Robotic Powered Exoskeleton Suits

Clinical & Quality Management MEDICAL POLICY

Policy Number: 2016M0104A Effective Date: May 01, 2016

Table of Contents: Page: Cross Reference Policy:

POLICY DESCRIPTION 2 Not Available COVERAGE RATIONALE/CLINICAL CONSIDERATIONS 2 BACKGROUND 2 REGULATORY STATUS 3 CLINICAL EVIDENCE 4 APPLICABLE CODES 6 REFERENCES 7 POLICY HISTORY/REVISION INFORMATION 7

INSTRUCTIONS: “Medical Policy assists in administering UCare benefits when making coverage determinations for members under our health benefit plans. When deciding coverage, all reviewers must first identify enrollee eligibility, federal and state legislation or regulatory guidance regarding benefit mandates, and the member specific Evidence of Coverage (EOC) document must be referenced prior to using the medical policies. In the event of a conflict, the enrollee's specific benefit document and federal and state legislation and regulatory guidance supersede this Medical Policy. In the absence of benefit mandates or regulatory guidance that govern the service, procedure or treatment, or when the member’s EOC document is silent or not specific, medical policies help to clarify which healthcare services may or may not be covered. This Medical Policy is provided for informational purposes and does not constitute medical advice. In addition to medical policies, UCare also uses tools developed by third parties, such as the InterQual Guidelines®, to assist us in administering health benefits. The InterQual Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. Other Policies and Coverage Determination Guidelines may also apply. UCare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary and to provide benefits otherwise excluded by medical policies when necessitated by operational considerations.”

Clinical & Quality Management MEDICAL POLICY

POLICY DESCRIPTION:

This policy describes the uses for the robotic lower body exoskeleton devices (e.g., ReWalkTM) on individuals with loss of lower limb function to ambulate on their own. These devices are intended for use by individuals with lower-limb disabilities to perform ambulatory functions or provide assistance in the rehabilitation of spinal cord injury and/or traumatic brain injury. The available published evidence addressing the safety and efficacy of these devices is limited and therefore considered experimental and/or investigational.

COVERAGE RATIONALE / CLINICAL CONSIDERATIONS:

The use of a robotic lower body exoskeleton suit (e.g., the ReWalkTM, Argo Medical Technologies Ltd, Marlborough, MA) in patients with lower-limb disabilities is considered EXPERIMENTAL AND/OR INVESTIGATIONAL for all medical conditions, including but not limited to the following:  To enable individuals with spinal cord injury to perform ambulatory functions.  To assist in the rehabilitation of spinal cord injury and/or traumatic brain injury. At this time there is inadequate evidence of their effectiveness and/or impact on health outcomes or patient management for the ReWalk Personal System. The available published evidence is limited to small pilot studies; therefore, additional studies are needed to establish the safety and efficacy of these devices.

Clinical Considerations: Candidates for the ReWalkTM must retain upper-limb strength and mobility to manage stabilizing crutches. Individuals should not use the device if they have a history of severe neurological injuries other than spinal cord injury, or have severe spasticity, significant contractures, spinal instability, unhealed limb or pelvic fractures. The devices should also not be used by individuals if they have severe concurrent medical conditions such as infection, vascular, heart or lung conditions, or pressure sores.

BACKGROUND:

The ReWalkTM exoskeleton (Argo Medical Technologies Ltd, Marlborough, MA) is designed for persons with a spinal cord injury (SCI) who retain upper-limb strength and mobility to manage stabilizing crutches. It is worn outside clothing and weighs 44 pounds. It consists of an upper-body harness, lower-limb braces, motorized joints, ground-force sensors, a tilt sensor, a locomotion-mode selector, and a backpack carrying a computerized controller and rechargeable battery. The device is strapped to the user at the waist, alongside each lower limb, and at the feet. Ordinary crutches help maintain stability. The ReWalkTM exoskeleton comes in 2 sizes: one that fits persons 5 feet 3inches to 5 feet 9 inches in height; and one that accommodates persons up to 6 feet 3 inches. The ReWalkTM can be worn by individuals weighing up to 220 pounds. Two types of the ReWalkTM

Clinical & Quality Management MEDICAL POLICY

exoskeletons are available: the institutional version, the ReWalk-I, which is designed for rehabilitation centers and physician private practices, and; a personal version, the ReWalk-P, which is designed for an individual’s sole use.

