MEDICAL POLICY – 1.01.

507
Electrical Stimulation Devices
BCBSA Ref. Policy: 1.01.09
Effective Date: Oct. 1, 2023 RELATED MEDICAL POLICIES:
Last Revised: Jan. 1, 2024 1.01.24 Interferential Current Stimulation
Replaces: N/A 1.01.27 Electrical and Electromagnetic Stimulation for the Treatment of Arthritis
2.01.57 Electrostimulation and Electromagnetic Therapy for Treating Wounds
2.01.106 Percutaneous Electrical Nerve Field Stimulation for Irritable Bowel
Syndrome
7.01.20 Vagus Nerve Stimulation
7.01.69 Sacral Nerve Neuromodulation/Stimulation
7.01.125 Occipital Nerve Stimulation
7.01.139 Peripheral Subcutaneous Field Stimulation
7.01.171 Remote Electrical Neuromodulation for Migraines
7.01.522 Gastric Electrical Stimulation
7.01.574 Implantable Peripheral Nerve Stimulation for the Treatment of Chronic
Pain and Other Conditions
7.01.588 Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous
Neuromodulation Therapy (PNT)
8.01.58 Cranial Electrotherapy Stimulation and Auricular Electrostimulation
8.03.01 Functional Neuromuscular Electrical Stimulation

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POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING

RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

When muscles can’t be used after an injury or surgery, there’s a risk that the tissue will
deteriorate or waste away. This is known as disuse atrophy. Neuromuscular electrical stimulation
(NMES) is a way to keep muscles active so they won’t atrophy. In NMES, an electrode — a patch
attached to skin that can transmit electrical signals into the body — is placed over the muscles
to be stimulated. A device then sends an electrical signal to the electrode and through the skin.
The muscle contracts. This contraction keeps the muscles active when they otherwise wouldn’t
be. This policy describes when NMES may be considered medically necessary. Other types of

1.01.507_LWWA (01-01-2024)
electrical stimulation have been proposed to try to improve function or relieve pain. These are
considered investigational (unproven). There’s not enough evidence to show they are effective.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a
service may be covered.

Policy Coverage Criteria

Service Medical Necessity

Services eligible for Use of a neuromuscular electrical stimulator (NMES) via an
reimbursement (E0745) open loop system, including but not limited to the RS 4m and
RS 2m, may be considered medically necessary for disuse
atrophy when the nerve supply to the muscle is intact and the
individual has any of the following non-neurological causes for
disuse atrophy:
• Previous casting or splinting of a limb (arm or leg)
• Contractures due to soft tissue scarring from burns
• Previous major knee surgery (e.g., total knee replacement),
when there is a failure to respond to physical therapy
• Recent hip replacement surgery (up until the time physical
therapy begins)

A conductive garment may be needed when a member meets

criteria for treatment with a neuromuscular electrical
stimulation device (NMES) and has one of the following
medical indications:
• The treatment site is large and using a large number of
standard electrodes is impractical
• There are multiple large treatment sites on the body that make
using standard electrodes impractical
• The treatment site is hard to reach using standard electrodes
and lead wires

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Service Medical Necessity
• The member has a skin sensitivity that precludes use of
standard electrodes, adhesive tape or lead wires

Note: Functional neuromuscular electrical stimulators (closed loop systems) are

addressed in a separate policy (see Related Medical Policies).

Service Investigational
Services not eligible for Galvanic or high-voltage galvanic stimulation is considered
reimbursement investigational for the treatment of chronic pain and for all
other indications (e.g., FastStart HVPC) (E1399)

H-wave stimulation is considered investigational for all

indications (e.g., H-WAVEMuscle Stimulator) (E1399)

Microcurrent electrical nerve stimulation (MENS) devices are

considered investigational for the treatment of chronic pain
and all other indications (e.g., Algonix, Alpha Stim M, MENS
2000-D, MICROCURRENT, Myopulse, Electro-Myopulse 75L,
Micro Plus Electrical Nerve Stimulator) (E1399)

Multimodal devices that incorporate interferential current

stimulation, neuromuscular electrical stimulation, and
transcutaneous electrical nerve stimulation are considered
investigational for all indications (e.g., NexWave) (E0745)

Neuromuscular electrical stimulators (NMES) are considered

investigational when used for ANY of the following unproven
indications:
• General muscle strengthening in healthy individuals
• Cardiac conditioning
• Treatment of denervated muscles
• Treatment of idiopathic scoliosis

Pulsed electrical stimulation and pulsed electromagnetic

therapy are considered investigational for any indication
including, but not limited to neuropathic pain (e.g., diabetic

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Service Investigational
peripheral neuropathy), chronic or acute pain, or to treat
wounds (including pressure and venous ulcers) (E0761)

Sympathetic electrical stimulation therapy devices are

considered investigational for the treatment of chronic pain
and for all other indications (e.g., Dynatron STS, Dynatron STS
RX) (E1399)

External trigeminal nerve stimulation (eTNS) for the

management of attention deficit hyperactivity disorder is
considered investigational (e.g., Monarch eTNS System)
(K1016)

Transcutaneous electrical modulation pain reprocessing

(TEMPR) (also called Scrambler therapy or Calmare pain
therapy) is considered investigational for the treatment of
cancer pain, chronic pain, neuropathic pain and all other
indications (0278T)

Transcutaneous electrical nerve stimulation of the wrist for

treatment of essential tremor is considered investigational
(e.g., Cala Trio) (K1018)

Transcutaneous supraorbital electrical nerve stimulator is

considered investigational for the prevention and treatment of
migraine headaches and all other indications (e.g., Cefaly)
(E1399)

Documentation Requirements
The individual’s medical records submitted for review should document that medical
necessity criteria are met. The record should include the following:
• For neuromuscular electrical stimulator (NMES):
o Clinical documentation showing that member has disuse atrophy (loss/decrease of muscle
mass due to lack of use) where the nerve supply to the muscle is intact and the member
has any of the following non-neurological reasons for disuse atrophy:
 Previous casting or splinting of a limb

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Documentation Requirements
 Contractures due to burn scarring or recent hip replacement surgery (up until the time
physical therapy begins)
 Previous major knee surgery when there is a failure to respond to physical therapy
• For a conductive garment clinical documentation of all of the above plus documentation of
one of the following medical reasons:
o The treatment site is large and using a large number of standard electrodes is impractical
o There are multiple large treatment sites on the body that make using standard electrodes
impractical
o The treatment site is hard to reach using standard electrodes and lead wires
o The individual has a skin sensitivity that precludes use of standard electrodes, adhesive
tape, or lead wires

Coding

Code Description
CPT
64999 Unlisted procedure, nervous system

0278T Transcutaneous electrical modulation pain reprocessing (eg, scrambler therapy), each
treatment session (includes placement of electrodes)

HCPCS
A4541 Monthly supplies for use of device coded at E0733 (new code effective 1/1/2024)

