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Transcutaneous Electrical Nerve Stimulators (TENS) and Associated Supplies
05.00.74l

Policy

MEDICALLY NECESSARY

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) (E0720, E0730)
Acute Postoperative Pain

A TENS and related supplies are considered medically necessary and, therefore, covered for the treatment of acute postoperative pain.
  • Coverage is provided for 30 days from the day of surgery. Reimbursement will only be made as a rental.
Chronic Pain Other than Lower Back Pain

For the treatment of chronic pain, a 30- to 60-day trial TENS is considered medically necessary and, therefore, covered when the following criteria are met:
  • The pain has been present for at least 3 months​
  • The presumed etiology of the pain must be a type that is accepted as responding to TENS therapy
  • The individual has tried and failed other appropriate treatment modalities (e.g., physical therapy, pharmacotherapy)​
Continued coverage after the 30- to 60-day trial of a TENS for the treatment of chronic pain is considered medically necessary and, therefore, covered when the following criteria are met:
  • ​The effectiveness in modulating pain with the TENS device has been monitored by a professional provider
  • The professional provider has documented in the individual's medical record that they are likely to derive significant therapeutic benefit from continuous use of the TENS unit over a long period of time​
During the 30- to 60-day trial period, reimbursement for the TENS will only be made as a rental. If the trial of the device is successful in modulating pain and the individual continues using the device, the rental cost of the device is included in the purchase price of the TENS.

If the continued coverage criteria after the trial of a TENS is not met, such that the trial period was not successful, reimbursement will not be made beyond the 30- to 60-day rental period. 

The professional provider ordering the TENS and related supplies must be the treating professional provider for the disease or condition justifying the need for the TENS. 

SUPPLIES
Replacement supplies are considered medically necessary and, therefore, covered when used with a medically necessary TENS. The usual maximum utilization for supplies are:
  • Two-lead TENS: a maximum of one unit of A4595 per month (12 per year)
  • Four-lead TENS: a maximum of two units of A4595 per month (24 per year)
  • Replacement of lead wires (A4557): once every 12 months
A TENS supply allowance (A4595) includes electrodes (any type) (A4556), conductive paste or gel (if needed, depending on the type of electrode) (A4558), tape or other adhesive (if needed, depending on the type of electrode), adhesive remover, skin preparation materials, batteries (9 volt or AA, single use or rechargeable) (A4630) and a battery charger (if rechargeable batteries are used). Therefore, these items will not be eligible for separate reimbursement if reported on the same date of service or within 30 days of A4595. ​

Rental

During the rental of a TENS (E0720, E0730), supplies for the device are included in the rental reimbursement; there is no additional allowance for supplies (e.g., electrodes, lead wires, batteries). 

Purchase

At the time of a TENS (E0720 or E0730) purchase following a successful trial period, the reimbursement for the TENS includes reimbursement for lead wires and 1 month’s supply of electrodes, conductive paste or gel (if needed), and batteries. 

CONDUCTIVE GARMENT
A conductive garment used with a TENS (E0731) is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The garment is approved for marketing by the US Food and Drug Administration (FDA)
  • It has been prescribed by the treating professional provider for use in delivering covered TENS treatment
  • The individual meets one of the following indications:
    • The individual cannot manage without the conductive garment because:
      • There is such a large area or so many sites to be stimulated, and
      • The stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes, and lead wires
    • The individual cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes, and lead wires
    • The individual has a documented medical condition, such as skin problems, that preclude the application of conventional electrodes, adhesive tapes, and lead wires
    • The individual requires electrical stimulation beneath a cast to treat chronic intractable pain.
A conductive garment used with a TENS (E0731) for chronic pain during the trial period is considered medically necessary and, therefore, covered when both of the following criteria are met:
  • The individual has a documented skin problem prior to the start of the trial period
  • The TENS is considered medically necessary and, therefore, covered
If the criteria above are not met for the conductive garment (E0731), it will be considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the treatment of illness or injury.​

