Clinical Policy Title: Transcutaneous electrical nerve stimulators (TENS)

Transcription

1 Clinical Policy Title: Transcutaneous electrical nerve stimulators (TENS) Clinical Policy Number: Effective Date: October 1, 2015 Initial Review Date: June 17, 2015 Most Recent Review Date: July 19, 2017 Next Review Date: July 2018 Policy contains: Transcutaneous electrical nerve stimulator Diabetic neuropathy Chronic pain syndromes Low back pain Related policies: CP# Spine pain epidural steroid injections ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy A. Select Health of South Carolina considers the use of transcutaneous electrical serve stimulators (TENS) to be clinically proven and, therefore, medically necessary when any of the following criteria are met: 1. Painful diabetic neuropathy. 2. Postoperative pain for no more than one month. 3. Chronic pain syndromes, excluding back pain not responsive to physical therapy and pharmacotherapy after a trial of alternative methods of pain management. B. Select Health of South Carolina considers the use of Transcutaneous Electrical Nerve Stimulators (TENS) to be investigational/experimental and, therefore, NOT medically necessary for the following conditions: 1. Chronic or acute low back pain. 2. Migraine headaches. 3. Childbirth 4. Deep abdominal or pelvic pain 1

2 5. All other uses of TENS not described. Limitations: All other uses of Transcutaneous Electrical Nerve Stimulators are not medically necessary. Alternative covered services: Medications prescribed by treating provider Physical therapy program Epidural steroid injections Approved surgery Background Transcutaneous Electrical Nerve Stimulation (TENS) uses low level electrical currents typically from a battery-based device through two or more surface electrodes with the goal of alleviating pain.. The first patent on a device incorporating the concepts behind TENS was obtained in 1974 by D. Maurer on the Medtronics Corporation. The concept of TENS therapy is based upon the gate theories of pain. A noxious electrical current is thought to block reception in the brain of pain stimuli originating through pain fibers more distal. However there are other theories on how electrical stimulation can reduce perception of pain including presynaptic inhibition in the dorsal horn of the spinal cord and increase in endorphins. A TENS unit modulates pulse width, frequency, and intensity. TENS can be used as the sole modality of treatment, but often is used in conjunction with other therapies. TENS does not cause many of the adverse effects associated with other modes of pain control (DeSantana, 2008). Searches: Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services. Searches were conducted on June 7, 2017, using terms "transcutaneous electrical nerve stimulator or "TENS" We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes 2

3 and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology, using nine studies with 565 subjects, recommended TENS for painful diabetic neuropathy, but not for chronic low back pain in 2010 (Dubinsky, 2010), and reaffirmed the decision in 2015 (AHRQ, 2015). The Institute for Health Economics issued a guideline recommending against TENS for acute or chronic low back pain as a singular treatment, and concluded that efficacy of TENS as an adjunct treatment for these conditions is still unknown (IHE, 2009). The American Society of Anesthesiologists recommends that TENS should be used as part of a multimodal approach for pain management for patients with chronic back pain, and may be used for other pain conditions such as neck and phantom limb pain (Rosenquist, 2010). Other guidelines address TENS efficacy for specific types of pain. The American Cancer Society issued a guideline, based on a review of multiple pain management guidelines, and concluded that cancerrelated pain is likely to be relieved by TENS (Harris, 2012). An American Academy of Orthopaedic Surgeons guideline recommended TENS in treating full-thickness rotator cuff tears (AAOS, 2013). A guideline by the Osteoarthritis Guidelines Development Group on treatment of osteoarthritis determined that TENS is not appropriate for multiple joint osteoarthritis, and uncertain for cases only involving the knee (McAlindon, 2014). However, the National Institute for Health and Clinical Excellence recommends that professionals should consider TENS as an adjunct for core treatments for pain relief (NICE, 2014). A large number of systematic reviews of the literature have addressed efficacy of TENS. The Cochrane library alone includes nine reviews with results since 2008 that were not subsequently withdrawn. Five additional Cochrane reviews on TENS are in progress as of the writing of this policy (June 2017). The findings of the nine articles include: 1. Acute pain (12 studies, n=919). Included procedural pain and non-procedural pain; no conclusion on efficacy (Walsh, 2009). 2. Acute pain (19 studies, n=1346). Tentative evidence that TENS improved pain compared to placebo after procedures (Johnson, 2015a). 3. Chronic low back pain (4 studies, n=585). Evidence was either conflicting or showed TENS results were no different than placebo (Khadilkar, 2008). 4. Cancer pain (3 studies, n=88). TENS results no different than placebo (Hurlow, 2012) 5. Pain management in labor (17 studies, n=1466). Very limited evidence that TENS reduces 3

