These comments are being submitted on behalf of the national, consumer-led coalition known as the “ITEM” Coalition, an acronym for Independence Through Enhancement of Medicare and Medicaid. The ITEM Coalition was formed in 2003 and its 74 member organizations include a diverse set of disability organizations, aging organizations, other consumer groups, labor organizations, voluntary health association, and non-profit provider associations.

The ITEM Coalition’s purpose is to raise awareness and build support for policies that will improve access to assistive devices, technologies, and related services for people of all ages with disabilities and chronic conditions. From coverage for hearing aids to augmentative communications devices (AACs) to advanced artificial limbs to screen readers for people with vision impairments, the Coalition’s mission is a broad one with implications for virtually every person with a disability who relies on assistive devices to be healthy, functional, and independent.

The ITEM Coalition appreciates this opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) as the agency begins its internal process of developing clear guidelines for Medicare coverage of mobility devices, including manual wheelchairs, power wheelchairs, and power operated vehicles (POVs). We commend CMS for its commitment to seek input from knowledgeable and experienced clinicians that work within relevant government agencies. We are also pleased to see that CMS is seeking input from clinicians outside of government with practical knowledge acquired from serving wheelchair users as well as researchers that focus on critical health care issues that affect people with mobility impairments. Other stakeholders, such as beneficiaries and other disability/consumer groups, also play a vital role and we are grateful that CMS has provided a mechanism for this input as well.

The ITEM Coalition has several clinical organizations as members such as the American Academy of Physical Medicine and Rehabilitation (“AAPM&R”), the Rehabilitation Engineering and Assistive Technology Society of North America (“RESNA”), the American Academy of Neurology (“AAN”), the American Physical Therapy Association (“APTA”), and the American Occupational Therapy Association (“AOTA”). Several of the clinically-oriented ITEM Coalition member organizations intend to provide the substantive clinical recommendations that CMS has requested to assist in modifying or clarifying its mobility device coverage policy. Our comments, therefore, will focus on recommendations that impact the process of reviewing and revising the Medicare mobility device coverage policies as well as some of the ITEM Coalition’s principles that CMS should consider during this process.

Process

The ITEM Coalition Encourages CMS to Ensure that this Process is Open, Accessible and Transparent.

We realize that this Open Door Forum is not realistically an occasion for definitive answers from CMS to our many questions regarding the Medicare mobility device benefit, but rather an opportunity to begin a process of genuine dialogue between clinicians, beneficiaries, and CMS officials. It is our recommendation that:

• CMS host several regularly scheduled Open Door Forums throughout the remainder of the year as the agency moves closer to issuing modifications and further guidance on the Medicare mobility device benefit;

• CMS schedule a separate Open Door Forum on the “in the home” requirement within the DME benefit to explore how this restriction can be eliminated or modified to ensure that mobility device coverage criteria are clinically appropriate for beneficiaries;

• CMS should meet with and seek input from outside clinical experts and beneficiary organizations to continue a dialogue in developing guidance on coverage policies for mobility devices.

• CMS should publicly disclose the contact information for the Interagency Working Group scheduled to be announced today, so that interested parties throughout the country can provide input despite their inability to participate in the Open Door Forum(s); and that

• CMS should release to the public drafts of their revised policies and institute a formal comment period to allow thoughtful input from clinicians and other stakeholders.

It is only through an open, transparent process that the difficult aspects of the Medicare mobility device benefit will be resolved to the satisfaction of all parties.

Fraud and Abuse in the Medicare Mobility Device Benefit

The ITEM Coalition Urges CMS Not to Restrict Coverage in its Attempt to Fight Fraud and Abuse in the Medicare System.

The ITEM Coalition understands the difficulty of crafting a coverage policy that strikes a balance between the legitimate needs of the program to protect against fraud and abuse while at the same time providing the most appropriate mobility device to the beneficiary. However, we are concerned that in light of Operation Wheeler Dealer, CMS is being driven by budgetary issues first and foremost rather than attempting to address beneficiary needs by targeting the right device for the right person. The critical goals of ensuring beneficiary health, independence and functional capacity appear to be secondary to the goal of achieving savings in the Medicare system.

The ITEM Coalition is strongly behind CMS and the HHS OIG in their attempts to purge fraudulent activities from the Medicare mobility device benefit, for every dollar spent on fraudulent activity is a dollar that cannot be spent to meet the legitimate needs of beneficiaries. But there are alternate and more effective ways to reduce fraudulent payments for wheelchairs than to restrict access to these devices and reject coverage for new and emerging mobility technologies that offer great promise to Medicare beneficiaries with mobility impairments.