A4542 Supplies and accessories for external upper limb tremor stimulator of the peripheral
nerves of the wrist (new code effective 1/1/2024)

E0733 Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal
nerve (new code effective 1/1/2024)

E0734 External upper limb tremor stimulator of the peripheral nerves of the wrist (new code
effective 1/1/2024)

E0745 Neuromuscular stimulator, electronic shock unit

E0761 Nonthermal pulsed high frequency radiowaves, high peak power electromagnetic
energy treatment device

E1399 Durable medical equipment, miscellaneous

K1016 Transcutaneous electrical nerve stimulator for electrical stimulation of the trigeminal

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Code Description
nerve (Monarch eTNS)

K1017 Monthly supplies for use of device coded at K1016 (Monarch eTNS)

K1018 External upper limb tremor stimulator of the peripheral nerves of the wrist (Cala Trio)
(code termed 1/1/2024)

K1019 Supplies and accessories for external upper limb tremor stimulator of the peripheral
nerves of the wrist (code termed 1/1/2024)

L8679 Implantable neurostimulator, pulse generator, any type

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

Related Information

Definition of Terms

Conductive garment: A form-fitted garment with integrated conductive fibers that are
separated from the individual’s skin by a layer of fabric.

Disuse atrophy: Gradual wasting or deterioration of a muscle when not used or subjected to
prolonged inactivity, such as when an arm is in a cast for a long time (see muscle atrophy).

Muscle atrophy: Muscle wasting or tissue loss that occurs when a muscle is no longer as active
as usual. When muscles are no longer used movement and strength decline causing weakness.

Neurogenic atrophy: This most severe type of muscle atrophy occurs when a nerve that
connects to the muscle is injured or has a disease. This type of muscle atrophy tends to occur
suddenly when compared to disuse atrophy that is more gradual.

Evidence Review

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Description

Electrical stimulation devices are being investigated to improve functional status and relieve
pain that is unresponsive to other standard therapies. Electrical stimulation is provided using
various devices that noninvasively deliver some form of electrical stimulation to the target site of
pain. Various types of electrical stimulation for the treatment of multiple conditions are
discussed below.

Background

Galvanic Stimulation Devices

Galvanic stimulation is characterized by high voltage, pulsed stimulation and is used primarily
for local edema reduction through muscle pumping and polarity effect. Edema is comprised of
negatively charged plasma proteins, which leak into the interstitial space. The theory of galvanic
stimulation is that by placing a negative electrode over the edematous site and a positive
electrode at a distant site, the monophasic high voltage stimulus applies an electrical potential
which disperses the negatively charged proteins away from the edematous site, thereby helping
to reduce edema.

H-wave Electrical Stimulation

H-wave stimulation is a distinct form of electrical stimulation, and an H-wave device is U.S. Food
and Drug Administration (FDA) approved for medical purposes that involve repeated muscle
contractions. While physiatrists, chiropractors, or podiatrists may perform H-wave stimulation,
H-wave devices are also available for home use. H-wave stimulation has been used for the
treatment of pain related to a variety of etiologies, such as diabetic neuropathy, muscle sprains,
temporomandibular joint dysfunctions, or reflex sympathetic dystrophy. H-wave stimulation has
also been used to accelerate healing of wounds such as diabetic ulcers and to improve range of
motion and function after orthopedic surgery.

A variety of devices may be used for H-wave stimulation. In general, the FDA has classified them
as “powered muscle stimulators.” As a class, the FDA describes these devices as “an
electronically powered device intended for medical purposes that repeatedly contracts muscles
by passing electrical currents through electrodes contacting the affected body area.” The H-

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WAVE Muscle Stimulator (Electronic Waveform Laboratory, Inc., CA) is FDA 510(k) approved as a
class II device.

Microcurrent Stimulation Devices (MENS)

MENS is characterized by subsensory current that acts on the body’s naturally occurring
electrical impulses in an effort to decrease pain and facilitate the healing process. MENS differs
from TENS in that it uses a significantly reduced level of electrical stimulation. TENS blocks pain,
while MENS acts on the naturally occurring electrical impulses to decrease pain by stimulating
the healing process.

Multimodal Devices

NexWave (Zynex Medical) is a multimodal device that incorporates interferential current

stimulation, neuromuscular electrical stimulation, and transcutaneous electrical nerve
stimulation. It is compromised of a control device and electrodes for in home use. Per the FDA it
is indicated for use for symptomatic relief of chronic intractable pain, muscle re-education,
increasing blood circulation, and relaxation of muscle spasms. Use of it for transcutaneous tibial
nerve stimulation for the treatment of overactive bladder or urge incontinence is considered off-
label use.

Neuromuscular Electrical Stimulation Devices (NMES)

These devices, through multiple channels, attempt to stimulate motor nerves and alternately
cause contraction and relaxation of muscles, unlike a TENS device which is intended to alter the
perception of pain. NMES are used to prevent or retard disuse atrophy, relax muscle spasm,
increase blood circulation, maintain or increase range of motion, and re-educate muscles.

This policy addresses the use of open loop neuromuscular systems which are used for simple
tasks such as muscle strengthening alone, and typically in healthy individuals with intact neural
control.

Functional neuromuscular stimulators are closed loop systems, which provide feedback
information on muscle force and joint position, thus allowing constant modification of
stimulation parameters which are required for complex activities such as walking. (These are
addressed in a separate policy, see Related Medical Policies.)

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The RS 4m and RS 2m muscle stimulator are examples of devices that deliver neuromuscular
electric stimulation.

Pulsed Electrical and Electromagnetic Stimulation Devices

Pulsed electrical and electromagnetic stimulation are being investigated to improve functional
status and to relieve neuropathic pain and the treatment of wounds that are unresponsive to
other standard therapies. Noninvasive electrical stimulators generate a weak electrical current
within the target site using pulsed electromagnetic fields, capacitive coupling, or combined
magnetic fields. Electrical stimulation is provided by an electronic device that noninvasively
delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed
electromagnetic fields are delivered via treatment coils that are placed over the skin. Combined
magnetic fields deliver a time-varying magnetic field by superimposing that field onto an
additional static magnetic field.

It is proposed that the device treats the underlying cause of the disease by stimulating the
injured tissue and improving the overall health of the tissue and that it provides a slow-acting,
but longer-lasting improvement in symptoms.

Sympathetic Stimulation Devices

Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is
designed to stimulate the sympathetic nervous system in an effort to “normalize” the autonomic
nervous system and alleviate chronic pain. Unlike TENS or interferential electrical stimulation,
sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic
effect on sympathetically induced pain.

Sympathetic therapy uses four intersecting channels of various frequencies with bilateral
electrode placement on the feet, legs, arms, and hands based on the location of the individual’s
pain and treatment protocols supplied by the manufacturer. Electrical current is then induced
with beat frequencies between 0 and 1000Hz. Treatment may include daily one-hour treatments
in the physician’s office, followed by home treatments if the initial treatment is effective.

