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A.1.03.04
The goal of the powered exoskeleton is to enable people who do not have volitional movement of their lower extremities to be able to fully bear weight while standing, to walk, and to navigate stairs. The devices have the potential to restore mobility and, thus, might improve functional status, quality of life, and health status for patients with spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and spina bifida.
An exoskeleton is an external structure with joints and links that might be regarded as wearable robots designed around the shape and functionof the human body. A powered exoskeleton, as described in this policy, consists of an exoskeleton-like framework worn by a person that includes a power source supplying energy for limb movement.
One type of powered lower-limb exoskeleton (eg, ReWalk™, Indego®) provides user-initiated mobility based on postural information. Standing, walking, sitting, and stair up/down modes are determined by a mode selector on a wristband. The ReWalk includes an array of sensors and proprietary algorithms that analyze body movements, such as tilt of the torso, and manipulate the motorized leg braces. The tilt sensor is used to signal the on-board computer when to take the next step. Patients using the powered exoskeleton must be able to use their hands and shoulders with forearm crutches or a walker to maintain balance. Instructions for ambulating with the ReWalk are to place the crutches ahead of the body, and then bend the elbows slightly, shifting weight toward the front leg, leaning toward the front leg side. The rear leg will lift slightly off of the ground and then begin to move forward. Using the crutches to straighten up will enable the rear leg to continue moving forward. The process is repeated with the other leg.
To move from a seated to standing position or vice versa, the desired movement is selected by the mode selector on the wrist. There is a 5-second delay to allow the individual to shift weight (forward for sit-to-stand and slightly backward for stand-to-sit) and to place their crutches in the correct position. If the user is not in an appropriate position, a safety mechanism will be triggered. Walking can only be enabled while standing, and the weight shift must be sufficient to move the tilt sensor and offload the back leg to allow it to swing forward. Continuous ambulation is accomplished by uninterrupted shifting onto the contralateral leg. The device can be switched to standing either via the mode selector or by not shifting weight laterally for 2 seconds, which triggers the safety mechanism to stop walking. Some patients have become proficient with the ReWalk by the third week of training.
In 2014, ReWalk (LIFEWARD, previously Argo Medical Technologies and ReWalk Robotics) was granted a de novo 510(k) classification (K131798) by the U.S. Food and Drug Administration (FDA) (class II; FDA product code: PHL). The new classification applies to this device and substantially equivalent devices of this generic type. The ReWalk (current version ReWalk Personal 6.0) is the first external, powered, motorized orthosis (powered exoskeleton) used for medical purposes that is placed over a person’s paralyzed or weakened limbs for the purpose of providing ambulation. The de novo classification allows novel products with moderate- or low-risk profiles and without predicates that would ordinarily require premarket approval as a Class III device to be down-classified in an expedited manner and brought to market with a special control as a Class II device.
The ReWalk 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” to 6’2”),
Weight does not exceed 100 kg (220 lb).
In 2019, the ReWalk ReStore™, a lightweight, wearable, exo-suit, was approved for rehabilitation of individuals with lower-limb disabilities due to stroke.
In 2016, Indego (Parker Hannifin) was cleared for marketing by the FDA through the 510(k) process (K152416). The FDA determined that this device was substantially equivalent to existing devices, citing ReWalk as a predicate device. Indego 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.” Indego has also received marketing clearance for use in rehabilitation institutions.
In 2016, Ekso™ and Ekso GT™ (Ekso Bionics® Inc) were cleared for marketing by the FDA through the 510(k) process (K143690). The ReWalk was the predicate device. Ekso is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations with upper extremity motor function of at least 4/5 in both arms: individuals with hemiplegia due to stroke; individuals with spinal cord injuries at levels T4 to L5; and individuals with spinal cord injuries at levels of C7 to T3.