We commend CMS for stating its interest in creating new and more comprehensive billing codes. The current codes have become seriously outdated and we believe that improved differentiation between models, amenities, and capabilities of mobility devices will lead to better benefit customization and a reduction of unnecessary expenditures for the program. If Medicare begins to view the mobility device benefit as a more comprehensive, holistic, preventative and community-oriented benefit, Medicare will undoubtedly see more healthy and independent beneficiaries who require less medical assistance, personal care, and, ultimately, Medicare expenditures.

ITEM Coalition Principles

The “In-the-Home” Requirement

The ITEM Coalition Strongly Recommends that CMS Eliminate or Modify the “in the home” Criterion for Determining Coverage of Mobility Devices.

The “in the home” restriction appears in the Medicare statute but the interpretation of this statutory language has been subject to significant controversy.1 The restriction was originally intended to define DME as devices that were provided outside of an institution such as a hospital or skilled nursing facility (“SNF”) and, therefore, warranted separate reimbursement under Medicare Part B. Unfortunately, over the years, this regulation has been interpreted to restrict coverage only to DME that is reasonable and necessary within the four walls of the beneficiary's home. Whether a mobility device is considered reasonable and necessary in the home turns on the question of whether the beneficiary is “bed or chair confined” (i.e. non-ambulatory).

The “in the home” requirement, as interpreted by CMS over the years, is an antiquated restriction, reminiscent of a time when people with disabilities were not expected to leave the home and participate in society. By confining the medical necessity inquiry to inside the home only, the Medicare coverage policy fails to provide adequate access to a substantial number of individuals who are unable to participate in activities of daily living that routinely occur in the community. Consideration of an individual’s need to access his or her physician’s office, pharmacy, grocery store, or church should be incorporated into Medicare’s coverage determination process as these constitute a set of reasonable and necessary medical and functional needs.

According to the Medicare Rights Center’s March 16, 2004 report, Forcing Isolation: Medicare’s “In the Home” Coverage Standard for Wheelchairs, by contemporary legal standards, the “in the home” restriction is inappropriate and quite possibly unlawful. During the past thirty years, Congress has had an increasing commitment to community integration of persons with disabilities. First, the Rehabilitation Act of 1973, 29 U.S.C.A. § 794, prohibits discrimination against people with disabilities by executive agencies, programs receiving federal financial assistance, and the U.S. Postal Service. Regulations promulgated under this section mandate that “[r]ecipients shall administer programs and activities in the most integrated setting appropriate to the needs of qualified handicapped persons.”2 Second, in 1990, a Congress enacted the Americans With Disabilities Act, intending to “provide a clear and comprehensive national mandate for the elimination of discrimination against individuals with disabilities.”3 Court cases under the ADA and the Rehabilitation Act support the principle that individuals with disabilities be provided with the necessary supports to live as independently as possible in their communities.

The US Supreme Court’s landmark decision, Olmstead v. L.C. ex rel. Zimring,4 enunciates many of these principles In that case, two women with mental disabilities challenged the state’s refusal to treat them in community-based settings although their needs could be met in one of the states’ community based programs. The Supreme Court concluded that the ADA prohibits “unjustified institutional isolation of persons with disabilities.” The Court based its decision, in part, on its understanding that “institutional placement of persons who can handle and benefit from community settings perpetuates unwarranted assumptions that persons so isolated are incapable or unworthy of participating in community life.”5

Further, enactment of the Ticket to Work and Work Incentives and Improvement Act (TWIIA) provided further support for the federal government to reassess its policies with respect to Medicare’s “in the home” rule. TWIIA is designed to extend Medicare coverage to an SSDI beneficiary who attempts to return to work and leave the SSDI income maintenance program. But without a mobility device that is appropriate for outside the four walls of one’s home, the goals of TWIIA may not be realized. Additionally, President Bush’s “New Freedom Initiative” supports the notion that individuals with disabilities be provided with the necessary supports to live as independently as possible in their communities.

Finally, no other federal health program (i.e. Veteran’s Administration, Federal Employee Health Benefit Program, TRICARE) has a in-the home requirement or has a policy as restrictive and, as interpreted, overtly dismissive of the beneficiary’s need to participate in activities of daily living outside the home through the use of wheeled mobility. Additionally, no other Medicare benefit has an “in the home requirement.” For example, the Medicare lower limb prosthetic device benefit categorizes beneficiaries based on their functional capabilities and potential, both inside and outside the home.

