Coding Code Description CPT

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

97014 Application of modality to one or more areas; electrical stimulation, unattended HCPCS

E0745 Neuromuscular stimulator, electronic shock unit

E0762 Transcutaneous electrical joint stimulation device system, includes all accessories

E1399 Durable medical equipment, miscellaneous (Determine if an alternative HCPCS Level II or a CPT code better describes the service being reported. This code should be used only if a more specific code is unavailable.)

G0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care

L8679 Implantable neurostimulator, pulse generator, any type

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 electrical signal is the same type that a nerve would send to a muscle. 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.

Policy Coverage Criteria

Service Medical Necessity Services eligible for reimbursement

Use of a neuromuscular electrical stimulator (NMES) via an 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 patient has any of the following non-neurological causes for disuse atrophy:
* Previous casting or splinting of a limb
* Contractures due to soft tissue scarring (eg, from burn)
* Previous major knee surgery (eg, total knee replacement), when there is a failure to respond to physical therapy
* 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
* 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 reimbursement

Neuromuscular electrical stimulators (NMES) are considered investigational for ANY other unproven indication (eg, when used for general muscle strengthening in healthy individuals, for cardiac conditioning, for the treat.

Service Investigational

Electrical sympathetic stimulation therapy devices are considered investigational.

Galvanic or high-voltage galvanic stimulation is considered investigational in the treatment of chronic pain.

Microcurrent electrical nerve stimulation (MENS) devices are considered investigational.

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. (HCPCS E0762).

Transcutaneous electrical modulation pain reprocessing (TEMPR) (also called Scrambler therapy or Calmare® pain therapy) is considered investigational (CPT 0278T).

Documentation Requirements

The patient’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
* 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

Documentation Requirements

o The treatment site is hard to reach using standard electrodes and lead wires
o The member has a skin sensitivity that precludes use of standard electrodes, adhesive tape, or lead wires

Related Information Definition of Terms

Conductive garment: A form-fitted garment with integrated conductive fibers that are separated from the patient’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

Background Pulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis (OA) and rheumatoid arthritis that is unresponsive to other standard therapies. Electrical stimulation is provided using a device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered using coils placed over the skin.

Neuromuscular Electrical Stimulation Devices (NMES)

These devices, through multiple channels, attempt to stimulate motor nerves and alternately causes 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 address 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.) The RS 4m and RS 2m muscle stimulator are examples of devices that delivers neuromuscular electric stimulation.

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.

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.

Pulsed Electrical and Electromagnetic Stimulation Devices

Pulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis (OA) and rheumatoid arthritis (RA) 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. In capacitive coupling, small skin pads or electrodes are placed on either side of the knee or wrist. 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 the time-varying magnetic field onto an additional static magnetic field.

In basic research studies, pulsed electrical stimulation has been shown to alter chondrocyterelated gene expression in vitro and to have regenerative effects in animal models of cartilage injury. It is proposed that the device treats the underlying cause of the disease by stimulating the joint tissue and improving the overall health of the joint 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 patient’s pain and treatment protocols supplied by the manufacturers, electrodes are placed in various locations on the lower legs and feet or the hands and arms. 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. 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. A “no-pain” message is transmitted to the nerve via disposable surface electrodes applied to the skin in the region of the patient’s pain. The perception of pain is 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, a patient’s pain can be completely removed for immediate relief. Maximum benefit is achieved through follow-up treatments. The patient 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.