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Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR) (CPT
0278T)

Scrambler Therapy/Calmare device is also known as transcutaneous electrical modulation pain

reprocessing (TEMPR). It is an electrocutaneous nerve stimulation device. It uses a biophysical
rather than a biochemical approach. It is proposed that a “no-pain” message is transmitted to
the nerve via disposable surface electrodes applied to the skin in the region of the individual’s
pain. The perception of pain is then cancelled when the no-pain message replaces that of pain,
by using the same pathway through the surface electrodes in a non-invasive way. Regardless of
pain intensity, an individual’s pain can reportedly be completely removed for immediate relief.
Maximum benefit is achieved through follow-up treatments. The individual may be able to go
for extended periods of time between subsequent treatments while experiencing significant pain
control and relief. The period of time between treatments depends on the underlying cause and
severity of the pain in addition to other factors. Treatment utilizing the Calmare medical device
may only be done under the direct supervision of allopathic physicians and other qualified
licensed healthcare professionals who are certified in its use and application and are familiar
with the principles, clinical applications, side effects and hazards associated with transdermal
pain modulation.

Transcutaneous Electrical Nerve Stimulation of the Wrist for Treatment of

Essential Tremor (Cala Trio)

Calo Trio (Cala Health, Inc) is described as an external upper limb tremor stimulator (also known
as a transcutaneous afferent pattern stimulator). The device is a wrist-worn device much like a
smartwatch and administers electrical stimulation (neuromodulation) to the median and radial
nerves in the affected wrist which is believed to disrupt the neural network relayed through the
nervous system to the brain so that tremors in the treated hand are temporarily reduced. The
Calo Trio consists of three components: a rechargeable stimulator (where calibration and
stimulation amplitude adjustments can be made and full color display messages and
instructions are delivered), the wrist band which includes integrated electrodes, and a base
station that charges the device. It is available for adults by prescription only for the left hand or
right hand in small, medium, or large wrist sizes. It is recommended to wear the device for
approximately 40 minutes prior to attempting tasks in which the tremor interferes. The band life,
including electrodes is noted to be approximately 90 days.

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Transcutaneous Electrical Nerve Stimulator (Cefaly)

Cefaly (STX-Med, Belgium) is a transcutaneous supraorbital nerve stimulator. The device is

battery-powered and worn liked a headband whereby self-adhesive electrodes are placed on
the forehead covering the supratrochlear and supraorbital nerves (branches of the trigeminal
nerve). The device is worn for 20 minutes daily. The device reportedly has a neuromodulatory
effect on the treated nerves, thereby blocking pain signals. In 2014, the Cefaly (Cefaly-
Technology, Belgium) device received an FDA de novo premarket review pathway with an
approved indication for the prophylactic treatment of episodic migraine in individuals 18 years
of age or older. It was then cleared for marketing in 2016 through the 510(k) process (K122566).
In 2017, the Cefaly Acute and Cefaly Dual were FDA approved as 510(k) Class II transcutaneous
electrical nerve stimulator (TENS) to treat headaches. The Cefaly Acute is indicated for the acute
treatment of migraine in individuals with or without aura. The Cefaly Dual is indicated for the
acute treatment of migraine with or without aura as well as the prophylactic treatment of
episodic migraine.

Figure 1: Cefaly Acute Device

Source: https://www.cefaly.com Accessed April 5, 2023.

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Trigeminal Nerve Stimulator (eTNS) (Monarch)

The Monarch external trigeminal nerve stimulation (eTNS) system is a non-invasive nerve
stimulation device indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)
in children aged 7 to 12 years who are not currently taking prescription ADHD medications.
Monarch external Trigeminal Nerve Stimulation (eTNS) System is based on a purported
mechanism of action that the trigeminal nerve stimulates brain areas thought to be involved in
ADHD. While the exact mechanism of action is not yet known, neuroimaging studies have shown
that eTNS increases activity in the brain regions that are known to be important in regulating
attention, emotion, and behavior. The system consists of a rechargeable, battery-operated
external pulse generator which is connected to a single-use, self-adhesive conductive patch that
is applied to the forehead just above the eyebrow. When the device is activated, bilateral high-
frequency nerve stimulation is delivered to the V1 branch of the trigeminal nerve. The V1 branch
of the trigeminal nerve carries sensory nerves from the skin of the forehead to the brain. The
level of stimulation delivered by the external pulse generator can be adjusted by the caregiver.
The device is designed to be used in the home at night while the child is sleeping under the
supervision of a caregiver, The most common side effects of eTNS use includes drowsiness or
trouble sleeping, increase in appetite, teeth clenching, headache, and fatigue. It may take up to
4 weeks for a response to eTNS to become noticeable.

Summary of Evidence

Galvanic Stimulation

A 2009 Cochrane review of electrotherapy concluded that the evidence was of low quality and
more studies are needed to reliably establish effectiveness.

H-wave Electrical Stimulation

Two small-controlled trials are insufficient to permit conclusions about the effectiveness of H-
wave electrical stimulation as a pain treatment. Additional sham-controlled studies are needed
from other investigators, preferably studies that are clearly blinded, specify the handling of any
withdrawals, and provide long-term, comparative follow-up data. One small RCT represents
insufficient evidence on the effectiveness of H-wave simulation for improving strength and
function after rotator cuff surgery. No comparative studies have been published evaluating H-
wave stimulation to accelerate wound healing. In addition, no studies were identified that

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evaluated H-wave stimulation for any clinical application other than those described above.
Thus, H-wave electrical stimulation is considered investigational.

Microcurrent Stimulation

Bertolucci and Grey (1995) compared the efficacy of MENS therapy to mid-laser and laser
placebo treatment of 48 individuals with TMJ pain. There was a difference in pain and functional
outcomes between laser and MENS therapy with laser being slightly higher; however, the
difference was not statistically significant. There was no data to suggest whether the effect was
durable and whether the effects continued with repeated use.

There is a lack of large controlled clinical trials testing the clinical effectiveness of microcurrent
electrical nerve stimulation against placebo devices. Therefore, this treatment remains
investigational.

Multimodal Devices

Multimodal devices that incorporate interferential current stimulation, neuromuscular electrical

stimulation, and transcutaneous electrical nerve stimulation are unproven as there is no
published peer reviewed literature to evaluate the evidence related to this type of device
including the off-label use of the NexWave device for the treatment of overactive bladder and
urge incontinence as a transcutaneous tibial nerve stimulator.

Neuromuscular Electrical Stimulation (NMES)

Coverage of NMES to treat muscle atrophy is limited to the treatment of disuse atrophy where
nerve supply to the muscle is intact, including brain, spinal cord and peripheral nerves, and other
non-neurological reasons for disuse atrophy. Some examples would be casting or splinting of a
limb, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery
(until orthotic training begins).

