Coverage Guideline. BioniCare System (formerly the BIO-1000 System) DEFINITION COVERAGE CRITERIA MEDICAL BACKGROUND

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1 Coverage Guideline System (formerly the BIO-1000 System) Disclaimer: Please note that Baptist Health Plan updates Coverage Guidelines throughout the year. A printed version may not be most up to date version available. The health plan reserves the right to review and update this policy as needed. Refer to the website to ascertain that you are utilizing the most current available version. Clinical guideline policies are not intended to serve as treatment guidelines or treatment recommendation. Treating providers must use their own clinical judgment in rendering care to their patient population. DEFINITION The System (formerly the BIO-1000 System) advances a notion that arthritis joint pain results from a deranged electrical milieu surrounding the affected joint, and that further manipulation of the joint electrical environment can render pain relief (e.g., in the knee or the hand). It consists of an electrical signal generator device, and a carrier that may be worn as a brace around the knee or as a wrap around the hand. 1 The scientific basis for the use of this technology appears to derive from an article published in 1995 by Zizic in the Journal of Rheumatology. Electromagnetic field therapy (also known as electrophysical agent therapy) is currently used by physiotherapists to promote growth and repair of bone and cartilage. COVERAGE CRITERIA Baptist Health Plan considers the use of electrical signal generation devices (e.g., System) for relief of pain associated with arthritis to be investigational, and therefore not medically necessary. MEDICAL BACKGROUND More than 20 years ago Zizac (1995) described a randomized controlled trial (RCT) inclusive of 78 subjects with osteoarthritis (OA) who were treated by "pulsed electrical stimulation (PES) " and assessed primarily by pain, function, and physician global evaluation of condition over a four-week treatment period. 2 The authors reported that individuals treated with active PES devices showed significantly greater improvement than the placebo group for all primary Page 1 of 5

2 efficacy variables in comparisons of mean change from baseline to the end of treatment (p < 0.05). Improvement of 50% from baseline was demonstrated in at least one primary efficacy variable in 50% of the active device group, in 2 variables in 32%, and in all 3 variables in 24%. In the placebo group improvement of 50% occurred in 36% for one, 6% for 2, and 6% for 3 variables. Mean morning joint stiffness decreased by 20 minutes in the active device group and increased 2 minutes in the placebo group (p < 0.05). No statistically significant differences were observed for tenderness, swelling, or walking time. A contemporary Cochrane systematic review inclusive of 636 patients sought to assess the benefits and harms of electromagnetic fields for the treatment of osteoarthritis as compared to placebo or sham. 3 All nine of the reviewed studies were noted to have inadequate design and conduct, and therefore were considered at high risk of bias or for incomplete outcome data. Participants who were randomized to electromagnetic field treatment rated their pain relief points more on a scale of 0 to 100 (MD 15.10, 95% CI 9.08 to 21.13; absolute improvement 15%) after 4 to 26 weeks' treatment compared with placebo. The authors of the review found that electromagnetic field treatment had no statistically significant effect on physical function (MD 4.55, 95% CI to 11.32; absolute improvement 4.55%) based on the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scale from 0 to 100 after 12 to 26 weeks' treatment. There was no statistically significant difference in quality of life on a scale from 0 to 100 (SMD 0.09, 95% CI to 0.54; absolute improvement 0.09%) after four to six weeks' treatment, based on the SF-36. No participants experienced any serious adverse events. The authors concluded that evidence suggests that electromagnetic field treatment may provide moderate benefit for osteoarthritis sufferers in terms of pain relief, but further studies are required to confirm whether this treatment confers clinically important benefits in terms of physical function and quality of life. An even more recent (2016) Cochrane review (n=2388) look at pulsed electro-magnetic field (PEMF) therapy for rotator cuff disease. 4 Sixteen (34%) trials investigated the effect of an electrotherapy modality delivered in isolation. Only 23% were rated at low risk of allocation bias, and 49% were rated at low risk of both performance and detection bias (for self-reported outcomes). The trials were heterogeneous in terms of population, intervention and comparator, so none of the data could be combined in a meta-analysis. In single, small trials, no clinically important benefits of PEMF, microcurrent electrical stimulation (MENS), acetic acid iontophoresis and microwave diathermy were observed. Adverse events were not measured in any trials investigating the effects of PEMF. Based on low quality evidence, PEMF may not provide clinically relevant benefits over placebo, or provide additional benefits when combined with other physical therapy interventions. 4 Another systematic review (n=276) provided little additional evidence that PEMF has utility in the management of OA of the knee or in significantly reducing knee pain. 5 An improvement in WOMAC physical function score was described by one study included in the review; however the study was compromised by a low methodological score and used a unique PEMF device. Its results were unreplicated by other studies, nor did this study report any improvement in pain. The authors of the review concluded that healthcare resources currently being used for the provision of PEMF may be better utilized in more clinically efficacious rehabilitation, such as the provision of exercise classes, and health and well-being advice sessions. A systematic review inclusive of 27 trials sought to investigate the efficacy of different electrical stimulation therapies in pain relief of patients with OA, including high-frequency transcutaneous electrical nerve stimulation (h-tens), low-frequency transcutaneous electrical nerve stimulation (l-tens), neuromuscular electrical stimulation (NMES), interferential current (IFC), PES, and Page 2 of 5

