These comments are submitted on behalf of a 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 groups, aging organizations, consumer groups, labor organizations, voluntary health associations, 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 communication 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.

There is a great demand and increasing need for assistive technology within the disability and aging communities. According to the National Institute on Disability and Rehabilitation Research (NIDRR), in 2001 over 15 million Americans with disabilities reported using assistive devices or technologies.1 AARP conducted a survey in 2003 in which they found that a third of persons 50 and over use some type of special equipment or assistive technology in their daily activities. However, the same survey found that almost one-quarter of persons 50 and older with disabilities who do not use any special equipment, feel that equipment such as a hearing aid, wheelchair, cane, or walker would improve their lives.2

We appreciate the opportunity to submit comments to the ICDR as it considers the future of disability-related research and development and would like to focus our remarks exclusively on the mission of our coalition; improving access to assistive devices, technologies and related services. In fact, we believe it is critical to have a strong federal investment in assistive technology research as well as proactive federal coordination of assistive technology research and development among the federal agencies that support disability and rehabilitation research. While many of the federal agencies that are represented on the IDCR have played a major role in assistive technology research efforts to date, in our view, the time has come for the ICDR to take the lead to ensure that further progress is made. The ITEM Coalition has three major recommendations:

1. Building the Foundation for Assistive Technology Coverage

With “evidence-based practice” becoming the predominant method that health programs and plans use to determine which medical interventions, drugs, and technologies to cover and make available to people who need them, the need has never been greater to focus federal research attention on comparative studies that assess the efficacy of various assistive devices and technologies. There are literally hundreds of prosthetic feet on the market today, dozens of wheelchairs designs, numerous types of hearing aids, and hundreds of assistive “technologies” that may be of benefit to people with disabilities. Unfortunately, the efficacy of these devices is more often defined by the manufacturers’ marketing materials than by objective assessments and comparative data. Consumers, health programs and plans, and other disability payers are left with little choice but to select assistive devices based on incomplete and often inaccurate information and to pay for devices and technologies that may prove through trial and error to be largely ineffective for the treatment of a particular functional deficit.

Third party payers are responding by demanding clinical studies and objective data that demonstrate the efficacy and value of assistive devices before such devices are covered and reimbursed. However, the Food and Drug Administration requires a much lower level of objective data than new medications or internal implants in order to determine whether assistive devices are “safe and effective” for entrance to the marketplace. This is because assistive devices and technologies are, for the most part, external to the human body and not invasive. As such, companies that bring assistive technologies to the market often do not have extensive, objective data on the efficacy of their devices, prompting prospective third party payers to reject coverage. This creates a regressive cycle, as the lack of a funding stream for commercial development tends to discourage private investment in assistive devices from the outset. In addition, because of the often small populations served by specific assistive devices, there is seldom the potential for a large payoff for extensive research and development activities.

This scenario speaks to the need for the federal government to support research centers that are specifically designed to assess and compare the efficacy of existing and new assistive devices. By providing consumers and potential payers with objective, measurable data about various types of assistive devices and technologies, these research centers could have a tremendous impact on the types of assistive devices that health care plans and other third party payers cover. In this manner, resources could be concentrated on those assistive technologies that make the greatest clinical impact on the functional improvement of people with disabilities and chronic conditions and, consequently, resources could be freed to expand coverage to additional types of assistive devices.

2. Increasing Federal Support for Assistive Technology Research

For many of the same reasons that the federal government should support centers to assess the efficacy of assistive devices, it should also devote additional resources to funding research and development activities to improve assistive devices and technologies. While development of innovative assistive technologies is absolutely essential, federal funding should also be available to assist companies in bringing promising technologies to the market through contracts and other funding mechanisms. It is only when innovative assistive technologies are in the hands of end users that the value of the federal investment in these devices is realized.

Research is needed to ensure that new and innovative assistive technologies are adopted and actually used by potential users. A high percentage of assistive devices are rejected by potential users due to the lack of appropriate training. There are other reasons that people with disabilities reject assistive devices, especially older individuals. Basic market research is needed to assess the level of acceptance and rejection of various assistive technologies amongst differing populations. In the workplace, research is needed to identify new adaptive technologies that will increase the success rate of people with disabilities entering and remaining in the workforce.

One of the primary ways of developing innovative assistive technologies is through technology transfer. The Interagency Subcommittee on Technology Transfer has the specific mission of “facilitating assistive technology transfer from the laboratory to the marketplace.” We commend the ICDR for recognizing the need for this type of research and creating a subcommittee with these responsibilities. Technology transfer has yielded some important developments in prosthetics such as lightweight and strong material applications. It has also played a role in the development of other important assistive devices, but the full potential for technology transfer has not yet been realized.

3. Development of a Research Agency Design to Meet Consumer Need

It is clear that the ICDR recognizes the complex nature of rehabilitation and disability research as it has also established subcommittees on technology, disability statistics, medical rehabilitation, and the New Freedom Initiative. Greater coordination between these aspects of rehabilitation and disability research is necessary to maximize progress in this area. We believe the ICDR is capable of creating an environment that fosters collaboration while influencing disability research to become more focused on outcomes identified by consumers.

While the needs of consumers should be the driving force behind the federal government’s disability and rehabilitation research agenda, another dimension warrants consideration. Those in the private sector that bring assistive technologies to market should reflect upon and coordinate their research priorities with those of the federal government so that assistive technologies and related services play as meaningful role a role as possible in the lives of people with disabilities of all ages. To begin this process, we suggest that ICDR take a leadership role in bringing together stakeholders and representatives from the research, disability, and private sectors to work together to develop a road map that addresses the various perspectives of these essential groups.

In conclusion, the ITEM Coalition commends the ICDR for its commitment to improving the lives of people with disabilities of all ages. The ITEM Coalition shares this enthusiasm, particularly in the area of the ever-changing field of assistive technology research and development. We hope you will use the ITEM Coalition and its members as resources in your work.

Thank you again for this opportunity to present our views and please feel free to contact us at 202-349-4260.

Sincerely,

Henry Claypool Advancing Independence: Modernizing Medicare and Medicaid ITEM Coalition Steering Committee Member		Paul W. Schroeder American Foundation for the Blind ITEM Coalition Steering Committee Member
Peter W. Thomas Consortium for Citizens with Disabilities Health Task Force 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. Carlson, D., Ehrlich, N., Berland, B.J., and Bailey, N., Assistive Technology Survey Results: Continued Benefits and Needs Reported by Americans with Disabilities, National Institute on Disability and Rehabilitation Research, 2001.

2. AARP, Beyond 50.03: A Report to the Nation on Independent Living and Disability, 2003 (using data collected as part of AARP/Harris Interactive Survey of Persons Age 50+ with disabilities, 2002).