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Pulsed Electrical Stimulation and Electromagnetic Stimulation

PEMF has been used for the treatment of numerous conditions, such as subacromial
impingement syndrome, lateral epicondylitis, tinnitus, soft tissue injuries, multiple sclerosis,
fibromyalgia, diabetic peripheral neuropathy, plantar fasciitis and for various other conditions
related to pain. However, study results are mixed. Some authors report no difference in pain
among study groups while others report improvement in various pain parameters after PEMF
therapy. In some studies, other treatment modalities were used, making study interpretations
and comparisons difficult.

Evidence based guidelines published by the Academy of Neurology (Bril, et al., 2011) do not
support electromagnetic field therapy as a treatment for peripheral diabetic neuropathy. The
authors noted electromagnetic field treatment is probably not effective for the treatment of
peripheral neuropathy.

Studies in the published medical literature comparing electromagnetic therapy devices with
established wound care management are lacking. The studies are limited in sample size with
poorly defined individual selection criteria and have limited reporting of methodological details.
There is little consensus among authors regarding duration of treatment or technique of
application. The results of two Cochrane reviews report no evidence of benefit to
electromagnetic therapy when used for wound healing. An additional systematic review also
found minimal data to support electromagnetic therapy for the treatment of pressure ulcers.

Sympathetic Therapy

In 2002 Guido and colleagues studied 20 individuals with chronic pain and peripheral
neuropathies treated daily with Dynatron STS for 28 days. Pain was reported as moderate to
severe by 11 of 15 individuals prior to treatment, with a decrease in pain reported by 6 of the
individuals at conclusion of the treatment. The author did not report on the reason why 5 of the
20 individuals did not provide self-reports of pain severity. For the 15 individuals who remained
in the study, the authors reported the mean cumulative VAS scores for multiple locations of pain
decreased from 107.8 to 45.3. However, drawing conclusions concerning the efficacy of
Dynatron STS for the management of chronic, intractable pain is limited due to the small
participant population, lack of a randomized control group, placebo effects and lack of data on
pain severity in a quarter of the subjects. There is a lack of peer-reviewed literature concerning
the efficacy of sympathetic therapy in terms of pain relief or for any other indication.

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Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR)

In 2012, Ricci and colleagues reported on a small retrospective study of 73 individuals whose
pain management had been unsatisfactory with other treatments. The primary objective of the
study was to assess efficacy and tolerability of the MC5-A Calmare device. This device is
described as “scrambling pain information with ‘no pain’ information in order to reduce the
perception of pain intensity.” There was no comparator treatment. The individuals were followed
for 4 weeks. The authors reported that the pain score had decreased by 74% after 10 days of
treatment. The authors concluded that cutaneous electrostimulation with the MC5-A Calmare
device can be proposed as part of a multimodality approach to the treatment of chronic pain.
However, they cautioned that further studies on larger numbers of individuals are needed to
assess its efficacy, to quantify the effects of inter-operator variability, and to compare results
obtained from the active device versus those from a sham machine.

In 2015, Moon and colleagues reported on a multicenter analysis which sought to identify which
factors are associated with treatment outcomes for Calmare therapy. They gathered data from 3
medical centers on 147 individuals with various pain conditions who underwent a minimum of
either 3 Calmare therapies on consecutive days or 5 therapies overall. A successful outcome was
predefined as ≥50% pain relief on a 0 to 10 numerical rating scale that persisted for longer than
1 month after the last treatment. Overall, the success rate was 38.1%. Variables found to be
associated with a positive outcome included the presence of neuropathic or mixed pain, and
treatment at either Walter Reed or Seoul National University. Factors that correlated with
treatment failure were disease or traumatic/surgical etiologies and antidepressant use. They
concluded that a neuropathic or mixed neuropathic-nociceptive pain condition was associated
with a positive treatment outcome and suggested that investigators consider these findings
when developing selection criteria in clinical trials designed to determine the efficacy of Calmare
therapy.

Transcutaneous Electrical Nerve Stimulation of the Wrist for Treatment of

Essential Tremor

For individuals who have essential tremor who receive TENS (Cala Trio), 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 individuals 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 individuals who exited the study early from

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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.

Transcutaneous Electrical Nerve Stimulator (Cefaly)

There is insufficient evidence in the peer-reviewed literature to support TENS for the treatment
of migraines, including the use of Cefaly devices. Studies investigating Cefaly are primarily
observational in design and include small individual populations with short-term follow-ups.
One study, PREMICE, was a double-blind, sham controlled RCT of 67 total individuals. The
protocol after a one month run in period had the individuals use the device daily for three
months. There were fewer number of migraine attacks, number of headache days and a
decrease in the number of acute antimigraine drugs in the TENS group than in the sham group.
However, there was no statistical significance in the reduction of the number of migraine days
for the TENS group versus the sham group. Published data from randomized controlled trials
with larger individual populations and longer-term outcomes comparing TENS to conventional
therapy are needed to establish the effectiveness of TENS/Cefaly for the treatment of migraines.

Trigeminal Nerve Stimulation (Monarch eTNS System)

For individuals who have attention deficit hyperactivity disorder (ADHD) who receive TENS, the
evidence includes one RCT. McCough et al (2019) assessed the efficacy and safety of TENS in a
double-blind, sham-controlled pilot study of pediatric individuals with ADHD. 62 individuals (8
to 12 years) with ADHD based on the KSADS and clinical interview with a minimum total of 24
on the clinician-administered parent ADHD-IV Rating Scale, baseline CGI-S ≥4, and full-scale IQ
≥85. Children were medication free for at least 1 month prior to enrollment. TENS device
(Monarch eTNS System) administered nightly for 4 weeks (n=32). Sham TENS device
administered nightly for 4 weeks (n=30). The study was a 4-week trial followed by 1 blinded
week without intervention. Clinical assessments included weekly clinician-administered ADHD-
Rating and Clinical Global Impression (CGI) scales, and quantitative electroencephalography
(EEG) at baseline and week 4. The primary outcome measure was the clinician completed ADHD-
Rating Scale total score. Results revealed that ADHD-Rating Scale totals showed significant
group-by-time interactions, demonstrating a differential treatment effect (F=8.12, df=1/228,
p=.005). The CGI-Improvement scale also favored active treatment over sham (p=.003).
Quantitative EEG readings were obtained in both groups but there were no participant specific
correlations to other outcomes. No serious adverse events were observed in either group and

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no individual withdrew from the study due to adverse events. Significant increases in weight and
pulse were seen with active TENS over the trial period; however, no differences between active
and sham TENS with regard to blood pressure were seen. Conclusions were that TENS therapy is
efficacious and well-tolerated in pediatric individuals with ADHD. Limitations cited were sample
size and short duration of treatment and follow-up. 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.

Ongoing and Unpublished Clinical Trials

Currently ongoing and unpublished trials that may influence this policy are listed in Table 1.

