Seat Elevation Systems as an Accessory to Power Wheelchairs (Group 3)

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The Centers for Medicare & Medicaid Services (CMS) finds that power seat elevation equipment on Medicare-covered power wheelchairs (PWCs) falls within the benefit category for durable medical equipment (DME). This Benefit Category Determination (BCD) expands the scope of the proposed benefit category decision based on consideration of public comments on the proposed decision memorandum. Section 1861(n) of the Social Security Act (the Act) defines what items are considered to be DME and 42 CFR 414.202 provides additional details on the definition of DME. After considering the public comments on the proposed decision memorandum, CMS is also expanding coverage beyond the proposed decision. CMS finds in this national coverage analysis that the evidence is sufficient to determine that power seat elevation equipment is reasonable and necessary for individuals using complex rehabilitative power-driven wheelchairs [1] when the following conditions are met: 1. The individual has undergone a specialty evaluation that confirms the individual’s ability to safely operate the seat elevation equipment in the home. This evaluation must be performed by a licensed/certified medical professional such as a physical therapist (PT), occupational therapist (OT), or other practitioner, who has specific training and experience in rehabilitation wheelchair evaluations; and, 2. At least one of the following apply: a. The individual performs weight bearing transfers to/from the power wheelchair while in the home, using either their upper extremities during a non-level (uneven) sitting transfer and/or their lower extremities during a sit to stand transfer. Transfers may be accomplished with or without caregiver assistance and/or the use of assistive equipment (e.g. sliding board, cane, crutch, walker, etc.); or, b. The individual requires a non-weight bearing transfer (e.g. a dependent transfer) to/from the power wheelchair while in the home. Transfers may be accomplished with or without a floor or mounted lift; or, c. The individual performs reaching from the power wheelchair to complete one or more mobility related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming and bathing in customary locations within the home. MRADLs may be accomplished with or without caregiver assistance and/or the use of assistive equipment. In addition, the Durable Medical Equipment Medicare Administrative Contractor (DME MAC) has discretion to determine reasonable and necessary coverage of power seat elevation equipment for individuals who use Medicare covered PWCs other than complex rehabilitative power-driven wheelchairs. See Appendices B and C for the NCD manual language. Revisions to Appendix C also include technical updates to the narrative background to reflect the current regulations at 42 CFR §§414.202, 414.114, and 414.240. We are including responses to public comments in this final decision memorandum, consistent with §1862(l)(3) of the Act, in two sections of this decision memorandum. Section IV.B includes comment summary and responses for the Benefit Category Determination. Section VIII.B.7 includes comment summary and responses with respect to section 1862(a)(1)(A) of the Act.

Decision Memo: TO: Administrative File: CAG-00461N SUBJECT: National Coverage Determination for Power Seat Elevation Equipment on Power Wheelchairs DATE: May 16, 2023 I. Decision The Centers for Medicare & Medicaid Services (CMS) finds that power seat elevation equipment on Medicare-covered power wheelchairs (PWCs) falls within the benefit category for durable medical equipment (DME). This Benefit Category Determination (BCD) expands the scope of the proposed benefit category decision based on consideration of public comments on the proposed decision memorandum. Section 1861(n) of the Social Security Act (the Act) defines what items are considered to be DME and 42 CFR 414.202 provides additional details on the definition of DME. After considering the public comments on the proposed decision memorandum, CMS is also expanding coverage beyond the proposed decision. CMS finds in this national coverage analysis that the evidence is sufficient to determine that power seat elevation equipment is reasonable and necessary for individuals using complex rehabilitative power-driven wheelchairs [1] when the following conditions are met: 1. The individual has undergone a specialty evaluation that confirms the individual’s ability to safely operate the seat elevation equipment in the home. This evaluation must be performed by a licensed/certified medical professional such as a physical therapist (PT), occupational therapist (OT), or other practitioner, who has specific training and experience in rehabilitation wheelchair evaluations; and, 2. At least one of the following apply: a. The individual performs weight bearing transfers to/from the power wheelchair while in the home, using either their upper extremities during a non-level (uneven) sitting transfer and/or their lower extremities during a sit to stand transfer. Transfers may be accomplished with or without caregiver assistance and/or the use of assistive equipment (e.g. sliding board, cane, crutch, walker, etc.); or, b. The individual requires a non-weight bearing transfer (e.g. a dependent transfer) to/from the power wheelchair while in the home. Transfers may be accomplished with or without a floor or mounted lift; or, c. The individual performs reaching from the power wheelchair to complete one or more mobility related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming and bathing in customary locations within the home. MRADLs may be accomplished with or without caregiver assistance and/or the use of assistive equipment. In addition, the Durable Medical Equipment Medicare Administrative Contractor (DME MAC) has discretion to determine reasonable and necessary coverage of power seat elevation equipment for individuals who use Medicare covered PWCs other than complex rehabilitative power-driven wheelchairs. See Appendices B and C for the NCD manual language. Revisions to Appendix C also include technical updates to the narrative background to reflect the current regulations at 42 CFR §§414.202, 414.114, and 414.240. We are including responses to public comments in this final decision memorandum, consistent with §1862(l)(3) of the Act, in two sections of this decision memorandum. Section IV.B includes comment summary and responses for the Benefit Category Determination. Section VIII.B.7 includes