EXPERIMENTAL/INVESTIGATIONAL

A TENS is considered experimental/investigational and, therefore, not covered for the treatment of chronic pain (present for at least 3 months) when the presumed etiology of the pain is a type that is not accepted as responding to TENS therapy because the safety and/or effectiveness of this device cannot be established by review of the available published peer-reviewed literature, including but not limited to, ​the following: 
  • Visceral abdominal pain
  • Pelvic pain
  • Temporomandibular joint (TMJ) pain
  • Headache disorder pain (i.e., migraine; tension-type headache; cluster headache and other trigeminal autonomic cephalgia; other primary headaches) 
  • ​Chronic low back pain  
  • Acute pain (<3 months' duration) other than postoperative pain ​
REQUIRED DOCUMENTATION

When a TENS device for the treatment of individuals with chronic pain, other than lower back pain, is used, the medical record documentation must include the following:
  • The location of the pain
  • The severity of the pain
  • The duration of time the individual has had the pain
  • The presumed etiology of the pain
  • Prior treatment and results of that treatment
  • Re-evaluation of the individual at the end of the trial period must include the following:
    • How often the individual used the TENS 
    • The typical duration of each time
    • The effectiveness of the TENS therapy
The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. 

STANDARD WRITTEN ORDER REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete standard written order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective standard written order at the time of an audit or after an audit for submission as an original standard written order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the durable medical equipment (DME) supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES ​(WHEN APPLICABLE)
The DME supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately 7 days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately 5 days before the individual would exhaust their on-hand supply. ​

If required documentation is not available on file to support a claim at the time of an audit or record request, the DME supplier may be required to reimburse the Company for overpayments.

Guidelines

A four-lead transcutaneous electrical nerve stimulator (TENS) may be used with either two leads or four leads, depending on the characteristics of the individual's pain. If it is ordered for use with four leads, the medical record must document why two leads are insufficient to meet the individual’s needs.​ 

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a TENS is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

Description

A transcutaneous electrical nerve stimulator (TENS) is a nonpharmacologic and noninvasive treatment for symptomatic pain relief. A TENS is a battery-operated device that utilizes electrical current delivered through electrodes placed on the surface of the individual's skin to decrease the individual's perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. Individuals do not feel pain until a coded message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain. There are several theories that have been hypothesized to support the clinical use of a TENS device for pain relief. Originally, ​Melzack and Wall's gate theory of pain was considered as the foundation of the mechanism of action for a TENS. In this theory, a “gate” in the dorsal horn of the spinal cord has the capacity to inhibit transmission of nociceptive stimulation to the ascending tracts of the nervous system. By using a TENS to activate the large-diameter afferent nerves of the peripheral nervous system, it was believed that these devices could block the painful sensations that were being felt by the individual. However, as more research has accumulated, investigators now believe that a TENS may produce pain relief by activating the supraspinal nervous system, as well as the afferent nerves that affect the spine. These effects are proposed to occur, at least in part, because of the modulation of the body’s endogenous chemicals (e.g., endorphins, glutamate) that affect the perception of pain (DeSantana et al., 2008). Some also report that the use of a TENS causes a local dilatation of blood vessels in injured tissues (Cramp et al. 2001), which might mitigate nociceptive sensations.

In clinical practice, the electrical characteristics of a TENS are varied among the devices used and the clinicians who apply them. They can be applied with varying frequencies, from low (<10 Hertz [Hz]) to high (>50 Hz). A TENS is usually perceived by an individual as a tingling sensation. High intensity usually involves motor contraction. A TENS can also be configured to deliver different types of output patterns for individuals, including those that produce constant pulses, and those that provide repetitive trains or bursts of electrical pulses delivered in a limited time period, followed by a specified period of no current flow. Moreover, a TENS may also be configured to produce a modulated output, so that one or several of the parameters of the electrical stimulation are cyclically changed during a single application of treatment.