Table 1. Summary of Key Trials

NCT No. Trial Name Planned Completion

Enrollment Date
Ongoing
NCT04428619 Percutaneous Electrical Field Stimulation for Adults with 54 Nov 2024
Irritable Bowel Syndrome (recruiting)

Unpublished
NCT04239976 Scrambler therapy for the reduction of chemotherapy- 16 Mar 2022
induced neuropathic pain

NCT05480215 Prospective Study for Symptomatic Relief of Action 20 Dec 2021

Tremor with Cala Trio Using Trio+ Bands

NCT: national clinical trial.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion if they were issued by, or
jointly by, a U.S. professional society, an international society with U.S. representation, or
National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that
are informed by a systematic review, include strength of evidence ratings, and include a
description of management of conflict of interest.

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American Academy of Pediatrics (AAP)

In 2019 the AAP updated its clinical practice guideline for the diagnosis, evaluation, and
treatment of ADHD in children and adolescents56. The revised guideline states that external
trigeminal nerve stimulation (eTNS) cannot be recommended as a treatment for ADHD because
supporting evidence is “sparse and in no way approaches the robust strength of evidence
documented for established medication and behavioral treatments for ADHD; therefore it
cannot be recommended as a treatment of ADHD without considerably more extensive study on
its efficacy and safety.”

International Essential Tremor Foundation

In 2021, IETF recommended Cala Trio and/or other non-invasive devices as an add-on non-
pharmacological/non-surgical treatment option that could be used to reduce tremor in a
targeted arm after first -line pharmacological approaches have been trialed, or after second-line
and third-line pharmacological approaches have been trialed. This was based on expert opinion
without a formal review process and did not include strength of evidence ratings, nor was there
any description of management of conflict of interest.

National Institute for Health and Care Excellence (NICE)

In 2016, the NICE published guidance on transcutaneous electrical stimulation of the

supraorbital nerve for treating and preventing migraine in adults. The recommendation stated,
“current evidence on transcutaneous electrical stimulation of the supraorbital nerve for treating
and preventing migraine raises no major safety concerns. The evidence on efficacy is limited in
quantity and quality.” The guideline also recommended clinicians ensure that individuals
understand, “the uncertainty about the procedure’s efficacy.”78

Medicare National Coverage

There is no national coverage determination.

Page | 18 of 28 ∞
Regulatory Status

• In 1992, the H-Wave muscle stimulator (Electronic Waveform Lab, Huntington Beach, CA)
was cleared for marketing by FDA through the 510(k) process. FDA classified H-wave
stimulation devices as “powered muscle stimulators.” As a class, FDA describes these devices
as being “intended for medical purposes that repeatedly contracts muscles by passing
electrical currents through electrodes contacting the affected body area.”

• Calmare Pain Therapy Medical Device also known as the Scrambler Therapy MC-FA TENS
device was FDA 510(k)- cleared in 2009 (K081255) and classified as a multi-channel
transcutaneous electrical nerve stimulator (TENS). European CE mark-certified for the
treatment of oncologic and neuropathic pain through biophysical stimulation. The Device
has five separate channels, convenient dial selectors with five corresponding channel meters,
indicator lights and an LCD display to monitor operation. FDA Product Code: GZJ.

• In 2011 the NexWave combination neuromuscular electrical stimulator, interferential

stimulator, and transcutaneous electrical nerve stimulator was cleared for marketing by the
FDA through the 510(k) process (K111279) as it was determined to be substantially
equivalent to predicate devices. The indications for use were noted for the interferential
mode for the symptomatic relief of chronic intractable pain, post-traumatic and post-
surgical pain. The neuromuscular electrical stimulation mode for muscle re-education,
prevention of disuse atrophy, increasing local blood circulation, maintaining range of
motion, and relaxation of muscle spasms, the transcutaneous electrical stimulation mode for
management and symptomatic relief of chronic intractable pain, post-traumatic pain and
post-surgical pain. FDA Product Code: IPF, GZJ, LIH

• In 2017 the Cefaly Acute (K171446) and Cefaly Dual (K173006) were cleared for marketing by
the FDA through the 510(K) process as they were determined to be substantially equivalent
predicate devices; they are considered Class II Transcutaneous Electrical Nerve Stimulators to
treat headaches. Cefafly was initially cleared for marketing in 2016 through the 510(k)
process (K122566) following a De Novo classification (DEN120019) in 2014. The Cefaly Acute
is indicated for the acute treatment of migraine in individuals with or without aura. The
Cefaly Dual is indicated for the acute treatment of migraine with or without aura as well as
the prophylactic treatment of episodic migraine; all of the devices are for use in individuals
18 years of age or older. FDA product code: PCC.

• In 2017, the FDA reviewed the Cala ONE TENS device (Cala Health) via the de novo pathway
(DEN170028) 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 individuals with an implanted electrical

Page | 19 of 28 ∞
 medical device, those that have suspected or diagnosed epilepsy or other seizure disorder,
those who are pregnant, and individuals with swollen, infected, inflamed areas, or skin
eruptions, open wounds, or cancerous lesions. In 2018, the Cala ONE device was cleared for
marketing by the FDA through the 510(k) process (K182706) as substantially equivalent to its
predicate device. 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 2021, the Cala Trio was rebranded and received FDA 510(k) clearance (K203288)
as substantially equivalent to the predicate device, Cala One. FDA Product Code QBC.

• 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 (DEN180041). This prescription only TENS device is indicated for individuals
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 individual’s forehead, just above the eyebrow. FDA Product code:
QGL.

References

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3. Centers for Medicare and Medicaid Services (CMS) Neuromuscular Electrical Stimulator (NMES) 160.12. NCD Manual Chap 1,
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8. Kwon DR, Kim J, Kim Y, et al. Short-term microcurrent electrical neuromuscular stimulation to improve muscle function in the
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14. Moon JY, Kurihara C, Beckles JP et al. Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a
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17. Lee SC, Park KS, Moon JY, Kim EJ, Kim YC, Seo H, Sung JK, Lee da J. An exploratory study on the effectiveness of "Calmare
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18. Notaro P, Dell'Agnola CA, Dell'Agnola AJ, Amatu A, Bencardino KB, Siena S. Pilot evaluation of scrambler therapy for pain
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19. Majithia N, Smith TJ, Coyne PJ, et al. Scrambler therapy for the management of chronic pain. Support Care Cancer. 2016; 24 (6):
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20. Competitive Technologies. Calmare. 2017. Available at URL address: http://calmarett.com/. Accessed April 5, 2023.

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22. Smith TJ, Razzak AR, Blackford AL, et al. A pilot randomized sham-controlled trial of mc5-a scrambler therapy in the treatment
of chronic chemotherapy-induced peripheral neuropathy (CIPN). J Palliat Care. 2020; 35 (1): 53-58. PMID:30714486.

