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Transcutaneous Electrical Nerve Stimulation (TENS)

Policy Number: MP-375

Latest Review Date: December 2024

Category: Durable Medical Equipment (DME)                                                                    

POLICY:

Transcutaneous electrical nerve stimulation (TENS) units, application of surface neurostimulator and related supplies (e.g. leads, batteries, electrodes, conductive garments, etc.) used with TENS devices are considered investigational for all indications.

For transcutaneous tibial nerve stimulation (e.g. ZIDA), please refer to Medical Policy 286- Posterior Tibial Nerve Stimulation for Voiding Dysfunction.

DESCRIPTION OF PROCEDURE OR SERVICE:

Transcutaneous electrical nerve stimulation (TENS) describes the application of electrical stimulation to the surface of the skin. In addition to more traditional settings such as a physician’s office or an outpatient clinic, TENS can be self-administered in a individual's home.

TENS has been used to treat chronic intractable pain, migraine headache pain, post-surgical pain, and pain associated with active or post-trauma injury unresponsive to other standard pain therapies. It has been proposed that TENS may provide pain relief through release of endorphins in addition to potential blockade of local pain pathways. TENS has also been used to treat dementia by altering neurotransmitter activity and increasing brain activity that is thought to reduce neural degeneration and stimulate regenerative process.

Percutaneous electrical nerve stimulation (MP #406) is similar to TENS, but uses micro-needles that penetrate the skin instead of surface electrodes. Interferential stimulation (MP #073) uses a modulated waveform for deeper tissue stimulation, and is believed to improve blood flow to the affected area.

KEY POINTS:

This policy was updated with a literature review through October 15, 2024.

Summary of Evidence:

For individuals who have chronic pain who receive TENS, the evidence includes numerous randomized controlled trials (RCTs) and systematic reviews. The relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The overall strength of the evidence is weak. The best evidence exists for the treatment of chronic, intractable pain. Available evidence indicates that TENS can improve chronic intractable pain in some patients, and there is support for its use in clinical guidelines by specialty societies. To best direct TENS toward patients who will benefit, a short-term trial of TENS is appropriate, with continuation only in patients who show an initial improvement. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have acute pain (e.g., surgical, musculoskeletal, labor, and mixed pain conditions) who receive TENS, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, QOL, and medication use. Overall, evidence for the use of TENS from high-quality trials remains inconclusive for most indications. A systematic review of TENS for acute and chronic pain found some evidence that TENS reduces pain intensity over and above that seen with placebo and other control groups inpatients with acute pain, but small-sized trials contributed to imprecision in magnitude estimates. Systematic reviews have found that TENS may help reduce pain in patients with post-operative pain (post-caesarean and total knee arthroplasty), dysmenorrhea, and pain associated with labor and delivery. For low back pain, systematic reviews have found insufficient evidence to support or refute the use of TENS. Randomized controlled trials have reported mixed results in the efficacy of TENS across various acute pain conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have attention deficit hyperactivity disorder (ADHD) who receive TENS, the evidence includes a RCT. Relevant outcomes are symptoms, functional outcomes, QOL, and medication use. Results of the RCT concluded that TENS is an effective and safe treatment option for pediatric patients with ADHD. However, the study included a small patient sample and was of short duration. Further, studies comparing TENS to standard of care therapy for ADHD are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic or episodic migraine who receive TENS for treatment of acute migraine, the evidence includes 3 double-blind, sham-controlled RCTs. Two of the RCTs evaluated healthcare-provider administration of a TENS device during a single episode in emergency departments, and 1 evaluated self-administration of the device at home during acute episodes over a 3-month period. The studies conducted in emergency departments showed clinically and statistically significant reductions in pain intensity and medication use within 2 hours of use. The self-administration study had mixed results: The difference in median pain scores before and after treatment was significantly higher in the TENS group at months 1 and 2, but at month 3 the difference was not statistically significant. Function and analgesic medication use did not differ between groups at any time point. Strengths of the RCTs included the use of a sham device and blinded outcome assessment using validated outcome measures. Although short-term pain relief was demonstrated at some time points, the quality of the overall body of evidence was downgraded due to inconsistency of results and heterogeneity in study settings. It is not clear whether the pain intensity reductions demonstrated in emergency department settings would generalize to other settings over longer time periods. Supporting evidence from RCTs is needed. Additionally, based on the existing evidence, it is unclear how TENS would fit into the current migraine treatment pathway, although it could provide benefit for those who do not receive adequate benefit from pharmacologic first- or second-line therapies, or who may have a contraindication to pharmacologic therapies. The specific intended use must be specified in order to adequately evaluate net health benefit. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have chronic or episodic migraine who receive TENS for migraine prevention, the evidence includes 1 RCT. Relevant outcomes are symptoms, functional outcomes, QOL, and medication use. The RCT (N=67) reported a greater proportion of participants achieving at least a 50% reduction in migraines with TENS than with sham placebo and modest reductions in the number of total headache and migraine days. In the intention-to-treat analysis, the reduction in the number of migraine days (run-in vs. 3-months) was not statistically significant. The proportion of responders (≥50% reduction in the number of migraine days/month) significantly higher in the TENS group. The number of migraine attacks from the run-in period to the 3-month evaluation, number of headache days, and antimigraine medication use were significantly lower for the active TENS group. The severity of migraine days did not differ significantly between groups. This manufacturer-sponsored trial needs corroboration before conclusions can be made with certainty about the efficacy of TENS for preventing migraine headaches. Additionally, based on the existing evidence, it is unclear how TENS would fit into the current migraine prevention pathway, although it could provide benefit for those who do not receive adequate benefit from pharmacologic first- or second-line therapies, or who may have a contraindication to pharmacologic therapies. 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 Neurology

