Latest Review Date: December 2023

Category: Durable Medical Equipment (DME)

POLICY:

Threshold Electrical Stimulation (TES), as a treatment of motor disorders including but not limited to cerebral palsy, spina bifida, idiopathic scoliosis, or brachial plexus injuries, is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Threshold electrical stimulation is provided by a small electrical generator, lead wires, and surface electrodes that are placed over the targeted muscles. This type of therapy relies on low-intensity electrical impulses and doesn't cause muscle contraction. Unlike many other electrical stimulation treatments, threshold electrical stimulation is typically administered while patients are asleep. Its designed to treat cerebral palsy and other motor disorders. As patients sleep, both blood flow and hormone secretion tend to increase. As a result, therapists believe that this is the ideal time to apply threshold electrical stimulation to enhance muscle growth and bulk.

Threshold electrical stimulation is described as the delivery of low intensity electrical stimulation to target spastic muscles during sleep at home. The stimulation is not intended to cause muscle contraction. Although the mechanism of action is not understood, it is thought that low intensity stimulation may increase muscle strength and joint mobility, leading to improved voluntary motor function. The technique has been used in children with spastic diplegia related to cerebral palsy (CP), where the patient may have disuse atrophy. It has also been used with other motor disorders, such as spina bifida, brachial plexus injuries, central nervous system injuries, post-polio syndrome, and idiopathic scoliosis.

The TES device is a small battery powered unit with two lead wires, and each of these has two electrodes attached at the ends. These electrodes are attached to certain areas of the skin. The technique involves the administration of small electrical stimuli to the skin overlying selected “weakened” muscles that are usually opposite the spastic muscles. TES is thought to work by increasing local blood flow, and along with the nightly secretion of trophic hormones, to enlarge the atrophic muscles and improve motor function. 

KEY POINTS:

The most recent literature search was performed through December 2023.

Summary of Evidence:

The studies published to date demonstrate that threshold electrical stimulation is not effective for treatment of spasticity, muscle weakness, reduced joint mobility or motor function. Many randomized trials have failed to show clinically significant improvement in muscle strength or function utilizing Threshold Electrical Stimulation (TES). Validation of therapeutic electrical stimulation requires randomized, controlled studies that can isolate the contribution of the electrical stimulation from other components of therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

None identified. 

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Threshold Electrical Stimulation (TES), cerebral palsy, spina bifida, idiopathic scoliosis, brachial plexus injuries

APPROVED BY GOVERNING BODIES:

Devices used for threshold electrical stimulation are classified as “powered muscle stimulators.” As a class, the U.S. Food and Drug Administration (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.” There are currently more than 30 devices with 510(k) approval from the FDA. Marketing clearance via the 510(k) process does not require data regarding clinical efficacy.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

HCPCS Codes:

This code may also be used for other neuromuscular stimulators

REFERENCES:

1. Barkoudah E, Glader L. Cerebral palsy: Treatment of spasticity, dystonia, and associated orthopedic issues. In: UpToDate Armsby C (Ed). UpToDate, Waltham, MA.
2. Castrillo-Fraile V, Peña EC, Gabriel YGJMT, et al. Tremor Control Devices for Essential Tremor: A Systematic Literature Review. Tremor Other Hyperkinet Mov (N Y). 2019;9.
3. Dali C, Hansen FJ, Pedersen SA, et al. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial. Dev Med Child Neurol. 2002;44(6):364-9.
4. Fehlings DL, Kirsch S, McComas A, et al. Evaluation of therapeutic electrical stimulation to improve muscle strength and function in children with types II/III spinal muscular atrophy. Dev Med Child Neurol. 2002;44(11):741-4.
5. Kerr C, McDowell B, Cosgrove A, et al. Electrical stimulation in cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. 2006;48(11):870-6.
6. National Institute of Health (NIH): National Institute of Neurological Disorders and Stroke (NINDS). All Disorder Index. Available at: http://www.ninds.nih.gov/disorders/disorder_index.htm.
7. National Institute of Neurological Disorders and Stroke. Cerebral Palsy: Hope through research. Last modified Nov 2018. Available online at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope Through Research/Cerebral-Palsy-Hope-Through-Research.
8. Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation and dynamic bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol. 2006;48(7):559-63.
9. Semel-Concepcion J, et al.  Neonatal brachial plexus palsies, http://www.emedicine.com/pmr/topic215.htm
10. Steinbok P, Reiner A, Kestle JR. Therapeutic electrical stimulation following selective posterior rhizotomy in children with spastic diplegic cerebral palsy: a randomized clinical trial. Dev Med Child Neurol. 1997;39(8):515-20.
11. van der Linden ML, Hazlewood ME, Aitchison AM, et al. Electrical stimulation of gluteus maximus in children with cerebral palsy: effects on gait characteristics and muscle strength. Dev Med Child Neurol. 2003;45(6):385-90.

POLICY HISTORY:

Medical Policy Group, May 2004 (1)

Medical Policy Administration Committee, May 2004

Available for comment May 17-June 30, 2004

Medical Policy Group, April 2006 (1)

Medical Policy Group, April 2008 (1)

Medical Policy Group, April 2010 (1): No policy changes, references added

Medical Policy Panel, February 2011

Medical Policy Group, June 2011 (2): Description updated, Policy statement changed, revision of Key Points

Medical Policy Group, November 2011 (1): Update to Key Points and References; no change to policy statement

Medical Policy Group, November 2012 (1): Update to Key Points; no change to Policy statement.

Medical Policy Panel, October 2013

Medical Policy Group, January 2014 (2): No change to policy statement. Policy no longer scheduled for regular literature reviews.

Medical Policy Group, August 2019 (3): 2019 Updates to Key Points. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy. 

 Medical Policy Group, January 2021 (6): Updates to Description, Key Points and References.

Medical Policy Group, January 2022 (6): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, December 2022 (6) Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, December 2023 (6): Updates to Description, Key Points, Benefit Application, Governing Bodies, USPSTF and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.