23. Loprinzi C, Le-Rademacher JG, Majithia N, et al, Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot
trial. Support Care Cancer: 2020; 28 (3): 1183-1197. PMID: 31209630.

24. Bosi E, Bax G, Scionti L, Spallone V, Tesfaye S, Valensi P, Ziegler D; FREMS European Trial Study Group. Frequency-modulated
electromagnetic neural stimulation (FREMS) as a treatment for symptomatic diabetic neuropathy: results from a double-blind,
randomised, multicentre, long-term, placebo-controlled clinical trial. Diabetologia. 2013 Mar;56(3):467-475. PMID:23238789.

25. Weintraub MI, Herrmann DN, Smith AG, Backonja MM, Cole SP. Pulsed electromagnetic fields to reduce diabetic neuropathic
pain and stimulate neuronal repair: a randomized controlled trial. Arch Phys Med Rehabil. 2009;90(7):1102-1109.PMID:
19577022.

26. Wróbel MP, Szymborska-Kajanek A, Wystrychowski G, et al. Impact of low frequency pulsed magnetic fields on pain intensity,
quality of life and sleep disturbances in patients with painful diabetic polyneuropathy. Diabetes Metab. 2008;34(4 Pt 1):349-354.
PMID: 18585071.

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27. Pieber K, Herceg M, Paternostro-Sluga T. Electrotherapy for the treatment of painful diabetic peripheral neuropathy: a review. J
Rehabil Med. 2010; 42(4):289-295. PMID: 20461329.

28. Bril V, England J, Franklin GM, et al. Evidence-based guideline: Treatment of painful diabetic neuropathy: report of the American
Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American
Academy of Physical Medicine and Rehabilitation. Neurology. 2011;76(20):1758-1765. PMID: 21482920.

29. Ravaghi H, Flemming K, Cullum N, Olyaee Manesh A. Electromagnetic therapy for treating venous leg ulcers. Cochrane
Database Syst Rev, 2006;19(2); CD002933. PMID: 16625565.

30. Aziz Z, Bell-Syer SE. Electromagnetic therapy for treating pressure ulcers. Cochrane Database of Syst Rev 2015; 9: CD002930.
PMID: 26334539..

31. Aziz Z, Cullum N. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. 2015;(7):CD002933.
PMID: 26134172.

32. Reddy M, Gill SS, Kalkar SR, Wu W, Anderson PJ, Rochon PA. Treatment of pressure ulcers: a systematic review. JAMA.
2008;300(22):2647-2662. PMID: 19066385.

33. Blum K, DiNubile NA, Tekten T et al. H-Wave, a nonpharmacologic alternative for the treatment of patients with chronic soft
tissue inflammation and neuropathic pain: a preliminary statistical outcome study. Adv Ther 2006; 23(3):446-455. PMID:
16912027.

34. Blum K, Chen TJ, Martinez-Pons M et al. The H-Wave small muscle fiber stimulator, a nonpharmacologic alternative for the
treatment of chronic soft-tissue injury and neuropathic pain: an extended population observational study. Adv Ther 2006;
23(5):739-749. PMID: 17142209.

35. Blum K, Chen AL, Chen TJ et al. The H-Wave device is an effective and safe non-pharmacological analgesic for chronic pain: a
meta-analysis. Adv Ther 2008; 25(7):644-657. PMID: 18636234.

36. Blum K, Chen AL, Chen TJ et al. Repetitive H-wave device stimulation and program induces significant increases in the range of
motion of post-operative rotator cuff reconstruction in a double-blinded randomized placebo controlled human study. BMC
Musculoskelet Disord 2009; 10:132. PMID: 19874593.

37. Blum K, Chen AL, Chen TJ et al. Healing enhancement of chronic venous stasis ulcers utilizing H-WAVE device therapy: a case
series. Cases J 2010; 3:54. PMID: 19204915.

38. Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gérard P, Magis D. Migraine prevention with a
supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013;80(8):697-704.PMID: 23390177.

39. Magis D, Sava S, d'Elia TS, Baschi R, Schoenen J. 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. PMID: 24289825.

40. Miller S, Sinclair AJ, Davies B, Matharu M. Neurostimulation in the treatment of primary headaches. Pract Neurol.
2016;16(5):362-375. PMID: 27152027.

41. Penning S, Schoenen J. A survey on migraine attack treatment with the CEFALY device in regular users. Acta Neurol Belg.
2017;117(2):547-549.PMID: 28185179.

42. Przeklasa-Muszyńska A, Skrzypiec K, Kocot-Kępska M, Dobrogowski J, Wiatr M, Mika J. Non-invasive transcutaneous

Supraorbital Neurostimulation (tSNS) using Cefaly device in prevention of primary headaches. Neurol Neurochir Pol. 2017;
51(2):127-134. PMID: 28159327.

43. Vikelis M, Dermitzakis EV, Spingos KC, Vasiliadis GG, Vlachos GS, Kararizou E. Clinical experience with transcutaneous
supraorbital nerve stimulation in patients with refractory migraine or with migraine and intolerance to topiramate: a prospective
exploratory clinical study. BMC Neurol. 2017;17(1):97. PMID: 28521762.

44. Di Fiore P, Bussone G, Galli A, Didier H, Peccarisi C, D'Amico D, Frediani F. Transcutaneous supraorbital neurostimulation for the
prevention of chronic migraine: a prospective, open-label preliminary trial. Neurol Sci. 2017;38(Suppl 1):201-206. PMID:
28527053.

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45. Chou DE, Gross GJ, Casadei CH, Yugrakh MS. External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine:
OpenLabel Trial on Safety and Efficacy. Neuromodulation. 2017;20(7):678-683. PMID: 28580703.

46. Tao H, Wang T, Dong X, Guo Q, Xu H, Wan Q. Effectiveness of transcutaneous electrical nerve stimulation for the treatment of
migraine: a meta-analysis of randomized controlled trials. J Headache Pain. 2018;19(1):42. PMID: 29845369.

47. U.S. Food and Drug Administration (FDA). De Novo Summary (DEN120019) De Novo Classification Request for Cefaly device.
Published March 11, 2014. https://www.accessdata.fda.gov/cdrh_docs/reviews/K122566.pdf. Accessed April 5, 2023.

48. National Institute for Health and Care Excellence. Transcutaneous electrical stimulation of the supraorbital nerve for treating
and preventing migraine. (IPG 559). Published May 25, 2016. https://www.nice.org.uk/guidance/IPG559/chapter/1-
Recommendations. Accessed April 5, 2023.

49. Krasaelap A, Sood MR, Li BUK, et al. Efficacy of auricular neurostimulation in adolescents with irritable bowel syndrome in a
randomized, double-blind trial. Clin Gastroenterol Hepatol. 2020; 18(9): 1987-1994.e2. PMID: 31622740.