comment summary and responses with respect to section 1862(a)(1)(A) of the Act. II. Background Throughout this document we use numerous acronyms, some of which are not defined as they are presented in direct quotations. Please find below a list of these acronyms and corresponding full terminology: ALS - Amyotrophic Lateral Sclerosis ANSI - American National Standards Institute ATP - Assistive Technology Professional BCD - Benefit Category Determination CDC - Centers for Disease Control and Prevention CIPD - Chronic Inflammatory Demyelinating Polyneuropathy CMS - Centers for Medicare & Medicaid Services CVA - cerebrovascular accident DME - durable medical equipment EMG - electromyography FDA - Food and Drug Administration IBM - Inclusion Body Myositis ICF - International Classification of Functioning, Disability and Health ITEM - Independence Through Enhancement of Medicare and Medicaid Coalition MAE - mobility assistive equipment MRADL - mobility related activity of daily living NCA - National Coverage Analysis NCD - National Coverage Determination OT - Occupational Therapist PT - Physical Therapist PWC - Power Wheelchair RESNA - Rehabilitation Engineering & Assistive Technology Society of North America SCI - spinal cord injury SPT - sitting pivot transfer UE - upper extremity US - United States According to the Centers for Disease Control and Prevention (CDC), 61 million adults in the United States live with a disability. A mobility device may be required to enhance the ability of persons to move about their homes, increasing participation and activity levels in daily tasks (Salminen, Brandt, Samuelsson, Töytäri and Malmivaara, 2009). In 2005, CMS established an algorithmic process to aid in the determination of the appropriate type and complexity of mobility assistive equipment that may restore a beneficiary’s ability to participate in mobility related activities of daily living (MRADLs) such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home. The resulting National Coverage Determination noted that various mobility limitations impair the ability of beneficiaries to participate in one or more MRADLs in the home. These mobility limitations include ones that: Prevent the beneficiary from accomplishing the MRADLs entirely, or, Place the beneficiary at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to participate in MRADLs, or, Prevent the beneficiary from completing the MRADLs within a reasonable time frame (NCD 280.3, 2005). In the United States, 5.5 million adults use wheelchairs (Taylor, 2018). Even as wheelchairs may improve mobility, they may also produce harms to their users. For example, musculoskeletal pain as a result of the use of a wheelchair is very common. In one study, pain affected 50% of wheelchair users. The most common site of pain found was that of the upper extremity, and specifically the shoulder, with a prevalence of approximately 44% (Liampas et al., 2021). Some authors have attributed shoulder pain to the use of manual wheelchairs alone. However, in those who experience spinal cord injuries, it has also been documented that a similar prevalence of shoulder pain exists in power wheelchair users. The mechanism of injury to cause shoulder pain in the power wheelchair user may include previous propulsion of a manual chair, excessive use of the upper extremities in order to perform activities of daily living, ischial pressure relief, etc. However, it is also possible that repetitive transfers are among the causes of this discomfort in those who use power chairs (Jain, Higgins, Katz & Garshick, 2010). It has been reported that in long-term wheelchair users, transferring to nonlevel surfaces are among the activities that produce the highest level of shoulder pain (Rice et al., 2013). Transfers are the act of maneuvering oneself into and out of the wheelchair to and from a variety of surfaces (e.g., bed, commodes, bathtubs) (Toro, Koontz & Cooper, 2013). By necessity, transfers must be accomplished in order to achieve mobility. It has been documented that transfers are performed on average 11-20 times per day by many active wheelchair users (Koontz, Bass, Cooper, 2015). In general, most transfers can be performed using seated or standing maneuvers, with the choice depending in part, on the individual’s functional capabilities (Mix & Specht, 2000). Examples of seated transfers include an anterior/posterior transfer and a sitting pivot transfer (SPT) (Ellwood, 1982). The SPT is the most common transfer employed by users of wheelchairs for activities of daily living. It is utilized in transfers onto level and non-level surfaces. Other names for the SPT are depression, side-approach, or lateral transfers (Koontz, Toro, Kankipati, Naber, & Cooper, 2012). During an SPT, the individual brings his/her/their buttocks forward towards the edge of the initial surface, places the feet in a stable position, leaves one hand on the initial surface (trailing) while placing the other hand on the target surface (leading). Then muscles in the arms are used to push up off of the surfaces and pivot the body about the feet, swinging the trunk over to land the buttocks onto the adjacent surface (Koontz et al., 2012). In individuals with spinal cord injuries, it has been documented that there is commonly a preferred direction of the transfer. However, individuals are likely to be proficient in transfers performed in both directions, as a preferred direction may not always be able to be accommodated within the environment ( b Gagnon et al., 2009). The SPT causes the individual to entirely or partially support themselves on their upper extremities (UEs) (Koontz, Bass & Kulich, 2021). However, the glenohumeral joint (shoulder) is not structurally designed for weight bearing as are the joints of the lower extremity. The glenoid, the socket for the humeral head, is shallow. The cartilage that surrounds it, the fibrous labrum, is the only structure available for the shoulder’s peripheral stability. The plane of the joint is vertical. During SPTs, the arms are in low angles of elevation, with the joint capsule loose and the reinforcing ligaments slack. Therefore, it is left to the shoulder muscles to provide joint stability. In doing so however, the forces generated can be the source of painful limitations to daily activities (Requejo et al., 2008). It has been reported that the intra-articular pressure in the shoulder during a wheelchair-to-bed transfer exceeds the mean arterial pressure by more than two and a half times, and that this pressure may be a factor that contributes to the high rate of musculoskeletal