The American Academy of Neurology (2010) published an evidence-based review of the efficacy of TENS in the treatment of pain in neurologic disorders. The AAN concluded that TENS is not recommended for the treatment of chronic low back pain due to lack of proven efficacy (level A, established evidence from two Class I studies), but stated that TENS should be considered for the treatment of painful diabetic neuropathy (Level B, probably effective, based on 2 Class II studies).

American College of Rheumatology

In 2019, the American College of Rheumatology made a strong recommendation against the use of TENS for knee and hiposteoarthritis.

American Congress of Obstetricians and Gynecologists

The 2019 (reaffirmed in 2021) ACOG guidelines on labor and delivery found that TENS may “help women cope with labor more than directly affect pain scores.”

American Society of Anesthesiologists et al.

The practice guidelines from the American Society of Anesthesiologists and American Society of Regional Anesthesia and Pain Medicine (2010) recommended that TENS be used as part of a multimodal approach to management for patients with chronic back pain and may be used for other pain conditions (e.g., neck and phantom limb pain). 

National Comprehensive Cancer Network

National Comprehensive Cancer Network guidelines on adult cancer pain (v2.2024) indicate that nonpharmacologic interventions, including TENS, may be considered in conjunction with pharmacologic interventions as needed (category 2A).

National Cancer Institute

National Cancer Institute’s Physician Data Query identifies TENS as a potential nonpharmacological modality for pain control for postthoracotomy pain syndrome.

National Institute for Health and Care Excellence

In 2016 (updated 2020), the NICE guidance on low back pain indicated that, despite the long history of use of TENS for back pain, the quality of research studies is poor. This guidance recommended against TENS as a treatment.

In 2014, the NICE guidance on osteoarthritis care and management in adults indicated that TENS be considered “as an adjunct to core treatments for pain relief.” In 2022, NICE osteoarthritis guidelines recommend against TENS for osteoarthritis.

In 2017, the NICE guidance on intrapartum care recommended against the use of TENS for “established labour.” In 2023, NICE recommendations for TENS included "there is very little evidence of its effectiveness in established labour, but no evidence of harm."

North American Spine Society

In 2020, the North American Spine Society clinical guidelines on the diagnosis and treatment of low back pain provided guidance on the effectiveness of different physical medicine and rehabilitation therapies. The guideline noted that there is conflicting evidence that TENS results in improvement in pain or function at short- to medium-term follow-up. The work group further recommended that randomized clinical trials with long-term follow-up are needed to evaluate the benefits of TENS compared to exercise/physical therapy or as adjunctive use to usual care for low back pain.

In 2011, the North American Spine Society clinical guidelines on the diagnosis and treatment of cervical radiculopathy from degenerative disorders discussed the role of ancillary treatments such as bracing, traction, electrical stimulation, acupuncture, and TENS. A consensus statement from the Society recommended that ozone injections, cervical halter traction, and combinations of medications, physical therapy, injections, and traction have been associated with improvements in patient-reported pain in uncontrolled case series. Such modalities may be considered, recognizing that no improvement relative to the natural history of cervical radiculopathy has been demonstrated. There were no specific statements about the role of TENS in this population.

Osteoarthritis Research Society International

Guidelines from the Osteoarthritis Research Society International (OARSI) 2014 recommend that TENS is not appropriate for the use of multiple-joint osteoarthritis and is of uncertain value in the treatment of knee-only osteoarthritis. Updated guidance (2019) on the non-surgical management of knee, hip, and polyarticular osteoarthritis does not address TENS nor include it in their patient-focused treatment recommendations.

