Cigna Wheelchairs/Power Operated Vehicles - (0030) Form

The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment and have discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. This Coverage Policy addresses criteria related to standard manual wheelchairs, specialized manual wheelchairs and strollers, power mobility devices, power operated vehicles (POVs), power wheelchairs (PWCs), custom motorized/power wheelchair bases, push-rim activated power assist devices, and wheelchair options and accessories. Coverage Policy Coverage for wheelchairs and power-operated vehicles (POV)/scooters (3–4-wheeled) varies across plans. Refer to the customer’s benefit plan document for coverage details. If coverage for wheelchairs and POV/scooters (3–4-wheeled) is available, the following conditions of coverage apply. Standard Manual Wheelchairs Medical Coverage Policy: 0030 A standard manual wheelchair (HCPCS code K0001) is considered medically necessary when ALL of the following criteria are met: The individual would otherwise be confined to a bed or chair. The individual is considered confined to a bed or chair if he or she is unable to ambulate from, for example, bed to bathroom, bedroom to kitchen, or around the home. The individual has a disease process or injury for which weight-bearing and/or ambulation is contraindicated. The individual has a disease process or injury that precludes use of the lower extremities (e.g., a neuromuscular disease). Specialized Manual Wheelchairs and Strollers A manual wheelchair that can accommodate rehabilitative accessories and features (e.g., tilt in space) is provided by a supplier that employs a certified Assistive Technology Professional (ATP) who specializes in wheelchairs. A specialized manual wheelchair and/or wheelchair enhancement is considered medically necessary when the individual meets medical necessity criteria for a standard wheelchair AND the additional accompanying criteria for the specified enhancement are also met: A standard hemi-wheelchair (HCPCS code K0002) is considered medically necessary when the individual requires a lower seat height (17"–18") because of short stature or cannot otherwise place his or her feet on the ground for propulsion. A lightweight wheelchair (HCPCS code K0003) is considered medically necessary when the individual cannot self-propel in a standard wheelchair but is able to self-propel in a lightweight wheelchair. A high-strength, lightweight wheelchair (HCPCS code K0004) is considered medically necessary when EITHER of the following additional criteria is met:  The individual can self-propel a high-strength lightweight wheelchair while engaging in frequently performed activities that cannot otherwise be completed in a standard or lightweight wheelchair.  The individual requires a seat width, depth or height that cannot be accommodated in a standard, lightweight or hemi-wheelchair and spends at least two hours per day in the wheelchair. An ultra-lightweight wheelchair (HCPCS code K0005) is considered medically necessary when the individual meets the above criteria for a lightweight wheelchair AND ALL of the following criteria:  The individual requires adjustability in the axle, seat and riggings of an ultra-lightweight wheelchair.  A specialty evaluation performed by a licensed/certified medical professional (LCMP), (such as a physical therapist, occupational therapist, or physician) who has specific training and experience in rehabilitation wheelchair evaluations documents the medical necessity for the wheelchair and its special features.  The enhanced features are needed for the individual to participate in the activities of daily living.* A heavy-duty wheelchair (HCPCS code K0006) is considered medically necessary if the individual weighs more than 250 pounds or has severe spasticity. An extra-heavy-duty wheelchair (HCPCS code K0007) is considered medically necessary if the individual weighs more than 300 pounds. A custom wheelchair base (HCPCS code K0008, K0009, E1220–E1224) is considered medically necessary only if the feature needed is not available as an option to an existing manufactured base. Medical Coverage Policy: 0030 A pediatric size wheelchair (HCPCS code E1229, E1231–E1238) is considered medically necessary if a seat width and/or depth of 14 inches or less is recommended. A customized pediatric stroller is considered medically necessary for an individual who is non- ambulatory when EITHER of the following conditions apply:  The individual requires more support than is available in a standard pediatric wheelchair.  The individual is too small to safely use a standard pediatric wheelchair. A manual wheelchair with tilt in space (HCPCS code E1161) is considered medically necessary when a specialty evaluation was performed by a licensed/certified medical professional (LCMP), such as a physical therapist, occupational therapist, or physician who has specific training and experience in rehabilitation wheelchair evaluations documents the medical necessity for the wheelchair and its special features. An ultra-lightweight wheelchair (HCPCS code K0005) which has enhanced features designed for use outside of the home or for leisure or recreational activities is considered a convenience item and not medically necessary. Power Mobility Devices The following power mobility devices are considered medically necessary contingent upon meeting the associated device-specific criteria: power wheelchair (PWC) • power-operated vehicle (POV)/scooter (i.e., 3–4 wheeled) • push-rim activated power assist device The supporting materials submitted with a request for a Power Mobility Device should include a formal written face-to-face evaluation by a physical therapist (PT), occupational therapist (OT), or physician. The requesting PT, OT, or physician should be trained and experienced in rehabilitation power mobility device evaluations and should have no financial relationship with the supplier or manufacturer. The evaluation should clearly state why the specific device and enhancements (if any) are being requested and why they are medically necessary for the individual. Power Operated Vehicle (POV) A POV (HCPCS code E1230, K0800–K0802, K0812) is considered medically necessary when ALL of the following criteria are met: The individual has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADLs) (e.g., toileting, feeding, dressing, grooming, and bathing) in the home. The individual’s mobility limitation cannot be resolved by the use of an appropriately fitted cane or walker. The individual does not have sufficient upper extremity function to self-propel a manual wheelchair in the home to perform MRADLs. The individual is able to transfer to and from a POV, can operate the tiller steering system and can maintain postural stability and position while operating the POV in the home. The individual’s mental capabilities (e.g., cognition, judgment) and physical capabilities (e.g., vision) are sufficient for safe mobility using a POV in the home. The individual’s home provides adequate access between rooms, maneuvering space, and surfaces for the operation of the POV being requested. The individual’s weight does not exceed the weight capacity of the POV being requested. Medical Coverage Policy: 0030 Use of a POV will significantly improve the individual’s ability to participate in MRADLs, and the individual will use it in the home. The individual is agreeable to the use of a POV in the home. A Group 2 POV (HCPCS code K0806–K0808) which has enhanced features designed for use outside of the home is considered medically necessary when the POV criteria above are met and the enhanced features are needed for the individual to participate in the activities of daily living in school and/or employment*. A Group 2 POV (HCPCS code K0806–K0808) which has enhanced features designed for use outside of the home or for leisure or recreational activities is considered a convenience item and not medically necessary. Power Wheelchair (PWC) A PWC (HCPCS code E1239, K0010–K0012, K0014) is considered medically