Latest Review Date: March 2024

Category: Durable Medical Equipment (DME)

POLICY:

Use of a powered exoskeleton for ambulation in individuals 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 might be regarded as wearable robots designed around the shape and function of the human body. A powered exoskeleton, as described in this evidence review, 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 (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 seconds, 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 18, 2024.

Summary of Evidence:

For individuals who have lower-limb disabilities who receive a powered exoskeleton, the evidence includes 1 systematic review, 1 randomized control trial (RCT), 1 randomized cross-over study, and 1 case series describing community use. Relevant outcomes are functional outcomes, quality of life, and treatment-related morbidity. At the present, evaluation of exoskeletons is limited to small studies primarily performed in institutional settings with patients who have spinal cord injury. These studies have assessed the user’s ability to perform, under close supervision, standard tasks such as the Timed Up & Go test, 6-minutewalk test, and 10-meter walk test. A recent systematic review included these studies and qualitatively described the effects of powered exoskeletons on walking and on secondary health conditions. However, lack of high-quality studies and heterogeneity of outcome measures precluded the ability to make general conclusions. Evidence on the use of powered exoskeletons in the community or home setting is even more limited. A recent RCT compared quality of life measures in patients with spinal cord injury using in-home powered exoskeleton plus wheelchair versus wheelchair alone, and reported similar results between both groups. In addition, 1 randomized, open-label cross-over study and a case series in patients with multiple sclerosis and spinal cord injury, respectively, assessed use of powered exoskeletons in the outpatient setting. Although these studies indicate powered exoskeletons may be used safely in the outpatient setting, these devices require significant training, and their efficacy has been minimally evaluated. Further evaluation of users’ safety with these devices under regular conditions, including the potential to trip and fall, is necessary. Additional studies, particularly high-quality RCTs, are needed to determine the benefits of these devices both inside and 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:

American Physical Therapy Association

The American Physical Therapy Association published guidelines in 2020 providing recommendations to guide improvement of locomotor function after brain injury, stroke, or incomplete spinal cord injury in ambulatory patients. The guidelines recommend against the use of powered exoskeletons for use on a treadmill or elliptical to improve walking speed or distance following acute-onset central nervous system injury in patients more than 6 months post-injury due to minimal benefit and increased costs and time.

A 2022 article by Hohl et al comments on how this guideline recommendation adds uncertainty to the clinical application of powered exoskeletons in rehabilitation. Several studies referenced in the guideline did not use the Food and Drug Administration (FDA)-approved devices discussed in this review; rather, the guideline focused on treadmill-based robots, specifically the Lokomat®. Therefore, the conclusions should be interpreted with caution, given the substantial differences in functionality and physical demand between the treadmill-based robots and the powered exoskeletons of interest. Taking into consideration the limited guidance on proper use of powered exoskeletons, Hohl et al developed a framework for clinical utilization of powered exoskeletons in rehabilitation settings. The aims of the framework are to: 1) assist practitioners with clinical decision making of when exoskeleton use is clinically indicated, 2) help identify which device is most appropriate based on patient deficits and device characteristics, 3) provide guidance on dosage parameters within a plan of care, and 4) provide guidance for reflection following utilization. The framework focuses specifically on clinical application, not use of powered exoskeletons for personal mobility.

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, ReWalk ReStore, ExoAtlet-II, Ekso, Ekso GT, GEMS-H, EksoNR, Atalante, Lokomat®.

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”), and
• Weight does not exceed 100 kg (220 lbs).

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 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, 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)

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.

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. 

CURRENT CODING:

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

HCPCS:

REFERENCES:

