Medical policy: Transcutaneous Electrical Nerve Stimulation and Transcutaneous Afferent Patterned Stimulation

Policy number: MP 6.020

Effective date: 4/1/2026

Policy

Trial of transcutaneous electrical nerve stimulation (TENS)

A trial of transcutaneous electrical nerve stimulation (TENS) of at least 30 days may be considered medically necessary to establish efficacy for the management of refractory chronic pain (e.g., chronic musculoskeletal pain or neuropathic pain) that causes significant disruption of function when the following conditions have been met:

• The pain is unresponsive to at least 3 months of conservative medical therapy; and
• The trial is monitored by a physician.

Continued use of transcutaneous electrical nerve stimulation (TENS)

Continued use of TENS may be considered medically necessary for treatment of refractory chronic pain (e.g., chronic musculoskeletal or neuropathic pain) that causes significant disruption of function when the following conditions have been met:

• Efficacy has been demonstrated in an initial therapeutic trial (see Policy Guidelines); and
• Compliance has been demonstrated in the therapeutic trial with the device used on a regular basis (e.g., daily or near daily use) throughout the trial period

Transcutaneous electrical nerve stimulation (TENS) garment

Form-fitting conductive garments may be considered medically necessary when the following conditions have been met:

• Pain condition meets TENS medically necessary criteria; and
• Garment has received permission or approval for marketing by the FDA; and
• Prescribed by a physician, nurse practitioner or physician assistant; and
• Prescribed for ANY of the following medical indications:
  • Area to be stimulated is large or there are multiple sites; or
  • Stimulation would be delivered so frequently that it is not feasible to use electrodes, adhesive tape, and lead wires; or
  • Areas are inaccessible with use of electrodes, adhesive tape, and lead wires; or
  • Documentation of medical condition (i.e., skin problems) that preclude the application of electrodes, adhesive tape, and lead wires

TENS is considered investigational for the management of acute pain (e.g., postoperative or during labor and delivery) as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

TENS is considered investigational for the prevention or treatment of migraine headaches as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

TENS is considered investigational for the management of attention deficit hyperactivity disorder as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Transcutaneous afferent patterned stimulation (TAPS) is considered investigational for the following conditions as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure:

• Essential tremor;
• Action tremor for Parkinson disease.

The use of TENS or TAPS for any other condition, including but not limited to the treatment of dementia, is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Policy guidelines

For the purposes of these policy guidelines, refractory chronic pain is defined as pain that causes significant disruption of function and has not responded to at least 3 months of conservative therapy, including nonsteroidal anti-inflammatory medications, ice, rest, and/or physical therapy.

Documentation for the trial should include:

• Initial assessment/evaluation of the nature, duration, and perceived intensity of pain;
• The types and duration of prior treatments;
• Treatment plan including ongoing medications and proposed use of TENS unit, including the frequency and duration of treatment.

Clinical summary of the trial to determine efficacy should include:

• Perceived intensity of pain with and without TENS (e.g., 2 point or 30% improvement in visual analog scale);
• Ongoing medication requirements for pain relief (if any);
• Other modalities (if any) in use for pain control;
• Actual use of TENS on a daily basis (frequency and duration of application).

TENS devices may be delivered through a practitioner and require a prescription or obtained without a prescription. It is possible that prescribed devices provide higher intensity stimulation than units sold directly to the public.

Supplies

Separate allowance will be made for replacement supplies when they are reasonable and necessary and are used with a covered TENS. Usual maximum utilization is:

• 2 TENS leads – a maximum of one unit of A4595 per month or four units of A4556
• 4 TENS leads – a maximum of two units of A4595 per month or eight units of A4556
• A maximum of one unit of A4630 per month

A 4-lead TENS unit may be used with either 2 leads or 4 leads, depending on the characteristics of the individual’s pain. If it is ordered for use with 4 leads, the medical record must document why 2 leads are insufficient to meet the individual’s needs.

If the use of the TENS unit is less than daily, the frequency of billing for the TENS supply code should be reduced proportionally. Replacement of lead wires (A4557) more often than every 12 months would rarely be reasonable and necessary.

For ongoing TENS supplies the medical record must include documentation of current frequency and duration of use, effect on pain, and effect on function.

Cross-references

• MP 2.062 Temporomandibular Disorder
• MP 6.046 Threshold Electrical Stimulation as a Treatment of Motor Disorders
• MP 6.047 Interferential Current Stimulation
• MP 6.049 H-Wave Electrical Stimulation
• MP 6.050 Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)
• MP 6.051 Neuromuscular and Functional Neuromuscular Electrical Stimulation

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/background

Transcutaneous electrical nerve stimulation and transcutaneous afferent patterned stimulation are noninvasive neuromodulation techniques that involve 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, these techniques can be self-administered in an individual’s home.

