Neuromuscular Electrical Stimulator (NMES) Corporate Medical Policy

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Neuromuscular Electrical Stimulator (NMES) Corporate Medical Policy File name: Neuromuscular Electrical Stimulator (NMES) File Code: UM.NS.04 Origination: 05/01/2007 Last Review: 06/2018 Next Review: 06/2019 Effective Date: 08/01/2018 Description/Summary Neuromuscular electrical stimulators (NMES) are divided into two broad categories: therapeutic and functional. Therapeutic electrical stimulation strengthens muscles weakened by disuse while functional electrical stimulation attempts to replace destroyed nerve pathways by electrical stimulation to the muscle in order to assist a functional movement. Functional neuromuscular electrical stimulation (NMES) involves the use of an orthotic device with microprocessor-controlled electrical muscular stimulation. These devices are being developed to restore function to patients with damaged or destroyed nerve pathways (eg, spinal cord injury, stroke, multiple sclerosis, cerebral palsy). For individuals who have loss of hand and upper-extremity function due to spinal cord injury or stroke who receive functional NMES, the evidence includes case series. Relevant outcomes are functional outcomes and quality of life. Evidence on fu nctional NMES for the upper limb in patients with spinal cord injury or stroke includes a few small case series. Interpretation of the evidence is limited by the low number of patients studied and lack of data demonstrating the utility of NMES outside the investigational setting. It is uncertain whether NMES can restore some upper-extremity function or improve the quality of life. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have chronic foot drop who receive functional NMES, the evidence includes randomized controlled trials and a systematic review. Relevant outcomes are functional outcomes and quality of life. For chronic post stroke foot drop, 2 large randomized trials have shown improved patient satisfaction with NMES; however, in objective measures (eg, walking), no significant difference has been observed between NMES and a standard ankle-foot orthosis. A small randomized trial examining neuromuscular stimulation for foot drop in patients with multiple sclerosis revealed a clinically significant reduction in falls; the trial also revealed an improvement in Page 1 of 9

patient satisfaction with the neuromuscular stimulation (as opposed to an exercise program). However, in the area of walking speed, the trial failed to demonstrate a clinically significant benefit to the neuromuscular stimulation over an exercise class. Studies in a larger number of patients are needed to obtain greater certainty about the generalizability of Last Review: August 2017 Next Review: March 2018 Issue: 8:2017 Related Policies 1.03.04 Powered Exoskeleton for Ambulation in Patients With Lower- Limb Disabilities 1.04.04 Myoelectric Prosthesis Components for the Upper Limb 1.04.05 Microprocessor-Controlled Prostheses for the Lower Limb Original Review Date: March 1996 Page: 2 2017 Blue Cross Blue Shield Association. Reproduction without prior authorization is prohibited. MPRM 8.03.01 Functional Neuromuscular Electrical Stimulation this health outcome. The literature on NMES for foot drop in children with cerebral palsy includes a systematic review of small studies that feature within-subject designs; additional study in a larger number of subjects is needed. Overall, there is insufficient evidence for some indications, and a lack of improvement in objective measures for others. The evidence is insufficient to determine the effects of the technology on health outcomes. For individuals who have spinal cord injury at segments T4 to T12 who receive functional NMES, the evidence includes case series. Relevant outcomes are functional outcomes and quality of life. No controlled trials were identified on functional NMES for standing and walking in patients with spinal cord injury. However, case series are considered adequate for this condition, because there is no chance for unaided ambulation in this population with spinal cord injury. Some studies have reported improvements in intermediate outcomes, but improvement in health outcomes (eg, ability to perform activities of daily living, quality of life) have not been demonstrated. The evidence is insufficient to determine the effects of the technology on health outcomes. Policy Coding Information Click the links below for attachments, coding tables & instructions. Attachment I Coding Table & Instructions When a service may be considered medically necessary Therapeutic NMES devices may be considered medically necessary for the treatment of adequately documented disuse atrophy when the nerve supply to the muscle is intact and results from listed conditions in which clinical improvement may be expected. When requesting prior authorization for the use of NMES in disuse atrophy, the medical record must show supporting documentation of the member's diagnosis of disuse atrophy (based on physical exam) and electromyography (EMG) as a result of one of the following: Recent hip surgery until the patient begins physical therapy, or Prolonged (greater than 12 weeks) casting or splinting of a joint, or Contractures as a result of scarring of soft tissue from burns. Treatment to improve wrist and finger function and prevent or correct shoulder Page 2 of 9

