Latest Review Date: July 2024

Category: Durable Medical Equipment (DME)

POLICY:

Standing Devices

Standing Devices may be considered medically necessary when the following criteria are met:

There is documentation that the stander is necessary for the user to be independent in one or more of the following activities of daily living in his/her home:

• Eating;
• Personal hygiene;
• Toileting;
• Dressing;
• Transfer.

AND

The individual is unable to accomplish the above activities with their current DME device or equipment;

OR

There is documentation that off-loading of a decubitus ulcer cannot be accomplished by other means;

AND

The individual has completed a one-month trial using the standing device/gait trainer and has shown meaningful improvement after the trial period. Documentation from the referring provider must show that the individual has shown meaningful improvement during the trial period.

Standing devices requested for vocational usage are considered investigational.

Powered standing systems or electric lift mechanisms are considered investigational.

Gait Trainers

Gait Trainers may be considered medically necessary when the following criteria are met:

There is documentation of the individual’s mobility limitation;

AND

The individual has the potential for ambulation;

AND

The individual is unable to accomplish gait training activities with their current DME device or equipment.

AND

There is a written home therapy plan (a plan for treatment in the home rather than an institutional setting) developed with emphasis on skill carryover, and goals that target the member's functional use of the requested gait trainer in the home, and there is a caretaker who can appropriately supervise use of the gait trainer.

Gait trainers are non-covered if the following applies:

• There is no expected improvement in mobility or maintenance of function.

• The individual currently has equipment to accomplish the same purpose.

• The equipment is non-medical, such as a glider.

• Deluxe/upgraded features that do not contribute to the therapeutic function of the gait trainer.

Standing devices or Gait Trainers for the sole purpose of helping an individual reach high places or storage areas are considered not medically necessary.

Accessories that are not primarily used to serve a medical purpose and are primarily used for comfort and/or convenience of the individual or caregiver including, but not limited to color options, tote bags, cup holders, baskets, are considered investigational.

Accessories that are used to serve a medical purpose (e.g., knee pads, elbow pads, tray for anterior support) that are upgraded over the standard product are considered investigational.

POLICY GUIDELINES:

Standers and Gait trainers require individualized, patient specific medical justification from the individual’s orthopedic surgeon, neurologist, developmental pediatrician, or physiatrist to determine medical necessity. Justification must be submitted for review that includes the individual’s diagnosis, a narrative description with functional criteria for the stander or gait trainer, and any requested non-standard features, including wheels. At a minimum, such documentation must include all the following:

• Diagnosis, prognosis and severity of condition;
• Description of functional goals and current standing/gait training program;
• Re-evaluation of the member at the end of the trial period for the standing/gait training program (e.g., how long and how many times per day or week the stander/gait trainer was used) and documented effectiveness of standing/gait training trial program;
• History of standing and compliance when a stander is requested; assessment of ability to ambulate or potential to ambulate when a gait trainer is requested.
• If nonstandard features are requested (e.g., mobile [wheeled] or multi-positional standing device) an explanation as to why a standard device is inadequate for the particular activity or indication AND that other standard devices have been trialed and found inadequate to meet the individual's needs;
• Other DME equipment the individual currently uses; and
• Relevant medical records.

When a wheelchair-integrated model is requested, a review is conducted to determine when the last wheelchair was obtained. If it is within 2 years, an additional allowance is made only for the basic standing device.

DESCRIPTION OF PROCEDURE OR SERVICE:

A stander is a device that enables the user of a wheeled mobility device (wheelchair or wheelchair and seated positioning system) to achieve a passive standing position. The devices are available by physician prescription only. There are three basic types of standers: supine, prone, and upright.

• Supine standers support the back surface of the body and require the least amount of trunk and head control.

• Prone standers support the front of the body while the user is supported in various angles.

• Upright standers are used primarily in the vertical position by individuals who have fair to good trunk and head control.

• Multi-positional standers combine all three types of standers into a single stander to allow for a variety of positioning needs. They are equipped with cushions to secure the head, trunk, hip, knees and feet. A foot operated pneumatic tilt permits the angle of the stander to be adjusted.

Standing devices have been proposed for individuals who are wheelchair dependent including, but not limited to, patients with cerebral palsy, spinal cord injuries, muscular dystrophy, paraplegia, quadriplegia, multiple sclerosis, spina bifida, traumatic brain injury and paralytic syndromes.