3 noninvasive interactive neurostimulation (NIN). 6 Of these modalities only IFC conferred significantly effective treatment in terms of both pain intensity and change pain score compared to control. The authors concluded that the recommendation level of the other ES therapies is either uncertain (h-tens) or not appropriate (l-tens, NMES, PES and NIN) for pain relief. A systematic review (n=459) aimed to determine if low frequency ( 100 Hz) pulsed sub-sensory threshold electrical stimulation produced either through PEMF or PES vs sham is effective in improving pain and physical function at treatment completion in adults with knee OA blinded to treatment. 7 PEMF/PES improved physical function (SMD = 0.22, 95% confidence interval (CI) = 0.04, 0.41, P = 0.02, I(2) = 0%), but did not reduce pain (SMD = 0.08, 95% CI = -0.17, 0.32, P = 0.55, I(2) = 43%). The strength of the body of evidence was low for physical function and very low for pain. Up until November, 2014 Hayes maintained a rating of the system as "C" or "potential but unproven benefit." 8 Although the Knee System was found to provide statistically significant small-to-moderate improvements in knee pain and function, obtaining these benefits required a high degree of long-term compliance. Hayes also noted that "... demand for the Knee System may increase since it is noninvasive and has been profiled frequently in the media. However, patients and providers may ultimately decide not to adopt this technology, since it requires a high degree of patient compliance and is not typically covered by payers." Hayes subsequently retired its assessment of the system as "outdated" in the fall of Zizic published again in 2013, reporting on the benefits of adding a knee-brace apparatus to the electrical stimulation device he had described many years ago, and aiming to determine if incorporating the electrical stimulator into an knee brace would produce more rapid improvement and result in increased "adherence and efficacy:" 9 "Two hundred eighty-nine patients treated only with served as control and 225 patients were treated with combined with an unloading (knee) brace. Means and standard deviations of the changes in scores for pain intensity in the past 48 hours, pain and associated symptoms, patient global assessment, pain on going up or down stairs, and pain on walking on a flat surface and the effect sizes at 1, 3, 6, and 12 months, as well as the percentages of patients achieving at least 20% improvement, and at least 50% improvement, demonstrated that treatment with stimulator and unloading brace combined was significantly superior to treatment with the stimulator alone." REGULATORY INFORMATION Kentucky No legislative mandates were found for coverage of pulsed electrical stimulation of the joints. Indiana No legislative mandates were found for coverage of pulsed electrical stimulation of the joints. Tennessee No legislative mandates were found for coverage of pulsed electrical stimulation Page 3 of 5

4 of the joints. System (formerly BIO-1000 System) The BIO-1000 System is FDA approved as a transcutaneous electrical stimulator for pain relief. is approved for use as an adjunctive therapy, but is not designed to be a treatment for osteoarthritis. COVERAGE DETAIL For self-funded plans, consult individual plan documents. If there is a conflict between this policy and a self-funded plan document, the provisions of the plan document will govern. In addition, coverage for Medicare Advantage members may differ. This is a result of applicable coverage statements by the Center for Medicare and Medicaid Services (CMS). The National Coverage Determinations, Local Coverage Determinations, and Local Medical Review Policies may be found at the CMS website, Please note that for all plans, the member s health plan benefits that are in effect on the rendered date of service must be used in coverage determinations. CPT Codes Description Application of surface (transcutaneous) neurostimulator HCPCs Codes Description Coverage Information May NOT be medically Coverage Information A4558 Conductive gel or paste, for use with electrical device May NOT be medically A4595 Electrical Stimulator supplies May NOT be medically E0762 Transcutaneous electrical joint stimulation device system, includes all accessories May NOT be medically Page 4 of 5

5 REFERENCES 1 What is? web site. Last accessed April 27, Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol. 1995;22(9): Li S, Yu B, Zhou D, He C, Zhuo Q, Hulme JM. Electromagnetic fields for treating osteoarthritis. Cochrane Database Syst Rev. 2013;(12):CD Page MJ, Green S, Mrocki MA, et al. Electrotherapy modalities for rotator cuff disease. Cochrane Database Syst Rev. 2016(6):CD McCarthy CJ, Callaghan MJ, Oldham JA. Pulsed electromagnetic energy treatment offers no clinical benefit in reducing the pain of knee osteoarthritis: a systematic review. BMC Musculoskelet Disord. 2006;7:51. 6 Zeng C, Li H, Yang T, et al. Electrical stimulation for pain relief in knee osteoarthritis: systematic review and network meta-analysis. Osteoarthritis Cartilage. 2015;23(2): 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. 2013;21(9): Hayes Inc., Hayes Medical Technology Report. Knee System (VQ OrthoCare) for treatment of osteoarthritis of the knee. Lansdale, Pa. Hayes Inc.; Archived Nov. 17, Hungerford DS, Maclaughlin EJ, Mines CM, et al. Synergistic effect of using a transcutaneous electrical joint stimulator and an unloading brace in treating osteoarthritis of the knee. Am J Orthop (Belle Mead NJ). 2013;42(10): SEARCH TERMS Osteoarthritis Knee brace Electrical stimulation Pulsed electrical stimulation Pulsed electromagnetic field therapy Page 5 of 5