World Health Organization

In 2023, the World Health Organization recommended against the use of TENS as part of routine care for patients with chronic low back pain. They found the net benefits across outcomes and comparators to be small or uncertain.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Transcutaneous electrical nerve stimulation, TENS, Flex-IT/Flex-Gar, Cefaly (STX-med, Herstal Belgium), dysphagia, The VitalStim® Therapy System, Cefaly® Acute, Cefaly® Dual, ZIDA, Monarch® external Trigeminal Nerve Stimulation (eTNS) System

APPROVED BY GOVERNING BODIES:

TENS devices consist of an electrical pulse generator, usually battery-operated, connected by wire to 2 or more electrodes, which are applied to the surface of the skin at the site of the pain. Since 1977, many devices have received marketing clearance through the U.S. Food and Drug Administration (FDA) 510(k) process. Marketing clearance via the 510(k) process does not require data regarding clinical efficacy; these devices are considered substantially equivalent to predicate devices marketed in interstate commerce before May 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified and do not require approval of a premarket approval application.

In 2014 the FDA granted de novo 510(k) approval for marketing to Cefaly® (STX-med, Herstal, Belgium), which is a TENS device for the prophylactic treatment of migraine in patients 18 years of age or older. 

The Cefaly® Acute and Cefaly® Dual devices were cleared by the FDA through the 510(k) process for the acute treatment of migraine in patients in 18 years of age or older and for both the acute treatment and prophylaxis of migraines in adults, respectively, in 2017. Other TENS devices cleared by the FDA through the 510(k) process for the prophylactic treatment of migraine in patients include Allive (Nu Eyne Co), Relivion (Leurolief Ltd) and HeadaTerm (EEspress) among others.

In 2019, the FDA permitted marketing of the first medical device to treat ADHD - the Monarch® external Trigeminal Nerve Stimulation (eTNS) System by NeuroSigma. The FDA reviewed the system through the de novo premarket review pathway. This prescription only TENS device is indicated for patients 7 to 12 years of age who are not currently taking prescription ADHD medication. The Monarch eTNS System is intended to be used in the home under the supervision of a caregiver. The device generates a low-level electrical pulse and connects via a wire to a small patch that adheres to a patient's forehead, just above the eyebrow.

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: 

CPT Codes:

97014 Application of a modality to 1 or more areas; electrical stimulation (unattended)
97032   Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes

                           

HCPCS Codes:

A4541

Monthly supplies for use of device coded at e0733 (TENS for trigeminal nerve)

A4595

Electrical stimulator supplies, 2 leads per month (e.g., TENS, NMES)

A4630

Replacement batteries, medically necessary, transcutaneous electrical stimulator, owned by patient

E0720

Transcutaneous electrical nerve stimulation (TENS) device, 2 lead, localized stimulation

E0730

Transcutaneous electrical nerve stimulation (TENS) device, 4 or more leads, for multiple nerve stimulation

E0731

Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient’s skin by layers of fabric)

E0733

Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve


PREVIOUS CODING:

K1016

Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal nerve (Deleted 12/31/23)

K1017

Monthly supplies for use of device coded at K1016 (Deleted 12/31/23)

K1018

External upper limb tremor stimulator of the peripheral nerves of the wrist (Deleted 12/31/23)

K1019

Supplies and accessories for external upper limb tremor stimulator of the peripheral nerves of the wrist (Deleted 12/31/23)


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  79. Oosterhof J, Wilder-Smith OH, de Boo T et al. The long-term outcome of transcutaneous electrical nerve stimulation in the treatment for patients with chronic pain: a randomized, placebo-controlled trial. Pain Pract 2012: 12(7):513-22.
  80. Oztas B, Iyigun E. The effects of two different electrical stimulation methods on the pain intensity of the patients who had undergone abdominal surgery with a midline incision: Randomized controlled clinical trial.. Contemp Nurse, 2019 Jun 7;55(2-3).
  81. Palmer S, Domaille M, Cramp F et al. Transcutaneous electrical nerve stimulation as an adjunct to education and exercise for knee osteoarthritis: a randomized controlled trial. Arthritis Care Res (Hoboken) 2014; 66(3):387-94.
  82. Parseliunas A, Paskauskas S, Kubiliute E, et al. Transcutaneous Electric Nerve Stimulation Reduces Acute Postoperative Painand Analgesic Use After Open Inguinal Hernia Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pain. May 2021; 22(5): 533-544.
  83. Platon B, Thorn SE, Mannheimer C, et al. Effects of high-frequency, high-intensity transcutaneous electrical nerve stimulation versus intravenous opioids for pain relief after hysteroscopy: a randomized controlled study. Obstet Gynecol Sci. Sep 2020; 63(5): 660-669.
  84. 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):810-33.
  85. Price CI, Pandyan AD. Electrical stimulation for preventing and treating post-stroke shoulder pain. Cochrane Database Syst Rev 2000; (4):CD001698.
  86. Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Apr 04 2017;166(7):514- 530.
  87. Rakel B, Cooper N, Adams HJ, et al. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain 2010; 11(3):230-8.
  88. Rakel BA, Zimmerman MB, Geasland K, et al. Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial. Pain. Dec 2014; 155(12):2599-2611.
  89. Ramanathan D, Saleh A, Klika AK, et al. The use of transcutaneous electrical nerve stimulation after total knee arthroplasty: a prospective randomized controlled trial. Surg Technol Int. Jul 25 2017; 30:425-434.
  90. Reichenbach S, Jüni P, Hincapié CA, et al. Effect of transcutaneous electrical nerve stimulation (TENS) on knee pain and physical function in patients with symptomatic knee osteoarthritis: the ETRELKA randomized clinical trial. Osteoarthritis Cartilage. Mar 2022; 30(3): 426-435.
  91. Sabancı Baransel E, Barut S, Uçar T. The Effects of Transcutaneous Electrical Nerve Stimulation Applied in the Early PostpartumPeriod After Cesarean Birth on Healing, Pain, and Comfort. J Midwifery Womens Health. 2024; 69(5): 681-688.
  92. Sawant A, Dadurka K, Overend T, et al. Systematic review of efficacy of TENS for management of central pain in people with multiple sclerosis. Mult Scler Relat Disord. May 2015; 4(3):219-227.
  93. Schneider MP, Tellenbach M, Mordasini L et al. Refractory chronic pelvic pain syndrome in men: can transcutaneous electrical nerve stimulation help? BJU Int 2013; 112(2):E159-63.
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POLICY HISTORY:

