Latest Review Date: March 2024

Category: Durable Medical Equipment (DME)                                                                   

POLICY:

Electrical or electromagnetic stimulation is considered investigational for the treatment of osteoarthritis and rheumatoid arthritis.

DESCRIPTION OF PROCEDURE OR SERVICE:

Electrical and electromagnetic stimulation are being investigated to improve functional status and to relieve pain related to osteoarthritis and rheumatoid arthritis that are 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 subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered via treatment coils placed over the skin. Combined magnetic fields deliver a time-varying field by superimposing that 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. 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. Therefore, pulsed electrical stimulation is proposed to be similar to bone stimulator therapy for fracture nonunion.

KEY POINTS:

The most recent literature review was performed through January 22, 2024.

Summary of Evidence

For individuals who have arthritis who receive pulsed electrical or electromagnetic stimulation, the evidence includes systematic reviews and a number of small RCTs. The relevant outcomes are symptoms, functional outcomes, health status measures, and treatment-related morbidity. A review of the literature did not find adequate evidence that use of pulsed electrical or electromagnetic stimulation for the treatment of arthritis improves health outcomes. A 2020 meta-analysis identified 15 randomized sham-controlled trials on treatment of OA of the knee. There was some evidence of clinically and statistically significant improvement in pain, but no evidence of clinically significant improvement in stiffness, function, or quality of life. These conclusions are limited by methodologic shortcomings and inconsistent trial results.Variable results seen in more recent RCTs might also be related to the different devices and treatment durations used. Additional studies with larger numbers of subjects are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS

American Academy of Orthopaedic Surgeons

In 2021, the American Academy of Orthopaedic Surgeons published updated guidelines on the treatment of osteoarthritis of the knee. The guidelines noted that there was only 1 study "that examined the use of a wearable pulsed electromagnetic field device for pain management in subjects with knee osteoarthritis."The strength of recommendation was downgraded to "limited" from inconclusive since there is only this single "moderate" quality study recommending for or against the intervention.

American College of Rheumatology

In 2019, the American College of Rheumatology released guidelines for the management of OA of the hand, hip, and knee. The guidelines do not mention pulsed electrical or electromagnetic stimulation, but they recommend against transcutaneous electrical stimulation for patients with knee and/or hip OA.

In 2021, the American College of Rheumatology released updated recommendations for the treatment of rheumatoid arthritis. All recommended treatments were pharmacologic. Use of electrical stimulation for treating rheumatoid arthritis was not addressed.

Osteoarthritis Research Society International

In 2019, the Osteoarthritis Research Society International published updated evidence-based consensus guidelines for the nonsurgical management of knee, hip, and polyarticular osteoarthritis. Sixty treatment modalities were evaluated for 3 patient groups: knee-only, hip, and multijoint osteoarthritis. Neuromuscular electrical stimulation was considered " strongly recommended against" for all groups due to low quality evidence from trials with small sample sizes and insufficient duration of follow-up. Electromagnetic therapy was considered "strongly recommended against" for all groups due to low quality evidence and an implausible biological mechanism.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

KEY WORDS:

Osteoarthritis, pulsed electrical stimulation, BioniCare® stimulator system, Bio-1000™, OrthoCor™ Active Knee System, OrthoCor™, SofPulse™, Roma3™, Rheumatoid Arthritis

APPROVED BY GOVERNING BODIES:

The BioniCare Bio-1000™ stimulator (VQ OrthoCare) was cleared for marketing by the US Food and Drug Administration (FDA) through the 510(k) process in 1997 to deliver pulsed electrical stimulation for adjunctive treatment of osteoarthritis of the knee, then later for rheumatoid arthritis of the hand. The FDA originally determined that this device was substantially equivalent to transcutaneous electrical nerve stimulation devices. The manufacturer requested reclassification due to the fact that the target tissue is joint tissue, not nerve. In 2006, the FDA reclassified the device as a transcutaneous electrical stimulator for arthritis. 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 self-adhesive fasteners. The battery-powered device delivers small pulsed electrical currents of 0.0- to 12.0-V output.

The OrthoCor™ Active Knee System (OrthoCor Medical) uses pulsed electromagnetic field energy at a radio frequency of 27.12 MHz to treat pain. The OrthoCor Knee System received marketing clearance from FDA in 2009 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). They are indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Palermo is a portable battery-operated device.

In 2017, the ActiPatch® (BioElectronics) was cleared for marketing by the FDA through the 510(k) process for nonprescription use for adjunctive treatment of plantar fasciitis of the heel and osteoarthritis of the knee (K152432). FDA product code: PQY. In January 2020, the ActiPatch indications for use were broadened to adjunctive treatment of musculoskeletal pain (K192234).