4 pain in labor, no evidence that it improves maternal/newborn outcomes (Dowswell, 2009). 6. Phantom pain/stump pain after amputation. No trials exist on TENS (Johnson, 2015b). 7. Osteoarthritis of the knee (18 studies, n=813). Only 29 percent of TENS patients responded to treatment, versus 26 percent for placebo. Both groups had 15 percent of patients with side effects (Rutjes AWS, 2009). 8. Child constipation (1 study, n=42). Compared to placebo, children given TENS had the same number of weekly bowel movements, significantly improved colonic transit; overall results are uncertain (Ng, 2016). 9. Spinal cord injury (1 study). No evidence was found to indicate TENS reduced pain in this patient population (Boldt, 2014). Hayes researchers have also performed multiple reviews on the efficacy of TENS; results, which are summarized below, generally concur with Cochrane reviews: 1. Acute pain (20 studies). Includes labor, primary dysmenorrhea, and other types of pain; there is limited or no evidence that TENS is superior to placebo in reducing pain (Hayes, 2014a). 2. Chronic pain (18 studies). Includes lower back pain, osteoarthritis of the knee, and other types of pain; evidence is of low quality, and conflicting, and thus no statement can be made about TENS efficacy (Hayes, 2014b). 3. Post-operative and procedural pain (26 studies). Includes dental procedures. While the evidence is equivocal and conflicting, improvement from TENS is generally more effective than placebo, but no different than other treatments (Hayes, 2014c). 4. Relief from nausea and vomiting (15 studies). Some evidence exists that TENS provides superior relief from nausea and vomiting (Hayes, 2012). A large number of systematic reviews and meta-analyses addressing effectiveness of TENS treatments have been published. Due to the large number of conditions assessed, researchers often have limited information to review, and cannot make a determination on TENS effectiveness. These conditions include multiple sclerosis, spasticity, urinary tract infection, voice disorders, and dementia. Another problem is that trials are not often randomized against placebo or against other forms of treatment. One disorder for which multiple systematic reviews exist with randomized trials comparing TENS to other treatment modalities is osteoarthritis of the knee. One review of 30 trials (seven of them TENS assessments) found the mean difference in pain from TENS was 1.796, second only to neuromuscular electrical stimulation (1.924), but greater than bracing (1.340) and insoles (0.992) (Cherian, 2016). Another review found no (or uncertain) benefits of TENS, acupuncture, valgus braces, and lateral wedge insoles for pain (Bennell, 2015). Another review of 27 trials included high-frequency TENS, lowfrequency TENS, neuromuscular electrical stimulation, pulsed electrical stimulation, noninvasive interactive neurostimulation, and inferential current the only one of the six treatments that showed positive results (Zeng, 2015). The understanding of the role of dose in TENS is still evolving. One systematic review of experimental 4