necessary when ALL of the following criteria are met: The individual has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADLs) (e.g., toileting, feeding, dressing, grooming, and bathing) in the home. The individual’s mobility limitation cannot be resolved by the use of an appropriately fitted cane or walker. The individual does not have sufficient upper extremity function to self-propel a manual wheelchair in the home to perform MRADLs. The individual has the mental and physical capabilities to safely operate the PWC being requested or the individual has a caregiver who is unable to adequately propel an optimally configured manual wheelchair, but is available, willing, and able to safely operate the PWC being requested. • The individual’s weight does not exceed the weight capacity of the PWC being requested. • The individual’s home provides adequate access between rooms, maneuvering space, and surfaces for the operation of the PWC being requested. Use of a power wheelchair will significantly improve the individual’s ability to participate in MRADLs, and the individual will use it in the home. For individuals with severe cognitive and/or physical impairments, participation in MRADLs may require the assistance of a caregiver. The individual is agreeable to the use a PWC in the home. A custom motorized/power wheelchair base (HCPCS code K0013) is considered medically necessary when the individual meets the above criteria for a PWC, AND BOTH of the following: The duration of need for the chair is expected to be three months or longer. • The specific configurational needs of the individual are not able to be met using wheelchair cushions, or options or accessories (prefabricated or custom fabricated) which may be added to another power wheelchair base. Power Wheelchair (PWC) with Group-Related Criteria A Group 2 and Group 3 PWC with power options is provided by a supplier that employs a certified Assistive Technology Professional (ATP) who specializes in wheelchairs. A PWC with group-related criteria (HCPCS code K0813–K0815, K0816, K0820–K0829, K0835–K0843, K0848–K0855, K0856–K0864, K0868–K0871, K0877–K0880, K0884–K0886, K0890, K0891) is considered medically necessary when the above PWC criteria are met AND the following group-related criteria for the PWC being requested are met: Medical Coverage Policy: 0030 Group 1 standard PWC (HCPCS code K0813–K0816) or Group 2 standard PWC (HCPCS code K0820–K0829) when the wheelchair is appropriate for the individual’s weight. Group 2 single power option PWC (HCPCS code K0835–K0840) when the individual requires a drive control interface other than a hand- or chin-operated standard proportional joystick (e.g., head control, sip and puff, switch control) or meets criteria for a power tilt, power recline, or combination power tilt/power recline seating system and the system is to be used on the wheelchair. Group 2 multiple power option PWC (HCPCS code K0841–K0843) when the individual meets medical necessity criteria for a power tilt, power recline, or combination power tilt/power recline seating system and the system is to be used on the wheelchair and/or the individual uses a ventilator which is mounted on the wheelchair. Group 3 PWC with no power options (HCPCS code K0848–K0855) when the individual's mobility limitation is due to a neurological condition, myopathy, or congenital skeletal deformity. Group 3 PWC with single power option (HCPCS code K0856–K0860) when the individual's mobility limitation is due to a neurological condition, myopathy, or congenital skeletal deformity and the Group 2 single power option criteria are met. Group 3 PWC with multiple power options (HCPCS code K0861–K0864) when the individual's mobility limitation is due to a neurological condition, myopathy, or congenital skeletal deformity and the Group 2 multiple power option criteria are met. Group 4 PWC with enhanced features for use outside the home (HCPCS code K0868–K0871, K0877–K0880, K0884–K0886) when ALL of the following apply:  The individual's mobility limitation is due to a neurological condition, myopathy, or congenital skeletal deformity.  Group 3 multiple power option criteria are met.  Enhanced features are needed for the individual to participate in the activities of daily living in school and/or employment*. A Group 5 pediatric PWC with single power option (HCPCS code K0890) when the individual is expected to grow in height and the Group 2 single power option criteria are met. A Group 5 pediatric PWC with multiple power options (HCPCS code K0891) when the individual is expected to grow in height and the Group 2 multiple power option criteria are met. A Group 4 PWC (HCPCS code K0868–K0871, K0877–K0880, K0884–K0886) for use outside of the home for leisure or recreational activities is considered a convenience item and not medically necessary. Push-Rim Activated Power Assist Device A push-rim activated power assist device (HCPCS code E0986) for a manual wheelchair is considered medically necessary when ALL of the following criteria are met: The individual has a mobility limitation that significantly impairs his/her ability to participate in one or more mobility-related activities of daily living (MRADLs) (e.g., toileting, feeding, dressing, grooming, and bathing) in the home. The individual’s mobility limitation cannot be resolved by the use of an appropriately fitted cane or walker. The individual has been self-propelling in a manual wheelchair for at least one year but no longer has sufficient upper extremity function to self-propel a manual wheelchair in the home to perform MRADLs. Medical Coverage Policy: 0030 The enhanced features are needed for the individual to participate in the activities of daily living in school and/or employment*. A push-rim activated power assist device (HCPCS code E0986) for a manual wheelchair for use outside of the home for leisure or recreational activities is considered a convenience item and not medically necessary One month’s rental of a PWC or POV (HCPCS code K0462) is considered medically necessary if the individual-owned PWC or PVC is being repaired. Wheelchair Options and Accessories Certain wheelchair components/accessories are considered incidental to/included in the allowance for particular wheelchairs/power-operated vehicles therefore separate reimbursement will not be allowed for these components/accessories when provided in association with the particular wheelchair/power- operated vehicle. Refer to the Coding Section of this policy for the list of items. Options and accessories for wheelchairs are considered medically necessary when the individual meets medical necessity criteria for a wheelchair and the options/accessories are required for the individual to function successfully in the home or to perform the usual activities of daily living. Any option or accessory that is primarily for the purpose of allowing the individual to perform leisure or recreational activities is considered not medically necessary. If an individual-owned POV* meets medical necessity criteria, necessary replacement items may be considered for coverage per the terms and conditions of the applicable DME benefit. In general, the allowance for a POV includes all options and accessories that are provided at the time of initial use, including but not limited to, batteries, battery chargers, seating systems, etc. Miscellaneous options, accessories or replacement parts for wheelchairs that do not have a specific HCPCS code and are not included in another code should be coded HCPCS K0108. Each of the following options is considered medically necessary when the accompanying qualifying criteria are met: Arm of chair: Adjustable arm height (HCPCS code E0973, K0017, K0018, K0020) is considered medically necessary if the individual requires an arm height that is different from the arm height of nonadjustable arms, and the individual spends at least two hours a day in the wheelchair. An arm trough (HCPCS code E2209) is considered medically necessary if the individual has quadriplegia, hemiplegia or uncontrolled arm movements. Batteries/Chargers: A battery charger (HCPCS code E2366) may be considered medically necessary, but it is generally included in the allowance for a PWC base. Special batteries are considered medically necessary if they are specifically designed to provide a power supply for a currently medically necessary PWC (HCPCS code E2359, E2361, E2363, E2365, E2371, K0733). Off-the-shelf batteries that can also be used to power non-medical items are not considered DME and are, therefore, considered not medically necessary. The usual maximum frequency of replacement for a lithium-based battery (HCPCS code E2397) is one every three years. Only one lithium battery is allowed at any one time. Footrest/Leg rest: Medical Coverage Policy: 0030 An elevating leg rest (HCPCS code E0990, K0046, K0047, K0053, K0195) is considered medically necessary when ANY of the following criteria is met:  The individual has a musculoskeletal condition requiring elevation of one or both legs.  