Medial Policy Group, September 1999

Medical Policy Group, June 2003

Medial Policy Group, August 2008

Medical Policy Panel, July 2009

Medical Policy Group, July 2009 (2)

Medical Policy Administration Committee, August 2009

Available for comment August 10-September 23, 2009

Medical Policy Group, January 2010 (2)

Medical Policy Group, April 2010 (2)

Medical Policy Administration Committee, May 2010

Medical Policy Group, June 2010 (2)

Available for comment June 4 – July 19, 2010

Medical Policy Group, September 2010 (2)

Medical Policy Administration Committee, September 2010

Available for comment October 4 – November 19, 2010

Medical Policy Administration Committee, January 2011

Medical Policy Group, January 2012 (2): Added new Key Word

Medical Policy Panel, August 2012

Medical Policy Group, September 2012 (2):  Key Points and References updated

Medical Policy Panel, July 2013

Medical Policy Group, September 2013 (2): No change to policy statement.   Key Points and References updated. 

Medical Policy Panel, April 2014

Medical Policy Group, April 2014 (5): No change to policy statement. Key Points, Key Words, Governing Bodies, and References updated. 

Medical Policy Panel, April 2015

Medical Policy Group, April 2015 (6):  Updates to Key Points and References; no change to policy statement; removed policy statements prior to January 1, 2011.

Medical Policy Panel, November 2015

Medical Policy Group, November 2015 (6): Updates to Key Points and References; no changes to policy statement.

Medical Policy Group, October 2017 (6): Updates to policy statement: The VitalStim® Therapy System for dysphagia is not covered, Key Words updated.

Medical Policy Administration Committee, October 2017

Available for comment October 11 through November 24, 2017

Medical Policy Panel, November 2017

Medical Policy Group, January 2018 (6): Updates to Key Points, Practice Guidelines and References. Combined non-coverage indications in policy statement, no change to policy intent.

Medical Policy Group, December 2017: Annual Coding Update 2018.  Updated verbiage for revised CPT code 64550.

Medical Policy Panel, November 2018

Medical Policy Group, November 2018 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, December 2018: 2019 Annual Coding Update. Moved CPT code from Current coding section to Previous coding.  Created Previous coding section to include code 64550.

Medical Policy Group, May 2019 (6): Updated coding to include 97014, 97032.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, and References. No change to Policy Statement.

Medical Policy Panel, November 2020

Medical Policy Group, November 2020 (6): Updates to Key Points, Governing Bodies, Practice Guidelines, Key Words (Cefaly® Acute, Cefaly® Dual) and References.

Medical Policy Group, August 2021 (6): Policy section updated to include reference for transcutaneous tibial nerve stimulation (e.g. ZIDA), referring to Medical Policy 286- Posterior Tibial Nerve Stimulation for Voiding Dysfunction. Key Words updated to include ZIDA.

Medical Policy Group, December 2021

Medical Policy Panel, December 2021 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words and References.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, December 2023: 2024 Annual HCPCS Coding Update: Added A4541-A4542, E0733-E0734. K1016-K1019 deleted and moved to Previous Coding section. 

Medical Policy Panel, December 2023

Medical Policy Group, December 2023 (6): Updates to Key Points, Approved by Governing Bodies and References.

Medical Policy Panel, December 2024

Medical Policy Group, December 2024 (6): Updates to Key Points, Governing Bodies, Practice Guidelines, Current Coding (Removed A4542/E0734) and References.

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.