Latest Review Date: May 2024                                                                                                                                                                                  

Category: Durable Medical Equipment (DME)                                          

POLICY:

Neuromuscular Electrical Stimulation (NMES) may be considered medically necessary for disuse atrophy where the nerve supply to the muscle is intact, and the individual has any of the following non-neurological reasons for disuse atrophy:

• Previous casting or splinting of a limb when unable to participate in physical therapy
• Major knee surgery (e.g., total knee replacement) when there is failure to respond to physical therapy 
• Sprain of cruciate ligament of knee
• Contractures due to scarring of soft tissue (e.g. burn scarring)
• Hip replacement prior to initiation of physical therapy

Disposable NMES devices (e.g., Geko) are considered investigational.

Neuromuscular Electrical Stimulation (NMES) for all other indications, including use where the nerve supply to the muscle is not intact, as a technique to increase circulation, and injuries not meeting the above criteria are considered investigational.

A form-fitting conductive garment (E0731) may be considered medically necessary when:

• It has received permission or approval for marketing by the Food and Drug Administration;
• It has been prescribed by a physician for use in delivering covered NMES treatment; and
• One of the medical indications outlined below is met:
  • The individual cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated, and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes and lead wires; or
  • The individual has a documented medical condition such as skin problems that preclude the application of conventional electrodes, adhesive tapes and lead wires; or
  • The individual requires electrical stimulation beneath a cast to treat disuse atrophy, where the nerve supply to the muscle is intact; or
  • The individual has a medical need for rehabilitation strengthening following an injury where the nerve supply to the muscle is intact.

DESCRIPTION OF PROCEDURE OR SERVICE:

Neuromuscular electrical stimulation (NMES) is a two-channel device that transmits an electrical impulse through the skin (transcutaneous) to selected muscle groups by way of electrodes. These devices are designed for use in the home for treating muscle atrophy and stimulates the muscle when the individual is in a resting state.

NMES is used as a treatment modality for disuse atrophy due to a condition such as limb casting or hip replacement surgery, where the nerve supply to the muscle is intact. The NMES device encompasses a portable stimulator with electrodes that are placed on the skin over targeted muscle or muscle group. The current passes through the electrodes into the body, and the motor nerves are stimulated, causing a muscle contraction. The intensity and frequency of stimulation can vary based on the level of muscular function and response to treatment.

NMES differs from TENS, PENS and FES, in that NMES stimulation is directed to the motor nerves, while TENS/PENS is directed to the sensory nerves and FES is for use in neurologically impaired individuals.

KEY POINTS:

Literature reviewed performed through May 1, 2024.

SUMMARY OF EVIDENCE:

Although the evidence is limited, NMES for the treatment of disuse atrophy in individuals where the nerve supply to the muscle is intact is considered standard of care. There is some evidence that the use of NMES may be an effective rehabilitative regimen to prevent muscle atrophy associated with prolonged knee immobilization following ligament reconstruction surgery or injury; however, controlled clinical trials are necessary to determine if the addition of NMES to the rehabilitation program will improve health outcomes.

For individuals using disposable NMES devices, the evidence is limited to case studies and retrospective audits. Further investigation with high quality randomized controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American Heart Association/American Stroke Association (AHA/ASA)

In its Guidelines for Adult Stroke Rehabilitation and Recovery, the AHA/ASA state that NMES combined with therapy may improve spasticity, but there is insufficient evidence that the addition of NMES improves functional gait or hand use. The AHA/ASA guidelines are endorsed by the American Academy of Physical Medicine and Rehabilitation and the American Society of Neurorehabilitation.

American Physical Therapy Association, Orthopaedic Section

Neuromuscular electrical stimulation should be used for 6 to 8 weeks to augment muscle strengthening exercises in patients after ACL reconstruction to increase quadriceps muscle strength and enhance short-term functional outcomes.

National Institute for Health and Care Excellence

In 2014, NICE reports the following regarding the geko™ device for reducing the risk of venous thromboembolism:

6.1 The Committee was mindful of the circumstances of the patient population included in the evaluation, who are at high risk of venous thromboembolism and unable to receive either any other mechanical or pharmacological method of prophylaxis. It considered that it is plausible that the geko device would reduce the risk of venous thromboembolism in these patients, despite the lack of direct evidence from clinical studies. It also took account of the low risk of harm from the device. Taking these considerations into account, the Committee judged that the case for adoption of the geko device in this population of patients was supported.

6.2 The Committee considered that further research on the geko device in clinical settings could focus on reducing the current uncertainties about the reduction in relative risk in the defined patient population, and allow investigation into its use in broader patient populations.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Neuromuscular electrical stimulation, Empi 300 PV, NexWave, NMES, ARPNeuro RX100, Muscle atrophy, kneehab®,Geko, Geko T-3, Geko W-3, OnPulse

APPROVED BY GOVERNING BODIES:

A variety of NMES devices have been cleared by the U.S. Food and Drug Administration (FDA) and are available for home use.