REGULATORY STATUS:

1. U.S. FOOD AND DRUG ADMINISTRATION (FDA): Powered Exoskeleton: ReWalkTM Personal System (ReWalk Robotics, formerly Argo Medical Technologies Ltd.): CLASS III DESIGNATION (K131798, cleared on June 26, 2014). The FDA reviewed the ReWalkTM through its de novo classification process, a regulatory pathway for novel, first-of-its-kind medical devices that are generally low-to moderate-risk. The FDA is requiring Argo Medical Technologies, Inc., the manufacturer of ReWalkTM, to complete a post-market clinical study that will consist of a registry to collect data on adverse events related to the use of the ReWalkTM device and prospectively and systematically assess the adequacy of its training program. The ARGO ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing. Candidates for the device should have the following characteristics: • Hands and shoulders can support crutches or a walker • Healthy bone density • Skeleton does not suffer from any fractures • Able to stand using a device such as a standing frame • In general good health • Height is between 160 cm and 190 cm (5’3” -6’2”) • Weight does not exceed 100 kg (220 lbs.) • The device has been contraindicated for use in sports or stair-climbing Warnings: • Users must be trained to use the ReWalkTM. Use of the device without training can result in serious injury. • Improper adjustment of device size to suit the user could cause skeletal fractures and injury to the patient. • Using the device on irregular surface could result in loss of balance and possible injury. Do not try to walk on sand, in stony areas, or on any surface that isn’t appropriate for crutches. Do not use the device on a non ADA compliant ramp. • Do not use the device if you are distracted or not paying careful attention to your operation of the system. • The device is designed for use with crutches. • Use the device on paved surfaces, dry, even surfaces.

Clinical & Quality Management MEDICAL POLICY

• The device must be fitted over clothing to prevent skin abrasions. Where necessary, use the extra padding provided with the device. 2. CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS): No National Coverage Determination (NCD) or Local Coverage Determination (LCD) for the ReWalkTM Personal System for home use was identified on the CMS website. In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. 3. MINNESOTA DEPARTMENT OF HUMAN SERVICES (DHS): Minnesota DHS does not have a policy statement regarding ReWalkTM Personal System for individuals with spinal cord injury (SCI) in its Provider Manual or other specific provider references.

CLINICAL EVIDENCE:

A literature search of PubMed was completed on March 21, 2015, using the terms “rewalk”; “lower limb robotic exoskeleton”. The search was limited to abstracts of English-language, human clinical studies and review articles published in the last 10 years. In addition, the manufacturer’s reference list was manually searched for references pertaining to the ReWalk Personal System. Seven articles were retrieved, including 1 longitudinal prospective self-controlled feasibility study (n=60); 1 open noncomparative nonrandomized study (n=12); 1 cross-sectional study (n=9); 3 case series studies (n=8; n=12; and n=6); and 1 review article.

1. EVIDENCE FROM AVAILABLE PUBLISHED STUDIES: In a pilot study, Zeilig et al., (2012) evaluated the safety and tolerance of use of the ReWalkTM exoskeleton ambulation system in people with SCI. Measures of functional ambulation were also assessed and correlated to neurological spinal cord level, age, and duration since injury. A total of 6 volunteer participants were recruited from the follow-up outpatient clinic. Safety was assessed with regard to falls, status of the skin, status of the spine and joints, blood pressure, pulse, and electrocardiography (ECG). Pain and fatigue were graded by the participants using a visual analog scale pre- and post-training. Participants completed a 10-statement questionnaire regarding safety, comfort, and secondary medical effects. After being able to walk 100 m, timed up and go, distance walked in 6 minutes and 10-m timed walk were measured. There were no adverse safety events. Use of the system was generally well-tolerated, with no increase in pain and a moderate level of fatigue after use. Individuals with lower level of SCI performed walking more efficiently. The authors concluded that volunteer participants were able to ambulate with the ReWalk for a distance of 100 m, with no adverse effects during the course of an average of 13 to 14 training sessions. The participants were generally positive regarding the use of the system. Moreover, the authors stated that the potential benefits of the ReWalk are many, including improved functional mobility, cardio-vascular and respiratory status, bone metabolism, and bowel and bladder function, as well as reduction of spasticity and neuropathic pain, but efficacy still needs to be demonstrated in a larger study. Also, these researchers noted that this study did not include any female subjects, individuals with tetraplegia, children, or older adults; future large-scale inclusive studies are needed. In an open, non-comparative, non-randomized study, Esquenazi et al., (2012) evaluated the safety and performance of ReWalk in enabling people with paraplegia due to SCI to carry out routine ambulatory