Because the TENS was marketed prior to the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, its market approval was “grandfathered” rather than the result of satisfying the requirements of the premarket approval (PMA) regime. TENS for pain relief is usually cleared under 510(k).

ACUTE POSTOPERATIVE PAIN AND CHRONIC PAIN

TENS has been widely used in the treatment of various types of pain, including acute postoperative pain and chronic pain. It has been shown that TENS is effective in relieving acute postoperative pain and reducing analgesic medications following surgical procedures. Evidence from prospective, randomized controlled studies (RCTs) supports the benefits of TENS for postoperative pain. DeSantana et al. (2008) tested the hypoalgesic effect of high-frequency TENS (100 Hz) applied using a strong but comfortable sensory intensity used for 30 minutes 2 and 4 hours after unilateral inguinal herniorrhaphy. TENS significantly decreased analgesic requirements and incisional pain intensity for 24 hours postoperatively when compared with placebo. In another study, Cipriano et al. (2008) tested a 4-hour high-frequency TENS treatment (80 Hz) with a strong but comfortable sensory intensity on 3 postoperative days following cardiac surgery and found significant decreases in incisional pain both at rest and with cough when compared with placebo TENS. This decrease in pain intensity was related to positive effects on pulmonary function, with significant increases in tidal volume, vital capacity, and electrical activity of the trapezius and pectoralis major muscles in individuals receiving active TENS but not sham TENS. Moreover, the use of TENS is also beneficial in the management of chronic pain. Meta-analyses for osteoarthritic knee pain has been supportive, suggesting that TENS is superior to sham for pain and stiffness (Bjordal et al., 2007).

Evidence continues to emerge from both basic science and clinical trials that may support the use of TENS for the treatment of a variety of painful conditions while identifying strategies to increase TENS effectiveness (DeSantana et al., 2008).

Johnson et al. (2022) performed a systematic review and meta-analysis of TENS, utilizing data from 381 RCTs that measured pain as an outcome. Studies include both individuals suffering from chronic and acute pain along with a variety of comparisons such as TENS versus placebo, TENS versus no treatment, TENS versus standard of care, TENS versus other treatments, and high- versus low-frequency TENS. The main results for the study were examining TENS versus placebo, which included 91 RCTS and found that TENS pain intensity was lower immediately after use compared to the placebo. The effect was not modified by pain characteristics such as acute or chronic diagnosis. The authors conclude that their findings were of moderate certainty largely attributed to the studies used having small sample sizes. Additionally, authors suggest that future studies include large RCTs with 200 participants in each trial arm or large ecologically valid studies that utilize real-world data. The authors suggest the latter research study type because no large RCTs have been completed using TENS and they do not foresee that changing due to funding.
HEADACHE DISORDERS

According to the International Headache Society (IHS), headache is defined as pain located above the orbitomeatal line. The International Classification of Headache Disorders Third Edition (ICHD-3) classifies all headache disorders into major groups. Primary headache disorders include migraine; tension-type headache; cluster headache and other trigeminal autonomic cephalgia; and other primary headaches such as primary stabbing headache, primary cough headache, and so on. Chronic primary headaches are described as attacks of headache that occur on more days than not over a period of longer than 3 months; except for trigeminal autonomic cephalgia, chronic status is not designated until the disorder has been unremitting for more than 1 year.

As noted, migraine is classified in the ICHD 3 as a primary headache disorder. Migraine is a chronic condition with recurrent episodic attacks. On March 11, 2014, the US Food and Drug Administration (FDA) approved the first TENS (i.e., Cefaly; Herstal, Belgium) through the de novo process for prophylactic treatment of episodic migraine in individuals 18 years of age or older based on a double-blinded, randomized, sham-controlled trial (Schoenen et al., 2013). This study evaluated the safety and effectiveness of trigeminal neurostimulation with a supraorbital transcutaneous stimulator with the intent-to-treat in 67 individuals over a 3-month treatment period. The authors concluded that supraorbital transcutaneous stimulation with the device used in this trial is effective and safe as a preventive therapy for migraine. Limitations of this small study include the possibility of partial unblinding in this trial, and individuals in the treatment group were on average younger than those in the sham group with somewhat shorter duration of their migraine. In addition, it is unclear whether supraorbital transcutaneous stimulation is effective in individuals with more frequent migraine attacks or with chronic migraines. 