The individual has a cast or brace that prevents 90-degree flexion at the knee.  The individual has significant edema of the lower extremities.  The criteria for a reclining back option are met. Nonstandard Seat Frame Dimensions: Nonstandard seat width and/or depth for a manual wheelchair (HCPCS code E2201–E2204) are considered medically necessary only if the individual’s body habitus justifies the need. Power Tilt and/or Recline Seating System A tilt or recline only, or combination tilt and recline power seating system, with or without power elevating leg rests (HCPCS code E1002–E1010, E1012) is considered medically necessary if the individual meets the medical necessity criteria for a PWC outlined above and ANY of the following criteria is met:  The individual is at high risk for development of a pressure ulcer and is unable to perform a functional weight shift.  The individual utilizes intermittent catheterization for bladder management and is unable to independently transfer from the wheelchair to bed.  The power seating system is needed to manage increased tone or spasticity. Power Wheelchair Drive Control Systems: An attendant control (HCPCS code E2331) is considered medically necessary when it is used in place of a patient-operated drive control system and ALL of the following are met:  The individual meets coverage criteria for a wheelchair.  The individual is unable to operate a manual or power wheelchair.  The individual has a caregiver who is unable to operate a manual wheelchair but is able to operate a power wheelchair. Wheels/Tires for Manual Wheelchairs: A gear reduction drive wheel for a manual wheelchair (HCPCS code E2227) is considered medically necessary for individuals who have been self-propelling in a manual wheelchair for at least one year. Other Power Wheelchair Accessories: An electronic interface (HCPCS code E2351) is considered medically necessary to allow a speech- generating device to be operated by the PWC control interface if the individual has a medically necessary speech-generating device. Seat Cushions/Supports: A general use seat cushion (HCPCS code E2601, E2602) and/or back cushion (HCPCS code E2611, E2612) are considered medically necessary for an individual who has a manual wheelchair or a PWC with a sling/solid seat/back. However, a seat or back cushion is considered a comfort item and not medically necessary if it is provided for use with a transport chair or the individual has a POV or a PWC with a captain’s seat. Medical Coverage Policy: 0030 A skin protection seat cushion (HCPCS code E2603, E2604, E2622, E2623), positioning seat (HCPCS code E2605, E2606) or back (HCPCS code E2613–E2616, E2620, E2621) cushion, combination skin protection and positioning seat cushion (HCPCS code E2607, E2608, E2624, E2625), and position accessory (HCPCS code E0953, E0955, E0956, E0957, E0960) are considered medically necessary for an individual who meets ANY of the following criteria:  past history of or current pressure ulcer on the area of contact with the seating surface  absent or impaired sensation in the area of contact with the seating surface due to one of the following diagnoses: spinal cord injury, other etiology of quadriplegia or paraplegia, other spinal cord disease, multiple sclerosis, other demyelinating disease, cerebral palsy, anterior horn cell diseases including amyotrophic lateral sclerosis, post-polio paralysis, spina bifida, childhood cerebral degeneration, Alzheimer’s disease, Parkinson’s disease, muscular dystrophy, hemiplegia, Huntington’s chorea, idiopathic torsion dystonia, athetoid cerebral palsy, arthrogryposis, osteogenesis imperfecta, spinocerebellar disease, or transverse myelitis  significant postural asymmetries due to one of the above diagnoses or to one of the following diagnoses: hemiplegia or monoplegia of the lower limb due to stroke, traumatic brain injury, or other etiology, spinocerebellar disease; above knee leg amputations, osteogenesis imperfecta, or transverse myelitis A custom fabricated back or seat cushion (HCPCS code E2609, E2617) is considered medically necessary if BOTH of the following criteria are met:  The individual meets all the criteria for a prefabricated positioning back or seat cushion.  A comprehensive written evaluation by a licensed/certified medical professional (i.e., PT, OT, or physician), which clearly explains why a prefabricated seating system does not meet the individual’s seating and positioning needs. A solid seat support base for a seat cushion with mounting hardware (HCPCS code E2231) is considered medically necessary when it is used with a manual wheelchair. A solid support base is included in the allowance for a PWC. Miscellaneous Accessories: An anti-rollback device (HCPCS code E0974) is considered medically necessary if the individual propels himself/herself and needs the device because of ramps. An electrical connection device upgrade (HCPCS code E2311) is considered medically necessary unless the need for the upgrade is due to non-medically necessary power accessories (i.e., seat lift and power seating). A safety belt/pelvic strap (HCPCS code E0978, E0980) is considered medically necessary if the individual has weak upper body muscles, upper body instability or muscle spasticity that requires use of this item for proper positioning. A fully reclining back option (HCPCS code E1226) is considered medically necessary if ANY of the following pertains to the individual:  high risk for development of a pressure ulcer and is unable to perform a functional weight shift  utilizes intermittent catheterization for bladder management and is unable to independently transfer from the wheelchair to the bed  manage increased tone or spasticity Medical Coverage Policy: 0030 A headrest (HCPCS code E0955) is considered medically necessary with a medically necessary manual tilt-in-space wheelchair, manual semi- or fully-reclining back on a manual wheelchair, a manually fully-reclining back on a PWC, or power tilt and/or recline power seating system. A crutch or cane holder (HCPCS code E2207) may be considered medically necessary for individuals who are able to ambulate for short distances. Shock absorbers (HCPCS code E1015-E1018) are considered medically necessary when there is a risk of spasm/myoclonus in an individual with a myoclonic condition (e.g., spastic cerebral palsy). Transport tie down (HCPCS code K0108) is considered medically necessary for transporting a power wheelchair. REPLACEMENT & DUPLICATE EQUIPMENT In general, duplicate equipment is considered a convenience item and not medically necessary. Replacement of a medically necessary wheelchair and power-operated vehicle (POV)/scooter (3–4- wheeled) is considered medically necessary only when there is anatomical change or when reasonable wear and tear renders the item nonfunctioning and not repairable and there is coverage for the specific item available under the plan. NON-MEDICALLY NECESSARY ITEMS Each of the following items is considered one or more of the following: not medically necessary, not primarily medical in