5 pain found that intense levels of TENS resulted in moderate improvements; conventional levels had conflicting evidence; and low levels had strong patterns of inefficacy (Claydon, 2011). Few economic analyses of TENS have been performed. The most recent analyzed TENS used on knee osteoarthritis, including 88 trials with 7507 subjects. Researchers determined that the cost of 13,502 British pounds per quality-adjusted life year (in studies with low selection bias) made the technology highly cost-effective (Woods, 2017). Policy updates: A total of seven guidelines/other were added to this policy in A total of 16 peer-reviewed articles were added, and 11 were removed, from this policy. Summary of clinical evidence: Citation Woods (2017) Cost-effectiveness of TENS treatment Johnson (2015a) TENS efficacy on acute pain Bennell (2015) TENS efficacy on osteoarthritis Hayes (2014b) Content, Methods, Recommendations Key points: Cost effectiveness analysis of several non-pharmacological interventions for osteoarthritis Data from 88 randomized controlled trials (n=7507) For all trials, TENS is cost-effective at 20,000 to 30,000 British pounds per quality-adjusted year of life (QALY) For only trials with low risk of selection bias, cost-effectiveness improves to 13,502 British pounds per QALY Key points: Second update of Cochrane review of adults with pain <12 weeks, with TENS given as sole treatment A total of 19 RCTs (n=1346) Relative risk of TENS vs. placebo to achieve >50% reduction in pain was positive (3.91) The average difference on a visual analog scale to reduce pain was better for TENS ( mm) compared to placebo (-17.46mm) Key points: Review of three recent trials comparing physical therapies for osteoarthritis No improvement observed for TENS, acupuncture, valgus braces, lateral wedge insoles for pain and function in knee osteoarthritis Small to moderate effect of exercise in comparison with not exercising observed for hip or knee osteoarthritis Key points: TENS efficacy on chronic pain Hayes review (18 studies) of TENS efficacy in treating chronic pain Includes lower back pain, osteoarthritis of the knee, and other types of pain Evidence is of low quality and conflicting, and thus no statement can be made about TENS efficacy 5

6 Citation Dubinsky (2010) Content, Methods, Recommendations Key points: Clinical guideline for TENS American Academy of Neurology guideline based on a literature search TENS compared with sham TENS TENS not recommended for chronic low back pain TENS probably effective for painful diabetic neuropathy References Professional society guidelines/other: American Academy of Orthopaedic Surgeons (AAOS). American Academy of Orthopaedic Surgeons appropriate use criteria for optimizing the management of full-thickness rotator cuff tears. Rosemont (IL): AAOS, September 20, p. Accessed June 7, Dubinsky RM, Miyasaki J. Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2010;74(2): Harris SR, Schmitz KH, Campbell KL, McNeely ML. Clinical practice guidelines for breast cancer rehabilitation: syntheses of guideline recommendations and qualitative appraisals. Cancer. 2012;118(8 Suppl): Institute for Health Economics (IHE). Toward Optimized Practice. Guideline for the evidence-informed primary care management of low back pain. Edmonton, Alberta, Canada, March 2009 (revised November 2011). 37 p. Accessed June 7, McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014;22(3): National Clinical Guideline Centre. Osteoarthritis. Care and management in adults. London: National Institute for Health and Care Excellence (NICE); February, p. Riker DK. Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review); utility of transcutaneous electrical nerve stimulation in 6

7 neurologic pain disorders. Neurology. 2010;74(21): Rosenquist RW, Benzon HT, Connis RT, et al. Practice Guidelines for Chronic Pain Management An Updated Report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010;112(4):1 24. Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Assessment: efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Update, January 24, Rockville MD: Agency for Healthcare Research and Quality (AHRQ), Accessed June 7, Peer-reviewed references: Bennell KL, Buchbinder R, Hinman RS. Physical therapies in the management of osteoarthritis: current state of the evidence. Curr Opin Rheumatol. 2015;27(3): Boldt I, Eriks-Hoogland I, Brinkhof MW, de Bie R, Joggi D, von Elm E. Non-pharmacological interventions for chronic pain in people with spinal cord injury. Cochrane Database Syst Rev. 2014(11): CD Claydon LS, Chesterton LS, Barlas P, Sim J. Dose-specific effects of transcutaneous electrical nerve stimulation (TENS) on experimental pain: a systematic review. Clin J Pain. 2011;27(7): Cherian JJ, Jaurequi JJ, Leichliter AK, Elmallah RK, Bhave A, Mont MA. The effects of various physical non-operative modalities on the pain in osteoarthritis of the knee. Bone Joint J. 2016;98-B(1 Suppl A): DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation (TENS) for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008;10(6): Dowswell T, Bedwell C, Lavender T, Neilsen JP. Transcutaneous electrical nerve stimulation (TENS) for pain management in labour. Cochrane Database Syst Rev. 2009; CD pub2. Hayes, Inc. Transcutaneous electrical nerve stimulation (TENS) in the treatment of nausea and vomiting. Lansdale PA: Hayes, Inc. Last annual review March 17, Hayes, Inc. Transcutaneous electrical nerve stimulation for acute pain. Lansdale PA: Hayes, Inc. Last 7

