ELECTRICAL STIMULATION

Transcription

1 ELECTRICAL STIMULATION Coverage for services, procedures, medical devices drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. The section identified as Description defines or describes a service, procedure, medical device or drug is in no way intended as a statement of medical necessity /or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food Drug Administration (FDA) may not be considered experimental or investigational thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" "investigational" are considered to be interchangeable. Description: Transcutaneous Electrical Neuromuscular Stimulation (TENS): Applies pulsed electrical stimulation through the surface of the skin to the peripheral nerves. It stimulates sensory nerves to alter or mask the perception of localized pain. Consists of an electrical pulse generator, usually battery operated, connected by wire(s) to two or four electrodes which are applied to the surface of the skin at the site of the pain. The sensation is topical no muscle contraction is produced. The use of a 2-lead, versus 4-lead TENS is dependent upon the area of the body under consideration, e.g., greater number of leads for a larger area to be treated entire back, lower extremities, etc. The Alpha Stim 100 microcurrent electrical stimulator is considered a TENS unit. Combination NMES/TENS unit: A single device which provides both neuromuscular electrical stimulation (NMES) to strengthen muscles transcutaneous electrical nerve stimulation (TENS) to manage pain. Devices include, but are not limited to, AvivaStim XP InTENSity Twin Stim III. O docx Page 1 of 9

2 Description: (cont.) Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR): TEMPR, also known as scrambler therapy device, is a multi-channel TENS device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated controlled according to a stored program to provide pain relief. Treatment involves the initial physician consultation to discern the most effective electrode placement points followed by interactive physician-supervised treatment sessions that typically last one hour. Treatment is administered in the physician office setting under direct supervision to treat neuropathic pain, including pain associated with chemotherapy-induced peripheral neuropathy. CALMARE Pain Therapy Treatment received FDA 510(K) marketing clearance as a multi-channel TENS device. Interferential Current (IFC): Applies pulsed electrical stimulation through the surface of the skin to the peripheral nerves with the intent of altering or masking the perception of localized pain. Devices may be 2 channel or 4 channel. Sequential Stimulation: Combination unit which utilizes IFC /or TENS to relieve pain NMES to restore muscle function. The RS-4i is a multi-stage sequential stimulator in which only one modality may be operated at a time in a sequential manner. High Voltage Galvanic Stimulation (HVGS): An interrupted, pulsed direct current that causes electrochemical changes at the cellular level. The cellular changes cause reflex vasodilation that may be effective in controlling localized pain. May also be called High Voltage Pulsed Current (HVPC), Electro-galvanic Stimulation, or Hi-Volt. Sympathetic Therapy: Delivers electrical current via four electrodes placed strategically on the lower legs feet, or on the arms hs. The electrodes access the autonomic nervous system through the peripheral nerves with the intent of altering or masking the perception of chronic systemic pain. Known as Dynatron STS Dynatron STS Rx Therapy System. Micro Current Therapy : A small, b-aid sized device attached directly to the skin over the intended treatment area. Once activated, produces a low amperage electrical current that radiates into the affected area, attracting blood oxygen to the injured part stimulating the body s healing process. O docx Page 2 of 9

3 Description: (cont.) BioniCare Stimulator: A transcutaneous pulsed electrical stimulator using a different array of amplitudes in an attempt to stimulate chondrogenesis enhance cartilage repair. The BioniCare BIO-1000 System is being investigated as treatment for osteoarthritis of the knees rheumatoid arthritis of the hs. Rebuilder System: A transcutaneous nerve muscle stimulator that has been investigated for pain relief by opening nerve pathways, causing muscles to contract relax stimulating the brain to release endorphins. Consists of controller electrode pads that are placed directly on affected area. Form-Fitting Conductive Garment: Customized body-contoured garment for NMES or TENS. All electrodes lead wires are sewn into the garment to simplify lead placement minimize setup time. Criteria: For H-wave electrical stimulation, see BCBSAZ Medical Coverage Guideline, H-Wave Electrical Stimulation. For neuromuscular electrical stimulation (NMES), see BCBSAZ Medical Coverage Guideline, Neuromuscular Electrical Stimulation. HVGS: For HVGS for treatment of wounds, see BCBSAZ Medical Coverage Guideline, Electrostimulation Electromagnetic Therapy for the Treatment of Wounds. HVGS is considered medically necessary for ANY of the following: 1. Symptomatic relief of chronic (3 months or greater), intractable, localized pain 2. Management of post-surgical localized pain when oral or intravenous medications have failed to control pain or are contraindicated 3. Management of post-traumatic, acute, localized pain. O docx Page 3 of 9

4 Criteria: (cont.) HVGS: (cont.) For HVGS for treatment of wounds, see BCBSAZ Medical Coverage Guideline, Electrostimulation Electromagnetic Therapy for the Treatment of Wounds. HVGS for all other indications not previously listed is considered experimental or investigational based upon: 2. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, 4. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Labor vaginal delivery pain relief Treatment of dementia Treatment of edema Treatment of swelling O docx Page 4 of 9

5 Criteria: (cont.) TENS IFC: For TENS for treatment of wounds, see BCBSAZ Medical Coverage Guideline, Electrostimulation Electromagnetic Therapy for the Treatment of Wounds. Requests for NMES/TENS combination units must meet both the criteria for NMES the criteria for TENS. For NMES, see BCBSAZ Medical Coverage Guideline, Neuromuscular Electrical Stimulation. TENS IFC units are considered medically necessary for ANY of the following: 1. Symptomatic relief of chronic (3 months or greater), intractable, localized pain 2. Management of post-surgical localized pain when oral or intravenous medications have failed to control pain or are contraindicated 3. Management of post-traumatic, acute, localized pain TENS IFC units for all other indications not previously listed is considered experimental or investigational based upon: 2. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, 4. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Labor vaginal delivery pain relief Treatment of dementia Treatment or prevention of muscle atrophy O docx Page 5 of 9