problems about the shoulder in individuals who are paraplegic (Bayley, Cochran & Sledge, 1987). As these forces may be applied in a repetitive manner throughout the day, any resultant impairment or injury may significantly and negatively impact the ability to perform activities of daily living, triggering a loss of independence and a decrease in quality of life (Rice et al., 2013). Not all wheelchair transfers are performed from the seated position. Some users of wheelchairs are able to come to a standing position from a chair in order to perform a transfer. For those with disabilities, the sit to stand movement may be performed with numerous compensatory mechanisms and transfer techniques (Butler, Nene & Major, 1991; van der Kruk, Silverman, Reilly, & Bull, 2021). For example, a stand-pivot transfer may be used by individuals who can achieve and maintain standing for a short period of time. During this transfer, the individual arises from a seated to a standing position and pivots to an adjacent surface to sit down (Mix & Specht, 2000). Being so common, the effort to rise from a chair seat is often taken for granted. However, research has shown that standing from a seated position requires more leg strength and greater joint ranges of motion than walking or stair climbing (Klein, Talaty, Esquenazi, Whyte & Keenan, 2001). Depending on circumstances, the difficulty of the act of sit to stand may be related to the development of shoulder pain and other symptoms of upper extremity overuse in people with lower extremity impairments and neuromuscular disorders as they use their upper extremities to compensate for leg weakness (Klein, Whyte, Keenan, Esquenazi & Polansky, 2000). For example, pushing on the chair arms has the effect of reducing joint moments [2] at the hip and knee, thereby reducing the muscular force necessary to accomplish the standing movement, and aiding in the accomplishment of the sit to stand task (Butler, et al., 1991). Given this information, it is interesting to note that in survivors of polio, the literature has described an association between lower extremity weakness and shoulder symptoms which could be detrimental to quality of life (Klein et al., 2000). This association in those who tend to increase their reliance on their upper extremities for mobility may not be surprising. In a more recent study of younger versus older adults, it was found that the older participants demonstrated significantly lower knee extensor and joint forces than the young when not using arm rests during a sit to stand activity. The older group were also found to have higher shoulder joint contact forces while using arm rests, suggesting a change in movement strategies as lower extremities naturally weaken with age (Smith, Reilly & Bull, 2020). This tendency to compensate for weakness by using other parts of the body could over time make everyday activities more susceptible to age-related (and disease-related) functional decline and may leave the individual vulnerable to injury without the ability to transfer into and out of a mobility device. Some individuals believe that power seat elevation equipment may mitigate these transfer related challenges for those who use a power wheelchair. A power seat elevation device is equipment that raises and lowers users of wheelchairs while they remain in the seated position. The device uses an electromechanical lift system to provide varying amounts of vertical seat to floor height. It does not change the seated angles or the seat’s angle relative to the ground. Other terms used to describe this device include a power elevating seat (PES) and power adjustable seat height (PASH) (Schiappa et al., 2019). Various devices of this nature can raise the seat 10 - 12 inches from a standard height with user operated controls in order to either accommodate the variable heights of surfaces in the home (e.g. wheelchair, bed, toilet, etc.) and allow level transfers or provide a higher surface from which to initiate standing (Sonenblum, Maurer, Hanes, Piriano & Sprigle, 2021). Besides transfers, it is possible that additional factors cause upper extremity injury in those who use wheelchairs. The most prevalent finding on magnetic resonance images in individuals with shoulder pain are abnormalities of the rotator cuff. While the etiology of rotator cuff disease is likely multi-factorial, mechanical compression of the rotator cuff tendons during shoulder motion is one mechanism that is thought to be a source of pain. Subacromial compression of the rotator cuff tendons is generally believed to occur during shoulder elevation motion and is defined as compression and abrasion of the bursal side of the rotator cuff against the underside of the corocoacromial arch (Lawrence, Schlangen, Schneider, et al., 2017). There are many authors who believe that excessive use of the upper extremities in the performance of activities of daily living and other overhead upper extremity activities might be likely sources of shoulder pain for individuals who use wheelchairs (Paralyzed Veterans of America Consortium for Spinal Cord Medicine, 2005; Jain, Higgins, Katz & Garshick, 2010; Requejo et al., 2008). As with transfers, a power seat elevation system may alleviate some of the difficulties that arise due to the need to perform repetitive overhead reaching from standard wheelchair height seating. III. History of Medicare Coverage The Medicare National Coverage Determinations Manual (CMS Pub. 100-03), Chapter 1, Part 4, addresses coverage of items and medical equipment within the benefit category of DME. Section 280.1 of this manual, “Durable Medical Equipment Reference List,” provides a quick reference tool for determining the coverage status of certain items. Even if an item falls within the benefit category definition of DME, it cannot be covered under Part B if it is subject to a statutory exclusion or is not reasonable and necessary for diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member. CMS has issued several NCDs regarding DME and mobility assistive equipment. The Durable Medical Equipment Reference List (NCD 280.1) includes several specific items of mobility assistance equipment that may be covered and especially for those items commonly referred to by both brand and generic names. Also, NCD 280.3 (effective 2005) established reasonable and necessary requirements for “mobility assistive equipment” (MAE), including some items that have been classified as DME since the Medicare program began. The most recent BCD NCD related to MAE was issued on July 26, 2006 for a product called