Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds
Policy #:MA07.013d

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

MEDICALLY NECESSARY

Electrical stimulation (ES) or electromagnetic stimulation for the treatment of wounds as an adjunctive therapy is considered medically necessary and, therefore, covered when both 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

The following services are considered not medically necessary and, therefore, not covered.
  • ES and electromagnetic therapy as an initial treatment modality
  • Continued treatment with ES or electromagnetic therapy if measurable signs of healing have not been demonstrated within any 30-day period of treatment
  • Unsupervised use (home use) of ES or electromagnetic therapy

All other uses of electrical stimulation and electromagnetic stimulation are considered not medically necessary and, therefore, not covered by the Company because they are services not covered by Medicare. Therefore, they not eligible for reimbursement consideration.

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 professional provider'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.
Policy Guidelines

This policy is consistent with Medicare's coverage criteria. The Company's reimbursement methodology may differ from Medicare.

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 US 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 Evidence of Coverage, electrical stimulation (ES) or electromagnetic stimulation for the treatment of wounds is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as not covered are not eligible for coverage or reimbursement by the Company.

Description

Electrical stimulation (ES) and electromagnetic stimulation have been used or studied for many different applications, one of which is accelerating wound healing. ES for the treatment of wounds is the application of electrical current through electrodes placed directly on the skin in close proximity to the wound. Electromagnetic therapy uses a pulsed magnetic field to induce current.

Standard wound care includes optimization of nutritional status, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, and necessary treatment to resolve any infection that may be present. Standard wound care based on the specific type of wound include: frequent repositioning of an individual with pressure ulcers (usually every 2 hours), offloading of pressure and good glucose control for diabetic ulcers, establishment of adequate circulation for arterial ulcers, and the use of a compression system for individuals with venous ulcers.
References

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). http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=131&ncdver=3&DocID=270.1&bc=gAAAABAAAAAA&. Accessed May 15, 2018.

Novitas Solutions. Local Coverage Article: Microvascular Treatment Therapy (A54342). Original 06/25/2015. http://mediquant.com/policy/A54342_20150625.pdf. Accessed May 15, 2018.

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 Coding







Policy History

Revisions from MA07.013d
10/01/2019This policy has been identified for the ICD-10 CM code update, effective 10/01/2019.

The following ICD-10 CM codes have been added to Attachment A in this policy:

L89.006, L89.006, L89.016, L89.026, L89.106, L89.116, L89.126, L89.136, L89.146, L89.156, L89.206, L89.216, L89.226, L89.306, L89.316, L89.326, L89.46, L89.506, L89.516, L89.526, L89.606, L89.616, L89.626, L89.816, L89.896, L89.96

The following ICD-10 CM codes have been revised in Attachment A in this policy:

I70.238: Atherosclerosis of native arteries of right leg with ulceration of other part of lower leg
I70.248: Atherosclerosis of native arteries of left leg with ulceration of other part of lower leg

Revisions from MA07.013c
06/20/2018This policy has been reissued in accordance with the Company's annual review process.
06/07/2017This policy has been reissued in accordance with the Company's annual review process.
10/12//2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds. Policy criteria unchanged; however, Medical Coding has been revised.


Revisions from MA07.013b
01/26/2015Policy revised to communicate Company's position on Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds. Policy statement and Guidelines revised.


Revisions from MA07.013a
10/01/2015Policy revised to communicate Company's continued position on Electrical Stimulation and Electromagnetic Stimulation for the Treatment of Wounds. ICD-10 Codes added to policy.


Revisions from MA07.013
01/01/2015This is a new policy.




Version Effective Date: 10/01/2019
Version Issued Date: 10/01/2019
Version Reissued Date: N/A