6 Criteria: (cont.) TEMPR: TEMPR devices for all indications are considered experimental or investigational based upon: 2. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, 4. Insufficient evidence to support improvement outside the investigational setting. These devices include, but are not limited to: CALMARE Pain Therapy Treatment Scrambler Therapy MC-5A Sequential Stimulation (RS-4i): Sequential stimulation is considered medically necessary for ALL of the following: 1. Pain relief for ANY of the following: a. Symptomatic relief of chronic (3 months or greater), intractable, localized pain b. Management of post-surgical localized pain when oral or intravenous medications have failed to control pain or are contraindicated c. Management of post-traumatic, acute, localized pain. 2. Muscle stimulation for ANY of the following: a. Prevent or retard disuse atrophy after > 4 weeks immobility (e.g., bedrest, casting of a body part) when nerve supply to the muscle is intact, including brain, spinal cord peripheral nerves b. Muscle atrophy contracture due to scarring of soft tissue as in burn lesions hip replacement surgery c. Relax muscle spasms that are secondary to central nervous system injuries or cerebral palsy O docx Page 6 of 9

7 Criteria: (cont.) Form-Fitting Conductive Garment: Form-fitting conductive garment is considered comfort convenience, therefore, a benefit plan exclusion not eligible for coverage. Micro Current Therapy (MCT patch): Micro Current Therapy is available as an over-the-counter device is, therefore, considered a benefit plan exclusion not eligible for coverage. Sympathetic Therapy: Sympathetic Therapy is considered experimental or investigational based upon insufficient scientific evidence to permit conclusions concerning the effect on health outcomes. Electrical Stimulation for Arthritis: Electrical Stimulation for the treatment of osteoarthritis or rheumatoid arthritis is considered experimental or investigational based upon: 2. Insufficient evidence to support improvement of the net health outcome, than, established alternatives. These devices include, but are not limited to: BioniCare stimulator Rebuilder System: Rebuilder System for home use that is obtainable without a prescription is considered a benefit plan exclusion not eligible for coverage as durable medical equipment under the medical benefit. Rebuilder System is considered experimental or investigational based upon: 2. Insufficient evidence to support improvement of the net health outcome, than, established alternatives. O docx Page 7 of 9

8 Resources: BCBS Association Medical Policy Reference Manual. Transcutaneous Electrical Nerve Stimulator (TENS). Re-issue date 08/09/2012, issue date 11/30/ BCBS Association Medical Policy Reference Manual. Interferential Current for Stimulation. Re-issue date 12/13/2012, issue date 08/17/ BCBS Association Medical Policy Reference Manual. Electrical Stimulation for the Treatment of Arthritis. Re-issue date 10/11/2012, issue date 04/25/ BCBS Association Medical Policy Reference Manual. Sympathetic Therapy for the Treatment of Pain. Re-issue date 09/10/09, issue date 02/15/ Blumenfeld L, Hahn Y, Lepage A, Leonard R, Belafsky PC. Transcutaneous electrical stimulation versus traditional dysphagia therapy: a nonconcurrent cohort study. Otolaryngol Head Neck Surg Nov 2006;135(5): California Technology Assessment Forum. Interferential Stimulation (IFS) for the Treatment of Musculoskeletal Pain. 10/19/ Centers for Medicare Medicaid Services. Electrical Stimulation Electromagnetic Therapy Coverage Guidelines. 03/19/ Griffin JW, Newsome LS, Stralka SW, Wright PE. Reduction of chronic posttraumatic h edema: a comparison of high voltage pulsed current, intermittent pneumatic compression, placebo treatments. Phys Ther May 1990;70(5): InterQual Care Planning Procedures Adult. Transcutaneous Electrical Nerve Stimulation (TENS). 10. Marineo G, Iorno V, Gini C, Moschini V, Smith TJ. Scrambler Therapy May Relieve Chronic Neuropathic Pain More Effectively Than Guideline-Based Drug Management: Results of a Pilot, Romized, Controlled Trial. J Pain Symptom Manage. Jul Michlovitz SL, Smith W, Watkins M. Ice high voltage pulsed stimulation in treatment of acute lateral ankle sprains*. J Orthop Sports Phys Ther ;9(9): Nelson, Hayes, Currier. Clinical Electrotherapy, 3rd edition O docx Page 8 of 9

9 Resources: (cont.) 13. NewCare Products. Micro Current Therapy Product Information. 2000, accessed 05/12/ Stralka SW, Jackson JA, Lewis AR. Treatment of h wrist pain. A romized clinical trial of high voltage pulsed, direct current built into a wrist splint. AAOHN J May 1998;46(5): TEC Medical Policy Clearinghouse News. BioniCare Stimulator. 10/15/ FDA 510K Summary for BioniCare Stimulator, Model BIO-1000 : - FDA-approved indication: For use as an adjunctive therapy in reducing the level of pain symptoms associated with osteoarthritis of the knee for overall improvement of the knee as assessed by the physician s global evaluation (clinical studies). FDA 510K Summary for Scrambler Therapy MC-5A TENS Device: - FDA-approved indication: For use as an adjunctive therapy in symptomatic relief of chronic, intractable pain, post-surgical post-traumatic acute pain, symptomatic relief of acute pain symptomatic relief of postoperative pain. O docx Page 9 of 9