Archived Policies - Medicine


Electrostimulation and Electromagnetic Therapy for the Treatment of Chronic Wounds

Number:MED201.027

Effective Date:12-01-2005

End Date:08-31-2007

Coverage:

Electrical stimulation using low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternative current (AC), or transcutaneous electrical nerve stimulation (TENS) for the treatment of wounds is considered experimental, investigational and unproven.

Electrical stimulation performed in the home setting is considered experimental, investigational and unproven.

Electromagnetic therapy for the treatment of wounds is considered experimental, investigational and unproven.

NOTE:  Diapulse® is one example of an electromagnetic therapy device; see MED201.026 for descriptions and examples of electrical stimulation devices.

Description:

The normal wound healing process involves inflammatory, proliferative, and remodeling phases. A wound that fails to progress properly and that persists for longer than one month 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 promote a moist wound environment, antibiotics to control infection, and nutritional supplementation optimization. Non-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 triphosphate (ATP) concentration in the skin,
  • Increase deoxyribonucleic acid (DNA) synthesis,
  • Attract epithelial cells and fibroblasts to wound sites,
  • Accelerate the recovery of damaged neural tissue,
  • Reduce edema,
  • Increase blood flow, and/or
  • 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 four groups based on the type of current:

  • Low-intensity direct current (LIDC),
  • High-voltage pulsed current (HVPC),
  • Alternative current (AC), and
  • Transcutaneous electrical nerve stimulation (TENS).

Electromagnetic therapy is a related but distinct form of treatment that involves the application of electromagnetic fields rather than direct electrical current. At the present time, there are no electrical stimulation or electromagnetic therapy devices that 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; however, use of these devices for wound healing is an off-label indication.

Rationale:

This policy is based on the Blue Cross Blue Shield Association (BCBSA) policy, which was initially based on a 2002 technology assessment performed by the Centers for Medicare and Medicaid Services (CMS) that serves as the basis for the national Medicare coverage policy. That technology assessment was in turn derived in part from a technology assessment conducted by ECRI (Emergency Care Research Institute, commissioned by CMS in 1996), which was then updated by CMS. In their policy development process, CMS decided to group all etiologies of chronic wounds together, and to also group all forms of electrical stimulation devices together, i.e., LIDC, HVPC, AC, and TENS. Electromagnetic therapy was considered a distinct form of therapy and was considered separately at that time.

The 2002 CMS technology assessment offered the following conclusions:

Although the clinical studies reviewed had important limitations, the large body of evidence as a whole is adequate to conclude that electrical stimulation is clinically effective for the treatment of the following chronic wound types under certain conditions after an adequate trial of standard wound therapy:

  • Chronic stage III and stage IV pressure ulcers
  • Chronic ulcers due to arterial or venous insufficiency or diabetes mellitus

There was insufficient evidence to determine the best type of device and most effective form of electrical stimulation for treatment of chronic wounds or ulcers. There appears to be no standard type, waveform or frequency of electrical stimulation. The treatments varied between studies, but involved one of four basic forms: LIDC, HVPC, AC, and TENS. Therefore, CMS cannot determine if one type of electrical stimulation is more or less clinically effective than another type.

In general, the duration of treatment varied between studies, often depending on the size of the initial ulcer and rate of healing. In the majority of clinical trials, electrical stimulation was given three times per week until the chronic ulcer healed. There was no direct evidence to determine the optimal duration or amount of electrical stimulation. However, it would be clinically rational and appropriate to discontinue treatment with electrical stimulation if the ulcer is not healing.

Consistent with previous CMS coverage decisions and the guidelines of the Agency for Health Care Policy and Research (AHCPR, which is now Agency for Healthcare Research and Quality AHRQ) on treatment of pressure ulcers, a chronic wound should demonstrate progressive healing within four weeks if the treatment being used is effective. Therefore, if progressive healing is not demonstrated after a 30-day period of treatment, electrical stimulation is unlikely to provide benefit. Progressive healing is generally demonstrated by decrease in wound size (surface area or volume), decrease in amount of exudate, and decrease in amount of necrotic tissue.

