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Medical Coverage Policy Effective Date ........................................... 09/15/2021 Next Review Date ..................................... 09/15/2022 Coverage Policy Number ................................... 0160 Electrical Stimulation Therapy and Home Devices Table of Contents Related Coverage Resources Overview .............................................................. 2 Acupuncture - (CPG 024) Coverage Policy ................................................... 2 Bone Growth Stimulators: Electrical (Invasive, General Background ............................................ 4 Noninvasive), Ultrasound Medicare Coverage Determinations .................. 55 Diaphragmatic/Phrenic Nerve Stimulation Coding/Billing Information .................................. 56 Electric Stimulation for Pain, Swelling and Function in a Clinic Setting - (CPG 272) References ........................................................ 62 Extracorporeal Shock Wave Therapy (ESWT) for Musculoskeletal Conditions and Soft Tissue Wounds Gastric Pacing/Gastric Electrical Stimulation (GES) Headache and Occipital Neuralgia Treatment Injectable Bulking Agents for Urinary Conditions and Fecal Incontinence Omnibus Codes Physical Therapy – (CPG 135) Plantar Fasciitis Treatments Sacral Nerve and Tibial Nerve Stimulation for Urinary Voiding Dysfunction, Fecal Incontinence and Constipation Speech Therapy Spinal Cord and Dorsal Root Ganglion Stimulation Transcranial Magnetic Stimulation Vagus Nerve Stimulation (VNS) INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Page 1 of 84 Medical Coverage Policy: 0160 Overview This Coverage Policy addresses outpatient electrical simulation therapy (e.g., wound care therapy, auricular electroacupuncture, transcutaneous electrical modulation pain reprocessing) and the use of in-home devices, conductive garments and other related supplies for the treatment of multiple conditions. Coverage Policy Electrical Stimulation Therapies Chronic Wound Healing Electrical stimulation (HCPCS Code G0281) is considered medically necessary for the treatment of a chronic wound when ALL of the following criteria are met: • Presence of ANY of the following chronic wound types: Stage 3 or stage 4 pressure ulcer arterial ulcer neuropathic (diabetic) ulcer venous stasis ulcer • Failure to demonstrate measurable signs of improved healing (e.g., signs of epithelialization and reduction in ulcer size) with a 30-day trial of conventional wound management, including optimization of nutritional status, moist dressings and debridement. • Electrical stimulation therapy is performed under the direct supervision of a medical professional with expertise in wound evaluation and management. The use of electrical stimulation in the home setting for wound healing in the absence of direct supervision by a health care provider is considered experimental, investigational or unproven. Electrical stimulation therapy for any other chronic wound indication including but not limited to prevention of a pressure ulcer or pressure sore is considered experimental, investigational or unproven. Other Electrical Stimulation Therapies Each of the following electrical stimulation therapies is considered experimental, investigational or unproven: • auricular electroacupuncture (e.g., PStim™) (HCPCS Code S8930) • transcutaneous electrical modulation pain reprocessing (TEMPR) (e.g., Scrambler therapy, Calmare®) (CPT Code® 0278T) Home Electrical Stimulation Devices (Electrical Stimulators) Coverage for Durable Medical Equipment (DME) including in-home electrical stimulation devices varies across plans. Please refer to the customer’s benefit plan document for coverage details. If coverage for an in-home electrical stimulation device is available, the following conditions of coverage apply. Neuromuscular Electrical Stimulation (NMES) Neuromuscular electrical stimulation (NMES) (HCPCS Code E0745) and related supplies (HCPCS Code A4595) are considered medically necessary when used as one component of a comprehensive rehabilitation program for the treatment of disuse atrophy when the nerve supply to the atrophied muscle is intact. Page 2 of 84 Medical Coverage Policy: 0160 Neuromuscular electrical stimulation (NMES) and related supplies (HCPCS Code A4595) for ANY other indication (e.g., idiopathic scoliosis [HCPCS Code E0744], heart failure) are considered experimental, investigational or unproven. Transcutaneous Electrical Nerve Stimulation (TENS) A transcutaneous electrical nerve stimulator (TENS) (HCPCS Code E0720, E0730) and related supplies (HCPCS Code A4595) are considered medically necessary for in-home use as an adjunct to conventional post-operative pain management within 30 days of surgery. TENS (HCPCS Code E0720, E0730, K1016) and related supplies (HCPCS Code A4595, K1017) for ANY other indication, including a device for the treatment of migraine headaches (e.g., Cefaly), are considered experimental, investigational or unproven. Conductive Garment A conductive garment (HCPCS Code E0731) is considered medically necessary when used in conjunction with a medically necessary in-home NMES or TENS device for ANY of the following clinical situations: • The use of conventional electrodes, tapes or lead wires is not feasible either because the individual has a large area requiring treatment or a large number of sites requiring stimulation. • The site(s) requiring stimulation (i.e., back) is/are difficult to reach with conventional electrodes, tapes or lead wires. • A co-existing medical condition (e.g., skin problems) precludes the use of conventional electrodes, tapes, or lead wires. A conductive garment for any other in-home indication is considered not medically necessary. Other Electrical Stimulation Therapies In-home use of ANY of the following electrical stimulation devices is considered experimental, investigational, or unproven for the treatment of any condition: • bioelectric nerve block (electroceutical therapy) (HCPCS Code E1399) • combination therapy (e.g., Neufit Neubie, Flex-MT+) (HCPCS code E1399) • cranial electrical stimulation (cranial electrotherapy stimulation) (HCPCS Code K1002) • electrical sympathetic stimulation therapy (HCPCS Code E1399) • electrotherapeutic point stimulation (ETPSSM) (HCPCS Code E1399) • functional electrical stimulation (FES) (HCPCS Codes E0764, E0770) • H-WAVE electrical stimulation (HCPCS Code E1399) • high-voltage galvanic stimulation (HVG) (HCPCS Code E1399) • interferential therapy (IFT) (HCPCS Codes S8130, S8131) • microcurrent electrical nerve stimulation (MENS), including frequency-specific microcurrent (FSM) stimulation (HCPCS Code E1399) • pelvic floor electrical stimulation (PFES) (HCPCS Code E0740) • percutaneous electrical nerve stimulation (PENS) (HCPCS Code K1018, K1019) • percutaneous neuromodulation therapy (PNT) (HCPCS Code E1399) • percutaneous nerve field stimulation (PNFS) (e.g., NSS-2 Bridge, IB-Stim) (CPT Code 64999) • threshold/therapeutic electrical stimulation (TES) (HCPCS Code E1399) • transcutaneous electrical acupoint stimulation (TEAS) (HCPCS Code E0765) • transcutaneous electrical joint stimulation (HCPCS Code E0762) Note: For electrical stimulation therapies in the outpatient setting please refer to the Cigna/American Specialty Health (ASH) Coverage Policy “Electric Stimulation for Pain, Swelling and Function in a Clinical Setting”. Page 3 of 84 Medical Coverage Policy: 0160 General Background Electrical stimulation (ES) therapy involves the application of electrodes to affected areas of the body for the purpose of delivering electrical current.
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