ELECTRICAL STIMULATION AND ELECTROMAGNETIC THERAPY FOR WOUND HEALING HS-125

Easy Choice Health Plan, Inc. Harmony Health Plan of Illinois, Inc. Missouri Care, Inc. ‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc.

WellCare Health Insurance of Illinois, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare Health Insurance of Arizona, Inc.

WellCare of Florida, Inc.

WellCare of Connecticut, Inc.

WellCare of Georgia, Inc.

WellCare of Kentucky, Inc.

WellCare of Louisiana, Inc.

WellCare of New York, Inc.

WellCare of Ohio, Inc.

WellCare of South Carolina, Inc.

Electrical Stimulation and Electromagnetic Therapy for Wound Healing Policy Number: HS-125

WellCare of Texas, Inc.

WellCare Prescription Insurance, Inc.

Windsor Health Plan

Windsor Rx Medicare Prescription Drug Plan

Original Effective Date: 8/20/2009 Revised Date(s): 8/20/2010; 8/2/2011; 8/2/2012; 8/1/2013; 8/7/2014

APPLICATION STATEMENT The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

ELECTRICAL STIMULATION AND ELECTROMAGNETIC THERAPY FOR WOUND HEALING HS-125

DISCLAIMER The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.

BACKGROUND Chronic wounds, including venous ulcers, diabetic foot ulcers, and pressure sores, are a major public health problem in the United States; the total prevalence of these wounds has been estimated to range from 3 to 6 million. Difficult-to-heal wounds lead to high rates of morbidity and mortality, negative effects on quality of life, and high healthcare costs. While leg and foot ulcers have numerous causes, such as venous disease, arterial disease, mixed venous-arterial disease, diabetic neuropathy, trauma, immobility, and vasculitis, over 90% of chronic lesions are related to venous disease, arterial disease, and neuropathy. Chronic wounds require intervention to promote 1 healing and to prevent infection, progression, and recurrence. Regardless of the cause, ulcer treatment usually begins with conservative therapies such as pressure relief, sterile dressings, and topical antibiotics. Debridement to remove necrotic tissue may also be necessary. If conservative treatments fail to promote wound healing, surgical treatments such as sclerotherapy of the affected vein, skin flap reconstruction, or amputation of a digit or foot may be necessary. A less invasive approach to management of chronic wounds involves electrical stimulation. This technique typically involves application of one electrode to the skin near the wound and application of a second electrode to saline-moistened gauze placed over the wound. The saline provides a conductive medium that allows electric current to pass directly through the wound. Although electrical stimulation for wound healing may involve electrical potentials as high as 200 volts, the parameters of stimulation such as pulse length or frequency of alternating current are adjusted such that muscle contractions do 1 not occur since contractions could cause pain or disrupt healing. Centers for Medicare and Medicaid Services Statement

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ES and electromagnetic therapy 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. CMS was asked to reconsider its national non-coverage determination for electromagnetic therapy. After thorough review, CMS determined that the results from the use of electromagnetic therapy for the treatment of wounds were similar to the results from the use of ES. Effective July 1, 2004, Medicare covered electromagnetic therapy for the same settings and conditions for which ES is covered. Medicare will allow either one covered ES therapy or one covered electromagnetic therapy for the treatment of wounds. FDA Regulations

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Electrical stimulation for wound healing is performed with devices similar to those designed to stimulate muscle contractions or to provide transcutaneous electrical nerve stimulation (TENS). These stimulators are regulated by the FDA as Class II devices, and over 500 of these devices have been approved via the FDA 510(k) process. American Physical Therapy Association (APTA) Statement

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According to the APTA, there is evidence that some forms of electrical stimulation enhance circulation and facilitate wound healing. When the Medicare Coverage Advisory Committee (MCAC) of the Health Care Financing Administration (HCFA) concluded that there was insufficient evidence that electrical stimulation improved healing of Clinical Coverage Guideline Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012, 8/1/2013, 8/7/2014

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ELECTRICAL STIMULATION AND ELECTROMAGNETIC THERAPY FOR WOUND HEALING HS-125

chronic wounds, the APTA filed a lawsuit against HCFA and obtained a reversal in the decision concerning noncoverage of this procedure. National Pressure Ulcer Advisory Panel (NPUAP)