the Independence iBOT 4000 Mobility System (iBOT). NCD 280.15 (effective 2006) addresses coverage of specific power wheelchair functions for the iBOT, including stair climbing, the ability to operate on uneven terrain, and the ability to operate with the user in a seated position at an elevated height (described as a balance function). The NCA for this BCD NCD discusses the definition of DME, and states that equipment that is primarily and customarily used for nonmedical purposes may not be considered “medical” equipment for which payment can be made under the Medicare program, even if the item has some remote medically related use. The NCA concluded the iBOT seat elevation equipment/balance function was not primarily medical in nature because seat elevation serves the same purpose as other equipment that assist all persons in reaching items out of reach or having an “eye-level” conversation with a standing person. CMS has not undertaken a significant review of these technologies in rulemaking or by an NCD since 2006. A. Current Request CMS received a formal request from the Independence Through Enhancement of Medicare and Medicaid (“ITEM’) Coalition and other supporting organizations, to reconsider National Coverage Determination (NCD) 280.3, Mobility Assistive Equipment in order to establish a benefit category for power seat elevation equipment in Group 3 PWCs and to include coverage of same for certain beneficiaries. Upon accepting this request, we believed it appropriate to consider both the benefit category and coverage of power seat elevation equipment on PWCs in a unique BCD NCD. The formal request letter can be viewed via the tracking sheet for this NCA on the CMS website at https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?ncaid=309&ncacaldoctype=all&status=all&sortBy=status&bc=17 The formal request from the ITEM coalition also asked to reconsider benefit category and coverage for standing equipment associated with Group 3 PWCs. While CMS has accepted that request, because the evidence base for power seat elevation wheelchair equipment is distinct from that of power wheelchair standing equipment, it is outside the scope of this analysis. CMS will consider these items in a separate future National Coverage Analysis. IV. Benefit Category Determination Medicare is a defined benefit program. An item or service must fall within a benefit category as a prerequisite to Medicare coverage. Title XVIII of the Act governs the Medicare program. Under the Medicare program, the scope of benefits available to eligible beneficiaries is prescribed by law and divided into several main parts. Part A is the hospital insurance program and Part B is the voluntary supplementary medical insurance program. The scope of benefits under Part B is described in section 1832 of the Act. Section 1861(n) of the Act defines DME and lists durable medical equipment (DME) items. Section 1861(s) of the Act defines the term “medical and other health services.” Section 1861(n) of the Act specifically identifies wheelchairs as DME. In addition to the statutory definition of DME, 42 CFR 414.202 of our regulations defines DME as equipment furnished by a supplier or a home health agency that meets the following conditions: Can withstand repeated use. Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years. Is primarily and customarily used to serve a medical purpose. Generally is not useful to an individual in the absence of an illness or injury. Is appropriate for use in the home. For items to be considered DME, all five criteria of the definition must be met. The CMS policies for determining whether an item meets the definition of DME are further outlined in the Medicare Benefit Policy Manual (CMS Pub. 100-02), Chapter 15, Section 110.1. In evaluating whether the first two criteria are satisfied, we will consider an item to be durable if it can withstand repeated use (i.e., the equipment can be rented and used by successive patients) and has an expected life of at least 3 years. Under the third and fourth criterion, equipment is considered to be medical equipment if it is primarily and customarily used to serve a medical purpose and generally is not useful to a person in the absence of an illness or injury. Equipment that is primarily and customarily used for a nonmedical purpose may not be considered “medical” equipment for which payment can be made under the Medicare program, even if the item has some remote medically-related use. Finally, under the fifth criteria, the equipment must be appropriate for use in the home. Additionally, the Medicare Benefit Policy Manual (CMS Pub. 100-02), Chapter 16, Section 20, describes the general exclusions from Medicare coverage. CMS uses the definitions in the Act and our regulations, as well as other established policies, to determine if an item or service falls within one or more Medicare benefit categories. Medicare payment is contingent upon a determination that an item or service falls under a benefit category, is not specifically excluded from coverage, and is “reasonable and necessary,” as required by section 1862(a)(1)(A) of the Act. In conducting our analysis of whether an item or service falls within the DME benefit category, CMS reviews the functions and features of the item or service, as well as applicable research and clinical studies that demonstrate how it meets the definition of DME, and serves a medical purpose. Historically, Medicare has covered power-operated wheelchairs as DME, but if the wheelchair includes other enhancing features, such as 4-wheel drive, Medicare has limited its coverage only to the wheelchair, since the enhancing features do not serve a medical purpose or are generally inappropriate for use in the patient’s home (and, thus, are not DME). A. Benefit Category Evidence Our analysis of diagnosis codes reported on Medicare claims for Group 3 PWCs in 2019-2022 shows that the majority of users of Group 3 PWCs are diagnosed with conditions that include but are not limited to Parkinson’s Disease, Multiple Sclerosis, Cerebral Palsy, Paraplegia (unspecified), Quadriplegia, Post-Polio Syndrome, and Amyotrophic Lateral Sclerosis (ALS). For those individuals who qualify for coverage of a Group 3 PWC, coverage of the additional seat elevation equipment can only be made if the equipment falls within a Medicare benefit category (i.e., DME), and is determined to be reasonable and necessary. Similar to individuals with Medicare who use Group 3 PWCs, some individuals who use Group 2 PWCs face the same obstacles with non-level transfers. The top diagnoses for those using