50. NeuroSigma Inc., Monarch eTNS System. Available online: https://www.monarch-etns.com/. Accessed April 5, 2023.

51. McGough JJ, Sturm A, Cowen J, et al. Double-blind, sham-controlled, pilot study of trigeminal nerve stimulation for attention-
deficity/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2019; 58(4):403-411.e3. PMID: 30768393.

52. American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-
deficity/hyperactivity disorder in children and adolescents. October 1, 2019. Available online:
https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-
Diagnosis?autologincheck=redirected. Accessed April 5, 2023.

53. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). De Novo Decision Summary
(DEN180041). De Novo Classification request for Monarch eTNS system. (NeuroSigma, Inc., Los Angeles, CA.) 04/19/2019.
Available online: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180041.pdf. Accessed April 5, 2023.

54. Hayes, Inc. Emerging Technology Report. Monarch eTNS for attention-deficit disorder. Lansdale, PA. Hayes, Inc. Dec 17, 2019.
Archived Apr 28, 2021.

55. Hayes, Inc. Evolving Evidence Review. Monarch eTNS System (NeuroSigma, Inc.) for Treatment of Attention-
Deficit/Hyperactivity Disorder in Children. Lansdale, PA. Hayes, Inc. February 9, 2023. Available at URL:
https://evidence.hayesinc.com/report/eer.monarch5149. Accessed April 5, 2023.

56. Medical Device Network. Cala Health’s tremor therapyreceives FDA breakthrough designation for Cala Trio therapy to treat
action tremors in Parkinson's disease. https://www.medicaldevice-network.com/news/cala-health-tremor-therapy-fda-
breakthrough-
designation/#:~:text=American%20bioelectronic%20medicine%20company%20Cala,FDA%20to%20relieve%20hand%2
0tremors. Accessed April 5, 2023.

57. Cala Health, Inc. Cala Trio™. Available at URL: https://calatrio.com/. Accessed April 5, 2023.

58. Isaacson SH, Peckham E, Tse W, et al. Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential
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59. Bhatia KP, Bain P, Bajaj N, et al. Consensus statement on the classification of tremors. From the task force on tremor of the
International Parkinson and Movement Disorder Society. Mov Disord. 2018;33(1):75-87. PMID: 29193359.

60. Pahwa R, Dhall R, Ostrem J, et al. An acute randomized controlled trial of noninvasive peripheral nerve stimulation in essential
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61. International Essential Tremor Foundation. Essential Tremor Guidelines Advisory. Essential Tremor in Adult Patients. June 17,
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62. Hayes, Inc. Evolving Evidence Review. Cala Trio (Cala Health, Inc.) for Treatment of Essential Tremor. Lansdale, PA. Hayes, Inc.
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63. U.S. Food and Drug Administration. Center for Devices and Radiological Health (CDRH). De Novo Decision Summary
(DEN170028). De Novo Classification Request for Cala ONE (Cala Health, Inc, Burlingame, CA). May 17, 2017. Available at URL:
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170028.pdf. Accessed April 5, 2023.

64. U.S. Food and Drug Administration. 510(k) Summary (K182706). Request for Cala ONE (Cala Health, Inc, Burlingame, CA).
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History

Date Comments
09/10/02 Add to Durable Medical Equipment Section - New Policy. Replaces 1.01.13 H-Wave
Electrical Stimulation; 1.01.104 (1.01.09) Transcutaneous Electrical Nerve Stimulator
(TENS); 1.04.03 Sympathetic Therapy for the Treatment of Pain; 7.01.29 Percutaneous
Electrical Nerve Stimulation (PENS)

04/15/03 Replace Policy - Policy reviewed with references added.

05/13/03 Replace Policy - Policy section revised for clarification only.

10/16/03 Replace Policy - Interferential Stimulation Devices description updated; references

added. No change to policy statement.

01/13/04 Replace Policy - TMJ as investigational for TENS was added. This is consistent with TMJ
policy.

06/08/04 Replace Policy - Policy reviewed; No change to policy statement.

07/13/04 Replace Policy - Description of PENS revised; information on percutaneous

neuromodulation included; policy statement revised to indicate that percutaneous
neuromodulation considered investigational. No change in policy statement regarding
PENS.

09/01/04 Replace Policy - Policy renumbered from PR.1.01.107. No date changes.

09/14/04 Replace Policy - Policy statement revised by adding pulsed electrical stimulation with
the BioniCare to be considered investigational as a treatment for osteoarthritis.
Rationale Section updated.

Page | 24 of 28 ∞
Date Comments
12/14/04 Replace Policy - Description of TENS revised; information on dementia added;
reference added; Medicare policy language on TENS added. No change to policy
statement.

02/08/05 Replace Policy - RS-4i Sequential Stimulator information added. No change to policy
statement.

05/31/05 Update only to web - HCPCS codes added only—no other changes and not presented
to MPC.

09/13/05 Replace Policy - Interferential Stimulation and PENS/ PNT added to Rationale section.
References updated; no change to policy statement.

02/06/06 Codes updated - No other changes.

05/26/06 Update Scope and Disclaimer - No other changes.

07/11/06 Replace Policy - Update description to include detail of RS 4M and RS 2M muscle

stimulators; no change to policy statement.

04/10/07 Cross Reference Update - No other changes.

06/12/07 Replace Policy - Policy updated with literature review; references added. No changes in
policy statement. Reviewed by practicing orthopedic surgeon in May 2007.

05/13/08 Replace Policy - Policy updated with literature search. Policy statement was updated to
include cranial electrostimulation therapy is considered investigational for all
indications listed. The manufacturer provided many articles to be reviewed. Many of
them were from the 1990s and earlier. Most of the later studies were not regarding the
FDA approved labeled indications. Additional and much larger double-blinded, sham
controlled studies are needed to document long-term effects of CES. References and
code added to support the update.

01/13/09 Code Update - Code E0770 added, effective 1/1/09.

08/11/09 Replace Policy - Policy updated with literature search; references added. No change to
policy statement.

04/13/10 Cross Reference Update - No other changes.

06/08/10 Replace Policy - Policy updated with literature search, reference added. Added
medically necessary statement re: conductive garment and TENS/IF. Also included Flex
IT to investigational statement.

06/13/11 Replace Policy - Policy updated with literature search, reference added. No change to
policy statement.

01/25/12 HCPCS codes S8130 and S8131 added to policy.

01/26/12 CPT code 0278T added.

03/13/12 Replace policy. Policy revised by removing indications, descriptions, and rationale
addressed in separate policies: 1.01.13, 1.01.24, 1.01.27, 7.01.29, and 8.01.58. Policy

Page | 25 of 28 ∞
Date Comments
now addresses TENS, open loop neuromuscular electrical stimulation, galvanic,
microcurrent, cranial electrostimulation and sympathetic electrical stimulation devices.

04/17/12 Related Policies updated; 7.01.546 added to replace 7.01.25 which has been deleted.

08/24/12 Update Related Policies. Change title for 7.01.106

11/20/12 Update Related Policies. Add 8.01.58.