There are number of additional devices that have FDA 510(k) approval under product control code (PCC) that list the Cefaly device as the predicate device. These devices include Allive and Ellixir (Nu Eyne Co.), HeadaTerm (eEspress), Migraine Tens Digital Pain Reliever (Shenzhen Dongdixin Technology), and Relivion MG (Neurolief). 

In September 2018, the FDA approved HeadaTerm (eEspress; Ningbo, China) through the FDA 510(k) process, based on the predicated Cefaly device. HeadaTerm is indicated for the prophylactic treatment of episodic migraine in individuals 18 years of age or older. This device was examined in a 2020 RCT by Hokenek et al., which used the device off-label for acute treatment of migraine in an emergency room population. There were 78 participants who were randomly assigned into active or sham treatment group. At times 20 minutes (after the 20-minute treatment) and 120 minutes, a visual analog scale (VAS) was used to evaluate pain. Additionally, a Likert-type verbal scale was used at 120th minute. The results observed that in the active group had a statically significant decrease in pain on the VAS compared to baseline along with compared to the sham treatment. There are limitations in this study, the authors discuss difficulties with blinding individuals working with an emergency room population, a general hesitancy by participants in using an electrical stimulation device, and they did not use intention to treat “as there were only a few patients that dropped out after randomization.” Additionally, this study examined the device off label, was limited in size, outcomes were not examined for long-term efficacy. A key limitation of this study was that the examined outcomes do not meet the current International Headache Society 2021 guidelines for clinical trials with neuromodulation devices for the treatment of migraine to evaluate the efficacy of these devices.

In August 2021, the FDA approved Relivion (Netanya, Israel) through the FDA 510(k) process, based on the predicated Cefaly device. Relivion is indicated for treatment of acute migraine with or without aura in individuals 18 years of age or older. The device provides external concurrent occipital and trigeminal neurostimulation (eCOT-NS). There is only one peer-revied published article examining the efficacy and safety of the device. In 2022, Daniel et al. performed a randomized, sham-controlled trial with a total of 55 participants with either episodic or chronic migraines. The primary outcome of the study was the percent change in pain scores on a VAS 1 hour after treatment. Secondary outcomes measured at 1 hour, 2 hours, and 24 hours include pain reduction and proportion of pain-free subjects and treatment responders, defined as 50% or higher pain reduction. The results of the study did observe significant decreases in pain intensity and pain-free (in subjects who were baseline moderate or severe) at 2 hours in the active treatment group. A key limitation of this study was that the examined outcomes do not meet the current IHS 2021 guidelines for clinical trials with neuromodulation devices for the treatment of migraine to evaluate the efficacy of these devices. Additional limitations include the small study size, along with only studying the device in the treatment of one acute migraine over 24 hours. The study did not assess multiple migraines over a longer period, thus prohibiting long-term efficacy results. There is a completed RCT listed on ClinicalTrials.gov from 2020 using Relivion to treat acute migraine in 131 individuals; however, the results of the study are not yet published in peer-reviewed resources. 

Scientific evidence in the form of large RCTs using TENS for the treatment of headache disorders is lacking.

CHRONIC LOW BACK PAIN

Chronic low back pain is defined as an episode of low back pain that has persisted for 3 months or longer, and it is not a manifestation of a clearly defined and generally recognizable primary disease entity. At this time, the evidence from the small number of placebo-controlled trials does not support the use of a TENS in the routine management of chronic low back pain. Further research is required to provide evidence of the clinical efficacy of TENS for chronic low back pain.