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING:

HCPCS:

REFERENCES:

1. American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee. 2013; www.aaos.org/research/guidelines/guidelineoaknee.asp.
2. American Academy of Orthopaedic Surgeons. Management of osteoarthritis of the knee (non-arthroplasty). 2021; https://www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/oak3cpg.pdf. 
3. Bagnato GL, Miceli G, Marino N, et al. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). Apr 2016; 55(4):755-762.
4. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticularosteoarthritis. Osteoarthritis Cartilage. Nov 2019; 27(11): 1578-1589.
5. de Paula Gomes CAF, Politti F, de Souza Bacelar Pereira C, et al. Exercise program combined with electrophysical modalitiesin subjects with knee osteoarthritis: a randomised, placebo-controlled clinical trial. BMC Musculoskelet Disord. Apr 20 2020;21(1): 258.
6. Department of Health & Human Services. Correction to substantially equivalent letter of June 6, 2003 for BionicCare Stimulator. June 8, 2006. https://www.accessdata.fda.gov/cdrh_docs/pdf3/K030332.pdf. 
7. Dundar U, Asik G, Ulasli AM, et al. Assessment of pulsed electromagnetic field therapy with Serum YKL-40 and ultrasonography in patients with knee osteoarthritis. Int J Rheum Dis. Mar 2016; 19(3):287-293.
8. Fary RE, Carroll GJ, Briffa TG et al. The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: results of a double-blind, randomized, placebo-controlled, repeated-measures trial. Arthritis Rheum 2011; 63(5):1333-1342.
9. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). Jul 2021;73(7): 924-939.
10. Fukuda TY, Alves da Cunha R, Fukuda VO et al. Pulsed shortwave treatment in women with knee osteoarthritis: a multicenter, randomized, placebo-controlled clinical trial. Phys Ther 2011; 91(7):1009-17.
11. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). Apr 2012; 64(4):465-474.
12. Kolasinski SL, Neogi T, Hochberg MC1, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee. Arthritis Care Res (Hoboken). 2020 Jan.
13. Li S, Yu B, Zhou D, et al. Electromagnetic fields for treating osteoarthritis. Cochrane Database Syst Rev. 2013; 12:CD003523.
14. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. Mar 2014; 22(3):363-388.
15. Negm A, Lorbergs A, Macintyre NJ. 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. Sep 2013; 21(9):1281-1289.
16. Nelson FR, Zvirbulis R, Pilla AA. Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study. Rheumatol Int 2013; 33(8):2169-2173.
17. Ozguclu E, Cetin A, Cetin M et al. Additional effect of pulsed electromagnetic field therapy on knee osteoarthritis treatment: a randomized, placebo-controlled study. Clin Rheumatol 2010; 29(8):927-931.
18. Singh JA, Saag KG, Bridges SL, Jr., et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. Jan 2016; 68(1):1-26.
19. Tong J, Chen Z, Sun G, et al. The Efficacy of Pulsed Electromagnetic Fields on Pain, Stiffness, and Physical Function in Osteoarthritis:A Systematic Review and Meta-Analysis. Pain Res Manag. 2022; 2022: 9939891.
20. Wuschech H, von Hehn U, Mikus E, et al. Effects of PEMF on patients with osteoarthritis: Results of a prospective, placebo-controlled, double-blind study. Bioelectromagnetics. Dec 2015; 36(8):576-585.
21. Yang X, He H, Ye W, et al. Effects of Pulsed Electromagnetic Field Therapy on Pain, Stiffness, Physical Function, and Quality of Life in Patients With Osteoarthritis: A SystematicReview and Meta-Analysis of Randomized Placebo-Controlled Trials. Phys Ther. Jul 19 2020; 100(7): 1118-1131.
22. Yabroudi MA, Aldardour A, Nawasreh ZH, et al. Effects of the combination of pulsed electromagnetic field with progressive resistance exercise on knee osteoarthritis:A randomized controlled trial. J Back Musculoskelet Rehabil. 2024; 37(1): 55-65.

POLICY HISTORY:

Medical Policy Group, January 2005 (1)

Medical Policy Administration Committee, February 2005

Available for comment February 14-March 30, 2005

Medical Policy Group, January 2006 (1)

Medical Policy Group, January 2007 (1)

Medical Policy Administration Committee, January 2007

Available for comment January 11-February 24, 2007

Medical Policy Group, January 2008 (1)

Medical Policy Group, February 2009 (1)

Medical Policy Group, February 2010 (1): Updated description and reference list

Medical Policy Group, February 2011 (3): Updated Key Points

Medical Policy Group, October 2011 (1): Update to Key Points and References; no change to policy statement

Medical Policy Group, October 2012 (1): No new references found, deleted ‘Pulsed’ from the title and coverage section

Medical Policy Panel, December 2013

Medical Policy Group, December 2013 (3): Updates to Description, Key Points, Key Words and References; no change in policy statement (removed specific technology example/name from policy statement as cosmetic update)

Medical Policy Panel, December 2014

Medical Policy Group, January 2015 (3): Updates to Description, Key Points, Approved by Governing Bodies and References; no change in policy statement

Medical Policy Panel, June 2016

Medical Policy Group, July 2016 (6): Updates to Description, Key Points, Key Words, Summary and References; no change to policy intent.

Medical Policy Group, July 2016 (6): Updated coding to include E0761.

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Updates to Key Points, Governing Bodies, Practice Guidelines and References. No change to policy statement.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Key Points, Governing Bodies. No change to policy statement.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Description, Key Points. No change to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points, Approved by Governing Bodies, Practice Guidelines and Position Statements, and References. Title changed from “Electrical Stimulation in the Treatment of Arthritis” to “Electrical and Electromagnetic Stimulation in the Treatment of Arthritis.” No change to Policy Statement.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Key Points, Governing Bodies, Practice Guidelines and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (6): Updates to Policy Statement, Key Points, Governing Bodies, Practice Guidelines, Current Coding and References. No change to policy intent.

Medical Policy Panel, March 2023

Medial Policy Group, March 2023 (6): Updates to Key Points, Practice Guidelines, Benefit Application and References.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6):  Updates to Description, Key Points, and References.  No change to policy statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.