mp-143 - Medical Policies - Florida
Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds
Policy Number: MP-143
Latest Review Date: February 2019
Policy Grade: A
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 not medically necessary and investigational.
Electrical stimulation performed by the patient in the home setting for the treatment of wounds is considered not medically necessary and investigational.
Electromagnetic therapy for the treatment of wounds is considered not medically necessary and 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.
The normal wound healing process involves inflammatory, proliferative, and remodeling phases. When the healing process fails to progress properly and the wound persists for longer than one month, it may be described as a chronic wound. The types of chronic wounds most frequently addressed in studies of electrical stimulation for wound healing are pressure ulcers, venous ulcers, arterial ulcers, and diabetic ulcers.
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.
Since the 1950s, investigators have used electrical stimulation 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 is a related but distinct form of treatment that involves the application of electromagnetic fields rather than direct electrical current.
Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields, rather than direct electrical current.
The most recent literature review was updated through November 16, 2018.
Summary of Evidence
For individuals who have any wound type (acute or nonhealing) who receive electrostimulation, the evidence includes systematic reviews, randomized controlled trials (RCTs), and observational studies. 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 decrease in wound size and/or the velocity of wound healing. There are few analyses on the more important clinical outcomes of complete healing and the time to complete healing, and many of the trials are of relatively low quality. The evidence is insufficient to determine the effects of the technology on health outcomes.
For individuals who have any wound type (acute or nonhealing) who receive electromagnetic therapy, the evidence includes 2 systematic reviews of RCTs (one 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 definitive conclusions. The evidence is insufficient to determine the effects of the technology on health outcomes.
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 the electrostimulation be used as adjunctive treatment in patients with pressure ulcers. This was considered by the College to be a weak recommendation, based on moderate-quality evidence.
Association for the Advancement of Wound Care
In 2014, the Association for the Advancement of Wound Care 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, in 2010, the Association 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 electrical stimulation can be considered as adjunctive treatment and rated the evidence as level A.
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
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.
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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes
Non-thermal pulsed high-frequency radiowaves, high peak power electromagnetic energy treatment device
Electrical stimulation or electromagnetic wound treatment device, not otherwise classified
Electrical stimulation, (unattended), to one or more areas, for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care, as part of a therapy plan of care
Electrical stimulation, (unattended), to one or more areas, for wound care other than described in G0281
Electromagnetic stimulation, to one or more areas, for wound care other than described in G0329 or for other uses
Electromagnetic therapy, to one or more areas for chronic stage III or stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care as part of a therapy plan of care.
- Adunsky A and Ohry A. Decubitus direct current treatment (DDCT) of pressure ulcers: Results of a randomized double-blinded placebo controlled study. Arch Gerontol Geriatr, November-December 2005; 41(3): 261-269.
- Altur S, Batzler A, Bernato DL, et al. Summary algorithm for venous ulcer care with annotations of available evidence. Association for the Advancement of Wound Care guideline recommendation (2005).
- Association for the Advancement of Wound Care (AAWC). Association for the Advancement of Wound Care guideline of pressure ulcer guidelines. Malvern, PA. Available online at: www.guideline.gov.
- Aziz Z, Cullum N. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev. Jul 2 2015; 7:CD002933.
- Aziz Z, Cullum NA, Flemming K. Electromagnetic therapy for treating venous leg ulcers. Cochrane Database Syst Rev 2013; (3):CD002933.
- Aziz Z, Flemming K, Cullum NA et al. Electromagnetic therapy for treating pressure ulcers. Cochrane Database Syst Rev 2012; (11):CD002930.
- 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.
- Benazzo F, Zanon G, Pederzini L, et al. Effects of biophysical stimulation in patients undergoing arthroscopic reconstruction of anterior cruciate ligament: Prospective, randomized and double blind study. Knee Surg Sports Traumatol Arthrosc, June 2008; 16(6): 595-601.
- Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Electrical stimulation or electromagnetic therapy as adjunctive treatments for chronic skin wounds. TEC Assessments 2005; Volume 20, Tab 2.
- 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.
- Callaghan MJ, Chang EI, Seiser N, et al. Pulsed electromagnetic fields accelerate normal and diabetic wound healing by increasing endogenous FGF-2 release. Plast Reconstr Surg, January 2008; 121(1): 130-141.