In 2009, guidelines from the American Academy of Neurology (AAN) published in an online version of Neurology in 2009 (Dubinsky and Miyasaki), stated that transcutaneous electric nerve stimulation is not effective for the treatment of chronic low back pain. This recommendation was a level A+, due to lack of proven efficacy.


In 2020, Leemans et al. evaluated the use of TENS and heat in an RCT in 50 individuals of chronic lower back pain. The individuals were split into a heat with TENS group or a no-treatment (control) group and the primary outcome assessed was pain measured on an 11-point numeric rating scale (NRS) at baseline and at 4 weeks after daily use. No significant difference was observed between the two groups for average pain or maximum pain experienced 24 hours after treatment. At 4 weeks, the same measurements were taken and no significant differences in pain scores were observed between the two groups.​


​OTHER ELECTRICAL STIMULATORS

A TENS must be distinguished from a neuromuscular stimulator, which is used to directly stimulate muscles and/or motor nerves, and from percutaneous electrical nerve stimulation (PENS), a minimally invasive stimulator, in which needle-like electrodes are temporarily inserted (to a depth of 1 to 4 cm) into the deep tissues (muscles, ligaments, tendons) around or immediately adjacent to the nerve serving the painful area in order to electrically stimulate the peripheral nerve fibers. A TENS must be distinguished from remote electrical neuromodulation (REN), a noninvasive device that is used to treat acute migraines. The device is placed on the upper arm and stimulates nerve fibers that signal to the brainstem, releasing pain-inhibiting neurotransmitters that block pain receptors in the trigeminal cervical complex. The stimulation is performed in a remote location from the pain and the mechanism of action is based on descending pain inhibition: conditioned pain modulation (CPM). A TENS must be distinguished from other surface electrical stimulators that are not used to treat pain.​

References

American Academy of Neurology Summary of Evidence-based Guideline for Clinicians. Efficacy of Transcutaneous Electric Nerve Stimulation in the Treatment of Pain in Neurologic Disorders. 2009. Available at:  https://www.aan.com/Guidelines/home/GetGuidelineContent/383. Accessed January 16, 2025.


Bjordal JM, Kloving A, Ljunggren AE, Slørdal L. Short-term efficacy of pharmacotherapeutic interventions in osteoarthritic knee pain: A meta-analysis of randomised placebo-controlled trials. Eur J Pain.  2007;11(2):125-138.


Brillman S, Colletta K, Borucki S, et al. Real-World Evidence of Transcutaneous Afferent Patterned Stimulation for Essential Tremor. Tremor Other Hyperkinet Mov (N Y). 2022;12:27.


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).10.2: Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-Operative Pain. Effective Date: 06/08/2012. Implementation Date: 01/07/2013. [CMS Website]. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=145. Accessed January 16, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 160.27: Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Low Back Pain (CLBP). Effective Date: 6/8/2012. Implementation: 1/7/2013. [CMS Website]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=354&ncdver=1&bc=AAAAQAAAAAAA&. Accessed January 16, 2025.

Centers for Medicare & Medicaid Services (CMS). Transcutaneous electrical nerve stimulation for chronic low back pain (CAG-00429N). Decision memo. [CMS Web site]. 06/08/12. Available at:  http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=256. Accessed January 16, 2025.


Cipriano G. Jr, de Camargo Carvalho AC, Bernardelli GF, et al. Short-term transcutaneous electrical nerve stimulation after cardiac surgery: effect on pain, pulmonary function and electrical muscle activity. Interact Cardiovasc Thorac Surg. 2008;7(4):539-43.

Cramp AF, Noble JG, Lowe AS, Walsh DM. Transcutaneous electrical nerve stimulation (TENS): the effect of electrode placement upon cutaneous blood flow and skin temperature. Acupunct Electrother Res. 2001;26(1-2):25-37. 