In 2017, Hybrid Assistive Limb (HAL™) for Medical Use (Lower Limb Type) (CYBERDYNE Inc.) was cleared for marketing by the FDA through the 510(k) process (K171909). The ReWalk was the predicate device. The HAL is intended to be used inside medical facilities while under trained medical supervision for individuals with spinal cord injury at levels C4 to L5 (American Spinal Injury Association [ASIA] Impairment Scale C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B). HAL for Medical Use (K233695) has expanded indications for post stroke paresis, paraplegia due to neuromuscular diseases, cerebral palsy, and spastic paraplegia.
In 2020, Keeogo™ (B-Temia) exoskeleton was cleared for marketing by the FDA through the 510(k) process (K201539). The Honda® Walking Assist Device was the predicate device. Keeogo is intended for use in patients with stroke in rehabilitation settings.
In 2021, ExoAtlet-II® (ExoAtlet Asia Co. Ltd.) was cleared for marketing by the FDA through the 510(k) process (K201473). The Ekso/Ekso GT was the predicate device. ExoAtlet-II is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations with upper extremity motor function of at least 4/5 in both arms: individuals with spinal cord injuries at levels T4 to L5, and individuals with spinal cord injuries at levels of C7 to T3 (ASIA D).
In 2022, GEMS-H® (Samsung Electronics Co. Ltd.) was cleared for marketing by the FDA through the 510(k) process (K213452). The Honda Walking Assist Device was the predicate device. GEMS-H is intended to help assist ambulatory function in rehabilitation institutions under the supervision of a trained healthcare professional for individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of 1 person.
In 2022, EksoNR™ (Ekso Bionics Inc) was cleared for marketing by the FDA through the 510(k) process (K220988). EksoNR is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations: individuals with multiple sclerosis (upper extremity motor function of at least 4/5 in at least 1 arm); individuals with acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least 1 arm); individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms), and individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).
In 2022, Atalante® (Wandercraft SAS) was cleared for marketing by the FDA through the 510(k) process (K221859). The Indego was the predicate device. Atalante is intended to enable individuals (>18 years of age, able to tolerate a stand-up position) with hemiplegia due to cerebrovascular accident to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator. The Atalante X® was cleared for marketing by the FDA through the 510(k) process (K232077) and is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions for individuals with hemiplegia due to cerebrovascular accident and individuals with spinal cord injuries at levels T5 to L5.
FDA product code: PHL.
Related medical policies –
Use of a powered exoskeleton for ambulation in individuals with lower-limb disabilities is considered investigational.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
04/09/2015: Approved by Medical Policy Advisory Committee.
08/14/2015: Code Reference section updated for ICD-10.
04/18/2016: Policy description updated regarding devices. Policy statement unchanged.
05/31/2016: Policy number A.1.03.04 added.
03/24/2017: Policy description updated regarding devices. Policy statement unchanged.
04/02/2018: Policy description updated regarding devices. Policy statement unchanged.
04/03/2019: Policy description updated regarding devices. Policy statement unchanged.
04/14/2020: Policy reviewed; no changes.
11/04/2020: Code Reference section updated to add HCPCS code K1007, effective 10/01/2020.
05/21/2021: Policy description updated regarding devices. Policy statement unchanged.
05/06/2022: Policy description updated regarding devices. Policy statement unchanged.
04/12/2023: Policy description updated regarding devices. Policy statement updated to change "patients" to "individuals."
04/12/2024: Policy description updated regarding devices. Policy statement unchanged.
04/16/2025: Policy description updated regarding devices. Policy statement unchanged.
Blue Cross and Blue Shield Association Policy #1.03.04
This may not be a comprehensive list of procedure codes applicable to this policy.
Code Number | Description |
CPT-4 | |
HCPCS | |
E1399 | Durable medical equipment, miscellaneous |
K1007 | Bilateral hip, knee, ankle, foot device, powered, includes pelvic component, single or double upright(s), knee joints any type, with or without ankle joints any type, includes all components and accessories, motors, microprocessors, sensors |
ICD-10 Procedure | |
ICD-10 Diagnosis |
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