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

CURRENT CODING:

HCPCS:

REFERENCES:

1. American Academy of Orthopaedic Surgeons Second Look, Exercise Benefits Total Knee Arthroplasty and NMES. J Orthop Sports Phys Ther. 2004 Jan;34(1):21-9. Neuromuscular Electrical Stimulation for Quadriceps Muscle Strengthening after Bilateral Total Knee Arthroplasty: A Case Series. Department of Physical Therapy, University of Florida.
2. Barnes R, Shahin Y, Tucker A, Chetter I, Haemodynamic augmentation in patients with peripheral arterial disease with the Geko™ transcutaneous neuromuscular electrical stimulation device, International Journal of Surgery, Volume 18, 2015, Page 239, ISSN 1743-9191, https://doi.org/10.1016/j.ijsu.2015.04.008.
3. Bistolfi A, et al. Evaluation of the effectiveness of neuromuscular electrical stimulation after total knee arthroplasty: a meta-analysis. Am J Phys Med Rehabil 2018 Feb;97(2):123-130.
4. Calbiyik M, Yılmaz S. Role of Neuromuscular Electrical Stimulation in Increasing Femoral Venous Blood Flow After Total Hip Prosthesis. Cureus. 2022;14(9):e29255. Published 2022 Sep 17. doi:10.7759/cureus.29255
5. de Oliveira Melo M, Aragão FA, Vaz MA. Neuromuscular electrical stimulation for muscle strengthening in elderly with knee osteoarthritis - a systematic review. Complement Ther Clin Pract. 2013 Feb;19(1):27-31.
6. Harris C, Duong R, Vanderheyden G, et al. Evaluation of a muscle pump-activating device for non-healing venous leg ulcers. Int Wound J. 2017;14(6):1189-1198. doi:10.1111/iwj.12784
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Kneehab XP® Conductive Garment, 510(k) Summary; accessed at accessdata.fda.gov. Maffiuletti NA, Gondin J, et al. Clinical Use of Neuromuscular Electrical Stimulation for Neuromuscular Rehabilitation: What Are We Overlooking? Arch Phys Med Rehabil, 99 (4), 806-812. Apr 2018.

9. Logerstedt, D. et al. Knee Stability and Movement Coordination Impairments: Knee Ligament Sprain Revision. Clinical Practice Guidelines Linked to the International Classification of Functioning, Disability and Health From the Orthopaedic Section of the American Physical Therapy Association2017.https://www.orthopt.org/uploads/content_files/files/Knee%20Ligament%20Sprain%20CPG%20-%202017.pdf

10. Monaghan B, Caulfield B,O’MathúnaDP. Surface neuromuscular electrical stimulation for quadriceps strengthening pre and post total knee replacement. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.:CD007177. DOI:10.1002/14651858.CD007177.

11. National Institute for Health and Care Excellence. The geko device for reducing the risk of venous thromboembolism. Medical technologies guidance. Published 2014 June 25.
12. Nussbaum, E. et al. Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Physiotherapy Canada. Volume 69 Issue 5, Special Issue 2017, pp. 1-76.
13. Stevens-Lapsley JE, Balter JE, Wolfe P, et al. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26.
14. Summers JA, Clinch J, Radhakrishnan M, Healy A, McMillan V, Morris E, Rua T, Ofuya M, Wang Y, Dimmock PW, Lewis C, Peacock JL, Keevil SF. The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance. Appl Health Econ Health Policy. 2015 Apr;13(2):135-47.
15. Talbot LA, Brede E, Metter EJ. Effects of Adding Neuromuscular Electrical Stimulation to Traditional Military Amputee Rehabilitation. Mil Med. 2017 Jan;182(1):e1528-e1535.
16. Thomas W Wainwright, Louise C Burgess and Robert G Middleton. Does Neuromuscular Electrical Stimulation Improve Recovery Following Acute Ankle Sprain? A Pilot Randomised Controlled Trial. Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders 2019, Volume 12: 1–6.
17. Walls RJ, McHugh G, O'Gorman DJ, et al. Effects of preoperative neuromuscular electrical stimulation on quadriceps strength and functional recovery in total knee arthroplasty. A pilot study. BMC Musculoskelet Disord. 2010 Jun 14;11:119.
18. Winstein CJ, Stein J, Arena R, et al. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169.
19. Zhao Y, Zhang B, Wang Y, Liu J. Effectiveness of neuromuscular electrical stimulation for enhanced recovery after total hip replacement surgery: A randomized controlled trial. Geriatr Orthop Surg Rehabil. 2022; 13:21514.

POLICY HISTORY:

Medical Policy Group, July 2020 (6): New policy, DRAFT dates extended through August 31, 2020.

Medical Policy Group, August 2021 (6): Updates to Description, Key Points, Coding and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, July 2022 (6): Updates to Key Points.

Medical Policy Group, March 2023 Quarterly Coding Update. Added HCPCS A4560 to Current Coding section.

Medical Policy Group, April 2023 (6): Updates to Policy statement to include non-coverage for disposable NMES devices. Disposable NMES previously considered investigational per MP 495 Investigational Criteria. Updates to Key Words, Benefit Application, and References. On Draft 4/1/23-5/15/23.

Medical Policy Group, May 2023 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, August 2023 (6): Updates to Description, Key Points and References.

Medical Policy Group, May 2024 (6): Updates to Key Points 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.