Group 2 PWCs in 2019-2022 were acquired absence of limb (amputation), pressure ulcer, chronic obstructive pulmonary disease (COPD), and congestive heart failure (CHF) respectively. While the majority of non-Group 3 wheelchair users have medical conditions that still permit full weight bearing activity, some users may have conditions such as myositis, lupus and rheumatoid arthritis or have amputations with comorbid conditions that may require them to use their devices as the primary means of mobility in their homes. As these aforementioned patients (e.g., myositis, lupus, rheumatoid arthritis, amputations) become reliant on their wheelchairs as the sole means of mobility, it is expected that they will use their upper extremities to bear weight and face the same obstacles as those patients in Group 3 PWCs. As noted in Section II (Background), transfers are the act of maneuvering oneself into and out of the wheelchair to and from a variety of surfaces (e.g., bed, commodes, bathtubs) (Toro, Koontz & Cooper, 2013). For individuals requiring routine use of mobility assist devices, it is the primary means by which all other mobility activities of daily living is achieved and can range on average of 11-20 times per day (Koontz, Bass, Cooper, 2015). Without the ability to transfer effectively, users would be unable to access their mobility devices to initiate certain MRADLs or partake in those activities that can affect improvement in their conditions (Selph et al., 2021, Haas et al, 1998, Majmudar et al, 2014). The inability to transfer effectively could lead to deterioration of a patient’s underlying condition and expose them to the well documented risks of prolonged immobility. While often described by users as gateways to independence, transfers are also described as one of the activities that produce the most pain in individuals who use wheelchairs long term (Daylan, Cardenas-1999). In addition, the transfer process can be risky with transfers accounting for 51% of falls in patients with spinal cord injuries and multiple sclerosis in one study (Sunga et al., 2019). Transfers have also been found to be the most frequent cause of falls in patients with MS (Rice et al., 2017) and are the second most common cause of falls in users of wheelchairs presenting to an emergency department (Xiang et al, 2006). In addition to producing traumatic injury, these falls can lead to additional immobility as the result of a voluntary decrease in activity due to a fear of falling (Sunga et al., 2019, Rice et al., 2017, Barbareschi, Cheng 2018). Numerous intrinsic and environmental factors contribute to the difficulties faced when users of wheelchairs attempt transfers. Intrinsic factors include the user’s underlying medical condition such as preexisting neuromuscular disorders, comorbidities, muscular strength, spasticity, level of fatigue, body habitus, training skills, and cognitive abilities that can impact their ability to transfer effectively (Desroches et al., 2013). With regards to environmental factors, the International Classification of Functioning, Disability and Health (ICF) provides a framework for discussing health and disability for persons who use wheeled mobility devices (WHO-2002). The ICF defines environmental factors as all external factors that influence participation either as barriers or facilitators and includes features within the natural and built environment (WHO-2002). The built environment would include those in a user’s home including the height of the surfaces required to move to/from on a daily basis. One of the most significant tasks and impediments that users must confront daily is the non-level transfer where there is a vertical height differential between the user’s wheeled mobility device and the surface they are transitioning to. One example is the differential between average bed height (24 inches), and the average static height of a wheelchair (19 inches). Depending on a user’s circumstances, this would imply several uphill transfers during the course of a day. While this differential may seem surmountable to some and falls within the current Americans with Disabilities Act guidelines of 8 inches, it may also present a significant impediment for those who lack the physical capacity or the additional assistance to perform the task. Large gaps in height and width are reported as one of the most common difficulties users of wheelchairs face in the built environment (Barabarsechi et al., 2020). A height differential of only 1-2 inches (2.54cm-5.08cm) may be challenging or impossible for some users to perform (Gagnon et al., 2009). A recent study (Koontz et al., 2021) of 112 users demonstrated that the majority of daily transfers occurred in a non-level manner and that 90.5% of participants viewed transferring from their wheeled mobility device to a higher surface as a limiting factor. A smaller observational study by Barbareschi et al. in 2022 of 13 users with above level transfer ability found their self-described ability to transfer was significantly lower for non-level transfers performed between surfaces featuring gaps of 5-15cm when compared to level transfers. The largest study was performed by Toro, Koontz, et al. in 2013 and involved 120 users of wheeled mobility devices with underlying conditions such as stroke, spinal cord injury, cerebral palsy, multiple sclerosis, ALS, and lower extremity amputation. Study participants were asked to transfer from their personal wheeled mobility devices to a custom-built station that had featured adjustable differentials in height, gap width, and obstacles such as arm rests to resemble commonly encountered environmental transfer situations. Results showed that the easiest transfer height (95% percentile) achieved occurred when the target height was close to the level of the participants’ wheeled mobility device, 55.9cm and 56cm respectively. This illustrates that transfers are best achieved when the height of the user’s wheeled mobility device is similar to the target height; in other words, level. With an average seat height of 56cm, the study found that the target should range from 54.4cm to 55.9cm in order to meet the 95th percentile needs of users when there are no gaps or obstacles present. Conversely, users had a more difficult time when trying to access larger gaps in height differential when obstacles were present. When grab bars were installed, some participants were able to overcome the height differential. Unfortunately, many users of wheeled mobility devices may lack the financial means or ability to add these aids to their personal