nature, a self-help or convenience item; and/or specifically excluded under the benefit plans: dual mode charger (HCPCS code E2367) or a non-sealed battery (HCPCS code E2358, E2360, E2362, E2364, E2372) for a PWC stair-climbing wheelchairs, computerized or gyroscopic mobility systems (e.g., iBOT® Personal Mobility Device) (HCPCS code K0011) transport chairs or rollabout chairs (HCPCS code E1031, E1037, E1038, E1039) • power seat elevation options (HCPCS code E2300) • adjustable manual height booster base seating system • • power or manual standing options or standing wheelchairs (HCPCS code E2301, E2230) • anterior power tilt (HCPCS code K0108) • powered wheelchair seat cushions (HCPCS code E2610) • electronic interfaces for lights or other electronic devices • electronic balance feature for a PWC • “ability to balance on two wheels” feature for a PWC • remote operation feature for a PWC • sensor system for collision avoidance (e.g., LUCI) • wheelchair accessory, tray (HCPCS code E0950) • commode seat, wheelchair (HCPCS code E0968) • rental or purchase of more than one mobility assistive device at a time • any wheelchair, option, or accessory that is primarily for the purpose of allowing the individual to perform leisure or recreational activities seat elevator wheelchairs (HCPCS code K0830, K0831) wheelchair-mounted assistive robotic arm (e.g., Kinova® Jaco® Assistive Robotic Arm) • home/property modifications or fixtures to real property including, but not limited to, ramps, accessible showers, elevators, lowered bath or kitchen counters and sinks, and grab bars miscellaneous items needed to adapt to the outside environment for convenience, work, leisure or recreational activities including, but not limited to:  auto carriers  baskets, backpacks, bags, seat pouches used to transport personal belongings Medical Coverage Policy: 0030   gloves     snow tires for wheelchairs  support or mounting frames for cellular phone firearm/weapon holder/support lifts for car trunk, stairways, seat lifts and individual lifts lowered seat elevator attachments for powered or motorized wheelchairs ramps General Background This information on wheelchairs has been developed through consideration of medical necessity and generally accepted standards of medical practice, as well as review of medical literature and government approval status. In May 2005, a national coverage decision for mobility assistive equipment (MAE) by the Centers for Medicare and Medicaid Services (CMS) stated that the evidence is adequate to determine that MAE (e.g., manual and power wheelchairs [PWCs] and scooters) is reasonable and necessary for individuals who have a personal mobility deficit sufficient to impair their participation in mobility-related activities of daily living (MRADLs) such as feeding, toileting, dressing, grooming, and bathing in customary locations in the home. The following sequential questions provide guidance for determining if a mobility deficit exists: Does the individual have a mobility limitation that significantly impairs his/her ability to participate in one or more MRADLs in the home? A mobility limitation is one that:  prevents the individual from accomplishing the MRADLs entirely, or  places the individual at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to participate in MRADLs, or  prevents the individual from completing the MRADLs within a reasonable time frame Are there other conditions that limit the individual’s ability to participate in MRADLs at home?  Some examples are: a significant impairment of cognition or judgment; a significant impairment of vision.  For these individuals, the provision of MAE might not enable them to participate in MRADLs if the comorbidity prevents effective use of the wheelchair or reasonable completion of the tasks even with MAE. If these other limitations exist, can they be ameliorated or compensated sufficiently such that the additional provision of MAE will be reasonably expected to significantly improve the individual’s ability to perform or obtain assistance to participate in MRADLs in the home?  A caregiver, for example, a family member, may be compensatory, if consistently available in the individual’s home and willing and able to safely operate and transfer the individual to and from the wheelchair and to transport the individual using the wheelchair. The caregiver’s need to use a wheelchair to assist the individual in the MRADLs is to be considered in this determination. If the amelioration or compensation requires the individual’s compliance with treatment, for example, medications or therapy, substantive noncompliance, whether willing or involuntary, can be grounds for denial of MAE coverage if it results in the individual continuing to have a significant limitation. It may be determined that partial compliance results in adequate amelioration or compensation for the appropriate use of MAE.  Does the individual or caregiver demonstrate the capability and the willingness to consistently operate the MAE safely? Medical Coverage Policy: 0030  Safety considerations include personal risk to the individual as well as risk to others. The determination of safety may need to occur several times during the process as the consideration focuses on a specific device.  A history of unsafe behavior in other venues may be considered. Can the functional mobility deficit be sufficiently resolved by the prescription of a cane or walker?  The cane or walker should be appropriately fitted to the individual for this evaluation.  Assess the individual’s ability to safely use a cane or walker. Does the individual’s typical environment support the use of wheelchairs, including scooters/power operated vehicles (POVs)?  Determine whether the individual’s environment will support the use of these types of MAE.  Keep in mind such factors as physical layout, surfaces and obstacles which may render MAE unusable in the individual’s home. Does the individual have sufficient upper extremity function to propel a manual wheelchair in the home to participate in MRADLs during a typical day? The manual wheelchair should be optimally configured (e.g., seating options, wheelbase, device weight, and other appropriate accessories) for this determination.  Limitations of strength, endurance, range of motion, coordination, and absence or deformity in one or both upper extremities are relevant.  An individual with sufficient upper extremity function may qualify for a manual wheelchair. The appropriate type of manual wheelchair, (e.g., lightweight), should be determined based on the individual’s physical characteristics and anticipated intensity of use.  The individual’s home should provide adequate access, maneuvering space and surfaces for the operation of a manual wheelchair.  Assess the individual’s ability to safely use a manual wheelchair. NOTE: If the individual is unable to self-propel a manual wheelchair, and if there is a caregiver who is available, willing, and able to provide assistance, a manual wheelchair may be appropriate. Does the individual have sufficient strength and postural stability to operate a POV/scooter?  A POV is a 3- or 4-wheeled device with tiller steering and limited seat modification capabilities. The individual must be able to maintain stability and position for adequate operation.  The individual’s home should provide adequate access, maneuvering space and surfaces for the operation of a POV.  Assess the individual’s ability to safely use a POV/scooter. Are the additional features provided by a PWC needed to allow the individual to participate in one or more MRADLs?  The pertinent features of a PWC compared to a POV are typically control by a joystick or alternative input device, lower seat height for slide transfers, and the ability to accommodate a variety of seating needs.  The type of wheelchair and options provided should be appropriate for the degree of the individual’s functional impairments.  The individual’s home should provide adequate access, maneuvering space and surfaces for the operation of a PWC.  