- Centers for Medicare & Medicaid Services (CMS). Decision Memo for Electrostimulation for Wounds (CAG-00068R). 2003; https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=28&fromdb=true. Accessed August 30, 2017.
- Cukjati, D, et al. Prognostic factors in the prediction of chronic wound healing by electrical stimulation, Medical and Biological Engineering and Computing, Sept 2001; 39(5): 542-50. (Abstract)
- Cullum, N, et al. Systematic reviews of wound care management: (5) beds; (6) compression; (7) laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy, Health Technology Assessment, January 2001, 5(9): 1-221. (Abstract)
- Fine, N, et al. Wound healing, Surgery, 3rd edition, 2001, pp. 69-85.
- Fitzgerald, GK, et al. Treatment of a large infected thoracic spine wound using high voltage pulsed monophasic current, Physical Therapy, Vol. 73, No. 6, June 1993.
- Flemming, K, et al. Electromagnetic therapy for the treatment of pressure sores, Cochrane Database of Systematic Reviews, January 2001. (Abstract)
- Flemming, K. Electromagnetic therapy for the treatment of venous leg ulcers, Cochrane Database of systematic Reviews, January 2001. (Abstract)
- 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.
- 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.
- Gardner, et al. Effect of electrical stimulation on chronic wound healing; a meta-analysis, Wound Repair and Regeneration, 1999; 7(6): 495-503. (Abstract)
- Griffin, et al. Efficacy of high voltage pulsed current for healing of pressure ulcers in patients with spinal cord injury, Physical therapy, Vol. 71, No. 6, June 1991.
- Gupta A. Efficacy of pulsed electromagnetic field therapy in healing of pressure ulcers: a randomized control trial. Neurology India 2009; 57(5):622-626.
- Health Technology Assessment 2001, Vol. 5, No. 9, research.familymed.ubc.ca/files/2012/03/HTA_questionnaires7810.pdf.
- 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.
- Houghton, et al. Effect of electrical stimulation on chronic leg ulcer size and appearance, Physical Therapy. January 2003; 83(1): 17-28.
- 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.
- 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.
- 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.
- Kloth, et al. Acceleration of wound healing with high voltage, monophasic, pulsed current. Physical Therapy, April 1988, Vol. 68, No. 4.
- 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.
- Lawson D and Petrofsky JS. A randomized control study on the effect of biphasic electrical stimulation in a warm room on skin blood flow and healing rates in chronic wounds of patients with and without diabetes. Med Sci Monit 2007; 13(6): 258-263. (Abstract)
- 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.
- McLean, S, et al. Wound healing and care. The Washington Manual of Surgery, 3rd edition, 2002, pp. 164-183.
- Medicare Technology Assessments for Electrostimulation for Wounds (CAG-00068N). //www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=13&NCAId=27&NcaName=Electrostimulation+for+Wounds&IsPopup=y&bc=AAAAAAAACAAAAA%3d%3d&.
- Mulder, G. Treatment of open-skin wounds with electric stimulation. Archives Physical Medicine Rehabilitation, May 1991, Vol. 72, pp. 375-377.
- 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.
- 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.
- Sumano, et al. The use of acupuncture-like electrical stimulation for wound healing of lesions unresponsive to conventional treatment, American Journal Acupuncture, 1999; 27: 5-14. (Abstract)
- Sussman, C and Byl, N. Electrical Stimulation for Wound Healing. Wound Care, Chapter 16, Collaborative Practice Manual for Physical Therapists and Nurses. Sussman, C. and Bates-Jensen, BM, Aspen Publishers 1998: www.medicaledu.com/estim.htm.
- 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.
- Todd, et al. Treatment of chronic varicose ulcers with pulsed electromagnetic fields: a controlled pilot study: www.curatronic.com/scientific6.html. (Abstract)
- Wainapel, S, et al. Electrotherapy for acceleration of wound healing: Low intensity direct current. Archives Physical Medicine Rehabilitation, July 1985, Vol. 66.
- Wound, Ostomy and Continence Nurses Society (WOCN). Guideline for prevention and management of pressure ulcers. 2016; https://www.guideline.gov/summaries/summary/50473. Accessed January 3, 2018.
- Zorzi C, Dall’Oca C, Cadossi R and Setti S. Effects of Pulsed electromagnetic fields on patients’ recovery after arthroscopic surgery: prospective, randomized and double-blind study. Knee Surg Sports Traumatol Arthrosc, July 2007; 15(7): 830-834.
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.
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.