It is for these reasons that the ITEM Coalition recommends that CMS hold an entirely separate Open Door Forum to discuss the clinical implications of the “in the home” policy. CMS has requested clinical input on Medicare’s mobility device benefit, but appropriate clinical guidance simply cannot be promulgated until the “in the home” rule is addressed. It is an artificial construct that has been interpreted by CMS in a way that it serves the primary purpose of limiting utilization of the mobility device benefit and thwarting the beneficiary’s ability to access the most reasonable and necessary mobility device for the particular needs of the individual.

While we understand that the “in the home” language derives from the Medicare statute, we believe that CMS has the authority to reinterpret the “in the home” criterion. For instance, CMS could simply redefine the “in the home” restriction more broadly to include activities outside the four walls of the “home.” CMS should consider interpreting “in the home” to simply mean a non-institutional setting, thereby permitting physicians and other clinicians to take into account the ability of the individual to participate in activities outside the home when determining whether a particular mobility device is reasonable and necessary.

The ITEM Coalition looks forward to working with CMS and clinicians in either redefining a more appropriate interpretation of the “in the home” rule or, ideally, creating a new coverage policy that values community participation, recognizes activities of daily living, and meets the real-life, daily needs of Medicare beneficiaries with mobility impairments. Either way, we urge CMS to place significant emphasis on the independence and community involvement of Medicare beneficiaries when assessing coverage for mobility devices. The current policy essentially fosters dependence for Medicare beneficiaries with disabilities and is, therefore, in need of review and revision.

Functional Maintenance and Improvements

The ITEM Coalition strongly recommends that CMS make functional maintenance and improvement the basis for the medical necessity determination.

Functional maintenance and improvement should be the basis for the structure of the medical necessity determination in Medicare’s wheeled mobility benefit. The benefit should not be structured around disease categorization or any other general configuration that fails to individually address the beneficiary’s prognosis, functional abilities and limitations, and functional goals. Functional assessments should be required for those interested in a power wheelchair prescription and specific criteria for these functional assessments should be developed by qualified clinicians.

Incorporation of functionality allows for an individualized and fluid benefit that has the ability to incorporate an increased emphasis on physician assessments, functional potential, and the beneficiaries’ goals. Medicare’s benefit for general DME, and specifically mobility devices, should be flexible enough that as new innovations become available, Medicare is able to provide its beneficiaries with these products and in turn continually improve the individuals’ functional capabilities and expectations.

There are several federal programs that the Interagency Wheelchair Work Group might look to for initial guidance. For example, in 2001, the TRICARE program redefined its DME benefit to include functionality. The new language includes coverage for “any durable medical equipment that can improve, restore, or maintain the function of a malformed, diseased, or injured body part, or can otherwise minimize or prevent the deterioration of the patient’s function or condition.”6 Additionally, the statute also specifies coverage for “any durable medical equipment that can maximize the patient’s function consistent with the patient’s physiological or medical needs.”7 Additionally, as stated before, the agency might look inward at it lower limb prostheses benefit which creates levels of beneficiary functional potential and grants prostheses bases on such functional assessments.8 Further, current Medicare policy for therapy and rehabilitation services recognizes that medically reasonable and necessary treatment for patients may include services to prevent decline and maintain or improve function for patients. For example, in the home health context, therapy will be covered if it is “reasonable and necessary to the treatment of the patient's illness or injury or to the restoration o[r] maintenance of function affected by the patient's illness or injury.”9

Recognizing functional maintenance and improvement in medical necessity determinations makes sense from a clinical perspective. It is not uncommon for individuals with debilitating conditions to physically deteriorate and lose a significant amount of functional capabilities in a short amount of time. The clinicians present at this forum and on the phone could more aptly attest to the difficulties such patients progressively experience. However, it clearly seems reasonable to prescribe such individuals the available assistive technology that will help them maintain a somewhat constant level of mobility and independence, despite disease progression. Additionally, it seems logical to provide coverage to individuals who could significantly improve their functional capabilities with available assistive devices.

Further, recognizing a person’s ability to maintain function in medical necessity determinations will also allow the agency to take into account the risk of injury and secondary medical conditions. Conditions with waxing and waning symptoms such as multiple sclerosis or other neurological or musculoskeletal conditions can put individuals at great risk for accidents and falls.