Assess the individual’s ability to safely use a PWC. NOTE: If the individual is unable to use a PWC, and if there is a caregiver who is available, willing, and able to provide assistance, a manual wheelchair is appropriate. A caregiver’s inability to operate a manual Medical Coverage Policy: 0030 wheelchair can be considered in covering a PWC so that the caregiver can assist the individual (CMS, 2005). For a POV or PWC to be covered, Medicare requires that the treating physician must conduct a face-to-face encounter. This face-to-face encounter must be conducted within six months prior to the order date on the standard written order. The face-to-face encounter report and the standard written order must be received by the supplier prior to the delivery of the power mobility device. The face-to-face encounter should provide information relating to if a mobility deficit exists. The physician may refer the patient to a licensed/certified medical professional, such as a physical therapist (PT) or occupational therapist (OT), who has experience and training in mobility evaluations to perform part of the face-to-face encounter. This person may have no financial relationship with the supplier. An exception would be if the supplier is owned by a hospital, PT or OT working in the inpatient or outpatient hospital setting may perform part of the face-to-face encounter. Wheelchair Bases and Descriptions Manual Wheelchairs: A manual wheelchair is one that relies on the individual/occupant or an assistant for manual propulsion. The following features are included in the allowance for all adult manual wheelchairs: • arm style: fixed, swing-away, or detachable; fixed height • footrests: fixed, swing-away, or detachable seat width and depth of 15”–19” A manual wheelchair with a seat width and/or depth of 14” or less is considered a pediatric wheelchair (HCPCS code E1229 or E1231–E1238). Push-rim activated power assist (HCPCS code E0986) is an option for a manual wheelchair in which sensors in specially designed wheels determine the force that is exerted by the patient on the wheel. Additional propulsive and/or braking force is then provided by motors in each wheel. Batteries are included. Manual wheelchairs are defined by the following: Wheelchair Type Standard Standard Hemi (low seat) Lightweight High Strength, Lightweight (Lifetime warranty on side frames and cross braces.) Ultra Lightweight (Lifetime warranty on side frames and cross braces.) Heavy Duty Extra-Heavy Duty Custom Manual Wheelchair/Base Adult tilt-in-Space (Ability to tilt the frame of the wheelchair ≥ 20 degrees from horizontal while maintaining the same back to seat angle. Lifetime warranty on side frames and cross braces.) HCPCS K0001 K0002 K0003 K0004 K0005 K0006 K0007 K0008 E1161 Weight > 36 lbs > 36 lbs 34–36 lbs < 34 lbs < 30 lbs Seat Height ≥ 19 inches < 19 inches any seat height any seat height any seat height any seat height any seat height any seat height any seat height Weight Capacity ≤ 250 lbs ≤ 250 lbs ≤ 250 lbs ≥ 250 lbs ≥ 300 lbs “Weight” represents the weight of the wheelchair itself in pounds without the front rigging as in the case of the K0001, K0002, K0003, K0004, and K0005 models. ”Weight capacity” represents the carrying capacity or the Medical Coverage Policy: 0030 amount of weight (individual plus all accessories) that the wheelchair can carry for safe operation as in the case of the K0001, K0002, K0003, K0006 and K0007 models. Manual wheelchair bases include construction of any type material, including but not limited to: titanium, carbon, or any other lightweight high strength material. Power Wheelchairs (PWCs): PWCs are chair-like battery-powered mobility devices with integrated or modular seating system, electronic steering, and four or more wheel, non-highway construction. PWC bases (HCPCS code K0010–K0012 and K0014) have the following features: • arm style: fixed, swing-away, or detachable; fixed height • footrests: fixed, swing-away, or detachable seat width and depth of 15”–19” A lightweight PWC (HCPCS code K0012) weighs less than 80 lbs., has a back and seat but without front riggings or battery, and has a folding back or collapsible frame. A PWC with HCPCS code K0014 is used for a patient with weight capacity of ≥ 350 lbs. and has programmable controls. A pediatric wheelchair (HCPCS code E1239) has a seat width or depth ≤ 14”. Each PWC is required to include these basic equipment items on initial issue. No separate billing/payment is allowed at the time of initial issue: • battery charger, single mode • • lap or safety belt (Shoulder harness/straps or chest straps/vest would be billed separately.) complete set of tires and casters, any type leg rests (No separate billing/payment if fixed, swingaway, or detachable non-elevating leg rests with or without calf pad are provided. Elevating leg rests may be billed separately) foot rests/foot platform (No separate billing/payment if fixed, swingaway, or detachable footrests or a foot platform without angle adjustment are provided. There is no separate billing for angle adjustable footplates with Group 1 or 2 PWCs. Angle adjustable footplates may be billed separately with Group 3, 4 and 5 PWCs) arm rests (There is no separate billing/ payment if fixed, swingaway, or detachable non-adjustable height armrests with arm pad are provided (HCPCS code K0015, K0020). Detachable, adjustable height armrests (HCPCS code K0017, K0018) may be billed separately.) any weight specific components (braces, bars, upholstery, brackets, motors, gears, etc.) as required by patient weight capacity. any seat width and depth. (Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately):     For Standard Duty, seat width and/or depth greater than 20 inches; For Heavy Duty, seat width and/or depth greater than 22 inches; For Very Heavy Duty, seat width and/or depth greater than 24 inches; For Extra Heavy Duty, no separate billing any back width (Exception: For Group 3 and 4 PWCs with a sling/solid seat/back, the following may be billed separately):  For Standard Duty, back width greater than 20 inches;  For Heavy Duty, back width greater than 22 inches;  For Very Heavy Duty, back width greater than 24 inches;  For Extra Heavy Duty, no separate billing Medical Coverage Policy: 0030  Controller and Input Device. There is no separate billing/payment if a non-expandable controller and a standard proportional joystick (integrated or remote) is provided. An expandable controller, a nonstandard joystick (i.e., non-proportional or mini, compact or short throw proportional), or other alternative control device may be billed separately. There are five PWC groups which are divided based on performance: PWC Group/ HCPCS codes Group 5 (K0890– K0891) Group 1 (K0813– K0816) Group 4 (K0868– K0886) Group 3 (K0848– K0864) ≤ 48 inches ≤ 34 inches 4.5 mph Group 2 (K0820– K0843) Length Width Minimum top end speed* Minimum range** Minimum obstacle climb*** Dynamic stability incline**** *Top end speed is the minimum speed acceptable for a given category of devices on a flat, hard surface. ≤ 40 inches ≤ 48 inches ≤ 24 inches ≤ 34 inches ≤ 48 inches ≤ 48 inches ≤ 34 inches ≤ 34 inches 6 mph 3 mph 4 mph 3 mph 7 miles 12 miles 16 miles 5 miles 12 miles 60 mm 60 mm 20 mm 75 mm 40 mm 6 degrees 9 degrees 9 degrees 6 degrees 7.5 degrees **Range is the minimum distance acceptable for a given category of devices on a single charge of the batteries. ***Obstacle climb is the vertical height of a solid obstruction that can be climbed. ****Dynamic stability incline is the minimum degree of slope at which the power mobility device in the most common seating and positioning configuration(s) remains stable at the required patient weight capacity. If the power mobility device is stable at only one configuration, the power mobility device may have protective mechanisms that prevent climbing inclines in configurations that may be unstable. The above PWC groups are divided based on the patient’s weight, seat type, portability and/or power seating system capability: Weight Capacity Groups (The terms “standard duty” or “heavy duty” refer to weight capacity, not performance.):  standard duty: up to and including 285 pounds  heavy duty: 285-400 pounds  very heavy duty: 428-600 pounds  extra-heavy duty: 570 pounds or more Seat Types:  Sling seat/back: Flexible cloth, vinyl, leather or equal material designed to serve as the support for buttocks or back of the user, respectively. They may or may not have thin padding but are not intended to provide cushioning or positioning for the user.  