living environment. These findings are in line with the findings in prior studies (Barbareschi et al, 2022, Koontz et al., 2012 and Gagnon 2005). In order to perform non-level transfers, users must use a variety of techniques such as the side pivot transfer. The side pivot transfer requires the user to push off with their arms and pivot the body about the feet, swinging the trunk onto the target surface. This requires significant use of the upper extremities making the integrity of the arms and shoulders paramount to a successful transfer. Users of wheelchairs long term reported that the greatest degree of shoulder pain occurred when performing non-level transfers (Curtis and Roach 1995) while one recent study (Barabareshci and Holland 2019) found that 66% of subjects felt that transfer activity exacerbated their underlying shoulder pain. Patients with spinal cord injury frequently suffer from chronic pain resulting from long term use of the upper extremities for weight bearing and the daily demands of mobility propulsion (Brose et al., 2008, Liampas et al., 2021). Users with neuromuscular disorders such as multiple sclerosis, ALS and inclusion body myositis (IBM) often experience upper extremity dysfunction. While lower extremity instability is a hallmark of multiple sclerosis, upper extremity dysfunction may also be present in the form of spasticity, ataxia, tremor, sensory loss, weakness and pain (Bertoni et al., 2015). Patients with inflammatory myopathies such as IBM experience progressive arm weakness while the presence of isolated shoulder weakness has been proposed as a new diagnostic feature of ALS (Hamada et al., 2022). In addition to those with Group 3 PWCs, beneficiaries who use non-Group 3 PWCs may also need to use their shoulders in performing non-level transfers to/from their devices as their underlying conditions progress. Studies have shown that some patients with rheumatoid arthritis, inclusion body myositis, and amputations who use non-Group 3 wheelchairs can decline to the point where they may require wheelchairs for full time mobility. A 5 year follow up study of 732 patients (Young, et al.,2000) with rheumatoid arthritis found that 10% of participants had progressed to requiring wheelchair use and/or home adaptations. Inclusion body myositis classically presents as proximal lower extremity weakness and/or distal arm weakness. In a long-term European study (Benveniste, et al., 2011) of 136 patients found that after a median duration of 14 years from the onset of symptoms, 37% were using wheelchairs. A study of military veterans from the Vietnam-era and recent conflicts with traumatic limb loss (Laferrier, et al. 2010) found that more than half of individuals with lower limb loss used their wheelchairs for mobility despite prosthetic training and years of prosthetic use. The highest rate of prosthetic abandonment occurred in those with transfemoral amputations. A smaller long-term study of Vietnam era veterans (Dougherty 1999) with bilateral transfemoral amputations found that only 22% utilized their prosthetic devices for walking. Elderly persons who have amputations may experience frailty in addition to having comorbid conditions such as cardiovascular disease, and end stage renal disease that make functional ambulation difficult due to its physical demands. A single center retrospective cohort study (Chopra, et al.,2018) found that only 46% of patients who received major lower extremity amputations for vascular disease were ambulatory one year following their procedures. A literature review (Fortington, et al., 2012) found that only 20% of elderly persons with lower extremity amputations were able to maintain household ambulation with their prosthetics long term. Shoulder pain is a common occurrence for persons with lower extremity amputations (Morgan, et al., 2017). In a survey of 255 persons with lower extremity amputations (Ehde, et al., 2000) that included a significant amount of transfemoral amputations, 31% of respondents described persistent shoulder pain. In a study of female users of wheelchairs who played basketball (Curtis, et al., 1999), those with lower extremity amputations averaged a higher shoulder index pain score (WUSPI) twice that of other groups with conditions such as spine bifida and spinal cord injury. A significant factor in the development of the shoulder pain and dysfunction described below is the degree of loading force experienced by the upper extremities during the transfer process. One study (Forslund et al., 2007), investigated the body and arm forces generated by SCI patients, during a non-level transfer of 7cm (2 inches) from a study platform to their personal wheelchair. Of note, the participants had no prior restrictions in their range of motion. The study found that the amount of weight experienced by the upper extremities constituted a significant percentage of their body weight. An early study (Wang et al., 1994) that measured upper extremity reaction forces in healthy volunteers who simulated non-level transfers found that the non-level transfer produced the greatest reaction forces while transfers to level or lower heights produced less force. While non-level transfers serve as obstacles to users of wheelchairs, level transfers make the process easier by minimizing the strain on the upper extremity joints (Wang 1994, Toro 2013). One type of equipment that helps users perform a level transfer is a seat elevation device. A study (Sonenblum et al., 2021) of users of PWCs with seat elevation devices found that the majority of participants used their seat elevation devices to facilitate transfers in a level or downhill fashion. B. Public Comment on Benefit Category Public comments sometimes cite the published clinical evidence and give CMS useful information. Public comments that give information on unpublished evidence such as the results of individual practitioners or patients are less rigorous and therefore less statistically reliable for making a coverage determination. CMS uses the initial public comments to inform its proposed decision. CMS responds in detail to the public comments on a proposed decision when issuing the final decision memorandum. All comments that were able to have personal health information redacted may be viewed in their entirety by using the following link https://www.cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaid=309&ncacaldoctype=all&status=all&sortBy=status&bc=17 Initial Comment Period: August 15, 2022 - September 14, 2022 During the initial 30-day public comment period following the release of the tracking