Unlike the situation with electrical stimulation, CMS did not find any new studies on the effectiveness of electromagnetic therapy since the ECRI technology assessment. In 1996, ECRI reported that there was insufficient data or no evidence on the clinical effectiveness of electromagnetic therapy. Since then, two published reviews and an assessment by the National Health Service Research and Development Health Technology Assessment Program have reiterated and concurred with the original conclusions. The lack of new research and evidence also raised questions about the clinical utility of electromagnetic therapy for the treatment of chronic wounds. Based on these reports, the evidence is adequate to conclude that electromagnetic therapy is not clinically effective.

In 2003, CMS issued an additional decision memo for electromagnetic therapy, stating that the results of studies on electromagnetic therapy were similar to those for electrical stimulation. Therefore, effective July 1, 2004, CMS expanded its coverage determination to include electromagnetic therapy for the same classes of ulcers as electrical stimulation devices.

In February 2005, BCBSA conducted a TEC Assessment on electrostimulation and electromagnetic therapy for the treatment of chronic wounds. The following summarizes the conclusions of that TEC Assessment:

  • The most clinically important outcome in evaluating treatments for wound healing is the percent of patients with wounds that heal completely following a course of treatment. Time to complete healing is another important, objective outcome measure. Secondary outcomes that have some clinical relevance are the decrease in the size of a wound, pain associated with a wound, and facilitation of surgical closure. Adverse outcomes with electrical stimulation and electromagnetic therapy are expected to be minimal, but may include discomfort and infection associated with the device.
  • The evidence is not sufficient to permit conclusions on the efficacy of electrical stimulation and electromagnetic therapy as adjunctive treatments for wound healing. For studies of wound healing, high-quality randomized controlled trials (RCTs) are essential to determining the efficacy of an intervention independent of the many confounding factors and the variable natural history of the disorder. The body of evidence for electrical stimulation and electromagnetic therapy consists of numerous small, relatively poor-quality RCTs (N=10 for electrical stimulation; N=5 for electromagnetic therapy) that compare active treatment with a placebo sham device.
  • Although results suggest that electrical stimulation and electromagnetic therapy may promote wound healing or some aspect of wound healing, considerable uncertainty remains as to whether these modalities lead to clinically significant health outcome benefits, given the relatively poor quality of the available evidence. Larger RCTs are needed that focus on one type of wound, that demonstrate baseline comparability on important confounders, and that report the outcome of complete healing.

Based on the conclusions of the February 2005 TEC Assessment, electrostimulation and electromagnetic therapy of wounds remains experimental, investigational, and unproven; it has not been established whether electrical stimulation or electromagnetic therapy improves net health outcomes as adjunctive treatment for chronic skin wounds.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

Medicare policy indicates electrostimulation and electromagnetic therapy may be covered as a treatment of stage III or stage IV pressure ulcers, arterial ulcers, diabetic ulcers, and venous stasis ulcers when a 30-day trial of initial wound management has failed and when performed in a supervised setting. Stage III and IV ulcers are defined as follows:

  • Stage III ulcer:  Full-thickness skin loss involving damage to, or necrosis of, subcutaneous tissue that may extend down to, but not through underlying fascia. The ulcer presents clinically as a deep crater with or without undermining of adjacent tissue.
  • Stage IV ulcer:  Full-thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle bone or supporting structures (e.g., tendon, joint capsule). Undermining and sinus tracts also may be associated with stage IV pressure ulcers.

According to the Medicare policy, electrical stimulation would no longer be considered medically necessary if, after a 30-day trial, there was no evidence of healing. The policy further recommends that use of electrical stimulation should be reviewed every 30 days for evidence of continued improvement.

The information contained in this section is for informational purposes only. HCSC makes no representation to its accuracy. This information is not to be used for claims adjudication for HCSC plans.

References:

Medicare Technology Assessments for Electrostimulation for Wounds (CAG-00068N). http://www.cms.hhs.gov/mcd/viewtechassess.asp?id=27 (accessed May 31, 2005)

Decision Memo for Electrostimulation of Wounds (CAG-00068R) http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=28 (accessed May 31, 2005)

Electrical Stimulation for the treatment of chronic wounds.  Technology Assessment. (1996 Apr) http://www.cms.hhs.gov/coverage/download/id27d.pdf (accessed May 31, 2005)

NCD for electrical stimulation (ES) and electromagnetic therapy for the treatment of wounds (270.1).  http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd#PE (accessed May 31, 2005)

Electrostimulation and Electromagnetic Therapy as Adjunctive Treatments for Chronic Skin Wounds. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Bulletin (April 7, 2005) 22(1): 8-11.

Policy History:

Archived Document(s):

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