subluxation in persons with partial paralysis following stroke. When a service is considered investigational Neuromuscular stimulation is considered investigational as a technique to restore function following nerve damage or nerve injury. This includes its use in the following situations: As a technique to provide ambulation in patients with spinal cord injury; or To provide upper-extremity function in patients with nerve damage (eg, spinal cord injury or post stroke); or To improve ambulation in patients with foot drop caused by congenital disorders (eg, cerebral palsy) or nerve damage (eg, post stroke, or in those with multiple sclerosis). Reference Resources 1. BCBSA Policy 8.03.01, updated 8/2017, Functional Neuromuscular Electrical Stimulation 2. UpToDate 11/2017 Related Policies Durable Medical Equipment (DME) Physical Medicine Document Precedence Blue Cross and Blue Shield of Vermont (BCBSVT) Medical Policies are developed to provide clinical guidance and are based on research of current medical literature and review of common medical practices in the treatment and diagnosis of disease. The applicable group/individual contract and member certificate language, or employer s benefit plan if an ASO group, determines benefits that are in effect at the time of service. Since medical practices and knowledge are constantly evolving, BCBSVT reserves the right t o review and revise its medical policies periodically. To the extent that there may be any conflict between medical policy and contract/employer benefit plan language, the member s contract/employer benefit plan language takes precedence. Audit Information BCBSVT reserves the right to conduct audits on any provider and/or facility to ensure compliance with the guidelines stated in the medical policy. If an audit identifies instances of non-compliance with this medical policy, BCBSVT reserves the right to re coup all noncompliant payments. Benefit Determination Guidance Administrative and Contractual Guidance Prior approval is required and benefits are subject to all terms, limitations and conditions of Page 3 of 9

the subscriber contract. Incomplete authorization requests may result in a delay of decision pending submission of missing information. To be considered compete, see policy guidelines above. An approved referral authorization for members of the New England Health Plan (NEHP) is required. A prior approval for Access Blue New England (ABNE) members is required. NEHP/ABNE members may have different benefits for services listed in this policy. To confirm benefits, please contact the customer service department at the member s health plan. Federal Employee Program (FEP): Members may have different benefits that apply. For further information please contact FEP customer service or refer to the FEP Service Benefit Plan Brochure. It is important to verify the member s benefits prior to providing the service to determine if benefits are available or if there is a specific exclusion in the member s benefit. Coverage varies according to the member s group or individual contract. Not all groups are required to follow the Vermont legislative mandates. Member Contract language takes precedence over medical policy when there is a conflict. If the member receives benefits through an Administrative Services Only (ASO) group, benefits may vary or not apply. To verify benefit information, please refer to the member s employer benefit plan documents or contact the customer service department. Language in the employer benefit plan documents takes precedence over medical policy when there is a conflict. This policy does not apply to commercially available exercycles that use electrical muscle stimulation technology as a means of physical therapy and exercise for patients with spinal cord injury. These exercycles are sometimes called functional neuromuscular exercisers. The goals for using these devices may be to promote cardiovascular conditioning, prevent muscle atrophy, and/or maintain bone mass. The patient s legs are wrapped in fabric strips that contain electrodes to stimulate the muscles, thus permitting the patient to pedal. When reviewing electrical muscle stimulation exercycles, these are considered durable medical equipment or physical therapy modality/services and would be reviewed based on medical necessity, according to those medical policies. Policy Implementation/Update information 05/2007 Reviewed by the CAC 01/2008 Annual review. No changes made. Reviewed by the CAC 05/2008 Updated and Transferred to new format. Criteria for medically 11/2011 necessary use updated. New language concerning use for cerebral palsy as investigational. Clarification as to the difference between functional and therapeutic uses of NMES. Page 4 of 9