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At a meeting of the MCAC held in October 2000, a representative of the NPUAP presented evidence concerning the efficacy of electrical stimulation for treatment of non-healing wounds. In February 2001, the Executive Committee of the MCAC gave unanimous approval for this use of electrical stimulation. A 2009 update by the NPUAP continued support of electrical stimulation for non-healing wounds. POSITION STATEMENT Applicable To: Medicaid – All Markets

Medicare – All Markets

The use of electrical stimulation (ES) and electromagnetic therapy are considered medically necessary for the treatment of the following types of chronic non-healing wounds:    

Stage III or IV pressure ulcers; OR, Arterial ulcers; OR, Diabetic ulcers; OR, Venous stasis ulcers

The use of ES and electromagnetic therapy is considered medically necessary only after 30 days of standard wound care has failed (The 30 day period may begin when the wound is acute). Standard wound care includes:        

Optimization of nutritional status Debridement by any means to remove revitalized tissue Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings Necessary treatment to resolve any infection that may be present Frequent repositioning (usually every two hours) of a member with pressure ulcers Offloading of pressure and good glucose control for diabetic ulcers Establishment of adequate circulation for arterial ulcers Use of compression system for members with venous ulcers

ES and electromagnetic therapy is considered NOT medically necessary in the following circumstances:   

As an initial treatment modality; OR, Measurable signs of healing have not been demonstrated within a 30-day period of treatment* Treatment is used in an unsupervised setting (home use) as this has not been found to be medically reasonable and necessary

*Measurable signs of improved healing include:

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A decrease in wound size (either surface area or volume) Decrease in amount of exudates Decrease in amount of necrotic tissue

NOTE: ES or electromagnetic therapy MUST BE discontinued when the wound demonstrates 100% epitheliliazed wound bed.

Clinical Coverage Guideline Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012, 8/1/2013, 8/7/2014

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ELECTRICAL STIMULATION AND ELECTROMAGNETIC THERAPY FOR WOUND HEALING HS-125

CODING Covered CPT®* Codes 97014 Application of a modality to one or more areas; electrical stimulation (unattended) 97032 Application of a modality to one or more areas; electrical stimulation (manual), each 15 minutes Covered HCPCS Level II ®*Codes E0761 Non-thermal pulsed high frequency radiowaves, high peak power electromagnetic energy treatment device E0769 Electrical stimulation or electromagnetic wound treatment device, not otherwise classified 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 G0282* Electrical stimulation, (unattended), to one or more areas, for wound care other than described in G0281 *(This Code is Non-Covered by Medicare) ICD-9-CM Procedure Codes - No applicable codes DRAFT 2013 ICD-10-PCS Codes – No applicable codes Covered ICD-9-CM Diagnosis Codes 250.70 - 250.73 Diabetes with peripheral circulatory disorders [non-healing infected deep ulcerations (reaching tendons or bone) of the lower extremity unresponsive to at least 1 month of meticulous wound care, including aggressive debridement, maximal antibiotic therapy, tight glycemic control, and appropriate treatment of arterial insufficiency, including revascularization if necessary] 250.80 - 250.83 Diabetes with other specified manifestations [non-healing infected deep ulcerations (reaching tendons or bone) of the lower extremity unresponsive to at least 1 month of meticulous wound care, including aggressive debridement, maximal antibiotic therapy, tight glycemic control, and appropriate treatment of arterial insufficiency, including revascularization if necessary] 440.23 Atherosclerosis of the extremities with ulceration Use additional code for any associated ulceration (707.10 – 707.91, 707.8 – 707.9) 440.24 Atherosclerosis of the extremities with gangrene Use additional code for any associated ulceration (707.10 – 707.91, 707.8 – 707.9) 447.8 Other specified disorders of arteries and arterioles 454.0 Varicose Stasis Ulcer with varicose veins of lower extremities 454.2 Varicose veins of lower extremities with ulcer and inflammation 459.11 Postphlebitic syndrome with ulcer 459.13 Postphlebitic syndrome with ulcer and inflammation 459.81 Venous Stasis Ulcer without varicose veins Use additional code for any associated ulceration (707.10 – 707.91, 707.8 – 707.9) 707.23 Pressure Ulcer Stages III 707.24 Pressure Ulcer Stage IV Covered Draft 2013 ICD-10-CM Diagnosis Codes E08.621 Diabetes mellitus due to underlying condition with foot ulcer Use additional code to identify site of ulcer (L97.4 – L97.5) E08.622 Diabetes mellitus due to underlying condition with other skin ulcer Use additional code to identify site of ulcer (L97.101 - L97.329, L97.801 - L97.929, L98.411 - L98.499)

