Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds

Policy #:07.07.07f

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

Electrical stimulation or electromagnetic stimulation for the treatment of wounds as an adjunctive therapy is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • There are no measurable signs of wound healing after at least 30 days of treatment with standard wound care (as discussed in the Description above).
  • The wounds being treated are Chronic Stage III and/or Stage IV and are any of the following:
    • Pressure ulcers
    • Arterial insufficiency ulcers
    • Diabetic ulcers
    • Venous stasis ulcers
  • The electrical stimulation or electromagnetic stimulation therapy being used is in addition to standard wound care, such as dressings, enzymes, topical agents, irrigation, debridement, soaks, antibiotics, and pressure relief.
    Note: Both electrical and electromagnetic stimulation cannot be used simultaneously.

NOT MEDICALLY NECESSARY

All other uses of electrical stimulation and electromagnetic stimulation are considered not medically necessary and, therefore, not covered. These not medically necessary uses of electrical stimulation and electromagnetic stimulation include, but are not limited to:
  • Electrical stimulation and electromagnetic therapy as an initial treatment modality.
  • Continued treatment with electromagnetic stimulation or electromagnetic therapy if measurable signs of healing have not been demonstrated within any 30-day period of treatment. (Measurable signs of healing include a decrease in wound size or depth and/or an increase in the size of the epithelialized area of the wound base).
  • Continued treatment of the wound when it demonstrates a 100 percent epithelialized wound bed after usage of electrical stimulation and electromagnetic stimulation.
  • Unsupervised use (e.g., home use) of electrical stimulation or electromagnetic therapy.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the health care professional's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are multiple FDA-approved devices used in wound stimulation therapy, but none of these devices have been specifically approved by the FDA for this indication. Therefore, electrical and electromagnetic stimulation for the treatment of wounds is considered an off-label use for these devices.

The U.S Patent Office has assigned patent pending status to MicroVas; there is no US Food and Drug Administration (FDA) approval of MicroVas. There was FDA approval for Bio-Stym 250, Microvas Technologies, Inc; the trade name of this device is EchoPulse Muscle Stimulator System, which is not the MicoVas radiofrequency stimulation device. The Bio-Stym 250, Microvas Technologies, Inc., is noted as a muscle stimulator for the relaxation of muscle spasms.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, electrical stimulation and electromagnetic stimulation for the treatment of wounds are covered under the medical benefits of the Company’s products when medical necessity criteria listed in the medical policy are met.

Description

The typical wound healing process involves three stages:
  • Inflammatory phase: This stage occurs during the first two days. The wounded area attempts to restore homeostasis by constricting blood vessels to control bleeding. Platelets and thromboplastin form a clot. Inflammation (redness, heat, and swelling) also occurs and is a visible indicator of the immune response.
  • Proliferative phase: This stage lasts about three weeks (or longer, depending on the severity of the wound). Granulation occurs and new blood vessels form. The wound gradually contracts and is covered by a layer of skin (scar tissue).
  • Remodeling phase: This stage may last up to two years. New collagen forms, changing the shape of the wound and increasing the strength of the tissue in the area.

When the healing process fails to progress properly and the wound persists for longer than 30 days, the wound is described as a chronic wound. Chronic wounds (lesions that have not healed within 30 days) usually heal with standard wound therapies, including debridement to remove necrotic tissue, cleansing, and the application of dressings that promote a moist wound environment. A chronic wound should demonstrate progressive healing within four weeks if the treatment being used is effective.

Wounds are staged according to their severity as follows:
  • Stage I: Nonblanchable erythema of intact skin, the heralding lesion of skin ulceration. In individuals with darker skin, discoloration of the skin, warmth, edema, induration, or hardness may also be indicators.
  • Stage II: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion, blister, or shallow crater.
  • Stage III: 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: Full-thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures (eg, tendon, joint capsule). Undermining and sinus tracts also may be associated with Stage IV pressure ulcers.

Electrical stimulation and electromagnetic stimulation are suggested as adjunctive therapies for Stage III and IV wounds that do not respond to standard wound therapies.

ELECTRICAL STIMULATION

Electrical stimulation is a wound care method that uses electrodes placed directly on the skin in close proximity to the wound as an adjunct to standard wound therapies such as dressings, enzymes, topical agents, irrigation, debridement, soaks, antibiotics, and pressure relief. Electrical stimulation devices are grouped into four categories based on the type of current used: low-intensity direct current (LIDC), high-voltage pulsed current (HVPC), alternating current (AC), and transcutaneous electrical nerve stimulation (TENS). These devices may be used three to seven times per week, for 45 to 60 minutes per session, as an adjunct to standard wound care therapy.

The physiologic principles for using electrical stimulation for the treatment of wounds include that it can, hypothetically, increase adenosine triphosphate concentrations in tissues, increase DNA synthesis, attract epithelial cells and fibroblasts to wound sites, accelerate the recovery of damaged neural tissue, reduce edema, increase blood flow, and inhibit pathogenesis. There are few randomized, controlled studies, but those that have been conducted show benefits from electrical stimulation. Electrical stimulation may benefit unresponsive Stage III and Stage IV chronic wounds.