sheet, CMS received 3,601 timely comments. Of these 3,601 comments, 57 were not published on the CMS website due to extensive personal health information content; however, all comments that were in scope and timely were considered for this proposed decision. Seventy-eight comments only discussed topics that are outside the scope of this national coverage analysis. Of the 3,523 in-scope comments, 3,468 supported a benefit category determination of DME for seat elevation equipment for Group 3 PWCs. No commenters indicated an objection to a benefit category determination of DME and 55 commenters did not state a clear position regarding a benefit category determination of DME for seat elevation equipment. Users of Group 3 wheelchairs and their caregivers support benefit category determination of DME for the seat elevation feature for wheelchair transfer purposes to move to and from the bed, toilet, shower, and vehicle. Users of wheelchairs and caregivers found the seat elevation feature useful and beneficial in preventing injuries, reaching items in the home to perform activities of daily living, and communicating with others using eye-to-eye contact. Patient advocacy organizations also support a benefit category determination of DME for seat elevation systems with Group 3 wheelchairs for transfer, reaching, communication purposes in order to foster a greater sense of independence for users of Group 3 wheelchairs. The majority of comments were provided by users of wheelchairs, caregivers and other individuals. Comments were also provided by many advocacy organizations and individual advocates, professional societies and member organizations, state agencies, assistive technology and DME manufacturers and their employees, DME suppliers and their employees, health systems, hospitals, rehabilitation and other healthcare providers, as well as individual healthcare professionals, providers of home and community-based services, and other school and community professionals. Many commenters provided references for our deliberation of this NCA. We very much appreciate this information. All such references were assessed for inclusion in our evidence review. Second Comment Period: February 15, 2023 - March 17, 2023 During the second 30-day public comment period, after the posting of the proposed decision memorandum, CMS received 2,133 timely comments, including one comment from an advocacy organization related to a neurological disease that included an attachment of comments from more than 500 of the association’s members representing individuals and caregivers/family of individuals. Of the 2,133 timely comments, 3 were not published on the CMS website due to extensive personal health information content; however, all comments that were in scope and timely were considered for this decision. Thirty comments only discussed topics that are outside the scope of this national coverage analysis. Of the 2,103 in-scope comments, the vast majority generally supported a benefit category determination of DME for power seat elevation equipment on PWCs. No commenters indicated an objection to a benefit category determination of DME for power seat elevation equipment; and 30 commenters did not state a clear position. Most commenters also discussed other reasons that individuals use seat elevation equipment in addition to transfers. Many also submitted specific recommendations for CMS to make a benefit category determination of DME for power seat elevation equipment based on (1) performing reaching activities, and (2) improving line of sight for safety purposes. Many commenters also discussed seat elevation with respect to reducing cervical spine strain and injury, reductions in strain, injury, time, cost, and/or burden to caregivers (paid and unpaid). The majority of commenters also discussed the physical and mental health or psycho-social benefits of conducting eye-level conversations and having vertical visual access to the world. Many described seat elevation equipment on PWCs as “vital”, “necessary”, “essential”, and not a “convenience item” or “luxury item.” Many spoke in both broad and specific terms about how PWCs and seat elevation equipment provide independence, safety for transfers and daily activities, meaning their use reduces falls and injuries or increases safe functioning in the home and community. Many commenters also discussed PWCs and seat elevation equipment in terms of access and participation in home activities, school, community and employment. Also, many of the commenters shared personal experiences using wheelchairs or shared their experiences as caregivers, family members, friends, neighbors, work and school colleagues and others in their communities. Finally, many commenters discussed the financial costs of PWCs, seat elevation equipment, other required equipment and/or home modifications. The majority of comments were provided by users of wheelchairs, caregivers and other individuals. Comments were also provided by many advocacy organizations and individual advocates. In addition, many comments were provided by health care professional societies and member organizations, state agencies including state Medicaid agencies, assistive technology and wheelchair manufacturers and their employees, DME suppliers and their employees, health systems, hospitals, rehabilitation and other healthcare providers as well as individual healthcare professionals, providers of home and community-based services and other school and community professionals. Many commenters provided references for our deliberation of this NCA. All such references were assessed for inclusion in our evidence review. Comments and Responses: General Comment: We received many comments from individuals who use PWCs as well as their family members, friends, caregivers and advocates. Response: We sincerely thank these commenters for openly sharing with us the challenges of their medical conditions. We have learned a great deal from these comments and are appreciative of the time and effort expended in providing comments. Many of the comments support the clinical literature reviewed by CMS. Powered Wheelchair Groups Comment: Many commenters requested that power seat elevation equipment on Group 2 PWCs be given a benefit category of DME. Some commenters requested that power seat elevation equipment on Group 4 and Group 5 PWCs be given a benefit category of DME. Response: After careful consideration of comments, we have expanded the scope of the proposed benefit category decision to include power seat elevation as DME on all Medicare-covered PWCs, i.e., Groups 