Proposed medical benefits of standing include:

• Improve/maintain bone integrity/skeletal development

• Lessen/manage the progression of scoliosis

• Strengthen cardiovascular system and build endurance

• Improve Circulation

• Reduce Swelling

• Improve bowel function and regularity

• Aid in kidney and bladder functions

• Improve/maintain range of motion

• Management of atrophy in the trunk and lower extremities

• Manage pressure (ulcers) through changing positions

• Improve strength to trunk and lower extremities

• Decrease joint/muscle contractures

Gait trainers are assistive devices which enable an individual to be placed in an upright position to learn or relearn mobility skills safely and efficiently. Gait trainers are lightweight and may be equipped with armrests, seat and chest supports. Gait trainers have been proposed for individuals with spinal cord injuries, broken legs or pelvis, strokes or neurological disorders, muscular dystrophy or other musculoskeletal disorders.

Gait training has been proposed for individuals who have had an illness or injury that affects their ability to get around or walk. Proposed medical benefits of gait training include:

• Strengthen your muscles and joints

• Improve your balance and posture

• Build your endurance

• Develop your muscle memory

• Retrain your legs for repetitive motion

• Lower your risk of falls, while increasing your mobility

Meaningful improvement after a one-month trial of a standing device may include: improvement in the functional use of the arms or hands, or head and trunk control, improvements in the performance of activities of daily living (ADLs), or improvements in digestive, respiratory, circulatory or excretory function, and skin integrity, by off-loading weight through standing (e.g., relief of pressure sores not achievable by other means). Improvements in skin integrity may include lack of progression or signs of healing in the decubiti ulcer.

KEY POINTS:

A literature review has been completed through July 9, 2024.

Summary of Evidence

Standing Device

For individuals who are not independent in one or more activities of daily living in their home, are unable to accomplish these activities of daily living without their DME device, off-loading a decubitus ulcer cannot be accomplished by any other means, and need of a standing device, the evidence includes systematic reviews, randomized control trials, and a cross-sectional study.  Relevant outcomes include duration of standing, bowel function, hip stability, range of motion, and bone mineral density. The participants in one study, were children with spastic diplegia cerebral palsy (CP), classified at Level III according to the Gross Motor Function Classification System (GMFCS). Thirteen children stood with hip abduction at least 1 hour daily from 12 to 14 months of age to 5 years with an individually fabricated standing frame with hip abduction. At the age of 5 years, radiologic results of the study group were compared with a comparison group of 13 children with spastic diplegia CP who had not taken part in a standing program. The migration percentage in all children who stood with abduction remained within stable limits (13-23%) at 5 years of age, in comparison to children who did not stand in abduction (12-47%) (p < 0.01).  A cross-sectional study compared 3 groups of patients with SCI: patients with daily standing times of more than 1 hour, patients with daily standing times of less than 1 hour, and non-standing patients. The patients in the group that stood more than 1 hour daily had a slight tendency to have higher t-scores than those in the control group. There was no significant difference among the 3 groups. Although there is limited evidence for standing programs as a therapeutic modality, they have been part of the program of management of children with developmental disorders and children and adults with spinal cord injuries for many years. Additionally, standing might be partially helpful in protecting the bone density in SCI by opposing the effects of immobilization. The evidence is sufficient that this technology may result in meaningful improvement in the net health outcome.

Gait Trainers

For individuals who have a mobility limitation and has the potential for ambulation and need of a gait trainer, the evidence includes systematic reviews, randomized control trials, non-randomized studies, and case reports. Relevant outcomes include walking distance, number of steps, level of mobility, range of motion and activity level. Evidence from one small randomized controlled trial suggests a non-significant trend toward increased walking distance while the other evidence level II study (concurrent multiple baseline design) reports increased number of steps. Two level III studies (non-randomized two-group studies) report statistically significant impact on mobility level with one finding significant impact on bowel function and an association between increased intervention time and bone mineral density. The evidence is sufficient that this technology may result in meaningful improvement in the net health outcome.

Practice Guidelines and Position Statements:

None identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Gait trainer, standing device, stander, supine standers, prone standers, upright standers, Rifton Supine Standers, Leckey Freestander, Jenx Monkey, Rifton Prone Stander, Tumbleform Tristander 45/58, Tumbleform 2 Tristander, Easy Stand Bantum, Ottobock, Mygo Stander, glider

APPROVED BY GOVERNING BODIES:

Not applicable.