ELECTROMAGNETIC STIMULATION

Electromagnetic stimulation is a wound care method that uses a nonthermal electromagnetic device (eg, Diapulse Wound Treatment System™ [Diapulse Corp. of America, Great Neck, NY]) to produce a nonthermal electromagnetic field to accelerate wound healing. The electromagnetic energy is transferred to the wound via a transducer that contains copper coils. Placed over the area of the wound, it penetrates dressings and clothing and does not require direct contact with the wound. It may be applied daily for 15 to 45 minutes, or more. It is used as an adjunct to standard wound care therapy.

Electromagnetic therapy uses a pulsed magnetic field to induce an electric current. The same type of device can be used with a continuous magnetic field; in this mode, called diathermy, the currents heat the tissue significantly. When used in the pulsed mode, currents are produced for a shorter amount of time and, therefore, result in minimal heating effects. Electromagnetic fields vary in frequency and strength. The highest frequency radiation, gamma and x-rays, have been used for diagnostic imaging. Unfortunately, they may also damage human tissue because of their ionizing properties. In the middle of the electromagnetic spectrum are ultraviolet and infrared light. The low end of the frequency range includes microwaves and radiowaves, which are uncommon but still used in some electromagnetic therapy devices.

The Federal Communication Commission (FCC) assigned a standard shortwave frequency of 27.12 MHz to medical carriers to prevent them from interfering with public communication. At a frequency of 27.12 MHz and a pulse duration of 65 microseconds (as with the Diapulse), a pulse would contain 1762.8 oscillations per second. The physiological mechanisms purported to support the clinical effects of electromagnetic therapy are not clear and remain theoretical. It has been suggested that these devices may alter or augment pre-existing endogenous electrical fields and may trigger specific, measurable cellular responses such as DNA synthesis, transcription, and protein synthesis. Studies have proposed benefits from electromagnetic stimulation for only certain types of wounds for which electrical stimulation may also be beneficial (i.e., certain types of unresponsive Stage III and Stage IV chronic wounds).

Electrical stimulation and electromagnetic stimulation for wounds are adjunctive therapies, not a substitute for standard wound therapy, such as wound cleansing, dressing changes, debridement, regular examination by health care professionals, and treatment of infections identified during examinations. The types of wounds most frequently addressed in studies evaluating the safety and effectiveness of electrical stimulation and electromagnetic stimulation are pressure ulcers, venous stasis ulcers, arterial insufficiency ulcers, and diabetic ulcers. There is a paucity of studies on electrical stimulation and electromagnetic stimulation usage for the treatment of wounds in the home setting.

Several electrical stimulator devices have been approved by the US Food and Drug Administration (FDA) for bone, deep brain, muscle, and nerve stimulation .The FDA has cleared electromagnetic devices for other uses, excluding the application of therapeutic deep heat. No electrical or electromagnetic device has been approved specifically for wound healing; therefore, this is considered an off-label use.
References


Centers for Medicare & Medicaid Services (CMS). Medicare Decision Memo for Electrical Stimulation for Wounds.[CMS Web site.] 12/17/2003. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=28&fromdb=true. Accessed May 16, 2018.

Centers for Medicare & Medicaid Services (CMS). Medicare National Coverage Determinations Manual. Chapter 1 - Coverage Determinations. 270.1: National Coverage Determination (NCD) Electrical Stimulation and Electromagnetic Therapy for the Treatment of Wounds. [CMS Web site.] Original: 07/01/04. (Revised: 03/19/04). Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=131&ncdver=3&DocID=270.1&bc=gAAAABAAAAAA&. Accessed May 15, 2018.

Diapulse Corporation of America. The New Proprietary Technology in Wound Care. [The Diapulse Wound Treatment System™ Web site.] 2000. Available at: http://www.diapulse.com/. Accessed May 15, 2018.

Panel on the Prediction and Prevention of Pressure Ulcers in Adults. Pressure ulcers in adults: prediction and prevention. Agency for Health Care Policy and Research. Clin Pract Guidel Ref Guide Clin. 1992;(3):1-15.

US Food and Drug Administration (FDA). 510K Summary. MicroVas. May 5, 2003. K023230. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/k023230.pdf. Accessed May 15, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

MEDICALLY NECESSARY


G0281 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

G0329 Electromagnetic therapy, to one or more areas for chronic Stage III and Stage IV pressure ulcers, arterial ulcers, diabetic and venous stasis ulcers not demonstrating measurable signs of healing after 30 days of conventional care as part of a therapy plan of care

NOT MEDICALLY NECESSARY

G0282 Electrical stimulation, (unattended), to one or more areas, for wound care other than described in G0281

G0295 Electromagnetic stimulation, to one or more areas, for wound care other than described in G0329 or for other uses




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Attachment A: Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds
Description: ICD-10 Codes




Policy History

Revisions from Policy 07.07.07f
06/20/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds.


Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 10/12/2016
Version Issued Date: 10/12/2016
Version Reissued Date: 06/20/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.