Solid seat/back: Rigid metal or plastic material usually covered with cloth, vinyl, leather or equal material, with or without some padding material designed to serve as the support for the buttocks or back of the user, respectively. They may or may not have thin padding but are not intended to Medical Coverage Policy: 0030 provide cushioning or positioning for the user. PWCs with an automotive-style back and a solid seat pan are considered as a solid seat/back system, not a captain’s chair.  Captain’s chair: A one or two-piece automotive-style seat with rigid frame, cushioning material in both seat and back sections, covered in cloth, vinyl, leather or equal as upholstery, and designed to serve as a complete seating, support, and cushioning system for the user. It may have armrests that can be fixed, swing-away, or detachable. It may or may not have a headrest, either integrated or separate.  Stadium style seat: A one- or two-piece stadium-style seat with rigid frame and cushioning material in both seat and back sections, covered in cloth, vinyl, leather or equal as upholstery, and designed to serve as a complete seating, support, and cushioning system for the user. It may have armrests that can be fixed, swing-away, or detachable. It will not have a headrest. Chairs with stadium style seats are billed using the captain’s chair codes. Portable PWC: A portable PWC is a device with lightweight construction or ability to disassemble into lightweight components that allows easy placement into a vehicle for use in a distant location. Power Options: PWCs can have power options added, including power tilt, recline, elevating leg rests, seat elevators or standing systems. There are three categories of PWCs based on the capability to adapt and operate power options:  No-power option PWCs are unable to accept any power options. If a PWC can only accept power elevating leg rests, it is considered to be a no-power option chair.  Single-power option PWCs have the capability to accept and operate a power tilt or power recline or power standing or, for Groups 3, 4, and 5, a power seat elevation system, but not a combination power tilt and recline seating system. It may be able to accommodate power elevating leg rests, seat elevator, and/or standing system in combination with a power tilt or power recline.  Multiple-power option PWCs have the capability to accept and operate a combination power tilt and recline seating system. It may also be able to accommodate power elevating leg rests, a power seat elevator, and/or a power standing system. All PWCs (HCPCS code K0813–K0891, K0898) must have the specified components and meet the following requirements: all components in the PWC basic equipment package • • any seat width and depth that is appropriate to the weight group • any seat and back height with no adjustment requirements • • may include semi-reclining back • fixed or adjustable seat to back angle with no adjustment requirements the seat option listed in the code descriptor Group 1 PWCs (HCPCS code K0813–K0816) must have the specified components and meet the following requirements: • non-expandable controller • • may have cross brace construction • except for captain’s chairs, accommodates non-powered options and seating systems (e.g., recline-only backs, manually elevating leg rests) the largest single component (HCPCS code K0813, K0814) may not exceed 55 pounds standard integrated or remote proportional control input device Medical Coverage Policy: 0030 Group 2 PWCs (HCPCS code K0820–K0843) must have the specified components and meet the following requirements: • may have cross brace construction • except for captain’s chairs, accommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports) the largest single component (HCPCS code K0820, K0821) may not exceed 55 pounds standard integrated or remote proportional control input device Group 2 no power option PWCs (HCPCS code K0820–K0829) must have the specified components and meet the following requirements: non-expandable controller • • • except for captain’s chairs, accommodates non-powered options and seating systems (e.g., recline-only backs, manually elevating leg rests) Group 2 seat elevator PWCs (HCPCS code K0830, K0831) must have the specified components and meet the following requirements: non-expandable controller • • • accommodates only a power seat elevating system incapable of upgrade to expandable controller and alternative control devices incapable of accommodating a power tilt, recline, seat elevation, standing system Group 2 single power option PWCs (HCPCS code K0835–K0840) must have the specified components and meet the following requirements: non-expandable controller • • capable of upgrade to expandable controller or alternative control devices see single power option definition for seating system capability Group 2 multiple power option PWCs (HCPCS code K0841–K0843) must have the specified components and meet the following requirements: non-expandable controller • • • accommodates a ventilator capable of upgrade to expandable controller or alternative control devices see multiple power options definition for seating system capability Group 3 PWCs (HCPCS code K0848–K0864) must have the specified components and meet the following requirements: • non-expandable controller • • may not have cross brace construction • except for captain’s chairs, accommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports) standard integrated or remote proportional control input device drive wheel suspension to reduce vibration Medical Coverage Policy: 0030 Group 4 PWCs (HCPCS code K0868–K0886) must have the specified components and meet the following requirements: • non-expandable controller • • may not have cross brace construction • except for captain’s chairs, accommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk supports, lateral hip supports, medial thigh supports) standard integrated or remote proportional control input device drive wheel suspension to reduce vibration Group 3 and 4 no-power option PWCs (HCPCS code K0848–K0855, K0868–K0871) must have the specified components and meet the following requirements: • accommodates non-powered options and seating systems (e.g., recline-only backs, manually elevating leg rests) incapable of accommodating a power tilt, recline, seat elevation, standing system Group 3 and 4 single power option PWCs (HCPCS code K0856–K0860, K0877–K0880) must have the specified components and meet the following requirements: see single power option definition for seating system capability Group 3 and 4 multiple power option PWCs (HCPCS code K0861–K0864, K0884–K0886) must have the specified components and meet the following requirements: • accommodates a ventilator see multiple power options definition for seating system capability All Group 5 PWCs (HCPCS code K0890, K0891) must have the specified components and meet the following requirements: • non-expandable controller • • • • • back height: adjustment requirements minimum of three options • • accommodates non-powered options and seating systems • accommodates seating and positioning items (e.g., seat and back cushions, headrests, lateral trunk special developmental capability (i.e., seat to floor, standing) standard integrated or remote proportional control input device capable of upgrade to expandable controller seat width has a minimum of five one-inch options seat depth has a minimum of three one-inch options seat height adjustment requirements are ≥ three inches adjustability for growth (minimum of three inches