2, 3, and 5 (Group 1 PWCs are not able to accommodate seat elevation systems). Our final determination is that power seat elevation equipment used primarily by people with Medicare for assistance in transfers and reaching while in a Medicare-covered power wheelchair meets the Medicare definition of DME. We consider the power seat elevation equipment in these cases to be equipment necessary for the effective use of a power wheelchair classified as DME by section 1861(n) of the Social Security Act, and as such, the equipment necessary for the effective use of the DME would also fall within the benefit category for DME. Note that HCPCS codes for Group 5 power wheelchairs were established to describe pediatric size PWCs for use for patients with a weight of up to 125 pounds which may be covered if it is determined that the PWC is reasonable and necessary for use in the home by the individual with Medicare. Therefore, seat elevation equipment could also be covered if it is considered reasonable and necessary for use with a Medicare-covered Group 5 power wheelchair. HCPCS codes for Group 4 PWCs were established to describe PWCs which are not covered by Medicare because they have performance capabilities not needed for use in the home; therefore, seat elevation equipment, while classified as DME per this NCD, would not be eligible for coverage for use on a PWC base that is non-covered by Medicare. BCD NCD Criteria Comment: Many commenters support the coverage of power seat elevation systems for Group 3 PWCs to carry out various activities outside of the home. Specifically, commenters provided numerous examples of how seat elevation equipment could be beneficial while shopping, crossing the street, accessing elevator buttons, traveling, dining in restaurants, providing child care, providing volunteer services, using public restrooms, and attending church services, concerts, and sporting events, etc. Also, commenters explained how seat elevation could be helpful while receiving medical care in clinical and diagnostic settings. Response: While power seat elevation equipment may be useful in settings outside of the home, it is important to note that section 1861(n) of the Social Security Act defines DME as equipment used in the patient’s home. Whether or not the equipment serves a medical purpose outside the home is not a factor when determining if the equipment is DME for Medicare purposes. As explained in Section IV (Benefit Category Determination), 42 CFR §414.202 of our regulations outlines five criteria that must be met for equipment to be categorized as DME for Medicare purposes, one of which is that the equipment must be appropriate for use in the home. We have determined that power seat elevation equipment on PWCs meets all five criteria and thus is DME. If power seat elevation equipment on a power wheelchair is determined to be medically necessary for use by an individual with Medicare in their home, the individual may also use the equipment outside their home and for nonmedical uses within the home. Comment: One commenter requested clarification for the definition of home with respect to DME. Response: The definition of home refers to a Medicare beneficiary’s dwelling, apartment, relative’s home, home for the aged, or some other type of institution used as the patient’s home other than a hospital or a skilled nursing facility. This definition is provided in detail in Section 110.1 of Chapter 15 of the Medicare Benefit Policy Manual (CMS 100-02). Comment: Several commenters questioned the requirement that an item (i.e., power seat elevation on PWCs) must be for use in the home to be categorized as DME. Response: The statute defines the term “durable medical equipment” to include wheelchairs used in the patient’s home and prohibits payment for items which are not reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member. Payment cannot be made for equipment which is not used for the treatment of illness or injury or to improve the functioning of a malformed body member in the home. Equipment which meets the Medicare definition of DME in regulations at 42 CFR §414.202 and is medically necessary for use by the individual with Medicare in the home may be covered as DME and used by the individual both inside and outside their home. Comment: Many commenters requested that power seat elevation equipment on PWCs serves a medical purpose to aid individuals in performing reaching activities and thus the equipment should be given a benefit category of DME. Response: After careful consideration of comments, our final determination is that power seat elevation equipment used primarily by people with Medicare for assistance in transfers and also for assistance in reaching while in a power wheelchair covered as DME meets the Medicare definition of DME. We consider the power seat elevation equipment in these cases to be equipment necessary for the effective use of a power wheelchair classified as DME by section 1861(n) of the Social Security Act, and as such, the equipment necessary for the effective use of the DME would also fall within the benefit category for DME. Comment: Many commenters requested that power seat elevation equipment on PWCs serves a medical purpose to improve line of sight and thus the equipment should be given a benefit category of DME. Response: We recognize that power seat elevation equipment on PWCs provides many benefits to the user, including that of improving line of sight. However, we believe that this is a common need among many persons and that if the primary purpose of the seat elevation function is to assist a patient in improving line of sight, then the function of that seat elevation would not be presumptively medical in nature. However, if power seat elevation equipment is also capable of assisting a user in making surfaces level for transfers in and out of the power wheelchair or in reaching from an elevated level, which evidence indicates may help eliminate or reduce shoulder pain and injury, such equipment can be considered DME when used on Medicare-covered PWCs. Comment: Many commenters support designation of power seat elevation equipment for Group 3 wheelchairs as DME to provide safe and effective lateral wheelchair transfers to and from the bed, toilet and seating furniture in the patient’s home. Response: We appreciate and agree with the supportive comments. Comment: Many commenters discussed the role that power seat elevation equipment may play in mitigating neck pain. Response: We reviewed two studies (Kovacs 2018, Llampas 2021) that illustrated that neck strain is common i