Additionally, many Medicare beneficiaries develop injuries secondary to long term manual wheelchair use. Many clinical studies have shown that prolonged manual wheelchair use is a major factor in the high incidence of secondary injuries to the upper limbs among wheelchair users, resulting in shoulder, elbow, and/or wrist pain.10 These injuries are predictable, avoidable, and costly to address medically once they manifest themselves. Unlike most injuries, injuries to the upper limbs among manual wheelchair users are both relatively predictable and avoidable. The injuries are predictable because incidence of upper limb pain has been directly correlated with the time of use of the wheelchair.11

Additionally, it is known that certain patient populations, such as tetraplegics and quadriplegics, individuals with degenerative neurological conditions, and individuals with poliomyelitis, are at an increased risk of experiencing upper limb pain due to manual wheelchair use.12 Accordingly, the research supports increasingly prescribing power wheelchairs to individuals with a high risk of upper limb pain due to prolonged manual wheelchair use.

Those individuals able to use manual wheelchairs should not automatically be excluded from obtaining a power wheelchair and their risk for injury and secondary conditions should be measured. The consideration of secondary conditions associated with poor access to assistive technology and devices is an absolutely necessary aspect of the reevaluation of Medicare’s power wheelchair benefit and completely in the interest of both beneficiary and Medicare provider.

Again, the ITEM Coalition is grateful for this opportunity and looks forward to working with CMS to develop an appropriate and comprehensive wheelchair, power wheelchair and POV coverage benefit under Medicare.

Sincerely,

Henry Claypool Advancing Independence: Modernizing Medicare and Medicaid ITEM Coalition Steering Committee Member		Peter W. Thomas Consortium for Citizens with Disabilities Health Task Force ITEM Coalition Steering Committee Member
Paul W. Schroeder American Foundation for the Blind ITEM Coalition Steering Committee Member		Lee Page Paralyzed Veterans of America ITEM Coalition Steering Committee Member
Kim Glaun Medicare Rights Center ITEM Coalition Steering Committee Member

1. 42 C.F.R. § 414.202. The “In the Home” requirement is not applicable to orthotics, prosthetics, or supplies.

2. 28 C.F.R. § 41.51.

3. 42 U.S.C. § 12101(b)(1).

4. 527 U.S. 581, 600 (1999).

5. Id. at 600.

6. 10 USC § 1077(f)(A)

7. 10 USC § 1077(f)(B)

8. Soc. Secur. Act § 1862(a)(I)(A); 42 USC §1395y(a)(I)(A).

9. Medicare Home Health Manual § 205.2.

10. Pentland, W. E. and Twomey, L. T., Upper Limb Function in Persons with Long Term Paraplegia and Implications for Independence: Part I, Paraplegia 32: 211-18 (1994) (finding the following pain prevalence among paraplegics: shoulder 39%, elbow 31%, and wrist/hand 40%); Cooper, Rory A., et al., Research on Physical Activity and Health Among People with Disabilities: a Consensus Statement, J. Rehabil. Res. Dev. 36(2): 142-54 (1999) (“Manual wheelchair users are particularly susceptible to rotator cuff tears, lateral epicondylitis, and cubital tunnel or carpal tunnel neuropathies due to micro-injury caused by the repetitive motions required to propel themselves.”); Dalyan M., et al., Upper Extremity Pain After Spinal Cord Injury, Spinal Cord 37(3): 191-5 (1999) (based on study of patients with spinal cord injury, 71% reported shoulder pain, 53% wrist pain, 43% hand pain, and 35% elbow pain).

11. Nichols, P.J.R., et al., Wheelchair User’s Shoulder?, Scand. J. Rehabil. Med. 11: 29-32 (1979) (“One-third had at least one attack of cervico-brachial pain within one year. The frequency [and] duration of the attack tending to increase as time passes. . . . After ten years, 54% have cervico-brachial pain.”)

12. Curtis, Kathleen, et al., Shoulder Pain in Wheelchair Users with Tetraplegia and Paraplegia, Arch. Phys. Med. Rehabil. 80: 453-57 (1999) (“In the current cross-sectional study, both the prevalence and intensity of shoulder pain during the performance of functional activities was significantly higher in subjects with tetraplegia than in subjects with paraplegia.”); Pentland, W. E. & Twomey, L. T., Upper Limb Function in Persons with Long Term Paraplegia and Implications for Independence: Part II, Paraplegia. 32: 219-24 (1994) (“Wheelchair users whose extremities are already compromised by weakness and muscle imbalance (e.g. quadriplegia, poliomyelitis, degenerative neurological conditions) may be especially at risk [for upper limb pain].”).