Daniel O, Tepper SJ, Deutsch L, Sharon R. External concurrent occipital and trigeminal neurostimulation relieves migraine headache: a prospective, randomized, double-blind, sham-controlled trial.  Pain Ther. 2022;11(3):907-922.


DeSantana J, Sluka K. Central mechanisms in the maintenance of chronic widespread noninflammatory muscle pain. Curr Pain Headache Rep. 2008(a);12:338-343.

DeSantana J, Walsh D, Vance C, et al. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Current Rheumatol Rep. 2008;10:492-499.

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):173-176.


Edemekong PF, Bomgaars DL, Sukumaran S, et al. Activities of Daily Living. [Updated 2022 Jul 3]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan.


Hokenek NM, Erdogan MO, Hokenek UD, Algin A, Tekyol D, Seyhan AU. Treatment of migraine attacks by transcutaneous electrical nerve stimulation in emergency department: A randomized controlled trial. Am J Emerg Med. 2021;39:80-85. 

Holland S, Silberstein SD, Freitag F, et al. Evidence-based guideline update: NSAIDs and other complementary treatments for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology. 2012;78(17):1346-53.

International Headache Society. (2018). 3rd Edition of the International Headache Classification (ICHD-3): THE PRIMARY HEADACHES. Available at: https://ichd-3.org/wp-content/uploads/2018/01/The-International-Classification-of-Headache-Disorders-3rd-Edition-2018.pdf. Accessed January 16, 2025.


Johnson MI, Paley CA, Jones G, et al. Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). BMJ Open. 2022;12(2):e051073. 

Khadilkar A, Odebiyi DO, Brosseau L, Wells GA. Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Cochrane Database Syst Rev. 2008;2008(4):CD003008. 

Leemans L, Elma O, Nijs J, et al. Transcutaneous electrical nerve stimulation and heat to reduce pain in a chronic low back pain population: a randomized controlled clinical trial. Braz J Phys Ther. Jan-Feb 2021; 25(1): 86-96.


Lin PT, Ross EK, Chidester P, et al. Noninvasive neuromodulation in essential tremor demonstrates relief in a sham-controlled pilot trial. Mov Disord. 2018;33(7):1182-1183. 

Magis D, Sava S, d'Elia TS, et al. Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly device in headache treatment: A survey of 2,313 headache sufferers in the general population. J Headache Pain. 2013;14:95.


McGough JJ, Loo SK, Sturm A, et al. An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder. Brain Stimul. 2015;8(2):299-304. 


McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2019; 58(4):403-411. 


Noridian Health Care Solutions, LLC. Local Coverage Article: Transcutaneous Electrical Nerve Stimulators (TENS) - Policy Article (A52520). Effective: 01/01/2020. Revision Effective Date: 01/01/2023. Available at:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52520. Accessed January 16, 2025.

Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD) Transcutaneous Electrical Nerve Stimulators (TENS), L33802. Effective 01/01/2020. Revision Effective Date: 01/01/2024. Available at:
https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33802. Accessed January 16, 2025.


Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013;80(8):697-704. 

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. TENS device. AMD 6605. Premarket approval letter. [FDA web site]. 10/23/09. Available at:
http://www.accessdata.fda.gov/cdrh_docs/pdf9/K092990.pdf. Accessed January 16, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. TENS device. AMED StimPad™ Transcutaneous Electrical Nerve Stimulation (TENS) System. Premarket approval letter. [FDA Web site]. 03/13/08. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071120.pdf. Accessed January 16, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Transcutaneous Electrical Nerve Stimulator (T.E.N.S.). EasyMed TN-28C TENS UNIT. Premarket approval letter. [FDA Web site]. 04/08/04. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k040253.pdf. Accessed January 16, 2025.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Transcutaneous Electrical Nerve Stimulator to treat headache. Premarket approval letter. [FDA Web site]. 03/11/14. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf12/K122566.pdf. Accessed January 16, 2025.