1. Alamro RA, Chisholm AE, Williams AMM, et al. Overground walking with a robotic exoskeleton elicits trunk muscle activity in people with high-thoracic motor-complete spinal cord injury. J Neuroeng Rehabil. Nov 20 2018; 15(1): 109.
2. 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).
3. 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.
4. 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.
5. Baunsgaard CB, Nissen UV, Brust AK, et al. Exoskeleton gait training after spinal cord injury: An exploratory study on secondary health conditions. J Rehabil Med. Sep 28 2018; 50(9): 806-813.
6. Benson I, Hart K, Tussler D, et al. Lower-limb exoskeletons for individuals with chronic spinal cord injury: findings from a feasibility study. Clin Rehabil. Jan 2016; 30(1): 73-84.
7. Birch N, Graham J, Priestley T, et al. Results of the first interim analysis of the RAPPER II trial in patients with spinal cord injury: ambulation and functional exercise programs in the REX powered walking aid. J Neuroeng Rehabil. Jun 19 2017; 14(1): 60.
8. Cahill A, Ginley OM, Bertrand C, et al. Gym-based exoskeleton walking: A preliminary exploration of non-ambulatory end-user perspectives. Disabil Health J. Jul 2018; 11(3): 478-485.
9. Chang SH, Afzal T, Berliner J, et al. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018; 4: 62.
10. Chun A, Asselin PK, Knezevic S, et al. Changes in bowel function following exoskeletal-assisted walking in persons with spinal cord injury: an observational pilot study. Spinal Cord. Apr 2020; 58(4): 459-466.
11. Escalona MJ, Brosseau R, Vermette M, et al. Cardiorespiratory demand and rate of perceived exertion during overground walking with a robotic exoskeleton in long-term manual wheelchair users with chronic spinal cord injury: A cross-sectional study. Ann Phys Rehabil Med. Jul 2018; 61(4): 215-223.
12. 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.
13. Evans N, Hartigan C, Kandilakis C, et al. Acute Cardiorespiratory and Metabolic Responses During Exoskeleton-Assisted Walking Overground Among Persons with Chronic Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015; 21(2): 122-32.
14. Fineberg DB, Asselin P, Harel NY, et al. Vertical ground reaction force-based analysis of powered exoskeleton-assisted walking in persons with motor-complete paraplegia. J Spinal Cord Med. Jul 2013; 36(4): 313-21.
15. Gagnon DH, Vermette M, Duclos C, et al. Satisfaction and perceptions of long-term manual wheelchair users with a spinal cord injury upon completion of a locomotor training program with an overground robotic exoskeleton. Disabil Rehabil Assist Technol. Feb 2019; 14(2): 138-145.
16. Gagnon DH, Escalona MJ, Vermette M, et al. Locomotor training using an overground robotic exoskeleton in long-term manual wheelchair users with a chronic spinal cord injury living in the community: Lessons learned from a feasibility study in terms of recruitment, attendance, learnability, performance and safety. J Neuroeng Rehabil. Mar 01 2018; 15(1): 12.
17. Guanziroli E, Cazzaniga M, Colombo L, et al. Assistive powered exoskeleton for complete spinal cord injury: correlations between walking ability and exoskeleton control. Eur J Phys Rehabil Med. Apr 2019; 55(2): 209-216.
18. 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.
19. Hohl K, Giffhorn M., Jackson S, et al. A framework for clinical utilization of robotic exoskeletons in rehabilitation. J NeuroEngineering Rehabil. 2022:19(1). Article number 115.
20. 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.
21. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
22. Juszczak M, Gallo E, Bushnik T. Examining the Effects of a Powered Exoskeleton on Quality of Life and Secondary Impairments in People Living With Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2018; 24(4): 336-342.
23. Karelis AD, Carvalho LP, Castillo MJ, et al. Effect on body composition and bone mineral density of walking with a robotic exoskeleton in adults with chronic spinal cord injury. J Rehabil Med. Jan 19 2017; 49(1): 84-87.
24. Khan AS, Livingstone DC, Hurd CL, et al. Retraining walking over ground in a powered exoskeleton after spinal cord injury: a prospective cohort study to examine functional gains and neuroplasticity. J Neuroeng Rehabil. Nov 21 2019; 16(1): 145.
25. KolakowskyHayner SCJ. A. Safety and Feasibility of using the EksoTM Bionic Exoskeleton to Aid Ambulation after Spinal Cord Injury. J Spine. 2013; 4:456.
26. Kozlowski AJ, Bryce TN, Dijkers MP. Time and Effort Required by Persons with Spinal Cord Injury to Learn to Use a Powered Exoskeleton for Assisted Walking. Top Spinal Cord Inj Rehabil. 2015; 21(2): 110-21.
