Subject:
Threshold Electrical Stimulation as a Treatment of Motor Disorders
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Threshold electrical stimulation is provided by a small electrical generator, lead wires, and surface electrodes that are placed over the targeted muscles. The intensity of the stimulation is set at the sensory threshold and does not cause a muscle contraction.
Background
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 most extensively in children with spastic diplegia related to cerebral palsy but also in those with other motor disorders, such as spina bifida.
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.”
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Threshold electrical stimulation as a treatment of motor disorders, including but not limited to cerebral palsy, is not considered medically necessary.
Medicare Coverage:
Per NCD 160.2, electric nerve stimulation used to treat motor function disorders is not reasonable and necessary, and therefore, is noncovered.
For additional information, refer to National Coverage Determination (NCD) for Treatment of Motor Function Disorders with Electric Nerve Stimulation (160.2). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: The most recent literature search was performed through October 1, 2019. Following is a summary of the key literature to date.
Validation of therapeutic electrical stimulation requires randomized, controlled studies that can isolate the contribution of the electrical stimulation from other components of therapy. Physical therapy is an important component of the treatment of cerebral palsy and other motor disorders. Therefore, trials of threshold electrical stimulation ideally should include standardized regimens of physical therapy. Randomized studies using sham devices are preferred to control for any possible placebo effect.
A randomized study published in 1997 included 44 patients with spastic cerebral palsy who had undergone a selective posterior lumbosacral rhizotomy at least 1 year previously.(1) All patients had impaired motor function, but some form of upright ambulation. Patients were randomly assigned to receive either a 12-month period of 8 to 12 hours of nightly electrical stimulation or no therapy. The principal outcome measure was the change from baseline to 12 months in the Gross Motor Function Measure (GMFM), as assessed by therapists blinded to the treatment. The patients and their parents were not blinded; the authors stated that the active device produced a tingling sensation that precluded a double-blind design. Patients were encouraged to maintain whatever ongoing therapy they were participating in. The type of physical therapy in either the control or treatment group was not described.
After 1 year, the mean change in the GMFM was 5.5% in the treated group, compared to 1.9% in the control group, a statistically significant difference. The authors state that this 3.6% absolute difference is clinically significant. For example, a child who was previously only able to rise and stand while pushing on the floor, could now do so without using hands. While these results point to a modest benefit, the lack of control for associated physical therapy limits the interpretation.
Five additional studies were identified in the literature over the next 10 years, none of them demonstrating effectiveness. Dali and colleagues published the results of a trial that randomly assigned 57 children with cerebral palsy to receive either threshold electrical stimulation or a dummy device for a 12-month period.(2) Visual and subjective assessments showed a trend in favor of the treatment group, while there was no significant effect of therapeutic electrical stimulation in terms of motor function, range of motion, or muscle size. The authors concluded that therapeutic electrical stimulation was not shown to be effective in this study.
Two smaller randomized controlled studies found no improvement in muscle strength with electrical stimulation. In the van der Linden et al. study, 22 children with cerebral palsy were randomly assigned to receive 1 hour of electrical stimulation to the gluteus maximus daily over a period of 8 weeks to improve gait. No clinical or statistically significant between-group differences were found in measurements of hip extensor strength, gait analysis, passive limits of hip rotation, and section E of the GMFM.(3) Fehlings and colleagues also found no evidence of improved strength in 13 children with types II/III spinal muscular atrophy who were randomly assigned to either receive electrical stimulation or a placebo stimulator during a 12-month period.(4) A study of 24 patients with cerebral palsy demonstrated positive results for the subset that received stimulation combined with dynamic bracing; however, the effect did not last after discontinuing treatment.(5)
Kerr and colleagues randomly assigned 60 children with cerebral palsy to 1 hour daily neuromuscular stimulation (n=18), overnight threshold electrical stimulation (n=20), or overnight sham stimulation (n=22).(6) Blinded assessment following 16 weeks of treatment showed no difference among the groups, as measured by peak torque or by a therapist-scored gross motor function. A parental questionnaire on the impact of disability on the child and family showed improvement for the 2 active groups but not the sham control. Compliance in the threshold electrical stimulation group was 38%; compliance in the placebo group was not reported. Retrospective analysis indicated that the study would require 110 to 190 subjects to achieve 80% power for measures of strength and function.
A 2006 systematic review of electrical stimulation or other therapies given after botulinum toxin injection, conducted by the American Academy for Cerebral Palsy and Developmental Medicine, concluded that the available evidence is poor.(7)
Summary
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; therefore the treatment is considered not medically necessary .
Practice Guidelines and Position Statements
According to the National Institute of Neurological Disorders and Stroke, many children and adolescents with cerebral palsy use some form of complementary or alternative medicine. Controlled clinical trials involving some of the therapies have been inconclusive or showed no benefit, and the therapies have not been accepted in mainstream clinical practice. Although there are anecdotal reports of some benefit in some children with cerebral palsy, these therapies have not been approved by the U.S. Food and Drug Administration for the treatment of cerebral palsy. Such therapies include hyperbaric oxygen therapy, special clothing worn during resistance exercise training, certain forms of electrical stimulation, assisting children in completing certain motions several times a day, and specialized learning strategies.(8)]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Threshold Electrical Stimulation as a Treatment of Motor Disorders
Electrical Stimulation as a Treatment of Motor Disorders, Threshold
References:
1. Steinbok P, Reiner A, Kestle JR. Therapeutic electrical stimulation (ThresholdES) following selective posterior rhizotomy in children with spastic diplegic cerebral palsy: a randomized clinical trial. Dev Med Child Neurol 1997; 39(8):515-20.
2. 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.
3. 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.
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. Ozer K, Chesher SP, Scheker LR. Neuromuscular electrical stimulation dynamic, bracing for the management of upper-extremity spasticity in children with cerebral palsy. Dev Med Child Neurol 2006; 48(7):559-63.
6. 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.
7. Lannin N, Scheinberg A, Clark K. AACPDM systematic review of the effectiveness of therapy for children with cerebral palsy after botulinum toxin A injections. Dev Med Child Neurol 2006; 48(6):533-9.
8. The National Institute of Neurological Disorders and Stroke. Cerebral Palsy: Hope through research. Available online at: http://www.ninds.nih.gov/disorders/cerebral_palsy/detail_cerebral_palsy.htm#179393104. Last accessed September, 2011.
9. UpToDate. Management and prognosis of cerebral palsy. Literature review current through: Nov 2015. This topic last updated: Nov 30, 2015.
10. Barkoudah E, Glader L. Cerebral Palsy: Treatment of spasticity, dystonia, and assorted orthopedic issues. In UpToDate, Patterson MC, Phillips WA, Armsby C (ed) UpToDate, Waltham, MA. (Accessed September 30, 2019)
11. Barkoudah E, Glader L. Cerebral Palsy: Overview of management and prognosis. In UpToDate, Patterson MC, Armsby C (ed) UpToDate, Waltham, MA. (Accessed September 30, 2019)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
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