US Food and Drug Administration (FDA). Center for Devices and Radiological Health. TENS device. HeadaTerm, eEspresso. Transcutaneous Electrical Nerve Stimulation (TENS) System. Premarket approval letter. [FDA Web site]. 09/13/2018. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172450.pdf. Accessed January 16, 2025.​​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
MEDICALLY NECESSARY

G89.12 Acute post-thoracotomy pain

G89.18 Other acute postprocedural pain

G89.21 Chronic pain due to trauma

G89.29 Other chronic pain

G89.3 Neoplasm related pain (acute) (chronic)

G89.4 Chronic pain syndrome

Please refer to Attachment A for a list of ICD-codes considered Experimental/Investigational for the use of TENS.
HCPCS Level II Code Number(s)
THE FOLLOWING CODES REPRESENT TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) DEVICES:

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


THE FOLLOWING CODES REPRESENT SUPPLIES USED WITH TENS DEVICES:

A4556 Electrodes (e.g., apnea monitor), per pair

A4557 Lead wires (e.g., apnea monitor), per pair

A4558 Conductive gel or paste, for use with electrical device (e.g., TENS, NMES), per oz

A4595 Electrical stimulator supplies, 2 lead, per month, (e.g., TENS, NMES)

A4630 Replacement batteries, medically necessary, transcutaneous electrical stimulator, owned by patient

E0731 Form-fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patient's skin by layers of fabric)​
Revenue Code Number(s)
N/A


​

Coding and Billing Requirements

Policy History

Revisions From 05.00.74l​:
​10/28/2026
​This policy has been reviewed and reissued to communicate the Company's continuing position on transcutaneous electrical nerve stimulators (TENS) and associated supplies.​
12/29/2025

This version of the policy will become effective 12/29/2025.

 

The medically necessary criteria have been revised to further clarify policy criteria and current benefits for the following:

  • Chronic Pain Other than Lower Back Pain
The Experimental/Investigational criteria have been revised to further clarify policy criteria and current benefits.​​

​The following criteria have been deleted from the medically necessary section of this policy:

At least a 50% reduction in pain as measured by objective evidence (e.g., decreased opioid usage, improved range of motion of the affected area, increased activity, increased pain relief according to the Visual Analog Scale [VAS] or the Numeric Pain Intensity Scale) has been demonstrated


Revisions From 05.00.74k:
10/01/2025

This policy has been identified for the ICD CM code update, effective 10/01/2025.


The following ICD CM code has been deleted from this policy:

  • R10.2 Pelvic and perineal pain

The following ICD-10 CM codes have been added to Attachment A of this policy:

  • R10.21  Pelvic and perineal pain right side
  • R10.22  Pelvic and perineal pain left side
  • R10.23  Pelvic and perineal pain bilateral
  • R10.24  Suprapubic pain​

Revisions From 05.00.74j:
10/01/2024

This policy has been identified for the ICD CM code update, effective 10/01/2024.
The following ICD CM codes have been deleted from this policy:

  • M51.36​​ Other intervertebral disc degeneration, lumbar region
  • M51.37 Other intervertebral disc degeneration, lumbosacral region​​
The following ICD-10 CM codes have been added to Attachment A of this policy as "Experimental/Investigational"​:
  • M51.360 Other intervertebral disc degeneration, lumbar region with discogenic back pain only
  • M51.361 Other intervertebral disc degeneration, lumbar region with lower extremity pain only
  • M51.362 Other intervertebral disc degeneration, lumbar region with discogenic back pain and lower extremity pain
  • M51.369 Other intervertebral disc degeneration, lumbar region without mention of lumbar back pain or lower extremity pain
  • M51.370 Other intervertebral disc degeneration, lumbosacral region with discogenic back pain only
  • M51.371 Other intervertebral disc degeneration, lumbosacral region with lower extremity pain only 
  • M51.372 Other intervertebral disc degeneration, lumbosacral region with discogenic back pain and lower extremity pain
  • M51.379​ Other intervertebral disc degeneration, lumbosacral region without mention of lumbar back pain or lower extremity pain​​

​
Revisions From 05.00.74i:

05/29/2024

This policy has been reviewed and reissued to communicate the Company's continuing position on transcutaneous electrical nerve stimulators (TENS) and associated supplies.