8 annual review June 23, 2014(a). Hayes, Inc. Transcutaneous electrical nerve stimulation for chronic pain. Lansdale PA: Hayes, Inc. Last annual review June 3, 2014(b). Hayes, Inc. Transcutaneous electrical nerve stimulation for postoperative and procedural pain. Lansdale PA: Hayes, Inc. Last annual review April 2, 2014(c). Hurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012;(3): CD Jin DM, Xu Y, Geng DF, Yan TB. Effect of transcutaneous electrical nerve stimulation on symptomatic diabetic peripheral neuropathy: a meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2010;89(1):10 15.Johnson MI, Paley CA, Howe TE, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2015a: CD Johnson MI, Mulvey MR, Bagnall A-M. Transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults. Cochrane Database Syst Rev. 2015b: CD pub3. Khadlikar A, Odebiyi DO, Brosseau L, Wells GA. Versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008: CD pub3. Ng RT, Lee WS, Ang HL, Teo KM, Yik YI, Lai NM. Transcutaneous electrical stimulation (TES) for treatment of constipation in children. Cochrane Database Syst Rev. 2016; CD Pieber K, Herceg M, Paternostro-Sluga T. Electrotherapy for the treatment of painful diabetic peripheral neuropathy: a review. J Rehabil Med. 2010;42(4): Rutjes AWS, Neusch E, Sterchi R, et al. Transcutaneous electrostimulation for osteoarthritis of the knee. Cochrane Database Syst Rev. 2009; CD pub2. Sbruzzi G, Silveira SA, Silva DV, Coronel CC, Plentz RD. Transcutaneous electrical nerve stimulation after thoracic surgery: systematic review and meta-analysis of 11 randomized trials. Rev Bras Cir Cardiovasc. 2012;27(1): Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014;4(3): Walsh DM, Howe TE, Johnson MI, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2009;(2): CD

9 Woods B, Manca A, Weatherly H, et al. Cost-effectiveness of adjunct non-pharmacological interventions for osteoarthritis of the knee. PLoS One. 2017;12(3):e 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): CMS National Coverage Determinations (NCDs): National Coverage Determination (NCD) for Transcutaneous Electrical Nerve Stimulators (TENS). Effective date August 7, KeyWord=TENS&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA%3d%3d&. Accessed June 8, Supplies Used in the Delivery of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES). Effective date July 14, KeyWord=TENS&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA%3d%3d&. Accessed June 8, Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP). Effective date June 8, KeyWord=TENS&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA%3d%3d&. Accessed June 8, Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain. Effective date August 7, KeyWord=TENS&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA%3d%3d&. Accessed June 8, Local Coverage Determinations (LCDs): L33802.Transcutaneous Electrical Nerve Stimulators (TENS). Effective date October 1, KeyWord=TENS&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAAAA%3d%3d&. Accessed June 8, Commonly submitted codes 9

10 Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comment Application of surface (transcutaneous) neurostimulator ICD-10 Code Description Comment G89.18 Other acute postoperative pain G89.21 Chronic pain due to trauma G89.22 Chronic post-thoracotomy pain G89.28 Other chronic postprocedural pain G89.4 Chronic pain syndrome HCPCS Level II Code A4558 A4595 E0720 E0730 Description Conductive gel or paste, for use with electrical device (e.g., TENS, NMES), per oz Electrical stimulator supplies, 2 lead, per month, (e.g. TENS, NMES) Transcutaneous electrical nerve stimulation (TENS) device, 2 lead, localized stimulation Transcutaneous electrical nerve stimulation (TENS) device, 4 or more leads, for multiple nerve stimulation Comment 10