02/11/13 Replace policy. Removed information on cranial electrostimulation which is addressed

in Medical Policy 8.01.58. Added policy statement on scrambler therapy.

12/30/13 Coding update. HCPCS code E0762 removed; this is addressed in policy No. 1.01.27,
Electrical Stimulation for the Treatment of Arthritis. Remove Related Policy 1.01.19; it
was archived effective 12/9/13.

03/21/14 Update Related Policies. Delete 7.01.106 and replace with 7.01.553.

05/12/14 Annual Review. TENS policy statements and information removed. Added references 3
and 4.

06/09/14 Interim update. HCPCS codes E0720, E0730 and E0731 are no longer reviewed and
from the policy. The Policy section has been updated with removal of the policy
statement related to code E0730 and the TENS unit.

03/10/15 Annual Review. Policy updated with literature search through November 2014. Added
statement from medical policy 1.01.27 (that is now archived) “Electrical stimulation is
considered investigational for the treatment of osteoarthritis or rheumatoid arthritis”
along with the HCPCS code. Added policy 7.01.529, removed policy 1.01.27 from
Related Policies section. Added information about conductive garment to the Policy
Guidelines. Added Definition of Terms to Policy Guidelines. Regulatory Status section
updated with additional device names. Reference 6-12, 14 added; others renumbered.
Added code E0762. Policy statement added as noted. Coding update: CPT codes
64553-64590 removed as there are more specific codes listed; HCPCS codes S8130,
S8131 removed as these are not being utilized; HCPCS codes E0770 and L8680
removed as these are listed on other policies to which they apply.

04/17/15 Update Related Policies. Remove 7.01.553 and 7.01.529 as they were archived, and add
7.01.07.

01/12/16 Annual Review. Policy updated with literature search through November 2015. No
studies were found which would prompt a change in the policy statement. References
added.

01/29/16 Minor update. Add code L8679 to coding table.

06/01/17 Annual Review, approved May 23, 2017. Put into new format. No changes to policy
statement.

05/01/18 Annual Review, approved April 18, 2018. Policy updated with literature review through
January 2018. References 16-23 added. Minor edits to policy statements for clarity.

Page | 26 of 28 ∞
Date Comments
Otherwise, policy statements unchanged. Removed 7.01.07 from Related Policies,
added 8.01.58. Removed CPT code 64550.

08/01/18 Interim Review, approved July 10, 2018. Policy updated with literature review through
June 2018. References 24-32 added. Policy statement modified to “Pulsed electrical
stimulation and pulsed electromagnetic therapy are considered investigational for any
indication including, but not limited to the treatment of osteoarthritis, rheumatoid
arthritis, neuropathic pain (diabetic peripheral neuropathy), post-operative or non-
post-operative pain, or to treat wounds.”

06/01/19 Annual Review, approved May 7, 2019. Policy updated with literature review through
January 2019; no references added. Minor edits for clarity; otherwise policy statement
unchanged. Removed CPT code 97014 and HCPCS code G0283.

06/01/20 Annual Review, approved May 12, 2020. Policy updated with literature review through
January 2020; references added. Added H-wave electrical stimulation and
transcutaneous supraorbital electrical nerve stimulator are considered investigational
Otherwise, policy statements unchanged. HCPCS code E0761 was added.

08/01/20 Update Related Policies. Add 1.01.24 Interferential Current Stimulation.

06/01/21 Annual Review, approved May 11, 2021. Policy updated with literature review through
December 13, 2020; references added and some references deleted. Added remote
electrical neuromodulation (REN) (e.g., Nerivio Migra) as investigational. Other minor
edits made for greater clarity.

10/01/21 Coding update, Added HCPC code K1023.

06/01/22 Annual Review, approved May 10, 2022. Policy updated with literature review through
January 18, 2022; references added. Added percutaneous electrical nerve field
stimulation (PENFS) used to treat abdominal pain associated with irritable bowel
syndrome as investigational (e.g., IB-Stim). Added CPT codes 0720T and 64999.
Removed HCPCS code E0762.

08/01/22 Interim Review, approved July 12, 2022. Added trigeminal nerve stimulation for the
treatment of ADHD is considered investigational. Removed remote electrical
neuromodulation (REN) (e.g., Nerivio) as it is now reviewed in 7.01.171 Remote
Electrical Neuromodulation for Migraine. Added HCPCS codes K1016 and K1017.
Removed HCPCS code K1023.

10/01/22 Interim Review, approved September 13, 2022. Added transcutaneous electrical nerve
stimulation of the wrist for treatment of essential tremor is considered investigational
(e.g., Cala Trio). Removed determination statement from HCPC E1399. Changed the
wording from "patient" to "individual" throughout the policy for standardization.

05/01/23 Annual Review, approved April 24, 2023. Policy reviewed. References updated. Policy
statements unchanged. Updated code description for HCPCS code K1019.

08/01/23 Interim Review, approved July 10, 2023. Removed policy statement for percutaneous
electrical nerve field stimulation (PENFS) used to treat abdominal pain associated with
irritable bowel syndrome (e.g., IB-Stim) as it is now reviewed in Policy 2.01.106

Page | 27 of 28 ∞
Date Comments
Percutaneous Electrical Nerve Field Stimulation for Irritable Bowel Syndrome. Deleted
CPT code 0720T due to criteria change.

10/01/23 Interim Review, approved September 12, 2023. Added policy statement that
multimodal devices that incorporate interferential current stimulation, neuromuscular
electrical stimulation, and transcutaneous electrical nerve stimulation are considered
investigational for all indications (e.g., NexWave). References added.

10/04/23 Updated related policy. Policy 7.01.29 Percutaneous Electrical Nerve Stimulation and
Percutaneous Neuromodulation Therapy was renumbered to 7.01.588 Percutaneous
Electrical Nerve Stimulation and Percutaneous Neuromodulation Therapy.

11/01/23 Update Related Policy. 7.01.574 – title changed from “Implantable Peripheral Nerve
Stimulation for the Treatment of Chronic Pain” to “Implantable Peripheral Nerve
Stimulation for the Treatment of Chronic Pain and Other Conditions.”

01/01/24 Coding update. Added new HCPCS codes A4541, A4542, E0733 and E0734 and termed
codes K1018 & K1019.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The
Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and
local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review
and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply.
CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2024 Premera
All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to
the limits and conditions of the member benefit plan. Members and their providers should consult the member
benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Page | 28 of 28 ∞
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discriminate on the basis of race, color, national origin, age, disability, sex, gender identity, or sexual orientation. LifeWise does not
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services or discriminated in another way on the basis of race, color, national origin, age, disability, sex, gender identity, or sexual
orientation, you can file a grievance with: Civil Rights Coordinator ─ Complaints and Appeals, PO Box 91102, Seattle, WA 98111, Toll
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Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health
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051267 (07-01-2021)