for width, depth and back height adjustment) • • drive wheel suspension to reduce vibration • passed crash testing Group 5 single power option PWC (HCPCS code K0890): See single power option definition for seating system capability. Group 5 Multiple Power Option PWC (HCPCS code K0891): must accommodate a ventilator Medical Coverage Policy: 0030 see multiple power options definition for seating system capability Increasingly, wheelchairs and wheelchair accessories are using advanced technologies to improve user safety, comfort, and independence. An example of a more recent “smart technology” wheelchair accessory is the LUCI system. LUCI is a hardware/software driver assistance system which attaches to select power wheelchairs. LUCI employs various technologies to evaluate surface sloping and detect solid obstacles in the environment, to aid in avoiding collisions, tipping, and drop-offs. According to the manufacturer, LUCI is an FDA Class I, exempt medical device. The LUCI hardware includes a metal frame, cameras, and multiple sensors (i.e., radar, ultrasonic), which are installed on an existing power wheelchair and powered by the wheelchair battery. LUCI utilizes GPS, Wi-Fi, cellular, and Bluetooth technologies to integrate with a smartphone- or other device-based app for user personalization, and to collect and share data. Per the manufacturer, LUCI may not detect fast- moving objects or objects under 3-5 centimeters in size. Additionally, abrupt changes in light level, extremely rough terrain, mud, snow, water, sand and/or other soft surfaces may cause incorrect sensor detection. As an add-on feature which is not primarily medical in nature, the LUCI system functions largely as a self- help/convenience accessory. Complex Rehabilitative Wheelchairs and Assistive Technology Supplier Requirement The Centers for Medicare and Medicaid Services (CMS) Supplier Product-Specific Service Requirements recommend that the supplier shall employ (W-2 employee) at least one qualified individual as a Rehabilitative Technology Supplier (RTS) per location. A qualified RTS is an individual who has one of the following credentials: Assistive Technology Professional (ATP) or Certified Rehabilitative Technology Supplier (CRTS). The RTS shall have at least one or more trained technicians available to service each location appropriately depending on the size and scope of its business. A trained technician is identified by ALL of the following: able to program and repair sophisticated electronics associated with power wheelchairs, alternative drive controls, and power seating systems completed at least 10 hours annually of continuing education specific to rehabilitative technology • experienced in the field of rehabilitative technology (e.g., on-the-job training, familiarity with rehabilitative clients, products and services) factory-trained by manufacturers of the products supplied by the company The RTS shall coordinate services with the prescribing physician to conduct face-to-face encounters of the member in an appropriate setting and include input from other members of the health care team (e.g., physical therapist, occupational therapist). These requirements are for complex rehabilitative wheelchairs which are Group 2 power wheelchairs with power options, Group 3 power wheelchairs and manual wheelchairs that can accommodate rehabilitative accessories and features (e.g., tilt in space) (CMS, 2020). Custom Wheelchairs: A custom manual wheelchair base is one that has been uniquely constructed or substantially modified for a specific individual and is so different from another item used for the same purpose that the two items cannot be grouped together for pricing purposes. The assembly of a wheelchair from modular components does not meet the requirements of a custom wheelchair base for payment purposes. The use of customized options or accessories does not result in the wheelchair base being considered customized. There must be customization of the frame for the wheelchair base to be considered customized. Definitions: Actuator: A motor that operates a specific function of a power seating system (i.e., tilt, back recline, power sliding back, elevating leg rest[s], seat elevation, or standing). Controller: The microprocessor and other related electronics that receive and interpret input from the joystick (or other drive control interface) and convert that input into power output which controls speed and direction. A high power wire harness connects the controller to the motor and gears. Codes E2310 and E2311 describe the electronic components that allow the patient to control two or more of the following motors from a single interface (e.g., proportional joystick, touch pad, or non-proportional Medical Coverage Policy: 0030 interface): power wheelchair drive, power tilt, power recline, power shear reduction, power leg elevation, power seat elevation, power standing. It includes a function selection switch which allows the patient to select the motor that is being controlled and an indicator feature to visually show which function has been selected. When the wheelchair drive function has been selected, the indicator feature may also show the direction that has been selected (forward, reverse, left, right). This indicator feature may be in a separate display box or may be integrated into the wheelchair interface. If a wheelchair has an electrical connection device described by code E2310 or E2311 and if the sole function of the connection is for a power seat elevation or power standing feature, it is considered not medically necessary and not covered. Cross Brace Chair: A type of construction for a PWC in which opposing rigid braces hinge on pivot points to allow the device to fold. Power Options: Tilt, recline, elevating leg rests, seat elevators, or standing systems that may be added to a PWC to accommodate a patient’s specific need for seating assistance. A power standing system (HCPCS code E2301) includes: a solid seat platform and a solid back; detachable or flip-up fixed height armrests; hinged leg rests; anterior knee supports; fixed or flip-up footplates; a motor and related electronics with or without variable speed programmability; a basic switch control which is independent of the power wheelchair drive control interface; any hardware that is needed to attach the seating system to the wheelchair base. It does not include a headrest. It must have the following features: ability to move the individual to a standing position; ability to support individual weight of at least 250 pounds. Proportional Control Input Device: A device that transforms a user’s drive command (i.e., a physical action initiated by the wheelchair user) into a corresponding and comparative movement, both in direction and in speed, of the wheelchair. The input device shall be considered proportional if it allows for both a non-discrete directional command and a non-discrete speed command from a single drive command movement. Non-proportional Control Input Device: A device that transforms a user’s discrete drive command (i.e., a physical action initiated by the wheelchair user, such as activation of a switch) into perceptually discrete changes in the wheelchair’s speed, direction, or both. Alternative Control Device: A device that transforms a user’s drive commands by physical actions initiated by the user to input control directions to a PWC that replaces a standard proportional joystick. Includes a mini-proportional, compact, or short throw joysticks, head arrays, sip-and-puff and other types of different input control devices. Non-expandable Controller: An electronic system that controls the speed and direction of the PWC drive mechanism. Only a standard proportional joystick used for hand or chin control can be used as the input device. This system may be in the form of an integral controller or a remotely placed controller. The non-expandable controller:  may have the ability to control up to two power seating actuators through the drive control (for example, seat elevator and single actuator power elevating leg rests) (Note: Control of the power seating actuators through the Control Input Device would require the use of an additional component, HCPCS code E2310 or E2311.)  