10/01/2023

This policy has been identified for the code update, effective 10/01/2023.


The following ICD-10 CM codes have been added to Attachment A of this policy as "Experimental/Investigational"
  • ​G43.E01 Chronic migraine with aura, not intractable, with status migrainosus​
  • ​G43.E09  Chronic migraine with aura, not intractable, without status migrainosus
  • G43.E11  Chronic migraine with aura, intractable, with status migrainosus
  • G43.E19  Chronic migraine with aura, intractable, without status migrainosus​​

Revisions From 05.00.74h:
12/05/2022
T​his version of this policy will become effective 12/05/2022. 

The following HCSPCS code has been removed from this policy. The Company's continuing position of experimental/investigational and therefore, not covered for this procedure code and the service(s) it represents is communicated through Company's policies for Experimental/Investigational Services​:
  • ​K1023​  Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm​​

Revisions From 05.00.74g:
​10/01/2021
This policy has been identified for the code update, effective 10/01/2021.

The following ICD-10 CM code has been removed from this policy:
  • M54.5 Chronic low back pain.​
The following ICD-10 CM codes have been added to this policy:
  • M54.50 Low back pain, unspecified
  • M54.51 Vertebrogenic low back pain
  • M54.59 Other low back pain​​
The following HCSPCS code has been added to this policy (experimental/investigational):
  • ​K1023​  Distal transcutaneous electrical nerve stimulator, stimulates peripheral nerves of the upper arm

Revisions From 05.00.74f:
07/12/2021

This version of the policy will become effective 07/12/2021. The following criteria have been deleted from this policy:

 

Face-to-face table related to specified items.​


Revisions From 05.00.74e:
10/01/2020This policy has been iden​tified for the ICD-10 CM code update effective 10/01/2020.

The following ICD-10 CM codes have been added to Attachment A of this policy as "Experimental/Investigational":
R51.0: Headache with orthostatic component, not elsewhere classified
R51.9: Headache, unspecified

The following ICD-10 CM code has been termed from Attachment A of this policy:
R51.0: Headache​

Revisions From 05.00.74d:
01/29/2020The policy has been reviewed and reissued to communicate the Company's continuing position on Transcutaneous Electrical Nerve Sti​mulators (TENS) and Associated Supplies.
​10/01/2019

This policy has been identified for the ICD-10 CM code update, effective 10/01/2019.

The following ICD-10 narrative has been revised in Attachment A in this policy:

Changed from:

G43.A1 Cyclical vomiting, intractable

Changed to:
G43.A1 Cyclical vomiting, in migraine, intractable

Revisions From 05.00.74c:
05/07/2018 The following ICD-10 CM codes have been added to this policy, in Attachment A, as indications that are considered experimental/investigational when billed with HCPCS codes E0720 and E0730:
    M26.621 Arthralgia of right temporomandibular joint
    M26.622 Arthralgia of left temporomandibular joint
    M26.623 Arthralgia of bilateral temporomandibular joint
    M26.629 Arthralgia of temporomandibular joint, unspecified side
    R10.10 Upper abdominal pain, unspecified visceral abdominal pain -
    R10.11 Right upper quadrant pain
    R10.12 Left upper quadrant pain
    R10.13 Epigastric pain
    R10.2 Pelvic and perineal pain
    R10.30 Lower abdominal pain, unspecified
    R10.31 Right lower quadrant pain
    R10.32 Left lower quadrant pain
    R10.33 Periumbilical pain

Effective 10/05/2017 this policy has been updated to the new policy template format.
12/29/2025
12/29/2025
10/28/2026
05.00.74
Medical Policy Bulletin
Commercial
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.