mp-375 - mp-375 - Medical Policies
Transcutaneous Electrical Nerve Stimulation (TENS)
Policy Number: MP-375
Latest Review Date: November 2022
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 not medically necessary for any indication, including but not limited to dysphagia.
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 patient’s home.
TENS has been used to treat chronic intractable 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.
This policy was updated with a literature review through September 19, 2022.
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 essential tremor who receive TENS, the evidence includes a nonrandomized study. Relevant outcomes are symptoms, functional outcomes, QOL, and medication use. Results from the nonrandomized study suggest that TENS therapy is effective and safe for patients with essential tremor. However, the trial was limited by its open-label, single-arm design, lack of defined standards for what constitutes a clinically meaningful improvement in stated endpoints, and exclusion of patients who exited the study early from the pre-specified primary and secondary endpoint analyses. Further studies comparing TENS to standard of care therapy for essential tremor are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have 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.
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), and 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 Physicians
The American College of Physicians (2017) published guidelines on therapies for acute and low back pain. No recommendations for TENS were made; the panel concluded that “evidence was insufficient to determine the effectiveness” of TENS and that there was no long-range data.
American Congress of Obstetricians and Gynecologists
The 2019 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). The American Society of Anesthesiologists’ 1997 guidelines on chronic pain management recommended that an office or home trial of TENS should be considered as an early management option or as an adjunctive therapy because of its low complexity and low risk.
National Comprehensive Cancer Network
National Comprehensive Cancer Network guidelines on adult cancer pain (v2.2022) 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 other nonpharmacological modality for pain control for postthoracotomy pain syndrome.
National Institute for Health and Care Excellence
The NICE (2016) 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.
The NICE (2014) guidance on osteoarthritis care and management in adults indicated that TENS be considered “as an adjunct to core treatments for pain relief.”
The NICE (2017) guidance on intrapartum care recommended against the use of TENS for “established labour.”
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 in the treatment of cervical radiculopathy from degenerative disorders. 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.
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.
U.S. Preventive Services Task Force Recommendations
Transcutaneous electrical nerve stimulation, TENS, Flex-IT/Flex-Gar, Cefaly (STX-med, Herstal Belgium), dysphagia, The VitalStim® Therapy System, Cefaly® Acute, Cefaly® Dual, ZIDA,Cala ONE™, 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, a large number of 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) and HeadaTerm (EEspress).
In 2018, the FDA reviewed the Cala ONE™ TENS device (Cala Health) via the de novo pathway and granted approval for the device as an aid in the transient relief of hand tremors following stimulation in the affected hand of adults with essential tremor. This prescription device is contraindicated for use in patients with an implanted electrical medical device, those that have suspected or diagnosed epilepsy or other seizure disorder, those who are pregnant, and patients with swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions. In October 2020, the FDA granted breakthrough device designation to the Cala Trio device for the treatment of action tremors in the hands of adults with Parkinson's disease.
In 2019, the FDA permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (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.
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.
|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|
|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)|
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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.
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.