27. Kressler J, Domingo A. Cardiometabolic Challenges Provided by Variable Assisted Exoskeletal Versus Overground Walking in Chronic Motor-incomplete Paraplegia: A Case Series. J Neurol Phys Ther. Apr 2019; 43(2): 128-135.
28. Kressler J, Thomas CK, Field-Fote EC, et al. Understanding therapeutic benefits of overground bionic ambulation: exploratory case series in persons with chronic, complete spinal cord injury. Arch Phys Med Rehabil. Oct 2014; 95(10): 1878-1887.e4.
29. Kubota S, Abe T, Kadone H, et al. Hybrid assistive limb (HAL) treatment for patients with severe thoracic myelopathy due to ossification of the posterior longitudinal ligament (OPLL) in the postoperative acute/subacute phase: A clinical trial. J Spinal Cord Med. Jul 2019; 42(4): 517-525.
30. 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. Oct 2016; 11(7): 535-47 Sep 4 2015: 1-13.
31. Lonini L, Shawen N, Scanlan K, et al. Accelerometry-enabled measurement of walking performance with a robotic exoskeleton: a pilot study. J Neuroeng Rehabil. Mar 31 2016; 13: 35.
32. Manns PJ, Hurd C, Yang JF. Perspectives of people with spinal cord injury learning to walk using a powered exoskeleton. J Neuroeng Rehabil. Jul 19 2019; 16(1): 94.
33. 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.
34. McIntosh K, Charbonneau R, Bensaada Y, et al. The Safety and Feasibility of Exoskeletal-Assisted Walking in Acute Rehabilitation After Spinal Cord Injury. Arch Phys Med Rehabil. Jan 2020; 101(1): 113-120.
35. Platz T, Gillner A, Borgwaldt N, et al. Device-Training for Individuals with Thoracic and Lumbar Spinal Cord Injury Using a Powered Exoskeleton for Technically Assisted Mobility: Achievements and User Satisfaction. Biomed Res Int. 2016; 2016: 8459018.
36. Ramanujam A, Cirnigliaro CM, Garbarini E, et al. Neuromechanical adaptations during a robotic powered exoskeleton assisted walking session. J Spinal Cord Med. Sep 2018; 41(5): 518-528.
37. Ramanujam A, Momeni K, Husain SR, et al. Mechanisms for improving walking speed after longitudinal powered robotic exoskeleton training for individuals with spinal cord injury. Annu Int Conf IEEE Eng Med Biol Soc. Jul 2018; 2018: 2805-2808.
38. Sale P, Russo EF, Scarton A, et al. Training for mobility with exoskeleton robot in spinal cord injury patients: a pilot study. Eur J Phys Rehabil Med. Oct 2018; 54(5): 745-751.
39. Sale P, Russo EF, Russo M, et al. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. Jan 28 2016; 16: 12.
40. Spungen AM, Bauman WA, Biswas K, et al. The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury. Contemp Clin Trials. Sep 2020; 96: 106102.
41. Stampacchia G, Rustici A, Bigazzi S, et al. Walking with a powered robotic exoskeleton: Subjective experience, spasticity and pain in spinal cord injured persons. NeuroRehabilitation. Jun 27 2016; 39(2): 277-83.
42. 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. Jun 2013; 2013: 6650469.
43. Tamburella F, Lorusso M, Tramontano M, et al. Overground robotic training effects on walking and secondary health conditions in individuals with spinal cord injury: systematic review. J Neuroeng Rehabil. Mar 15 2022; 19(1): 27.
44. 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.
45. Tsai CY, Delgado AD, Weinrauch WJ, et al. Exoskeletal-Assisted Walking During Acute Inpatient Rehabilitation Leads to Motor and Functional Improvement in Persons With Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. Apr 2020; 101(4): 607-612.
46. 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.
47. 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.
48. van Dijsseldonk RB, Rijken H, van Nes IJW, et al. Predictors of exoskeleton motor learning in spinal cord injured patients. DisabilRehabil. Jul 2021; 43(14): 1982-1988.
49. Yang A, Asselin P, Knezevic S, et al. Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015; 21(2): 100-9.
50. Yatsugi A, Morishita T, Fukuda H, et al. Feasibility of Neurorehabilitation Using a Hybrid Assistive Limb for Patients Who Underwent Spine Surgery. Appl Bionics Biomech. 2018; 2018: 7435746.
51. 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.

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (6): Updates to Key Points, Governing Bodies, Practice Guidelines and Key Words.

Medical Policy Panel, March 2023

Medical Policy Group, March 2023 (6) Updates to Key Points, Governing Bodies, Benefit Application, Key Words (ExoAtlet-II, Ekso, Ekso GT, GEMS-H, EksoNR, Atalante, Lokomat®) and References.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6): Updates to Description, Key Points, Governing Bodies, and Current Coding (+E0739 April HCPCS coding update).

Medical Policy Group, September 2024 (6): Quarterly Coding Update, updated E0739 to read Rehabilitation.

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.