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 contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

HCPCS Codes:

REFERENCES:

1. Altizer W, Noritz G, Paleg G Use of a dynamic gait trainer for a child with thoracic level spinal cord injury Case Reports 2017;2017:bcr-2017-220756.
2. Booth ATC, Buizer AI, Meyns P, Oude Lansink ILB, Steenbrink F, van der Krogt MM. The efficacy of functional gait training in children and young adults with cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2018;60(9):866-883. doi:10.1111/dmcn.13708
3. Caulton JM, Ward KA, Alsop CW, et al. A randomized controlled trial of a standing program on bone mineral density in nonambulant children with cerebral palsy. Archives of Disease in Childhood. 2004; 89:131-5.
4. Eng JJ, et al. Use of prolonged standing for individuals with spinal cord injuries. Phys Ther 2001 Aug;81(8):1392-9.
5. Glickman, LB, Geigle PR, Paleq GS. A systematic review of supported standing programs. J Pediatr Rehabil Med. 2010; 3(3):197- 213.
6. Gharib NM, El-Maksoud GM, Rezk-Allah SS. Efficacy of gait trainer as an adjunct to traditional physical therapy on walking performance in hemiparetic cerebral palsied children: a randomized controlled trial. Clin Rehabil. 2011 Oct;25(10):924-34.
7. Gibson SK, Sprod JA, Maher CA. The use of standing frames for contracture management for nonmobile children with cerebral palsy. Int J Rehabil Res. 2009 Dec;32(4):316-23.
8. Goktepe A., Does standing protect bone density in patients with chronic spinal cord injury? J Spinal Cord Med. 2008; 31(2):197-201.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. Kwok S., Spinal Cord. Does regular standing improve bowel function in people with spinal cord injury? A randomised crossover trial. 2015 Jan;53(1):36-41.
11. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrés M, A Stuberg W. Disabil Rehabil.  Effects of the standing program with hip abduction on hip acetabular development in children with spastic diplegia cerebral palsy. 2016 Jun;38(11):1075-81.
12. Ostensjo S, Carlberg EB, Vollestad NK. The use and impact of assistive devices and other environmental modifications on everyday activities and care in young children with cerebral palsy. Disabil Rehabil. 2005; 27(14):849-861.
13. Paleg G, Livingstone R. Outcomes of gait trainer use in home and school settings for children with motor impairments: a systematic review. Clin Rehabil. 2015b Nov;29(11):1077-91.
14. Paleg GS, Smith BA, Glickman LB Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther.2013 Fall;25(3):232-47.
15. Paleg G, Livingstone R. Outcomes of gait trainer use in home and school settings for children with motor impairments: a systematic review. Clin Rehabil. 2015; 29(11):1077-1091.
16. Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord. 2015a Nov 17;16:358.
17. Paleg G, Livingstone R. Evidence-informed clinical perspectives on selecting gait trainer features for children with cerebral palsy. Int J Ther Rehabil. 2016 Aug;23(8).
18. Paleg, Ginny & Livingstone, Roslyn. (2016). Evidence-informed clinical perspectives on selecting gait trainer features for children with cerebral palsy. International Journal of Therapy and Rehabilitation. 23. 444-454. 10.12968/ijtr.2016.23.9.444.
19. Shemy SA, Trunk endurance and gait changes after core stability training in children with hemiplegic cerebral palsy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1159-1167.
20. Walter JS, Sola PG, Sacks J, Lucero Y, Langbein E, Weaver F. Indications for a home standing program for individuals with spinal cord injury. J Spinal Cord Med. 1999 Fall;22(3):152-8.

POLICY HISTORY:

New Medical Policy. DRAFT comment period through July 12, 2019.

Medical Policy Group, June 2020 (6): Updates to Key Points. No change to policy intent.

Medical Policy Group, December 2020 (6): Expanded policy statement to include non-covered statement regarding medical accessory upgrades.

Medical Policy Group, August 2021 (6): Updates to Key Points and References.

Medical Policy Group, July 2022 (6): Updates to Policy statement, Key Points, Key Words and References.

Medical Policy Group, March 2023 (6): Updates to Benefit Application and Key Words.

Medical Policy Group, July 2023 (6): Updates to Key Points and Benefit Application. No change to policy intent.

Medical Policy Group, July 2024 (6): Updates to Key Points and References.

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.