Clinical & Quality Management MEDICAL POLICY

functions. All 12 subjects have completed the active intervention; 3 remained in long-term follow-up. After training, all subjects were able to independently transfer and walk, without human assistance while using the ReWalk, for at least 50 to 100 m continuously, for a period of at least 5 to 10 mins continuously and with velocities ranging from 0.03 to 0.45 m/sec (mean of 0.25 m/sec). Excluding 2 subjects with considerably reduced walking abilities, average distances and velocities improved significantly. Some subjects reported improvements in pain, bowel and bladder function, and spasticity during the trial. All subjects had strong positive comments regarding the emotional/psychosocial benefits of the use of ReWalk. The authors concluded that the ReWalk holds considerable potential as a safe ambulatory powered orthosis for motor-complete thoracic-level SCI patients. Most subjects achieved a level of walking proficiency close to that needed for limited community ambulation. A high degree of performance variability was observed across individuals. Some of this variability was explained by level of injury, but other factors have not been completely identified. Further development and application of this rehabilitation tool to other diagnoses are expected in the future. In 2013, Esquenazi et al., published a small, randomized comparative trial involving 16 subjects with traumatic brain injury (TBI). This study compared the use of the ReWalk device in treadmill assisted rehabilitation training (n=8) vs. manually assisted treadmill rehabilitation training (n=8). Following training, the average self-selected walking velocity (SSV) increased by 49.8% for the ReWalk group (p=0.01) and by 31% for the manual group (p=0.06). The average maximal velocity increased by 14.9% for the ReWalk group (p=0.06) and by 30.8% for the manual group (p=0.01). Step-length asymmetry ratio improved during SSV by 33.1% for the ReWalk group (p=0.01) and by 9.1% for the manual group (p=0.73). The distance walked increased by 11.7% for the ReWalk group (p=0.21) and by 19.3% for manual group (p=0.03). While each group demonstrated benefits from their assigned training method, no differences between groups were reported. The value of the ReWalk system in rehabilitation training following TBI is unclear given these results. Fineberg, et al., (2013) conducted a study using vertical ground reaction force (vGRF) to show the magnitude and pattern of mechanical loading in persons with spinal cord injury (SCI) during powered exoskeleton-assisted walking with ReWalk. The authors conducted a cross-sectional study to analyze vGRF during powered exoskeleton-assisted walking compared with vGRF of able-bodied gait. Six persons with thoracic motor-complete SCI (T1-T11 AIS A/B) and three age-, height-, weight- and gender-matched able-bodied volunteers participated. SCI participants were trained to ambulate over ground using a ReWalk. vGRF was recorded using the F-Scan system (TekScan, Boston, MA, USA). Peak stance average (PSA) was computed from vGRF and normalized across all participants by percent body weight. Peak vGRF was determined for heel strike, mid-stance, and toe-off. Relative linear impulse and harmonic analysis provided quantitative support for analysis of powered exoskeletal gait. The investigators reported that participants with motor-complete SCI, ambulating independently with a ReWalk, demonstrated mechanical loading magnitudes and patterns similar to able-bodied gait. Harmonic analysis of PSA profile by Fourier transform contrasted frequency of stance phase gait components between able-bodied and powered exoskeleton-assisted walking. Spungen (2013) reported the results of a pilot study from the Bronx Veterans Affairs Hospital of a trial of the ReWalkTM system in 7 subjects with paraplegia due to SCI with permanent paralysis and loss of mobility. The study was not published in a peer-reviewed medical journal, but was made available on a Veterans Affairs website. This pre/post intervention pilot case series was performed to determine the number of sessions and level of assistance needed to execute standing, walking, and stair climbing skills