E09.621 E09.622

Drug or chemical induced diabetes mellitus with foot ulcer Use additional code to identify site of ulcer (L97.4 – L97.5) Drug or chemical induced diabetes mellitus with other skin ulcer Use additional code to identify site of ulcer (L97.101 - L97.329, L97.801 - L97.929, L98.411 - L98.499)

Clinical Coverage Guideline Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012, 8/1/2013, 8/7/2014

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ELECTRICAL STIMULATION AND ELECTROMAGNETIC THERAPY FOR WOUND HEALING HS-125

E10.621 E10.622

Type 1 diabetes mellitus with foot ulcer Use additional code to identify site of ulcer (L97.4 – L97.5) Type 1 diabetes mellitus with skin ulcer

E11.51 E11.52 E11.59 E11.618 E11.620 E11.621

Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene Type 2 diabetes mellitus with other circulatory complications Type 2 diabetes mellitus with other diabetic arthropathy Type 2 diabetes mellitus with diabetic dermatitis Type 2 diabetes mellitus with foot ulcer

E11.622

Type 2 diabetes mellitus with other skin ulcer

E13.621

Other specified diabetes mellitus with foot ulcer

E13.622

Other specified diabetes mellitus with other skin ulcer

Use additional code to identify site of ulcer (L97.101 - L97.329, L97.801 - L97.929, L98.411 – L98.499)

Use additional code to identify site of ulcer on the foot (L97.401 - L97.529) Use additional code to identify site of ulcer (L97.101 - L97.329, L97.801 - L97.929, L98.411 - L98.499) Use additional code to identify site of ulcer (L97.4 – L97.5) Use additional code to identify site of ulcer (L97.101 - L97.329, L97.801 - L97.929, L98.411 – L98.499)

E11.628 Type 2 diabetes mellitus with other skin complications E11.630 Type 2 diabetes mellitus with periodontal disease E11.638 Type 2 diabetes mellitus with periodontal disease E11.649 Type 2 diabetes mellitus with hypoglycemia without coma E11.65 Type 2 diabetes mellitus with hyperglycemia E11.69 Type 2 diabetes mellitus with other specified complication I70.231 - I70.269 Atherosclerosis of native arteries of extremities; with ulceration; with gangrene I77.2 Rupture of artery; erosion, fistula, ulcer I77.3 Arterial fibromuscular dysplasia I77.89 Other specified disorders of arteries and arterioles I83-I83.229 Varicose veins I87.2 Venous insufficiency (chronic) (peripheral) L89.000 - L89.95 Pressure Ulcers L97.101 - L98.499 Non-pressure Ulcers

*Current Procedural Terminology (CPT) 2014 American Medical Association: Chicago, IL.®©

REFERENCES 1. National coverage determination for electrical stimulation (ES) and electromagnetic therapy for the treatment of wounds (270.1). Centers for Medicare and Medicaid Services Web site. http://www.cms.hhs.gov/mcd/search.asp. Published July 6, 2004. Accessed July 24, 2014. 2. APTA continuing education series: management of the individual with pain (no. 1, part 2). American Physical Therapy Association Web site. http://www.apta.org. Published 2003. Accessed July 24, 2014. 3. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel. Pressure ulcer treatment recommendations. In: Prevention and treatment of pressure ulcers: clinical practice guideline. Washington (DC): National Pressure Ulcer Advisory Panel; 2009. p. 51-120. http://guideline.gov/content.aspx?id=25139. Accessed July 24, 2014. MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS Date

Action

8/7/2014 8/1/2013 8/2/2012 12/1/2011 8/2/2011

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Approved by MPC. No changes. Approved by MPC. No changes. Approved by MPC. No changes. New template design approved by MPC. Approved by MPC. No changes.

Clinical Coverage Guideline Original Effective Date: 8/20/2009 - Revised: 8/20/2010, 8/2/2011, 8/2/2012, 8/1/2013, 8/7/2014

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