TENS has been used to treat chronic intractable pain, migraine headache pain, postsurgical 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 the release of endorphins and 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 processes. Transcutaneous afferent pattern stimulation (TAPS) is a similar treatment used for essential tremor and action tremor due to Parkinson disease.

Percutaneous electrical nerve stimulation is similar to TENS but uses microneedles that penetrate the skin instead of surface electrodes. Interferential stimulation uses a modulated waveform for deeper tissue stimulation and is believed to improve blood flow to the affected area.

Regulatory status

TENS devices consist of an electrical pulse generator, usually battery-operated, connected by wire to two 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 been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Marketing clearance via the 510(k) process does not require data on clinical efficacy; as a result, these cleared devices are considered substantially equivalent to predicate devices marketed in interstate commerce before May 1976, the enactment date of the Medical Device Amendments. The cleared devices are also equivalent to devices that have been reclassified and do not require a premarket approval application. FDA product code: GZJ.

In 2014, the Cefaly^® (STX‑Med), which is a TENS device, was granted a de novo 510(k) classification by the FDA for the prophylactic treatment of migraine in patients 18 years of age or older. The Cefaly^® Acute and Cefaly^® Dual devices were later approved by the FDA through the 510(k) process for the acute treatment of migraine in patients 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 Eue No), Relivion (Neurolief Ltd.) and Headaterm (Espresso), among others. FDA product code: PCC.

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 who 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 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 November 2022, the Cala kIQ™ device was approved via the 510(k) pathway (K222327). The device is indicated for the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor. It was also approved to aid in the transient relief of postural and kinetic hand tremors symptoms that impair some activities of daily living in the treated hand of adults with Parkinson’s disease. Cala Trio and Cala kIQ use transcutaneous afferent patterned stimulation (TAPS).

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 via 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.

In 2021, the FDA approved the Axon Therapy device (Neuralace Medical, Inc.) for marketing through the 510(k) process for relief of chronic, intractable postsurgical or posttraumatic pain in adults. The Axon Therapy device is an electromagnetic transcutaneous peripheral nerve stimulation stimulator. FDA product codes: QPL, IPF.

Rationale

Summary of evidence

For individuals who have chronic pain (e.g., musculoskeletal, neuropathic, and mixed pain conditions) who receive TENS, the evidence includes numerous randomized controlled trials (RCTs) and systematic reviews. 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 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 sufficient 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, quality of life, 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 controls in patients 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 on 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 tremors who receive TAPS, the evidence includes a pragmatic RCT, a nonrandomized, prospective study, and a retrospective database study. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Although the RCT indicated reduced tremor power among patients receiving TAPS, the trial lacked thorough analysis of clinically relevant outcomes, was 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 TAPS to standard of care therapy for essential tremors are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have action tremors associated with Parkinson disease who receive TAPS, the evidence includes a prospective, open-label, single-arm study. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. Results of the prospective trial suggest that repeated in-home TAPS therapy is effective for reducing tremor power and safe for patients with essential tremors. Limitations identified were open-label, single-arm design, and lack of long-term outcomes. Further studies comparing TAPS to pharmacologic therapy for tremors associated with Parkinson disease are needed. 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 RCT. Relevant outcomes are symptoms, functional outcomes, quality of life, 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 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 administered of a TENS device during a single episode in emergency departments, and 1 evaluated self-administered of the device during episodic migraine 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 sham device and blinded outcome assessment using validated outcomes. Although some results demonstrated short-term pain relief showed 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 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, quality of life, 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 (runs vs. 3-months) was not statistically significant. The proportion of responders (>50% reduction in 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 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.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Covered when medically necessary

References

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2. Food and Drug Administration. Cefaly Dual Device. K173006. 2017
3. Food and Drug Administration. Cefaly Acute Device. K177446. 2017
4. Food and Drug Administration. Headaterm Device: K172450. 2018
5. Food and Drug Administration. Allive Device: K192773. 2019
6. Food and Drug Administration. Relivion Device: K203419. February 2021
7. Cala Health news release. Cala Health receives FDA breakthrough device designation for Cala Trio therapy to treat action tremors in Parkinson’s disease.
8. FDA news release. FDA permits marketing of first medical device for treatment of ADHD. April 19, 2019
9. Food and Drug Administration. Axon Therapy Device: K210021. 2021
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65. Zhu Y, Feng Y, Peng Z. Effect of transcutaneous electrical nerve stimulation for pain control after total knee arthroplasty: A systematic review and meta-analysis. J Rehabil Med. Nov 21 2017; 49(9): 700-704. PMID 28935310
66. Ögren C, Varkey E, Wolf A, et al. High-frequency, high-intensity TENS compared to standard treatments with opioids for postoperative pain relief after laparoscopic cholecystectomy: A multicentre randomized controlled trial. Eur J Pain. Jun 29 2024. PMID 38943342
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