mp-575
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Powered Exoskeleton for Ambulation in Patients with Lower Limb Disabilities

Policy Number: MP-575

Latest Review Date: March 2021

Category:  DME

Policy Grade:  B

POLICY:

Use of a powered exoskeleton for ambulation in patients with lower limb disabilities is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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, may lead to improvements in 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 correspond to parts of the human body. A powered exoskeleton, as described in this evidence review, consists of an exoskeleton-like framework worn by a person and a power source that supplies the energy for limb movement.

One type of powered lower-limb exoskeleton (e.g. ReWalk, Indego) provides user-initiated mobility based on postural information. Standing, walking, sitting, and stair up/down modes via 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 walking with the ReWalk are to place the crutches ahead of the body. Then bend the elbows slightly, shifting weight towards the front leg, leaning towards 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 then repeated with the other leg.

To move from seated to standing or from standing to seated, 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 to 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 sec, which triggers a safety mechanism to stop walking. Some patients are able to obtain proficiency with the ReWalk by the third week of training.

KEY POINTS:

The most recent literature review was updated through January 25, 2021.

SUMMARY OF EVIDENCE:

For individuals who have who have lower-limb disabilities who receive a powered exoskeleton, the evidence includes case series. Relevant outcomes include functional outcomes, quality of life, and treatment-related morbidity. At the present time, evaluation of exoskeletons is limited to small studies performed in the institutional setting in patients with spinal cord injury. These studies have assessed the user’s ability to perform, under close supervision, standard tasks such as the Timed Up and Go test, 6-minute walk test, and 10-meter walk test. There are concerns about the safety of the device under regular use, including the potential to trip and fall. Further study is needed to determine whether these devices can be successfully used outside of the institutional setting. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

No guidelines or statements were identified.

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS:

Not applicable

KEY WORDS:

ReWalk, Ekso GT Robotic Exoskeleton, Rex Rehab, Argo Rewalk, Indego® Powered Exoskeleton, Vanderbilt Exoskeleton, Mina X-1, Power Assist Exoskeleton, REX®, REX P®, Rewalk, WPAL, Wearable Power-Assist Locomotor), X1 Mina, HAL (Hybrid Assistive Limb), Phoenix, Keeogo

APPROVED BY GOVERNING BODIES:

In 2014, ReWalk™ (ReWalk Robotics, previously Argo Medical Technologies) was granted a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (class II). The new classification applies to this device and substantially equivalent devices of this generic type. The ReWalk device 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. De novo classification process 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 T7to 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)

In 2016, Indego® (Parker Hannifin) was cleared for marketing by FDA through the 510(k) process (K152416). FDA determined that this device was substantially equivalent to existing devices, citing the ReWalk as a predicate device. The 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; individuals with spinal cord injuries at levels of C7 to T3.

In 2017, 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 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B)

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 stroke patients in rehabilitation settings.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

There is no specific code for these devices.  An unlisted HCPCS code such as E1399 would likely be reported.

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 (Effective 10/1/2020)

REFERENCES:

  1. Asselin PK, Avedissian M, Knezevic S, et al. Training persons with spinal cord injury to ambulate using a powered exoskeleton. J Vis Exp. Jun 16 2016(112).
  2. 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.
  3. Bach Baunsgaard C, Vig Nissen U, Katrin Brust A, et al. Gait training after spinal cord injury: safety, feasibility and gait function following 8 weeks of training with the exoskeletons from Ekso Bionics. Spinal Cord. Feb 2018; 56(2): 106-116.
  4. Esquenazi A, Talaty M, Packel A, et al. The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury. Am J Phys Med Rehabil. Nov 2012; 91(11):911-921.
  5. Hartigan C, Kandilakis C, Dalley S, et al. Mobility Outcomes Following Five Training Sessions with a Powered Exoskeleton. Top Spinal Cord Inj Rehabil. Spring 2015; 21(2):93-99.
  6. Hornby TG, Reisman DS, Ward IG, et al. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. JNeurol Phys Ther. Jan 2020; 44(1): 49-100.
  7. Lajeunesse V, Vincent C, Routhier F, et al. Exoskeletons' design and usefulness evidence according to a systematic review of lower limb exoskeletons used for functional mobility by people with spinal cord injury. Disabil Rehabil Assist Technol. Sep 4 2015: 1-13.
  8. McGibbon CA, Sexton A, Jayaraman A, et al. Evaluation of the Keeogo exoskeleton for assisting ambulatory activities in people with multiple sclerosis: an open-label,randomized, cross-over trial. J Neuroeng Rehabil. Dec 12 2018; 15(1): 117.
  9. Tefertiller C, Hays K, Jones J, et al. Initial Outcomes from a Multicenter Study Utilizing the Indego Powered Exoskeleton in Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018;24(1): 78-85.
  10. U.S. Food and Drug Administration (FDA). Evaluation of automatic class III designation (de novo) for Argo ReWalk 2014; www.accessdata.fda.gov/cdrh_docs/reviews/K131798.pdf.
  11. van Dijsseldonk RB, van Nes IJW, Geurts ACH, et al. Exoskeleton home and community use in people with complete spinal cord injury. Sci Rep. Sep 24 2020; 10(1): 15600.
  12. 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. Mar 2012; 35(2):96-101.

POLICY HISTORY:

Medical Policy Panel, December 2014

Medical Policy Group, December 2014 (5): New Medical Policy which has previously been considered investigational and continues to be investigational.

Medical Policy Administration Committee, January 2015

Available for comment January 2 through February 16, 2015

Medical Policy Panel, March 2016

Medical Policy Group, March 2016 (6): Updates to Description,  Key Points,  Key Words, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, March 2017

Medical Policy Group, April 2017 (6): Updates to Description, Key Points, Key Words, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Panel, March 2018

Medical Policy Group, April 2018 (6): Updates to Description, Key Points and Key Words.  No change to policy statement.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6): Updates to Description, Key Points; No change to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points.

Medical Policy Group, September 2020: Quarterly coding update.  Added HCPCS code K1007 to Current Coding.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Description, Key Points, Governing Bodies, Practice Guidelines, Key Words and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.