may allow for the incorporation of an attendant control Expandable Controller: An electronic system that is capable of accommodating one or more of the following additional functions:  proportional input devices (e.g., mini, compact, or short throw joysticks, touch pads, chin control, head control, etc.) other than a standard proportional joystick Medical Coverage Policy: 0030  non-proportional input devices (e.g., sip-and-puff, head array)  operate three or more powered seating actuators through the drive control (Note: Control of the power seating actuators through the Control Input Device would require the use of an additional component, HCPCS code E2310 or E2311.) An expandable controller may also be able to operate one or more of the following:  a separate display (i.e., for alternate control devices)  other electronic devices (e.g., control of an augmentative speech device or computer through the chair’s drive control)  an attendant control Integral Control System: Non-expandable wheelchair control system where the joystick is housed in the same box as the controller. The entire unit is located and mounted near the hand of the user. A direct electrical connection is made from the Integral Control box to the motors and batteries through a high power wire harness. Remotely Placed Controller: Non-expandable or expandable wheelchair control system where the joystick (or alternative control device) and the controller box are housed in separate locations. The joystick (or alternative control device) is connected to the controller through a low power wire harness. The separate controller connects directly to the motors and batteries through a high power wire harness. Power Operated Vehicles (POVs)/Scooters: POVs are chair-like battery powered mobility devices with integrated seating systems, tiller steering, and three or four-wheel non-highway construction. There are two POV groups which are divided based on performance: POV Group/HCPCS codes Group 1 (K0800–K0802) ≤ 48 inches ≤ 28 inches 3 mph 5 miles 20 mm ≤ 54 inches 6 degrees Group 2 (K0806–K0808) ≤ 48 inches ≤ 28 inches 4 mph 10 miles 50 mm ≤ 54 inches 7.5 degrees Length Width Minimum top end speed Minimum range Minimum obstacle climb Radius pivot turn* Dynamic stability incline *Radius pivot turn is the distance required for the smallest turning radius of the Power Mobility Device base. The above two groups of POVs are subdivided into four weight capacities: • heavy duty: 285-400 pounds • very heavy duty: 428-600 pounds • extra heavy duty: 570 pounds or more standard duty: up to and including 284 pounds Each POV base code is required to include all these basic equipment package items on initial issue. No separate billing/payment is allowed at the time of initial issue: battery or batteries required for operation • battery charger, single mode • weight-appropriate upholstery and seating system • • non-expandable controller with proportional response to input • • all accessories needed for safe operation tiller steering Medical Coverage Policy: 0030 All POVs (HCPCS code K0800–K0808, K0812) must have the specified components and meet the following requirements: all components in the POV basic equipment package • • any seat or back height with no adjustment requirements • • seat width and depth that is appropriate to the weight group fixed or adjustable seat-to-back angle with no adjustment requirements fatigue test of 200,000 cycles and drop test of 6,666 cycles U.S. Food and Drug Administration (FDA) Mechanical wheelchairs and accessories are classified as Class I medical devices by the FDA; wheelchair accessories not intended for use in a protective restraint capacity are exempt from the premarket notification process. Power wheelchairs and power operated vehicles are classified as Class II medical devices. In 2021, the FDA approved the latest iteration of the iBOT Personal Mobility Device (iBOT PMD) (Mobius Mobility, Manchester, NH) via the 510(k) premarket notification process, as a Class II device. The iBOT PMD is a multi-mode power wheelchair which utilizes various sensors and gyroscopes to climb stairs; to navigate uneven surfaces and varied terrain using 4-wheel drive; to elevate and move the user at a standing height; and can be operated remotely. The indications for use note that the device is intended to provide indoor and outdoor mobility to people restricted to a sitting position, who meet the requirements of the manufacturer-provided user assessment and training certification program. Companions required to provide assistance during Assisted Stair Climbing Mode must also meet the requirements of the training certification program. The enhancements (i.e., balance, stair, 4-wheel, and remote functions) are chiefly for convenience and do not primarily serve a medical purpose (CMS, 2006). Literature Review Wheelchair-Mounted Assistive Robotic Arm (e.g., Kinova Jaco® Assistive Robotic Arm): The JACO assistive robotic arm is a wheelchair-mounted robotic device with six interlinking segments that correspond with the shoulder, elbow, and wrist and a hand with two or three fingers. Using a joystick or other control interfaces (e.g., sip and puff, head control, head array), the arm and hand can be moved in three-dimensional space and the fingers can be opened and closed for gripping. The robotic arm is intended to mimic a fully functioning arm. JACO uses the same power source as the wheelchair (Hayes, 2020). In a 2020 Hayes Evidence Analysis Research Brief for the JACO assistive robotic arm for use by patients with neuromuscular disorders, the authors’ evidentiary conclusion states that there is insufficient published evidence to assess the safety and/or impact on health outcomes or patient management with regards to use of the JACO assistive robotic arm for patients with neuromuscular diseases. Studies that reported outcomes specific to the performance of JACO included one retrospective uncontrolled study (n=31); one small case series (n=7 users and n=5 caregivers), and one report of two individual cases (n=2) (Hayes, 2020). Professional Societies/Organizations The Rehabilitation Engineering and Assistive Technology Society of North America (RESNA): RESNA has published several position papers concerning manual wheelchairs, power wheelchairs, wheelchair components and accessories, and other assistive technologies. Key position papers have included: Power Mobility Devices for Pediatric Users  RESNA’s position is that early use of power mobility by children with mobility limitations improves independence and development in several areas (e.g. cognitive, social, perceptual). Difficulty accessing controls, limited vision, cognitive deficits, age, ability to use other mobility means for short distances, and/or parental concerns should not necessarily eliminate the child as a power mobility user (RESNA, 2017). Ultralight Manual Wheelchairs  RESNA recommends an ultra-lightweight manual wheelchair for individuals who use a wheelchair as their primary mode of mobility. The chair should be highly adjustable, configurable Medical Coverage Policy: 0030 to the user, and as lightweight as possible. A properly configured chair will decrease the incidence of secondary complications and is less prone to breakdowns (as compared to manual or lightweight wheelchairs) (RESNA, 2022). Use Outside of the US National Institute for Health and Care Excellence (NICE) (United Kingdom): The updated NICE guideline on the assessment and management of motor neuron disease encouraged the prompt referral for and provision of manual and/or powered wheelchairs for this patient population. The guideline recommended collaboration of the healthcare team to ensure all equipment is integrated (e.g., integrating alternative and augmentative communication [AAC] devices and environmental control systems with wheelchairs) (NICE, 2019).