Latest Review Date: February 2024

Category:  Medical                                                  

POLICY:

Electrical stimulation for the treatment of wounds, including but not limited to low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS), is considered investigational.

Electrical stimulation performed by the individual in the home setting for the treatment of wounds is considered investigational.

Electromagnetic therapy for the treatment of wounds is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Electrostimulation (electrical stimulation) refers to the application of electrical current through electrodes placed directly on the skin. Electromagnetic therapy involves the application of electromagnetic fields, rather than direct electrical current. Both are proposed as treatments for wounds, generally chronic wounds.

Standard Treatment

Conventional or standard therapy for chronic wounds involves local wound care, as well as systemic measures including debridement of necrotic tissues, wound cleansing, and dressing that promotes a moist wound environment, antibiotics to control infection, and optimizing nutritional supplementation.  Avoidance of weight bearing is another important component of wound management.

Electrical Stimulation

Since the 1950s, investigators have used electrostimulation as a technique to promote wound healing, based on the theory that electrical stimulation may:

• Increase adenosine 5’-triphosphate (ATP) concentration in the skin
• Increase DNA synthesis
• Attract epithelial cells and fibroblasts to wound sites
• Accelerate the recovery of damaged neural tissue
• Reduce edema
• Increase blood flow
• Inhibit pathogenesis

Electrical stimulation refers to the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. The types of electrical stimulation and devices can be categorized into groups based on the type of current. This includes low-intensity direct current, high-voltage pulsed current, alternating current, and transcutaneous electrical nerve stimulation. 

Electromagnetic Therapy

Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields, rather than direct electrical current.

KEY POINTS:

The most recent literature review was updated through November 22, 2023.

Summary of Evidence

For individuals who have any wound type (acute or nonhealing) who receive electrostimulation, the evidence includes systematic reviews and randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. Systematic reviews of RCTs on electrical stimulation have reported improvements in some outcomes, mainly intermediate outcomes such as a decrease in wound size and/or the speed of wound healing. There are few analyses of the more important clinical outcomes of complete healing and the time to complete healing, and many of the trials are relatively low quality. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have any wound type (acute or nonhealing) who receive electromagnetic therapy, the evidence includes 2 systematic reviews of RCTs (1 on pressure ulcers and the other on leg ulcers) and an RCT of electromagnetic treatment following Cesarean section. Relevant outcomes are symptoms, change in health status, morbid events, quality of life, and treatment-related morbidity. The systematic reviews identified a few RCTs with small sample sizes that do not permit drawing definitive conclusions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Physicians

In 2015, the American College of Physicians published guidelines on the treatment of pressure ulcers. The guidelines recommended that electrostimulation be used as adjunctive treatment in individuals with pressure ulcers. This was considered by the College to be a weak recommendation, based on moderate-quality evidence. This guideline is listed as "inactive" on the ACP website.

Association for the Advancement of Wound Care

In 2014, the Association for the Advancement of Wound Care (AAWC) published guidelines on the care of venous ulcers and pressure ulcers. Guidelines for venous ulcer care included electrostimulation and electromagnetic stimulation as treatment modalities. Guidelines for pressure ulcer care include electrostimulation as adjunctive interventions when pressure ulcers do not respond to the first-line of treatment.

Previously, the AAWC (2010) published guidelines on the care of pressure ulcers. Electrostimulation was included as a potential second-line intervention if first-line treatments did not result in wound healing.

Wound, Ostomy and Continence Nurses Society

In 2016, the Wound, Ostomy and Continence Nurses Society published guidelines on prevention and management of pressure ulcers. The guidelines stated that electrostimulation can be considered as adjunctive treatment and rated the evidence as level A.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Electrical stimulation, electromagnetic therapy, chronic wounds, low intensity direct current (LIDC), high voltage pulsed current (HVPC), alternative current (AC), transcutaneous electrical nerve stimulation (TENS), pressure ulcers, venous ulcers, arterial ulcers, and diabetic ulcers

APPROVED BY GOVERNING BODIES:

No electrical stimulation or electromagnetic therapy devices have received approval from the U.S. Food and Drug Administration (FDA), specifically for the treatment of wound healing. A number of devices have been cleared for marketing for other indications. Use of these devices for wound healing is an off-label indication.

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

CURRENT CODING: 

CPT codes:

HCPCS code:

REFERENCES:

1. American College of Physicians (ACP).Inactive ACP guidelines. www.acponline.org/clinical-information/guidelines/inactive-acp-guidelines.
2. Arora M, Harvey LA, Glinsky JV, et al. Electrical stimulation for treating pressure ulcers. Cochrane Database Syst Rev. Jan 22 2020; 1: CD012196.
3. Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Malvern, PA. www.guideline.gov.
4. Aziz Z, Cullum N. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. Jul 2 2015; 7:CD002933.
5. Barnes R, Shahin Y, Gohil R, et al. Electrical stimulation vs. standard care for chronic ulcer healing: a systematic review and meta-analysis of randomized controlled trials. Eur J Clin Invest. Apr 2014; 44(4):429-440.
6. Bolton LL, Girolami S, Corbett L, et al. The Association for the Advancement of Wound Care (AAWC) venous and pressure ulcer guidelines. Ostomy Wound Manage. Nov 2014; 60(11):24-66.
7. Franek A, Kostur R, Polak A et al. Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled clinical study. Ostomy Wound Manage 2012; 58(3): 30-44.
8. Game FL, Hinchliffe RJ, Apelqvist J et al. A systematic review of interventions to enhance the healing of chronic ulcers of the foot in diabetes. Diabetes Metab Res Rev 2012; 28 Suppl 1:119-141.
9. Girgis B, Duarte JA. High Voltage Monophasic Pulsed Current (HVMPC) for stage II-IV pressure ulcer healing. A systematic review and meta-analysis. J Tissue Viability, 2018 Sep 5;27(4).
10. Houghton PE, Campbell KE, Fraser CH, et al. Electrical stimulation therapy increases rate of healing of pressure ulcers in community-dwelling people with spinal cord injury. Arch Phys Med Rehabil. 2010 May; 91(5):669-678.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Kawasaki L, Mushahwar VK, Ho C, et al. The mechanisms and evidence of efficacy of electrical stimulation for healing of pressure ulcer: a systematic review. Wound Repair Regen. Mar-Apr 2014; 22(2):161-173.
13. Khooshideh M, Latifi Rostami SS, Sheikh M, et al. Pulsed electromagnetic fields for postsurgical pain management in women undergoing cesarean section: a randomized, double-blind, placebo-controlled trial. Clin J Pain. Feb 2017;33(2):142-147.
14. Khouri C, Kotzki S, Roustit M, et al. Hierarchical evaluation of electrical stimulation protocols for chronic wound healing: An effect size meta-analysis. Wound Repair Regen. Oct 20 2017.
15. Lala D, Spaulding SJ, Burke SM, et al. Electrical stimulation therapy for the treatment of pressure ulcers in individuals with spinal cord injury: a systematic review and meta-analysis. Int Wound J. Dec 2016;13(6):1214-1226.
16. Liu LQ, Moody J, Traynor M, et al. A systematic review of electrical stimulation for pressure ulcer prevention and treatment in people with spinal cord injuries. J Spinal Cord Med. Nov 2014;37(6):703-718.
17. Polak A, Kloth LC, Blaszczak E, et al. The Efficacy of Pressure Ulcer Treatment With Cathodal and Cathodal-Anodal High-Voltage Monophasic Pulsed Current: A Prospective, Randomized, Controlled Clinical Trial. Phys Ther. Aug 1 2017;97(8):777-789.
18. Qaseem A, Humphrey LL, Forciea MA, et al. Treatment of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. Mar 3 2015; 162(5):370-379.
19. Thakral G, La Fontaine J, Kim P, et al. Treatment options for venous leg ulcers: effectiveness of vascular surgery, bioengineered tissue, and electrical stimulation. Adv Skin Wound Care. Apr 2015; 28(4):164-172.
20. Todd, et al. Treatment of chronic varicose ulcers with pulsed electromagnetic fields: a controlled pilot study: www.curatronic.com/scientific6.html. (Abstract)
21. Wound Ostomy and Continence Nurses Society (WOCN). 2016 Guideline for Prevention and Management of Pressure Injuries (Ulcers). An Executive Summary. J Wound Ostomy Continence Nurs. 2017 May/Jun; 44(3): 241-246.
22. Zheng Y, Du X, Yin L, et al. Effect of electrical stimulation on patients with diabetes-related ulcers: a systematic review and meta-analysis. BMC Endocr Disord. Apr 27 2022; 22(1): 112. 

POLICY HISTORY:

Medical Policy Group, October 2003 (1)

Medical Policy Administration Committee, October 2003

Available for comment November 3-December 17, 2003

Medical Policy Group, October 2005 (1)

Medical Policy Group, October 2007 (1)

Medical Policy Group, June 2008 (1)

Medical Policy Group, June 2010 (1): No policy changes

Medical Policy Group, October 2010 (1): No policy changes, Key Points updated.

Medical Policy Group, November 2010 No policy changes, References updated.

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

Medical Policy Group, January 2013 (1): 2012 Update to Key Points and References; no change to policy statement

Medical Policy Panel, October 2013

Medical Policy Group, October 2013 (1): Update to Description, Policy, Key Points and References with change in coverage criteria related to electrical stimulation for wounds, now considered investigational, effective 01/01/2014; electromagnetic stimulation remains investigational

Medical Policy Administration Committee, November 2013

Available for comment November 8 through December 22, 2013

Medical Policy Panel, September 2014

Medical Policy Group, September 2014 (1) Update to Key Points and References; no change to policy statement.

Medical Policy Panel, September 2015

Medical Policy Group, October 2015 (2): 2015 Updates to Description, Key Points, Benefit Application, Current Coding, and References, no change to policy statement.

Medical Policy Panel, January 2016

Medical Policy Group (2): 2016 Updates to Key Points; no change to policy statement.

Medical Policy Panel, September 2017

Medical Policy Group, September 2017 (7): Updates to Key Points, Practice Guidelines, and References; deleted policy statement prior to 2014, no change in intent.

Medical Policy Panel, January 2018

Medical Policy Group, January 2018 (7): Updates to Description, Key Points, Practice Guidelines and References. No change in Policy Statement.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (5): Updates to Description, Key Points, and References. Title changed from "Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds" to "Electrostimulation and Electromagnetic Therapy for Treating Wounds." No change in Policy Statement.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (5): Updates to Key Points and References. No change to Policy Statement.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to remove “not medically necessary,” no change in policy intent.

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (5): Updates to Key Points and References. Policy statement updated to replace the word “patient” with the word “individual.” No change to policy intent.

Medical Policy Panel, January 2024

Medical Policy Group, February 2024 (9): Updates to Key Points, Benefit Application and References. No change to policy intent.

Medical Policy Group, March 2024 (5): CPT code 97032 removed from Current Coding section as it is not applicable to this medical policy. Update to Benefit Application. No change to Policy Statement.

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.