarthritis Research Society International (OARSI). (2019). OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis 2019. Retrieved May 3, 2023 from https://www.oarsi.org/education/oarsi-guidelines.org/.
Tong, J., Chen, Z., Sun, G., Zhou, J., Zeng, Y., et al. (2022). The efficacy of pulsed electromagnetic fields on pain, stiffness, and physical function in osteoarthritis: A systematic review and meta-analysis. Pain Research & Management, 2022, 9939891, doi: 10.1155/2022/9939891. (Level 1 evidence)
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.
Yang, X., He, H., Ye, W., Perry, T.A., & He, C. (2020). Effects of pulsed electromagnetic field therapy on pain, stiffness, physical function, and quality of life in patients with osteoarthritis: A systematic review and meta-analysis of randomized placebo-controlled trials. Physical Therapy, 100 (7), 1118-1131. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 3/14/2013
MOST RECENT REVIEW DATE: 6/8/2023
ID_BA
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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