01/2013 11/2017 06/2018 References updated. Coding table updated to include new CPT codes for 2012. CPT and HCPSC investigational codes designations added to coding table. Description section updated to include FDA approved systems. New Investigational wording added. Codes updated, some codes moved to investigational (formally required PA). Approved by both the Medical Policy and Medical Policy and Provider Committees. Medical/ Clinical Coder reviewed. RLJ Reviewed BCBSA MPRM 8.03.01 no changes in policy statement. Removed CPT code 64577 code deleted 01.01.2012. Removed CPT code 95973 deleted 01/01/2016. Reviewed BCBSA MPRM 8.03.01 no changes in policy statement. Removed CPT code 64577 from PA list and medical policy -code deleted 01.01.2012. Deleted 95973 01/01/2016 Eligible providers Qualified healthcare professionals practicing within the scope of their license(s). Approved by BCBSVT Medical Directors Date Approved Gabrielle Bercy-Roberson, MD, MPH, MBA Senior Medical Director Chair, Health Policy Committee Joshua Plavin, MD, MPH, MBA Chief Medical Officer Attachment I Coding Table & Instructions Code Type Number Brief Description Policy Instructions The following codes will be considered as medically necessary when applicable criteria have been met. Percutaneous implantation of CPT 63650 neurostimulator electrode array, epidural Page 5 of 9

CPT 63655 CPT 63661 CPT 63662 CPT 63663 CPT 63664 - CPT 63685 CPT 63688 CPT 64580 CPT 64581 Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling Revision or removal of implanted spinal neurostimulator pulse generator or receiver Incision for implantation of neurostimulator electrodes; neuromuscular Incision for implantation of neurostimulator electrodes; sacral nerve (transforaminal placement) Page 6 of 9

CPT 95971 CPT 95972 A4595 E0731 E0745 Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude & duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance & patient compliance measurements); simple spinal cord, or peripheral (i.e., peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, first hour Electrical stimulator supplies, 2 lead, per month, (e.g., TENS, NMES) Form fitting conductive garment for delivery of TENS or NMES (with conductive fibers separated from the patients skin by layers of fabric) Neuromuscular stimulator, electronic shock unit L8680 Implantable neurostimulator electrode (with any number of contact points) L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only Page 7 of 9

L8682 Implantable neurostimulator radiofrequency receiver L8683 L8685 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver Implantable neurostimulator pulse generator, single array, rechargeable, includes extension L8686 L8687 L8688 L8689 Implantable neurostimulator pulse generator Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension External recharging system for battery (internal) for use with implantable neurostimulator, replacement only The following codes will be denied as Investigational CPT 64575 CPT 64585 CPT 95970 Incision for implantation of neurostimulator electrodes; peripheral nerve (excludes sacral nerve) Revision or removal of peripheral neurostimulator electrodes Electronic analysis of implanted neurostimulator pulse generator system (e.g., rate, pulse amplitude & duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance & patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e., cranial nerve, peripheral nerve, autonomic nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming Page 8 of 9

CPT CPT CPT CPT 0282T 0283T 0284T 0285T E0762 E0764 E0744 E0770 Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar; for trial, including removal at the conclusion of trial period Percutaneous or open implantation of neurostimulator electrode array(s), subcutaneous (peripheral subcutaneous field stimulation), including imaging guidance, when performed, cervical, thoracic or lumbar; permanent, with implantation of a pulse generator Revision or removal of pulse generator or electrodes, including imaging guidance, when performed, including addition of new electrodes, when performed Electronic analysis of implanted peripheral subcutaneous field stimulation pulse generator, with reprogramming when performed Transcutaneous electrical joint stimulation device system Functional neuromuscular stimulation, transcutaneous stimulation of sequential muscle groups of ambulation with computer control, used for walking by spinal cord injured, entire system, after completion of training program Neuromuscular stimulator for scoliosis Functional electrical stimulator, transcutaneous stimulation of nerve and/or muscle groups, any type, complete system, not otherwise specified Type of Service Place of Service Surgery, Durable Medical Equipment Outpatient Page 9 of 9