Clinical & Quality Management MEDICAL POLICY

with the ReWalkTM device. Subjects were studied over an average of 45 ± 20 sessions consisting of 1 to 2 hours of standing and overground ambulation for 3 sessions per week. All 7 participants learned to perform sit-to-stand, stand-to-sit, and ambulation to 50 to 166 meters in 6 minutes with no (n=4) to varying (n=3) levels of assistance. Ascending and descending ≥ 5 stairs with assistance was achieved by 4 subjects. These same 4 subjects also achieved some outdoor-specific walking skills. The authors reported that there was no relationship with achievement of exoskeletal-assisted mobility skills and the duration or level of SCI. Asselin and others (2015) reported the results of a small case series study of 8 non-ambulatory subjects with paraplegia who were trained to ambulate with the ReWalkTM device. The authors reported that the average value of oxygen update (VO2) during walking with the device was significantly higher in all subjects vs. when sitting and standing (p<0.001). Also, the heart rate response during walking with the device was significantly greater vs. when subjects were either sitting or standing (p<0.001). These findings are not unexpected, and align with what is commonly known about human physiology. The authors concluded that individuals with paraplegia are able to ambulate efficiently using the powered exoskeleton for overground ambulation, providing potential for functional gain and improved fitness. This study provided no data regarding the safety of the device.

2. EXTERNAL SOURCES/ GROUPS POLICY: A comprehensive search of the Internet yielded no information regarding evidence-based practice guidelines.

SUMMARY: At this time, the available published evidence addressing the safety and efficacy of robotic lower body exoskeleton devices is limited to small pilot studies. There is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management for the ReWalk Personal System for home use.

APPLICABLE CODES:

The Current Procedural Terminology (CPT®) codes and HCPCS codes listed in this policy are for reference purposes only. Listing of a service or device code in this policy does not imply that the service described by this code is a covered or non-covered health service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other medical policies and coverage determination guidelines may apply.

HCPCS Codes Description L2999 Lower extremity orthoses, not otherwise specified [when specified as a powered robotic lower body exoskeleton device] ICD-10 Codes Description Investigational and Not Medically Necessary for All diagnoses CPT® Codes Description

CPT® is a registered trademark of the American Medical Association.

Clinical & Quality Management MEDICAL POLICY

REFERENCES:

1. Asselin P, Knezevic S, Kornfeld S, et al. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015; 52(2):147-158. 2. Esquenazi A, Lee S, Packel AT, Braitman L. A randomized comparative study of manually assisted versus robotic-assisted body weight supported treadmill training in persons with a traumatic brain injury. PM R. 2013; 5(4):280-290. 3. Esquenazi A, Talaty M, Packel A, Saulino M. The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. 2012; 91(11):911-921. 4. Hayes, Winifred S. Hayes Search & Summary. ReWalk Personal System (ReWalk Robotics) for Home Use in Spinal Cord Injury. August 13, 2015. 5. Spungen AM, Asselin P, Fineberg DB, et al. VA Rehabilitation Research and Development National Center of Excellence for the Medical Consequences of Spinal Cord Injury. Exoskeletal-assisted walking for persons with motor-complete paraplegia. Research and Technology Organization, Human Factors, and Medicine Panel: North Atlantic Treaty Organization; 2013. 6. Talaty M, Esquenazi A, Briceno JE. Differentiating ability in users of the ReWalk(TM) powered exoskeleton: an analysis of walking kinematics. IEEE Int Conf Rehabil Robot. 2013; 2013:6650469. 7. Zeilig G, Weingarden H, Zwecker M, et al. Safety and tolerance of the ReWalk™ exoskeleton suit for ambulation by people with complete spinal cord injury: a pilot study. J Spinal Cord Med. 2012; 35(2):96- 101.

POLICY HISTORY: DATE ACTION/DESCRIPTION 03/23/2016 New Policy 2013M0104A. Reviewed and approved by Medical Policy Committee.